HK1171932B - Biopsy device - Google Patents

Abstract

The present invention relates to a biopsy device with motorized needle cocking. A needle may be fired into tissue by a needle firing mechanism, which may include a fork for holding the needle and a firing rod coupled with the fork. A spring urges the fork to a distal, fired position. A screw gear is coupled with the rod. A sled is positioned at the proximal end of the rod. A catch is configured to engage the sled when the sled is moved to a proximal position. The screw gear is operable to convert rotational motion from a motor and gear set into linear motion to move the rod proximally to engage the sled with the catch, thereby cocking the needle firing mechanism. The motor may also be used to translate the screw gear distally relative to the rod after the sled has engaged with the catch. A trigger is used to fire the cocked needle firing mechanism.

Description

Biopsy device

The present application is a divisional application of an invention patent application entitled "biopsy device with component having electric pre-firing needle" having a priority date of 2007 at 20/11/2007, an application date of 2008 at 20/11, and an application number of 200810176677.5.

Technical Field

The invention relates to a biopsy device.

Background

Biopsy samples have been obtained in a variety of ways during various medical procedures using a variety of devices. These biopsy devices are used under the guidance of stereotactic guides, ultrasound guides, magnetic resonance imaging guides, or other guides. Biopsy devices, by way of example only, are disclosed in the following documents: U.S. Pat. No.5,526,822, entitled "method and Apparatus for Automated Biopsy and Collection of Soft Tissue", published at 18.6.1996; U.S. patent No.6,086,544 entitled "Control Apparatus for an Automated scientific Biopsy Device" issued at 11.7.2000; U.S. patent application publication No.2003/0109803 entitled "MRICompatible scientific Biopsy Device" published on 12.6.2003; U.S. patent application publication No.2007/0118048 entitled "Remote thumb for a scientific Biopsy Device" published 24/5/2007; U.S. provisional patent application entitled "Biopsy System" and Ser. No.60/869,736, filed on 13.12.2006; U.S. provisional patent application entitled "Biopsy Sample Storage" filed on 13.2006, serial No.60/874,792. The disclosure of each of the above-mentioned U.S. patents, U.S. patent application publications, and U.S. provisional patent application documents is incorporated herein by reference. While various systems and methods have been made and used to obtain biopsy samples, it is believed that no one prior to the inventors has made or used the invention defined in the appended claims.

Disclosure of Invention

The invention specifically relates to the following:

(1) a biopsy device, wherein the biopsy device comprises:

(a) a needle having a tissue piercing tip and a transverse bore proximal to the tip;

(b) a cutter configured to cut tissue protruding through the aperture;

(c) a body portion, wherein the needle is longitudinally movable relative to the body portion; and

(d) a needle firing mechanism, wherein the needle firing mechanism comprises a motor operable to proximally retract the needle relative to the body portion.

(2) The biopsy device of (1), wherein the needle firing mechanism further comprises a helical gear coupled to the motor and the needle, wherein the motor is operable to retract the needle proximally relative to the body portion by rotating the helical gear.

(3) The biopsy device of (1), wherein the needle firing mechanism further comprises a resilient member, wherein the resilient member is biased to distally advance the needle when the needle is in a proximal position.

(4) The biopsy device of item (3), wherein the resilient member comprises a coil spring.

(5) The biopsy device of item (1), further comprising a fork connected to a firing bar, wherein the fork engages the needle to move the needle longitudinally.

(6) The biopsy device of (5), wherein the firing bar is spring loaded to distally advance the fork and the needle.

(7) The biopsy device of item (1), wherein the body portion comprises a probe portion and a holster portion, wherein the probe portion is removably secured relative to the holster portion.

(8) The biopsy device of (7), wherein the needle extends from the probe portion and the needle firing mechanism is located in the holster portion.

(9) The biopsy device of item (1), wherein the needle firing mechanism comprises a sled configured to move with the needle.

(10) The biopsy device of (9), wherein the needle firing mechanism further comprises a catch, wherein the catch is configured to selectively engage the sled when the sled is moved to the proximal position.

(11) The biopsy device of (10), further comprising a resilient member configured to distally advance the needle, wherein the sled and the catch are configured to maintain a proximal position of the needle even when the resilient member is pressed distally.

(12) The biopsy device of (11), wherein the resilient member is configured to distally fire the needle when the sled is disengaged from the catch.

(13) The biopsy device of (9), further comprising a trigger mechanism, wherein the trigger mechanism is operable to disengage the slider from the catch.

(14) The biopsy device of item (1), further comprising a trigger component operable to activate the motor to retract the needle proximally, readying the firing mechanism for firing.

(15) The biopsy device of item (1), further comprising a trigger mechanism coupled to the needle firing mechanism, wherein the trigger mechanism is operable to fire the needle from a proximal position to a distal position.

(16) The biopsy device of (15), wherein the trigger mechanism comprises a lever and a button, wherein the trigger mechanism is operable to fire the needle from a proximal position to a distal position upon actuation of the lever and the button by a user.

(17) The biopsy device of (1), wherein the needle firing mechanism further comprises a movable member coupled to the motor, wherein the movable member is operable to apply pressure proximally to the needle, wherein the motor is further configured to move the movable member distally after the needle reaches the proximal position.

(18) A biopsy device, wherein the biopsy device comprises:

(a) a needle having a tissue piercing tip;

(b) a cutter configured to cut tissue in the needle;

(c) a body portion, wherein the needle is longitudinally movable relative to the body portion; and

(d) a needle firing mechanism, wherein the needle firing mechanism comprises:

(i) a spring biased to advance the needle distally relative to the body portion;

(ii) a motor operable to retract the needle proximally relative to the body portion against the urging of the spring.

(19) The biopsy device of (18), further comprising a trigger member coupled to the needle firing mechanism, wherein the trigger member is operable to activate the motor to retract the needle proximally, wherein the trigger member further comprises a trigger member operable to fire the needle distally under advancement of the spring.

(20) A method for firing a biopsy needle into tissue, the method comprising:

(a) providing a biopsy device comprising:

(i) a needle having a tissue piercing tip;

(ii) a cutter configured to cut tissue, wherein the cutter is movable relative to the needle;

(iii) a body portion, wherein the needle is longitudinally movable relative to the body portion;

(iv) a needle firing mechanism, wherein the needle firing mechanism comprises a motor operable to retract the needle proximally relative to the body portion; and

(v) a user input component operable to activate the needle firing mechanism to fire the needle distally;

(b) positioning the biopsy device near a target site of a patient;

(c) activating the motor to proximally retract the needle; and

(d) engaging the user input component to fire the needle distally.

Drawings

While the specification concludes with claims particularly pointing out and distinctly claiming the invention, it is believed that the present invention will be better understood from the following description of certain embodiments taken in conjunction with the accompanying drawings, in which like reference numerals identify like elements, and wherein:

FIG. 1 depicts a schematic diagram of an exemplary biopsy system;

FIG. 2 depicts a perspective view of an assembled exemplary biopsy device for use with a stereotactic apparatus;

FIG. 3 depicts an exploded view of the biopsy device of FIG. 2 with the probe detached from the holster;

FIG. 4 depicts a perspective view of an assembled exemplary biopsy device for use with an ultrasound apparatus;

FIG. 5 depicts an exploded view of the biopsy device of FIG. 4 with the probe detached from the holster;

FIG. 6 depicts a perspective view from above of the probe portion of the biopsy device of FIG. 3;

FIG. 7 depicts a perspective view from below of the probe portion of FIG. 6;

FIG. 8 depicts a perspective view of the probe portion of FIG. 6 from above with the top cover removed;

FIG. 9 depicts a perspective view from below of the probe portion of FIG. 6 with the base removed;

FIG. 10 depicts a side cross-sectional view of the probe portion of FIG. 6 along a longitudinal plane;

FIG. 11 depicts a perspective view of the needle component elements of the probe portion of FIG. 6;

FIG. 12 depicts a partial perspective view of the probe portion of FIG. 6, showing a needle hub assembly (needle hub assembly);

FIG. 13 depicts a partial perspective view of the probe portion of FIG. 6 showing the needle hub assembly with the needle manifold removed;

FIG. 14 depicts a partial cross-sectional view, taken along a longitudinal plane, of the cutter rotation and movement mechanism of the probe portion of FIG. 6;

fig. 15 depicts a front perspective view of an exemplary tissue sample holder;

fig. 16 depicts the tissue sample holder of fig. 15 with the cups and other components removed;

FIG. 17 depicts the tissue sample holder of FIG. 15 with the tissue sample tray removed;

FIG. 18 depicts a rear view of the tissue sample holder of FIG. 15;

fig. 19 depicts a rear view of the tissue sample holder of fig. 15 with the cups and other components removed;

FIG. 20 depicts a perspective view of the engagement member;

FIG. 21 depicts an exploded view of the applicator and the tissue sample holder of FIG. 15;

FIG. 22 depicts a perspective view of the applier of FIG. 21 inserted into the tissue sample holder of FIG. 15;

FIG. 23 depicts a perspective view of the holster of the biopsy device of FIG. 2;

FIG. 24 depicts a top view of the rack of FIG. 23 with the top cover removed;

FIG. 25 depicts a side view of the frame of FIG. 23 with the side panel removed;

FIG. 26 depicts another side view of the rack of FIG. 23 with the side panel removed;

FIG. 27 depicts a partial view of the holster of FIG. 23, showing an exemplary needle rotation mechanism;

FIG. 28 depicts a partial view of the frame of FIG. 23, showing an exemplary needle firing mechanism;

FIG. 29 depicts a partial view of the frame of FIG. 23, showing an exemplary needle firing mechanism in a cocked configuration;

FIG. 30 depicts a partial view of the holster of FIG. 23, showing an exemplary cutter drive mechanism;

fig. 31 depicts a partial view of the gantry of fig. 23, showing an exemplary tissue holder rotation mechanism;

fig. 32 depicts another partial view of the gantry of fig. 23, showing an exemplary tissue holder rotation mechanism;

FIG. 33 depicts a perspective view from below of the probe portion of the biopsy device of FIG. 4;

FIG. 34 depicts a perspective view from above of the probe portion of FIG. 33 with the top cover removed;

FIG. 35 depicts a perspective view from below of the probe portion of FIG. 33 with the base removed;

FIG. 36 depicts a partial perspective view of the probe portion of FIG. 33 showing a needle hub assembly;

FIG. 37 depicts a partial perspective view of the probe portion of FIG. 33 showing the needle hub assembly with the needle manifold removed;

fig. 38 depicts a front perspective view of an exemplary tissue sample holder with the cups and other components removed;

FIG. 39 depicts the tissue sample holder of FIG. 38 with the tissue sample tray removed;

fig. 40 depicts a rear view of the tissue sample holder of fig. 38 with the cups and other components removed;

FIG. 41 depicts a front perspective view of the holster of the biopsy device of FIG. 4;

FIG. 42 depicts a rear perspective view of the stand of FIG. 41;

FIG. 43 depicts a top view of the rack of FIG. 41 with the top cover removed;

FIG. 44 depicts a partial view of the holster of FIG. 41, showing an exemplary cutter drive mechanism;

FIG. 45 depicts a partial view of the holster of FIG. 41, showing an exemplary tissue holder rotation mechanism;

FIG. 46 depicts a perspective view of an example vacuum control module and an example vacuum canister;

FIG. 47 depicts the vacuum control module of FIG. 46 with the vacuum canister of FIG. 46 separated therefrom;

FIG. 48 depicts a perspective view of the vacuum canister of FIG. 46;

FIG. 49 depicts a top view of the vacuum canister of FIG. 46;

FIG. 50 depicts a top view of the vacuum canister of FIG. 46 with the tube engaged with the top of the vacuum canister;

FIG. 51 depicts a cross-sectional view along a longitudinal plane of the vacuum canister shown in FIG. 46;

FIG. 52 depicts a rear perspective view of the vacuum control module of FIG. 46;

FIG. 53 depicts the vacuum control module of FIG. 46 with the housing removed;

FIG. 54 depicts a perspective view of the vacuum tank port assembly of the vacuum control module of FIG. 46;

FIG. 55 depicts a front view of the vacuum tank port assembly of FIG. 54;

FIG. 56 depicts a rear view of the vacuum tank port assembly of FIG. 54;

FIG. 57 depicts a cross-sectional view of the vacuum tank port assembly of FIG. 54;

FIG. 58 depicts a cross-sectional view of the vacuum canister port assembly of FIG. 54 with the vacuum canister of FIG. 46 inserted therein;

FIG. 59 depicts a perspective cross-sectional view of an exemplary tube;

FIG. 60 depicts a schematic flow diagram showing an exemplary rotation sequence of a tissue sample holder;

FIG. 61 depicts an exemplary sequence of the position of the cutter within the cannula relative to the fluid communication provided by the lateral and axial vacuum tubes in an exemplary "sample" cycle;

FIG. 62 depicts an exemplary sequence of the position of the cutter within the cannula relative to the fluid communication provided through the lateral and axial vacuum tubes in an exemplary "clean probe" cycle;

FIG. 63 depicts an exemplary sequence of the position of the cutter within the cannula relative to the fluid communication provided through the lateral and axial vacuum tubes in an exemplary "position" cycle;

FIG. 64 depicts an exemplary sequence of the position of the cutter within the cannula relative to the fluid communication provided by the lateral and axial vacuum tubes in an exemplary "aspiration" cycle;

FIG. 65 depicts an exemplary sequence of the position of the cutter within the cannula relative to the fluid communication provided by the lateral and axial vacuum tubes in an exemplary "Smart vacuum" cycle;

FIG. 66 depicts an exemplary "status" page of an exemplary user interface for a biopsy system;

FIG. 67 depicts an exemplary "probe" page of an exemplary user interface for a biopsy system;

FIG. 68 depicts an exemplary "systems" page of an exemplary user interface for a biopsy system; and

FIG. 69 depicts an exemplary user interface that may be applied to a portion of a biopsy device.

Detailed Description

The following description of some embodiments of the invention should not be used to limit the scope of the invention. Other embodiments, features, aspects, implementations, and advantages of the invention will become apparent to those skilled in the art from the following description, which is by way of example, one of the best modes contemplated for carrying out the invention. As will be realized, the invention is capable of other different and obvious aspects, all without departing from the invention. Accordingly, the drawings and description are to be regarded as illustrative in nature and not as restrictive.

As shown in fig. 1, exemplary biopsy system 2 includes biopsy devices 100, 101 and vacuum control module 400. As shown in FIGS. 2 and 3, biopsy device 100 includes a probe 102 and a holster 202. Similarly, as shown in fig. 4 and 5, biopsy device 101 includes probe 103 and holster 302. As will be described in more detail below, each probe 102, 103 may be separate from its respective holster 202, 302. The term "holster" as used herein should not be construed to require insertion of any portion of the probe 102, 103 into any portion of the holster 202, 302. Indeed, in some variations of biopsy devices 100, 101, probes 102, 103 may simply be placed on holster 202, 302. In other variations, portions of the holster 202, 302 may be inserted into the probe 102, 103. Furthermore, in some biopsy devices 100, 101, the probe 102, 103 and holster 202, 302 may be a unitary or monolithic structure, with the two components not being separable. Other suitable structural and functional relationships between the probes 102, 103 and the gantries 202, 302 will be apparent to those skilled in the art in view of the teachings herein.

Some variations of biopsy devices 100, 101 may include one or more sensors (not shown) located in probe 102, 103 and/or holster 202, 302 that are configured to detect when probe 102, 103 is coupled with holster 202, 302. Such sensors or other features may be further configured to allow only certain types of probes 102, 103 and gantries 202, 302 to be coupled together. Additionally, or alternatively, such sensors may be configured to disable one or more functions of the probe 102, 103 and/or holster 202, 302 until the appropriate probe 102, 103 and holster 202, 302 are coupled together. Of course, such sensors and features may be varied or omitted as desired.

By way of example only, the probe 102, 103 may be provided as a disposable component, while the holster 202, 302 may be provided as a reusable component. Vacuum control module 400 is provided on a surgical cart (not shown) in this embodiment, but like the other components described herein, the surgical cart is merely optional. Among other components described herein, a foot switch (not shown) and/or other devices may be used to provide at least some degree of control over at least a portion of biopsy system 2. Catheter 200 provides for the transmission of power (e.g., electrical, pneumatic, etc.), control signals, saline, vacuum, and ventilation from vacuum control module 400 to biopsy devices 100, 101. Each of these constituent elements will be described in more detail below.

1. Exemplary Probe for stereotactic applications

As shown in fig. 6-14, the probe 102 includes a needle portion 10 and a body portion 112. The body portion 112 includes a cover member 114 and a base member 116. Tissue sample holder 140 is removably secured to base member 116, although tissue sample holder 140 may alternatively be secured to cover member 114 or other component. As will be described in greater detail below, a pair of tubes 402, 404 are coupled with the probe 102.

A. Exemplary needle

In this embodiment, needle portion 10 includes an outer cannula 12, with outer cannula 12 having a tissue piercing tip 14 and a transverse tissue receiving aperture 16 proximal of tissue piercing tip 14. The tissue piercing tip 14 is configured to pierce tissue without requiring a significant amount of force and without requiring an opening to be formed in the tissue prior to insertion of the tip 14. Suitable configurations for tissue piercing tip 14 will be apparent to those skilled in the art in view of the teachings herein. For example, as shown in fig. 11, the tip 14 of the present embodiment is a portion of the needle member 18, and the needle member 18 is formed of a pressed metal piece. Specifically, the needle member 18 is pressed to form the tip 14 and the wall 30, as will be described in more detail below. A plurality of openings 32 including vents 34 are formed through the wall. Various ways in which fluid may be communicated through the openings 32, 34 will be described in more detail below with reference to fig. 61-65. The needle member 18 is then twisted so that the tip 14 and the wall 30 are substantially perpendicular to each other. The needle member 18 is then inserted into the cannula 12 and the tip 14 protrudes through a slot formed in the distal end of the cannula 12. A tissue stop 26 is disposed proximal of the tip 14. Other ways of forming the tip 14, including alternative techniques, materials, and configurations, will be apparent to those skilled in the art in view of the teachings herein.

The interior of the outer sleeve 12 of this embodiment defines a sleeve lumen 20 and a vacuum lumen 40, and a wall 30 separates the sleeve lumen 20 from the vacuum lumen 40. A plurality of external openings 22 are formed in the outer sleeve 12 and are in fluid communication with the vacuum chamber 40. An example of an opening similar to the outer opening 22 is disclosed in U.S. patent application publication No.2007/0032742 entitled "Biopsy Device with vacuum assisted illumination Control" published on 8.2.2007, the disclosure of which is incorporated herein by reference. Of course, as with the other components described herein, the outer opening 22 is merely optional.

In some embodiments, the wall 30 extends along a substantial length of the needle portion 10. In other embodiments, wall 30 extends proximally only beyond the distal end region of cutter 50 (described below) and terminates in needle portion 10. For example, cannula lumen 20 may be sized and configured such that when cutter 50 is within cannula lumen 20, a gap exists between the exterior of cutter 50 and at least a portion of the interior of cannula 12. Such a gap may provide a vacuum lumen 40 along the length of cannula 12 proximal of the proximal end of wall 30. Other ways of providing the vacuum chamber 40 will be apparent to those skilled in the art in view of the teachings herein.

In this embodiment, a plurality of lateral openings 32, 34 are formed through the wall to provide fluid communication between the cannula lumen 20 and the vacuum lumen 40. As will be described in greater detail below, vacuum, saline, and/or pressurized air may be communicated from the vacuum lumen 40 to the cannula lumen 20 via the lateral openings 32, 34.

B. Exemplary cutter

A hollow cutter 50 is disposed within cannula lumen 20. The interior of cutter 50 defines a cutter lumen 52 such that fluids and tissue may be transferred through cutter 50 via cutter lumen 52. As will be described in greater detail below, cutter 50 is configured to rotate within cannula lumen 20 and to move axially within cannula lumen 20. Specifically, cutter 50 is configured to cut a biopsy sample from tissue protruding through transverse bore 16 of outer cannula 12. Cutter 50 is also configured to allow severed tissue sample 4 to be passed proximally through cutter lumen 52, as will be described in greater detail below. An illustrative example of such cutting and proximal delivery is described in U.S. Pat. No.5,526,822, the disclosure of which is incorporated herein by reference, but any other suitable structure or technique may be used to cut and/or deliver the tissue sample 4 in the biopsy system 2.

Cutter 50 may be subjected to various treatments or configurations to facilitate the proximal passage of tissue sample 4 through cutter lumen 52. For example, the finished inner surface of the cutter 50 defining the cutter lumen 52 may be subjected to peening (e.g., using glass beads, sodium bicarbonate, etc.) to reduce adhesion between the tissue and the cutter 50. Additionally, or alternatively, the interior of cutter 50 defining cutter lumen 52 may be subjected to acid etching and/or plasma etching to reduce adhesion between tissue and cutter 50. In addition, or in the alternative, a hydrogen lubricious material (hydrophilic) or other non-stick coating may be applied to the inner surface of cutter 50 defining cutter lumen 52 in order to reduce friction between the tissue and cutter 50. Additionally, or alternatively, the inner surface of cutter 50 defining cutter lumen 52 may be subjected to rifling surface cutting. Other suitable processes for the interior of cutter 50 will be apparent to those skilled in the art in view of the teachings herein. Alternatively, in some embodiments, the interior of the cutter 50 may not be subjected to any treatment.

In an alternative embodiment of cutter 50, the inner and outer diameters of the distal portion of cutter 50 are smaller than the inner and outer diameters of the proximal portion of cutter 50. For example, the distal-most dimension of the cutter 50 may form a necked region (not shown) that transitions to a region of greater diameter along the remaining proximal length of the cutter 50. This necked configuration may reduce tissue compression forces as the tissue sample 4 moves proximally through the cutter lumen 52. The distal end of the outer sleeve 12 may also have a corresponding necked down region which may be the same, shorter or longer in length than the necked down region of the cutter 50. Other suitable lengths of the cutter 50 and/or the necked-down region of the outer sleeve 12 will be apparent to those skilled in the art in view of the teachings herein.

In another alternative embodiment of cutter 50, a plurality of raised surfaces are provided that extend inwardly along the length of cutter 50 within the interior of cutter 50. Such raised surfaces may be configured to reduce contact of the tissue surface with the interior of cutter 50.

In yet another alternative embodiment of cutter 50, an inner sleeve (not shown) may be disposed within the distal interior of cutter 50. For example, such an inner sleeve may have a length of about 0.15 inches or any other suitable length. The distal end of cutter 50 may be beveled after such an inner sleeve is inserted, such that the beveled cutter 50 end and the beveled sleeve end together provide a sharp edge for cutting tissue. As the severed tissue sample 4 travels proximally through the cutter lumen 52, it passes through the larger inner diameter of the cutter lumen 52 at the point where the tissue sample 4 passes the proximal end of the inner sleeve. The increase in effective diameter may reduce compression of the tissue sample 4, thereby improving the transport reliability of the tissue sample 4. Other suitable modifications of cutter 50 will be apparent to those skilled in the art in view of the teachings herein.

C. Exemplary needle hub

As shown in fig. 12 and 13, needle hub 60 is secured to outer cannula 12 and includes a thumbwheel 62 and a sleeve portion 64 extending proximally from thumbwheel 62. Needle hub 60 of the present embodiment is overmolded around a proximal portion of outer cannula 12, although needle hub 60 may be formed and/or secured relative to outer cannula 12 using any other suitable technique (e.g., set screws, adhesives, etc.). Moreover, although the needle hub 60 of the present embodiment is formed of a plastic material, any other suitable material or combination of materials may be used.

The sleeve portion 64 of the present embodiment includes an annular projection 66, a longitudinal slot 68, and a transverse opening 70 formed near the proximal end of the sleeve portion 64. One or more additional transverse openings 70 (e.g., diametrically opposed transverse openings 70) may be provided in the sleeve portion 64. A pair of O-rings 72 are positioned such that one O-ring 72 is located proximal to the lateral opening 70 and the other O-ring 72 is located distal to the lateral opening 70. As will be described in greater detail below, the transverse opening 70 is in fluid communication with an interior defined by the needle hub 60, which is also in fluid communication with the vacuum lumen 40 of the overtube 12. Other suitable configurations for sleeve portion 64 will be apparent to those skilled in the art in view of the teachings herein.

Thumbwheel 62 is operable to rotate outer sleeve 12 about its longitudinal axis relative to cover member 114 and base member 116. For example, thumbwheel 62 may be used to orient hole 16 to a plurality of desired directions about a longitudinal axis defined by outer sleeve 12. By way of example only, these multiple orientations may be desirable in order to obtain multiple tissue samples 4 from a biopsy site without removing the needle portion 10 from the patient's body during the taking of the multiple tissue samples 4. Examples of such rotation and acquisition of a plurality of tissue samples 4 are disclosed in U.S. Pat. No.5,526,822, the disclosure of which is incorporated herein by reference. Other ways of obtaining a plurality of tissue samples 4 at various locations will be apparent to those skilled in the art in view of the teachings herein. For example, rotation of outer sleeve 12 may be motorized or automated, such as using any of the constituent elements that will be described in more detail below, or using any other suitable constituent element or technique. As another non-exhaustive example, the entire biopsy device 101 may be rotated during the acquisition of the tissue sample 4 without having to remove the biopsy device 101 from the patient during such rotation and the acquisition of the tissue sample 4 to obtain the tissue sample 4 from multiple orientations about the longitudinal axis defined by the outer cannula 12.

It will be appreciated that other structures may be used to perform manual rotation of outer sleeve 12. Specifically, as shown in fig. 12 and 13, the exposed gear 74 may be engaged with the outer sleeve 12. In this embodiment, gear 74 is slid onto the proximal end of sleeve portion 64. Radially inwardly extending projections (not shown) of gear 74 are configured to mate with slots 68 of sleeve portion 64 such that gear 74 rotates with sleeve portion 64 while being movable longitudinally of sleeve portion 64. With sleeve portion 64 integrally engaged with outer sleeve 12, rotation of gear 74 will further cause sleeve 12 to rotate for reorienting bore 16. The gear 74 is further configured to mesh with a corresponding exposed gear 206 of the frame 202, as will be described in more detail below. Specifically, the gear 74 is configured to mesh with the gear 206 such that the gear 206 is capable of imparting rotation to the gear 74, thereby rotating the outer sleeve 12. Some exemplary structures and techniques for selectively causing rotation of gear 206 will be described in greater detail below, and others will occur to those skilled in the art in view of the teachings herein.

It is also to be appreciated that the orientation of the aperture 16 can be indicated on a graphical user interface in view of the teachings herein. For example, one or more sensors may be operable to detect the orientation of the bore 16 and communicate the indicating data to the processor. The processor may communicate with a display (e.g., display screen 702 described below, etc.) to provide a visual indication of the orientation of the aperture 16. Other ways of indicating the orientation of the aperture 16 to the user will be apparent to those skilled in the art in view of the teachings herein. Alternatively, the orientation of the aperture 16 may not be indicated to the user.

D. Exemplary needle manifold

As shown in fig. 12, a needle manifold 80 is disposed about the sleeve portion 64. In this embodiment, the needle manifold 80 is fixed relative to the base member 116. The needle manifold 80 is in fluid communication with the tubing 402 such that the tubing 402 may deliver saline, vacuum, atmospheric and/or pressurized air, etc. to the needle manifold 80, as will be described in more detail below. The needle manifold 80 is also in fluid communication with the interior of the sleeve portion 64 via the transverse opening 70. The O-ring 64 is configured to maintain a fluid seal between the needle manifold 80 and the sleeve portion 64 even if the sleeve portion 64 moves longitudinally relative to the needle manifold 80, such as during firing of the needle 10 as will be described in greater detail below; and even during rotation of the sleeve portion 64 about its longitudinal axis. A seal (not shown) is also provided at the proximal end of sleeve portion 64 at the interface between sleeve portion 64 and cutter 50. Thus, the needle manifold 80, sleeve portion 64, and outer sleeve 12 are constructed and arranged such that saline, vacuum, atmospheric air, and/or pressurized air, etc. delivered through the tube 402 to the needle manifold 80 will also be delivered to the vacuum lumen 40 via the transverse opening 70. Of course, any other suitable structure or arrangement may be used to transfer saline, vacuum, atmospheric air, and/or pressurized air, etc. from the tube 402 to the vacuum chamber 40.

E. Exemplary cutter rotation and translation mechanism

In this embodiment, as shown in FIG. 14, the body portion 112 of the probe 102 includes a cutter rotation and movement mechanism 120, the cutter rotation and movement mechanism 120 being operable to rotate and move the cutter 50 within the outer sleeve 12. The cutter rotation and movement mechanism 120 includes a sleeve 122, a nut member 124, and a gear 138 integrally fixed to the cutter 50. In this embodiment, sleeve 122 is formed from a plastic material that is overmolded around cutter 50, although any other suitable material may be used, and sleeve 122 may be fixed relative to cutter 50 using any other suitable structure or technique (e.g., set screws, etc.). The nut member 124 is fixed relative to the base member 116 and has internal threads 126. A portion of the sleeve 122 has external threads 128, the external threads 128 configured to engage the internal threads 126 of the nut member 124. The threads 126, 128 are configured such that, when the sleeve 122 is rotated relative to the nut member 124, the sleeve 122 will move longitudinally relative to the nut member 124 depending on the direction of such relative rotation. By way of example only, the threads 126, 128 may be configured to have a pitch capable of providing approximately 40-50 threads per inch. Such a thread pitch may provide a desired ratio of cutter 50 rotation and cutter 50 movement for cutting tissue. Alternatively, any other thread pitch may be used. In this embodiment, with the sleeve 122 integrally secured to the cutter 50, longitudinal movement of the sleeve 122 relative to the nut member 124 will result in the same movement of the cutter 50.

Another portion of the sleeve 122 has a plurality of outer flats 130, the outer flats 130 configured to engage a corresponding plurality of inner flats 132 of the gear 138. Gear 138 is positioned coaxially around sleeve 122 and cutter 50. The flats 130, 132 are configured such that rotation of the gear 138 causes rotation of the sleeve 122. In this embodiment, with the sleeve 122 integrally secured to the cutter 50, rotation of the gear 138 and sleeve 122 will result in the same rotation of the cutter 50. The flats 130, 132 are further configured such that the sleeve 122 is longitudinally movable relative to the gear 138 (e.g., the fit between the sleeve 122 and the gear 138 is less tight so as to prevent movement). It will thus be appreciated that as the gear 138 rotates, given the relative configuration of the threads 126, 128 and flats 130, 132, such rotation of the gear 138 will result in both rotation and longitudinal movement of the sleeve 122, which in turn results in simultaneous rotation and longitudinal movement of the cutter 50.

In this embodiment, the gear 138 is partially exposed through the base 116 and is configured to mesh with a corresponding exposed gear 208 of the rack 202, as will be described in more detail below. Specifically, the gear 138 is configured to mesh with the gear 208 such that the gear 208 is capable of imparting rotation to the gear 138, thereby activating the cutter rotation and movement mechanism 120. As will be described in greater detail below, the gear 208 is coupled to a motor 272 located within the housing 202. In this embodiment, the gears 138, 208 and threads 126, 128 are configured such that each revolution of the motor 272 causes the cutter 50 to move approximately 0.00012 inches. Of course, any of these components may have other configurations that result in any other suitable ratio of movement of cutter 50 and rotation of motor 272.

It will be appreciated in light of the teachings herein that the cutter rotation and movement mechanism 120 described above is merely exemplary, and that movement and/or rotation of the cutter 50 may alternatively be provided in a variety of other ways. For example, biopsy probe 102 may include a motor (not shown) or other device such that biopsy probe 102 lacks exposed gear 138. Alternatively, any suitable structure (e.g., a rack, etc.) other than the exposed gear 138 may be used to receive transmitted motion or energy from some other component in order to rotate and/or move the cutter 50. Also, the cutter rotation and translation mechanism 120 may be configured such that there is more than one exposed gear 138 (e.g., one gear 138 for receiving translation motion, another gear 138 for receiving rotation motion, etc.). In other merely exemplary alternatives, the rotating and/or moving cutter 50 may be operated at least in part by a pneumatic actuator (not shown), a pneumatic motor (not shown), or various other components. Moreover, it is understood that the pneumatic components may be combined with other mechanical and/or electromechanical components to move and/or rotate cutter 50.

Base member 116 also includes cutter passage 54, with the proximal end of cutter 50 disposed through cutter passage 54. A seal 56 is provided at the distal interface of cutter 50 and cutter channel 54 to prevent vacuum or fluid leakage between the outer surface of cutter 50 and the inner surface of the distal end of cutter channel 54. Cutter channel 54 is sized such that the distal end of cutter 50 remains within cutter channel 54 as cutter 50 moves during use of biopsy device 100. Of course, any other suitable structure or configuration may be used.

F. Exemplary "Sharpness reduction" variations

In this embodiment, needle portion 10 and cutter 50 are configured to be detachable from biopsy probe 102, such as after a procedure using biopsy device 100. Specifically, base member 116 of body portion 112 of biopsy probe 102 includes release tabs 118, and release tabs 118 are resiliently movable relative to base member 116 via arms 119. Release tab 118 is configured to limit axial movement of needle portion 10 when release tab 118 is in the default position by limiting axial movement of gear 74, which gear 74 engages sleeve portion 64 of hub 60 as described above. Of course, even when release tab 118 is in the default position, the configuration of and engagement between gear 74 and sleeve portion 64 still allows for a degree of axial movement of needle portion 10, such as for firing of needle portion 10. However, when release tab 118 is sufficiently depressed, such as by a user, the release tab provides clearance for gear 74 to be moved distally of base member 116. In other words, when release tab 118 is fully depressed, the entire needle portion 10, including the entire needle hub 60 and gear 74, may be pulled axially distally from the body portion 112 of biopsy probe 102; such that the entire needle portion 10, including the entire needle hub 60 and gear 74, is completely separated from the body portion 112.

It will be appreciated in view of the disclosure herein that with the entire needle portion 10 including the entire needle hub 60 and gear 74 completely separated from body portion 112, cutter 50 still extends from body portion 112. To remove the cutter 50 from the body portion, the user simply "unscrews" the cutter 50 from the body portion 112. Specifically, the user may grasp the portion of cutter 50 extending from body portion 112, rotate cutter 50 relative to body portion 112, and pull cutter 50 distally. Such rotation and pulling of cutter 50 may result in interaction of threads 126, 128, ultimately resulting in threading 128 passing fully distally through threading 126. When thread 128 fully passes distally through thread 126, no other component of body portion 112 substantially constrains cutter 50 axially, such that cutter 50 can be fully pulled distally from body portion 112 without further rotation. In other words, after the cutter 50 has been fully rotated relative to the body portion 112, the cutter 50 may be fully separated from the body portion 112. It will be appreciated in light of the teachings herein that the sleeve 122 and needle manifold 80 may be configured such that the sleeve 122 may pass axially entirely through the needle manifold 80. The gear 138 may substantially remain in place as the sleeve 122 and the remainder of the cutter 50 are pulled axially relative to the gear 138. Other suitable relationships between the components may be envisioned by those skilled in the art in view of the teachings herein to provide, allow or facilitate detachment of needle portion 10 and cutter 50 from body portion 112.

Although release tab 118 and other components have been described as providing and/or allowing complete detachment of needle portion 10 and cutter 50 from body portion 112, it will be appreciated in light of the teachings herein that various other structures and techniques may be employed to provide such detachability. For example, in some embodiments, tab 118 or some other feature is configured to break away from base member 116 when subjected to a sufficient force to allow the entire needle portion 10, including the entire needle hub 60 and gear 74, to be removed. In yet another alternative embodiment, probe 102 is configured such that when needle portion 10 and needle hub 60 are manually angled relative to the remainder of body portion 112, the retention features on base component 116 are disengaged, thereby allowing the entire needle portion 10, including entire needle hub 60 and gear 74, to be axially detached from body portion 112. Other components, features, and techniques for providing, allowing, or facilitating detachment of needle portion 10 and cutter 50 from body portion 112 will be apparent to those skilled in the art in view of the teachings herein.

It will also be appreciated that such removability may reduce the amount of "sharp elements" provided by biopsy device 100. In particular, if sharp device components that have been exposed to bodily fluids need to be disposed of in a different manner than other waste disposal (e.g., placed in a "sharp cartridge" as compared to a conventional waste cartridge), complete detachment of needle portion 10 and cutter 50 from body portion 112 may allow needle portion 10 and cutter 50 to be disposed of according to a "sharp" waste disposal procedure without necessarily requiring the remainder of body portion 112 to undergo the same waste disposal. In other words, by way of example only, after biopsy device 100 is used, needle portion 10 and cutter 50 may be removed from body portion 120 and placed in a "sharp cartridge," while the remainder of body portion 112 may be placed in a conventional waste cartridge.

G. Exemplary tissue sample holder manifold

As shown in fig. 15-19, a tissue sample holder 140 is provided at the end of the body portion 112 of the probe 102. Tissue sample holder 140 includes a cup 142, a manifold 144, and a plurality of disks 160. The manifold 144 includes a central recess 146, a plurality of longitudinal channels 148, a plurality of chambers 150 defined by radially extending walls 152, and a plurality of radial channels 154. Each longitudinal channel 148 is substantially fluidly isolated from the other longitudinal channels 148. However, each radial passage 154 is in substantial fluid communication with the other radial passages 154 via an annular passage (not shown) located in the rear portion of the manifold 144. Alternatively, each radial passage 154 may be substantially fluidly isolated from the other radial passages 154. In the present embodiment, each longitudinal passage 148 is in fluid communication with a respective one of each radial passage 154. Specifically, each longitudinal channel 148 terminates proximally in a respective radial channel 154.

In addition, each radial passage 154 is in fluid communication with a respective one of each chamber 150 via a respective pair of openings 156. Thus, it will be appreciated that each longitudinal passage 148 is in fluid communication with a respective chamber 150 via a respective radial passage 154 and a pair of openings 156. Specifically, the radial position of each longitudinal channel 148 relative to the central groove 146 corresponds to the radial position of the associated radial channel 154, pair of openings 156, and chamber 150. Of course, any other suitable structure or configuration for the manifold 144 may be used.

In some variations, a filter, mesh, or other component is disposed on manifold 144, in manifold 144, or elsewhere in tissue sample holder 140 to prevent tissue from entering or passing through some opening or gap. In other variations, these constituent elements may be omitted.

H. Exemplary tissue sample tray

The tray 160 of the present embodiment is configured for placement on the manifold 144 and to receive the tissue sample 4, as described in more detail below. Each disk 160 may be rigid and may be pre-formed to have a generally arcuate configuration. Alternatively, the disk 160 may be formed of a flexible material such that the disk 160 may be bent to conform to the curvature of the manifold 144. Alternatively, the disk 160 may include one or more joints such that portions of the disk 160 may bend or flex at these joints. Other suitable configurations may also be used.

Each tray 160 of the present embodiment has a base portion 162 and a plurality of hollow wall portions 164. The hollow wall portion 164 defines a chamber 166. By way of example only, each chamber 166 may be configured to receive a single tissue sample 4 captured by cutter 50. Alternatively, chambers 166 may be configured such that each chamber 166 may hold more than one tissue sample 4. The manifold 144 and chambers 166 of the present embodiment may also be configured such that, even when a tissue sample 4 is in such a chamber 166, blood, saline, and/or other fluids may pass through the chamber 166 and out through the tube 404. In other words, chamber 166 will allow fluid to pass around tissue sample 4.

As shown, the underside of each hollow wall portion 164 is configured to receive the wall 152 of the manifold 144. Wall portions 164 and walls 152 are configured to provide a gap between each base portion 162 and manifold 144 when disk 160 is placed on manifold 144. As also shown, each hollow wall portion 164 has a generally tapered configuration, although any other suitable configuration may be used. In addition, the disk 160 has a plurality of openings 168, the openings 168 being formed in groups through the base portion 162 within each of the chambers 164. Thus, each chamber 166 of disk 160 is in fluid communication with an associated chamber 150 of manifold 144 through opening 168. Thus, each longitudinal channel 148 of the manifold 144 is in fluid communication with a respective chamber 166 of the disc 160. It will thus be appreciated that when the tube 404 is placed in fluid communication with a given longitudinal passage 148, the tube 404 will be in fluid communication with the chamber 166 associated with the longitudinal passage 148.

In the present embodiment, the manifold 144 and the disk 160 provide eighteen chambers 150, 166. Alternatively, any other number of chambers 150, 166 (i.e., more or less than eighteen) may be provided. For example, in one variation, the manifold 144 provides three chambers 150 and three disks 160 are used, each disk 160 having only one chamber 166. In another variation, a single disk 160 is used. For example, a single disk 160 may provide a single large chamber 166 or any suitable number of chambers 166. Other suitable numbers of chambers 150, 166 and ways of providing chambers 150, 166 will be apparent to those skilled in the art in view of the teachings herein. Moreover, the manifold 144 and the disk 160 may have any suitable shape.

Each tray 160 may further include one or more types of markings or other indicia to distinguish one compartment 166 from another compartment 166. For example, a number or other distinguishing indicia may be provided on or near each chamber 166, such as in an embossed form, a debossed form, or otherwise. In another embodiment, radiopaque markers are provided on or near each chamber 166. For example, the entire tray 160 carrying one or more tissue samples 4 may be placed under X-ray for evaluation, and the radiopaque markers associated with each chamber 166 (and thus each tissue sample 4) may be visible in the images obtained using X-ray. In other words, it is not necessary to remove the tissue sample 4 from the tray 160 in order to obtain an X-ray or radiographic image of the tissue sample 4. Furthermore, tray 160 may be placed directly into formalin or any other liquid while tissue sample 4 remains on tray 160. Further, trays 160 may be placed individually or in groups in sleeves or containers to protect tissue samples 4 and/or to ensure that tissue samples 4 are placed in trays 160 or for other purposes. Such sleeves or containers may be flexible, rigid, or have other properties. By way of example only, the sleeve or other container may be flat or may be configured to flatten the flexible disk 160 inserted therein. Other structures and techniques that may be used with tray 160, such as after transferring tissue samples 4 to tray 160, may be envisioned by those skilled in the art in view of the teachings herein.

The cup 142 is configured to engage the bayonet 134 of the base member 116 such that the cup 142 may be removed from the base member 116 or secured to the base member 116 upon sufficient rotation of the cup 142 relative to the base member 116. In addition, an O-ring 136 is disposed around the base member 116 to provide a seal between the base member 116 and the cup 142. Of course, any other suitable structure may be used to provide engagement of the cup 142 with the base member 116 and/or to provide a seal between the base member 116 and the cup 142. In this embodiment, cup 142 is also made of a transparent material so that a user can visually observe tissue sample 4 located in tissue sample holder 140 while tissue sample holder 140 is still coupled with base member 116. For example, the user may observe the color, size, and density of the tissue sample 4 (e.g., if the chamber 166 is filled with saline, etc.).

It will also be appreciated in view of the teachings herein that the removability of the cup 142 and tray 160 may allow a user to obtain a relatively large number of tissue samples in a relatively short period of time. Moreover, the removability of the cup 142 and tray 160 may allow a user to remove an unsatisfactory tissue sample 4 from the tissue sample holder 140 (e.g., using forceps, etc.) and then reconnect the tray 160 and cup 142 for further sampling. Other ways of using the removability and other characteristics of tissue sample holder 140 of the present embodiment may be devised by those skilled in the art in view of the teachings herein.

I. Exemplary manifold rotation and alignment

The manifold 144 of the present embodiment is configured to rotate relative to the base member 116, as will be described in more detail below. The manifold 144 of the present embodiment is also configured such that each longitudinal channel 148 may be selectively aligned with a port 406, which port 406 is in fluid communication with the tube 404. Alignment of the longitudinal channel 148 with the port 406 will place the aligned longitudinal channel 148 in fluid communication with the tube 404 such that the conduction of vacuum within the tube 404 causes the vacuum to be conducted within the longitudinal channel 148 and within the chamber 166 connected to the longitudinal channel 148. In addition, manifold 144 and disk 160 of the present embodiment are configured such that each chamber 166 is selectively placed in fluid communication with cutter lumen 52. Thus, it will be appreciated that the vacuum in tube 404 may be communicated to cutter lumen 52 through port 406, associated longitudinal passageway 148, associated radial passageway 154, associated pairs of openings 156, associated chambers 150, associated sets of openings 168, and associated chambers 166. Of course, there are various other ways in which vacuum may be communicated into cutter lumen 52, and any other suitable structure or technique may be used. Also, instead of or in addition to passing a vacuum into cutter lumen 52, pressurized air, a fluid (e.g., saline), or any other fluid may be passed through the above-described components in any direction.

The gear 170 is engaged with the manifold 144 of the present embodiment. Specifically, the gear 170 has a shaft 172 that is inserted into the central recess 146 of the manifold 144. The shaft 172 has a flat surface 174 configured to engage a corresponding flat surface 147 of the central recess 146. The engagement of the flats 174 and 147 causes the gear 170, shaft 172 and manifold 144 to rotate as a unit. Alternatively, the gear 170 and the manifold 144 may have any other suitable configuration or relationship. However, gear 170 of the present embodiment may be used to rotate manifold 144, in addition to simultaneously allowing alignment of chamber 166 with cutter lumen 52, manifold 144 in turn allows for selective alignment of longitudinal channel 148 with port 406. Specifically, and as will be described in greater detail below, the gear 170 is configured to mesh with a corresponding gear 210 of the rack 202 such that the gear 210 may be used to impart rotation to the gear 170. Such rotation may be used to selectively (e.g., sequentially) align chambers 166 with cutter lumen 52 to sequentially collect a separate tissue sample 4 into each chamber 166 during use of biopsy device 100. Moreover, in such procedures, such collection of the tissue sample 4 may be performed without having to retract and reinsert the needle portion 10 relative to the patient.

J. Exemplary "dog parkingpaw") "

The body portion 112 of this embodiment also includes an engagement member 180, the engagement member 180 being secured to the base member 116. As shown in fig. 20, the engagement member 180 includes a pawl portion 182 with teeth 184. The claw portion 182 is elastically urged to engage the teeth 184 with the gear 170. Specifically, the engagement of the teeth 184 of the pawl portion 182 with the gear 170 prevents rotation of the gear 170 (and thus prevents rotation of the manifold 144). Accordingly, the pawl portion 182 is configured to prevent rotation of the manifold 144 when the pawl portion 182 is in the default position. In this embodiment, when biopsy probe 102 is not attached to holster 202, jaw portion 182 is in a default position. However, when biopsy probe 102 is coupled to holster 202, projections 212 on holster 202 are configured to engage with jaw portions 182. In particular, projections 212 on holster 202 are configured to disengage pawl portion 182 from gear 170 when biopsy probe 102 is coupled to holster 202 such that pawl portion 182 no longer prevents rotation of gear 170 or manifold 144 when biopsy probe 102 is coupled to holster 202. When biopsy probe 102 is removed from holster 202, the resiliency of engagement member 180 urges pawl portion 182 back to the default position, such that pawl portion 182 again prevents rotation of gear 170 and manifold 144.

When biopsy probe 102 is shipped from a manufacturing facility or otherwise, tissue sample holder 140 may be configured to align predetermined chamber 166 with cutter lumen 52. The jaw portion 182 maintains this alignment until the biopsy probe 102 is attached to the holster 202 for first use, and software or control logic for controlling the biopsy device 100 can "safely assume": predetermined chambers 166 are aligned with cutter lumen 52 and biopsy device 100 may be controlled accordingly. Moreover, if biopsy probe 102 is removed from holster 202 during sampling of tissue sample 4, software or control logic for controlling biopsy device 100 may "remember" chamber 166 that was last aligned with cutter lumen 52, the software tracking the chamber 166 in use or already in use during the procedure. If biopsy probe 102 is reconnected to holster 202 to continue the procedure, software or control logic may continue to control biopsy device 100 according to chamber 166 that the software "remembers". Alternatively, the user may determine that a new biopsy probe 102 has been connected to the holster 202, which may cause the software or control logic to "assume" again: the predetermined chamber 166 is the chamber 166 aligned with the cutter lumen 52.

Although the pawl portion 182 has been described as a structure that selectively prevents rotation of the gear 170 and manifold 144, it will be appreciated that any other alternative structure may be used for this purpose. For example only, a geneva wheel mechanism (not shown) may be used as an alternative mechanism for rotating manifold 144 and maintaining the rotational position of manifold 144 between set rotations. For example, gear 170 may be replaced by an intermittently operated driven wheel (not shown), while gear 210 may be replaced by an intermittently operated drive wheel (not shown). Other suitable alternatives for rotating manifold 144 and maintaining the rotational position of manifold 144 will be apparent to those skilled in the art in view of the teachings herein. Further, it will be appreciated that biopsy device 100 may be devoid of a pawl portion 182 or other rotation prevention feature such that manifold 144 may rotate freely when biopsy probe 102 is not coupled to holster 202.

K. Exemplary dedicated channel

As shown in fig. 16-17, 19 and 21, tissue sample holder 140 of the present embodiment has a channel 158 formed through manifold 144. The channel 158 extends longitudinally completely through the manifold 144 and is offset from and parallel to a central axis defined by the manifold 144. Similar to chamber 166, channel 158 is configured to be selectively aligned with cutter lumen 52. However, unlike the chamber 166, the passage 158 is not in fluid communication with any of the longitudinal passages 148 or the radial passages 154. In other forms, the channel 158 may be disposed in fluid communication with one or more of the longitudinal channels 148 and/or the radial channels 154.

The channel 158 of the present embodiment is configured to allow instruments and/or fluids, other materials, etc. to pass through the manifold 144 and cutter lumen 52. For example, channel 158 may be used to insert instruments for placing one or more markers at a biopsy site through cutter lumen 52, outer cannula 12, and out-going aperture 16. Only exemplary marker applicators insertable through the channel 158 may include MAMMOMARK biopsy site marker applicators (Ethicon Endo-Surgery, inc., Cincinnati, Ohio). Other suitable marker applicator devices that may be inserted through the channel 158 may include those described in the following documents: U.S. patent nos. 7,047,063; U.S. patent nos. 6,996,433; U.S. patent nos. 6,993,375; or U.S. patent publication No.2005/0228311, the contents of which are incorporated herein by reference. Any one or more of these applicators (including variations thereof) may be guided through the channel 158 while the needle portion 10 remains inserted into the patient to place one or more markers at the biopsy site through the aperture 16 (e.g., shortly after the biopsy sample is withdrawn from the patient, etc.). Such marker placement may even be accomplished while the tissue sample 4 remains within the tissue sample holder 140, secured to the biopsy probe 102. Alternatively, such a marker applier may be inserted directly into cutter lumen 52 with tissue sample holder 140 removed from biopsy probe 102.

As described above, biopsy probe 102 may be initially provided with a predetermined chamber 166 that is aligned with cutter lumen 52 by default. However, in other forms, biopsy probe 102 may be initially provided with a channel 158 that aligns with cutter lumen 52 by default. Moreover, if a user desires to have channel 158 aligned with cutter lumen 52 during use of biopsy device 100, a controller may be used to control manifold 144 to rotate to align channel 158 with cutter lumen 52 after manifold 144 has been rotated during such use.

The cup 142 also includes an opening 176 and a hatch 178. The opening 176 is configured to align with the channel 158, such as by rotating the manifold 144, when the cup 142 is secured to the base member 116 to align the channel 158 with the opening 176. Hatch 178 is configured to selectively cover opening 176. For example, the hatch 178 may be configured to seal the opening 176 when the hatch 178 covers the opening 176. The hatch 178 may also be configured to allow a user to "peel" the hatch 178 and/or pivot the hatch 178 to access the opening 176 and the channel 158. It will be appreciated in view of the teachings herein that the hatch 178 may be replaced or supplemented by various alternative structures, including but not limited to removable stops or other structures.

L. exemplary drug applicator

As shown in fig. 21 and 22, the applier 90 may be coupled to the biopsy probe 102 through an opening 176 in the cup 142 and a channel 158 in the manifold 144. In this embodiment, applier 90 includes a hollow shaft portion 92 and a luer portion 94. Shaft portion 92 is sized and configured such that when applier 90 is inserted through opening 176 and passage 158, shaft portion 92 forms a seal with cutter lumen 52 (e.g., by engagement with the inner surface of cutter lumen 52). Shaft portion 92 and luer portion 94 may thereby be disposed in fluid communication with cutter lumen 52. By way of example only, a syringe (not shown) or other device may be coupled to luer portion 94. From such a syringe, a therapeutic agent may thus be injected through applier 90, cutter lumen 52, outer cannula 12, and out aperture 16 to reach the biopsy site. Such injection may be performed before or after tissue sample 4 is obtained using biopsy device 100, and may be performed while needle portion 10 remains inserted into the patient. Other suitable ways of using the applicator 90 and alternative ways of constructing the applicator 90 will be apparent to those skilled in the art in view of the teachings herein. By way of example only, applier 90 may alternatively be inserted directly into cutter lumen 52 with tissue sample holder 140 removed from biopsy probe 102.

Exemplary Rack for stereotactic applications

As shown in fig. 23-32, the frame 202 includes a top cover 204, side panels 214, 216, and a base member 218, wherein a portion of each gear 206, 208, 210 is exposed from the top cover 204. As described above, boss 212 is disposed on cap 204 and is configured to disengage pawl portion 182 from gear 170 when biopsy probe 102 is coupled to holster 202. The holster 202 of the present embodiment also includes a needle rotation mechanism 220, a needle firing mechanism 240, a cutter drive mechanism 270, and a tissue holder rotation mechanism 280. In addition, a user interface 800 is provided on each side panel 214, 216. Each of these merely exemplary constituent elements will be described in detail below.

As described above, holster 202 of the present embodiment is configured to couple with biopsy probe 102 (such as biopsy probe 102 described above) to provide biopsy device 100. In addition, the gantry 202 is configured to mount to a table, fixture, or other device, such as for a stereotactic setup or an X-ray setup. However, it is to be understood that the housing 202 may be used in a variety of arrangements and combinations thereof in view of the teachings herein.

A. Exemplary needle rotation mechanism

In this embodiment, as shown in fig. 27, the needle rotation mechanism 220 includes a pair of knobs 222, each knob 222 having a corresponding gear 224 that is in angular engagement with a gear 226 on the proximal end of an elongate shaft 228. A gear (not shown) disposed on the distal end of the elongate shaft 228 is engaged with the gear 230. The gear 230 in turn meshes with another gear 232 on the proximal end of another shaft 234. The distal end of the shaft 234 has another gear 236 that meshes with the gear 206. Thus, as will be appreciated in light of the teachings herein, rotation of one or both knobs 222 will result in rotation of the gear 206, and such rotation is transmitted through the gears 224, 226, 230, 236 and the shafts 228, 234. Also, as described above, when biopsy probe 102 is attached to holster 202, gear 206 will engage gear 74. Thus, when the biopsy probe 102 is coupled to the holster 202, rotation of one or both knobs 222 will cause the needle portion 10 of the biopsy probe 102 to rotate. Of course, various alternative mechanisms, structures or configurations may be used in place of or in addition to the needle rotation mechanism 220. By way of example only, a motor (not shown) is used to effect rotation of the needle portion 10. In other forms, the needle rotation mechanism 220 may simply be omitted.

B. Exemplary needle firing mechanism

As shown in FIGS. 28 and 29, the needle firing mechanism 240 of the present embodiment includes a pair of triggers 242, a button 244, a motor 246, a firing bar 248, and a fork 250. Fork 250 is configured to engage sleeve portion 64 of needle hub 60 when biopsy probe 102 is connected to holster 202. For example, the fork 250 may engage the sleeve portion 64 between the thumbwheel 62 and the annular protrusion 66. In this embodiment, the engagement between the fork 250 and the sleeve portion 64 causes the sleeve portion 64 (and thus the needle portion 10) to move longitudinally with the fork 250. The fork 250 is coupled to the firing bar 248 such that the fork 250 moves longitudinally with the firing bar 248.

A dampener 252 with a washer 253 is disposed about the firing bar 248. A coil spring 254 is also disposed about the firing bar 248. Specifically, the coil spring 254 engages the washer 253 and a portion of the base member 218. A coil spring 254 is biased to urge the dampener 252, the washer 253, and the firing bar 248 distally. However, it will be appreciated that coil spring 254, as with the other components described herein, is merely exemplary and that various alternative components (resilient or otherwise) may be used in addition to or in place of coil spring 254.

A slider 256 and a helical gear 258 are also coupled to the firing bar 248. Specifically, the sled 256 is coupled to a proximal end of the firing bar 248 and is configured to move longitudinally integrally with the firing bar 248. Similarly, the helical gear 258 is configured to move longitudinally (through at least a range of motion) with the firing bar 248 while being prevented from rotating about the firing bar 248. The external gear 260 is engaged with the helical gear 258. Specifically, an inner portion (not shown) of the outer gear 260 engages threads of the helical gear 258 such that when the outer gear 260 rotates relative to the helical gear 258, such rotation causes the helical gear 258 to move longitudinally relative to the outer gear 260. The external gear 260 is connected to another gear 262, which gear 262 is in turn connected to a gear 264 connected to the motor 246. Thus, when the motor 246 is activated to rotate, such rotation causes the helical gear 258, the firing bar 248, and the sled 256 to move longitudinally. In other words, rotation of the motor 246 is transmitted to the external gear 260 through the gears 262, 264, and due to the configuration and engagement of the external gear 260 and the helical gear 258, such rotation will be translated into longitudinal motion. Of course, all of these components are merely exemplary, and any other suitable components, configurations, or techniques may be used to cause longitudinal movement of the firing bar 248.

Each of the triggers 242 of the present embodiment is configured to partially rotate forward and backward, while the push button 244 is configured to be pressed inward. In addition, a plurality of switches (not shown) may be communicatively coupled to the trigger 242 and/or the button 244, the switches being selectively activated by a user when the trigger 242 is moved forward or backward and/or when the button 244 is depressed. One or more resilient members (e.g., springs, etc.) may be included to bias each trigger 242 into a centered or substantially vertical orientation. One or more resilient members (e.g., springs, etc.) may also be included to bias each button 244 to the outboard position. In this embodiment, the trigger 242 and button 244 are also sealed to prevent fluid from entering the housing 202, but like other features, this is merely optional.

In this embodiment, the triggers 242 are further configured such that when one or more of the triggers 242 is moved rearward, such movement activates a switch connected to the motor 246. This activation causes the motor 246 to rotate, which in turn causes the firing bar 248 to move longitudinally proximally as described above. As will be described in greater detail below, this rearward movement of the trigger 242 may thus cause the motor 246 to prime or "cocking" the needle firing mechanism 240.

The needle firing mechanism 240 of the present embodiment also includes a catch 266 configured to selectively engage the sled 256. Specifically, as the firing bar 248 and sled 256 are moved longitudinally proximally (e.g., by rotation of the motor 246), the sled 256 approaches the catch 266. When the catch 266 and the sled 256 are engaged, the catch 266 is configured to hold the sled 256 (and thus the firing bar 248) in place. The catch 266 may even hold the sled 256 in place when the motor 246 has stopped rotating, and even when the spring 254 urges the sled 256 and firing bar 248 toward the distal position. When the components are in the proximal positions and configurations, the needle firing mechanism 240 can be said to be in a "cocked" configuration. FIG. 29 shows a ready-to-fire configuration of the needle firing mechanism 240 by way of example only.

As will be appreciated in view of the teachings herein, with the needle firing mechanism 240 in this cocked configuration, the fork 250 and needle portion 10 will be in a proximal, cocked position. One or more components of biopsy device 100 may be configured to provide an audible and/or visual indication that needle firing mechanism 240 is fully cocked. For example, biopsy device 100 may produce a clear click, beep, or other audible signal; and/or a graphical user interface that may provide some visual indication that the needle firing mechanism 240 is ready to fire.

Additionally, the chassis 202 may also include one or more sensors (not shown) or other features configured to sense or detect when the needle firing mechanism 240 has been cocked and/or the needle firing mechanism 240 has been fired. For example, biopsy system 2 may be configured such that one or more functions of biopsy system 2 are substantially disabled when needle firing mechanism 240 has been cocked until needle firing mechanism 240 is fired. For example only, biopsy system 2 may prevent initiation of a "sample" cycle (as described below), initiation of a "clear probe" cycle (as described below), or other functions when needle firing mechanism 240 is ready to fire. These functions are again permitted after the needle firing mechanism 240 has been fired and after the needle portion 10 has reached the fully fired position. Alternatively, cocking of needle firing mechanism 240 may have no or other effect on one or more functions of biopsy system 2.

In one variation, the motor 246 may be reversed when the sled 256 has been moved into engagement with the catch 266 to ready the needle firing mechanism 240 for firing. In this variation, the proximal end of the firing bar 248 may have a longitudinal slot or groove (not shown) formed transversely through the firing bar 248 or in the firing bar 248. The helical gear 258 can have an internal pin or other feature (not shown) that is configured to engage with such a slot or other feature of the firing bar 248, the pin or other feature of the helical gear 258 also being configured to prevent rotation of the helical gear 258 about the firing bar 248 and allow the helical gear 258 to move through a range of motion relative to the firing bar 248. For example, such a slot or other feature of the helical gear 258 may be positioned at or near the proximal end of the longitudinal slot or groove of the firing bar 248 before the needle firing mechanism 240 is ready to fire; when the motor 246 is activated to move the helical gear 258 proximally to ready the needle firing mechanism 240 for firing, a pin or other feature engages the firing bar 248 to push the firing bar 248 and helical gear 258 together proximally. Then, after the slider 256 has been moved proximally into engagement with the catch 266, the motor 246 may be reversed. This reverse rotation of the motor 246 may move the helical gear 258 distally. The configuration of the slot or other feature of the firing bar 248 and the configuration of the pin or other feature of the helical gear 258 may allow such distal movement of the helical gear 258 relative to the firing bar 248, leaving the firing bar in a proximal, ready-to-fire position. Moreover, the configuration of the slot or other feature of the firing bar 248 and the configuration of the pin or other feature of the helical gear 258 may allow the firing bar 248 to move relatively easily distally relative to the helical gear 258 during such firing when the needle portion 10 is fired as described below. Other suitable relationships between the firing bar 248 and the helical gear 258 may also be used, including but not limited to the following variations.

When the user is ready to fire needle portion 10, the user may push and hold one or both of triggers 242 forward and may push one or both of buttons 244 while the one or both of triggers 242 remain forward. This actuation of trigger 242 and button 244 may cause catch 266 to release slide 256. Suitable structures and configurations for actuating trigger 242 and button 244 to cause catch 266 to release slide 256 will be apparent to those skilled in the art in view of the teachings herein. With the sled 256 thus released, the spring force of the spring 254 may urge the dampener 252 and washer 23 (and thus the firing bar 248, fork 250, and needle portion 10) distally, thereby firing the needle portion 10. Such distal movement of the needle portion 10 may be relatively abrupt and may be performed with sufficient force to cause the tip 14 of the needle portion 10 to pierce tissue.

In another variation, the motor 246 is not reversed to push the helical gear 258 back to the distal position before the needle portion 10 is fired. For example, the helical gear 258 may be integrally fixed to the firing bar 248 and may not be capable of longitudinal movement in any direction relative to the firing bar 248 through any range of motion. In this variation, the gears 260, 262, 264 may be configured to rotate freely as the needle portion 10 is fired, thereby providing only negligible resistance to distal movement of the firing bar 248. Alternatively, a clutch mechanism (not shown) may be provided to disengage one or more of the gears 260, 262, 264 during firing of the needle portion 10. Other ways of constructing or operating the needle firing mechanism 240 will be apparent to those skilled in the art in view of the teachings herein.

In this embodiment, trigger 242 and button 244 are configured such that pushing or actuating button 244 does not have a firing effect unless trigger 242 is held forward. Similarly, retention of trigger 242 does not result in firing of needle portion 10 until button 244 is also depressed while trigger 242 is held forward. One skilled in the art can appreciate suitable structures and configurations that provide interdependence of trigger 242 and button 244. For example, the button 244 may rotate with the trigger 242 such that the button 244 rotates forward with the trigger 242. In this form, the button 244 and catch 266 may be configured such that actuation of the button 244 does not cause the catch 266 to release the slider 256 unless the button 244 is rotated forward. In addition to or in lieu of button 244 being rotatable with trigger 242, trigger 242 can be configured to lock catch 266 in place (e.g., even when button 244 is actuated) until trigger 242 is rotated forward, which forward rotation of trigger 242 allows catch 266 to be released when button 244 is actuated. Other ways of providing button 244 and trigger 242 as interdependent elements for firing (or other purposes) will be apparent to those skilled in the art in view of the teachings herein.

C. Exemplary cutter drive mechanism

As shown in FIG. 30, the cutter drive mechanism 270 of this embodiment includes a motor 272 with a shaft 274 extending therefrom. The gear 208 is mounted to the shaft 274 and is configured to rotate integrally with the shaft 274. As described above, a portion of gear 208 is exposed through cap 204, and gear 208 engages gear 138 of cutter rotation and translation mechanism 120 when biopsy probe 102 is coupled to holster 202. Thus, when the motor 272 is activated to rotate, such rotation may be transmitted through the shaft 274 and gears 208, 138 to effect simultaneous rotation and movement of the cutter 50 as described above. Other ways of constructing or operating cutter drive mechanism 270 will be apparent to those skilled in the art in view of the teachings herein.

D. Exemplary tissue holder rotation mechanisms

As shown in fig. 31-32, the tissue holder rotation mechanism 280 of the present embodiment includes a motor 282 having a shaft 284, with a gear 286 mounted to the shaft 284, the gear 286 rotating integrally with the shaft 284. Gear 286 is configured to mesh with gear 288, and gear 288 is mounted to shaft 290. The gear 210 is also mounted to the shaft 290 and is located at the proximal end of the shaft 290. Specifically, gear 210 is configured to mesh with gear 170 of tissue sample holder 140 when biopsy probe 102 is coupled to holster 202. Thus, when the motor 282 is activated to rotate, such rotation may be transmitted through the shafts 284, 290 and gears 286, 288, 210, 170 to effect rotation of the manifold 144 as described above.

Further, the encoder wheel 292 is connected to the shaft 290, and is configured to rotate integrally with the shaft 290. The encoder wheel 292 has a plurality of slots 294 formed therethrough. The slots 294 are flared radially outward and are angularly spaced relative to each other. Of course, the slot 294 may have any other suitable configuration. A sensor 296 is positioned near the encoder wheel 292. Specifically, the sensor 296 is positioned such that the slot 294 passes in front of the sensor 296 continuously as the encoder wheel 292 rotates with the shaft 290. Accordingly, the sensor 296 may be used to count the passage of the slot 294, which may be converted into data indicative of the rotational position of the manifold 144. In other words, since the encoder wheel 292 and manifold 144 rotate together when the biopsy probe 102 is coupled to the holster 202 in this embodiment, the passage of the slot 294 past the sensor 296 during rotation of the shaft 290 may indicate rotation of the manifold 144 and, thus, the position of the manifold 144. It will be appreciated that information indicative of the position of manifold 144 may further indicate which particular chamber 166 is aligned with cutter lumen 52. Suitable uses for such information will be apparent to those skilled in the art in view of the teachings herein.

Suitable devices for sensor 296 will be apparent to those skilled in the art in view of the teachings herein. Similarly, suitable alternatives for the encoder wheel 292 and sensor 296 will occur to those skilled in the art, including, but not limited to, a combination of magnets and hall sensors, a combination of light sources and light sensors, and the like. Moreover, other ways of constructing or operating tissue holder rotation mechanism 280 will be apparent to those skilled in the art in view of the teachings herein.

Exemplary probes for ultrasound applications

As shown in fig. 33-37, an alternative biopsy probe 103 includes a needle portion 350 and a body portion 352. The body portion 352 includes a cover member 354 and a base member 356. Tissue sample holder 368 is removably secured to base member 356, but tissue sample holder 368 may alternatively be secured to cover member 354 or other component. As will be described in greater detail below, a pair of tubes 402, 404 are coupled with the probe 103. As will also be described in more detail below, and as described above, biopsy probe 103 is configured to couple with holster 302 to provide biopsy device 101.

A. Exemplary needle

In this embodiment, the needle portion 350 includes an outer cannula 12, the outer cannula 12 having a tissue piercing tip 14 and a transverse tissue receiving aperture 16 proximal to the tissue piercing tip 14. In the present embodiment, these constituent elements are the same as those of the same names and reference numerals described above, and thus, detailed description thereof will not be given here. In other words, the features, properties and constituent elements of the outer cannula 12, tip 14 and bore 16 (including cannula lumen 20, vacuum lumen 40, wall 30, lateral opening 32, etc.) as described above are the same for the needle portion 350 as described above with respect to the needle portion 10. Of course, they may alternatively be varied in various suitable ways, as desired.

Similarly, the cutter 50 in the probe 103 may have the same relationship with the needle portion 350 as described above for the cutter 50 and needle portion 10; and have the same features, properties and components as cutter 50 described above in the probe 102 section. Accordingly, these aspects of the cutter 50 are not repeated here.

B. Exemplary needle hub

As shown in fig. 36 and 37, needle hub 358 is secured to outer sleeve 12 of probe 103 and includes thumbwheel 62 and a sleeve portion 360 extending proximally from thumbwheel 62. Needle hub 358 of the present embodiment is overmolded around a proximal portion of outer cannula 12, although needle hub 358 may be formed and/or secured relative to outer cannula 12 using any other suitable technique (e.g., set screws, etc.). Moreover, although the needle hub 358 of the present embodiment is formed from a plastic material, any other suitable material or combination of materials may be used.

The sleeve portion 360 of this embodiment includes an annular projection 66, a plurality of flats 362, and a transverse opening 70 formed near the proximal end of the sleeve portion 360. A pair of O-rings 72 are positioned such that one O-ring 72 is located proximal to the lateral opening 70 and the other O-ring 72 is located distal to the lateral opening 70. As will be described in greater detail below, the transverse opening 70 is in fluid communication with the interior defined by the needle hub 60, the transverse opening 70 also being in fluid communication with the vacuum lumen 40 of the outer cannula 12. In this embodiment, another transverse opening 70 is formed through the sleeve portion 360, and is located between the O-rings 72 and opposite the other transverse opening 70. Other suitable configurations for sleeve portion 360 will be apparent to those skilled in the art in view of the teachings herein.

The thumbwheel 62 of the sleeve portion 360 is substantially the same as the thumbwheel 62 of the sleeve portion 64 of the probe 102 described above and operates in a similar manner. The thumbwheel 62 will not be described in further detail herein. Of course, if the thumbwheel 62 is not omitted in the case of the probes 102, 103, the thumbwheel 62 can instead be varied in various ways as desired.

In this embodiment, the exposed gear 364 is slid onto the sleeve portion 360. Specifically, the interior of gear 364 is configured to mate with flat 362 of sleeve portion 360 such that gear 364 rotates with sleeve portion 360. With sleeve portion 360 integrally engaged with outer sleeve 12, rotation of gear 364 will further cause sleeve 12 to rotate for reorienting bore 16. The gears 364 are exposed through the base member 356 and are further configured to mesh with corresponding exposed gears (not shown) of the holster (not shown). Specifically, the gears 364 are configured to mesh with the respective exposed gears such that the respective gears can impart rotation to the gears 364, thereby rotating the outer sleeve 12. However, in this embodiment, when probe 103 is connected to holster 302, gears 364 do not mesh with corresponding gears. It is understood that the gears 364 and the flats 362 may simply be omitted, if desired, as may other components and features described herein.

C. Exemplary needle manifold

As shown in fig. 34-36, a needle manifold 366 is disposed about the sleeve portion 360. In this embodiment, the needle manifold 366 is fixed relative to the base member 356. The needle manifold 366 is in fluid communication with the tubing 402 such that the tubing 402 can deliver saline, vacuum, and/or pressurized air, etc. to the needle manifold 366 as will be described in more detail below. The needle manifold 366 is also in fluid communication with the interior of the sleeve portion 360 via the transverse openings 70 (one of which is shown in fig. 37). O-ring 64 is configured to maintain a fluid seal between needle manifold 366 and sleeve portion 360 even as sleeve portion 360 rotates relative to needle manifold 366. A seal (not shown) may also be provided at the proximal end of sleeve portion 360 at the interface between sleeve portion 360 and cutter 50. Thus, needle manifold 366, sleeve portion 360 and outer sleeve 12 are constructed and arranged such that saline, vacuum and/or pressurized air, etc. delivered through tube 402 to needle manifold 366 will be delivered to vacuum lumen 40 via transverse opening 70. Of course, any other suitable structure or arrangement may be used to transfer saline, vacuum, and/or pressurized air, etc. from the tube 402 to the vacuum chamber 40.

D. Exemplary cutter rotation and translation mechanism

In this embodiment, as shown in fig. 34-35, the body portion 350 of the probe 103 includes a cutter rotation and movement mechanism 120, the cutter rotation and movement mechanism 120 being operable to rotate and move the cutter 50 within the outer sleeve 12. The cutter rotation and translation mechanism 120 of the present embodiment may have substantially the same components, features and operability as the cutter rotation and translation mechanism 120 described above in the probe 102 section. Accordingly, the cutter rotation and movement mechanism 120 will not be described in detail herein. Of course, cutter rotation and movement mechanism 120 may alternatively be varied in various ways, if the case of probes 102, 103.

E. Exemplary "Sharp element reduction" variations

Additionally, needle portion 350 and cutter 50 of biopsy probe 103 can be configured to be removable from biopsy probe 103 in substantially the same manner as described above with respect to the removal of needle portion 10 from biopsy probe 102. For example, the body portion 352 may include features similar to the release tabs 118, or any other suitable features, to provide, allow, or facilitate detachment of the needle portion 350 and cutter 50 from the body portion 352.

F. Exemplary tissue sample holder manifold

As shown in fig. 38-40, a tissue sample holder 368 is provided at the end of the body portion 352 of the probe 103. Tissue sample holder 368 includes cup 142, manifold 370, and a plurality of discs 372. The manifold 370 includes a central recess 146, a plurality of openings 374, and a longitudinally extending sidewall 382. In the present embodiment, the side wall 382 extends only a portion of the length of the manifold 370, but the side wall 382 may alternatively extend to any degree as desired. Manifold 370 also includes a plurality of radially extending walls 380. The inner surfaces of the walls 380 and 382 define a plurality of longitudinal channels 376. Each longitudinal channel 376 is in fluid communication with a respective opening 374.

In addition, the outer surfaces of the walls 380 and 382 define a plurality of chambers 378. Where the sidewalls 382 provide clearance (e.g., by not extending the entire length of the manifold 370), each chamber 378 is in fluid communication with a respective longitudinal channel 376. The manifold 370 is thus configured such that each opening 374 is in fluid communication with a respective chamber 378. Of course, any other suitable structure or configuration for the manifold 370 may also be used. For example, the manifold 144 described above with respect to the biopsy probe 102 may be used with the biopsy probe 103 in place of the manifold 370 used with the biopsy probe 103. Likewise, manifold 370 may be used with biopsy probe 102 in place of manifold 144 used with biopsy probe 102.

G. Exemplary tissue sample tray

The disk 372 of the present embodiment is configured for placement on the manifold 370 and receiving a tissue sample 4, as described in more detail below. Each disk 372 has a plurality of base portions 382, a plurality of hollow wall portions 384, and a plurality of webs 386. Base portion 382, hollow wall portion 384, and web 386 define chamber 388. By way of example only, each chamber 388 may be configured to receive a single tissue sample 4 captured by cutter 50. Alternatively, chambers 388 may be configured such that each chamber 388 may hold more than one tissue sample 4. As shown, the underside of each hollow wall section 384 is configured to receive a wall 380 of the manifold 370. As also shown, each hollow wall portion 384 has a generally tapered configuration, although any other suitable configuration may be used.

In addition, the disk 372 has a plurality of openings 390, the openings 390 being formed through the base portion 382 and extending longitudinally within each chamber 388. The opening 390 extends continuously radially outwardly through a portion of each web 386. Thus, the openings 390 allow fluid communication between each longitudinal channel 376 and each respective chamber 388 without the side walls 382 extending along the entire length of the manifold 370. In other words, each opening 374 is in fluid communication with a respective chamber 388.

Each disc 372 may also include one or more types of markings or other indicia to distinguish one chamber 388 from another chamber 388. Such markings or indicia may be the same as those described with respect to chamber 166 of tray 160. Accordingly, the description of such indicia or markings will not be repeated here. Similarly, cup 142 of tissue sample holder 368 is substantially identical to cup 142 of tissue sample holder 140 described above. Accordingly, discussion of the cup 142 is not repeated here.

H. Exemplary manifold rotation and alignment

The manifold 370 of the present embodiment is configured to rotate relative to the base member 356, as will be described in more detail below. The manifold 370 of the present embodiment is also configured such that each opening 374 can be selectively aligned with a port (not shown) that is in fluid communication with the tube 404. The alignment of the opening 374 with the port will place the aligned opening 374 in fluid communication with the tube 404 such that the conduction of vacuum within the tube 404 causes the vacuum to be conducted within the opening 374 and within the chamber 388 connected to the opening 374. In addition, the manifold 370 and disk 372 of the present embodiment are configured such that each chamber 388 is selectively placed in fluid communication with the cutter lumen 52. Thus, it will be appreciated that the vacuum in tube 404 may be communicated to cutter lumen 52 through the ports, associated opening 374, associated longitudinal channel 376, associated chamber 388 described above. Of course, there are various other ways of communicating the vacuum into cutter lumen 52, and any other suitable structure or technique may be used. Also, instead of or in addition to passing a vacuum into cutter lumen 52, pressurized air, a fluid (e.g., saline), or any other fluid may be passed through the above-described components in any direction.

The gear 170 is engaged with the manifold 370 of the present embodiment. Specifically, the gear 170 is inserted into the central recess 146 of the manifold 370. The gear 170 and the central recess 146 of the manifold 370 are identical in construction and operation to the gear 170 and the central recess 146 described with respect to the manifold 144. For example, the gear 170 is configured to mesh with a corresponding gear 210 of the rack 302 such that the gear 210 can be used to impart rotation to the gear 170. Such rotation may be used to selectively (e.g., sequentially) align chambers 388 with cutter lumen 52 to sequentially collect separate tissue samples 4 into each chamber 388 during use of biopsy device 101. Moreover, in such a procedure, such collection of the tissue sample 4 may be performed without having to retract and reinsert the needle portion 350 relative to the patient.

I. Exemplary "dog"

The body portion 352 of this embodiment also includes a claw portion 182 with teeth (not shown). The claw portion 182 is elastically urged to mesh the teeth with the gear 170. The jaw portion 182 is therefore substantially identical in construction and operation herein to the jaw portion 182 described in the context of the engagement member 180 of the probe 102. Accordingly, similar details regarding construction, function, operation, etc. are not repeated herein. However, it should be understood that in the present embodiment, the pawl portion 182 is integral with the remainder of the base member 356, rather than being provided as part of a separate engagement member 180. Of course, the body portion 352 may be modified such that the claw portion 182 is provided as part of a separate piece that is fixed relative to the base member 356. Similarly, the base member 116 of the probe 102 may be modified, and instead of being part of a separate engagement member 180 that is fixed relative to the base member 116, the jaw portion 182 may be formed as an integral piece of the base member 116. Other variations will occur to those skilled in the art in view of the teachings herein. Further, it is understood that biopsy device 101 may lack jaw portion 182 and that manifold 370 may rotate freely when biopsy probe 103 is not coupled to holster 302.

J. Exemplary dedicated channel

As shown in FIGS. 38-40, tissue sample holder 368 of the present embodiment has a channel 158 formed through manifold 370. The channels 158 of the manifold 370 are identical in construction, function, operability, etc. to the channels 158 of the manifold 144 described above. The details of the channel 158 are not repeated here. It will be appreciated that, similar to the channel 158 of the manifold 144, the channel 158 of the manifold 370 may be used to transfer instruments (such as biopsy site marker placement devices, appliers 90, and/or other devices) or fluids, etc. into and/or through the cutter lumen 52. Similarly, biopsy probe 103 may be initially provided with a channel 158 that is aligned with cutter lumen 52 in a default state.

Cup 142 of tissue sample holder 368 also includes opening 176 and hatch 178. Cup 142, opening 176, and hatch 178 of tissue sample holder 368 are substantially identical in construction, function, operability, etc., to cup 142, opening 176, and hatch 178 of tissue sample holder 140 described above. The details of the cup 142, opening 176, and hatch 178 are not repeated here.

Exemplary Frames for ultrasound applications

As shown in fig. 41-45, the alternative frame 302 includes a top housing member 304 and a bottom housing member 306, with a portion of each gear 208, 210 exposed through the top housing member 304. A boss 212 is disposed on top housing member 304 and is configured to disengage pawl portion 182 from gear 170 when biopsy probe 103 is coupled to holster 302. A plurality of hook members 305 extend from the top housing member 304 for selectively securing the probe 103 to the holster 302, although other structures or techniques may be used. The holster 302 of this embodiment also includes a cutter drive mechanism 310 and a tissue holder rotation mechanism 320. Each of these merely exemplary constituent elements will be described in more detail below. Holster 302 of the present embodiment is configured to couple with a biopsy probe 103 (such as biopsy probe 103 described above) to provide a biopsy device 101. In addition, holster 302 is configured to be portable so that a user may hold and manipulate biopsy device 101 with a single hand (e.g., using an ultrasound guide device, etc.). However, it will be appreciated in light of the teachings herein that the housing 302 may be used in various other arrangements and combinations. By way of example only, holster 302 may alternatively be coupled to biopsy probe 102 instead of biopsy probe 103. As just another illustrative example, holster 302 may be coupled to a modified biopsy probe 102 having a modified needle hub 60 (e.g., a shorter needle hub 60 not configured for firing needle portion 10, etc.).

A. Exemplary cutter drive mechanism

As shown in FIG. 44, the cutter drive mechanism 310 of this embodiment includes a motor 312 with a shaft 314 extending from the motor 312. The gear 208 is mounted to the shaft 314 and is configured to rotate integrally with the shaft 314. As described above, a portion of gear 208 is exposed through top housing member 304, and gear 208 engages gear 138 of cutter rotation and translation mechanism 120 when biopsy probe 103 is coupled to holster 302. Thus, when the motor 312 is activated to rotate, such rotation may be transmitted through the shaft 314 and gears 208, 138 to effect simultaneous rotation and movement of the cutter 50 as described above. Other ways of constructing or operating the cutter drive mechanism 310 will be apparent to those skilled in the art in view of the teachings herein.

B. Exemplary tissue holder rotation mechanisms

As shown in fig. 45, the tissue holder rotation mechanism 320 of the present embodiment includes a motor 322 having a shaft 324, a gear 326 mounted to the shaft 324, the gear 326 rotating integrally with the shaft 324. Gear 326 is configured to mesh with gear 328, and gear 328 is mounted to shaft 330. The gear 210 is also mounted to the shaft 330 and is located at the proximal end of the shaft 330. Specifically, gear 210 is configured to mesh with gear 170 of tissue holder 368 when biopsy probe 103 is coupled to holster 302. Thus, when the motor 322 is activated to rotate, such rotation may be transmitted through the shafts 324, 330 and gears 326, 328, 210, 170 to effect rotation of the manifold 370 as described above.

Further, the encoder wheel 292 is connected to the shaft 330, and is configured to rotate integrally with the shaft 330. The encoder wheel 292 has a plurality of slots 294 formed therethrough, similar to the slots 294 described previously. A sensor 296 is positioned near the encoder wheel 292. Specifically, the sensor 296 is positioned such that the slot 294 passes continuously in front of the sensor 296 as the encoder wheel 292 rotates with the shaft 330. Accordingly, the sensor 296 may be used to count the passage of the slot 294, which may be converted into data indicative of the rotational position of the manifold 366. In other words, since the encoder wheel 292 and manifold 366 rotate together when the biopsy probe 103 is coupled to the holster 302 in this embodiment, passage of the slot 294 past the sensor 296 during rotation of the shaft 330 may indicate rotation of the manifold 366 and, thus, the position of the manifold 366. It will be appreciated that information indicative of the position of the manifold 366 may further indicate which particular chamber 388 is aligned with the cutter lumen 52. Suitable uses for such information will be apparent to those skilled in the art in view of the teachings herein. Suitable devices for sensor 296 will be apparent to those skilled in the art in view of the teachings herein. Moreover, other ways of constructing or operating tissue holder rotation mechanism 320 will be apparent to those skilled in the art in view of the teachings herein.

C. Exemplary illumination feature

As shown in fig. 41 to 43, the housing 302 of the present embodiment further includes a plurality of light emitting diodes 308, 316, 318. Specifically, a pair of light emitting diodes 308 are disposed on the distal end of the housing 302. Light emitted by the light emitting diodes 308 may be viewed through an opening formed in the distal end of the top housing member 304. Light emitting diodes 308 are positioned and configured to function as "illumination lights" for biopsy device 101, such as by providing illumination for insertion of needle portion 350 into a site of a patient. The light emitting diode 308 may be activated continuously, such as when the biopsy device 101 is activated. Alternatively, the light emitting diodes 308 may be selectively activated, such as by a switch (not shown) located on the holster 302, on the probe 103, on the vacuum control module 400, or elsewhere. Other ways of activating, positioning, or operating or configuring the light emitting diodes 308 will be apparent to those skilled in the art in view of the teachings herein.

Light emitting diodes 316, 318 are disposed on the proximal end of the housing 302. Light emitted by the light emitting diodes 316, 318 may be viewed through an opening formed in the distal end of the bottom housing member 306. As shown, the light emitting diodes 316 are disposed on both sides of the light emitting diodes 318, respectively, the light emitting diodes 318 being positioned between the gear 210 and the boss 212. The light emitting diodes 316 are configured to provide illumination to the tissue sample holder 368. Specifically, in the present embodiment, manifold 370 and other components are configured to allow illumination of tissue sample holder 368 by light emitting diodes 316, 318. For example, the manifold 370, the gears 170, the shafts 172, and/or other constituent elements may be formed from a substantially transparent or substantially translucent material, including combinations of materials that provide combinations of transparent and/or translucent properties. The cup 142 may also be substantially transparent or substantially translucent to allow a user to see at least a portion of the light emitted by the light emitting diodes 316, 318. Appropriate selection and arrangement of materials and components for providing illumination to tissue sample holder 368 via light emitting diodes 316, 318 will be apparent to those skilled in the art in view of the teachings herein.

It will also be appreciated that one or more light emitting diodes 316, 318 may be positioned to provide illumination for a particular chamber 388 within tissue sample holder 368, rather than illumination for the entire tissue sample holder 368. For example, the light emitting diodes 316, 318 can be configured to illuminate active chambers 388, such as chambers 388 located at the nine o ' clock, twelve o ' clock, and/or three o ' clock positions. Moreover, one or more of the light emitting diodes 308, 316, 318 may be configured to blink or change color to indicate an error condition (e.g., blockage of the cutter lumen 52, insufficient connection of the probe 103 to the holster 302, leakage in the tubes 402, 404, 408, 410, etc.). Other ways of activating, positioning, or operating or configuring the light emitting diodes 316, 318 will be apparent to those skilled in the art in view of the teachings herein.

It is also understood that the chassis 202 may be modified to include any of the light emitting diodes 308, 316, 318. Similarly, the manifold 144 and/or other components of the probe 102 may be configured to allow illumination of the manifold 144 by the light emitting diodes 316, 318; and the cup 142 may be configured to allow an observer to observe the illumination of the manifold 144 in the biopsy device 100. Alternatively, any or all of the light emitting diodes 308, 316, 318 may simply be omitted from the biopsy device 100, 101.

Although the use of light emitting diodes 308, 316, 318 to provide illumination has been described in this embodiment, any other suitable light source may be used, including but not limited to incandescent lamps. Alternatively, biopsy devices 100, 101 may lack a light source.

V. exemplary vacuum control Module and vacuum canister

Fig. 46-47 illustrate an exemplary vacuum control module 400 and an exemplary vacuum canister 500. As shown, the vacuum canister 500 is configured to be inserted into the vacuum control module 400. As will be explained in more detail below, vacuum control module 400 is operable to direct a vacuum through vacuum canister 500, and such vacuum may be communicated to biopsy probes 102, 103 as described above. Furthermore, the vacuum canister 500 may be operated to collect fluid transferred from the biopsy probe 102, 103 during use of the biopsy probe 102, 103. Thus, vacuum canister 500 may be considered a fluidic interface between biopsy probes 102, 103 and vacuum control module 400.

A. Exemplary vacuum canister

As shown in fig. 48 to 51, the vacuum canister 500 includes a base 502, a cover 506, and a handle 508. The handle 508 is configured to be grasped by a user when inserting the vacuum canister 500 into the vacuum control module 400 or retrieving the vacuum canister 500 from the vacuum control module 400, as will be described in more detail below. The base 502 is substantially hollow and is configured to provide a reservoir 504 for collecting fluid (e.g., saline, blood, etc.) communicated from the biopsy probe 102, 103.

The cover 506 of the present embodiment has a rail 530 formed at a side thereof. The rails 530 are configured to engage guide rails 460 in the canister compartment 458 of the vacuum control module 400, as will be described in more detail below. Each rail 530 has a flared portion 532 to provide a guide for engaging rail 530 with rail 460, thereby facilitating insertion of vacuum canister 500 into canister compartment 458 in vacuum control module 400. In other embodiments, the track 530 is disposed on the base 502. Alternatively, any other suitable structure may be used in addition to or in place of track 530 at any other suitable location, or track 530 may be omitted.

In the present embodiment, the cover 506 has a plurality of grooves 510 formed therein. The groove 510 is configured to receive the tubes 402, 404, 408, 410, as described below. A plurality of top ports 512 are formed on the cover 506, and each top port 512 is configured to have one of the tubes 402, 404 connected thereto. Specifically, each top port 512 is configured to provide a path for fluid transfer from the connected tubes 402, 404 to the reservoir 504 defined by the base 502. The cover 506 also includes a vacuum port 514, the vacuum port 514 configured to be in fluid communication with a vacuum source 412 in the vacuum control module 400, as will be described in more detail below. The vacuum ports 514 include a pair of O-rings 534, the O-rings 534 configured to provide a seal when engaged with a corresponding vacuum port 462, as will be described in more detail below. It will be appreciated in view of the teachings herein that when the vacuum source 412 is used to generate a vacuum, such vacuum may be communicated to the tubes 402, 404 through the vacuum port 514, the reservoir 504, and the top port 512. The vacuum may be further transferred to the biopsy probes 102, 103 through the tubes 402, 404. The cover portion 506 also includes a ventilation access opening 544 for accessing the open end of the ventilation tube 410. This ventilation will be described in more detail below.

The cover 506 also has a cap 526, the cap 526 being removably secured to the access port 528. Cap 526 is configured to provide a seal of access port 528 during use of biopsy system 2. After biopsy system 2 has been used, and liquid is present in reservoir 504, cap 526 may be removed to use reservoir 504. Of course, as with the other components mentioned herein, the cap 526 and the access port 528 are merely optional and may be changed, replaced, supplemented, or omitted as desired.

As best shown in fig. 51, the float 516 is disposed in a cartridge 518, the cartridge 518 extending from the bottom of the cover 506 into the reservoir 504. Although the float 516 is shown as being spherical, any other suitable shape may be used. A resilient chimney member 520 is partially disposed within the box 518 and engages the box 518. Further, a hydrophobic filter 522 is provided between the bottom of the cover 506 and the chimney member 520. A conduit 524 is formed in the cover 506 providing fluid communication from the vacuum port 514 to the filter 522 and chimney member 520 and, thus, to the reservoir 504. The filter 522 is configured to prevent fluid (e.g., saline, blood, etc.) from the reservoir 504 through the tubing 524 to the vacuum port 514; while allowing vacuum to be transferred or directed therethrough.

The float 516 has characteristics (e.g., density) such that it floats in the liquid but is not drawn upward when a vacuum is directed in the reservoir 504. In other words, when the vacuum source 412 is activated to direct a vacuum through the vacuum port 514, the float 516 does not have to be drawn up against the chimney 520. Thus, a vacuum may be transmitted "around" the float and through the chimney member 520. However, when the reservoir 504 is full of liquid, the float 516 begins to float upward toward the chimney member 520. Eventually, liquid is drawn into the reservoir 504 through the tubes 402, 404 and the top port 512 reaches a height within the reservoir 504 to a position where the float 516 engages the chimney 520 in a manner sufficient to prevent fluid from passing between the float 516 and the chimney 520. Moreover, such engagement between the float 516 and the chimney member 520 may prevent the vacuum from being transferred to the reservoir 504 through the vacuum port 514. This blockage of vacuum delivery may be sensed in biopsy system 2 and some notification may be initiated indicating that vacuum canister 500 is substantially full of liquid. For example, a vacuum blockage may cause an automatic shut-off of the vacuum source 412. The vacuum occlusion may also initiate an audible indication and/or a visual indication on a graphical user interface.

As may be recognized by those of ordinary skill in the pertinent art based on the teachings herein, the filter 522, the float 516, the cartridge 518, and the chimney member 520 are merely exemplary. Indeed, any other suitable device or structure may be used in addition to or in place of these constituent elements. Alternatively, these constituent elements may simply be omitted. In other words, the inventors contemplate that various other configurations for vacuum canister 500 may be used, and that, as with every other component element of biopsy system 2 described herein, vacuum canister 500 need not be limited to the particular configuration specifically described herein.

B. Exemplary pipe connections and configurations

FIG. 50 shows tubes 402, 404, 408, and 410 disposed in a groove 510. The groove 510 includes one or more features configured to retain the tubes 402, 404, 408, and 410 in the groove 510. For example, inwardly directed ribs or protrusions may be provided near the top of the groove 510. Alternatively, the sidewalls of the groove 510 may provide an interference fit; or may be sloped such that the top of the sidewalls of the trench 510 provides a smaller gap than the bottom of the sidewalls. Alternatively, an adhesive may be used to secure the tubes 402, 404, 408, and 410 within the groove 510. As another variation, one or more caps, clasps, or other members may be secured to portions of the tubes 402, 404, 408, and 410 to secure the tubes 402, 404, 408, and 410 within the groove 510. Other ways of securing or retaining the tubes 402, 404, 408, and 410 within the groove 510 will be apparent to those skilled in the art.

A plurality of top ports 512 are formed on the cover 506, and each top port 512 is configured to connect with one of the tubes 402, 404. Specifically, each top port 512 is configured to provide a fluid transfer path for fluid from the connected tubes 402, 404 to the reservoir 504 defined by the base 502. In one embodiment, rather than attaching the tubes 402, 404 to the probes 102, 103 prior to product packaging, the vacuum canister 500 is prepackaged with the tubes 402, 404, 408, and 410 already positioned in the channel 510. In other embodiments, the vacuum canister 500 and/or the probes 102, 103 may be packaged without connecting some or all of the tubes 402, 404, 408, and 410. However, in some embodiments in which the vacuum canister 500 and probes 102, 103 are pre-connected to tubes 402, 404, 408 and 410, the user may connect tube 408 to saline bag 444 as the only fluid connection the user needs to make, in addition to inserting the vacuum canister 500 into the canister chamber 458 as described below. Of course, in some embodiments, saline is not used and the fluid transfer of biopsy system 2 is ready for use, so long as the user inserts vacuum canister 500 into canister chamber 458.

As shown in fig. 1, tube 408 feeds into tube 402. As shown in fig. 1 and 50, tube 410 is also fed into tube 402. Specifically, connector 446 connects vent tube 410 to tube 402; and a connector 448 connects the saline tube 408 to the tube 402. As shown, connector 446 is disposed proximate vacuum canister 500; and the connector 448 is disposed proximate the biopsy probes 102, 103. In this embodiment, the connectors 446, 448 simply provide a constant conduit between the tubes 410, 402 and the tubes 408, 402, respectively. In other embodiments, the connectors 446, 448 may have any other suitable elements (e.g., valves, etc.). It will be appreciated in view of the teachings herein that the configuration of the tubes 402, 408, 410 and connectors 446, 448 allow any one or more of vacuum, air, or saline to pass through the tube 402. Exemplary ways in which these substances may be passed through the tube 402 will be described in detail below.

C. Exemplary vacuum control Module

As shown in fig. 46, 47, and 52-58, the vacuum control module 400 of the present embodiment includes a housing 414, a vacuum canister slot 416, a handle portion 418, and a user interface 700. The housing 414 includes: a face 420 behind which a display 702 is placed; a capacitive switch 704; and a speaker 706. The face 420 is configured to: the display 702 may be viewed through the face 420, the capacitive switch 704 activated, and sound from the speaker 706 heard. As described in detail below, the display 702, the capacitive switch 704, and the speaker 706 can be considered to together form the user interface 700. The housing 414 also includes a top cover 422, a surrounding cover 424, and a trim piece 426.

The housing 414 is configured to be relatively easy to clean. For example, surface transitions (e.g., between the face 420, the top cover 422, the surrounding cover 424, and the trim piece 426) are reduced. Also, instead of conventional buttons or other mechanical input elements, capacitive switches 704 are disposed behind face 420, which eliminates or reduces fluid intrusion and dirty areas.

As shown in FIG. 53, the vacuum control module 400 of this embodiment also includes a base 428 having a pair of upstanding members 430, the upstanding members 430 extending upwardly from the base 428 and inwardly toward each other and meeting at the handle portion 418. Thus, the base 428, the upright members 430, and the handle portion 418 are configured such that when a user carries the vacuum control module 400 through the handle portion 418, the weight of the vacuum control module 400 is borne by the base 428 and the upright members 430. In one embodiment, the upright member 430 and the handle portion are formed integrally by an integral metal member that is fixedly attached to the base 428 by screws, bolts, welding, or using other elements or techniques. Handle portion 418 further includes an overmold of plastic material formed around the integral metal member. Of course, as with other elements described herein, the upright member 430 and the handle portion 418 may be formed in a variety of alternative ways using a variety of alternative structures and techniques.

With the handle portion 418, the vacuum control module 400 may be provided as a substantially portable unit. For example, the size and weight of the vacuum control module 400 (e.g., less than 10kg), it may be relatively easy for a single user to lift and carry the vacuum control module 400 by grasping the handle portion 418 or otherwise. The vacuum control module 400 may be used with or without a cart. For example, the portability of the vacuum control module 400 allows it to be simply placed on a table top or other location. Such portability may be desirable in magnetic resonance imaging devices or other devices.

The vacuum control module 400 of the present embodiment also includes a fan 432 and a vent 433, but these elements may be varied or omitted. The vacuum control module 400 also includes a ground pad 434, a USB port 436, and a network port 438. In addition, the vacuum control module 400 includes a cord receptacle 435 for connecting the vacuum control module 400 to an AC outlet using a conventional cord and a power switch 439. As may be recognized by those of ordinary skill in the pertinent art based on the teachings herein, the USB port 436 and/or the network port 438 may be used to connect the vacuum control module 400 to various other devices, including but not limited to a local or remote desktop or laptop computer, the internet, a local area network, other networks, storage devices, or devices connected to one or more imaging modalities (e.g., a box or cart connected to magnetic resonance imaging). Such ports 436, 438 may allow data and/or instructions to be communicated from the vacuum control module 400 to an external device. Additionally or alternatively, the ports 436, 438 may allow data and/or instructions to be communicated from an external device to the vacuum control module 400. Other ways of using the ports 436, 438 will be apparent to those skilled in the art in view of the teachings herein.

As shown in fig. 53, a vacuum pump 440 is provided in the vacuum control module 400. The muffler assembly 442 is coupled to the vacuum pump 440 to reduce noise generated by the vacuum pump 440. Vacuum pump 440 and muffler assembly 442 thus collectively provide vacuum source 412 in this embodiment, although any other suitable components may be used. For example, the muffler assembly 442 is merely optional. Vacuum pump 440 and muffler assembly 442 are fixedly attached to base 428 by screws, bolts, welding, or using other elements or techniques. One or more rubber feet (not shown) or similar elements are positioned between the vacuum pump 440 and the base 428 to absorb vibrations generated by the vacuum pump 440, for example, to reduce noise. Other ways of reducing the noise of the vacuum pump 440 will be apparent to those skilled in the art in view of the teachings herein.

In this embodiment, saline is provided to biopsy system 2 through a conventional saline bag 444, where saline bag 444 is separate from vacuum control module 400. For example, the saline bag 444 may be connected to the tube 408 using any suitable conventional tube connector. In other embodiments, saline is provided from within the vacuum control module 400. For example, the vacuum control module 400 may include features (not shown) operable to receive a conventional saline bag 444 having ports (not shown) for fluidly communicating the tube 408 with the saline bag 444. The vacuum control module 400 may alternatively include some other type of reservoir within the housing 414 for providing saline. In other embodiments, saline is not used with biopsy system 2. It will also be appreciated that the vacuum control module 400 may also include a source of pressurized air, such as a pump or a flush tank, for example. Such pressurized air may be delivered to biopsy device 100, 101 for any suitable purpose, including but not limited to delivering pressurized air through one or more lumens 20, 40, 52, activating elements (e.g., pneumatic motors or actuators, etc.) in biopsy device 100, 101, or for any other purpose. Other elements that may be incorporated into or coupled to the vacuum control module 400 will be apparent to those skilled in the art in view of the teachings herein.

D. Exemplary vacuum canister in control Module

As shown in fig. 53-58, the vacuum control module 400 of the present embodiment further includes a vacuum tank port assembly 450. The vacuum tank port assembly 450 includes a bracket 452, an inner housing 454, and a plurality of electromagnetic coils 456. The bracket 452 is configured to be fixedly attached to the base 428, such as by screws, bolts, welding, or using other elements or techniques. The heat sink 459 is secured to the bracket 452, as are the electromagnetic coil 456 and the inner housing 454.

The inner housing 454 defines a canister chamber 458, the canister chamber 458 configured to receive the vacuum canister 500 as described above. Specifically, guide rails 460 extend inwardly from the interior of bracket 452, through the side walls of inner housing 454, and into canister compartment 458. As described above, the guide rail 460 is configured to engage the rail 530 on the vacuum canister 500 to guide the vacuum canister 500 as the vacuum canister 500 is inserted into the canister chamber 458. In this embodiment, each rail 460 has a tapered portion 466 to facilitate engagement with the track 530, although the tapered portion 466 is merely optional. It will be appreciated in light of the teachings herein that the guide rails 460 may alternatively extend inwardly only from the side walls of the inner housing 454, rather than from the brackets 452. Alternatively, the guide rail 460 may be constructed or positioned, or omitted.

E. Exemplary vacuum canister quick connect

The inner housing 454 of this embodiment also includes a vacuum port 462. A port connector 464 is disposed exterior of the inner housing 454 opposite the vacuum port 462 and is in fluid communication with the vacuum port 462. The port connector 464 is configured to connect with tubing, hoses, or other structures for connecting it to the vacuum pump 440. In other words, the vacuum pump 440 may be in fluid communication with the vacuum port 462 through a tube (not shown) connected to the port connector 464, such that the vacuum pump 440 may draw a vacuum through the vacuum port 462. The vacuum port 462 is configured to engage the vacuum port 514 of the vacuum canister 500 when the vacuum canister 500 is inserted into the canister chamber 458. Specifically, vacuum port 462 provides a female connection that is complementary to the male connection of vacuum port 514, and O-ring 534 on vacuum port 514 is configured to provide a sealing engagement between vacuum port 462 and vacuum port 514. Of course, the male-female connection engagement between the vacuum ports 462, 514 may be reversed, or some other relationship between the vacuum ports 462, 514 may be provided. Also, other variations in which the O-ring 534 is replaced, supplemented, or omitted may be used.

F. Exemplary throttle valve System

Each electromagnetic coil 456 includes a respective rod 470. Each rod 470 has a respective engagement tip 472, 474, 476, 478 integrally secured thereto. Each electromagnetic coil 456 is operable to selectively move the rod 470 when the electromagnetic coil 456 is activated, causing the tips 472, 474, 476, 478 to move up or down depending on the signal delivered to the electromagnetic coil 456. The rod 470 is positioned such that the tips 472, 474, 476, 478 selectively engage the tubes 402, 404, 408, 410 by selective actuation of the solenoid 456 when the vacuum canister 500 is inserted into the canister chamber 458. Specifically, when the vacuum canister 500 is inserted into the canister chamber 458 of the vacuum control module 400, the tip 472 is positioned to selectively engage the saline tube 408; the tip 474 is positioned to selectively engage the vent tube 410; the tip 476 is positioned to selectively engage the axial vacuum tube 404; and the tip 478 is positioned to selectively engage the transverse vacuum tube 402.

Grooves 536, 538, 540, 542 are formed in the cover 506 of the vacuum canister 500 and are configured to provide sufficient clearance for the tips 472, 474, 476, 478 to fully engage the tubes 402, 404, 408, 410. Such engagement may include the tips 472, 474, 476, 478 pinching the tubes 402, 404, 408, 410 against the cap 506 (e.g., using the cap 506 as an engagement surface), thereby preventing fluid communication through the tubes 402, 404, 408, 410.

In this embodiment, recess 536 is configured to allow tip 472 to fully engage saline tube 408, recess 538 is configured to allow tip 474 to fully engage vent tube 410, recess 540 is configured to allow tip 476 to fully engage axial vacuum tube 408, and recess 542 is configured to allow tip 478 to fully engage transverse vacuum tube 402. In this embodiment, full engagement of the tips 472, 474, 476, 478 with the tubes 402, 404, 408, 410 will serve to prevent fluid from passing through the fully engaged tubes 402, 404, 408, 410. In other words, the solenoid 456, the stem 470, and the tips 472, 474, 476, 478 may be used to perform a valve function with respect to the tubes 402, 404, 408, 410 such that selective activation of the solenoid 456 allows or prevents fluid from passing through the tubes 402, 404, 408, 410. The combination of verifications to allow/prevent fluid transfer through the tubes 402, 404, 408, 410 during use of the biopsy system 2 will be described in detail below.

In some variations, each electromagnetic coil 456 is engaged with one or more resilient members (e.g., springs, etc.). For example, such a resilient member may be located at the bottom of the electromagnetic coil 456 and used to control stack-up tolerances and match the force profile of the electromagnetic coil 456 to the force profile of the tubes 402, 404, 408, 410. Of course, such resilient members may be located in other positions and perform other functions in addition to or in place of those described above. Similarly, other elements may be used to control stack-up tolerances and match force profiles. Alternatively, such resilient members or other elements may simply be omitted.

Although fluid control is provided by solenoid 456, rod 470 and tips 472, 474, 476, 478 in this embodiment, it will be appreciated that fluid control may be provided in a variety of alternative ways. For example, an alternative valve arrangement or system may be provided in the vacuum control module 400. Alternatively, all or part of the valve function may be performed in the biopsy device 101, 102. For example, a constant vacuum may be delivered to biopsy devices 101, 102, and valve members in biopsy devices 101, 102 may be operated to selectively deliver such vacuum to vacuum lumen and/or cutter lumen 52. In other embodiments, one or more motors located in biopsy devices 100, 101 may be used to control a vacuum pump located in biopsy devices 100, 101 to provide a vacuum. Such vacuum motors may be dedicated to controlling such pumps, or preexisting motors 246, 272, 282, 312, 322 may be used to control such pumps. In view of the teachings herein, one skilled in the art may contemplate selectively controlling or providing fluid (e.g., saline, vacuum, air, etc.) communication through tubes 402, 404, 408, 410, etc. within biopsy system 2.

G. Exemplary collapsible tube

In some embodiments, as shown in fig. 59, the tubes 402, 404, 408, 410 are formed with a plurality of longitudinal slits 490. In the present embodiment, the slit 490 extends along the entire length of each tube 402, 404, 408, 410. In other embodiments, the slit 490 extends only over the portion of the tube 402, 404, 408, 410 selectively engaged by the tip 472, 474, 476, 478. When the tubes 402, 404, 408, 410 are made of a low durometer polymer and have slits 490, the tubes 402, 404, 408, 410 have a relatively low resistance to collapse by the tips 472, 474, 476, 478 sufficient to stop fluid transfer in the tubes 402, 404, 408, 410 collapsed by the tips 472, 474, 476, 478. However, despite the slots 490, the tubes 402, 404, 408, 410 still have sufficient strength to recover from the collapsed state when a vacuum is introduced therein. The tubes 402, 404, 408, 410 may also have sufficient thickness to provide resistance to twisting.

It will be appreciated in light of the teachings herein that the slits 490 can be formed in the tubes 402, 404, 408, 410 using a variety of techniques. For example, in forming the tubes 402, 404, 408, 410 using a thermoplastic extrusion process, a low temperature knife may be provided at the exit of the extrusion die to cut the material while it is still hot. Alternatively, when forming the tubes 402, 404, 408, 410 using a thermoset extrusion process, a high temperature knife may be provided at the exit of the extrusion guide to cut the material as it is not dry. Instead, the slit 490 is formed by cutting downstream of a curing oven or cooling chamber. Other ways of forming the slit 490 will be apparent to those skilled in the art in view of the teachings herein. It will also be appreciated that any other suitable configuration of the slits 490 (e.g., number of slits 490, depth of the slits 490, length of the slits 490, selection of tubes 402, 404, 408, 410 having slits 490, etc.). Of course, the slit 490 may simply be omitted.

Also, one or more of the tubes 402, 404, 408, 410 may be colored or translucent, such as to hide blood that may be transferred therethrough.

H. Exemplary Motor control

The vacuum control module 400 of the present embodiment also includes a controller 480 operable to control the motors 246, 272, 282, 312, 322 in the racks 202, 302. For example, a single controller 480 may coordinate the motor functions of the different motors 246, 272, 282, 312, 322 within the same biopsy system 2. The vacuum control module 400 includes a port 482 for providing motor control signals and the transfer of energy to the motors 246, 272, 282, 312, 322 via a cable 484. In other embodiments, the motor control signal is provided wirelessly. Although the rack 202 of the present embodiment has three motors 246, 272, 282 and the rack 302 of the present embodiment has two motors 312, 322, the same controller 480 and port 482 may be used to control each rack 202, 302. Alternatively, each rack 202, 302 may have a respective dedicated port on the vacuum control module 400.

The motors 246, 272, 282, 312, 322 may include any suitable combination of brush or brushless technology. For example, one or more of the motors 246, 272, 282, 312, 322 may be a brushless motor using an optical switch. In some embodiments, the use of optical switches may provide the ability to be immune to high ambient magnetic fields, such as those in a magnetic resonance imaging environment. A Motor using an optical switch, by way of example only, is described in U.S. patent No.5,424,625 entitled "replacement Motor", published on 13.6.1995, the contents of which are incorporated herein by reference. Another Motor using an optical switch, by way of example only, is described in U.S. patent No.7,053,586 entitled "Brush failure report Motor Speed Control System" published on 30/5 2006, the contents of which are incorporated herein by reference.

For example only, one or more of the motors 246, 272, 282, 312, 322 may include an OPTEK OPR5005 reflective micro-surface mount light source/monitor sensor pair. Suitable sensors include those that are transmissive and/or those that are reflective. Also, the light used may be interfering light (e.g., laser light) or non-interfering light (e.g., light generated by a light emitting diode). Either the visible spectrum or the invisible spectrum may be used. In this embodiment, a reflective Infrared (IR) sensor including an infrared photodiode and an infrared phototransistor is used. The photosensors are arranged in a circular array on the printed circuit board at 120 degree increments around the motor shaft and in angular alignment with the phase coils of the motor. A flag or photo-interrupter aligned with a magnet on the rotor is fixed to the motor shaft, which is transmissive/non-refractive on one half of its circumference and refractive/non-transmissive on the other half. When the phase coils are properly aligned with the optical sensors and the optical markers are properly aligned with the magnetic poles on the rotor, the 60 degree position of the rotor can be sensed as long as it has a hall effect sensor. Further, the logic level output from the optical sensor may be the same as that of the hall effect sensor, allowing interchangeability of sensing types with control hardware such as controller 480. Other suitable configurations for motors 246, 272, 282, 312, 322, including those using light switches, etc., will be apparent to those skilled in the art in view of the teachings herein.

The controller 480 of the present embodiment includes a Magellan 4 axle chipset from Performance Motion Devices, Inc. of Lincoln, Massachusetts. In one embodiment, the controller 480 is configured to use hall effect signals for position based control of any of the motors 246, 272, 282, 312, 322. For example, as described above, the motors 282, 322 of the present embodiment are operatively coupled with the encoder wheel 292 and the sensor 296. This configuration may provide a three-channel (A, B and marker pulse) integral encoder that, together with the controller 480, allows repeatability of positioning the manifolds 144, 366 within about 0.1 degrees.

In some embodiments, hall effect sensors are used to provide rectification and position control of at least one of the motors 246, 272, 282, 312, 322. The controller 480 is configured to provide a multiplexing scheme with the signals provided by such hall effect sensors and the signals provided by the sensors 296, whereby sixteen differential signals are multiplexed to four or six differential lines associated with the ports 482 or effectively continuous through the cables 484. Of course, any other suitable multiplexing scheme, if used, may be used. Other suitable configurations or methods of operation via the controller 480 will be apparent to those skilled in the art in view of the teachings herein.

Exemplary mode of operation

As may be appreciated in light of the teachings herein, there are a variety of ways to operate biopsy system 2. For example, regardless of the structure or technique used to selectively control the delivery of fluid (e.g., saline, vacuum, air, etc.) within biopsy system 2 through tubes 402, 404, 408, 410, etc., there are a variety of timing algorithms that may be used. These timing algorithms vary depending on the mode of operation selected by the user. Moreover, there may be an overlap in the operational modes (e.g., biopsy system 2 may be in more than one operational mode at a given time). In addition to the fluid delivery timing algorithm being variable based on the selected mode of operation, other operational aspects of biopsy system 2 are also variable based on the selected mode of operation. For example, the operation of tissue sample holders 140, 368 may vary based on the selected mode of operation, as may the operation of cutter 50 and other elements of biopsy system 2. Several modes of operation, by way of example only, will be described in greater detail below, and others will occur to those skilled in the art in view of the teachings herein.

A. Introduction to exemplary capturing tissue samples

One exemplary enabling mode includes an "observe sample" mode. In this mode, the manifold 144, 366 is configured to rotate after the tissue sample 4 is obtained in order to present the tissue sample 4 to the operator for viewing before the user obtains the next tissue sample. Specifically, as shown in fig. 60, the tissue sample 4 is drawn into the chamber 166, 388 which was in the twelve o' clock position when the tissue sample 4 was initially taken. Manifold 144, 366 is then rotated until tissue sample 4 is in the three o' clock position, thereby allowing the user to easily view tissue sample 4 from the side of biopsy device 100, 101. Such rotation may occur substantially immediately after the tissue sample 4 is drawn into the chambers 166, 388. Alternatively, biopsy system 2 may "wait" to see if any user input has occurred for a period of time (e.g., 2 seconds) after tissue sample 4 has been captured, and then rotate tissue sample 4 to the three o' clock position only if no user input has occurred for that period of time.

The rotational position of the manifold 144, 366 may be maintained to maintain the tissue sample 4 in the three o' clock position until some other user input is provided. For example, if the user provides input indicating a desire to obtain another tissue sample 4, the biopsy system 2 may rotate the manifold 144, 366 to align the next available chamber 166, 388 (e.g., the chamber 166, 388 that is stored immediately adjacent to the chamber 166, 388 from which the recently obtained tissue sample 4 was obtained) with the cutter lumen 52. After the next available chamber 166, 388 has been aligned with the cutter lumen 52, the cutter 50 is activated to take the next tissue sample 4, and the next tissue sample 4 may be aspirated to the next available chamber 166, 388 using an axial vacuum. If provided with user input of a "clean probe" or "aspirate," the manifolds 144, 366 may be rotated to realign the chambers 166, 388 in which the tissue sample 4 is stored with the cutter lumen 52, and then perform a "clean probe" or "aspirate" control as described below. Similarly, if a "smart vacuum" cycle (described in detail below) is initiated, the manifold 144, 366 may then be rotated to realign the chambers 166, 388 in which the tissue sample 4 is stored with the cutter lumen 52, thereby performing the "smart vacuum" cycle.

Fig. 60 shows a view of the rotation sequence of the present embodiment. As shown in block 600, the tissue sample holder 140, 368 is initially configured with the first chamber 166, 388 in the twelve o' clock position. Tissue sample 4 is then transferred to first chambers 166, 388, as shown in block 602. With the "observe sample" mode activated, the manifold 144, 366 is rotated such that the first chamber 166, 388 is at the three o' clock position, as indicated at block 604. Upon receiving a user input to initiate another sampling cycle, the manifold 144, 366 is rotated such that the second chamber 166, 388 is at the twelve o' clock position, and the tissue sample 4 is then transferred to the second chamber 166, 388 via the cutter lumen 52, as shown in block 606. As shown in block 608, the manifolds 144, 366 are rotated such that the second chambers 166, 388 are in the three o' clock position to present the tissue sample 4 to the user. The process of the present embodiment is repeated as shown in block 610 to obtain a tissue sample 4 in the third chambers 166, 388. This process may be repeated until all of the chambers 166, 388 in the tissue sample holders 140, 368 are filled.

Instead of waiting for user input, the tissue sample 4 may be held in the three o' clock position for a period of time (e.g., 5 seconds), and the manifold 144, 366 automatically rotated to align the next available chamber 166, 388 with the cutter lumen 52, regardless of whether the user provides input. As another non-limiting variation, biopsy system 2 may only hold tissue sample 4 in the three o' clock position for a period of time unless the user provides some type of input before that time expires, which would result in rotating manifolds 144, 366 as described above. In view of the teachings herein, one skilled in the art may contemplate other ways for determining the timing and/or user input for maintaining the tissue sample 4 in the three o' clock position for an extended period of time. It will also be appreciated that rotational control of the manifolds 144, 366 may be performed, at least in part, by the controller 480 in conjunction with feedback from the encoder wheel 292 and sensor 296, or using any other suitable element.

Biopsy system 2 may also be configured to allow a user to select a nine o 'clock position (or any other position) instead of the three o' clock position described above for presentation to tissue sample 4. Biopsy system 2 may also allow a user to disable the "view sample" mode, with the only rotation of manifolds 144, 366 between acquisitions of tissue samples 4 being to align the next available chamber 166, 388 with cutter lumen 52. Variations of biopsy system 2 may lack a "view sample" mode or similar mode, and the constituent elements that may be used for that mode.

B. Exemplary "sampling" cycle

Another exemplary mode of operation that may overlap the "observe sample" mode described above is the sample mode, in which a "sample" cycle is initiated. Fig. 61 shows an exemplary sequence of cutters 50 positioned in the outer cannula 12 during a "sample" cycle relative to the fluid communication provided through the tubes 402, 404. The cycle is initiated after the needle portion 10 has been inserted into the patient's chest. With the needle portion 10 inserted, a transverse and axial vacuum is applied. Specifically, the solenoid 456 is activated and the tips 476, 478 are moved upward to substantially disengage the tubes 402, 404, thereby allowing vacuum to be transferred through the tubes 402, 404. Assuming tube 402 is in fluid connection with needle manifolds 80, 366 and transverse opening 32 formed through wall 30, the transmission of vacuum through tube 402 will draw a transverse vacuum relative to cannula lumen 20. Given that tube 404 is fluidly connected to cutter lumen 52 via tissue sample holders 140, 368 in this embodiment, the transmission of vacuum through tube 404 will draw an axial vacuum through cutter lumen 52.

With the application of axial and lateral vacuum as described above, cutter 50 is axially retracted. This axial retraction is performed by the motors 272, 312 and the cutter rotation and movement mechanism 120 as described above. Axial retraction of cutter 50 serves to "open" aperture 16, which "opens" aperture 16, causing tissue to prolapse into aperture 16 under the influence of the vacuum described above. The cutter 50 may be parked in the retracted position for a period of time to ensure that the tissue is sufficiently prolapsed.

Next, cutter 50 is advanced distally to cut tissue prolapsed through aperture 16. This advancement may be accomplished simply by rotating the motors 272, 312 in a direction opposite to the direction of rotation of the motors 272, 312 during retraction of the cutter 50. In some embodiments, vacuum lumen 40 is switched from vacuum to saline as cutter 50 is advanced. For example, the solenoid 456 may move the tip 478 downward to pinch the tube 402, thereby preventing further transfer of vacuum through the tube 402; the solenoid 456 may move the tip 472 upward to substantially disengage the tube 408, thereby allowing saline to pass through the tube 408. In some other embodiments, the vacuum lumen 40 is switched from vacuum to venting as the cutter 50 is advanced. For example, the solenoid 456 may move the tip 478 downward to pinch the tube 402, thereby preventing further transfer of vacuum through the tube 402; the solenoid 456 may move the tip 474 upward to substantially disengage the tube 410, thereby allowing venting (e.g., into the atmosphere) through the tube 408. In some other embodiments, the vacuum lumen 40 is alternately supplied with saline and vented. As cutter 50 advances, an axial vacuum is transmitted through cutter lumen 52.

When the distal end of cutter 50 passes the distal end of aperture 16, cutter 50 "closes" aperture 16 and the prolapsed tissue is cut and at least partially contained within cutter lumen 52. The lateral openings 32 are configured such that at least one or more of the lateral openings 32 are not covered by the cutter 50 when the cutter 50 reaches a position to "close" the aperture 16. With the aperture 16 closed and venting provided through the tube 402 via the lateral opening 32, the axial vacuum delivered through the tube 404 in the cutter lumen 52 draws the severed tissue sample 4 proximally into the chambers 166, 388 of the tissue sample holders 140, 368. Cutter rotation and translation mechanism 120 may be controlled to cause cutter 50 to repeatedly move one or more times through a small range of motion in the distal position to sever any remaining portion of the first pass into cutter 50 that has not yet been completely severed.

Aperture 16 is closed by cutter 50, vacuum lumen 40 is vented by tubes 402, 410, and cutter 50 is retracted slightly rearwardly to expose a portion of aperture 16 for a short period of time by virtue of cutter lumen 52 providing an axial vacuum from tube 404 prior to proximal transfer of tissue sample 4 through cutter lumen 52. During this time, saline is supplied at atmospheric pressure to the vacuum chamber 40 through the tubing 402, 408. Further retraction of cutter 50 exposes more of transverse cuts 32, thereby increasing fluid communication between vacuum lumen 40 and cannula lumen 20. Retraction of cutter 50 also exposes the distal surface of tissue sample 4 to the pressure of the tissue lumen through which tissue sample 4 was obtained. In this particular embodiment, the likelihood of atmospheric pressure being applied to the distal surface of the tissue sample 4 is increased due to the slight retraction of the cutter 50, thereby helping to ensure that the severed tissue sample 4 does not remain in the needle portion 10 (i.e., dry drawing). Cutter 50 is then fully advanced distally, closing aperture 16 and all lateral openings 32. "closing" the lateral opening 32 ensures that if administered at this time (between samplings) to relieve pain, the drug will reach the chest cavity through the outer opening 22 without being aspirated through the lateral opening 32 and the cutter lumen 52 and tissue sample holders 140, 368.

With cutter 50 fully advanced (e.g., with aperture 16 and all lateral openings 32 closed) and the severed tissue sample 4 passing proximally through cutter lumen 52 and drawn through the axial aspiration of tube 404 into chamber 166, 388, biopsy device 100, 101 will be in a ready state. In the ready state, the vacuum chamber 40 is vented to atmosphere and the axial vacuum tube 404 is sealed (i.e., "sealed"). In other words, tip 472 clamps saline tube 408 to prevent fluid transfer therethrough, tip 474 is substantially disengaged from vent tube 410 to allow access to the atmosphere therethrough, tip 476 clamps axial vacuum tube 404 to prevent fluid transfer therethrough, and tip 478 clamps transverse vacuum tube 402 to prevent fluid transfer therethrough. In this ready state, the biopsy device 100, 101 is ready to take another tissue sample 4, such as by another sampling sequence as described above.

It will be appreciated that the "sampling" cycle may be performed in various alternative ways. For example, the movement of cutter 50 may be varied during the acquisition of a tissue sample. Moreover, the timing, sequence, and interrelationship between the lateral vacuum, axial vacuum, venting, and saline may be varied in a number of ways. Accordingly, the inventors contemplate other numerous permutations of such variations, and consider that the present invention should not be limited in any way to the illustrative illustrations described above.

C. Exemplary "cleaning Probe" cycle

It will be appreciated that at some point during use of biopsy device 100, 101, biopsy device 100, 101 may signal occlusion by tissue or other debris. Such signals will be apparent to those skilled in the art in view of the teachings herein. At this point, it is desirable to initiate a step that can clean such tissue or debris to improve the performance of biopsy device 100, 101. To this end, biopsy system 2 allows a "clean probe" cycle to be initiated. The "cleaning probe" cycle will be described in detail below by way of example only, but other variations of the "cleaning probe" cycle will occur to those skilled in the art in view of the teachings herein. Fig. 62 depicts the sequence of positioning of cutter 50 within needle portion 10 relative to fluid communication provided through tubes 402, 404 in an exemplary "clean probe" cycle.

If the "clean probe" cycle of the present embodiment is initiated while biopsy system 2 is in the "view sample" mode as described above, manifolds 144, 366 will rotate, moving chambers 166, 388 from the three o ' clock position (or the nine o ' clock position) back to the twelve o ' clock position. If biopsy system 2 is not in "view sample" mode at the start of the "clean probe" cycle of the present embodiment, manifolds 144, 366 do not rotate. Next, the cutter 50 is retracted slightly to expose a portion of the hole 16 for a short period of time. During this exposure time, air and/or saline (atmospheric pressure) is transferred through the tube 402. Also during this time, vacuum is provided through tube 404. The cutter 50 is then advanced to close the aperture 16, but not all of the lateral openings 32. This same cycle is repeated an additional number of times (e.g., one to four additional times, etc.) to complete the "clean probe" cycle. After the "clean probe" cycle is complete, biopsy system 2 enters a ready state. If the next "sample" cycle is not initiated within a certain time (e.g., a few seconds, etc.), the "observe sample" mode does not restart until the next "sample" cycle is initiated.

It will be appreciated that the "clean probe" cycle may be performed in a number of alternative ways. For example, the movement of the cutter 50 is varied during cleaning of the probes 102, 103. Moreover, the timing, sequence, and interrelationship between the lateral vacuum, axial vacuum, venting, and saline may be varied in a number of ways. Accordingly, the inventors contemplate other numerous permutations of such variations, and consider that the present invention should not be limited in any way to the illustrative illustrations described above.

D. Exemplary "position" cycle

Fig. 63 depicts the sequence of positioning of cutter 50 within needle portion 10 relative to the fluid communication provided through tubes 402, 404 in an exemplary "position" cycle. If the "position" cycle is initiated when the aperture 16 is closed (e.g., when the cutter 50 is advanced to a distal position), and when the biopsy device 100, 101 is in a ready state, the cutter 50 is retracted proximally. During this time, the tube 402 continues to vent to atmosphere and the tube 404 is sealed (i.e., sealed) by being pinched by the tip 476.

The "position" cycle may be used in a variety of situations. For example, during an ultrasound guided procedure or other procedure, the needle portion 10 may be inserted into tissue and the aperture 16 closed. To confirm the location of the aperture 16 in the tissue, a "position" cycle may be initiated to open the aperture 16, aiding visualization of the aperture 16. After confirming the location of the aperture 16, a "location" cycle is initiated to close the aperture 16. Another application of the "position" cycle is when a marker is to be placed into tissue through cutter lumen 52 and into tissue through aperture 16. In this case, a "position" cycle may be initiated to open the aperture 16, allowing placement of the tissue marker into the tissue through the opened aperture 16. Other suitable applications for the "position" cycle will be apparent to those skilled in the art in view of the teachings herein.

If the "position" cycle is initiated when aperture 16 is open (e.g., when cutter 50 is retracted to a proximal position), and when biopsy device 100, 101 is in a ready state, cutter 50 is advanced distally. During this time, the tube 402 continues to vent to atmosphere and the tube 404 is sealed (i.e., sealed) by being pinched by the tip 476.

One variation of the "position" cycle is that the cutter 50 may be used to vary the size of the aperture 16 so that the aperture 16 does not open more than a predetermined size during the "sample" cycle. For example, it may be desirable to "shorten" the length of the aperture 16 in order to obtain a tissue sample 4 of relatively short length, to obtain a tissue sample 4 that is relatively close to the skin surface of the patient, or for other purposes. An example of varying the size of the aperture 16 using the position of the cutter 50 during the acquisition of the tissue sample 4 is found in U.S. patent application publication No.2006/0200040 entitled "Biopsy Device with Variable SideAperture" on 7.9.2006, the contents of which are incorporated herein by reference. As described in detail below, the user interfaces 700, 800 may be used to variably select the degree to which the aperture 16 opens during a "sample" cycle.

It will be appreciated that the "position" loop may be performed in a number of alternative ways. For example, the movement of the cutter 50 is varied during positioning of the cutter 50. Moreover, the timing, sequence, and interrelationship between the lateral vacuum, axial vacuum, venting, and saline may be varied in a number of ways. Accordingly, the inventors contemplate other numerous permutations of such variations, and consider that the present invention should not be limited in any way to the illustrative illustrations described above.

E. Exemplary "Pumping" cycle

It may be desirable to remove fluid from the biopsy site during the biopsy procedure. Accordingly, biopsy system 2 of the present embodiment includes a "suction" cycle that may be used to remove such fluids or for other purposes. Fig. 64 depicts the sequence of positioning of cutter 50 within needle portion 10 relative to the fluid communication provided through tubes 402, 404 in an exemplary "aspiration" cycle.

If the "aspirate" cycle of the present embodiment is initiated while biopsy system 2 is in the "view sample" mode as described above, manifolds 144, 366 will rotate, moving chambers 166, 388 from the three o ' clock position (or the nine o ' clock position) back to the twelve o ' clock position. If biopsy system 2 is not in the "view sample" mode at the initiation of the "aspirate" cycle of the present embodiment, manifolds 144, 366 do not rotate. Next, the aspirate button is actuated, or when some other user input is provided, the cutter 50 is retracted until such actuation or input ceases. Thus, the longer the button or input is pressed, the more the hole 16 is exposed by the cutter 50. Further, when the suction button is actuated, or when some other user input is provided, vacuum is provided through the tubes 402, 404. Such vacuum is thus transmitted axially through cutter lumen 52 and laterally (relative to cannula lumen 20) through lateral opening 32. It will be appreciated that with the aperture 16 at least partially open, the vacuum provided by the tubes 402, 404 may be used to aspirate fluid from the biopsy site. In this embodiment, the fluid would be placed in the vacuum tank 500.

The tube 402 may switch from providing lateral vacuum to providing ventilation when the suction button is released, or similar user input is stopped or changed. In other words, the solenoid 456 may be activated, with the tip 478 substantially engaging the tube 402, to prevent further transmission of vacuum through the tube 402; the tips 474 substantially disengage the tubes 410 to allow venting through the tubes 410, 402. In addition, tube 404 is sealed (sealed) at this point to prevent further transfer of vacuum through tube 402. After a brief pause (e.g., a few seconds), cutter 50 is fully advanced distally, closing aperture 16 and covering transverse aperture 32. Biopsy device 100, 101 then enters the ready state again.

If the aperture 16 is open (e.g., the cutter 50 is at least partially retracted) at the initiation of the "aspirate" cycle, the aperture 16 will remain open during the "aspirate" cycle, with vacuum being provided through the tubes 402, 404 during the time that the aspirate button is initiated (or during the time that some other user input is provided). Once the aspirate button is released (or other user input is stopped or changed), aperture 16 remains open and biopsy device 100, 101 again enters a ready state. Thus, cutter 50 need not move during the "aspiration" cycle.

It will be appreciated that the "pumping" cycle may be performed in a number of alternative ways. For example, the movement of cutter 50 is varied during aspiration by probes 102, 103. Moreover, the timing, sequence, and interrelationship between the lateral vacuum, axial vacuum, venting, and saline may be varied in a number of ways. Accordingly, the inventors contemplate other numerous permutations of such variations, and consider that the present invention should not be limited in any way to the illustrative illustrations described above.

F. Exemplary "Smart vacuum" cycle

Some situations may arise during use of biopsy system 2 when needle portion 10 remains inserted into a patient's chest without taking a tissue sample 4 for a period of time. It may be desirable to remove fluid from the biopsy site during this period. Accordingly, biopsy system 2 of the present embodiment includes a "smart vacuum" cycle, which may be used to periodically remove fluid during the period or for other purposes. Fig. 65 depicts the sequence of positioning of cutter 50 within needle portion 10 relative to fluid communication provided through tubes 402, 404 in an exemplary "smart vacuum" cycle.

The "smart vacuum" cycle of the present embodiment is initiated when biopsy system 2 is in a ready state for an extended period of time (e.g., 1 minute, 30 seconds, other time periods, etc.) during which no user input is provided. This sleep period causes the "smart vacuum" cycle to be automatically initiated, thereby slightly retracting the cutter 50 to expose a portion of the aperture 16 for a short period of time (e.g., a few seconds). With cutter 50 slightly retracted, vacuum is applied through tubes 402, 404 to remove fluid from the biopsy site. Cutter 50 is then automatically advanced to close aperture 16 and biopsy system 2 returns to the ready state. If no other user input is provided for a certain period after the "smart vac" cycle is completed, the "smart vac" cycle repeats itself automatically. This process can be repeated indefinitely.

In an alternative embodiment, the vacuum level during the "smart vac" cycle is lower than the vacuum level during other operating cycles. Such a low vacuum level may be provided in various ways. For example, the tips 476, 478 may partially pinch the tubes 402, 404 to limit, but not cut off, fluid transfer through the tubes 402, 404. Alternatively, the operation of the vacuum pump 44 may be modified to adjust the level of vacuum induced by the vacuum pump 44. Other ways of varying the vacuum level will be apparent to those skilled in the art in view of the teachings herein.

It will be appreciated that the "smart vacuum" cycle may be performed in a number of alternative ways. For example, the movement of cutter 50 may be varied during the removal of fluid from the biopsy site. Moreover, the timing, sequence, and interrelationship between the lateral vacuum, axial vacuum, venting, and saline may be varied in a number of ways. Accordingly, the inventors contemplate other numerous permutations of such variations, and consider that the present invention should not be limited in any way to the illustrative illustrations described above.

Exemplary user interface on vacuum control Module

As described above, the display 702, the switch 704, and the speaker 706 may be considered together to form the user interface 700, and further, as described above, the face 420 is configured to: the display 702 may be viewed through the face 420, the capacitive switch 704 activated, and sound from the speaker 706 heard. Capacitive switch 704 is configured to activate when a user's finger is sufficiently close to switch 704. In particular, the capacitive switch 704 may generate an electric field such that a finger in proximity of a user may cause a perturbation of the electric field that can be detected by the proximate switch 704. The capacitive switch 704 may have sufficient sensitivity so that a user does not even need to touch the face 420 to activate the capacitive switch 704. In other words, the capacitive switch 704 may be configured such that a user's finger need only be spaced above the capacitive switch 704 from the face 420 to actuate the capacitive switch 704. Of course, any other "contactless" technology (e.g., ultra wideband radar, etc.) may be used in place of or in addition to the capacitive switch 704. Alternatively, other input devices (e.g., conventional buttons, switches, sliders, dials, etc.) may be used.

The capacitive switch 704 of this embodiment incorporates a light emitting diode (not shown). In particular, the light emitting diode is positioned relative to the capacitive switch 704 to provide visual feedback when the capacitive switch 704 is sufficiently actuated by a user. For example, the light emitting diode associated with each capacitive switch 704 may remain illuminated by default and be turned off when its associated capacitive switch 704 is sufficiently activated. Alternatively, the light emitting diode associated with each capacitive switch 704 may remain off by default and illuminate when its associated capacitive switch 704 is sufficiently activated. The light emitting diodes may also be used to provide visual feedback regarding the status of the vacuum control module 400. For example, the status leds remain constant bright while the vacuum control module 400 is operating, and may blink (e.g., dim and bright) when the vacuum control module 400 is in a "sleep mode" (e.g., powered on but not actively being used). One skilled in the art will appreciate in view of the teachings herein that light emitting diodes or other light sources or visual indicators may be incorporated into the vacuum control module, or into the capacitive switch 704, among other ways.

In addition, the speaker 706 may emit audible tones to enhance feedback associated with use of the vacuum control module 400. For example, the speaker 706 emits a tone when the capacitive switch 704 is activated. In addition, certain switches 704 may have certain tones or audible patterns associated therewith. Similarly, certain selections of the actuation switch 704 by the user, such as the selections and operations detailed below, may each have different associated tone or hearing patterns. Of course, audible tones or patterns or other uses for the speaker 706 may be incorporated into the vacuum control module 400 and used in a variety of ways that may be substituted.

Other aspects of the user interface 700 are shown in fig. 66-68. In particular, FIGS. 66-68 show various exemplary screen shots 720, 740, 760 that can be displayed on the display 702. Each of these exemplary screen views 720, 740, 760 will be described in more detail below. In one embodiment, the face 420 and the display 702 are configured such that the perimeter of the display 702 is not visible through the face 420. Moreover, the face 420 may not provide a definition of the perimeter of the display 702. Thus, the text, icons, and other visual indicia displayed on the display screen 702 appear to "float" on the face of the vacuum control module 400. Of course, this configuration is merely optional.

As also shown in fig. 66-68, capacitive switch 704 is shown as buttons 708, 710 that are vertically aligned adjacent to screenshots 720, 740, 760. The buttons 708, 710 include: an upper button 708 for cycling between various screen shots 720, 740, 760; and a lower button 710 for providing input selections with respect to the active screenshots 720, 740, 760. In particular, each time the upper button 708 is actuated, the actuation causes the display 702 to change from one active screenshot 720, 740, 760 to the next active screenshot 720, 740, 760.

Each screen map 720, 740, 760 has a respective tab 722, 742, 762 associated therewith. In particular, "status" tab 722 is associated with status screenshot 720, "probe" tab 742 is associated with probe screenshot 740, and "system" tab 762 is associated with system screenshot 760. Tabs 722, 742, 762 are provided at the top of each respective screenshot 720, 740, 760, and the tabs 722, 742, 762 of the other screenshots 720, 740, 760 remain visible when a given screenshot 720, 740, 760 is active. For example, in FIG. 66, the status screen map 720 is active, while the probe "tab 742 and the" System "tab 762 are still visible. However, in fig. 66, the "status" tab 722 is brighter than the probe "tab 742 and the" system "tab 762. In fig. 67, the probe screen map 740 is active and the system screen map 760 in fig. 68 is active. Those skilled in the art will appreciate in view of the teachings herein that tabs 722, 742, 762 are merely exemplary, and tabs 722, 742, 762 may be incorporated into user interface 700 in a variety of alternative ways. Further, there are a variety of alternative feature elements that are used in addition to or in place of the tabs 722, 742, 762.

A. Exemplary "status" screenshots

Referring to FIG. 66, the merely exemplary status screen map 720 includes a plurality of visual indicators 724, 726, 728, 730. For example, "view sample" indicator 724 indicates whether biopsy system 2 is in a "view sample" mode, an example of which will be described in detail below. As shown, the "view sample" indicator 724 of this embodiment includes an icon that appears as a circle with a slash to indicate that the "view sample" mode is turned off. A check mark or other flag may be used to indicate that the "view sample" mode is turned on. While the probe screenshot 740 is active, the user may turn the "view sample" mode off or on, as will be described in more detail below. Of course, any other suitable visual indicator may be used in addition to or in place of the circle with slash and/or the check mark to indicate the status of the "view sample" mode.

A "vacuum" indicator 726 is also provided on the status screen map 720. As shown, the "vacuum" indicator 726 of this embodiment includes an icon that is displayed as a set of ascending bars to indicate the vacuum level of the biopsy system 2. While system plane 760 is active, the user may adjust the vacuum level of biopsy system 2, as will be described in detail below. In this embodiment, the increment in vacuum level is indicated by the other bars in the set of ascending bars illuminating the vacuum level of the "vacuum level" indicator 726. In other words, the number of illuminated bars in "vacuum" indicator 726 will indicate the vacuum level of biopsy system 2. Of course, any other suitable visual indicator (e.g., analog gauge, digital, etc.) may be used in addition to or in place of the lift bar to indicate the vacuum level within biopsy system 2.

A "pinhole" indicator 728 is also provided on the status screen diagram 720. As shown, the "pinhole" indicator 728 of this embodiment includes an icon that is displayed as a needle with a lighted cutter. This "pinhole" indicator 728 may be used to indicate the maximum distance that cutter 50 will retract within needle portion 10 during use of biopsy system 2. For example, as described above in the "position" cycle portion, the user may wish to limit the proximal movement of cutter 50 to limit the extent to which hole 16 is flared within the chest cavity. Such use of a cutter 50 to alter a Biopsy surgically opened Aperture 16 is described in U.S. patent application published 7/9/2006 entitled "Biopsy Device with Variable Side Aperture," publication No.2006/0200040, the contents of which are incorporated herein by reference. When the biopsy plane 740 is in the active state, the user may adjust the effective pinhole 16, as will be described in detail below. The position of the cutter portion of the icon in the "pinhole" indicator 728 relative to the needle portion of the icon in the "pinhole" indicator 728 may indicate that there is a valid pinhole 16 set by the user. Of course, any other suitable visual indicator may be used in addition to or in place of the rendering of the needle and cutter ends to indicate the effective needle aperture set by the user.

A "Smart vacuum pulse" indicator 730 is also provided on status screen map 720 to indicate whether biopsy system 2 is in the "Smart vacuum" mode as described in detail above. As shown, the "smart vacuum pulse" indicator 730 of this embodiment includes an icon that is displayed as a check mark to indicate that the "smart vacuum" mode is turned on. A circle with a slash or other indicator may be used to indicate that the "smart vacuum pulse" mode is turned off. While the probe screen 740 is active, the user may turn the "smart vacuum" mode on or off, as will be described in detail below. Of course, any other suitable visual indicator may be used in addition to or in place of the circle with slash and/or the verification mark to indicate the status of the "smart vacuum" mode.

As described above, status screen map 720 of the present embodiment is merely used to indicate the status of several variables within biopsy system 2. The status screen diagram 720 of this particular embodiment is not configured to receive user input to change these variables or to change the operation of biopsy system 2. When status screen diagram 720 is in the active state, button 710 is not available. To change any variable, the user must actuate the upper button 708 in the status screen diagram 720 in order to switch the active screen diagram from the status screen diagram 720 to the probe screen diagram 740 or the system screen diagram 760, where the user can then provide input to change the variable. However, in other embodiments, the status screen diagram 720 may allow the user to change some or all of the variables for which the status is indicated on the status screen diagram 720. Other ways in which status screen map 720 or other screen maps may be provided will be apparent to those skilled in the art in view of the teachings herein. Additionally, in some embodiments, the status screenshot 720 is simply omitted (e.g., so that only the probe screenshot 740 and the system screenshot 760 and/or other screenshots, etc. are used).

B. Exemplary "Probe" Screen map

Referring to FIG. 67, a probe screen image 740, which is merely exemplary, includes a plurality of visual indicators 744, 746, 748, 750. For example, "hole" indicator 742 indicates the maximum distance that cutter 50 retracts within needle portion 10 during use of biopsy system 2. For example, as described above in the "position" cycle portion, the user may wish to limit the proximal movement of cutter 50 to limit the extent to which hole 16 is flared within the chest cavity. The user can adjust the effective pinhole 16 by actuating the button 710 just following the "hole" indicator 742. Each time the user actuates the button 710, the biopsy system 2 will adjust the effective needle aperture 16 accordingly, e.g., via the controller 480. Such adjustment may be incremental, for example providing 50%, 75% or 100% open apertures 16, although other increments may be used. In addition, each time the user actuates the button 710, the cutter portion of the icon in the "pinhole" indicator 742 moves relative to the needle portion of the icon in the "hole" indicator 742. An arrow is also displayed over the needle portion of the icon to emphasize the maximum proximal position of the needle selected by the user. Also, a textual representation (e.g., "Sm" for small holes 16, "Lg" for large holes, etc.) may be included to further indicate the size of the effective hole 16 selected by the user.

It will be appreciated in view of the teachings herein that the "hole" indicator 742 on the probe screen 740 is similar to the "pinhole" indicator 728 on the status plane 720, except that the "hole" indicator 742 on the probe screen 740 provides information about the effective hole 16 length selected by the user. Also, unlike the status screen 720 in this embodiment, the probe screen 740 allows the user to adjust the length of the active aperture 16 by actuating the button 710 next to the "aperture" indicator 742. Each time the user activates the button 710, the length of the effective aperture 16 may be incrementally decreased until the length reaches zero, at which point the next activation of the button 710 may cause the length to "rewind" the full length of the aperture 16. Instead of allowing incremental changes in the length of the effective aperture 16, the user interface 700 may allow the user to gradually change the length of the effective aperture 16, such as by using a slider, dial, knob, or the like, including through the use of a touch-sensitive virtual display (e.g., on a touch screen) of such an input device. Other ways in which the user may adjust the length of the effective aperture 16 will be apparent to those skilled in the art in view of the teachings herein. Further, any other suitable visual indicator may be used in addition to or in place of the rendering of the needle and cutter ends to indicate the effective needle hole set by the user.

Probe screenshot 740 of the present embodiment also includes a "view sample" indicator 746 indicating whether biopsy system 2 is in a "view sample" mode as described above. As shown, the "view sample" indicator 746 of this embodiment includes an icon that appears as a circle with a slash to indicate that the "view sample" mode is off. To turn on the "view sample" mode, the user may actuate button 710 next to the "view sample" indicator 746. A checkmark or other icon or indicator may be used in place of the circle with a slash to indicate that the "view sample" mode is turned on. To re-turn off the "view sample" mode, the user may again actuate the button 710 next to the "view sample" indicator 746.

It will be appreciated in view of the teachings herein that the "view sample" indicator 746 on the probe screen 740 is similar to the "view sample" indicator 724 on the status plane 720, except that the probe screen 740 allows the user to turn the "view sample" mode on or off by actuating the button 710 next to the "view sample" indicator 746. Of course, other suitable visual indicators may be used in addition to or in place of the circle with slash and/or the check mark to indicate the status of the "view sample" mode.

The probe screen view 740 of this embodiment also includes a "pivot reset" indicator 748 indicating that a button 710 next to the "pivot reset" indicator 748 may be actuated to reset the position of the manifolds 144, 366. Specifically, as described above, in some embodiments, the encoder wheel 292 and the sensor 296 are used to track the rotational position of the manifold 144, 366 during use of the biopsy system 100, 101. When the user replaces the manifold 144, 366 such that the last chamber 166, 388 "considered" by the biopsy system 2 to be aligned with the cutter lumen 52 is no longer aligned with the cutter lumen 52, the user may activate the button 710 next to the "swivel reset" indicator 748 to indicate to the biopsy system 2 that a new manifold 144, 366 has been connected to the probe 102, 103. Biopsy system 2 then aligns the "what-if" predetermined chambers 166, 388 or channels 158 with cutter lumen 52. The button 710 next to the "swivel reset" indicator 748 may also be activated under other conditions, such as when a user has manually rotated the manifolds 144, 366 to align the predetermined chambers 166, 388 with the cutter lumen 52.

Probe screenshot 740 of the present embodiment also includes a "Smart vacuum pulse" indicator 750 to indicate whether biopsy system 2 is in "Smart vacuum" mode as described in detail above. As shown, the "smart vacuum pulse" indicator 750 of this embodiment includes an icon that displays as a checkmark to indicate that the "smart vacuum" mode is turned on. A circle with a slash or other indicator may be used to indicate that the "smart vacuum pulse" mode is turned off. To turn off the "smart vacuum" mode, the user may activate button 710 next to the "smart vacuum pulse" indicator 750. A circle with a slash or other icon or indicator may be used in place of the check mark to indicate that the "smart vacuum" mode is turned off. To reopen the "smart vacuum" mode, the user may again actuate the button 710 next to the "smart vacuum pulse" indicator 750.

It will be appreciated in view of the teachings herein that the "smart vacuum pulse" indicator 750 on the probe screenshot 740 is similar to the "smart vacuum pulse" indicator 730 on the status plane 720, except that the probe screenshot 740 allows the user to turn the "smart vacuum" mode on or off by actuating the button 710 next to the "smart vacuum pulse" indicator 750. Of course, other suitable visual indicators may be used in addition to or in place of the circle with slash and/or the check mark to indicate the status of the "smart vacuum" mode.

C. Exemplary "System" Screen map

Referring to fig. 68, a merely illustrative system screen view 760 includes several visual indicators 764, 766, 768, 770. For example, a "vacuum" indicator 764 is also provided on the system screenshot 760. As shown, the "vacuum" indicator 764 of this embodiment includes an icon that is displayed as a set of ascending bars to indicate the vacuum level of the biopsy system 2. To adjust the vacuum level of biopsy system 2, the user may actuate button 710 next to "vacuum" indicator 764. Each time the user actuates the button 710, the vacuum level of biopsy system 2 may be incrementally increased. The increment of the vacuum level may be indicated by illuminating the other bars in the set of ascending bars of the "vacuum level" indicator 764. In other words, the number of illuminated bars in the "vacuum" indicator 764 will indicate the vacuum level of the biopsy system 2.

If the user actuates button 710 when all bars are illuminated (i.e., indicating that the vacuum is at its highest value), the vacuum level may be significantly reduced to its lowest level so that only the first bar in the set of bars is illuminated. Thus, the user may cycle through incremental vacuum levels by repeatedly actuating the button 710 next to the "vacuum" indicator 764, and these incremental transitions in vacuum levels may be shown in the set of ascending bars of the "vacuum" indicator 764.

It should be appreciated that when a vacuum level is selected by a user via the system screenshot 760, control of the vacuum level may be accomplished in a variety of ways. For example, the selected vacuum level may be achieved by operating the vacuum pump 440. Alternatively, when a vacuum is applied through the tubes 402, 404, a selected vacuum level may be achieved by varying the degree to which the tips 476, 478 disengage from the tubes 402, 404. For example, the solenoid 456 may be activated to release the tip 476, 478 only slightly from the tube, such that the tip 476, 478 creates a restriction in the tube 402, 404, but does not prevent the vacuum from being transmitted through the tube 402, 404. In another variation, additional valves (not shown) or other components at any suitable location are used to vary the vacuum level at the user's option.

It should be appreciated in light of the teachings herein that the "vacuum" indicator 764 on the system screenshot 750 is similar to the "vacuum" indicator 764 on the status plane 720, except that the system screenshot 750 allows the user to change the vacuum level of the biopsy system 2 by actuating the button 710 next to the "vacuum" indicator 764. Of course, any other suitable visual indicator (e.g., analog gauge, digital, etc.) may be used in addition to or in place of the lift bar to indicate the vacuum level within biopsy system 2.

The system screen map 760 of this embodiment also includes a "volume" indicator 766. As shown, the "volume" indicator 766 of this embodiment includes an icon that is displayed as a speaker and a set of bars of increasing size to indicate the volume level of the tone emitted by the speaker 706. To adjust the volume, the user may actuate button 710 next to "volume" indicator 766. Each time the user actuates the button 710, the volume may be increased in increments. The increment in volume may be indicated by illuminating the other bars of the set of ascending bars of the "volume" indicator 766. In other words, the number of illuminated bars in the "volume" indicator 766 will indicate the volume of the tone or other sound emitted by the speaker 706. Thus, the "volume" indicator 766 and its associated button 710 are similar to the "vacuum" indicator 764 and its associated button 710 described above, except that the former is associated with a volume level and the latter is associated with a vacuum level. Of course, any other suitable visual indicator (e.g., analog dial, digital, etc.) may be used to indicate the volume level in addition to or in place of the speaker and the increased size bar.

The system screen diagram 760 of this embodiment also includes a "standby" indicator 768. As shown, the "standby" indicator 768 of this embodiment includes icons that display stars and months. To put biopsy system 2 into standby mode, the user may activate button 710 next to "standby" indicator 768. In one variation of the standby mode, the vacuum pump 440 is turned off and at least some of the user input devices (e.g., the user interface 800, foot pedal, etc. on the racks 202, 302) are disabled. Other variations of standby mode may be contemplated by those skilled in the art in view of the teachings herein, and the user may actuate any capacitive switch 704 on the user interface 700, actuate any switch or button on the holster 202, 302, or perform some other action in order to bring the biopsy system 2 out of standby mode.

The system screen view 760 of this embodiment also includes a "power off" indicator 770. as shown, the "power off" indicator of this embodiment includes an icon representing a power button. To turn off biopsy system 2, the user may activate button 710 next to "off" indicator 770. Of course, the user may be allowed to turn off biopsy system 2 in various other ways.

Although not illustrated in the figures, it should be understood that the display 702 may display various other displays not explicitly described above. For example only, when the cable 484 is not attached to the port 482, the display 702 may display a message indicating that the user is connected to the cable 484. Similarly, when the vacuum canister 500 is not inserted into the canister compartment 458, or if there is not a satisfactory seal between the vacuum ports 462, 512, the display 702 may display a message instructing the user to properly insert the vacuum canister 500 into the canister compartment 458.

Exemplary on-chassis user interface

In addition to or in lieu of the user interface 700 provided by the vacuum control module 400, a user interface 800 may be provided on the biopsy device 100, 101, for example, such a user interface 800 may be provided on the probe 102, 103 and/or holster 202, 302. In this embodiment, a user interface 800 is provided on the chassis 202 that is merely exemplary. Also in this embodiment, the control provided through user interface 700 of vacuum control module 400 is more relevant to the setup of biopsy system 2, while the control provided through user interface 800 of holster 202 is more relevant to the actual operation of biopsy device 100. However, it should be understood that the roles may be reversed or combined. For example, user interface 800 may be configured to allow a user to adjust at least some settings of biopsy system 2, and/or user interface 700 may be configured to allow a user to operate biopsy device 100.

Referring to fig. 69, the user interface 800 of this embodiment is configured as a diaphragm that can be secured to one or both of the side plates 214, 216. The user interface 800 may also be provided, at least in part, with in-line decoration (IMD). This IMD configuration may provide a seal for the housing 202 such that the presence of the user interface 800 does not create undesirable leakage points. However, the IMD construct may provide flexible regions for user input, such as buttons 802, 803, 804, 806, 808 as described below. In other embodiments, the user interface 800 is provided at least in part by a dual injection molding process. Other ways of providing the user interface 800 will be apparent to those skilled in the art in view of the teachings herein.

The user interface 800 of this embodiment includes five buttons 802, 803, 804, 806, 808 (each of which will be described in detail below), however, any other suitable number of buttons may be used. In some embodiments, the buttons 802, 803, 804, 806 are provided as membrane switches that are part of the membrane. In other embodiments, the buttons 802, 803, 804, 806 are formed in the side panels 214, 216 of the diaphragm to be bonded. In other embodiments, the buttons 802, 803, 804, 806 comprise capacitive switches. In this embodiment, the buttons 802, 803, 804, 806 may be illuminated by light emitting diodes or other light sources behind the membrane. Other ways in which buttons 802, 803, 804, 806 may be provided will be apparent to those skilled in the art in view of the teachings herein.

The buttons 802, 803 of this embodiment may be actuated to advance or retract the cutter 50, respectively. As described above, such advancement or retraction may be used to selectively reduce the size of the effective aperture 16 during a sampling cycle. Alternatively, the user may wish to vary the size of the aperture 16 while suctioning. Other situations in which a user may wish to advance or retract the cutter 50 by actuating the buttons 802, 803 will be apparent to those skilled in the art in view of the teachings herein. As described in detail below, the position of the cutter 50 achieved by actuation of the buttons 802, 803 by a user may be indicated by discrete light emitting areas 812 of a cutter position indicator 810 located on the user interface 800.

The button 804 of this embodiment is operable to initiate a sampling cycle. Exemplary sampling cycles are described in detail above and thus will not be described in detail herein. One skilled in the art will recognize, in view of the teachings herein, a suitable manner in which button 804 can be made operable to initiate a sampling cycle. Also, in some variations, the button 804 also performs the same function of the button 802 described above, such that the button 802 may be omitted. Similarly, in some variations, the button 802 performs the same functions as the button 804 described above, such that the button 804 may be omitted.

The button 806 of this embodiment is operable to initiate a lateral vacuum within the probe 102. For example, actuating the button 806 may cause a vacuum to be delivered through the tube 402, which in turn may be delivered through the lateral opening 32. In view of the teachings herein, one skilled in the art may contemplate a suitable manner by which the button may be made operable to initiate a lateral vacuum.

The button 808 of this embodiment is operable to initiate a cleaning probe cycle. Exemplary cleaning probe cycles are described in detail above and thus again will not be described in detail. In view of the teachings herein, one of ordinary skill in the art will recognize the appropriate manner in which the button may be made operable to initiate a cleaning probe cycle.

The user interface 800 also includes a cutter position indicator 810 comprising indicia comprising a distal end of the outer cannula 12 and a plurality of discrete lighted segments 812. For example only, one or more light emitting diodes or other light sources may be used to illuminate the dispersion section 812. Illumination of the discrete section 812 may be used to indicate the position of the cutter 50 relative to the aperture 16. For example, the last segment 812 illuminated may represent the distal end of the cutter 50. In some embodiments, the discrete sections 812 corresponding to the position of the cutter 50 are illuminated with one color (e.g., red) while the remaining discrete sections 812 are illuminated with another color (e.g., yellow). Other ways in which cutter position indicator 810 may be used to indicate the position of cutter 50 will be apparent to those skilled in the art in view of the teachings herein. In addition, there are various ways to effectively communicate the cutter 50 position data to the cutter position indicator 810. By way of example only, one or more sensors may be communicatively coupled to cutter 50, cutter rotation and movement mechanism 120, and/or cutter drive mechanism 270.

User interface 800 also includes an icon 814 for indicating a needle cocking orientation for trigger 242, and an icon 816 for indicating a trigger unlocking orientation. The manner in which trigger 242 may be used to prime and fire needle portion 10 (e.g., in conjunction with actuation of button 24) is described in detail above. The icons 814, 816 may simply provide a visual indication of the direction of trigger rotation to effect such an action.

In addition, the user interface 800 includes a fault light 820. The fault light 820 may be selectively illuminated under various conditions. For example, the failed light 820 may be illuminated when tissue blocks the cutter lumen 52 or anywhere else within the biopsy system 2. The fault light 820 may also provide an "obstruction code" by flashing in a particular sequence or pattern associated with a particular adjustment. For example, the number of times the fault light 820 blinks before repeating the blinking sequence may vary depending on the fault condition. It should also be understood that other components of user interface 800 may be used to convey one or more fault conditions instead of or in addition to fault light 820. For example, the discrete sections 812 of the cutter position indicator 810 may blink or may be illuminated in a pattern or sequence to indicate a certain fault condition. Other ways in which fault conditions may be communicated to a user optically or otherwise will be apparent to those skilled in the art in view of the teachings herein. Similarly, means for detecting fault conditions may be devised by those skilled in the art in view of the teachings herein.

Where both sides of the holster 202, 302 have buttons 802, 803, 804, 806, 808, the biopsy system 2 may be configured to assign the first side on which the buttons 802, 803, 804, 806, 808 are actuated as the "active" side of the holster 202, 302. Likewise, the biopsy system may assign the first side on which trigger 242 or button 244 is actuated as the "active" side of the holster 202, 203. By way of example only, where a "view sample" mode is provided as described above, such an "active" side assignment may indicate whether the most recently obtained tissue sample 4 is present at a three o 'clock position or a nine o' clock position. In other words, if the user first actuates the buttons 802, 803, 804, 806, 808 or trigger 242 located on the side of the tissue sample holder 140, 368 corresponding to the three o 'clock position, the manifold 144, 366 can be rotated to present the most recently obtained tissue sample 4 to the user at the three o' clock position. Alternatively, biopsy system 2 may be configured to change other functions based on the assignment of the "active" side, or may simply not assign the "active" side at all.

It should be understood that various components may be used to affect the buttons 802, 803, 804, 806, 808, the illuminated segment 812 and the fault light 820. For example, one or more printed circuit boards (not shown) may be at least partially in communication with the vacuum control module 400, such as by a cable or otherwise. Other ways in which user interface 800 may be incorporated into biopsy system 2, as well as other variations of user interface 800, will be apparent to those skilled in the art in view of the teachings herein.

Embodiments of the present invention find application in conventional endoscopic and open surgical instruments, as well as for robotic-assisted surgery.

Embodiments of the devices disclosed herein may be designed to be disposed of after a single use, or may be designed to be used multiple times. In either or both cases, embodiments may include a combination of disassembly steps of the device, followed by cleaning or replacement of particular pieces, followed by assembly. In particular, embodiments of the device may be disassembled, and any number of the particular pieces or parts of the device may be selectively replaced or removed in any combination. With cleaning and/or replacement of particular components, embodiments of the device may be assembled for subsequent use at a repair facility or by a surgical team immediately prior to a surgical procedure. Those skilled in the art will appreciate that the device may be reconditioned using a variety of techniques for disassembly, cleaning/replacement, and assembly. The use of these techniques and the resulting reconditioned device are all within the scope of the present invention.

By way of example only, embodiments described herein may be processed prior to surgery. First, a new or used instrument is obtained and cleaned as needed. The instrument may then be sterilized. In one sterilization technique, the instrument is placed in a closed, sealed container (e.g., a plastic or TYVEK bag). The container and instrument may then be placed in a radiation zone that is transparent to the container, such as a gamma radiation zone, an x-ray zone, or a high energy electron zone. The radiation may kill bacteria on the instrument and in the container. The sterilized instrument may then be stored in the sterile container. The sealed container may keep the instrument sterile until the container is opened in a medical facility. The device may also be sterilized using other techniques known in the art, including but not limited to beta or gamma radiation, ethylene oxide, or steam.

While various embodiments of the present invention have been shown and described, further adaptations of the methods and systems described herein may be accomplished by appropriate modifications by one of ordinary skill in the art without departing from the scope of the present invention. Several of these possible modifications have been mentioned, while others will occur to those skilled in the art. For example, the above examples, embodiments, geometries, materials, dimensions, ratios, steps, and the like are illustrative and not required. The scope of the invention should, therefore, be considered in terms of the following claims and is understood not to be limited to the details of structure and operation shown and described in the specification and drawings.

Claims (13)

1. A biopsy device, wherein the biopsy device comprises:

(a) a needle having a tissue piercing tip and a transverse bore proximal to the tip;

(b) a cutter configured to cut tissue protruding through the aperture;

(c) a body portion, wherein the needle is longitudinally movable relative to the body portion; and

(d) a needle firing mechanism, wherein the needle firing mechanism comprises:

i. a motor for driving the motor to rotate in a forward direction,

a helical gear connected to the motor,

a firing bar extending distally from the body portion and detachably engaged with the needle via a fork member, wherein the helical gear is configured to move longitudinally integrally with the firing bar, an

A catch configured to selectively secure the firing bar in combination with a sled, wherein the catch is further operable to release the firing bar.

2. The biopsy device of claim 1, wherein the needle firing mechanism further comprises a resilient member biased to advance the needle distally when the needle is in a proximal position.

3. The biopsy device of claim 2, wherein the motor is operable to compress the resilient member by cooperative proximal movement of the helical gear and external gear.

4. The biopsy device of claim 2, wherein the catch is configured to selectively secure the firing bar through engagement of the catch and sled when the resilient member is compressed.

5. The biopsy device of claim 2, wherein the resilient member comprises a coil spring.

6. The biopsy device of claim 1, further comprising a fork member coupled to the firing bar, wherein the fork member engages the needle to move the needle longitudinally.

7. The biopsy device of claim 6, wherein the firing bar is spring loaded to distally advance the fork member and the needle.

8. The biopsy device of claim 1, wherein the body portion comprises a probe portion and a holster portion, wherein the probe portion is removably secured relative to the holster portion.

9. The biopsy device of claim 8, wherein the needle extends from the probe portion, the needle firing mechanism being located in the holster portion.

10. The biopsy device of claim 1, wherein the needle firing mechanism comprises a sled configured to move with the needle.

11. The biopsy device of claim 10, wherein the catch is configured to selectively engage the sled when the sled is moved to the proximal position.

12. The biopsy device of claim 1, wherein the needle firing mechanism further comprises an external gear disposed about the helical gear, an interior of the external gear being engaged with threads of the helical gear, the motor being operable to rotate the external gear through other gears.

13. The biopsy device of claim 12, wherein the motor is operable to move the helical gear proximally by rotating the external gear via the other gear.