HK1132446B - Surgical instrument - Google Patents

Description

Surgical instrument

RELATED APPLICATIONS

The present application claims priority from commonly owned co-pending U.S. provisional patent application No.60/838,059, filed 2006, 8, 16, § 119 (e). The foregoing application is incorporated herein by reference in its entirety.

Technical Field

The present invention relates generally to surgical instruments and, more particularly, to manually operated surgical instruments intended for use in minimally invasive or other forms of surgical or medical procedures or techniques. The instruments described herein are primarily intended for use in laparoscopic or endoscopic procedures, however, it should be understood that the instruments of the present invention can also be used in a variety of other procedures, including endoluminal procedures and the like.

Background

Endoscopic and laparoscopic instruments currently available on the market are difficult to learn to operate and use, mainly due to the lack of flexibility in applying these instruments. For example, when using a typical laparoscopic instrument during a surgical procedure, the orientation of the tool of the instrument is entirely determined by the location of the target and the wound. These devices generally operate using a fulcrum action by using the patient's own wound area as a fulcrum. As a result, common tasks such as suturing, knotting, and fine dissection become tricky tasks for the surgeon. Various laparoscopic instruments have been studied for several years, and this deficiency has typically been overcome by providing additional joints, often controlled by separately provided control members for added control. However, even so, these instruments do not provide sufficient flexibility to enable the surgeon to perform common tasks such as suturing, particularly at any arbitrarily selected orientation. Moreover, such prior devices do not provide an effective way to hold the device in a particular position. Furthermore, existing instruments require the use of both hands to operate to effectively control the instrument.

It is therefore an object of the present invention to provide an improved laparoscopic or endoscopic surgical instrument that allows the surgeon more flexibility in controlling the tool end of the surgical instrument.

It is another object of the present invention to provide an improved surgical or medical instrument that passes through a wound, an inherent hole or incision in the body, having a wide variety of applications.

It is another object of the present invention to provide an improved medical instrument which is characterized by the ability to lock the instrument in a particular position.

It is another object of the present invention to provide a locking feature which is a very important attribute for other controls of the instrument so that the surgeon can once lock the instrument in the desired position. This makes it easier for the surgeon to perform the surgical procedure after performing the action, without having to hold the instrument in a particular bent configuration while the procedure is in progress.

It is another object of the present invention to provide an improved medical device that can be effectively controlled by a user with one hand.

It is another object of the present invention to provide an improved medical instrument characterized by the ability to lock the position of the instrument in a preselected position while being able to rotate the end of the instrument.

Disclosure of Invention

According to the present invention, there is provided a medical device comprising: a proximal control handle; a distal working member; a proximal movable member controlled from a proximal control handle; a distal movable member controlled from the proximal movable member to provide controlled movement of the distal working member from the proximal control handle; an instrument shaft interconnecting the proximal and distal movable members; and an actuation device coupled between the movable members. The proximal movable member includes a ball and socket assembly supported between the handle and the instrument shaft and constructed and arranged for three-dimensional movement.

According to other aspects of the invention, the medical device may further comprise a locking member supported from the proximal control handle and having a locked state and an unlocked state; the locking member in the unlocked state enables control of the distal working member from the proximal control handle via the movable member; and the locking member in the locked state holds the movable member in a desired fixed position; the locking member in the locked state fixes the position of the proximal movable member; the distal movable member may comprise a unitary structure; the ball and socket assembly may include a ball supported by the instrument shaft, a socket defined in the handle, and an anchor ring rotatably supported at the handle; the actuation means may comprise a plurality of cables supported at the proximal end by the anchor ring; the ball may have a pin that bridges a slot in the socket; a rotary control member and a piston assembly couplable between the handle and the rotary control member; the piston assembly may further include a piston, a ring on the rotational control member, a connecting rod pivotably connected between the ring and the piston, and a locking knob for maintaining the position of the piston; the piston assembly may further include a holder supported by the handle and rotatable, a slide supported by the holder, and a connecting rod coupled between the slide and the rotational control member; comprises a driven member positioned on the handle and comprises a bridging member, a ball member for supporting the bridging member and an anchor ring rotatably supported on the bridging member; a locking member including a split ball, and a wedge member movable into the split ball to lock a position of the proximal movable member; including a rotational control member adjacent the proximal control handle for controlling the distal working member to rotate about a distal working member axis; the actuation means may comprise a set of cables coupled between said movable members and further comprising a cable retainer supported by the handle and for retaining a proximal end of the cables; the handle may comprise a pistol grip handle comprising a bottom and a top defining a ball socket for supporting a ball and at the same time a ball supports the proximal movable member; and the proximal movable member may comprise a unitary bendable member and further comprise a rotatable control member in line with the proximal bendable member.

In another embodiment of the present invention, a medical instrument is provided having a proximal control handle and a distal tool interconnected by an elongated instrument shaft for passing internally through the anatomy, proximal and distal movable members respectively interconnecting the proximal control handle and the distal tool with the instrument shaft, a cable actuation device disposed between the movable members, and a swivel ball, and wherein the control handle includes a bottom portion and a top portion defining a ball socket supporting the swivel ball for three-dimensional pivoting therein.

According to other aspects of the invention, the proximal movable member may comprise a proximal bendable member supported by a rotating ball; a rotational control member may be supported in line with the proximal bendable member for controlling three-dimensional pivoting; the rotation control member may control the three-dimensional pivoting and rotation about the longitudinal axis of the proximal bendable member, thereby controlling the rotation of the tool about its distal tool axis; a pivot control member at the proximal end of the proximal bendable member may control three-dimensional pivoting; the pivot control member may also control rotation of the instrument shaft; and preferably a locking means which is manually operated by the user and locks the ball in the socket.

In accordance with another embodiment of the present invention, in a medical instrument having a proximal control handle and a distal tool interconnected by an elongated instrument shaft for passing internally through the anatomy, proximal and distal movable members respectively interconnecting the proximal control handle and the distal tool with the instrument shaft, and cable actuation means disposed between the movable members, there is provided a method of controlling the tool from the handle by means of a control element, comprising pivoting the control element so as to control the positioning of the tool in three dimensions, and controlling the rotational orientation of the tool by rotating the instrument shaft. The method may further include providing a socket as a component of the proximal movable member and controlling the control element to pivot the ball relative to the socket.

Drawings

It is to be understood that the following drawings are for illustrative purposes only and are not intended to limit the scope of the present invention. The foregoing and other objects and advantages of the embodiments described herein will become more apparent with reference to the following detailed description when taken in conjunction with the accompanying drawings wherein:

FIG. 1 is a schematic, partially cut-away side view of a first embodiment of a surgical instrument of the present invention;

FIG. 2 is a cross-sectional view of the embodiment of the instrument illustrated in FIG. 1, as taken along line 2-2 of FIG. 1;

FIG. 3 is a cross-sectional view of the instrument illustrated in FIG. 1, as taken along line 3-3 of FIG. 1;

FIG. 4 is a cross-sectional view taken along line 4-4 of FIG. 3;

FIG. 4A is a partial perspective view of a portion of the cable actuation mechanism used in the instrument shown in FIG. 1;

FIG. 4B is a perspective view of a transfer disk apparatus for use in the mechanism of FIG. 4A;

FIG. 5 is a partially cut-away schematic side view of the instrument of FIG. 1 manually controlled to bend and rotate the end effector;

FIG. 6 is a partial cross-sectional top view of another embodiment of the instrument;

FIG. 7 is a cross-sectional view taken along line 7-7 of FIG. 6;

FIG. 8 is a cross-sectional view taken along line 8-8 of FIG. 6;

FIG. 9 is a partially exploded perspective view of the embodiment as shown in FIGS. 6-8;

FIG. 10 is a partial cross-sectional view of an alternative embodiment of a bearing between a shaft and a ball;

FIG. 11 is a partial cross-sectional side view of another embodiment of the instrument;

FIG. 11A is a partial cross-sectional view taken along line 11A-11A of FIG. 11;

FIG. 12 is a schematic perspective view of the bearing ring and piston assembly of FIG. 11;

FIG. 13 is a cross-sectional side view of another embodiment of the present invention;

FIG. 14 is a cross-sectional end view taken along line 14-14 of FIG. 13; and

fig. 15 is a cross-sectional side view of another embodiment of the instrument of the present invention.

Detailed Description

The instrument of the present invention may be used to perform minimally invasive procedures. "minimally invasive surgery" refers herein to a surgical procedure in which a surgeon performs a procedure through a small incision or wound that is used to access a surgical site. In one embodiment, the length of the wound ranges from 1 mm to 20 mm in diameter, preferably from 5 mm to 10 mm in diameter. This procedure is different from those requiring a large incision to reach the surgical site. Thus, flexible instruments are preferably used to be inserted through such small incisions and/or through the natural body cavity or lumen to position the instrument at an internal target site for a particular surgical or medical procedure. Surgical instruments may also be introduced into the anatomy by percutaneous or surgical access to the lumen or vessel, or by introduction through an aperture inherent in the anatomy.

In addition to use in laparoscopic surgery, the instruments of the present invention may be used in a variety of other medical or surgical procedures including, but not limited to, colonoscopic surgery, upper gastrointestinal surgery, arthroscopic surgery, sinus surgery, thoracic surgery, vaginal surgery, orthopedic surgery, and cardiac surgery. The instrument may be rigid, semi-rigid or flexible, depending on the particular procedure.

Although reference is made herein to a "surgical instrument," it is contemplated that the principles of the present invention are equally applicable to other medical instruments, not necessarily for surgery, and including, but not limited to, other instruments such as catheters and diagnostic, therapeutic and therapeutic instruments and implements.

FIG. 1 is a side view schematic of one embodiment of a surgical instrument 710 of the present invention. In this surgical instrument, the tool and handle moving or bendable members can be bent in any direction. They are interconnected by a cable in such a way that the bending action at the proximal member also provides the associated bending at the distal member. The user of the instrument controls proximal bending by movement, pivoting or deflection at the rotational control member 724. In other words, the surgeon grasps the pistol grip handle and once the instrument is in place, any movement (deflection) at the knob immediately controls the proximal bendable member 718, which in turn controls the corresponding bending or deflection at the distal bendable member 720 via the cable. This action in turn controls the positioning of the remote tool 716. For an explanation of this movement, please refer to the positions shown in fig. 1 and 5, respectively.

Preferably, the proximal member 718 is generally larger than the distal member 720, such as shown in fig. 1, to provide enhanced ergonomic control. In one form according to the invention, there may be provided a bending action in which the distal bendable member is bent in the same direction as the proximal bendable member. In alternative embodiments, the bendable, rotatable or flexible member may be configured to bend in opposite directions by rotating the actuation cable 180 degrees, or may be controlled to bend in virtually any other direction depending on the relationship between the distal and proximal bearing points for the cable.

It should be noted that the amount of bending motion that is generated at the distal bending member is determined by the size of the proximal bendable member compared to the size of the distal bendable member. In such embodiments, the proximal bendable member is generally larger than the distal bendable member, and therefore the magnitude of motion produced at the distal bendable member is greater than the magnitude of motion at the proximal bendable member. The proximal bendable member is capable of bending in any direction (about 360 degrees) to thereby control the distal bendable member to bend in the same plane, in the same or opposite direction, simultaneously. Moreover, the surgeon can bend and rotate the tool of the instrument at any orientation about the longitudinal axis of the tool of the instrument simply by turning or rotating the axial knob 724.

Reference is made to bendable members in this description. These members may also be referred to as rotatable members or flexible members. In the description herein, terms such as "bendable portion," "bendable section," "bendable motion member," or "rotatable member" refer to an element on the instrument that is controllably bendable as compared to an element that pivots at a joint. The bendable elements of the present invention enable the manufacture of instruments that can be bent in any direction without any dead spots, preferably all in a single unitary or monolithic structure, and which are further characterized by being capable of bending in any direction. The definition of "monolithic" or "monolithic" structure is: rather than a plurality of combined or mated parts forming a single structure, a structure is made up of only a single, unitary member.

These bendable motion members are defined as: an instrument element, either formed as a control device or as a controlled device, and capable of being constrained by tension or compression forces to change from a linear to a curved configuration without any sharp breaks or corners. The bendable members may be in the form of a unitary structure, as shown here in fig. 1, or may be in other forms as shown in fig. 6-15. For other forms of bendable members, see co-pending applications serial No.11/505,003 filed on 16/8/2006, No.11/523,103 filed on 19/9/2006, and No.11/528,134 filed on 27/9/2006, which applications are incorporated herein by reference in their entirety.

Fig. 1 shows a first embodiment of the instrument of the present invention. Fig. 1 depicts the surgical instrument 710 in position, as may occur during a surgical procedure. For example, the instrument may be passed through the abdominal wall for laparoscopic surgery. For this purpose, an insertion site is usually provided at which the cannula or trocar is arranged. The shaft 714 of the instrument 710 is adapted to pass through a wound, thereby disposing the distal end of the instrument at a surgical site. The end effector 716 as shown in fig. 1 may be considered to be at such a surgical site. FIG. 1 also depicts the rotations that can be performed using the instrument of the present invention. This can occur by rotating knob 724 about axis T relative to handle 712. This is illustrated in fig. 1 by the annular arrow R1. When the knob 724 is rotated, this will result in a corresponding rotation of the instrument shaft 714 in either direction. This is illustrated in fig. 1 by the rotating arrow R2. This same movement also causes rotation of the end effector 716 about axis P, as indicated by rotational arrow R3. It should be noted that in fig. 1 the instrument is arranged in a straight position with axes T and P coinciding. Referring also to FIG. 5, the tip of the instrument is shown extending along axis P at an angle B2. With rotation occurring in the position shown in fig. 5, then the tip (end effector) movement is then rotated about axis P whether the instrument is locked or unlocked.

Any rotation of knob 724 while locking (or unlocking) the instrument maintains the instrument tip at the same angular position, but rotates the orientation of the tip (tool). For further explanation of the rotation feature, see co-pending application serial No.11/302,654 filed on 12/14/2005, specifically fig. 25-28, which is incorporated herein by reference in its entirety.

In fig. 1, the handle 712 is shown in a neutral position in which the axis T of the knob 724 is in line with the axis U of the instrument shaft 714. In this position, the distal bendable member 720 and the end effector 716 are also in line. On the other hand, an instrument that bends by deflecting, pivoting or tilting the knob 724 upward, which in turn controls the bending of the proximal bendable member 718, is shown in FIG. 5. In fig. 5, the knob 724 is shown as being inclined at an angle B1 along axis T relative to the instrument shaft longitudinal central axis U. The tilting, deflecting or bending can be considered to occur in the paper, although it should be understood that the deflection can occur in and out of the paper as well.

By means of the cable 700, this action causes a corresponding bending at the distal bendable member 720 to a position where the tip points along the axis P and is at an angle B2 relative to the instrument shaft longitudinal central axis U. The surgeon controls the bending at the proximal bendable member 718 primarily by the inclination of a knob that can be tilted up and down or into or out of the page in fig. 5. This operation directly controls bending at the distal bendable member via bending control cables that are connected at their opposite ends to the distal and proximal bendable members, respectively.

Thus, the control at the handle is used to bend the instrument at the proximal motion member to thereby control the positioning of the distal motion member and the tool. The "location" of the tool is primarily determined by this bending or movement and can be considered as a coordinate location at the distal end of the distal motion member. In practice, one would consider the coordinate axes at both the proximal and distal motion members and at the tip of the instrument. This positioning is in three-dimensional coordinates. On the other hand, the "orientation" of the tool is related to the rotational positioning of the tool about the distal tip axis (see axis P in fig. 5) as shown.

Thus, the knob 724 can be considered to have a dual function: as a means for controlling the bending action, referred to herein as "pivoting" for controlling the positioning of the end effector; and means for controlling the orientation of the end effector by a rotational function for positioning the end effector about the distal tip axis.

A set of jaws is shown in the figures, however, other tools or devices may be conveniently adapted for use with the apparatus of the present invention. These include, but are not limited to, cameras, detectors, optics, scopes, fluid delivery devices, syringes, and the like. The tool may include various assembly tools, such as: jaws, scissors, graspers, needle holders, micro-dissectors, tackers, tacking lapsers (tackers), suction irrigation tools, and clip appliers. Additionally, the tool may include non-assembly tools, such as: a blade, a probe, a syringe, a catheter, or an aspiration orifice.

A first embodiment of a surgical instrument 710 according to the present invention is shown in the surgical instrument of fig. 1, in use, e.g., inserted through a cannula or trocar at an insertion site through the skin of a patient. Many of the components described herein, such as the instrument shaft 714, end effector 716, distal bending member 720, and proximal bending member 718, are similar to and interact in the same manner as the same instrument components described in co-pending U.S. application serial No.11/185,911 filed on 7/20 2005, the entire contents of which are incorporated herein by reference. And U.S. patent application serial No.10/822,081 filed on 12/4/2004, U.S. application serial No.11/242,642 filed on 3/10/2005, and U.S. application serial No.11/302,654 filed on 14/12/2005 are also incorporated herein by reference in their entirety.

In the first embodiment described herein, it should be noted that the instrument uses a pistol grip handle and that it supports the instrument shaft 714 with a shaft that can rotate in the handle. The distal end of the instrument shaft supports the distal bendable member 720 and the end effector 716. Control of the distal bendable members is from the distal bendable members via cables 700 interconnected between the bendable members. The proximal bendable member 718 is housed within the handle, specifically within the bulbous top 713 of the handle housing 711. The top of the handle housing includes a ball and socket arrangement wherein a ball 715 is adapted to be rotatably supported in a handle socket 717.

Like the knob 724, the proximal bendable member 718 is supported by a ball 715. In this embodiment, the proximal bendable member is controlled primarily by pivoting or deflecting the ball 715 in three dimensions, rather than by a handle that directs the motion of the proximal bendable member. The pivoting of the ball 715 is in turn directly controlled by the knob 724. FIG. 1 shows the instrument with the knob in a neutral or neutral position in which the bendable members are substantially in line with each other. On the other hand, FIG. 5 shows the knob having been tilted or pivoted upwardly at the angle B1 as shown. In this form, the bend control cables 700 (see fig. 2) are interconnected by the instrument shaft such that upward movement of the knob causes the distal bendable member to bend upward. This is accomplished by twisting the cable 180 degrees while passing from one end of the instrument shaft to the other. If the cable is connected without twisting 180 degrees, upward movement of the knob results in downward movement of the distal bendable member. Of course, the knob 724 can also be controlled to move the knob 724 into or out of the page, thereby controlling the distal bendable member to likewise move into or out of the page.

As previously mentioned, in this embodiment, the cables within the instrument shaft are shown in a straight configuration as shown in fig. 1, and in a curved state as shown in fig. 5. The end effector or tool 716 is actuated by means of a pawl actuator consisting essentially of an elongated rod 722 placed near the bottom 709 of the pistol grip handle 712. The lever 722 is supported by the housing at a lever pivot pin 723. The rod 722 acts on a slide 728 adjacent the handle base 709, the slide 728 being adapted to receive the proximal-most end of a tool actuation cable 738. When the lever 722 is not actuated (separated from the handle housing), this corresponds to the end effector pawl being in the fully open position. When lever 722 approaches, as shown in fig. 1, this causes slide 728 to move downward and then move jaws 744 and 746 toward an approximated position. A pawl actuator cable 738 is defined at its two ends at a bell crank 748 and a rotating barrel 766 (see fig. 1), respectively.

In each of the bendable portions or bendable members 718 and 720, a plastic tube may be provided. This includes a distal tube and a proximal tube. Both tubes may be constructed of a plastic such as Polyetheretherketone (PEEK). The material of these tubes is sufficiently rigid to retain the cables 762, and it is also sufficiently flexible that it can easily bend as the bendable members 718 and 720 bend. The tubes are of sufficient strength to receive and guide the cable, they are also sufficiently flexible that they will not kink or twist, thereby keeping the cable in the proper state for actuation, and also define a fixed length for the cable. The tube is stiff in the longitudinal direction but flexible in the lateral direction. For further details regarding these bendable portions and tubes, see the aforementioned co-pending application, serial No.11/185,911.

Control of the end effector 716 originates at the pawl actuator cable 738. The proximal most end of the pawl actuator cable 738 is retained within the barrel 766 as previously described. A rotating tube 766 is supported within slide 728. The slider 728 is also provided with a slot extending from the slider recess and accommodating the link 770. Linkage 770 is the primary means for actuating slider 728, and thus actuator cable 738, from rod 722.

The actuating link 770 is supported at one end by the lever 722 by means of a pivot pin 771. The opposite end of link 770 bears against another pin, referred to herein as slide pin 772. Pin 772 is maintained for longitudinal movement within a slot (not shown) in slide 728. Fig. 1 and 5 show pins 771 and 772 at opposite ends of link 770, respectively. Fig. 1 and 5 also schematically illustrate the slider being urged against the actuator spring 776. A spring 776 is disposed within the compartment of the slider 728. For further details of the rod and slide arrangement, reference is made to the aforementioned application serial No.11/185,911. In addition, the arrangement may also include a return spring.

When the lever 722 is pressed toward the handle body, the lever 722 actuates the end effector 716. The lever 722 is operated by a ratchet and pawl arrangement, while the lever can be pressed into the ratcheted gap. The ratchet and pawl arrangement includes a ratchet 786 and a pawl 788. To accommodate ratchet 786, slide 728 may be provided with ends that are provided or cut away. The pawl 788 is held by the handle 712. Ratchet 786 pivots at pivot pin 790 and is provided with a series of ratchet teeth that are capable of holding the ratchet in successive positions corresponding to successive degrees of closure of the end effector. A torsion spring (not shown) is preferably disposed partially around pivot 790 and facilitates the ratchet tooth coming into contact with pawl 788. The ratchet and pawl arrangement also includes an integral release arrangement that is normally engageable by the surgeon's thumb. This is illustrated in fig. 1 by release button 796. When a force is applied to the button 796, this then releases the ratchet and pawl arrangement and returns the lever 722 to its release position with the pawl fully open. Pressing on button 796 rotates ratchet 786 out of engagement with pawl 788.

Fig. 1 shows the instrument shaft 714 supported at the flange 708 of the handle. This support includes bearings 719 that enable the instrument shaft to be rotatably supported relative to the instrument handle. Fig. 1 also shows a possible alternative position of the knob at 721 in the outline of the dotted line. In this device, the knob is tightly attached to the exterior of the instrument shaft, enabling it to be manually rotated.

Reference is now made to the cables extending between the proximal and distal bendable members. The cable is arranged so as to transform any bending at the proximal bendable member into a corresponding bending at the distal bendable member. The bendable members described herein are capable of bending in all directions. In the preferred embodiment described herein, the diameter of the distal bendable member is approximately one-half the diameter of the proximal bendable member, as shown in FIG. 5. However, as previously described, other diameter relationships can be used depending on the particular application of the instrument and the medical procedure in which it is used. In one embodiment, it is even possible that the diameter of the distal bendable member is greater than the diameter of the proximal bendable member.

Control between the proximal bendable member 718 and the distal flexible member 720 may be achieved by means of a flexible control cable 700. Four such cables may be provided. At the distal ends of these cables, they may be connected to the reeds at the distal most ends of the distal bendable members. As shown in fig. 2, a cable end lug 702 holds cable 700 at the proximal end of cable 700. Four springs 704 are held between these end lugs 702 and the walls of the hub 701. The spring may be replaced with an elastic pad. Referring to fig. 2, fig. 2 shows an end lug 702, a spring 704 and a hub 701, the hub 701 being disposed at the proximal-most end of the proximal bendable member. The spring 704 tensions the cable 700 or takes up slack on the cable 700. Between the bendable members, the cable 700 may be guided by means of a slot in a spacer (not shown), which may be arranged along the support tube of the instrument shaft.

Both bendable members may be constructed as a unitary slotted structure, as shown in FIG. 1. For more details on the distal bendable member, reference is made to the aforementioned application serial No.11/185,911 which shows the use of spaced plates defining slots and which may be interconnected by rib means which render the bendable member susceptible to bending in either direction when controlled by bending control cables attached to the distal bendable member and controlled by the proximal bendable member.

A partial cross-sectional view of the proximal bendable member 718 is shown in FIG. 2, which includes spaced disks 706 defined between slots 707. The proximal bendable member preferably further includes ribs interconnected between the disks, and the ribs are preferably disposed at 60 degree intervals to provide effective three dimensional bending.

Referring again to fig. 1 and 5, the ball 715 is substantially spherical and is received in a spherical socket 717. To enable assembly between the ball and the handle housing, the handle may be made in two parts that are assembled around the ball 715. The ball 715 also includes a tapered cavity 725 in which a proximal bendable member is disposed. This tapered lumen 725 provides an open space in which the proximal bendable member 718 can bend. In fig. 1, the proximal bendable member 718 is shown in the middle region of the tapered lumen, while in fig. 5, the proximal bendable member 718 is shown in a bent condition, thus close to the wall of the lumen. In the position shown in fig. 5, it should be noted that the tapered lumen 725 provides sufficient space to enable the proximal bendable member 718 to bend.

The ball 715 also includes a groove 726, the groove 726 receiving a tool actuation cable 738. The tool actuation cable 738 is disposed within a sheath 729 that extends from directly above the sled 728 to a position adjacent the tool actuation assembly 750. Both ends of the sheath 729 are fixed in position and when the actuation tool actuates the cable 738, it moves through the sheath 729. Referring to fig. 3, one end of a sheath 729 is shown at 742. Fig. 3 also shows the end (bulbous end) of cable 738 attached to one leg of bell crank 748 at 749. In fig. 3, arrow a indicates the direction of pull of cable 738 in sheath 729 for actuating the tool, closing the tool jaws.

Referring now to fig. 3 and 4, these views show further details of the bell crank mechanism 748. This mechanism is used to transfer cable actuation from the lever 722 to the tool actuation cable 762 through the transfer plate assembly 760. The bell crank mechanism 748 includes an arm 764 and a yoke 768. The arm and yoke are disposed on either side of the pivot 769. Bell crank pivot 769 is in turn supported by mounting hub 752 which is fixed to ball 715. Thus, when the proximal bendable member is pivoted to the position shown, for example, in FIG. 5, the support for the bell crank mechanism moves with it.

In fig. 4A, the bell crank mechanism is shown in perspective view. The yoke 768 has opposing legs terminating at 768A and 768B. These terminal ends form pads adapted to push against the transfer plate assembly 760. Separate resilient pads may be attached at 768A, 768B.

Transfer disc assembly 760 is supported by proximal stub shaft 753. One end of the shaft 753 is supported at the hub 701 or is integrally formed with the hub 701. A knob 724 is fixed to the other end of the stub shaft 753, as shown in fig. 2. A set of bolts 754 is shown in fig. 2 for securing knob 724 to proximal stub shaft 753. End plate 755 also supports stub shaft 753. Fig. 2 also shows bearings 756 and 757, which are used to support the end plate 755 and hub 701, respectively, from the spherical balls 715. In this manner, the knob 724, transfer plate assembly 760, and the entire proximal bendable member are supported for rotation relative to the spherical ball 715.

The transfer plate assembly 760 is shown in a separate perspective view in fig. 4B. This assembly includes an outer disk 780 and a concentrically disposed inner disk 782. The disks 780 and 782 are interconnected by four pins 784. These pins are adapted to ride in corresponding slots 785 in the proximal stub shaft 753 to enable linear translation of the transfer disc assembly 760. Referring to fig. 2-4, they are used to describe the positioning of the slot 785 relative to the pin 784. This slot arrangement allows the transfer disc assembly 760 to move linearly a limited amount longitudinally of the proximal stub shaft 753. Fig. 2 shows the transfer plate assembly 760 at the right end of the slot 785. This corresponds to the unactuated position of the tool actuation lever 722. On the other hand, fig. 3 shows the transfer plate assembly 760 at or near the left end of the slot 785, which corresponds to the actuation position of the tool actuation lever 722.

Fig. 2 and 3 also show a cable return spring 783. It is disposed at one side where the fixed disk 787 forming a spring seat. Disc 787 is maintained in position in proximal stub shaft 753 by means of one or more set bolts 789. Pushing the opposite end of the return spring 783 against the inner disk 782 of the transfer disk assembly 760. Thus, in fig. 3, the return spring 783 biases the transfer plate assembly 760 to the right so that the end effector position is normally in the jaw open position.

Fig. 3 shows the actuation cables 738 that have been pulled in the direction of arrow a by the yoke 768 to move the transfer plate assembly to the actuated position. In fig. 3, arrow B indicates the linear movement direction of the transfer disc assembly 760. The inner disk 782 has a central passage for receiving a tool actuation cable 762. Fig. 3 shows a reduced diameter cable end ball 792 attached to cable 762 and receiving the cable in transfer plate assembly 760. Of course, movement of transfer plate assembly 760 in the direction of arrow B moves tool actuation cable 762 in the same direction. In fig. 2 and 3, the tool actuation cable 762 is shown disposed in a cable sheath 794, the cable sheath 794 also extending through the proximal bendable member. The tool actuation cable 762 actuates the end effector in a similar manner as described in U.S. application serial No.11/185,911.

The medical device shown in fig. 1-5 also has a locking feature. For example, this is illustrated in fig. 1 by a locking lever 795 pivotally mounted to the handle housing. The locking lever 795 actuates the friction pad 797 and the friction pad 797 is pushed by the lever 795 against the outer spherical surface of the spherical ball 715. In one position of the rod 795, as shown in FIG. 1, it is disengaged so that the ball can easily rotate within the socket 717. In another position of the lever 795, as shown in FIG. 5, it is pushed against the friction pad 797, which in turn engages the outer spherical surface of the ball 715. In this locked position, the ball is prevented from any further rotation within the socket 717, thereby maintaining the bendable member in a particular selected position. However, even in this locked position, the tip of the instrument can still be rotated by knob 724 to change the orientation of the end effector. The knob 724 and the proximal bendable member 718 are rotatably supported in the handle so that this rotation is possible even when the position of the instrument is locked.

For another embodiment of the present invention, reference is now made to FIGS. 6-10. This embodiment is somewhat simplified in that it does not require the use of telescoping tubes or a series of interconnected discs, particularly at the proximal end of the instrument. In this embodiment, the entire instrument is not disclosed, but it should be understood that the entire instrument will include the entire handle assembly and the entire distal portion with the end effector. A portion of the distal bendable member is shown in fig. 6. In this embodiment, the distal bendable member is a unitary structure. In fig. 6, rather than the handle being pistol grip, it is recessed.

FIG. 6 is a partial cross-sectional top view of the instrument of this embodiment, showing only a portion of the handle 812, the instrument shaft 814 and the distal bendable member 820. For further details of the distal portion of the instrument, reference is made to U.S. application serial No.11/185,911, the entire contents of which are incorporated herein by reference. In FIG. 6, a cable 800 is shown that extends through the instrument shaft 814 and couples to an end effector not specifically shown in FIG. 6. The configuration of the handle is shown in only a partial view at the interface with the proximal bendable member 818. The handle includes a lever for actuating the tool actuation cable 838. For further details of the handle mechanism and the actuating lever, reference is again made to fig. 1-5 of the present application and U.S. application serial No.11/185,911. In the embodiment of fig. 6-10, the handle is preferably linearly configured.

Fig. 7 is a sectional view taken along line 7-7 in fig. 6. FIG. 8 is a cross-sectional view also taken along line 8-8 in FIG. 6. Fig. 9 is an exploded perspective view of a portion of the mechanism of the embodiment of fig. 6. Figure 10 is a partial cross-sectional view showing another embodiment of a bearing for an inner shaft.

In the embodiment of fig. 6, handle 812 is configured to include two halves of handle halves 812A and 812B (see fig. 9). It is the tilt of the handle 812 relative to the adapter 826 that controls the distal bending at the distal bendable member 820. Alternatively, the user may consider tilting the shaft relative to the handle. The knob 824 is integrally formed with the adapter 826 and provides for rotation of the instrument shaft, particularly the outer tube 832 of the instrument shaft relative to the inner tube 834 of the instrument shaft. Rotation of the outer tube 832 of the instrument shaft rotates the distal bendable member and the end effector supported at its distal end. This provides rotation of the distal tip axis at the tip of the instrument about axis P in fig. 5, for example.

Outer shaft tube 832 is secured within adapter 826. The inner tube 834 is supported relative to the outer tube 832 via bearings 833 and 835. These bearings enable the outer tube 832 to rotate the inner tube 834 relative to a fixed position. The bearings 833 and 835 are preferably provided with through holes or slots for receiving the cable 800, through which the cable 800 passes. A spacer (not shown) having a guide slot for the cable 800 may also be provided within the instrument shaft 814. In the embodiment shown in fig. 6-10, four control cables 800 are provided as shown in the cross-sectional view of fig. 7. In other embodiments, fewer or more than four cables may be provided.

The proximal-most end 836 of the inner tube 834 bears against the ball 815. The ball 815 is fixedly mounted on the end of the inner shaft that does not rotate. As shown in fig. 6, a tool actuation cable 838, housed in a flexible sheath 839, passes through the ball 815. To this end, the ball 815 is provided with a slightly conical cavity 817. In fig. 6, the handle is shown in its tilted position, and the cavity 817 allows the tool actuation cable 838 and sheath 839 to deflect in the cavity 817 without any binding between the cable and the ball.

The ball 815 is firmly attached to the proximal end 836 of the inner tube 834 and thus may be considered substantially non-rotatable. Tilting of the end effector in three dimensions is accomplished by handle 812, which handle 812 also has the ability to bend or tilt in three dimensions relative to adapter 826. To this end, the handle 812 is provided in two halves with a socket 825 defined between the two halves. Referring also to fig. 9, there is shown handle halves 812A and 812B which are engaged with each other through the use of a locking pin 807. The exploded view of fig. 9 also shows a spherical ball 815, and a mating socket 825 in the handle 812. The ball 815 is provided with diametrically disposed pins 827 which are received in diametrically disposed slots 828 in the handle at sockets 825, the pins 827. The pin and slot arrangement enables the handle to move in three dimensions relative to the ball 815. When the handle is moved within the page in fig. 6, the pin 827 may translate within the slot 828. Also, the handle can pivot relative to the pin 827 when moved into or out of the page of fig. 6. This provides three-dimensional positioning.

Fig. 6 also shows a rotating anchor ring 840 that is supported relative to the handle 812 and carries the proximal most end of each cable 800. To this end, the rotating anchor ring 840 includes four holes disposed at 90 degrees to each other that receive the proximal end (ball 841) of each cable 800. Fig. 6 and 7 show cable anchor balls 841 which are proximal terminal ends for each cable. A spring 842 is provided between each cable termination and the rotating anchor ring 840. In the position shown in fig. 6, it should be noted that the handle is tilted upwards. This tilting of the handle through the distal bendable member 820 results in a corresponding downward movement of the end effector as long as the cable 800 is not twisted within the instrument shaft.

The proximal bendable member 818 may also be considered to include a retainer 844 and a metal reinforcement ring 846. A metal reinforcement ring 846 secures the two handle halves together and secures the socket 825 around the ball 815. The reinforcement ring 846 may be secured in place by a snap fit, with or without some type of retention means. The retainer 844 is adjacent to the metal reinforcing ring and holds the rotating anchor ring 840 in place while allowing the rotating anchor ring 840 to be rotated relative to the handle 812. A cable passage 847 is provided between the rotating anchor ring 840 and the handle 812.

As previously mentioned, the rotating anchor ring 840 represents the most proximal means for retaining the cable 800. Also, the rotating anchor ring 840 is the interface between the knob 824 and the handle. To this end, diametrically disposed pins 849 are provided on the ring 840, which are received in arcuate slots 850 in the knob 824, as shown in fig. 6 and 7. The pin and slot arrangement enables rotation of the knob, and thus the outer tube of the instrument shaft and the end effector. Regardless of the position of the handle, knob 824 rotates the end effector and pin 849 moves in slot 850 to enable this rotational movement. As with the other pin and slot arrangements 827, 828, the pin 849 and slot 850 enable rotational movement of the knob 824 regardless of the position of the handle relative to the instrument shaft.

The cross-sectional view of FIG. 6 also shows a locking mechanism that is used with the proximal bendable member 818. The locking mechanism includes a sleeve 852 that supports a flange 853 at one end and a cup 854 at the other end. Cup 854 is disposed in seat 855. See fig. 9 for a description of the seats 855 for receiving the cups 854. The sleeve 852 is adapted to translate linearly toward the ball 815 and away from the ball 815. In one position, the sleeve is disposed away from the ball and in the opposite position it is moved into contact with the ball for locking the position of the handle relative to the ball 815.

Translation of the sleeve 852 is controlled by the wedge members 856. The wedge member 856 has a flat surface that rests on the flange 853 and has a tapered surface that engages the tapered wall 857 of the handle. The wedge member 856 also includes an elongated slot 858 that is provided with sufficient clearance so as not to contact the tool actuation cable and its associated sheath when the wedge member 856 is moved between its locked and unlocked positions. The cross-sectional view of fig. 8 shows the wedge member 856 and its associated elongated slot 858.

The wedge member 856 is controlled by a pair of buttons. This includes a lock button 860 supported at the end of the shaft 861. The shaft 861 is secured to the wedge member 856. On the opposite side of the wedge member 856, as shown in fig. 6, there is a release button 862, which is supported by the wedge member by means of a shaft 863. Reference is also made to the cross-sectional view of fig. 8.

When the lock button 860 is pressed inward toward the handle, this causes the wedge member 856 to move against the tapered surface 857, thereby moving the sleeve 852 longitudinally such that the cup 854 exerts a clamping pressure or force on the ball 815. When this occurs, the handle 812 is held in a fixed position relative to the ball 815. In other words, regardless of the position of the instrument when button 862 is pressed, the instrument is maintained in a state in which the end effector is at a particular respective position.

The locking member may be released by depressing the release button 862, thereby moving the wedge member 856 longitudinally in the opposite direction. This releases the pressure on the casing 852 so that it is no longer in intimate contact with the ball 815. This enables the handle to be moved in any three-dimensional position relative to the adapter 826. A biasing means or a detent means may be associated with the locking mechanism.

Reference is now made to the partial sectional view of fig. 10. Fig. 10 is a schematic view of an alternative embodiment in which the ball 815 is rotatably mounted on the end of the inner shaft 834. In fig. 10, this rotational mounting is achieved by bearings 808. In this embodiment, the bearings 833 and 835 shown in fig. 6 are not used, and thus, the inner tube 832 and the outer tube 834 rotate together.

Another embodiment of the present invention is shown in fig. 11, 11A and 12. In this embodiment, the entire instrument is not shown. It should be appreciated that the handle 865 includes a mechanism for actuating the tool actuation cable. At the distal end of the instrument, there is an instrument shaft coupled to the end effector via a distal bendable member. In this embodiment, primarily the proximal bendable member 866 is shown. The proximal bendable member 866 includes a ball joint that further utilizes a sliding rod or piston that is clamped to hold and lock the instrument in a desired position. This rod and piston arrangement acts as a follower with respect to the bending action.

Fig. 11 is a partial cross-sectional side view of this embodiment of the invention. Fig. 11A is a partial sectional view taken along line 11A-11A of fig. 11. FIG. 12 is a schematic perspective view of a bearing ring and piston assembly used in the embodiment of FIG. 11.

In the partial cross-sectional view of fig. 11, the handle 865 is connected with an adapter 868. The adapter 868 may be substantially similar to the adapter 826 shown in the embodiment of fig. 6. Also, the instrument shown in FIG. 11 includes an outer shaft tube, which is not shown in FIG. 11, but may be the same as that shown in FIG. 6. Figure 11 does show the inner shaft tube 870 connected to the ball 872. The connection may be substantially the same as that shown in fig. 10 by use of a bearing 873 to allow the inner and outer tubes of the instrument shaft to rotate together.

The adapter 868 has been integrally formed with a knob 874, which knob 874 may have substantially the same structure as shown in the cross-sectional view of fig. 7. The adapter 868 is also provided with slots or tracks 876, one at separate diametrically disposed locations as shown in FIG. 11. The tracks 876 receive the pins 878, respectively, of the anchor ring 880. Adapter 868 also receives a bearing ring and piston assembly 890, which is shown in an exemplary perspective view in FIG. 12. To this end, an annular groove is provided in the adapter at its proximal side, which forms a passage 891 for the bearing 899. Snap ring 882 holds assembly 890 in place at the adapter. In the embodiment of fig. 11, piston assembly 890 acts as a follower when the handle is manipulated to move the piston in and out.

A bearing ring and piston assembly 890 is shown in perspective view in fig. 12, the bearing ring and piston assembly 890 including a ring 892 and a plurality of rods 893 disposed at 90 degree intervals around the ring 892. A joint is formed at each end of each rod. Each of these joints is depicted in fig. 12 as a ball joint. However, it should be understood that other types of pivot-restricting joints, such as hinge joints or living hinges, may also be used. Thus, each rod has a joint 894 and 895 at each end thereof. These joints provide at least limited pivoting of each rod relative to ring 892. Fig. 11 shows the positioning of the rod relative to the ring 892 in the event of bending of the proximal bendable member 866.

A connector 894 connects the rod to ring 892, while a connector 895 connects the opposite end of the rod to each piston 896. Each piston 896 is received in an open cylinder 897 within a handle 865. Fig. 11 shows a top piston 896 at one end of a cylinder 897 and a lower piston 896 at the opposite end of the cylinder. Each piston 896 has an elongate rib 898, the rib 898 extending through a slot in the housing so that it can be contacted by the resilient member 871. The resilient member 871 is preferably annular in shape and is held in place by a locking knob 875. The resilient member 871 has an inclined surface adapted to contact the piston ribs 898 to retain the piston in a selected position to maintain the proximal and distal bendable members in their selected positions.

The annular locking knob 875 receives the resilient member 871 and includes a threaded engagement with the handle 865. This is shown at 877 in FIG. 11. Rotation of the locking knob 875 causes the interface between the knob 875 and the resilient member 871 at 879 to engage and force the resilient member against the piston rib 898 to lock the position. Fig. 11 shows the direction of translation of the locking knob 875 and the resilient member 871 with arrow D.

Fig. 11 also shows a rotating anchor ring 880, which is supported relative to the handle 865 and carries the proximal-most end of each cable 900. To this end, the rotating anchor ring 880 includes four holes that are arranged at 90 degrees relative to each other and receive the proximal end of each cable 900. Fig. 11 shows cable anchor ball 901, which is the proximal termination end of each cable. A spring 902 is provided between each cable termination end and the rotating anchor ring 880. In the position shown in fig. 11, it should be noted that the proximal bendable member is inclined relative to the handle 865. This relative tilting between the handle and the proximal bendable member then causes a corresponding downward or upward movement of the end effector through the distal bendable member, depending on whether the cable 800 is twisted within the instrument shaft or not.

The proximal bendable member 866 may also be considered to include a retainer 867 and a metal reinforcing ring 869. A metal reinforcement ring 869 secures the two handle halves together and the handle socket around the ball 872. The reinforcement ring 869 may be secured in place by a snap fit, with or without the use of some type of restraining means. A retainer 867 is disposed adjacent the metal reinforcement ring and holds the rotation anchor ring 880 in place while allowing rotation of the rotation anchor ring 880 relative to the extension of the handle 865. As previously noted, a passage is provided between the rotating anchor ring 880 and the handle 865.

As previously described, the rotating anchor ring 880 represents the most proximal means for retaining the cable 900. Also, the rotating anchor ring 880 is the interface between the knob 874 and the handle 865. To this end, diametrically disposed pins 878 are provided that are received in arcuate slots or tracks 876 in the knob 874. The pin and slot assembly enables rotation of the knob, which in turn rotates the inner and outer tubes of the instrument shaft and the end effector. Regardless of the position of the handle, knob 874 rotates the end effector and pin 878 moves in slot 876 to enable this rotational movement.

In the embodiment of fig. 11-12, it should be noted that the anchor ring 880 is attached to the handle, but is capable of rotating relative to the handle. It is the relative movement (tilting) between the proximal bendable member and the handle in three dimensions that controls the positioning of the distal bendable member by the cable 900. Once the surgeon has the instrument in the desired position and wants to lock the instrument in that particular position, the locking ring or knob 875 is then rotated along arrow D in fig. 11. The threads 877 are preferably roughened so that the knob 875 does not have to be rotated to any significant extent to lock the instrument position. This rotation of the knob 875 pushes on the resilient member 871 which in turn moves the member into engagement with the piston rib or slide 898. This same action occurs at each piston 896, thereby locking the position of the proximal bendable member and, in turn, the distal bendable member tightly. This locking action is released by rotating knob 875 in the opposite direction. Either left-handed or right-handed threads 877 may be used.

Another embodiment of the present invention is shown in fig. 13 and 14. The entire instrument is not shown in this embodiment. It should be appreciated that the handle 912 includes a mechanism for actuating a tool actuation cable, such as the lever arrangement of FIG. 1. At the distal end of the instrument is an instrument shaft that is coupled to an end effector via a distal bendable member. In this embodiment, the proximal bendable member 918 is primarily shown. The proximal bendable member 918 includes a ball and socket arrangement that further employs a sliding and pivoting rod or piston in conjunction with a locking mechanism similar to that previously shown in fig. 6.

Fig. 13 is a cross-sectional side view of another embodiment of the present invention which is similar to the embodiment of fig. 11 in that it employs a limited pivot rod or piston. FIG. 14 is a cross-sectional end view taken along line 14-14 of FIG. 13.

In the embodiment of fig. 13, the handle 912 may be constructed in two halves, and is preferably a straight structure, but may also be a pistol grip. It is the tilting of the handle 912 relative to the adapter 926 that controls the distal bending at the distal bendable member, which is not shown in FIG. 13, but which may be of the type previously described. The knob 924 is integrally formed with the adapter 926 and provides for rotation of the instrument shaft 914, and in particular, the outer tube 932 of the instrument shaft, relative to the inner tube 934 of the instrument shaft. Rotation of the outer tube 932 of the instrument shaft rotates the distal bendable member and the end effector supported at its distal end. This provides rotation of the tool about its distal tool axis.

The outer shaft tube 932 is secured within the adapter 926. The inner tube 934 is supported relative to the outer tube 932 via bearings at each end of the instrument shaft 914. Only one bearing 933 is shown in fig. 13, it being understood that a bearing is also provided at the distal end of the instrument shaft, as shown in fig. 6. These bearings allow the outer tube 932 to rotate relative to the fixed position inner tube 934. The shaft support bearing is preferably provided with a through hole or slot for receiving the cable 910, through which the cable 910 passes. A spacer (not shown) having a guide slot for the cable 910 may also be provided within the instrument shaft 914. In the embodiment shown in fig. 13 and 14, four control cables may be provided as shown in the cross-sectional view of fig. 14. In other embodiments fewer or more than four cables may be provided.

In the embodiment shown in fig. 13, the outer tube 932 is rotatable relative to the inner tube 934. For this purpose, bearings are provided between the inner and outer tubes. In an alternative embodiment, the inner and outer portions of the instrument shaft may rotate together, in which case the bearing is between the inner tube and the ball, as shown in FIG. 10.

The proximal most end 936 of inner tube 934 supports ball 915. The ball 915 is fixedly mounted on the end of the inner shaft that does not rotate. As shown in fig. 13, a tool actuation cable 938, contained within a flexible sheath, passes through ball 915. To this end, the ball 915 is provided with a slightly tapered cavity 917. In FIG. 13, the handle is shown in its tilted position, and lumen 917 allows tool actuation cable 938 and sheath 939 to deflect in lumen 917 without any binding between the cable and the ball.

The ball 915 is firmly attached to the proximal end of the inner tube 934 of the instrument shaft and thus may be considered substantially non-rotatable. Tilting of the end effector in three dimensions is accomplished by a handle 912, which handle 912 also has the ability to bend or tilt in three dimensions. To this end, the handle 912 may be provided in two halves with a ball socket 925 defined therebetween. The handle halves may be interlocked by using aligned locking pins. The socket 925 is disposed at the terminal end of the handle collar 941. The ball 915 is provided with a diametrically arranged pin 927, the pin 927 being received in a diametrically arranged slot 928 in the handle at a socket 925. The pin and slot arrangement allows the handle to move in three dimensions relative to the ball 915. The pin 927 may translate in the slot 928 as the handle is moved in the page in fig. 13. Also, the handle can pivot relative to the pin 927 as it is moved into and out of the page in fig. 13.

The cross-sectional view of FIG. 13 also shows a portion of a locking mechanism that is used with the proximal bendable member 918. The mechanism may be the same as that shown and described above in connection with the embodiment of fig. 6. The locking mechanism comprises a sleeve 952, which supports a flange (not shown in fig. 13) at one end and a cup 954 at the other end. Cup 954 is disposed within a seat of socket 925. The sleeve 952 is adapted for linear translation toward the ball 915 and away from the ball 915. In one position, the sleeve is disposed away from the ball and in the opposite position it is moved into contact with the ball for locking the position of the handle relative to the ball 915. Translation of the sleeve 952 is controlled by a wedge-shaped device such as that shown in fig. 6. Movement of the sleeve 952 in the direction of arrow F in fig. 13 locks the cup-shaped end 954 against the ball 915, thereby retaining the proximal bendable member in the desired selected locked position.

In the embodiment shown in fig. 13, each cable 910 is held by a slider 920 rather than using an anchor ring for holding the ends of the cable 910. Each slider 920 is in turn retained in a respective slider guide slot 923 by a rotatable retainer 922. Fig. 13 shows a bearing 921 that supports a cage 922 relative to the handle 912. The holder 922 is supported to rotate in response to rotation of the knob 924 through a link 935. Each slide 920 is slidable within its respective guide slot 923. Each slide 920 holds an end of a respective control cable 910. For this purpose, each cable is provided with an end fixing lug 943 held by the slider 920. Also shown is a spring 944 used to bias cable 910. Fig. 13 shows the top cable 910 being pulled while the corresponding bottom cable is being released.

The link 935 forms a means of translation between the adapter 926 and the instrument handle 912. Limited motion joints are provided at respective ends of the connecting rods 935. Thus, each link 935 has a joint 937 that enables some limited pivoting of the link relative to the adapter 926. The other end of the link supports a further joint 931 which again enables the link to undergo some limited pivoting relative to the slide 920.

Fig. 13 shows an instrument having a handle that is bent at an angle to the longitudinal central axis of the instrument shaft. This is shown in fig. 13 as angle B1. The complement of this angle is also shown in fig. 13 as B1' which is between the longitudinal axis of the handle and the line through the joint 931.

FIG. 15 is a cross-sectional side view of another embodiment of the present invention which is similar to the embodiment of FIG. 13 in that it employs a motion bar or linkage for the control cables.

In the embodiment of fig. 15, the handle 960 may be constructed in two halves and may have a straight configuration or be in the form of a pistol grip. It is the tilting of the handle 960 relative to the adapter 966 that controls the distal bending at the distal bendable member not shown in FIG. 15, but may be of the type previously described. The knob 964 is integrally formed with the adapter 966 and is provided for rotation of the instrument shaft 967, and in particular the outer tube 968 of the instrument shaft, along with the inner tube 969 of the instrument shaft. Rotation of the inner and outer tubes of the instrument shaft rotates the distal bendable member and the end effector supported at its distal end. Fig. 15 shows the rotation of the shaft with arrow R1.

The outer shaft tube 968 is secured within the adapter 966. The inner tube 969 is supported relative to the outer tube 968 so as to rotate together as in the embodiment shown in fig. 10. This embodiment includes a bearing 970 that enables relative rotation between the inner shaft tube 989 and the ball 972. In the embodiment shown in fig. 15, four control cables 973 may be provided to provide three-dimensional directional positioning. In other embodiments fewer or more than four cables may be provided.

In the embodiment shown in fig. 13, the outer tube 932 is rotatable relative to the inner tube 934. For this purpose, bearings are provided between the inner and outer tubes. However, in the embodiment of fig. 15, the inner or outer portion of the instrument shaft rotates together, in which case the bearing is located between the inner tube and the ball, as shown in fig. 10 and 15.

The proximal most end of inner tube 969 supports ball 972 via bearing 970. Ball 972 is located in handle socket 974. As shown in fig. 15, a tool actuation cable 975, housed in a flexible sheath 976, passes through ball 972. To this end, ball 972 is provided with a slightly tapered cavity 977. In fig. 15, the handle is shown in a tilted position relative to the proximal bendable member, and the cavity 977 allows the tool actuation cable 975 and sheath 976 to deflect in the cavity 977 without any binding between the cable and the ball.

The ball 972 is rotatably attached to the proximal end of the inner tube 969 of the instrument shaft and is able to rotate within the handle socket 974. Tilting of the end effector in three dimensions is achieved by a handle 960, which handle 960 also has the ability to bend or tilt in three dimensions. To this end, the handle 960 may be provided in two halves, and further comprises a handle tube 979, the handle tube 979 having a cup-shaped end 980 at a distal end thereof, at which cup-shaped end 980 a ball socket 974 is defined. The handle halves may be interlocked by using aligned locking pins. The ball 972 is provided with a diametrically arranged pin 982, said pin 982 being received at a socket 974 in a diametrically arranged slot 983 in the handle. The pin and slot arrangement allows the handle to move in three dimensions relative to ball 972. As the handle moves within the page in fig. 15, the pin 982 may translate within the slot 983. Likewise, the handle can pivot relative to the pin 982 as it is moved into and out of the plane of the paper in fig. 15.

The embodiment of fig. 15 also shows a ball 984 formed along tube 979. The ball 984 supports the anchor ring 985 via a bridge member 986. The retaining member 987 holds the anchor ring 985 in place. A channel is formed between the anchor ring 985 and the bridge member 986.

The link or pin 988 forms a transmission between the adapter 966 and the instrument handle 960, and more particularly the anchor ring 985. Limited motion joints are provided at respective ends of these links 988. Thus, each link 988 has a joint 989, the joints 989 enabling some limited pivoting of the links relative to the adapter 966. The other end of the link supports another joint 990 which also enables some limited pivoting of the link relative to the anchor ring 985.

The cross-sectional view in FIG. 15 also shows a locking mechanism used with the proximal bendable member. This mechanism is similar to the one shown and described above in connection with the embodiment of fig. 6. The locking mechanism includes a sliding button arrangement that controls the wedge member 991. Wedge member 991 is controlled by a pair of buttons. This includes a lock button 992 supported at the end of the shaft 994. Shaft 994 is fixed to wedge member 991. On the opposite side of the wedge member 991, as shown in fig. 15, there is a release button 993 which is supported by the wedge member by means of a shaft 995.

When the lock button 992 is pressed inward toward the handle, this causes the wedge member 991 to move against the surface of the slider 996, thus moving the cone 997 into the split in the ball 984. When this occurs, the handle 960 is held in a fixed position relative to the proximal bendable member and the knob. In other words, regardless of the position of the instrument at this time, the button 992 is depressed, maintaining the instrument in that position while the end effector is at the desired position. Movement of the cone 997 into the ball causes the outer surface of the ball to lock against the bridge 986.

The locking member may be released by pressing the release button 993, thereby moving the wedge member 991 in the opposite direction. This releases the tension on the cone so that it is no longer in intimate contact with the ball 984. This enables the handle to be moved into any three-dimensional position relative to the adapter 966.

Having now described a limited number of embodiments of the present invention, it should now be apparent to those of ordinary skill in the art that other embodiments of the present invention and variations thereof are considered to be within the scope of the present invention. For example, the embodiments described herein have used primarily four control cables for providing all directions of movement of the moving member. In alternative embodiments, a fewer or greater number of cables may be provided. In its simplest form, only two cables are used, providing a single degree of freedom of motion at the bendable motion member. Another example are other embodiments of the prior art that show pistol grip or built-in handle structures, but it should be understood that all embodiments can use any type of handle structure. In the illustrated embodiment, a knob has been used to perform the function of rotating the distal instrument tip. In alternative embodiments of the invention, other means may be provided to effect such tip rotation. For example, a sliding member may be used instead of a knob or any other movable member that controls the instrument shaft and instrument tip for rotating the end effector about a distal tool axis (axis P) such as shown in fig. 1. Also, for example, in the embodiment of fig. 1-5, knob 724 provides a rotational feature (for controlling the tool about axis P), as well as pivotal control over the bending action. In an alternative embodiment of the present invention, knob 724 can be used only to control bending or tilting by rotation independently controlled by a knob, such as knob 721 shown in FIG. 1. Knob 724 may also be replaced with a lever arrangement to control bending.

Claims (25)

1. A medical device, comprising:

a proximal control handle;

a distal working member;

a proximal movable member controlled from the proximal control handle;

a distal movable member controlled from the proximal movable member to provide controlled movement of the distal working member from the proximal control handle;

an instrument shaft that interconnects the proximal and distal movable members;

and an actuation device coupled between the proximal movable member and the distal movable member;

the proximal movable member comprises a ball and socket assembly including a ball supported by the instrument shaft and a ball socket defined in the proximal control handle;

the ball socket is for receiving the ball and is constructed and arranged for three-dimensional movement between the ball socket and the ball.

2. The medical device of claim 1, further comprising a locking member supported from the proximal control handle and having a locked state and an unlocked state; the locking member in the unlocked state enables control of the distal working member from the proximal control handle via the movable member; and the locking member in the locked state holds the movable member in a desired fixed position.

3. The medical device of claim 2, wherein the locking member in the locked state fixes the position of the proximal movable member.

4. The medical device of claim 1, wherein the distal movable member comprises a unitary structure.

5. The medical device of claim 1, wherein the ball and socket assembly further comprises an anchor ring rotatably supported at the handle.

6. The medical instrument of claim 5, wherein the actuation means comprises a plurality of cables supported at a proximal end by the anchor ring.

7. The medical device of claim 6, wherein the ball has a pin that bridges a slot in the socket.

8. The medical device of claim 6, comprising a rotational control member and a piston assembly coupled between the handle and rotational control member.

9. The medical device of claim 8, wherein the piston assembly further comprises a piston, a ring on the rotational control member, a connecting rod pivotably connected between the ring and piston, and a locking knob for maintaining the position of the piston.

10. The medical instrument of claim 8, wherein the piston assembly further comprises a cage supported by the handle and rotatable, a slider supported by the cage, and a linkage coupled between the slider and the rotational control member.

11. The medical device of claim 6, including a follower on the handle and including a bridge, a ball for supporting the bridge, and an anchor ring rotatably supported on the bridge.

12. The medical device of claim 11, comprising a locking member having a split ball, and a wedge member movable into the split ball to lock a position of the proximal movable member.

13. The medical device of claim 1, including a rotational control member adjacent the proximal control handle for controlling the distal working member to rotate about a distal working member axis.

14. The medical instrument of claim 1, wherein the actuation device includes a set of cables coupled between the movable members, and further comprising a cable retainer supported by the handle and for retaining a proximal end of the cables.

15. The medical device of claim 1, wherein the handle comprises a pistol grip handle including a bottom and a top defining a bulbous socket that supports the ball, the ball supporting the proximal movable member.

16. The medical instrument of claim 15 wherein said proximal movable member comprises a unitary bendable member and further comprising a rotatable control member in line with said proximal bendable member.

17. A medical instrument having a proximal control handle and a distal tool interconnected by an elongated instrument shaft for passing internally through an anatomy, proximal and distal movable members respectively interconnecting the proximal control handle and the distal tool with the instrument shaft, a cable actuation device disposed between the proximal and distal movable members, and a rotation ball, and wherein the control handle includes a bottom portion and a top portion defining a spherical socket that supports the rotation ball for three-dimensional pivoting therein.

18. The medical instrument of claim 17, wherein the proximal movable member comprises a proximal bendable member supported by the swivel ball.

19. The medical instrument of claim 18 further comprising a rotational control member supported in line with said proximal bendable member for controlling said three dimensional pivoting.

20. The medical instrument of claim 19 wherein said rotation control member controls said three dimensional pivoting and rotation about the longitudinal axis of said proximal bendable member thereby controlling the rotation of said tool about its distal tool axis.

21. The medical instrument of claim 18 further comprising a pivot control member at the proximal end of said proximal bendable member for controlling said three dimensional pivoting.

22. The medical instrument of claim 21, wherein the pivot control member further controls rotation of the instrument shaft.

23. The medical device of claim 18, comprising a locking means that is manually operated by a user and locks the ball in the socket.

24. A method of controlling a distal tool in a medical instrument with a proximal control handle and the distal tool interconnected by an elongated instrument shaft for passing internally through an anatomy, a proximal movable member and a distal movable member respectively interconnecting the proximal control handle and the distal tool with the instrument shaft, and a cable actuation device disposed between the proximal movable member and the distal movable member, wherein the proximal movable member includes a ball and socket assembly including a ball supported by the instrument shaft and a ball socket defined in the proximal control handle for receiving the ball and configured and arranged for three-dimensional movement between the ball socket and the ball, the method comprising pivoting the control element, to control the positioning of the tool in three dimensions and to control the rotational orientation of the tool by rotating the instrument shaft.

25. The method of claim 24, comprising providing the ball socket as a component of a proximal movable member, and controlling the control element to pivot the ball relative to the ball socket.