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WO1993015672A1 - Catheter a laser a fibres multiples - Google Patents

Catheter a laser a fibres multiples Download PDF

Info

Publication number
WO1993015672A1
WO1993015672A1 PCT/US1993/001062 US9301062W WO9315672A1 WO 1993015672 A1 WO1993015672 A1 WO 1993015672A1 US 9301062 W US9301062 W US 9301062W WO 9315672 A1 WO9315672 A1 WO 9315672A1
Authority
WO
WIPO (PCT)
Prior art keywords
catheter
distal end
catheter body
laser
lumen
Prior art date
Application number
PCT/US1993/001062
Other languages
English (en)
Inventor
Steven D. Savage
Gregory G. Brucker
Original Assignee
Angelase, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Angelase, Inc. filed Critical Angelase, Inc.
Publication of WO1993015672A1 publication Critical patent/WO1993015672A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • A61B18/20—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser
    • A61B18/22—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor
    • A61B18/24—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor with a catheter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00017—Electrical control of surgical instruments
    • A61B2017/00022—Sensing or detecting at the treatment site
    • A61B2017/00084—Temperature
    • A61B2017/00092—Temperature using thermocouples
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/00234—Surgical instruments, devices or methods for minimally invasive surgery
    • A61B2017/00238—Type of minimally invasive operation
    • A61B2017/00243—Type of minimally invasive operation cardiac
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22038—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for with a guide wire
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00005—Cooling or heating of the probe or tissue immediately surrounding the probe
    • A61B2018/00011—Cooling or heating of the probe or tissue immediately surrounding the probe with fluids

Definitions

  • the present invention pertains to a medical device, and more particularly, pertains to a catheter with multiple optical fibers for carrying laser energy to a site within a patient having tissue to be treated.
  • the general purpose of the present invention is to provide a laser catheter with a multiple fiber laser assembly including a temperature sensing means, a cooling means and a flushing means.
  • a catheter with a central lumen consisting of a plastic tube approximately 100 cm long to which is affixed at its distal end a metallic or plastic inner ring.
  • the inner ring is shaped in a conical manner with the base of the cone directed distally of the catheter.
  • the central lumen contains a fixation wire which consists of a central wire core of a 0.010 inch diameter stainless steel to which is attached multiple temperature sensors.
  • a fixation wire which consists of a central wire core of a 0.010 inch diameter stainless steel to which is attached multiple temperature sensors.
  • two thermocouples are affixed to the fixation wire at the distal end at a predetermined location from the tip of the wire.
  • This assembly is enclosed in a PTFE tubular sheath and then in a stainless steel sheath extending from a Y-connector.
  • the distal end of the centrally aligned fixation wire assembly serves as one pole of a bipolar sensing probe, and is used to monitor the effect of the
  • An outer sheath typically 6 French in diameter, is used to house the tip assembly and the inner tubular sheath, and is made of a plastic tube to which is attached at its distal end an outer brass ring.
  • the outer ring serves as the second pole of a bipolar sensing element.
  • the annular space between the inner and outer tubes, or sheaths, serves as conduit for a flushing media such as sterile saline solution. This liquid cools the tissue and also removes blood from the field of view of the laser energy during the irradiation process.
  • a plurality of optical fibers for carrying the laser energy to the tissue to be radiated, such as myocardial tissue.
  • the fibers are configured such that they are not parallel to the axis of the catheter. This provides a more diffuse pattern of the laser energy than the diffusion ordinarily associated with an optical fiber. In this way, a larger surface area is irradiated than is possible with a single fiber.
  • multiple fibers also provide a catheter having a lower axial stiffness than single fiber systems for a given total energy capacity.
  • a multiple arm Y-connector At the proximal end is a multiple arm Y-connector.
  • the central port of the Y-connector contains the interface for the fixation wire, which consists of two distinct parts.
  • a mechanical plunger extends from the most proximal branch for retracting the fixation wire.
  • Attached to the inner part of the plunger are two optional thermocouple junction blocks. These blocks allow for quick connection of the temperature sensors at the tip of the fixation wire to their measuring instruments.
  • One branch of the Y-connector is attached to the annular space between the inner and outer plastic tubes. This port is used to pass a coolant and flushing medium along the fibers and out the tip. This flow keeps all materials of the delivery device cool to prevent mechanical degradation or loss of structural integrity from overheating and also to bath the myocardial tissue being treated. This helps prevent photocoagulation of blood and also reduces tissue surface temperature to reduce likelihood of carbonization and vaporization.
  • the other branch of the Y-connector houses the multiple optical fibers. This connection seals against water flow and fixes the optical fiber relationship to the laser delivery device.
  • a metal ring is provided at one of the Y-connector ports which provides an electrical connection to the tip of the laser catheter. This can be used as an electrode for electrophysiological monitoring of cardiac potentials.
  • Significant aspects and features of the present invention include the diffusing of concentrated laser light.
  • Other significant aspects and features of the present invention include a flexible catheter, monitoring of thermal response of the tissue, the use of standard fibers, a larger planar area of treatment, and a simple distal tip yielding a smaller more reliable catheter. Having thus described the embodiments of the present invention, it is the principal object hereof to provide a multi-fiber laser catheter including temperature sensing means, cooling means, and flushing means.
  • FIG. 1 illustrates a plan view of a multi-fiber laser catheter of the present invention
  • FIG. 2 illustrates a cutaway view of the syringe and Y- connector
  • FIG. 3 illustrates a cross-sectional view of the catheter tip area along line 3-3 of FIG. 1;
  • FIG. 4 illustrates a view along line 4-4 of FIG. 3; and, FIG. 5, an alternative embodiment, illustrates a cross- sectional view of the distal end including a fixed thermocouple assembly.
  • FIG. 1 illustrates a plan view of a multi-fiber laser catheter 10.
  • the multi-fiber laser catheter 10 includes a dual port Y- connector 12 and a syringe 14 coupled to each other by a coupler nut 16.
  • a stainless steel tube 18 is affixed to and extends from one end of the dual port Y-connector 12.
  • a syringe plunger 20 is integral to the syringe 14.
  • An axially movable fixation wire assembly 26 extends through and from the annular metallic tip 24.
  • Multi-fiber optic cable 30 passes through the flush port 28 of the dual port Y-connector 12.
  • the stainless steel tube 18 is coupled to the plastic catheter tube 22 which in turn connects with the annular metallic tip 24.
  • a plurality of wires including wires 34, 36 and 38 pass through a stainless steel tube 40 which is coaxial to the syringe 14, syringe plunger 20, the dual port Y-connector 12, the stainless steel tube 18, the plastic catheter tube 22, and is mated within the annular metallic tip 24 as later described in detail.
  • Wire 34 is a stiffening wire and wires 36 and 38 are wires leading to thermocouples on the fixation wire assembly 26.
  • Another wire 32 aligns in the flush port 28 of the dual port Y-connector 12 and connects electrically to an outer metallic ring or tip 24.
  • Wire 32 passes through the stainless steel tube 18, the plastic catheter tube 22 and connects electrically to the annular metallic tip 24 to provide means of recording' electrical potentials inside the heart.
  • Bipolar mapping can be carried out by measuring local activation potentials of the endocardial surface.
  • the signals generated can be used to determine electrophysiological properties of the tissue that lies between the electrodes. During ablation, the signals can be watched for changes.
  • the flush port 29 of the dual port Y-connector 12 is a coolant port, and is connected to the interior regions of the dual port Y-connector 12, and more importantly, to the interior lumen of the stainless steel tube 18 and the attached plastic catheter tube 22.
  • a flushing fluid is routed through the flush port 29 along the multi- fiber optic cable 30, through the stainless steel tube 18 and the plastic catheter tube 22 and out of the annular metallic tip 24 as described later in detail.
  • FIG. 2 illustrates a cutaway view of the syringe 14 and dual port Y-connector 12 where all numerals correspond to those elements previously described.
  • a stainless steel tube 40 aligns coaxially within and affixes to the syringe plunger tube 41.
  • the wires 34, 36 and 38 align in and are secured within the lumen of the stainless steel tube 40.
  • End 40a of the stainless steel tube 40 which includes wires 34, 36, and 38, slidingly aligns in the lumen 43 of the stainless steel tube 18.
  • the multi-fiber optic cable 30 aligns in the metallic plug 31, tubular plastic member 42 of port 28 of the dual port Y- connector 12, and lumen 43 of the stainless steel tube 18.
  • the multi- fiber optic cable 30 shares the lumen 43 with wires 34, 36, and 38, all of which align in the lumen 43 of the stainless steel tube 18, and in the central lumen 46 of the plastic catheter tube 22 as illustrated in FIG. 3. Actuation of the syringe plunger 20, and hence the attached stainless steel tube 40, causes the wires 34, 36, and 38, which ultimately make up the majority of the structure in the fixation wire assembly 26, to move axially as depicted by the double arrow 47 as illustrated in FIG. 1.
  • FIG. 3 illustrates a cross-sectional view of the catheter tip area along line 3-3 of FIG. 1 where all numerals correspond to those elements previously described.
  • the metallic tip 24, such as a brass tip, is multi-radiused so that the lesser radius will frictionally engage the lumen 46 of the plastic catheter tube 22.
  • a conically shaped member 48, including a central passageway, aligns coaxially within the annular metallic tip 24 and is aligned longitudinally with and mated to an inner sheath or tubing 50.
  • a lumen 51 includes the central passageway of the conically shaped member 48 and the interior of the tubing 50, which has a plastic sheath over it.
  • a conically ramped surface 48a of the conically shaped member 48 causes the individual optic fibers 30a- 30n of the multi-fiber optic cable 30 to diverge from the central axis and to be distributed adjacent to the inner circumference of the annular metallic tip 24.
  • Wire 32 is electrically connected to the metallic tip 24 and passes through the lumen 46 to the dual port Y— connector 12 as previously described.
  • the fixation wire assembly 26 slidingly aligns in the lumen 51 and includes thermocouples 52 and 54 embedded or otherwise attached thereto. The thermocouples are used to monitor tissue temperature during irradiation.
  • the inner tubing 50 encompasses the wires 34, 36, and 38 and terminates within the stainless steel tube 18.
  • the wires 36 and 38 connect electrically to the thermocouples 52 and 54, respectively, and are routed through with the inner tubing 50, the dual port Y-connector 12, and the proximal end 40a of the stainless steel tube 40 as previously described.
  • the fixation wire assembly 26 contains a plurality of thermocouples including the thermocouples 52 and 54. Preferably, at least two thermocouples are used to provide more complete data. Preferably, the thermocouples are located along the fixation wire such that upon penetration of the fixation wire into the tissue, the thermocouples are at the highest temperature.
  • Fixation wire assembly 26 is also adapted for electrical connection to one pole of the bipolar sensing system.
  • the metallic tip 24 provides an electrical connection for the second pole of the electrophysiological monitoring system.
  • the annular space between the outer plastic catheter tube 22 and the inner plastic tube or sheath 50 serves as a conduit for a flushing media such as sterile saline solution.
  • a flushing media such as sterile saline solution. This liquid cools the tissue and the metallic tip 24, and also " removes blood from the field of laser energy during the irradiation process.
  • the fixation wire assembly 26 is retracted into the metallic tip 24 during advancement of the catheter.
  • the wire is coated with TEFLON to allow for easy sliding in the inner lumen.
  • the profile of the metallic tip 24 presents a very low profile device whose leading edge is smooth and free of any protrusions which would cause the catheter to hang-up during its passages through portions of the human anatomy.
  • the fixation wire assembly 26 is deployed to penetrate the myocardial surface.
  • the fixation wire assembly 26 may also serve a bipolar mapping assembly.
  • FIG. 4 illustrates a view along line 4-4 of FIG. 3 where all numerals correspond to those elements previously described. Illustrated in particular is the distribution of the individual fiber optic cables 30a-30n about the inner circumference of the annular metallic tip 24. Sterile saline solution passes through the lumen 46 between the outer plastic tubing and the inner plastic tubing and the unramped portion of the conical member 48 as illustrated in FIG. 3.
  • FIG. 5 illustrates an alternative embodiment of the distal end of the catheter system including a fixed fixation wire assembly 70 where all numerals correspond to those elements previously described.
  • the fixation wire assembly is fixed in the position illustrated and is used in an environment where retraction of the fixation wire is not required.

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Physics & Mathematics (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Medical Informatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Electromagnetism (AREA)
  • Optics & Photonics (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Otolaryngology (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Laser Surgery Devices (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

Cathéter à laser à fibres multiples (10) servant à irradier les tissus du myocarde humain et contenant un mécanisme à réaction mobile (26) pour surveiller les lésions provoquées par l'irradiation au laser à la fois sur une base electrophysiologique et thermique. Des moyens détectant la température distale sont prévus sous la forme d'une multiplicité de capteurs de température (52, 54). Un élément conique (48) situé dans l'extrémité annulaire (24) confère aux fibres optiques individuelles (30a - 30n) une configuration telle qu'elles ne sont pas parallèles à l'axe du cathéter, ce qui produit une émission d'énergie de laser plus diffuse. Des moyens de refroidissement et de rinçage sont inclus pour refroidir les tissus et l'extrémité (24) et pour enlever le sang du champ du laser au cours du processus d'irradiation.
PCT/US1993/001062 1992-02-05 1993-02-05 Catheter a laser a fibres multiples WO1993015672A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US83152492A 1992-02-05 1992-02-05
US07/831,524 1992-02-05

Publications (1)

Publication Number Publication Date
WO1993015672A1 true WO1993015672A1 (fr) 1993-08-19

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1993/001062 WO1993015672A1 (fr) 1992-02-05 1993-02-05 Catheter a laser a fibres multiples

Country Status (1)

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WO (1) WO1993015672A1 (fr)

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1996017655A1 (fr) * 1994-12-09 1996-06-13 Schwarzmaier Hans Joachim Dispositif de traitement d'un tissu corporel par de la lumiere laser
EP0797957A1 (fr) * 1996-03-29 1997-10-01 Eclipse Surgical Technologies, Inc. Butée de profondeur pour un appareil à laser pour la revascularisation à travers le myocarde
US5807383A (en) * 1996-05-13 1998-09-15 United States Surgical Corporation Lasing device
US5947989A (en) * 1996-12-12 1999-09-07 United States Surgical Corporation Method and apparatus for transmyocardial revascularization
US5980545A (en) * 1996-05-13 1999-11-09 United States Surgical Corporation Coring device and method
US6135996A (en) * 1998-04-17 2000-10-24 Baxter International, Inc. Controlled advancement lasing device
US6283955B1 (en) 1996-05-13 2001-09-04 Edwards Lifesciences Corp. Laser ablation device
US6368318B1 (en) 1998-01-23 2002-04-09 The Regents Of The University Of California Opto-acoustic recanilization delivery system

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0290685A1 (fr) * 1987-05-11 1988-11-17 GV Medical, Inc. Dispositif pour le contrôle et la protection d'une extrémité de fibre
US4985028A (en) * 1989-08-30 1991-01-15 Angeion Corporation Catheter

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0290685A1 (fr) * 1987-05-11 1988-11-17 GV Medical, Inc. Dispositif pour le contrôle et la protection d'une extrémité de fibre
US4985028A (en) * 1989-08-30 1991-01-15 Angeion Corporation Catheter

Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1996017655A1 (fr) * 1994-12-09 1996-06-13 Schwarzmaier Hans Joachim Dispositif de traitement d'un tissu corporel par de la lumiere laser
US5861020A (en) * 1994-12-09 1999-01-19 Schwarzmaier; Hans-Joachim Apparatus for irradiating body tissue with laser light
EP0797957A1 (fr) * 1996-03-29 1997-10-01 Eclipse Surgical Technologies, Inc. Butée de profondeur pour un appareil à laser pour la revascularisation à travers le myocarde
US5807383A (en) * 1996-05-13 1998-09-15 United States Surgical Corporation Lasing device
US5980545A (en) * 1996-05-13 1999-11-09 United States Surgical Corporation Coring device and method
US6283955B1 (en) 1996-05-13 2001-09-04 Edwards Lifesciences Corp. Laser ablation device
US5947989A (en) * 1996-12-12 1999-09-07 United States Surgical Corporation Method and apparatus for transmyocardial revascularization
US6368318B1 (en) 1998-01-23 2002-04-09 The Regents Of The University Of California Opto-acoustic recanilization delivery system
US6135996A (en) * 1998-04-17 2000-10-24 Baxter International, Inc. Controlled advancement lasing device

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