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WO1997018767A1 - Valvulotome d'electrocauterisation bipolaire - Google Patents

Valvulotome d'electrocauterisation bipolaire Download PDF

Info

Publication number
WO1997018767A1
WO1997018767A1 PCT/US1996/018278 US9618278W WO9718767A1 WO 1997018767 A1 WO1997018767 A1 WO 1997018767A1 US 9618278 W US9618278 W US 9618278W WO 9718767 A1 WO9718767 A1 WO 9718767A1
Authority
WO
WIPO (PCT)
Prior art keywords
electrode
valvulotome
main body
catheter main
bipolar electrocautery
Prior art date
Application number
PCT/US1996/018278
Other languages
English (en)
Inventor
Dilip S. Kittur
John Petronis
Original Assignee
The Johns-Hopkins University
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 The Johns-Hopkins University filed Critical The Johns-Hopkins University
Priority to AU10762/97A priority Critical patent/AU1076297A/en
Publication of WO1997018767A1 publication Critical patent/WO1997018767A1/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
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1492—Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
    • 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
    • A61B2017/22097—Valve removal in veins
    • 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
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00184—Moving parts
    • A61B2018/00196—Moving parts reciprocating lengthwise
    • 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
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/1206—Generators therefor
    • A61B2018/1246—Generators therefor characterised by the output polarity
    • A61B2018/126—Generators therefor characterised by the output polarity bipolar
    • 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
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1442—Probes having pivoting end effectors, e.g. forceps
    • A61B2018/145—Probes having pivoting end effectors, e.g. forceps wherein the effectors remain parallel during closing and opening

Definitions

  • the present invention relates to apparatuses for removing or disabling valves within veins and more particularly to an electrocautery valvulotome .
  • the invention also relates to side- branch ligation in conjunction with bypass graft procedures.
  • valvulotome The most common valvulotome in use is the mechanical valvulotome, of which Leather & Karmody is an example, which is a set of instruments consisting of knives and scissors specially designed to be passed into veins to cut the valves mechanically.
  • Another disadvantage of the mechanical valvulotome is that multiple incisions in the vein have to be made to pass the valvulotome.
  • Yet another disadvantage of the mechanical valvulotome is the possibility of injury to the walls of the vein.
  • a valve could be missed since the valvulotome could slip past the valve. This potential problem is of major concern as it would lead to intraoperative angiograms and increased length of the primary surgical procedure.
  • a valvulotome that may be adapted to cut venous valves in a circular or circumferential manner and therefore overcome the potential disadvantages of incising but not removing valves completely.
  • the foregoing and other objects of the invention are realized by providing a valvulotome including first and second opposed electrodes, one mounted for movement relative to the other. In use a valve to be disabled is located between the electrodes and the electrode (s) are displaced into engagement with the valve leaflets. An electrical current source coupled to the electrodes is then actuated whereby the valve is ablated.
  • FIGURE 1 is a schematic cross-section of an electrocautery valvulotome provided in accordance with the present invention
  • FIGURE 2 is an end view of an exemplary fixed electrode configuration provided in accordance with the present invention, taken along line 2-2 of FIGURE 1;
  • FIGURE 3A is a first alternate embodiment of a moveable electrode configuration in accordance with the invention, taken along line 3-3 of FIGURE l;
  • FIGURE 3B is a second alternate moveable electrode configuration in accordance with the invention, taken along line 3-3 of FIGURE 1;
  • FIGURES 4A and 4B illustrate exemplary alternate configurations of the moveable head and fixed electrode components of the valvulotome provided in accordance with the present invention;
  • FIGURES 5A and 5B illustrate another exemplary embodiment of the valvulotome head with electrodes, in non-engaged and engaged dispositions, respectively;
  • FIGURES 6A and 6B illustrate further exemplary alternate embodiments of the valvulotome of the present invention wherein the moveable head has a passage defined therethrough;
  • FIGURE 7 illustrates an exemplary use of the valvulotome of FIGURE 6B; and FIGURE 8 illustrates a further optional feature of the invention.
  • the electrocautery device 10 includes, by way of example, a multiple lumen catheter 12 having a fixed electrode 14 exposed at the distal end of the catheter main body.
  • the fixed electrode 14 is generally circular in plan view (FIGURE 2) .
  • a flexible wire 16 is electrically coupled to the fixed electrode 14 and operatively coupled to an adjustable bipolar or multipolar cautery current source 18 which may be of any suitable construction available.
  • a second wire 20 extends through one of the lumens of the catheter 12 and is electrically coupled to a moveable head 22 having a second electrode 24 defined on a face thereof, in opposition to the fixed electrode 14.
  • fixed and movable as used herein are for convenience and should be understood to be relative terms.
  • the "fixed” electrode can be moved relative to the "movable” electrode while the latter is held in a fixed disposition and vice versa, or both electrodes can be moved at the same time .
  • the valvulotome of the invention may be used as a part of an in si tu saphenous vein bypass procedure.
  • the entire catheter assembly 10 including moveable head 22 and wire 20 coupled thereto is inserted into the vein through a venotomy incision at the distal end of the vein segment of interest.
  • the catheter with electrodes abutting is advanced to the proximal end of the vein, remote from the venotomy incision.
  • the distal or forward end of the movable head is generally convexly curved as at 25, 25', 25", for example bullet shaped, so that it can be advanced through the venous valve (s) in the direction of normal blood flow. That the distal end has reached the end of the vein or vein segment, may be confirmed by injecting dye through port(s) 26 of the catheter 12 and examining an image of the vein or vein segment .
  • the moveable head 22 then is pushed away from the fixed electrode 14 or the fixed electrode 14 is retracted to suitably space the electrodes, as appropriate to the procedure and the valvulotome structure being utilized.
  • the flexible coated guide wire 20 extending proximally therefrom (FIG. 1) must be sufficiently rigid for controlled advancement, otherwise retraction of the fixed electrode would be preferred.
  • a conduit 28 extends proximally from the movable head, as in the embodiment of FIGURES 6A and B, moveable head advancement independently of the fixed electrode 14 is clearly an option.
  • the fixed electrode is retracted independently or simultaneously with the movable head so that the fixed electrode 14 passes through the valve.
  • Providing a fixed electrode having an arcuate proximal surface as at 30, 30', 30" defining a gradual transition from the catheter body 32 will facilitate passage of the fixed electrode back through the valve, as is apparent from FIGURES 1, 4A and 4B.
  • the so-called fixed electrode 14 may be provided as electrode segments 34 on each of two or more flexing tabs or wings 36 defined at the distal end of the catheter. Where a plurality of electrode segments 34 are provided each must be suitably electrically coupled to the cautery device 18 as will be apparent to one skilled in the art.
  • Such tabs or wings 36 extend via a living hinge or the like 38 from the main body 32' of the catheter. Isolated tabs or wings permit the distal end of the catheter structure to which the fixed electrodes are coupled to collapse for ease of passage back through the venous valve.
  • the tabs are preferably configured so as to project at an angle from the longitudinal axis of the catheter when not exposed to a collapsing or spreading force as shown in FIG. 5A.
  • Such an inclined structure facilitates passage of the catheter back through the valve but ensures that, on advancement of the catheter towards the movable head as explained in greater detail below, the electrode segment carrying tabs or wings 36 can be deflected to a substantially orthogonal disposition as shown in FIGURE 5B. In that disposition the fixed electrode segment (s) 34 will be in opposed facing relation to the electrode (s) 24' of the movable head.
  • tabs or wings are provided for carrying electrodes
  • their number and configuration can be varied greatly without departing from the principles of the invention, provided they are of sufficient size and dimensions so as to be deflected to the disposition shown in FIGURE 5B upon engagement with a venous valve and not buckle or collapse when exposed to such an axial force; and so as to present an electrode surface of sufficient size and in an appropriate orientation to effectively disable a valve upon actuation.
  • the valve will collapse or close against the coated wire intermediate the fixed and movable electrodes.
  • the flat face of the movable head will engage the valve.
  • further displacement will be resisted.
  • the catheter main body with the fixed electrode at its distal end is pushed toward the moveable head. This motion will capture the valve between the two electrodes.
  • a bipolar electrical current is then applied to initiate cautery action.
  • a gentle force is kept on the valvulotome while the current is applied to ablate the valve. Pulling back on the moveable head will indicate whether the valve has been completely ablated.
  • the moveable head is disengaged from the fixed electrode.
  • the catheter is withdrawn in an open position to engage the next valve .
  • dye may be injected through the catheter port(s) 26 to access the valve and venous anatomy.
  • electrodes 24, 24' having a generally circular configuration FIGGS. 1, 3B
  • FIG. 3A Providing electrodes of other configurations (e.g. as electrode 24" shown in FIG. 3A) will disable the valves in other ways such as by radial ablation or part circular ablation.
  • the fixed and moveable electrodes may be provided in any one of several sizes and configurations so as to allow passage through the valves in the direction of (venous) blood flow and then selective retraction through the vein to allow excision of the valve structures.
  • the catheter of the invention may advantageously be provided with interchangeable guide wire and moveable head assemblies or otherwise detachable and interchangeable fixed and/or moveable electrode components or heads to accommodate the surgical procedure, the patient's physiology or the "cut" or ablation pattern desired.
  • One skilled in this art upon a review of this disclosure would appreciate how such modifications could be effected.
  • a variety of moveable and fixed electrode heads are illustrated, but not deemed to be limiting.
  • the moveable head 22 may be coupled to a longitudinally extending conduit 28 to permit the infusion of fluids at, as at 40, or beyond, as at 42, the moveable head.
  • a structure of the type shown in FIGURE 6B may be used to inject suitable material, such as a gel foam, to close off a branch vessel, a procedure known as branch ligation.
  • suitable material such as a gel foam
  • another, flexible tube may be inserted through conduit 28, through which suitable material (s) may be injected.
  • an infusion conduit as in FIGURES 6A and B, furthermore, facilitates a determination of the position of the moveable electrode relative to the fixed electrode by observation of the relative position of the proximal end of the catheter main body relative to the proximal end of the conduit, when the valvulotome is disposed within the target vein.
  • the handle structure of the valvulotome will allow the operator to sense resistance of the valve and to determine through tactile feel feedback the relative position and disposition of the components of the structure.
  • an insulating lip 50 is provided in surrounding relation or adjacent to one or both electrode (s) provided on the respective heads to protect the vein surface from discharge through the electrodes.
  • the lip may be separately provided, for example made of an insulating, bio-compatible, resilient material and secured to the head(s) or integrally formed therewith.
  • triggering of current will only be enabled when the electrodes are closely adjacent and/or both closely touching the target valve to minimize the potential for a spark jumping the gap between electrodes, which may risk damage to the vein wall.
  • current may only be enabled when the lip(s) are in contact with the valve structure.
  • a vein is grafted or anastomosed in si tu to an artery.
  • the vein is pressurized by arterial blood flow to the vein, thereby causing the first valve leaflet pair to close tightly.
  • the valvulotome is inserted from the distal end into the proximal most portion of the vein, near the grafting site.
  • the catheter is then drawn down through the vein such that the fixed electrode passes through the valve leaflets so that the valve is disposed between the moveable head and the fixed electrode. Because of its shape, passage of the moveable head, through the valve leaflets is resisted.
  • the fixed electrode is then advanced towards the moveable head to sandwich the valve leaflet pairs between the electrodes and the current source is actuated.
  • the next adjacent segment of the vein will be pressurized with blood and the moveable head can easily move with the fixed electrode through the vein approaching the next leaflet pair with minimal trauma to the vein walls.
  • the fixed electrode is displaced from the moveable head to pass through the leaflet pair.
  • the moveable head is advanced to the leaflet pair and into engagement therewith.
  • the fixed electrode is advanced towards the moveable head to sandwich the leaflet pair between opposing electrodes. In this manner the leaflets in the vein can be sequentially rendered incompetent quickly and reliably.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Plasma & Fusion (AREA)
  • Medical Informatics (AREA)
  • Otolaryngology (AREA)
  • Physics & Mathematics (AREA)
  • Cardiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)

Abstract

L'invention concerne un valvulotome d'électrocautérisation bipolaire (10) constitué d'un cathéter allongé (12) présentant un axe longitudinal, une extrémité proximale destinée à être tenue et manipulée par un utilisateur, et une extrémité distale. Une première électrode (14) adjacente à l'extrémité distale du corps principal du cathéter, laquelle présente une surface exposée tournée vers l'extrémité distale du cathéter, est couplée électriquement à un dispositif (18) générateur de courant. Une seconde électrode (24), disposée à distance de la première électrode, est elle aussi couplée électriquement au dispositif générateur de courant et présente une surface exposée située dans un plan sensiblement perpendiculaire à l'axe longitudinal du cathéter. La première ou la seconde électrode ou les deux peuvent être déplacées l'une par rapport à l'autre de façon à capturer sélectivement entre elles la structure valvulaire veineuse que l'on veut cautériser.
PCT/US1996/018278 1995-11-22 1996-11-21 Valvulotome d'electrocauterisation bipolaire WO1997018767A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU10762/97A AU1076297A (en) 1995-11-22 1996-11-21 Bipolar electrocautery valvulotome

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US56209095A 1995-11-22 1995-11-22
US08/562,090 1995-11-22
US887695P 1995-12-19 1995-12-19
US60/008,876 1995-12-19

Publications (1)

Publication Number Publication Date
WO1997018767A1 true WO1997018767A1 (fr) 1997-05-29

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Application Number Title Priority Date Filing Date
PCT/US1996/018278 WO1997018767A1 (fr) 1995-11-22 1996-11-21 Valvulotome d'electrocauterisation bipolaire

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AU (1) AU1076297A (fr)
WO (1) WO1997018767A1 (fr)

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2333964A (en) * 1999-03-04 1999-08-11 Falah Hasan Ali Intravenous coagulation catheter for treatment of varicose veins
US7717930B2 (en) 2004-02-27 2010-05-18 Cook Incorporated Valvulotome with a cutting edge
US8398663B2 (en) 2004-02-27 2013-03-19 Cook Medical Technologies Llc Valvulotome device and method
EP2182860A4 (fr) * 2007-08-21 2013-07-24 Valvexchange Inc Procédé et appareil de retrait d'une valvule prothétique
CN104411265A (zh) * 2012-09-12 2015-03-11 奥林巴斯医疗株式会社 高频电刀
US9782191B2 (en) 2014-01-21 2017-10-10 Cook Medical Technologies Llc Cutting devices and methods

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4924882A (en) * 1988-02-26 1990-05-15 Donovan Thomas J Electronic cuspotome and method of using the same
US5085659A (en) * 1990-11-21 1992-02-04 Everest Medical Corporation Biopsy device with bipolar coagulation capability
US5197964A (en) * 1991-11-12 1993-03-30 Everest Medical Corporation Bipolar instrument utilizing one stationary electrode and one movable electrode

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4924882A (en) * 1988-02-26 1990-05-15 Donovan Thomas J Electronic cuspotome and method of using the same
US5085659A (en) * 1990-11-21 1992-02-04 Everest Medical Corporation Biopsy device with bipolar coagulation capability
US5197964A (en) * 1991-11-12 1993-03-30 Everest Medical Corporation Bipolar instrument utilizing one stationary electrode and one movable electrode

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2333964A (en) * 1999-03-04 1999-08-11 Falah Hasan Ali Intravenous coagulation catheter for treatment of varicose veins
GB2333964B (en) * 1999-03-04 1999-12-29 Falah Hasan Ali Intravenous coagulation catheter for treatment of varicose veins
US7717930B2 (en) 2004-02-27 2010-05-18 Cook Incorporated Valvulotome with a cutting edge
US8398663B2 (en) 2004-02-27 2013-03-19 Cook Medical Technologies Llc Valvulotome device and method
EP2182860A4 (fr) * 2007-08-21 2013-07-24 Valvexchange Inc Procédé et appareil de retrait d'une valvule prothétique
CN104411265A (zh) * 2012-09-12 2015-03-11 奥林巴斯医疗株式会社 高频电刀
US9782191B2 (en) 2014-01-21 2017-10-10 Cook Medical Technologies Llc Cutting devices and methods
US10918408B2 (en) 2014-01-21 2021-02-16 Cook Medical Technologies Llc Cutting devices and methods

Also Published As

Publication number Publication date
AU1076297A (en) 1997-06-11

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