Method and apparatus for ligating a blood vessel, tissue or other bodily duct

• US 5,792,151 A
• Filed: 01/24/1996
• Issued: 08/11/1998
• Est. Priority Date: 01/24/1996
• Status: Expired due to Fees

• Current Assignee: Ohio State University
• Original Assignee: Ohio State University
• Inventors: Strater, William H., Schertel, Eric R., Heck, Christopher F.
• Primary Examiner(s): Jackson, Gary
• Application Number:
  US08/590,786
• Time in Patent Office: 930 Days
• Field of Search: 606/139, 606/144, 606/145, 606/148, 112/169, 112/80.03
• US Class Current: 606/144
• CPC Class Codes: A61B 17/0491 Sewing machines for surgery
• CPC Class Codes: A61B 17/12009 Implements for ligaturing other than by clamps or clips, e.g. using a loop with a slip knot
• CPC Class Codes: A61B 2017/0477 with pre-tied sutures
• CPC Class Codes: A61B 2017/2915 arcuate shaped guiding means
• CPC Class Codes: A61B 2017/2916 pins in guiding slots
• CPC Class Codes: A61B 2017/2931 with releasable head

Abstract

A reusable ligation apparatus includes a suture tying or knot tying instrument and a suture cartridge containing a preformed ligature. The cartridge is releasably attached to the instrument so that after a first ligature is made, the apparatus enables one-handed ligation, and can be quickly reloaded with a second cartridge for making another ligature without delay. The cartridge contains a preformed ligature and the instrument includes an activation system which automatically pulls one end of the preformed ligature through loops formed in the other end to thereby form a completed ligature knot.

Claims

1. A reusable ligation assembly for use in ligating a vessel or duct, said ligation assembly comprising:

an elongated frame;

a holding member for receiving the vessel or duct therein, said holding member releasably secured to said frame and carrying a length of suture material having a noose formed on a first end, a second end and at least one loop therebetween, said holding member having

(a) means for retaining a piece of suture material around a portion of the vessel or duct when the vessel or duct is placed therein,

(b) means for releasably retaining said noose,

(c) means for releasably retaining said at least one loop, and

(d) means for securing the second end of the suture material;

capture means for moving said noose around the blood vessel and through said at least one loop to form a knot and connected to and extendable from said elongated frame member;

tightening means for tightening the suture material around the blood vessel and connected to and extendable from said elongated frame member; and

cutting means incorporated within and extendable from said elongated frame member for cutting the suture material intermediate the ends of the suture material and the knot.

2. The ligation assembly of claim 1 wherein the means for securing the second end of the suture material comprises an aperture positioned through the base section with the second end of the suture material positioned therethrough, the second end of the suture material having a tip end extending beyond the outer surface of the base section with a diameter larger than the diameter of said aperture.

3. The ligation assembly of claim 1 wherein said capture means comprises:

a first rod member extending axially from a first end to second end, said first rod member being partially supported within said elongate frame and axially moveable between extended and retracted positions within said elongate frame;

a capture member disposed on the first end of said first rod member for engaging the noose on the suture material when said first rod member is moved to the extended position and for transferring the noose into engagement with the loops on the suture material when said first rod member is moved to a retracted position;

first actuating means comprising a handle and an actuator pivotally connected to said handle, said actuating means responsive to the manipulation of said actuator for moving said first rod member between extended and retracted positions;

wherein movement of said first rod member from extended to retracted position transfers the noose into engagement with the loops to form a ligation loop around the blood vessel and to form a knot.

4. The ligation assembly of claim 1, wherein the means for cutting the suture material intermediate the ends of the suture material and the knot comprises:

a cutting mechanism configured to cut the suture material between the second end and the loops and also between the loops and the noose after the knot is tightened by said tightening means and said capture means.

5. A reusable ligation assembly for use in ligating a vessel or duct, said ligation assembly comprising:

an elongated frame;

a C-shaped holding member for receiving the vessel or duct therein comprising a first end section removably attachable to said elongated frame having an outer surface adjacent said holding member, an inner surface, and an aperture extending transversely therethrough;

a second end section having an inner surface opposing the inner surface of said first end section, an outer surface, and a cavity with an opening defined by the inner surface of said second end section;

a base section integral with said first end section and said second end section and having an outer surface and an inner surface contiguous with the inner surfaces of said first end section and said second end section, and a longitudinal bore extending transversely therethrough,

said holding member releasably secured to said frame and carrying a length of suture material having a noose formed on a first end, a second end and at least one loop therebetween, said holding member having

(a) means for retaining a piece of suture material around a portion of the vessel or duct when the vessel or duct is placed therein,

(b) means for releasably retaining said noose,

(c) means for releasably retaining said at least one loop, and

(d) means for securing the second end of the suture material;

capture means for moving said noose around the blood vessel and through said at least one loop to form a knot and connected to and extendable from said elongated frame;

tightening means for tightening the suture material around the blood vessel and connected to and extendable from said elongated frame; and

cutting means incorporated within and extendable from said elongated frame for cutting the suture material intermediate the ends of the suture material and the knot.

6. The ligation assembly of claim 5, wherein the means for retaining a piece of suture material around a portion of the blood vessel comprises a channel positioned along the inner surfaces of said first end section, said base section and said second end section for releasably holding the suture material between the loops and the noose in the suture material and around a portion of the blood vessel when the blood vessel is placed therein.

7. The ligation assembly of claim 5, wherein the means for releasably retaining at least one loop intermediate the noose and the second end of the suture material comprises a loop holder disposed within the aperture of said first end section, said loop holder having a bore, a loop holder region defining the bore, and a retaining means to releasably hold at least one loop in the suture material around the bore.

8. The ligation assembly of claim 7 wherein said loop holder comprises a cylinder having a first end surface extending at an oblique angle from the inner surface of the first end section to further envelop a portion of the blood vessel.

9. The ligation assembly of claim 5, wherein the means for releasably retaining a noose at one end of the suture material comprises a noose holder seated in the cavity of said second end section having a bore and a region surrounding said bore configured to releasably hold the noose around a portion of the bore.

10. The ligation assembly of claim 9 wherein said noose holder further comprises a C-shaped member surrounding the opening of the bore of said noose holder for press fitting the noose into a resilient stirrup configuration.

11. The ligation assembly of claim 9, wherein said noose holder comprises a paraffin coated C-shaped member surrounding the opening of the bore of said noose holder for press fitting the noose into a resilient stirrup configuration thereby permitting the grasping member of said first rod to pass through the stirrup when said first rod is moved into the extended position and further permitting the grasping member to retain the noose in the stirrup configuration when said first rod member is retracted.

12. The ligation assembly of claim 5 wherein said capture means comprises:

a first rod member extending axially from a first end to second end, said first rod member being partially supported within said elongate frame and axially moveable between extended and retracted positions within said elongate frame;

a capture member disposed on the first end of said first rod member for engaging the noose on the suture material when said first rod member is moved to the extended position and for transferring the noose into engagement with the loops on the suture material when said first rod member is moved to a retracted position;

first actuating means comprising a handle and an actuator pivotally connected to said handle, said actuating means responsive to the manipulation of said actuator for moving said first rod member between extended and retracted positions;

an outer link bar having a first end and a second end having a outer cam pin extending therefrom;

an outer drive cam rotatably positioned within said elongate frame and having an outer surface, said outer surface having an outer drive cam groove therein, said outer cam pin positioned in said outer drive cam groove such that manipulation of said handle assembly causes said outer cam pin to rotate said outer drive cam;

an inner drive cam movable with said outer drive cam such that rotation of said outer drive cam rotates said inner drive cam, said inner drive cam having an inner drive cam surface, said inner drive cam surface having an inner drive cam groove therein;

a said first rod member having an inner cam pin extending therefrom, said inner pin positioned in said inner drive cam groove such that upon rotation of said inner drive cam the inner cam pin moves through the inner groove axially moving the first rod member from retracted to extended positions; and

wherein movement of said first rod member from extended to retracted position transfers the noose into engagement with the loops to form a ligation loop around the blood vessel and to form a knot.

13. The ligation assembly of claim 12 wherein said tightening means comprises:

a second rod member axially extending from a first end to a second end, said second rod member being partially supported within said elongate frame and axially moveable within said frame to an extended position wherein the first end of said second rod member engages a piece of suture material lying between the second end and loops thereof;

a front drive cam having a sloped front end surface and a back end surface, said back end surface fixedly secured to the front end of said outer drive cam, said sloped front end surface having placed thereon the second end of said second rod member such that rotation of said outer drive cam rotates said front drive cam axially moving said second rod member to an extended position;

biasing means for biasing the second end of said second rod member against said front drive cam;

wherein said first actuating means moves said second rod member to the extended position as said first actuating means moves said first rod member from a retracted position to an extended position and back to a retracted position so that said second rod member pushes on the second end of the suture material while said first rod member pulls on the noose thereby tightening the knot in the suture material.

14. The ligation assembly of claim 13, wherein said second rod member is moved into engagement with the suture material as said first rod member transfers the noose into engagement with the loops on the suture material thereby tightening the knot.

15. The ligation assembly of claim 5 wherein said means for cutting the suture material intermediate the ends of the suture material and the knot comprises:

a cutting mechanism configured to cut the suture material between the second end and the loops and also between the loops and the noose after the knot is tightened by said tightening means and said capture means comprising;

a) a third rod member extending axially from a first end to second end, said third rod member being partially supported within said elongated frame and movable into an extended position and back to a retracted position;

b) a first cutter integrally connected to the first end of said third rod member and extending a predetermined distance therefrom such that movement of said third rod member to an extended position moves said first cutter into cutting engagement with the portion of suture material between the second end and the loops of said suture material; and

c) a second cutter connected adjacent to said first cutter and to the first end of said third rod member, said second cutter having a geometric configuration such that movement of said third rod member to an extended position moves the second cutter into cutting engagement with the portion of suture material between the noose and the loops of the suture material after the knot is tightened.

16. The ligation assembly of claim 15 wherein said cutting mechanism includes second actuation means for movement of said third rod from a retracted position to an extended position and back to a retracted position.

17. The ligation assembly of claim 16 wherein said second actuation means comprises:

a pin affixed to the second end of said third rod member;

a link member extending axially from a first end to a second end, said link member being partially supported within said elongate frame and having said second end affixed to said pin;

a trigger mechanism pivotally connected to the first end of said link member such that engagement of said trigger extends said third rod member;

a spring disposed between said second end of said third rod member and said elongate frame so as to bias the third rod member from an extended position to a retracted position;

wherein said second actuating means moves said third rod member from a retracted position to an extended position moving the first and second cutters into cutting engagement while said spring biases the third rod member to the retracted position upon cutting.

18. A holding member for retaining a pre-formed length of suture material having a noose found on a first end thereof, a second end and a plurality of loops therebetween and for attachment to an instrument having a suture material grasper comprising:

a first end section having an outer surface and an inner surface and an aperture extending between the inner and outer surfaces, said outer surface of said first end section removably attachable to the instrument;

a loop holder disposed within the aperture of said first end section having a bore dimensioned for receiving the grasper on the instrument and a loop holder region defining the bore and adapted to releasably hold a plurality of loops in the suture material around the bore;

a second end section having an inner surface opposing the inner surface of said first end section, and a cavity extending between the inner and outer surfaces of said second section and in substantial axial alignment with said aperture of said first end section, said cavity having an opening defined by the inner surface of said second end section and dimensioned for receiving the instrument grasper;

a noose holder seated in the first cavity of said second end having a bore with a diameter larger than the grasper for receiving the grasper, and a region defining the bore and configured to releasably hold the noose around a portion of the bore; and

a base section integral with said first end and said second end and having an inner surface contiguous with the inner surfaces of said first end and said second end.

22. The holding member of claim 18 wherein said second end includes a recess with an opening defined by the inner surface of said second end for receiving a portion of the suture material between the noose and the loops.

19. A holding member for retaining a pre-formed length of suture material having a noose found on a first end thereof, a second end and a plurality of loops therebetween and for attachment to an instrument having a suture material grasper comprising:

a first end section having an outer surface and an inner surface and an aperture extending between the inner and outer surfaces, said outer surface of said first end section removably attachable to the instrument;

a loop holder disposed within the aperture of said first end section having a bore dimensioned to receive the grasper on the instrument and a loop holder region defining the bore and adapted to releasably hold a plurality of loops in the suture material around the bore;

a second end section having an inner surface opposing the inner surface of said first end section, and a cavity extending between the inner and outer surfaces and in substantial axial alignment with said aperture of said first end section, said cavity having an opening defined by the inner surface of said second end section and dimensioned to receive the instrument grasper;

a noose holder seated in the first cavity of said second end having a bore with a diameter larger than the grasper for receiving the grasper, and a region defining the bore and configured to releasably hold the noose around a portion of the bore; and

a base section integral with said first end and said second end and having an inner surface contiguous with the inner surfaces of said first end and said second end and having a first longitudinal bore, a second longitudinal bore and an aperture perpendicular to the first and second longitudinal bores of said base member for positioning a portion of the suture material across the diameters of the longitudinal bores.

20. The holding member of claim 19 wherein said holding member has a channel positioned along the inner surfaces of said first end, said second end and said base section for releasably retaining the portion of suture material lying between a plurality of loops and a noose formed in the suture material.

21. The holding member of claim 19 wherein said loop holder comprises a cylinder having a first end surface which extends below the inner surface of said first end at an oblique angle thereto,

removing a sutureless holding member from the elongate frame providing for the releasable attachment of another holding member having a piece of preformed suture material therein.

23. A method for ligating a blood vessel with suture material comprising the steps of:

a) providing an elongated frame having a distal end, a proximal end and tying means disposed therein;

b) providing a holding member having a piece of pre-formed suture material having a noose end releasably secured to the holding member and a second end secured to the distal end of said holding member with at least one loop intermediate the noose and second end;

c) positioning the holding member in the distal end of the elongated frame;

d) receiving the blood vessel in the holding member intermediate the noose and loop of the suture material with a portion of the suture material around the blood vessel;

e) moving the noose of the suture material around the blood vessel and through the loop intermediate the ends of the suture material to form a knot;

f) tightening the suture material around the blood vessel; and

g) cutting the suture material intermediate the ends of the suture material and the knot.

24. The method of claim 23, further comprising the step of:

removing a sutureless holding member from the elongate frame providing for the releasable attachment of another holding member having a piece of preformed suture material therein.

25. The method of claim 23, wherein the moving step includes extending a first rod through the plurality of loops to retain the noose and retracting the first rod retaining the noose through the loops thereby releasing the suture material from the holding member configuration to surround the vessel or duct with the suture material forming a loose knot, and extending a second rod into contact with the portion of suture material between the plurality of loops and second end to tighten the knot.

26. The method of claim 23, wherein the cutting step includes extending a third rod having a distal end with at least one cutting element thereon into cutting engagement with the portions of suture material intermediate the ends and the knot.

27. A cartridge for carrying a preformed ligature, said cartridge to be attached to a surgical delivery instrument thereby forming a ligation apparatus for use in ligating a tissue conduit with said ligature, said cartridge comprising

a body member having a proximal arm, a distal arm and a base, said body member defining a C-shaped opening for receiving said tissue conduit such that remote ends of said proximal and distal arms remote from said base protrude past said conduit when said conduit is received in said C-shaped opening, said proximal arm and distal arm having inside surfaces facing said C-shaped opening,

the remote end of said distal arm being adapted to hold a first end of said ligature,

the remote end of said proximal arm defining a guide adaptable for receiving and allowing the leading end and body of an elongated capture member adapted to move through said guide, the leading end of said elongated capture member being adapted to capture said first ligature end from the remote end of said distal arm, said guide being adaptable for receiving and holding at least one loop formed in said ligature remote from the first ligature end while said elongated capture member moves therethrough,

said base adapted to receive an elongated tightening member arranged generally parallel to said elongated capture member,

the inside surfaces of said proximal and distal arms being adapted to hold a body portion of said ligature between the first ligature end and said loop while said cartridge is moved into a use position with said tissue conduit being received in said C-shaped opening,

said body member being adapted to hold the second end of said ligature so that movement of said tightening member from a retracted position remote from said body member to an engaged position associated with said base causes tension to be placed on said second ligature end for closing said at least one loop and thereby tying a knot in said ligature.

28. The cartridge of claim 27, wherein said body member defines a cutting aperture therein for receiving the leading end of an elongated cutting member, said cutting aperture arranged so that the leading end of a severing member can sever said ligature between said at least one loop and the second ligature end.

29. The cartridge of claim 28, wherein said proximal arm has an outside surface adapted to be releasably attached to said surgical instrument.

30. The cartridge of claim 27, wherein said proximal arm has an outside surface adapted to be releasably attached to said surgical instrument.

31. A cartridge to be attached to a surgical delivery instrument thereby forming a ligation apparatus for use in ligating a tissue conduit, said cartridge comprising a cartridge and a preformed ligature in said cartridge, said cartridge comprising

a body member having a proximal arm, a distal arm and a base, said body member defining a C-shaped opening for receiving said tissue conduit such that remote ends of said proximal and distal arms remote from said base protrude past said conduit when said conduit is received in said C-shaped opening, said proximal arm and distal arm having inside surfaces facing said C-shaped opening,

the remote end of said distal arm holding a first end of said ligature,

the remote end of said proximal arm defining a guide for receiving the leading end and body of an elongated capture member and allowing the capture member to move through said guide with the leading end of said elongated capture member being adapted to capture said first ligature end from the remote end of said distal arm, said guide receiving and holding at least one loop formed in said ligature remote from the first ligature end such that said loop remains in place in said guide while said elongated capture member moves therethrough,

said base adapted to receive an elongated tightening member arranged generally parallel to said elongated capture member,

the inside surfaces of said proximal and distal arms holding a body portion of said ligature between the first ligature end and said loops such that said body portion remains in place while said cartridge is moved into a use position with said tissue conduit being received in said C-shaped opening,

said body member holding the second end of said ligature so that movement of said tightening member from a retracted position remote from said body member to an engaged position associated with said base causes tension to be placed on said second ligature end for closing said at least one loop and thereby tying a knot in said ligature.

32. A cartridge to be attached to a surgical delivery instrument thereby forming a ligation apparatus for use in ligating a tissue conduit, said cartridge comprising a cartridge and a preformed ligature in said cartridge, said cartridge comprising

a body member having a proximal arm and a distal arm, said body member defining a C-shaped opening for receiving said tissue conduit, said proximal arm and distal arm holding said ligature while said cartridge is moved into a use position with said tissue conduit being received in said C-shaped opening, said proximal arm being adapted to be releasably attached to said surgical instrument.

33. A surgical delivery instrument for use in ligating a tissue conduit, said delivery instrument to be releasably attached to a suture cartridge carrying a preformed ligature, said surgical delivery instrument and said cartridge together forming a ligation apparatus, said cartridge comprising a body member defining a C-shaped opening for receiving said tissue conduit, said body member being adapted to hold said ligature in said C-shaped opening while said cartridge is moved by said instrument into a use position with said tissue conduit being received in said C-shaped opening, said surgical delivery instrument comprising

an elongated frame,

a front end for releasably mounting said cartridge on said frame,

an elongated capture member in said frame, said capture member having a leading end adapted to capture a first end of said ligature held by said cartridge, and

an actuator attached to said frame, said actuator adapted to move said capture member from an initial position to an engaged position in which said leading end captures said first ligature end and then to a retracted position,

the leading end of said capture member being adapted to hold said first ligature end while said capture member moves from said engaged position to said retracted position so that said preformed ligature is pulled tight around said tissue conduit as said capture member moves back to its retracted position.

34. A surgical delivery instrument for use in ligating a tissue conduit, said delivery instrument to be releasably attached to a suture cartridge carrying a preformed ligature, said surgical delivery instrument and said cartridge together forming a ligation apparatus, said cartridge comprising a body member defining a C-shaped opening for receiving said tissue conduit, said body member being adapted to hold said ligature in said C-shaped opening while said cartridge is moved by said instrument into a use position with said tissue conduit being received in said C-shaped opening, said surgical delivery instrument comprising

an elongated frame,

a front end for releasably mounting said cartridge on said frame,

an elongated capture member in said frame, said capture member having a leading end adapted to capture a first end of said ligature held by said cartridge, and

an actuator attached to said frame, said actuator adapted to move said capture member from an initial position to an engaged position in which said leading end captures said first ligature end and then to a retracted position,

the leading end of said capture member being adapted to hold said first ligature end while said capture member moves from said engaged position to said retracted position so that said preformed ligature is pulled tight around said tissue conduit as said capture member moves back to its retracted position;

and

an elongated tightening member in said frame, said tightening member being movable from a retracted position to an engaged position associated with said cartridge, said tightening member engaging said ligature near the second end of said ligature when said tightening member is in said engaged position to thereby cause tension to be placed on said second ligature end for helping pull said ligature tight.

35. The surgical delivery instrument of claim 34, further comprising an elongated severing member in said frame, said severing member being movable from a retracted position to a severing position in which said severing member severs said ligature to thereby release said ligature from said cartridge.