Wound closure apparatus and method for its use

• US 5,496,332 A
• Filed: 10/20/1994
• Issued: 03/05/1996
• Est. Priority Date: 10/20/1994
• Status: Expired due to Term

• Current Assignee: Cordis Corporation (Cardinal Health, Inc.)
• Original Assignee: Cordis Corporation (Cardinal Health, Inc.)
• Inventors: Weinstein, Lawrence A., Sierra, Rolando
• Primary Examiner(s): Jackson, Gary
• Application Number:
  US08/326,465
• Time in Patent Office: 502 Days
• Field of Search: 606/139, 606/144, 606/148, 606/146, 606/213, 606/215
• US Class Current: 606/139
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 2017/00637 for sealing trocar wounds through abdominal wall
• CPC Class Codes: A61B 2017/00663 the implement being a suture
• CPC Class Codes: A61B 2017/0472 Multiple-needled, e.g. double-needled, instruments

Abstract

A wound closure apparatus and a method for its use are described. The apparatus includes a trilumen tubular member dimensioned to be positioned within a blood vessel through a conventional catheter sheath introducer. A mesh assembly extends longitudinally through the center lumen of the tubular member to position an expandable mesh portion within the vessel. The expandable mesh portion can be configured between a collapsed condition and an expanded condition by the attending surgeon or other medical personnel. Sutures are deposited into the blood vessel by a pair of medical needles inserted through the vessel wall adjacent the wound so that the leading ends of the sutures are deposited directly into the expandable mesh portion and are captured therein. The leading ends of the sutures can be withdrawn from the vessel through the center lumen of the trilumen body and pulled outside of the wound area where the surgeon can tie the ends thereof to close and seal the vessel wound.

Claims

1. A surgical apparatus for closing an incision or wound in a vessel wall within a living patient, the apparatus comprising:

a tubular member dimensioned for insertion within an incision, said tubular member having a proximal end and a distal end and a center lumen extending longitudinally through said tubular member from said proximal end to said distal end;

a mesh assembly including an expandable portion, said mesh assembly dimensioned for insertion within said center lumen of said tubular member to reversibly position said expandable portion through an incision or wound into a vessel within a living patient, said expandable portion constructed to be configured between an expanded condition and a collapsed condition;

first and second side lumens longitudinally disposed along opposing sides of said center lumen and extending along said tubular member, each said side lumen dimensioned to receive a piercing element therein;

a pair of tubular piercing elements dimensioned to be slidably received within said side lumens, said piercing elements each having a pointed end capable of piercing the wall of a vessel to deliver first and second sutures within the vessel through the wall thereof.

2. The surgical apparatus as defined in claim 1 wherein said tubular member has an outer diameter dimensioned to be slidably received within a catheter sheath introducer.

3. The surgical apparatus as defined in claim 2 wherein said first and second side lumens extend through said tubular member from said proximal end to said distal end substantially parallel to said center lumen.

4. The surgical apparatus as defined in claim 1 wherein said mesh assembly includes a shaft of sufficient length to extend from at least said proximal end of said tubular member through said center lumen and past said distal end to position said expandable portion within said vessel, said shaft stem member including an outer sheath and a control cord positioned within said sheath and axially moveable with respect thereto, said control cord affixed at one end thereof to said expandable portion to enable said control cord to position said expandable portion between said expanded condition and said collapsed condition.

5. The surgical apparatus as defined in claim 4 wherein said mesh assembly includes means for moving said control cord relative to said outer sheath to thereby position said expandable portion between said expanded condition and said collapsed condition.

6. The surgical apparatus as defined in claim 5 wherein said expandable portion includes first and second collar members disposed axially along said mesh assembly, said first collar disposed at the distal end of said outer sheath and said second collar disposed along said control cord;

said expandable portion further including a plurality of fibers extending between said first and second collars, said collars positioned adjacent one another in said expanded condition to thereby position a portion of said fibers in a substantially perpendicular orientation with respect to the longitudinal axis of said tubular member, said expandable portion having a diameter in said expanded condition greater than the diameter of said center lumen.

7. The surgical apparatus as defined in claim 4 wherein said mesh assembly further includes a leading coil extending from said expandable portion and forming the distal end of said mesh assembly.

8. The surgical apparatus as defined in claim 1 wherein said piercing elements are hollow needles having lumens extending therethrough and said apparatus further comprises at least one plunger member dimensioned to extend into the lumen of said needles to thereby guide said sutures therethrough.

9. A surgical apparatus for closing an incision or wound in a vessel wall within a living patient, the apparatus comprising:

a tubular member dimensioned for insertion within an incision, said tubular member having a proximal end and a distal end and a center lumen extending longitudinally through said tubular member from said proximal end to said distal end;

a mesh assembly including an expandable portion, said mesh assembly dimensioned for insertion within said center lumen of said tubular member to reversibly position said expandable portion through an incision or wound into a vessel within a living patient, said expandable portion constructed to be configured between an expanded condition and a collapsed condition;

first and second piercing members associated with said tubular member, each said piercing member having a proximal end and a distal end with a lumen extending therethrough, said distal end having a piercing point thereon to penetrate the wall of a vessel to deliver a suture through said piercing member lumen and within said vessel through said wall thereof.

10. The surgical apparatus as defined in claim 9, further comprising:

first and second side lumens longitudinally disposed along opposing sides of said center lumen and extending along said tubular member parallel to said center lumen, each said side lumen dimensioned to receive one of said piercing members and to position said piercing points to penetrate the wall of a vessel adjacent the wound or incision therein.

11. The surgical apparatus as defined in claim 9 wherein said tubular member has an outer diameter dimensioned to be slidably received within a catheter sheath introducer.

12. A surgical apparatus as defined in claim 10 wherein said first and second side lumens extend through said tubular member from said proximal end to said distal end substantially parallel to said center lumen.

13. The surgical apparatus as defined in claim 9 wherein said mesh assembly includes a shaft of sufficient length to extend from at least said proximal end of said tubular member through said center lumen and past said distal end to position said expandable portion within said vessel, said shaft stem member including an outer sheath and a control cord positioned within said sheath and axially moveable with respect thereto, said control cord affixed at one end thereof to said expandable portion to enable said control cord to position said expandable portion between said expanded condition and said collapsed condition.

14. The surgical apparatus as defined in claim 13 wherein said mesh assembly includes means for moving said control cord relative to said outer sheath to thereby position said expandable portion between said expanded condition and said collapsed condition.

15. The surgical apparatus as defined in claim 9 wherein said expandable portion includes first and second collar members disposed axially along said mesh assembly, said first collar disposed at the distal end of said outer sheath and said second collar disposed along said control cord;

said expandable portion further including a plurality of fibers extending between said first and second collars, said collars positioned adjacent one another in said expanded condition to thereby position a portion of said fibers in a substantially perpendicular orientation with respect to the longitudinal axis of said tubular member, said expandable portion having a diameter in said expanded condition greater than the diameter of said center lumen.

16. The surgical apparatus as defined in claim 13 wherein said mesh assembly further includes a leading coil extending from said expandable portion and forming the distal end of said mesh assembly.

17. A method for closing an incision or wound in a vessel wall within a living patient, comprising:

providing a tubular member having a proximal end and a distal end thereon with a center lumen extending through said tubular member from said proximal end to said distal end;

inserting said distal end of said tubular member into a wound or incision within the wall of a vessel;

advancing an expandable mesh through said center lumen past said distal end of said tubular member and within said vessel, said mesh constructed to be configured between a longitudinally collapsed condition and an expanded condition wherein at least a portion of said mesh is substantially perpendicular to the longitudinal axis of said tubular member;

configuring said expandable mesh in said expanded condition;

delivering first and second sutures within said vessel by injecting the leading ends thereof through the wall of said vessel adjacent said incision or wound;

capturing said leading ends of said sutures within said expandable mesh; and

withdrawing said expandable mesh and said leading ends of said sutures from said vessel through said wound and said center lumen of said tubular member so that said sutures are threaded first through said vessel wall adjacent said wound, into said vessel and exiting from said vessel through said wound to thereby be positioned outside of the body of a living patient where said sutures can be tied to close and seal said wound.

18. The method as defined in claim 17 wherein said providing of a tubular member further includes providing first and second side lumens extending longitudinally along opposing sides of said center lumen, each said side lumen dimensioned to receive a piercing element therein.

19. The method as defined in claim 18 wherein said delivering of first and second sutures within said vessel is accomplished using a pair of tubular piercing elements dimensioned to be slidably received within said first and second side lumens, said piercing elements each including a pointed end capable of piercing the wall of said vessel to deliver said first and second sutures within the vessel through the wall thereof.

20. The method as defined in claim 17 wherein said inserting of said distal end of said tubular member into a wound or incision is accomplished using a catheter sheath introducer to position said distal end of said tubular member within said wound.

21. The method as defined in claim 17 wherein said advancing of an expandable mesh through said center lumen is accomplished by first providing said expandable mesh as part of a mesh assembly including a shaft of sufficient length to extend from at least said proximal end of said tubular member through said center lumen and past said distal end to thereby position said expandable mesh within said vessel, said shaft member including an outer sheath and a control cord positioned within said sheath and axially moveable with respect thereto, said control cord affixed at one end to said expandable portion to enable said control cord to position said expandable portion between said expanded condition and said collapsed condition.

22. The method as defined in claim 21 wherein configuring said expandable mesh in said expanded condition includes moving said control cord relative to said outer sheath to thereby position said expandable portion between said expanded condition and said collapsed condition;

said expandable portion including first and second collar members disposed axially along said mesh assembly, said first collar disposed at the distal end of said outer sheath and said second collar disposed along said control cord;

a plurality of fibers extending between said first and second collars, said collars positioned adjacent one another in said expanded condition to thereby position a portion of said fibers in a substantially perpendicular orientation with respect to the longitudinal axis of said tubular member, said expandable portion having a diameter in said expanded condition greater than the cross sectional diameter of said center lumen.

23. The method as defined in claim 17 wherein said delivering of said first and second sutures within said vessel is accomplished by inserting said sutures through first and second piercing elements having lumens extending therethrough, said piercing elements including first and second plunger members dimensioned to extend into the lumen of said piercing elements to thereby guide said sutures therethrough.

24. The method as defined in claim 17 wherein said capturing of said leading ends of said sutures is accomplished by injecting the leading ends of said sutures directly into said expandable mesh once said expandable mesh is configured in said expanded condition.

25. The method as defined in claim 17 wherein said capturing of said leading ends of said sutures is accomplished by rotating said expandable mesh with respect to the longitudinal axis of said tubular member when said expandable mesh is in said expanded condition.

26. The method as defined in claim 17 wherein said withdrawing of said expandable mesh and said leading ends of said sutures includes configuring said expandable mesh into said collapsed condition prior to withdrawing said mesh member from said vessel.