Method for the percutaneous suturing of a vascular puncture site

• US 5,860,991 A
• Filed: 08/22/1997
• Issued: 01/19/1999
• Est. Priority Date: 12/10/1992
• Status: Expired due to Term

• Current Assignee: Abbott Laboratories Incorporated
• Original Assignee: Perclose Incorporated (Abbott Laboratories Incorporated)
• Inventors: Vetter, James W., Gross, T. Daniel, Hinohara, Tomoaki, Klein, Enrique J.
• Primary Examiner(s): Buiz, Michael Powell
• Assistant Examiner(s): TRINH, HOA B
• Application Number:
  US08/916,353
• Time in Patent Office: 515 Days
• Field of Search: 606/139, 606/144, 606/148, 606/147, 606/145, 606/157, 606/158, 606/184, 606/187, 606/222, 606/223, 112/169, 112/80.03, 604/168, 604/900
• US Class Current: 606/144
• 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 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/0482 Needle or suture guides guides for drills, pins or wire A61B17/17; for puncturing needles A61B17/3403
• CPC Class Codes: A61B 17/06066 Needles, e.g. needle tip configurations making needles B21G1/00
• CPC Class Codes: A61B 17/0625 the needle being specially adapted to interact with the manipulator, e.g. being ridged to snap fit in a hole of the manipulator A61B17/06109 takes precedence
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61B 2017/00637 for sealing trocar wounds through abdominal wall
• CPC Class Codes: A61B 2017/00641 for closing fistulae, e.g. anorectal fistulae
• CPC Class Codes: A61B 2017/00663 the implement being a suture
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/0458 Longitudinal through hole, e.g. suture blocked by a distal suture knot
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/047 having at least one proximally pointing needle located at the distal end of the instrument, e.g. for suturing trocar puncture wounds starting from inside the body J-shaped suture needles A61B2017/0608
• CPC Class Codes: A61B 2017/0472 Multiple-needled, e.g. double-needled, instruments
• CPC Class Codes: A61B 2017/0474 Knot pushers
• CPC Class Codes: A61B 2017/06057 Double-armed sutures, i.e. sutures having a needle attached to each end
• CPC Class Codes: A61F 2002/30092 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2210/0019 operated at only one temperature whilst inside or touching the human body, e.g. constrained in a non-operative shape during surgery, another temperature only occurring before the operation
• CPC Class Codes: Y10S 604/90 Telltale showing entry of blood into body inserted conduit

Abstract

A suture applying device comprises a shaft which carries a pair of needles near its distal end. The needles are joined by a length of suture, and the shaft is used to both introduce the needles into a lumen of a body structure and to push the needles back through tissue on either side of the puncture site. After the needles have passed through the tissue, they are captured on the shaft and drawn outward through the tract, leaving a loop of suture behind to close the puncture site near the body lumen. The suture can then be tied and the knot pushed back through the tract to complete the closure. Alternatively, a locking fastener formed of a resorbable material can be placed into the penetration over the sutures and the sutures tied over the fastener.

Claims

1. A method for suturing a puncture site in a blood vessel wall at the end of a tissue tract, the blood vessel wall having a distal side and a proximal side, said method comprising:

forming at least two penetrations in the blood vessel wall at the end of the tissue tract adjacent to the puncture site with at least one needle;

passing a suture material through the two penetrations outwardly from the blood vessel wall to span the distal side of the puncture site; and

drawing the penetrations together with the suture material.

2. The method of claim 1 wherein the step of passing the suture material through the two penetrations occurs simultaneously to span the distal side of the puncture site.

3. The method of claim 1 wherein the step of passing the suture material through the two penetrations uses only one length of suture material.

4. The method of claim 1 wherein the step of passing the suture material through the two penetrations includes passing a single strand of suture material through the penetrations.

5. The method of claim 1 wherein the step of passing the suture material through the two penetrations includes passing the suture material through the penetrations from the distal side of the blood vessel wall.

6. The method of claim 1 wherein the step of forming the penetrations includes penetrating a needle through the blood vessel wall.

7. The method of claim 1 wherein the step of passing the suture through the penetrations to span the distal side of the blood vessel opening includes pulling the suture through each penetration with the needle used to form the respective penetration.

8. The method of claim 7 wherein the needles are passed from the distal side of a membrane to form the penetrations in the blood vessel wall and pull the suture therethrough.

9. A method of suturing a puncture site in a blood vessel wall, the method comprising:

positioning a length of suture into a lumen of the blood vessel;

forming at least two penetrations in the blood vessel wall at the end of a tissue tract adjacent the puncture site with more than one needle;

passing a first end of a length of suture through one of the penetrations outwardly from the lumen and a second end of the length of suture through another penetration outwardly from the lumen with the needles; and

securing the first and second ends of the suture to close the aperture.

10. The method of claim 9 wherein the passing step includes simultaneously passing the first end and second end of the length of suture through at least two of the penetrations outwardly from the lumen.

11. The method of claim 9 wherein the step of passing the second end of the suture through the penetrations includes pulling the suture through each penetration with the needle used to form the respective penetration.

12. The method of claim 11 wherein a first needle is used to form the first penetration and pull through the first suture end and a second needle is used to form the second penetration and pull through the second suture end.

13. The method of claim 12 wherein both needles are passed from the blood vessel lumen to form the penetrations in the blood vessel wall and pull the suture therethrough.

14. A method for suturing vascular tissue, the method comprising:

forming at least two penetrations in one or more layers of vascular tissue at the end of a tissue tract with more than one needle;

passing a first end of a length of suture through one of the penetrations and a second end of the length of suture through the other penetration with the needles; and

securing the first and second ends of the suture to pull the penetrations in one or more layers of vascular tissue together.

15. The method of claim 14 wherein one of the penetrations is in a first layer and the other penetration is in a second layer of tissue.

16. The method of claim 14 wherein the step of passing the first and second ends of a length of suture material through the at least two penetrations occurs simultaneously.

17. The method of claim 14 wherein the step of passing the first and second ends of the length of the suture material through the at least two penetrations uses only one length of suture material.

18. The method of claim 14 wherein the step of passing the suture material through the at least two penetrations includes passing a single strand of suture material through the penetrations.

19. The method of claim 14 wherein the blood vessel wall has a distal side and a proximal side and the step of passing the suture material through the at least two penetrations includes passing the suture material through the penetrations from the distal side of blood vessel wall.

20. The method of claim 14 wherein the one or more layers of tissue have a distal side and a proximal side and the needles are passed from the distal side of the one or more layers of vascular tissue to form the penetrations and pull the first and second ends of the length of the suture material therethrough.

21. A method for suturing vascular tissue having a distal side and a proximal side, the method comprising:

penetrating a layer of vascular tissue at the end of a tissue tract with at least one needle;

drawing a length of suture proximally through the penetration with the needle; and

detaching the length of suture from the needle to free the length of suture for fastening to the same length.

22. The method of claim 21 wherein the detaching step is performed on the proximal side of the tissue layer.

23. The method of claim 21 wherein the drawing step further includes retrieving the needle from the proximal side of the tissue layer.

24. The method of claim 21 wherein the tissue layer includes an aperture, the method includes the step of passing the length of suture distally through the aperture.

25. The method of claim 21 wherein the step of drawing a length of suture includes passing a single strand of suture material through the penetration.