Device and method for suturing of internal puncture sites

• US 6,517,553 B2
• Filed: 01/24/2001
• Issued: 02/11/2003
• Est. Priority Date: 11/08/1993
• Status: Expired due to Term

• Current Assignee: Abbott Laboratories Incorporated
• Original Assignee: Abbott Laboratories Incorporated
• Inventors: Andreas, Bernard H., Klein, Enrique J.
• Primary Examiner(s): Jackson, Gary
• Application Number:
  US09/769,109
• Publication Number:
  US 20020016614A1
• Time in Patent Office: 748 Days
• Field of Search: 606/213, 606/144, 606/224
• 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 17/0469 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 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 2017/0472 Multiple-needled, e.g. double-needled, instruments
• CPC Class Codes: A61B 2017/22038 with a guide wire
• CPC Class Codes: A61B 2017/2927 the angular position of the head being adjustable with respect to the shaft
• 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

Abstract

A suture applying device comprises a shaft having a nose piece attached at its distal end. The shaft and the nose piece are separated by a transition region, and a needle entry lumen in the shaft permits a flexible needle to be introduced in the distal direction. The needle is able to cross the transition region and penetrate tissue held therein and enter into a return lumen in the nose piece. The return lumen is U-shaped and acts to bend the flexible needle as it is advanced. In this way, the needle passes from the nose piece through the transition region in a proximal direction, and is able to pass through tissue within the transition region generally on the opposite side of a tissue puncture from the first suture passage. The needle then exits from the device, permitting the suture attached to the needle to be drawn fully through the device. The suture may then be tied in order to close and seal the tissue penetration.

Claims

1. A method of closing a puncture in a blood vessel wall, the method comprising:

positioning a suture placement device in a tissue tract and into a puncture in the blood vessel wall;

advancing a length of suture in a distal direction from the device through a first penetration in the blood vessel wall adjacent to the puncture;

guiding the suture length from the first penetration across a proximal side of the puncture to a second penetration adjacent to the puncture opposite the first penetration;

advancing the suture length in a proximal direction through the second penetration and the device so that the two ends of the suture length are accessible external to the tissue tract; and

securing the suture length across an anterior side of the puncture to close the puncture.

2. The method of claim 1, wherein advancing a length of suture in a distal direction comprises pushing a needle which carries the suture through the first penetration.

3. The method of claim 2, wherein guiding the suture length comprises elastically bending the needle as it tracks within the blood vessel to the second penetration.

4. The method of claim 3, wherein advancing the suture in a proximal direction comprises pushing the needle so that a needle tip passes proximally out through the tissue tract.

5. A method for suturing a puncture site in a wall of a blood vessel, said method comprising:

providing a suturing device having a pair of axially advanceable penetrating elements;

advancing the penetrating elements to form two penetrations in the blood vessel wall on opposite sides of the puncture site;

advancing suture distally through the suture device distally through one of the two penetrations into a lumen of the blood vessel, proximally through the other of the two penetrations, and proximally through the suturing device; and

securing the suture to close the puncture site.

6. The method of claim 5, wherein the penetrating elements are needle guides.

7. The method of claim 6, wherein advancing the suture comprises pushing the suture distally through a lumen of a first needle guide tube and pulling the suture proximally through a second needle guide tube.

8. The method of claim 7, wherein advancing the suture comprises providing a needle having the suture attached thereto and pushing the needle distally through the lumen of the first needle guide tube and pulling the needle proximally through the second needle guide tube.

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

providing a length of suture;

pushing the suture distally through a tissue tract over the puncture site through a penetration on one side of the puncture site into a lumen of the blood vessel;

pulling the suture proximally through a second penetration on another side of the puncture site and proximally through the tissue tract; and

securing the suture to close the puncture site.

10. A device for suturing a puncture in a blood vessel wall, said device comprising:

a body arranged to be positioned through a tissue tract over the blood vessel puncture, said body having a path for, (a) advancing a suture length in a distal direction past a first gap in the body, (b) advancing the suture laterally on a distal side of the gap, and (c) proximally through a second gap in the body, wherein the gaps are arranged to capture the edges of the blood vessel wall adjacent to the puncture so that the suture advances distally through one edge, laterally across a distal side of the puncture, and proximally through the other edge of the puncture.

11. The device according to claim 10, wherein the body comprises a shaft having a nose piece, wherein the gaps are positioned between a distal end of the shaft and a proximal surface of the nose piece.

12. The device according to claim 10, wherein the device further includes a needle, the needle being configured to carry the suture through the suture path.

13. The device according to claim 12, wherein the device further comprises a pair of needle guide tubes, said guide tubes arranged to be advanced across the gaps to penetrate the edges of the blood vessel wall to form penetrations prior to advancement of the needle.