Articulating suturing device and method

• US 8,057,491 B2
• Filed: 12/13/2010
• Issued: 11/15/2011
• Est. Priority Date: 03/04/1999
• Status: Expired due to Fees

• Current Assignee: Abbott Laboratories Incorporated
• Original Assignee: Abbott Laboratories Incorporated
• Inventors: Isbell, Lewis, Modesitt, D. Bruce, Andreas, Bernard H., Barrett, Michael, Zung, Michael
• Primary Examiner(s): WOO, JULIAN W
• Application Number:
  US12/966,961
• Publication Number:
  US 20110224699A1
• Time in Patent Office: 337 Days
• Field of Search: 606/139, 606/144, 606/145, 606/148, 606/150, 606/153
• 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 17/0483 Hand-held instruments for holding sutures A61B17/0469 takes precedence; other holders for needles or sutures A61B17/06061; surgical forceps A61B17/28; surgical pincettes A61B17/30
• 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 2017/00637 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 2017/00672 Locating means therefor, e.g. bleed back lumen
• 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 2017/0477 with pre-tied sutures
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61B 2017/06057 Double-armed sutures, i.e. sutures having a needle attached to each end
• CPC Class Codes: A61B 2017/2927 the angular position of the head being adjustable with respect to the shaft

Abstract

Devices, systems, and methods for suturing of body lumens allow the suturing of vascular puncture sites located at the distal end of a percutaneous tissue tract. An elongated articulated foot near a distal end of a shaft is inserted through the penetration and actuated so that the foot extends along the lumenal axis. The foot carries suturing attachment cuffs, and needles are advanced from the shaft through the vessel wall outside of the penetration and into engagement with the needle cuffs after the foot has been drawn proximally up against the endothelial surface of the blood vessel. The cross-section of the shaft within the tissue tract can be minimized by laterally deflecting the needles as they leave the shaft, while tapered depressions within the foot can guide the advancing needles into engagement with the cuffs. The cuffs lockingly engage the needles and can be withdrawn proximally along the needle paths and through the tissue tract so as to form a loop of suture across the puncture. The articulating foot may be realigned with the shaft and withdrawn proximally through the tissue tract without dilating the tissue tract.

Claims

1. A method for suturing a puncture in a tissue, the method, comprising:

positioning a suturing device through the puncture in the tissue, wherein the suturing device includes;

a first needle configured to form a first penetration about a periphery of an incision, the first needle having a pre-tied knot disposed thereabout at a point spaced back from a distal end of the device;

a second needle configured to form a second penetration about the periphery of the incision device that includes, the second needle having a length of suture extending from a free end of the pre-tied knot connected thereto; and

a link disposed at the distal end of the suturing device;

advancing a first end of the length of suture through the tissue using the second needle;

coupling the first end of the suture to a corresponding second end of the link;

advancing the first needle through the tissue and coupling the first needle to a corresponding first end of the link;

withdrawing the first needle through the tissue so as to withdraw the first needle, the link, and the first end of the length of suture through the pre-tied knot; and

tensioning the suture across the puncture formed in the tissue.

2. The method of claim 1, wherein advancing the first end of the length of suture through the tissue, coupling the first end of the suture to the link, coupling the first needle to the link, and withdrawing the first needle, the link, and the first end of the length of suture through the pre-tied knot forms a loop of suture that spans the puncture so as to close the puncture when the suture is tensioned.

3. The method of claim 1, the suturing device further including a foot disposed at the distal end of the suturing device with the link being disposed on the foot.

4. The method of claim 3, wherein the foot includes a first cuff and a second cuff connected to the first cuff via the link, the second and first cuffs being configured to receive the first end of the suture first and the first needle, respectively.

5. The method of claim 4, the second needle further comprising a detachable sharpened distal penetrating tip connected to the length of suture, wherein the detachable sharpened distal penetrating tip is capable of penetrating the tissue around the periphery of the incision and capable of fixedly connecting the length of suture to the second cuff.

6. The method of claim 4, the first needle further comprising a sharpened distal penetrating tip capable of penetrating the tissue around the periphery of the incision and capable of fixedly connecting to the first cuff, and wherein drawing the first end of the suture through the pre-tied knot includes pulling the suture with the sharpened distal penetrating tip of the first needle.

7. The method of claim 1, further comprising:

positioning a shaft through the puncture in the tissue, wherein the shaft is configured to house the first needle, the second needle, and the link; and

advancing the first needle and second needle along the shaft, the pre-tied knot being releasably attached to the shaft.

8. A method for suturing a puncture in a tissue using a device, the method comprising:

inserting at least a first end of a length of suture through a tissue tract of a patient body and through the tissue using a second needle;

coupling the first end of the suture to a corresponding second end of a link, wherein the link is disposed in the tissue tract on a distal end of the device;

inserting a first needle through the tissue tract, the first needle passing through a pre-tied knot that is disposed at a point spaced back from a distal end of the device;

coupling the first needle to a corresponding first end of the link;

withdrawing the first needle back through the tissue tract so as to withdraw the first needle, the link, and the first end of the length of suture through the pre-tied knot so as to form a loop of suture that spans the puncture and passes through the pre-tied knot; and

tensioning the loop of suture adjacent the pre-tied knot to form a knot affixing the loop of suture across the puncture.

9. The method of claim 8, further comprising:

positioning a shaft through the puncture in the tissue, wherein the shaft is configured to house the first needle, the second needle, and the link; and

advancing the first needle and second needle along the shaft, the pre-tied knot being releasably attached to the shaft.

10. The method of claim 8, the device further comprising a foot disposed at the distal end of the device with the link being disposed on the foot.

11. The method of claim 10, wherein the foot includes a first cuff and a second cuff connected to the first cuff via the link, the first and second cuffs being configured to receive the first end of the length of suture first and the first needle.

12. The method of claim 11, wherein the first and second cuffs include mating surfaces that correspond to and mate with the first end of the length of suture first and the first needle.

13. The method of claim 8, wherein the link comprises a short length of suture.

14. A method for closing an opening in tissue using a suturing device, the method comprising:

inserting a first end of a length of suture through a tissue tract and through a tissue wall using a second needle;

coupling the first end of the suture to a corresponding second end of a link, wherein the link is disposed distal to the tissue wall;

inserting a first needle through the tissue tract and through the tissue wall, the first needle passing through a pre-tied knot that is disposed at a point spaced back from a distal end of the device;

coupling the first needle to a corresponding first end of the link;

withdrawing the first needle back through the tissue wall and the tissue tract so as to withdraw the link and the first end of the length of suture through the pre-tied knot so as to form a loop of suture that spans the opening and passes through the pre-tied knot; and

tensioning the loop of suture adjacent the pre-tied knot to form a knot affixing the loop of suture across the opening.

15. The method of claim 14, the suturing device further including a foot disposed at the distal end of the suturing device with the link being disposed on the foot.

16. The method of claim 15, wherein the foot includes a first cuff and a second cuff connected to the first cuff via the link, the second and first cuffs being configured to receive the first end of the suture first and the first needle, respectively.

17. The method of claim 14, further comprising:

positioning a shaft through the puncture in the tissue, wherein the shaft is configured to house the first needle, the second needle, and the link; and

advancing the first needle and second needle along the shaft, the pre-tied knot being releasably attached to the shaft.

18. The method of claim 14, wherein inserting the first end of the length of suture through the tissue tract and through the tissue wall using a second needle includes inserting the second needle through the tissue tract and the tissue wall.

19. The method of claim 14, wherein the link fixedly captures both the first end of the length of suture and the first needle.

20. The method of claim 19, wherein the link fixedly couples the length of suture to the first needle.

21. The method of claim 20, wherein the first needle and the second needle substantially simultaneously fixedly attach to the link.