Articulating suturing device and method

• US 7,001,400 B1
• Filed: 08/29/2000
• Issued: 02/21/2006
• Est. Priority Date: 03/04/1999
• Status: Expired due to Term

• 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:
  US09/651,344
• Time in Patent Office: 2,002 Days
• Field of Search: 606/139, 606/144, 606/145, 606/148, 606/150, 606/153, 128/898
• 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 of a blood vessel through a tissue tract of a patient body, the vessel having a vessel wall, the method comprising:

inserting a distal end of a probe through the puncture and into the blood vessel;

advancing a first end of a suture from the probe within the tissue tract, through the vessel wall, and into the vessel;

withdrawing the first end of the suture from the vessel, through the vessel wall, wherein said first end of said suture passes through a bight, said bight releasably attached to the probe to form a loop of suture across the puncture; and

tensioning the first end of the suture and a second end of the suture adjacent to the bight to form a knot affixing the loop of suture across the puncture.

2. A method of closing an aperture in a wall of a vessel, the method comprising:

causing a device to place at least one suture element through a vessel wall adjacent an aperture in the vessel wall, such that opposed portions of the suture element extend from the vessel wall;

causing the device to form a knot formation between the opposed portions of the suture element by causing the device to pass the other of the opposed portions of the suture element through a loop formation, the loop formation defined by one of the opposed portions of the suture element; and

tightening the knot formation thereby at least partially to close the aperture in the vessel wall.

3. The method of claim 2, wherein tightening of the knot formation comprises pulling the opposed portions of the suture element away from each other after the other of the opposed portions had been passed through the loop formation.

4. The method of claim 3, which comprises causing the knot formation to travel toward the aperture in the vessel wall and the knot formation to tighten when at the aperture in response to pulling the opposed portions away from each other.

5. The method of claim 3, which comprises causing the loop formation to be released from the device in response to pulling the opposed portions away from each other.

6. The method of claim 2, wherein causing the device to place at least one suture element through the vessel wall adjacent the aperture in the vessel wall comprises causing the device to place at lease two suture elements through the vessel wall adjacent the aperture such that opposed portions of each suture element extends from the vessel wall.

7. The method of claim 6, wherein causing the device to place at least two suture elements through the vessel wall comprises causing the device to place each suture element through the vessel wall such that each suture element extends through the vessel wall on one side of the aperture, across the aperture, and through the vessel wall on an opposed side of the aperture.

8. The method of claim 7, wherein causing the device to form a knot formation between the opposed portions of the at least one suture element comprises causing the device to form a knot formation between the opposed portions of each suture element.

9. The method of claim 8, wherein one of the opposed portions of each suture element defines a loop formation, causing the device to form a knot formation between the opposed portions of each suture element comprising causing the device to pass the other of the opposed portions of each suture element through the loop formations.

10. The method of claim 9, wherein the loop formations are held on the device releasably, causing the device to pass the other of the opposed portions of each suture element through the loop formations comprising causing the device to pass the other of the opposed portions through the loop formations while the loop formations are held on the device.

11. The method of claim 10, which comprises tightening each knot formation thereby to close the aperture in the vessel wall.

12. The method of claim 11, wherein tightening the knot formations comprises pulling the opposed portions of each suture element away from each other after the other of the opposed portions have been passed through the loop formations.

13. The method of claim 12, which comprises causing the knot formations to travel toward the aperture and the knot formations to tighten when at the aperture in response to pulling the opposed portions away from one another.

14. The method of claim 12, which comprises causing the loop formations to be released from the device in response to pulling the opposed portions away from each other.

15. The method of claim 8, wherein one of the opposed portions of each suture element defines a loop formation, causing the device to form a knot formation between the opposed portions of each suture element comprising causing the device to pass the other of the opposed portions of each suture element through the loop formations.

16. The method of claim 15, wherein the device comprises at least one connection element releasably held on the foot, the or each connection element being arranged to extend across the aperture when the foot is deployed, causing the device to place the or each suture element through the vessel wall comprising causing the device to engage the end of the or each suture element with an end of the or each connection element after the end of the or each suture element has been passed through the vessel wall on the one side of the aperture.

17. The method of claim 16, wherein causing the device to place the or each suture element through the vessel wall further comprises causing the device to pull an opposed end of the or each connection element through the vessel wall on the opposed side of the aperture after the end of the or each suture element has been engaged with the end of the or each connection element, thereby to cause the device to pass the end of the or each suture element through the vessel wall at the opposed side of the aperture.

18. The method as claimed in claim 2, wherein causing the device to place the or each suture element through the vessel wall comprises causing the device to pass an end of the or each suture element through the vessel wall on one side of the aperture to form a position outside the vessel, causing the device to pass the or each end across the aperture inside the vessel, and causing the device to pass the or each end through the vessel wall at the opposed side of the aperture such that the or each suture element extends through the vessel wall on the one side of the aperture, across the aperture, and through the vessel wall on the opposed side of the aperture.

19. The method of claim 18, wherein causing the device to place the or each suture element through the vessel wall comprises passing an end portion of the device through the aperture in the vessel wall.

20. A device for closing an aperture in a wall of a vessel, the device comprising:

a body;

at least one suture element held within the body; and

means for passing the suture element through the vessel wall adjacent an aperture in the vessel wall, such that opposed portions of the suture element extend from the vessel wall wherein one of the opposed portions passes through a bight disposed within the body thereby forming a loose knot between the opposed portions thereof after the suture element has been passed through the vessel wall.

21. The device of claim 20, wherein the means for passing the suture element through the vessel wall adjacent the aperture is arranged to pass the suture element through the vessel wall such that the suture element extends through the vessel wall on one side of the aperture, across the aperture, and through the vessel wall on an opposed side of the aperture.

22. The device of claim 21, which comprises at least two suture elements held within the body and means for passing each suture element through the vessel wall such that each suture element extends through the vessel wall on one side of the aperture, across the aperture, and through the vessel wall on an opposed side of the aperture and each suture element is positioned to form a loose knot formation between opposed portions thereof and after the suture elements have been passed through the vessel wall.

23. A device for closing an aperture in a vessel wall, the device comprising:

a body;

at least one suture element held within the body; and

at least one needle within the body, the needle being operatively associated with the suture element and arranged to pass the suture element through the vessel wall and through a bight of the suture element, the bight being disposed within the body and defining a loop formation, such that the opposed portions of the suture element extend from the vessel wall and the suture element defines a knot between opposed portions thereof after the suture element has been passed through the bight.

24. The device of claim 23, wherein the at least one needle is arranged to pass the suture element through the vessel wall such that the suture element extends through the vessel wall on one side of the aperture, across the aperture, and through the vessel wall on an opposed side of the aperture.

25. The device of claim 24, wherein the needle being arranged to pass an opposed portion of the suture element through the loop formation after the suture element has been passed through the vessel wall, thereby to position the suture element to form the knot formation between the opposed portions thereof.

26. The device of claim 25, which comprises at least two needles operatively associated with the suture element, the one needle being arranged to pass the suture element through the vessel wall on one side of the aperture and the other needle being arranged to pass the suture element through the vessel wall on the opposed side of the aperture.

27. The device of claim 26, wherein the one needle is arranged to pass the suture element through the vessel wall on the one side of the aperture from a position outside the vessel and the other needle is arranged to pass the suture element through the vessel wall on the opposed side of the aperture from a position inside the vessel.

28. The device of claim 27, wherein the other needle is arranged to pass through the vessel wall on the opposed side of the aperture and then to draw the suture from inside the vessel through the vessel wall and through the loop formation.

29. The device of claim 28, which further comprises at least one filament on the body, the filament being arranged to extend across the aperture.

30. The device of claim 29, wherein the filament is arranged to cooperate with the first and second needles such that when the one needle passes the suture element through the vessel wall on the one side of the aperture, an end of the suture element engages with an end of the filament, and when the other needle passes through the vessel wall on opposed sides of the aperture, the other needle engages an opposed end of the filament.

31. The device of claim 30, wherein the suture element is releasably engaged on the one needle so that when the one needle has passed the suture element through the vessel wall on the one side of the aperture and the end of the suture element has engaged with the end of the filament and the other needle has been passed through the vessel wall on the opposed side of the aperture and has engaged the opposed end of the filament, the suture element can be passed through the vessel wall in response to the other needle drawing the filament through the vessel wall on the opposed side of the aperture.

32. The device of claim 31, wherein the body comprises a shaft portion arranged to be passed through the aperture in the vessel wall.

33. The device of claim 32, which comprises an elongate foot formation on the shaft portion, the foot formation being selectively displaceable between a low profile condition, in which the foot is generally aligned with the shaft, and a deployed condition, in which the foot extends generally at an anile relative to the shaft.

34. The device of claim 33, wherein the filament is disposed OD the foot formation such that the filament extends across the aperture when the shaft portion has been passed through the aperture and the foot formation has been displaced into the deployed position.

35. A method for suturing a puncture in a blood vessel wall, the method comprising:

providing a first needle carrying a suture element, the suture element having a first end and a bight spaced from said first end;

advancing the first end of the suture element through the blood vessel wall adjacent the puncture with the first needle;

coupling the first end of the suture element to a filament;

providing a second needle;

advancing the second needle through the blood vessel wall adjacent the puncture;

coupling the second needle to the filament;

pulling the second needle, filament, and first end of the suture element through the bight to form a knot; and

tensioning the suture to affix the suture across the puncture.

36. The method of claim 35, further comprising providing a shaft, said first and second needles advanceable along said shaft, said bight being releasably attached to said shaft, and advancing said shaft through a tissue tract of a patient body.