Articulating suturing device and method

• US 20040122449A1
• Filed: 12/05/2003
• Published: 06/24/2004
• Est. Priority Date: 03/04/1999
• Status: Active Grant

• Current Assignee: Bernard H. Andreas, Lewis Isbell, Michael Barrett, Michael Zung, Modesitt D. Bruce
• Original Assignee: Bernard H. Andreas, Lewis Isbell, Michael Barrett, Michael Zung, Modesitt D. Bruce
• Inventors: Isbell, Lewis, Modesitt, D. Bruce, Andreas, Bernard H., Barrett, Michael, Zung, Michael
• Granted Patent: US 7,837,696 B2
• Time in Patent Office: Days
• 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 device for closing an opening in a tissue, the device comprising:

a shaft having a proximal end and a distal end;

a foot on the distal end of the shaft, the foot being movable with respect to the shaft; and

a flexible guidebody extending from the distal end of the shaft.

2. The device of claim 1, wherein the flexible guidebody defines a guidewire lumen.

3. The device of claim 2, wherein the flexible guidebody has a distal end, wherein the flexible guidebody defines a guidewire entry port at the flexible guidebody distal end, and wherein the flexible guidebody defines a guidewire exit port situated along the flexible guidebody at a location proximal to the guidewire entry port.

4. The device of claim 3, wherein the guidewire exit port is situated at a location distal to the distal end of the shaft.

5. The device of claim 1, wherein a portion of the shaft curves such that the flexible guidebody extends from the shaft at an angle relative to an axis of the shaft.

6. The device of claim 1, further comprising a length of suture supported by the foot, the length of suture having a first end and a second end, wherein the flexible guidebody defines a lumen, and wherein the length of suture between the first end and the second end extends distally within the lumen of the flexible guidebody.

7. The device of claim 1, further comprising a needle advanceable from the shaft through the tissue and to the foot when the foot is moved to a deployed position.

8. The device of claim 1, wherein the tissue is a wall of a blood vessel.

9. A method for closing an opening in a tissue, the method comprising:

providing a shaft having a distal end and a proximal end, a flexible guidebody extending from the distal end of the shaft, the shaft having a movable foot at the distal end of the shaft; and

inserting the flexible guidebody through the opening, the flexible guidebody guiding the shaft to the opening.

10. The method of claim 9, further comprising partially withdrawing the flexible guidebody from the opening to reduce a flow of blood through the opening.

11. The method of claim 9, further comprising using a guidewire to guide the flexible guidebody through the opening.

12. The method of claim 9, further comprising:

moving the foot from a parked position to a deployed position;

forming a needle path from the shaft through the tissue; and

advancing a suture through the tissue along the needle path to position a suture loop across the opening.

13. The method of claim 12, further comprising:

securing the suture loop to close the opening; and

fully withdrawing the flexible guidebody from the opening after the suture loop is at least partially secured.

14. The method of claim 9, wherein the tissue is a wall of a blood vessel.

15. A device for closing an opening in a tissue, the device comprising:

a shaft having a proximal end and a distal end, a portion of the shaft being curved adjacent the distal end; and

a flexible guidebody extending from the distal end of the shaft at an angle relative to an axis of the shaft.

16. The device of claim 15, wherein the flexible guidebody defines a guidewire lumen.

17. The device of claim 16, wherein the flexible guidebody has a distal end, wherein the flexible guidebody defines a guidewire entry port at the flexible guidebody distal end, and wherein the flexible guidebody defines a guidewire exit port situated along the flexible guidebody at a location proximal to the guidewire entry port.

18. The device of claim 17, wherein the guidewire exit port is situated at a location distal to the distal end of the shaft.

19. The device of claim 15, further comprising a foot near the distal end of the shaft, the foot being movable with respect to the shaft.

20. The device of claim 19, further comprising a length of suture supported by the foot, the length of suture having a first end and a second end.

21. The device of claim 15, wherein the flexible guidebody defines a suture storage lumen.

22. The device of claim 19, further comprising a needle advanceable from the shaft through the tissue and to the foot when the foot is in a deployed position.

23. A method for closing an opening in a tissue, the method comprising:

providing a shaft having a distal end and a proximal end, a flexible guidebody extending from the distal end of the shaft, the shaft having a movable foot at the distal end of the shaft; and

inserting the flexible guidebody through the opening; and

partially withdrawing the flexible guidebody from the opening to reduce a flow of blood through the opening.

24. The method of claim 23, further comprising using a guidewire to guide the flexible guidebody through the opening.

25. The method of claim 23, wherein the opening in the tissue is accessed through a tissue tract through subcutaneous tissue.

26. The method of claim 23, further comprising:

forming a needle path from the shaft through the vessel wall; and

advancing a suture through the vessel wall along the needle path to position a suture loop across the opening.

27. The method of claim 26, further comprising:

securing the suture loop to close the opening; and

fully withdrawing the flexible guidebody from the vessel after the suture loop is at least partially secured.

28. A method for closing an opening in a tissue, the method comprising:

providing a shaft having a distal end and a proximal end, a flexible guidebody extending from the distal end of the shaft, the shaft having a movable foot at the distal end of the shaft; and

using a guidewire to guide the flexible guidebody through the opening.

29. The method of claim 28, further comprising partially withdrawing the flexible guidebody from the opening to reduce a flow of blood through the opening.

30. The method of claim 28, further comprising:

forming a needle path from the shaft through the tissue adjacent the opening; and

advancing a suture through the tissue along the needle path to position a suture loop across the opening.

31. The method of claim 30, further comprising:

securing the suture loop to close the opening; and

fully withdrawing the flexible guidebody from the vessel after the suture loop is at least partially secured.

32. A method for closing an opening in a vessel wall of a blood vessel, the opening disposed within a tissue tract of a patient body, the method comprising:

providing a shaft having a distal end and a proximal end, a flexible guidebody extending from the distal end of the shaft, wherein a portion of the shaft has a curve such that the flexible guidebody extends from the shaft at an angle relative to an axis of the shaft; and

inserting the flexible guidebody through the opening into the vessel such that the flexible guidebody is positioned coaxially within the vessel and the shaft is positioned coaxially within the tissue tract.

33. The method of claim 32, wherein the shaft includes a movable foot at the distal end of the shaft, the foot being movable from a parked position to a deployed position, wherein the foot is aligned with the vessel when in the deployed position.

34. The method of claim 32, further comprising partially withdrawing the flexible guidebody from the vessel to reduce a flow of blood through the opening.

35. The method of claim 32, further comprising using a guidewire to guide the flexible guidebody through the opening and into the blood vessel.

36. The method of claim 32, further comprising:

forming a needle path from the shaft through the vessel wall; and

advancing a suture through the vessel wall along the needle path to position a suture loop across the opening.

37. The method of claim 36, further comprising:

securing the suture loop to close the opening; and

fully withdrawing the flexible guidebody from the vessel after the suture loop is at least partially secured.