Surgical Puncture Cinch and Closure System

• US 20110028995A1
• Filed: 07/27/2010
• Published: 02/03/2011
• Est. Priority Date: 07/28/2009
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Nguyen, Frank, Kwon, Yoon H., Miraki, Manouchehr
• Granted Patent: US 8,500,757 B2
• Time in Patent Office: Days
• US Class Current: 606/144
• 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 17/06109 Big needles, either gripped by hand or connectable to a handle
• CPC Class Codes: A61B 17/06119 of cylindrical shape
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/0406 Pledgets
• CPC Class Codes: A61B 2017/06052 Needle-suture combinations in which a suture is extending inside a hollow tubular needle, e.g. over the entire length of the needle hollow suture needles A61B2017/061
• CPC Class Codes: A61B 2017/06076 helically or spirally coiled for sutures A61B2017/06171
• CPC Class Codes: A61B 2017/06095 pliable
• CPC Class Codes: A61B 2090/036 abutting on tissue or skin
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442

Abstract

A system for forming a purse string suture, including a suture applicator having a proximal handle having a suture spool mounted thereon or in an internal chamber. A length of suture is partly wound on the spool, and a hollow suture needle extends from a distal end of the handle and contains a free end of the length of suture. The suture needle projects distally from the handle in a helical shape and terminates in a sharp distal tip with an opening in one side close to the distal tip. The free end of the length of suture may extend out of the distal tip and back into the hollow suture needle through the opening. The suture needle may have a deflection segment adjacent the distal tip that is more flexible than the rest of the helical distal portion of the suture needle. A linear hollow pivot shaft extends from a distal end of the handle substantially along an axis of the helical distal portion of the suture needle. The pivot shaft has a blunt tip with a substantially larger radial profile than the shaft to prevent puncturing tissue.

Claims

1. A method of forming a purse string closure at a site of puncture in tissue, comprising;

providing a suture applicator having a proximal handle with a length of suture in the handle and a hollow suture needle extending from a distal end of the handle and containing a free end of the length of suture, the suture needle having a distal portion projecting from the handle in a helical shape and terminating in a sharp distal tip, the suture applicator further including a hollow pivot shaft extending from a distal end of the handle substantially along an axis of the helical distal portion of the suture needle, the pivot shaft having a blunt tip with a substantially larger radial profile than the shaft to prevent puncturing tissue;

providing a puncture needle;

passing the puncture needle through the hollow pivot shaft to extend distally therefrom;

forming a puncture through a heart wall with the puncture needle;

advancing the suture applicator until the blunt tip of the pivot shaft contacts the tissue;

simultaneously advancing and rotating the suture needle into the tissue so that the sharp distal tip passes helically into the tissue around the pivot shaft and continues at least 270°

therearound;

directing the free end of the length of suture out of the tissue;

grasping the free end of the length of suture that emerges from the tissue; and

reversing rotation of the suture needle so that the suture needle retracts from the tissue while the length of suture remains.

2. The method of claim 1, wherein the suture applicator further includes a mechanism within the handle permitting the pivot shaft to be displaced in a proximal direction relative to the handle but biasing the pivot shaft in a distal direction, the method including advancing the suture applicator distally such that the suture needle is advanced past the point that the blunt tip of the pivot shaft contacts the tissue and displacing the pivot shaft in a proximal direction against the distal bias.

3. The method of claim 2, wherein the suture applicator further includes a lock to fix the axial position of the puncture needle, the method including fixing the axial position of the puncture needle.

4. The method of claim 1, wherein the suture needle includes a deflection segment adjacent the distal tip that is more flexible than the rest of the helical distal portion of the suture needle, the method including deflecting the deflection segment in a proximal direction to direct the free end of the length of suture out of the tissue.

5. The method of claim 1, wherein the suture applicator further includes an inner needle arranged to translate through the suture needle and extend from the distal tip thereof, a portion of the length of suture positioned at the distal end portion of the inner needle, the inner needle having a relaxed shape at the distal end portion thereof that has a proximal bend so that it deflects in a proximal direction with respect to the suture applicator when extended from the distal tip of the suture needle, the method including translating the inner needle along the suture needle so that the distal end portion of the inner needle extends from the distal tip of the suture needle and deflects in a proximal direction to direct the portion of the length of suture out of the tissue.

6. The method of claim 5, wherein the inner needle is hollow and the length of suture extends therethrough, the method including deflecting the distal end portion out of the tissue and grasping the portion of the length of suture.

7. The method of claim 1, wherein the suture needle extends from a distal end of the handle at a point that is offset from a longitudinal axis of the handle.

8. The method of claim 1, further including a stop member on the suture needle that indicates to the user when the suture needle has rotated approximately one revolution into the tissue.

9. The method of claim 1, wherein the site of puncture is the apex of a ventricle, and the method further comprises:

installing a guidewire through the puncture needle into the ventricle;

leaving a second free end of the length of suture extending from the point of entry of the suture needle after reversing rotation of the suture needle so that it retracts from the tissue;

passing a cardiac surgery device along the guidewire and into the ventricle;

performing a cardiac surgery with the cardiac surgery device;

removing the cardiac surgery device from the heart; and

applying tension to the first and second free ends of the length of suture to cinch the heart wall tissue and close the puncture.

10. The method of claim 9, wherein the cardiac surgery device includes an introducer sheath carrying a heart valve, and performing a cardiac surgery comprises performing a heart valve replacement using the introducer sheath extending through the puncture.

11. A suture applicator, comprising;

a proximal handle;

a length of suture;

a hollow suture needle extending from a distal end of the handle, the hollow suture needle comprising a helical distal portion and a distal end, the hollow suture needle further comprising a deflection segment positioned at the distal end, wherein the deflection segment extends proximally, with respect to the suture applicator, from the distal end of the hollow suture needle;

wherein the length of suture passes through the hollow suture needle to the deflection segment.

12. The suture applicator of claim 11, wherein the deflection segment is more flexible than the rest of the hollow suture needle.

13. The suture application of claim 12, further comprising:

a deflection mechanism configured to deflect the deflection segment from a first shape to a second shape.

14. The suture applicator of claim 13, wherein in the first shape the deflection segment is generally in helical alignment with the helical distal portion, and wherein in the second shape the deflection segment is deflected to extend proximally, with respect to the suture applicator, from the distal end of the hollow suture needle.

15. The suture applicator of claim 11, wherein the helical distal portion defines a helical axis, and the suture applicator further comprises:

a pivot shaft extending distally from the handle, the pivot shaft extending through the helical distal portion in longitudinal alignment with the helical axis of the helical distal portion.

16. A suture applicator, comprising;

a proximal handle;

a length of suture;

a hollow suture needle extending from a distal end of the handle, the suture needle projecting distally from the handle and having a helical distal portion terminating in a sharp distal tip; and

a flexible inner needle extending through the suture needle and being movable therein, the inner needle being hollow and containing a distal portion of the length of suture, the inner needle including a distal deflection segment that is formed to emerge from the distal tip of the suture needle and angle in a proximal direction.

17. The suture applicator of claim 16, wherein the distal deflection segment is biased, when in a relaxed state and extended from the distal tip of the suture needle, to deflect in a generally proximal direction with respect to the suture applicator.

18. The suture application of claim 17, wherein the distal deflection segment comprises Nitinol.

19. The suture applicator of claim 16, wherein the proximal handle comprises a chamber housing a suture spool, and wherein a proximal portion of the length of suture is at least partly wound onto the suture spool.

20. The suture applicator of claim 16, further comprising:

a linear hollow pivot shaft extending from a distal end of the handle substantially along a helical axis of the helical distal portion of the suture needle, the pivot shaft having a blunt tip with a substantially large radial profile to prevent puncturing of tissue by the pivot shaft; and

a mechanism within the handle biasing the pivot shaft in a distal direction.

21. The suture applicator of claim 20, further comprising:

a puncture needle extending through the linear hollow pivot shaft, the puncture needle having a sharpened distal tip configured to puncture tissue.

22. The suture applicator of claim 21, further comprising:

a guidewire extending through the puncture needle.

23. The suture applicator of claim 16, further comprising:

a puncture needle extending from the distal end of the handle substantially along a helical axis of the helical distal portion of the suture needle, the puncture needle having a sharpened distal tip configured to puncture tissue.