Helical suturing device

• US 20060036265A1
• Filed: 08/11/2005
• Published: 02/16/2006
• Est. Priority Date: 08/16/2004
• Status: Active Grant

• Current Assignee: Zimmer Spine, Inc. (Zimmer Biomet Holdings, Inc.)
• Original Assignee: Zimmer Spine, Inc. (Zimmer Biomet Holdings, Inc.)
• Inventors: Dant, Jack A.
• Granted Patent: US 7,637,918 B2
• Time in Patent Office: Days
• US Class Current: 606/144
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/0485 Devices or means, e.g. loops, for capturing the suture thread and threading it through an opening of a suturing instrument or needle eyelet
• CPC Class Codes: A61B 17/06066 Needles, e.g. needle tip configurations making needles B21G1/00
• CPC Class Codes: A61B 17/06109 Big needles, either gripped by hand or connectable to a handle
• CPC Class Codes: A61B 2017/0472 Multiple-needled, e.g. double-needled, instruments
• CPC Class Codes: A61B 2017/06042 located close to needle tip
• 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
• CPC Class Codes: A61B 2017/06076 helically or spirally coiled
• CPC Class Codes: A61B 2017/061 hollow or tubular
• CPC Class Codes: A61B 90/92 coded with colour

Abstract

An apparatus for repairing a tear in an annulus fibrosus of a spinal disc includes a hollow, helically-shaped suturing needle and a retriever. The needle is used to insert a suture along a helical pathway bridging the tear. The retriever is used to retrieve one end of the suture from the inside of the annulus and bring it close the other end of the suture outside the annulus, where the suture can be tensioned and tied to fixate the tear. In other embodiments, multiple sutures are placed with helically-shaped needles of differing dimensions.

Claims

1. An apparatus for fixation of a soft tissue tear comprising:

a length of flexible material having a first end and a second end;

a substantially helically-shaped needle including a plurality of helical loops between a distal end and a proximal end, the loops defining an interior region and an exterior region, the needle further adapted for forming a capturable segment of the flexible material at or near its distal end; and

a retriever including a distal end configured for capturing the capturable segment of the flexible material.

2. The apparatus of claim 1 wherein the soft tissue tear includes a tear in an annulus fibrosus.

3. The apparatus of claim 1 wherein the length of flexible material is suture material.

4. The apparatus of claim 1 wherein the length of flexible material includes bioactive material.

5. The apparatus of claim 1 wherein the needle further comprises:

a lumen extending substantially from the distal end to the proximal end; and

three bores communicating with the lumen, a first bore at or near the proximal end, a second bore at or near the distal end, and a third bore between the first and second bores and essentially adjacent to the second bore.

6. The apparatus of claim 5 wherein the flexible material enters the lumen of the needle at the first bore, extends within the lumen from the first bore to the second bore, exits the needle at the second bore, reenters the lumen at the third bore, further extends within the lumen to the first bore, and exits the needle at the first bore, arranged so that both the first and second ends of the flexible material protrude from the first bore at or near the proximal end of the needle, and when the first and second ends of the flexible material are held taut, the second and third bores of the needle support the capturable segment of the flexible material.

7. The apparatus of claim 1 wherein the retriever further comprises an elongated rod having a distal end and a proximal end.

8. The apparatus of claim 1 wherein the retriever includes a hook at or near the distal end of the retriever.

9. The apparatus of claim 1 wherein the retriever includes double opposing hooks at or near the distal end of the retriever.

10. The apparatus of claim 7 further comprising a needle handle, the needle handle fitted to the proximal end of the needle and having a retriever guide slidably connectable to the retriever and formed to constrain the motion of that the distal end of the elongated rod of the retriever along a path within the interior region of the helical loops of the needle up to a point at or near the distal end of the needle, where the distal end of the retriever may capture the capturable segment of the flexible material.

11. The apparatus of claim 10 wherein the retriever guide and retriever include corresponding structures to prevent the distal end of the retriever from sliding beyond the distal end of the needle.

12. The apparatus of claim 10 wherein the retriever guide and retriever include corresponding structures to restrict the possible rotational orientations of the retriever relative to the retriever handle.

13. The apparatus of claim 1 wherein the retriever includes a structure marking its rotational orientation.

14. The apparatus of claim 1 wherein the helically-shaped needle has a longitudinal depth ranging from about 3 mm to about 25 mm.

15. The apparatus of claim 1 wherein the helically-shaped needle has a longitudinal depth of about 5 mm.

16. The apparatus of claim 1 wherein the helically-shaped needle has a longitudinal depth of about 11 mm.

17. The apparatus of claim 1 wherein the helically-shaped needle has a diameter of the helical shape ranging from about 2 mm to about 13 mm.

18. The apparatus of claim 1 wherein the helically-shaped needle has a diameter of about 3 mm.

19. The apparatus of claim 1 wherein the helically-shaped needle has a diameter of about 7 mm.

20. The apparatus of claim 1 wherein the helically-shaped needle has a pitch of the helical shape ranging from about 2 mm per turn to about 7 mm per turn.

21. The apparatus of claim 1 wherein the needle forms a right-handed helical shape.

22. The apparatus of claim 1 wherein the needle forms a left-handed helical shape.

23. The apparatus of claim 1 wherein the flexible material has a distinctive visual appearance.

24. The apparatus of claim 10 wherein the needle handle has a distinctive visual appearance corresponding to the longitudinal depth, diameter, pitch, and handedness of the needle;

and

the retriever further includes a handle having a distinctive visual appearance corresponding to the needle handle to which it is associated.

25. An apparatus for fixation of a soft tissue tear comprising:

a substantially helically-shaped suturing needle including;

a plurality of helical loops between a distal end and a proximal end, the loops defining an interior region and an exterior region, dimensioned such that when the needle is inserted in the manner of a corkscrew along the tissue tear, at least some of the loops will bridge the tear and the majority of the tear will reside in the interior region of the helical loops;

a lumen extending substantially from the distal end to the proximal end; and

three bores communicating with the lumen, a first bore at or near the proximal end, a second bore at or near the distal end, and a third bore between the first and second bores and essentially adjacent to the second bore;

a length of suture material having a first end and a second end, the suture material positioned so that it enters the lumen of the needle at the first bore, extends within the lumen from the first bore to the second bore, exits the needle at the second bore, reenters the lumen at the third bore, further extends within the lumen to the first bore, and exits the needle at the first bore, arranged so that both the first and the second ends of the suture material protrude from the first bore at or near the proximal end of the needle, and when the first and second ends of the suture material are held taut, the second and third bores of the needle support a capturable segment of the suture material;

a retriever comprising an elongated rod including a distal end and a proximal end, the distal end having a hook capable of capturing the capturable segment of the suture material; and

a needle handle fitted to the proximal end of the needle, the needle handle having a retriever guide, the retriever guide slidably connectable to the retriever and formed to constrain the motion of the distal end of the elongated rod of the retriever along a path within the interior region of the helical loops of the needle up to a point at or near the distal end of the needle, where the hook of the rod of the retriever may capture the capturable segment of the suture material.

26. A method of repairing a soft tissue tear comprising:

inserting a helically-shaped needle containing a suture along the soft tissue tear, the suture protruding from a portion of the helically-shaped needle;

advancing a retriever into the soft tissue tear and through an interior region of the helically-shaped needle;

capturing the protruding portion of the suture with the retriever;

withdrawing the retriever with the protuding portion of the suture;

withdrawing the helically-shaped needle;

exerting a desired tension on the suture; and

tying the suture.