Surgical knot pusher and method of use

• US 5,601,576 A
• Filed: 08/10/1994
• Issued: 02/11/1997
• Est. Priority Date: 08/10/1994
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences LLC (Edwards Lifesciences Corporation)
• Original Assignee: Heartport, Inc. (Johnson & Johnson)
• Inventors: Garrison, Michi E.
• Primary Examiner(s): Jackson, Gary
• Application Number:
  US08/288,674
• Time in Patent Office: 916 Days
• Field of Search: 606/139, 606/148, 289/17
• US Class Current: 606/148
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• 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 2017/00243 cardiac
• CPC Class Codes: A61B 2017/0474 Knot pushers

Abstract

A surgical knot pusher device is described which has a knot pushing head mounted on the distal end of an elongated rod. The head of the device has a smoothly radiused knot pushing surface on the leading edge with two symmetrical suture paths which curve smoothly away from the knot pushing surface. The suture rests in a shallow groove which has a wall on either side to keep the suture in the groove. Near the leading edge of the pushing head the walls of the groove are lower so that the knot can be pushed directly against the tissue being sutured. On one side of the knot pushing head, there is a single eyelet in the path of one of the suture ends. The eyelet is made so that the suture can be easily threaded through the eyelet with the curved needle which is on the end of the suture without any need to remove the needle. Preferably, at least the head of the device is made from polysulfone or another suitable plastic material. A method for tying knots in surgical sutures using the surgical knot pusher device is described with special reference to using the device and method for endoscopic surgery. The surgical knot pusher device is especially well adapted for tying sutures in a new procedure for closed chest mitral valve replacement surgery. A method of using the surgical knot pusher device for tying knots in sutures to secure a valve prosthesis in place during closed chest mitral valve replacement surgery is described.

Claims

1. A surgical knot pusher, comprising:

an elongate shaft having a proximal end and a distal end,

a knot pushing surface proximate said distal end, said knot pushing surface defining an arc having a convex curvature, said arc having a first end, a second end and an apex intermediate said first end and said second end,

a first suture path extending along said arc from said apex to said first end and a second suture path extending along said arc from said apex to said second end,

said first suture path and said second suture path lie within a groove, said groove being defined by a first wall and a second wall, said first wall and said second wall being approximately parallel to one another,

said groove between said first wall and said second wall has a first depth proximate said apex of said arc and a second depth proximate said first end and said second end of said arc, said second depth being greater than said first depth,

and an eyelet positioned along said first suture path, said eyelet having an aperture therethrough, said aperture being in alignment with said first suture path.

2. The surgical knot pusher of claim 1 wherein said first suture path and said second suture path are approximately symmetrical with one another about said apex of said arc.

3. The surgical know pusher of claim 1 wherein said groove has a concave arc-shaped curvature in a direction transverse to said groove.

4. The surgical knot pusher of claim 1 wherein said convex curvature of said arc comprises a circular arc.

5. The surgical knot pusher of claim 1 wherein said second suture path is open along said arc from said apex to said second end.

6. A surgical knot pusher, comprising:

an elongate shaft having a proximal end and a distal end,

a knot pushing surface proximate said distal end, said knot pushing surface defining an arc having a convex curvature, said arc having a first end, a second end and an apex intermediate said first end and said second end,

a first suture path extending along said arc from said apex to said first end and a second suture path extending along said arc from said apex to said second end,

and an eyelet positioned along said first suture path, said eyelet having an aperture therethrough, said aperture being in alignment with said first suture path,

said convex curvature of said arc including a continuous curve having a circular arc proximate said apex of said arc, a first linear extension extending tangential from said circular arc to said first end of said arc, and a second linear extension extending tangential from said circular arc to said first end of said arc.

7. The surgical knot pusher of claim 6 wherein said circular arc subtends an angle of approximately 60 degrees centered symmetrically about said apex of said arc.

8. A surgical knot pusher, comprising:

an elongate shaft having a proximal end and a distal end,

a knot pushing surface proximate said distal end, said knot pushing surface defining an arc having a convex curvature, said arc having a first end, a second end and an apex intermediate said first end and said second end,

a first suture path extending along said arc from said apex to said first end and a second suture path extending along said arc from said apex to said second end,

and an eyelet positioned along said first suture path, said eyelet having an aperture therethrough, said aperture being in alignment with said first suture path,

wherein said knot pushing surface is located on a knot pushing head attached to said distal end of said elongate shaft, said knot pushing head having a major axis aligned with said first suture path and said second suture path and a minor axis transverse to said first suture path and said second suture path, said knot pushing head being longer in the direction of said major axis than in the direction of said minor axis.

9. A method of tying surgical sutures comprising the steps of:

a) providing a surgical knot pusher, comprising;

an elongate shaft having a proximal end and a distal end,

a knot pushing surface proximate said distal end, said knot pushing surface defining an arc having a convex curvature, said arc having a first end, a second end and an apex intermediate said first end and said second end,

a first suture path extending along said arc from said apex to said first end and a second suture path extending along said arc from said apex to said second end, said second suture path being open along said arc from said apex to said second end,

and an eyelet positioned along said first suture path, said eyelet having an aperture therethrough, said aperture being in alignment with said first suture path,

b) placing a surgical suture through an article to be sutured, said surgical suture having a standing end and a free end,

c) passing said standing end of said surgical suture through said eyelet of said surgical knot pusher,

d) passing said free end of said surgical suture around said standing end of said surgical suture;

to form a knot in said suture between said surgical knot pusher and said article to be sutured,

e) aligning said free end of said surgical suture with said second suture path of said surgical knot pusher,

f) advancing said surgical knot pusher along said surgical suture toward said article to be sutured while maintaining said free end of said surgical suture aligned with said second suture path and maintaining said standing end of said surgical suture within said eyelet until said knot contacts said knot pushing surface proximate said apex of said arc.

10. The method of tying surgical sutures of claim 9 further comprising the steps of:

g) retracting said surgical knot pusher along said surgical suture while maintaining said standing end of said surgical suture within said eyelet,

h) passing said free end of said surgical suture around said standing end of said surgical suture to form a second knot in said suture between said surgical knot pusher and said article to be sutured,

i) aligning said free end of said surgical suture with said second suture path of said surgical knot pusher,

j) advancing said surgical knot pusher along said surgical suture toward said article to be sutured while maintaining said free end of said surgical suture aligned with said second suture path and maintaining said standing end of said surgical suture within said eyelet until said knot contacts said knot pushing surface proximate said apex of said arc.

11. The method of tying surgical sutures of claim 9 further comprising the steps of:

k) applying further tension on said free end and said standing end of said surgical suture, while holding said knot pushing surface against said second knot to tighten said second knot against said knot.

12. The method of tying surgical sutures of claim 9 wherein said article to be sutured is at a surgical site within a body which is accessible through a cannula, said cannula having a distal end located within said body and a proximal end located external to said body, said cannula having an internal lumen sufficient for passage of said surgical knot pusher through said cannula, said surgical suture being placed through said article to be sutured with said free end and said standing end of said surgical suture extending from said article to be sutured through said internal lumen of said cannula from said distal end to said proximal end of said cannula, said knot in said surgical suture being initially formed external to said body, and said knot being advanced by said surgical knot pusher through said internal lumen of said cannula to said article to be sutured.

13. The method of tying surgical sutures of claim 9 wherein step c) comprises the substep of passing a curved suture needle attached to said standing end of said surgical suture through said eyelet of said surgical knot pusher.

14. A method of tying surgical sutures in heart valve replacement surgery comprising the steps of:

a) providing a surgical knot pusher, comprising;

an elongate shaft having a proximal end and a distal end,

a knot pushing surface proximate said distal end, said knot pushing surface defining an arc having a convex curvature, said arc having a first end, a second end and an apex intermediate said first end and said second end,

a first suture path extending along said arc from said apex to said first end and a second suture path extending along said arc from said apex to said second end, said second suture path being open along said arc from said apex to said second end,

and an eyelet positioned along said first suture path, said eyelet having an aperture therethrough, said aperture being in alignment with said first suture path,

b) providing a replacement heart valve, said replacement heart valve having a suture ring around said replacement heart valve,

c) creating a surgical access to a heart valve within the heart of a patient, said heart valve having an annulus around said heart valve,

d) placing at least one surgical suture through said annulus of said heart valve, said surgical suture having a standing end and a free end,

e) passing at least one of said standing end or said free end of said surgical suture through said suture ring of said replacement heart valve,

f) advancing said replacement heart valve along said surgical suture until said suture ring is in contact with said annulus of said heart valve,

g) passing said standing end of said surgical suture through said eyelet of said surgical knot pusher,

h) passing said free end of said surgical suture around said standing end of said surgical suture to form a knot in said suture between said surgical knot pusher and said suture ring of said replacement heart valve,

i) aligning said free end of said surgical suture with said second suture path of said surgical knot pusher,

j) advancing said surgical knot pusher along said surgical suture toward said suture ring of said replacement heart valve while maintaining said free end of said surgical suture aligned with said second suture path and maintaining said standing end of said surgical suture within said eyelet until said knot contacts said knot pushing surface proximate said apex of said arc,

k) further advancing said surgical knot pusher along said surgical suture while maintaining said free end of said surgical suture aligned with said second suture path and maintaining said standing end of said surgical suture within said eyelet to advance said knot toward suture ring of said replacement heart valve while keeping an approximately equal tension on said free end and said standing end of said surgical suture to maintain said knot approximately centered on said knot pushing surface.

15. The method of tying surgical sutures of claim 14 further comprising the steps of:

l) retracting said surgical knot pusher along said surgical suture while maintaining said standing end of said surgical suture within said eyelet,

m) passing said free end of said surgical suture around said standing end of said surgical suture to form a second knot in said suture between said surgical knot pusher and said suture ring of said replacement heart valve,

n) aligning said free end of said surgical suture with said second suture path of said surgical knot pusher,

o) advancing said surgical knot pusher along said surgical suture toward said suture ring of said replacement heart valve while maintaining said free end of said surgical suture aligned with said second suture path and maintaining said standing end of said surgical suture within said eyelet until said second knot contacts said knot pushing surface proximate said apex of said arc,

p) further advancing said surgical knot pusher along said surgical suture while maintaining said free end of said surgical suture aligned with said second suture path and maintaining said standing end of said surgical suture within said eyelet to advance said second knot toward said suture ring of said replacement heart valve until said second knot contacts said knot, while keeping an approximately equal tension on said free end and said standing end of said surgical suture to maintain said second knot approximately centered on said knot pushing surface.

16. The method of tying surgical sutures of claim 15 further comprising the steps of:

q) applying further tension on said free end and said standing end of said surgical suture, while holding said knot pushing surface against said second knot to tighten said second knot against said knot.

17. A method of tying surgical sutures in closed-chest heart valve replacement surgery comprising the steps of:

a) creating a surgical access passage to the heart of a patient through a small incision in an intercostal space in the chest of the patient;

b) introducing a replacement heart valve into said heart of said patient through said surgical access passage;

c) placing at least one surgical suture through the tissue of said heart and through said replacement heart valve, said at least one surgical suture having a first end and a second end, at least one of said first end and said second end of said surgical suture extending through said surgical access passage to a point external to said chest of said patient;

d) passing said first end of said surgical suture around said second end of said surgical suture to form a knot in said surgical suture;

e) pushing said knot with a surgical knot pusher placed through said surgical access passage to advance said knot along said surgical suture toward said replacement heart valve, thereby securing said replacement heart valve to the tissue of said heart.

18. The method of tying surgical sutures of claim 17 wherein step c) comprises the substep of extending said first end and said second end of said surgical suture through said surgical access passage to a point external to said chest of said patient, and step d) comprises forming said knot in said surgical suture external to said chest of said patient, and step e) comprises pushing said knot through said surgical access passage with said surgical knot pusher to advance said knot along said surgical suture from a point external to said chest of said patient toward said replacement heart valve, thereby securing said replacement heart valve to the tissue of said heart.

19. The method of tying surgical sutures of claim 17 wherein step e) comprises the substep of passing said second end of said surgical suture through an eyelet proximate a distal end of said surgical knot pusher prior to pushing said knot toward said replacement heart valve with said surgical knot pusher.

20. The method of tying surgical sutures of claim 19 wherein step e) further comprises the substep of pushing said knot with a convexly curved arcuate knot pushing surface adjacent said eyelet.

21. The method of tying surgical sutures of claim 19 wherein step e) further comprises the substep of pushing said knot with a convexly curved arcuate knot pushing surface lying within a groove proximate said distal end of said surgical knot pusher, said convexly curved arcuate knot pushing surface defining a first suture path for said first end of said surgical suture and a second suture path for said second end of said surgical suture, said first suture path and said second suture path being positioned approximately symmetrically about a central point on said convexly curved arcuate knot pushing surface, said eyelet being located along said second suture path.

22. A surgical knot pusher, comprising:

an elongate shaft having a proximal end and a distal end,

a knot pushing surface proximate said distal end, said knot pushing surface defining an arc having a convex curvature, said arc having a first end, a second end and an apex intermediate said first end and said second end,

a first suture path extending along said arc from said apex to said first end and a second suture path extending along said arc from said apex to said second end,

and an eyelet positioned along said first suture path, said eyelet having an aperture therethrough, said aperture being in alignment with said first suture path,

wherein said eyelet is configured to allow passage of a curved suture needle through said eyelet.

23. A surgical knot pusher, comprising:

an elongate shaft having a proximal end and a distal end,

a knot pushing surface proximate said distal end, said knot pushing surface having a first end and a second end,

a first suture path extending from said first end of said knot pushing surface, an eyelet positioned along said first suture path, said eyelet having an aperture therethrough, said aperture being in alignment with said first suture path, and

a second suture path extending from said second end of said knot pushing surface, said second suture path being open along the length of said second suture path.

24. The surgical knot pusher of claim 23 wherein said knot pushing surface has a convex curvature.

25. The surgical knot pusher of claim 24 wherein said convex curvature of said knot pushing surface comprises a circular arc, said first suture path comprises a first linear extension extending tangentially from said first end of said knot pushing surface, and said second suture path comprises a second linear extension extending tangentially from said second end of said knot pushing surface.

26. The surgical knot pusher of claim 25 wherein said circular arc of said knot pushing surface subtends an angle of approximately 60 degrees.

27. The surgical knot pusher of claim 23 wherein said knot pushing surface and said second suture path lie within a groove, said groove being defined by a first wall and a second wall, said first wall and said second wall being approximately parallel to one another.

28. The surgical knot pusher of claim 27 wherein said groove between said first wall and said second wall has a first depth proximate said knot pushing surface and a second depth along said second suture path, said second depth being greater than said first depth.

29. The surgical knot pusher of claim 23 wherein said knot pushing surface, said first suture path and said second suture path lie within a groove, said groove being defined by a first wall and a second wall, said first wall and said second wall being approximately parallel to one another.

30. The surgical knot pusher of claim 29 wherein said groove between said first wall and said second wall has a first depth proximate said knot pushing surface and a second depth along said first suture path and said second suture path, said second depth being greater than said first depth.

31. The surgical knot pusher of claim 29 wherein said groove has a concave arc-shaped curvature in a direction transverse to said groove.

32. The surgical knot pusher of claim 23 wherein said knot pushing surface is located on a knot pushing head attached to said distal end of said elongate shaft, said knot pushing head having a major axis aligned with said first suture path and said second suture path and a minor axis transverse to said first suture path and said second suture path, said knot pushing head being longer in the direction of said major axis than in the direction of said minor axis.