Automatic suture fixation apparatus and method for minimally invasive cardiac surgery

• US 20020058994A1
• Filed: 11/16/2001
• Published: 05/16/2002
• Est. Priority Date: 11/16/2000
• Status: Active Grant

• Current Assignee: Cameron Dale Hinman, Geoff Briggs, Hill J. Donald, Michael Sims
• Original Assignee: Cameron Dale Hinman, Geoff Briggs, Hill J. Donald, Michael Sims
• Inventors: Hill, J. Donald, Sims, Michael, Briggs, Geoff, Hinman, Cameron Dale
• Granted Patent: US 7,175,659 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• 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 2017/0496 for tensioning sutures
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation

Abstract

An apparatus for automatically fixing sutures used in the surgical replacement of a heart valve, includes a first cylinder having a first end and a second end and an interior surface and an exterior surface and a valve sleeve including an annular cuff surrounding the exterior surface adjacent to the first end of the first cylinder. An annular lip is formed on the exterior surface adjacent to the second end of the first cylinder, and a replacement heart valve is positioned within the valve sleeve. The apparatus further includes a second cylinder having second securing means formed on an interior surface of the second cylinder, such that the second securing means corresponds to and are adapted to fixedly engage the first securing means. The invention further includes a method for automatically fixing sutures to secure a valve sleeve including an annular cuff and a replacement heart valve to an annulus formed in a patient'"'"'s heart. The method includes the steps of positioning the annular cuff of the valve sleeve in the annulus and securing the cuff to the annulus with sutures, threading the sutures over an exterior surface of a first cylinder and over an interior surface of a second cylinder; applying pressure against the first cylinder and tension to the sutures to ensure a blood-tight seal between the cuff of the valve sleeve and the annulus; and securing the sutures between the first cylinder and the second cylinder.

Claims

1. An apparatus for automatically fixing sutures used in the surgical replacement of a heart valve, comprising:

a first cylinder having a first end and a second end and an interior surface and an exterior surface;

a valve sleeve comprising an annular cuff and a plurality of securing struts surrounding said exterior surface adjacent to said first end of said first cylinder, said struts extending beyond said first end of said first cylinder;

first securing means formed on said exterior surface adjacent to said second end of said first cylinder;

a replacement heart valve positioned within said valve sleeve and having a circumferential outer edge, wherein said circumferential outer edge is affixed to said valve sleeve;

a second cylinder having second securing means formed on an interior surface of said second cylinder, such that said second securing means corresponds to and is adapted to fixedly engage said first securing means.

2. The apparatus of claim 1, wherein said first securing means is an annular lip and said second securing means is an annular groove.

3. The apparatus of claim 1, wherein said first securing means is an annular groove and said second securing means is an annular lip.

4. The apparatus of claim 1, wherein said valve sleeve is manufactured from a surgical fabric.

5. The apparatus of claim 4, wherein said surgical fabric is selected from the group consisting of a Dacron ®

fabric, a Teflon®

fabric, a Gore-Tex®

fabric, and the like.

6. The apparatus of claim 1, wherein said replacement heart valve comprises a heart valve harvested from a human donor.

7. The apparatus of claim 1, wherein said replacement heart valve comprises a heart valve harvested from a pig.

8. The apparatus of claim 1, wherein said replacement heart valve comprises a prosthetic heart valve.

9. The apparatus of a claim 1, further comprising:

a guiding rod including a rod end piece formed at a first end of said rod, said rod end piece having a plurality of support brackets extending from said rod end piece and a guiding ring affixed to said support brackets, said ring being adapted to engage said second end of said first cylinder, wherein said interior surface of said second cylinder slidingly engages an exterior surface of each of said support brackets;

a securing member including a rod sleeve which slidingly engages said guiding rod, and a sleeve end piece formed on a first end of said rod sleeve, said sleeve end piece having plurality of securing brackets, which are adapted to engage said second cylinder and which are positioned to interfit with said support brackets; and

urging means for sliding said securing member on said guiding rod, whereby said second securing means of said second cylinder are urged into engagement with said first securing means on said first cylinder.

10. The apparatus of claim 9, wherein said urging means comprises a handle, said handle affixed to a second end of said guiding rod and including a grip having a levered projection, such that when said grip is pressed against said handle, said levered projection contacts said securing member and urges said securing member toward said rod end piece.

11. The apparatus of claim 9, wherein at least one eyelet is formed on each of said supporting brackets for receiving at least one suture, whereby said guiding ring is guided into contact with said second end of said first cylinder.

13. The apparatus of claim 12, wherein said first securing means is an annular lip and said second securing means is an annular groove.

14. The apparatus of claim 12, wherein said first securing means is an annular groove and said second securing means is an annular lip.

15. The apparatus of claim 12, wherein said cuff is manufactured from a surgical fabric selected from the group consisting of a Dacron®

fabric, a Teflon®

fabric, a Gore-Tex®

fabric, and the like.

16. The apparatus of a claim 12, further comprising:

a guiding rod including a rod end piece formed at a first end of said rod, said rod end piece having a plurality of support brackets extending from said rod end piece and a guiding ring affixed to said support brackets, said ring being adapted to engage said second end of said first cylinder, wherein said interior surface of said second cylinder slidingly engages an exterior surface of each of said support brackets;

a securing member including a rod sleeve which slidingly engages said guiding rod, and a sleeve end piece formed on a first end of said rod sleeve, said sleeve end piece having a plurality of securing brackets, which are adapted to engage said second cylinder and which are positioned to interfit with said support brackets; and

urging means for sliding said securing member on said guiding rod, whereby said second securing means of said second cylinder are urged into engagement with said first securing means on said first cylinder.

17. The apparatus of claim 12, wherein said urging means comprises a handle, said handle affixed to a second end of said guiding rod and including a grip having a levered projection, such that when said grip is pressed against said handle, said levered projection contacts said securing member and urges said securing member toward said rod end piece.

18. The apparatus of claim 12, wherein at least one eyelet is formed on each of said supporting brackets for receiving at least one suture, whereby said guiding ring is guided onto said first cylinder.

20. The apparatus of claim 19, wherein said first securing means is an annular lip and said second securing means is an annular groove.

21. The apparatus of claim 19, wherein said first securing means is an annular groove and said second securing means is an annular lip.

22. The apparatus of a claim 19, further comprising:

a guiding rod including a rod end piece formed at a first end of said rod, said rod end piece having a plurality of support brackets extending from said rod end piece and a guiding ring affixed to said support brackets, said ring being adapted to engage said second end of said first cylinder, wherein said interior surface of said second cylinder slidingly engages an exterior surface of each of said support brackets;

a securing member including a rod sleeve which slidingly engages said guiding rod, and a sleeve end piece formed on a first end of said rod sleeve, said sleeve end piece having a plurality of securing brackets, which are adapted to engage said second cylinder and which are positioned to interfit with said support brackets; and

urging means for sliding said securing member on said guiding rod, whereby said second

securing means of said second cylinder are urged into engagement with said first securing means on said first cylinder.

23. The apparatus of claim 22, wherein said urging means comprises a handle, said handle affixed to a second end of said guiding rod and including a grip having a levered projection, such that when said grip is pressed against said handle, said levered projection contacts said securing member and urges said securing member toward said rod end piece.

24. The apparatus of claim 22, wherein at least one eyelet is formed on said supporting brackets for receiving at least one suture, whereby said guiding rod is directed to said first cylinder.

26. The method of claim 25, further comprising the step of trimming said plurality of sutures at a length in a range of about 3 mm to about 5 mm, above said second cylinder.

27. The method of claim 25, further comprising the step of trimming said plurality of sutures flush with said second cylinder.

28. The method of claim 25, wherein said plurality of sutures is in a range of about 18 to 24 sutures.

29. The method of claim 25, further comprising the steps of:

positioning a guiding rod including a rod end piece formed at a first end of said rod, said rod end piece having a plurality of support brackets extending from said rod end piece and a guiding ring affixed to said support brackets, wherein said ring is adapted to engage a second end of said first cylinder, to engage said first cylinder and to hold said cuff against said annulus;

positioning said second cylinder, such that said interior surface of said second cylinder slidingly engages an exterior surface of each of said support brackets of said guiding rod;

positioning a securing member which slidingly engages said guiding rod, and has a rod sleeve end piece formed on a first end of said rod sleeve, said sleeve end piece having a plurality of securing brackets, which are adapted to engage said second cylinder and which are positioned to interfit with said support brackets, such that said securing member engages said second cylinder;

threading said plurality of sutures through a plurality of eyelets formed on said plurality of securing brackets; and

urging said securing member on said guiding rod, whereby said second securing means of said second cylinder is urged into engagement with said first securing means on said first cylinder.

12. An apparatus for automatically fixing sutures used in the surgical replacement of a heart valve, comprising:

a first cylinder having a first end and a second end and an interior surface and an exterior surface, a valve sleeve including an annular cuff, and a prosthetic heart valve positioned within said first cylinder and affixed to said valve sleeve;

wherein said sleeve surrounds said exterior surface adjacent to said first end of said first cylinder, and wherein first securing means are formed on said exterior surface adjacent to said second end of said first cylinder; and

a second cylinder having second securing means formed on an interior surface of said second cylinder, such that said second securing means corresponds to and are adapted to fixedly engage said first securing means.

19. An apparatus for automatically fixing sutures used in the surgical replacement of a heart valve, comprising:

a first cylinder having a first end and a second end and an interior surface and an exterior surface;

a valve sleeve comprising an annular cuff surrounding said exterior surface adjacent to said first end of said first cylinder,

first securing means formed on said exterior surface adjacent to said second end of said first cylinder;

a replacement heart valve positioned within said valve sleeve; and

a second cylinder having second securing means formed on an interior surface of said second cylinder, such that said second securing means corresponds to and are adapted to fixedly engage said first securing means.

25. A method for automatically fixing sutures to secure a valve sleeve including an annular cuff and a replacement heart valve to an annulus formed in a patient'"'"'s heart, comprising the steps of:

removing an existing heart valve thereby forming an annulus in the patient'"'"'s heart;

placing a first cylinder having a first end and a second end and an interior surface and an

exterior surface and comprising first securing means formed on said exterior surface adjacent to said second end of said first cylinder, wherein said first cylinder includes a valve sleeve having an annular cuff, such that said annular cuff surrounds said exterior surface adjacent to said first end of said first cylinder;

positioning said annular cuff of said valve sleeve in said annulus and securing said cuff to said annulus with a plurality of sutures;

threading said plurality of sutures over said exterior surface of said first cylinder and over an interior surface of a second cylinder, said second cylinder having second securing means corresponding to and adapted to fixedly engage said first securing means of said first cylinder;

applying pressure against said first cylinder and tension to said plurality of sutures to ensure a blood-tight seal between said cuff of said valve sleeve and said annulus; and

securing said plurality of sutures between said first cylinder and said second cylinder by engaging said first securing means of said first cylinder with said second securing means of said second cylinder.

30. A method for automatically fixing sutures to secure a valve sleeve including an annular cuff and a replacement heart valve to an annulus formed in a patient'"'"'s heart, comprising the steps of:

removing an existing heart valve thereby forming an annulus in the patient'"'"'s heart;

positioning said annular cuff of said valve sleeve in said annulus and securing said cuff to said annulus with a plurality of sutures;

placing a first cylinder having a first end and a second end and an interior surface and an

exterior surface and comprising first securing means formed on said exterior surface adjacent to said second end of said first cylinder, within said valve sleeve, such that said annular cuff surrounds said exterior surface adjacent to said first end of said first cylinder;

threading said plurality of sutures over said exterior surface of said first cylinder and over an interior surface of a second cylinder, said second cylinder having second securing means corresponding to and adapted to fixedly engage said first securing means of said first cylinder;

applying pressure against said first cylinder and tension to said plurality of sutures to ensure a blood-tight seal between said cuff of said valve sleeve and said annulus; and

securing said plurality of sutures between said first cylinder and said second cylinder by engaging said first securing means of said first cylinder with said second securing means of said second cylinder.

31. The method of claim 30, further comprising the step of trimming said plurality of sutures at a length in a range of about 3 mm to about 5 mm, above said second cylinder.

32. The method of claim 30, further comprising the step of trimming said plurality of sutures flush with said second cylinder.

33. The method of claim 30, wherein said plurality of sutures is in a range of about 18 to 24 sutures.

34. The method of claim 30, further comprising the steps of:

positioning a guiding rod including a rod end piece formed at a first end of said rod, said rod end piece having a plurality of support brackets extending from said rod end piece and a guiding ring affixed to said support brackets, wherein said ring is adapted to engage a second end of said first cylinder, to engage said first cylinder and to hold said cuff against said annulus;

positioning said second cylinder, such that said interior surface of said second cylinder slidingly engages an exterior surface of each of said support brackets of said guiding rod;

positioning a securing member which slidingly engages said guiding rod, and has a rod sleeve end piece formed on a first end of said rod sleeve, said sleeve end piece having a plurality of securing brackets, which are adapted to engage said second cylinder and which are positioned to interfit with said support brackets, such that said securing member engages said second cylinder;

threading said plurality of sutures through a plurality of eyelets formed on said plurality of securing brackets; and

urging said securing member on said guiding rod, whereby said second securing means of said second cylinder is urged into engagement with said first securing means on said first cylinder.