Method and apparatus for sizing, stabilizing and/or reducing the circumference of an anatomical structure

• US 5,961,539 A
• Filed: 01/17/1997
• Issued: 10/05/1999
• Est. Priority Date: 01/17/1997
• Status: Expired due to Term

• Current Assignee: Peters Surgical
• Original Assignee: Segmed, Inc.
• Inventors: Northrup, Joanne B., Northrup, William F. III
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): TRUONG, KEVIN THAO
• Application Number:
  US08/786,892
• Time in Patent Office: 991 Days
• Field of Search: 606/148, 606/139, 606/144, 606/232, 623/2
• US Class Current: 606/232
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/0406 Pledgets
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2496 Devices for determining the dimensions of the prosthetic valve to be implanted, e.g. templates, sizers

Abstract

An annuloplasty system is disclosed that respects the uniqueness of each anterior mitral or tricuspid valve leaflet as the appropriate template for an annuloplasty ring. Each dilated tissue annulus is brought to a precise anterior mitral or tricuspid leaflet perimeter dimension, rather than to the dimension of a specific-sized annuloplasty ring. Thus, precise measured plication of the dilated mitral or tricuspid annulus is possible in every case, resulting in mitral or tricuspid repair with greater predictability and reproduceability. Substantially rigid suture support segments to be placed at least partially circumferentially about an anatomical structure, such as a heart valve, are delivered to the heart valve by a plurality of linked-together segment holders. The segment holders also function as sizing elements for precisely and easily measuring the perimeter of an anterior mitral or tricuspid leaflet, for example. The segments are enclosed in a double layer of autologous viable pericardium, according to one embodiment, forming a pericardial tube. Together, the pericardial tube and the segments create an annuloplasty ring presenting significant advantages over the prior art. Devices and methods according to the invention can also be used to size, stabilize, and/or reduce the circumference of other anatomical structures, not just mitral and tricuspid valves.

Claims

1. A delivery system for delivering a plurality of substantially rigid suture support segments during a surgical procedure, the substantially rigid suture support segments to be placed at least partially circumferentially about an anatomical structure to form a line of discrete suture support segments for at least stabilizing the anatomical structure along the line of discrete suture support segments, the delivery system comprising a plurality of segment holders, the plurality of segment holders being readily releasably securable to the plurality of substantially rigid suture support segments and separating the plurality of substantially rigid suture support segments from each other.

2. The delivery system of claim 1, wherein the plurality of segment holders comprise linking structure to link the segment holders together.

3. The delivery system of claim 2, wherein the segment holders, when linked together, define consistent dimensions to precisely size an anatomical vascular structure.

4. The delivery system of claim 2, wherein the segment holders, when linked together, define consistent intervals for delivering the suture support segments to an anatomical vascular structure.

5. The delivery system of claim 2, wherein the linking structure is constructed to allow a desired number of segment holders to be linked together to fit a particular anatomical structure.

6. The delivery system of claim 2, wherein the linking structure comprises a plurality of universal joints connecting adjacent segment holders together.

7. The delivery system of claim 2, wherein the linking structure comprises a plurality of ball-and-socket joints connecting adjacent segment holders together.

8. The delivery system of claim 2, wherein the linking structure comprises a plurality of joints connecting adjacent segment holders together, the joints having sufficient friction to maintain linked-together segment holders in a desired overall shape but allowing relative movement between adjacent segment holders.

9. The delivery system of claim 1, wherein each segment holder readily releasably secures exactly one substantially rigid support segment.

10. The delivery system of claim 1, wherein each segment holder comprises at least one belt constructed to extend at least partially around a respective suture support segment to readily releasably secure the suture support segment to the segment holder.

11. The delivery system of claim 10, wherein each segment holder comprises opposite ends, further wherein the at least one belt of each segment holder is disposed at a predetermined location between the opposite ends to provide a visual reference point.

12. The delivery system of claim 10, wherein the at least one belt of each segment extends through at least one aperture of the suture support segment.

13. The delivery system of claim 10, wherein the at least one belt defines a separation notch, the belt being severable at the separation notch to separate the suture support segment from the segment holder.

14. The delivery system of claim 1, wherein each segment holder comprises a clamp fin, the clamp fin being constructed for ready grasping to allow easy relocation of the segment holder.

15. The delivery system of claim 1, further comprising a packaging material, the packaging material encasing each of the plurality of segment holders individually.

16. The delivery system of claim 1, further comprising a packaging material, the packaging material encasing the plurality of segment holders collectively.

17. The delivery system of claim 16, wherein the packaging material is substantially in the shape of the mitral or tricuspid orifice of a human heart.

18. A sizing system for measuring an anatomical structure during a surgical procedure, the sizing system comprising a plurality of discrete sizing elements, each sizing element being of a known substantially uniform length, the plurality of sizing elements including linking structure to link the sizing elements together, the linking structure having sufficient friction to maintain linked-together sizing elements in a desired overall shape but allowing relative movement between adjacent sizing elements to accommodate the particular shape of the anatomical structure, the sizing elements being constructed for placement generally along the anatomical structure to be measured.

19. The sizing system of claim 18, wherein the sizing elements are segment holders, the sizing system further comprising a plurality of substantially rigid suture support segments to be placed at least partially circumferentially about an anatomical structure to form a line of suture support segments to at least stabilize the anatomical structure along the line of suture support segments, the suture support segments being readily releasably secured to the segment holders.

20. The sizing system of claim 19, wherein the suture support segments have opposite ends, the sizing elements supporting facing ends of adjacent suture support segments about 3 mm apart.

21. The sizing system of claim 18, wherein the linking structure comprises a plurality of joints connecting adjacent sizing elements together, the joints being spaced about 1 cm apart.

22. The sizing system of claim 18, wherein the linking structure comprises a plurality of universal joints connecting adjacent sizing elements together.

23. The sizing system of claim 18, wherein each sizing element comprises a clamp fin, the clamp fin being constructed for ready grasping to allow easy relocation of the sizing element.

24. A sizing and delivery system for use in a surgical procedure on the heart of a patient, the sizing and delivery system comprising:

segment means for reducing the circumference of a heart valve, the segment means comprising a plurality of substantially rigid, substantially identical suture support segments, the suture support segments having aperture means therethrough for receiving sutures, the segment means being constructed for placement at least partially circumferentially about the heart valve to form a line of discrete suture support segments for reducing the circumference of and stabilizing the heart valve along the line of discrete suture support segments; and

segment holding means for releasably holding the segment means during delivery of the segment means to the heart during the surgical procedure, the segment holding means comprising a plurality of substantially identical segment holders that are readily releasably securable to the plurality of substantially rigid suture support segments, the segment holders each including linking means for connecting adjacent segment holders together;

wherein;

a desired number of segment holders can be linked together by linking structure to form a chain of linked segment holders of a desired length, corresponding to the size of the heart valve of the patient, the linking structure having sufficient friction to maintain the linked-together segment holders in a desired overall shape but allowing relative movement between adjacent segment holders to accommodate the particular shape of the heart valve of the patient;

the segment holders are each discrete sizing elements of a known, substantially uniform length for precise valve sizing, the sizing elements being constructed for placement generally along the heart valve of the patient; and

the segment holders maintain each suture support segment a known distance from an adjacent suture support segment, creating substantially uniform intervals for implantation of the suture support segments.

25. The sizing and delivery system of claim 24, wherein the segment holders are each about 1 cm long.

26. The sizing and delivery system of claim 24, wherein the segment holders maintain each suture support segment about 3 mm from an adjacent suture support segment, creating uniform intervals of about 3 mm for implantation of the suture support segments.

27. The sizing and delivery system of claim 24, further comprising belt means for readily releasably securing the segment means to the segment holding means.

28. The sizing and delivery system of claim 27, wherein the belt means comprises separation notch means for allowing the belt means to be readily severed to release the segment means from the segment holding means.

29. A method of measuring an anatomical structure during a surgical procedure, the method comprising:

(a) placing, during the surgical procedure, a sizing system generally along an anatomical structure to be measured, the sizing system comprising a plurality of discrete sizing elements of known substantially uniform length, the plurality of sizing elements including linking structure to link the sizing elements together;

(b) maintaining the linked-together sizing elements in a desired overall shape, due at least in part to friction of the linking structure;

(c) accommodating the particular shape of the anatomical structure by allowing relative movement between adjacent sizing elements with the linking structure; and

(d) determining the perimeter of the anatomical structure based on the number of sizing elements needed to extend along an entire desired portion of the anatomical structure.

30. The method of claim 29, further comprising:

(e) using the sizing system to maintain a plurality of discrete, substantially rigid suture support segments at consistent intervals;

(f) suturing the suture support segments into fixed relationship with the anatomical structure at the consistent intervals maintained by the sizing system, the suture support segments being disposed in a line of suture support segments for at least stabilizing the anatomical structure along the line of suture support segments.

31. The method of claim 30, further comprising:

(g) releasing the plurality of suture support segments from the plurality of sizing elements.

32. The method of claim 29, wherein step (a) includes placing the sizing system along the perimeter of an unfurled anterior leaflet of a mitral or tricuspid heart valve, and step (d) includes determining the perimeter of the unfurled anterior leaflet.

33. The method of claim 32, further comprising:

(e) using the sizing system to maintain a plurality of discrete, substantially rigid suture support segments at consistent intervals; and

(f) suturing the suture support segments into fixed relationship with a posterior mitral annulus or a posterior and anterior tricuspid annulus at the consistent intervals maintained by the sizing system to bring the circumference of the posterior mitral annulus or posterior and anterior tricuspid annulus into correlation with the perimeter of the unfurled anterior leaflet.

34. The method of claim 33, wherein step (f) includes leaving the anterior mitral annulus or the septal tricuspid annulus free of sutures.

35. The method of claim 32, wherein the method further includes enclosing the support segments within an autologous pericardium ring that is sutured onto the posterior mitral or posterior and anterior tricuspid annulus.

36. A delivery system for delivering a plurality of substantially rigid suture support segments during a surgical procedure, the substantially rigid suture support segments to be placed at least partially circumferentially about an anatomical structure to form a line of discrete suture support segments for at least stabilizing the anatomical structure along the line of discrete suture support segments, the delivery system comprising a plurality of segment holders, the plurality of segment holders being readily releasably securable to the plurality of substantially rigid suture support segments, the plurality of segment holders comprising linking structure to link the segment holders together, the linking structure comprising a plurality of joints connecting adjacent segment holders together, the joints having sufficient friction to maintain linked-together segment holders in a desired overall shape but allowing relative movement between adjacent segment holders.

37. A delivery system for delivering a plurality of substantially rigid suture support segments during a surgical procedure, the substantially rigid suture support segments to be placed at least partially circumferentially about an anatomical structure to form a line of discrete suture support segments for at least stabilizing the anatomical structure along the line of discrete suture support segments, the delivery system comprising a plurality of segment holders, the plurality of segment holders being readily releasably securable to the plurality of substantially rigid suture support segments, wherein each segment holder readily releasably secures exactly one substantially rigid support segment.

38. A delivery system for delivering a plurality of substantially rigid suture support segments during a surgical procedure, the substantially rigid suture support segments to be placed at least partially circumferentially about an anatomical structure to form a line of discrete suture support segments for at least stabilizing the anatomical structure along the line of discrete suture support segments, the delivery system comprising a plurality of segment holders, the plurality of segment holders being readily releasably securable to the plurality of substantially rigid suture support segments, wherein each segment holder comprises a clamp fin, the clamp fin being constructed for ready grasping to allow easy relocation of the segment holder.

39. A delivery system for delivering a plurality of substantially rigid suture support segments during a surgical procedure, the substantially rigid suture support segments to be placed at least partially circumferentially about an anatomical structure to form a line of discrete suture support segments for at least stabilizing the anatomical structure along the line of discrete suture support segments, the delivery system comprising a plurality of segment holders, the plurality of segment holders constructed to be released from the plurality of substantially rigid suture support segments once the suture support segments are delivered to the anatomical structure, the suture support segments being constructed to remain at the anatomical structure after delivery and the plurality of segment holders being constructed for complete removal from the anatomical structure after delivery.

40. A delivery system for delivering a plurality of substantially rigid suture support segments during a surgical procedure, the substantially rigid suture support segments to be placed at least partially circumferentially about an anatomical structure to form a line of discrete suture support segments for directly supporting sutures extending into the anatomical structure and for at least stabilizing the anatomical structure along the line of discrete suture support segments, the delivery system comprising a plurality of segment holders, the plurality of segment holders being readily releasably securable to the plurality of substantially rigid suture support segments, the plurality of segment holders being distinct from the sutures.