Method for altering the geometry of the heart

• US 8,591,576 B2
• Filed: 02/14/2012
• Issued: 11/26/2013
• Est. Priority Date: 05/15/2006
• Status: Active Grant

• Current Assignee: Edwards Lifesciences AG (Edwards Lifesciences Corporation)
• Original Assignee: Edwards Lifesciences AG (Edwards Lifesciences Corporation)
• Inventors: Smerup, Morten, Nielsen, Sten Lyager, Hasenkam, John Michael
• Primary Examiner(s): Sweet, Thomas
• Assistant Examiner(s): STEWART, JASON-DENNIS NEILKEN
• Application Number:
  US13/396,498
• Publication Number:
  US 20120143323A1
• Time in Patent Office: 651 Days
• Field of Search: 623 236- 242, 623 21- 219, 128/898, 606/108
• US Class Current: 623/2.37
• 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 17/0467 Instruments for cutting sutures surgical cutting instruments A61B17/32
• CPC Class Codes: A61B 2017/00238 Type of minimally invasive operation A61B2017/00805 takes precedence
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2454 Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses
• CPC Class Codes: A61F 2/2466 Delivery devices therefor

Abstract

A system (1) for altering the geometry of a heart (100), comprising an annuloplasty ring; a set of elongate annulus-papillary tension members (21, 22, 23, 24), adapted for forming a link between said ring (10) and a papillary muscle, and a first set of papillary anchors (30) for connecting each of the tension members (21, 22, 23, 24) to the papillary muscle; and where said annuloplasty ring (10) has at least one aperture (12, 13); where each of said annulus-papillary tension members (21, 22, 23, 24) are extendable through said ring (10) through said apertures (11, 12, 13), and through an atrium to an exterior side of said atrium, such that the distance of each link between the annulus and the muscles is adjustable from a position exterior to the heart while the heart is beating.

Claims

1. A method for adjusting, from outside the heart and while the heart is beating, the distance between a native heart valve annulus and associated papillary muscles located within the adjacent ventricle, comprising:

stopping the heart of the patient from beating;

resecting the heart wall of one of the atriums;

inserting a system for altering the geometry of a heart into the atrium, the system comprising a substantially rigid annuloplasty ring having an upper side and a lower side, an upper aperture located on the upper side and at least two lower apertures located on the lower side that are spaced apart from each other and at least one being spaced from the upper aperture around the annuloplasty ring, the annuloplasty ring further including channels that extend between the upper aperture and each of the lower apertures, the system further including at least two flexible, elongate annulus-papillary tension members that each extend from a second end through one of the lower apertures in the annuloplasty ring, through one of the channels, and through the upper aperture to a first end;

passing the second ends of the tension members into the ventricle associated with the atrium;

attaching each of the second ends of the tension members to a papillary muscle;

attaching the annuloplasty ring to the heart valve annulus between the atrium and the associated ventricle;

extending the first ends of the tension members from the upper aperture of the annuloplasty ring to a position outside the atrium; and

after restarting the heart of the patient and while the heart is beating, adjusting the distance between the second ends of the tension members and the annuloplasty ring by manipulating the first ends of the tension members from outside the atrium.

2. The method of claim 1, wherein the step of passing the second ends of the tension members into the ventricle includes passing the second ends of the tension members through the tissue of the annulus.

3. The method of claim 1, wherein the annuloplasty ring further includes a tension member hub open to the upper side of the annuloplasty ring, the hub defining the upper aperture and further including a locking part that engages the hub and is adapted for locking the position of the tension members through the upper aperture, and the method includes operating the locking part to lock the position of the tension members through the upper aperture.

4. The method of claim 3, wherein the system includes a fastening member for tightening the locking part against the tension member hub, and a tightening tool that engages the fastening member and has a length sufficient to extend from the annuloplasty ring through the atrium to a position outside the atrium for manipulation thereof, and the method includes engaging the fastening member with the tightening tool so as to tighten the locking part against the tension member hub.

5. The method of claim 4, wherein the tightening tool is hollow, and the tension members extend from the upper aperture through the tightening tool.

6. The method of claim 1, further including locking the position of the tension members through the upper aperture, cutting the tension members at the annuloplasty ring, and removing from the atrium portions of the tension members between where they were cut to their first ends.

7. The method of claim 1, further including locking the position of the tension members through the upper aperture and securing the tension members to the outer wall of the atrium.

8. A method for adjusting, from outside the heart and while the heart is beating, the distance between a native heart valve annulus and associated papillary muscles located within the adjacent ventricle, comprising:

stopping the heart of the patient from beating;

resecting the heart wall one of the atriums;

inserting a system for altering the geometry of a heart into the atrium, the system comprising a substantially rigid annuloplasty ring having an upper side and a lower side, an upper aperture located on the upper side and a lower aperture located on the lower side and spaced from the upper aperture around the annuloplasty ring, the annuloplasty ring further including channels that extend between the upper aperture and the lower aperture, the system further including a flexible, elongate annulus-papillary tension member that extends from a second end through the lower aperture in the annuloplasty ring, through one of the channels, and through the upper aperture to a first end;

passing the second end of the tension member into the ventricle associated with the atrium;

attaching the second end of the tension member to a papillary muscle;

attaching the annuloplasty ring to the heart valve annulus between the atrium and the associated ventricle;

extending a tool from outside the atrium through an opening in the wall of the atrium to the upper aperture;

sealing the opening in the wall of the atrium around the tool;

restarting the heart of the patient;

after restarting the heart of the patient and while the heart is beating, adjusting the distance between the second end of the tension member and the annuloplasty ring by manipulating the first end of the tension member; and

locking the position of the tension member through the upper aperture using the tool.

9. The method of claim 8, wherein the annuloplasty ring further includes a tension member hub open to the upper side of the annuloplasty ring, the hub defining the upper aperture and further including a locking part that engages the hub and is adapted for locking the position of the tension member through the upper aperture, and the method includes operating the locking part to lock the position of the tension member through the upper aperture.

10. The method of claim 9, wherein the system includes a fastening member for tightening the locking part against the tension member hub, and the tool engages the fastening member and has a length sufficient to extend from the annuloplasty ring through the atrium to a position outside the atrium for manipulation thereof, and the method includes engaging the fastening member with the tool so as to tighten the locking part against the tension member hub.

11. The method of claim 8, wherein the tool is hollow, and the first end of the tension member extends through the tool to a position outside the atrium.

12. The method of claim 8, further including locking the position of the tension member through the upper aperture, cutting the tension member at the annuloplasty ring, and removing from the atrium a portion of the tension member between where it was cut to its first end.

13. The method of claim 8, further including locking the position of the tension member through the upper aperture and securing the tension member to the outer wall of the atrium.

14. The method of claim 8, wherein the annuloplasty ring has two of the lower apertures located on the lower side that are spaced apart from each other, at least one being spaced from the upper aperture around the annuloplasty ring, and wherein there are two of the channels extending between the upper aperture and each of the two lower apertures, the system further including two of the flexible, elongate annulus-papillary tension members, and each tension member extends from a respective second end through one of the lower apertures in the annuloplasty ring, through one of the channels, and through the upper aperture to a respective first end, the method including:

after restarting the heart of the patient and while the heart is beating, adjusting the distance between the second ends of the two tension members and the annuloplasty ring by manipulating the first ends of the tension member; and

locking the positions of the two tension members through the upper aperture using the tool.

15. A method for adjusting, from outside the heart and while the heart is beating, the distance between a native heart valve annulus and associated papillary muscles located within the adjacent ventricle, comprising:

stopping the heart of the patient from beating;

resecting the heart wall one of the atriums;

inserting a system for altering the geometry of a heart into the atrium, the system comprising a substantially rigid annuloplasty ring having an upper side and a lower side, an upper aperture located on the upper side and a lower aperture located on the lower side and spaced from the upper aperture around the annuloplasty ring, the annuloplasty ring further including channels that extend between the upper aperture and the lower aperture, the system further including a flexible, elongate annulus-papillary tension member that extends from a second end through the lower aperture in the annuloplasty ring, through one of the channels, and through the upper aperture to a first end;

passing the second end of the tension member into the ventricle associated with the atrium;

attaching the second end of the tension member to a papillary muscle;

attaching the annuloplasty ring to the heart valve annulus between the atrium and the associated ventricle;

extending the first end of the tension member from the upper aperture of the annuloplasty ring to a position outside the atrium;

sealing the opening in the wall of the atrium around the tension member;

restarting the heart of the patient;

after restarting the heart of the patient and while the heart is beating, monitoring cardiac function and valve competence while adjusting the distance between the second end of the tension member and the annuloplasty ring by manipulating the first end of the tension member; and

locking the position of the tension member through the upper aperture.

16. The method of claim 15, wherein the annuloplasty ring further includes a tension member hub open to the upper side of the annuloplasty ring, the hub defining the upper aperture and further including a locking part that engages the hub and is adapted for locking the position of the tension member through the upper aperture, and the method includes operating the locking part to lock the position of the tension member through the upper aperture.

17. The method of claim 16, wherein the system includes a fastening member for tightening the locking part against the tension member hub, and a tightening tool that engages the fastening member and has a length sufficient to extend from the annuloplasty ring through the atrium to a position outside the atrium for manipulation thereof, and the method includes engaging the fastening member with the tool so as to tighten the locking part against the tension member hub.

18. The method of claim 17, wherein the tool is hollow, and the first end of the tension member extends through the tool to a position outside the atrium.

19. The method of claim 15, further including locking the position of the tension member through the upper aperture, cutting the tension member at the annuloplasty ring, and removing from the atrium a portion of the tension member between where it was cut to its first end.

20. The method of claim 15, further including locking the position of the tension member through the upper aperture and securing the tension member to the outer wall of the atrium.

21. The method of claim 15, wherein the annuloplasty ring has two of the lower apertures located on the lower side that are spaced apart from each other, at least one being spaced from the upper aperture around the annuloplasty ring, and wherein there are two of the channels extending between the upper aperture and each of the two lower apertures, the system further including two of the flexible, elongate annulus-papillary tension members, and each tension member extends from a respective second end through one of the lower apertures in the annuloplasty ring, through one of the channels, and through the upper aperture to a respective first end, the method including:

after restarting the heart of the patient and while the heart is beating, adjusting the distance between the second ends of the two tension members and the annuloplasty ring by manipulating the first ends of the tension member; and

locking the positions of the two tension members through the upper aperture using the tool.