SYSTEM AND A METHOD FOR ALTERING THE GEOMETRY OF THE HEART

• US 20100063586A1
• Filed: 05/15/2007
• Published: 03/11/2010
• 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: Hasenkam, John Michael, Smerup, Morten, Nielsen, Sten Lyager
• Granted Patent: US 8,142,495 B2
• Time in Patent Office: Days
• US Class Current: 623/2.370
• 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), each of which tension members are adapted for forming a link between said ring (10) and a papillary muscle, each of said tension members (21, 22, 23, 24) having a first end (21b, 22b, 23b, 24b) and a second end (21a, 22a, 23a, 24a); and a first set of papillary anchors (30) for connecting each of the first ends (21b, 22b, 23b, 24b) of said tension members (21, 22, 23, 24) to said 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.

Claims

1. A system (1) for altering the geometry of a heart (100), comprising

an annuloplasty ring (10) for supporting the geometry of an annulus (180) of the heart (100), being attachable to said annulus (180), and having an upper side (10a) and a lower side (10b);

a set of elongate annulus-papillary tension members (21, 22, 23, 24), each of which tension members are adapted for forming a link between said annuloplasty ring (10) and a papillary muscle (170, 171) of the heart (100), each of said tension members (21, 22, 23, 24) having a first end (21a, 22a, 23a, 24a) and a second end (21b, 22b, 23b, 24b); and

a first set of papillary anchors (30) for connecting each of the second ends (21b, 22b, 23b, 24b) of said annulus-papillary tension members (21, 22, 23, 24) to said papillary muscle (170, 171);

characterized in that said annuloplasty ring (10) has at least one aperture (12, 13) located on said lower side (10b) and at least one aperture (11) located on said upper side (10a);

where each of said annulus-papillary tension members (21, 22, 23, 24) are extendable through said annuloplasty ring (10) through said apertures (11, 12, 13), and through an atrium (150) of said heart (100) to an exterior side (151a) of an exterior wall (151) of said atrium (150), such that the distance of each link between the annulus (180) and the papillary muscles (170, 171) is adjustable from a position exterior to the heart (100).

2. A system (1) according to claim 1 characterized in that it further comprises

an inter-papillary tension member (25) for forming a link between said papillary muscles (170), said inter-papillary tension member (25) having a first end (25a) and a second end (25b);

a first inter-papillary anchor (31) for fixing the second end (25b) of said interpapillary tension member (25) to a papillary muscle (170); and

a second inter-papillary anchor (32) through which the first end (25a) of said inter-papillary tension member (25) is extendable,

said inter-papillary tension member (25) further being extendable through a ventricle (110) of said heart, and through a through said annuloplasty ring (10) via said apertures (11, 12, 13), and through an atrium (150) of said heart (100) to an exterior side (151a) of an exterior wall (151) of said atrium (150), such that the distance of the inter-papillary link between the papillary muscles (170, 171) is adjustable from a position exterior to the heart (100).

3. A system (1) according to claim 1 or 2, characterized in that at least one circumferential channel (14) is formed inside the annuloplasty ring (10), and that a single aperture (11) is formed in the upper side (10a) of said annuloplasty ring (10), said channel communicating with said aperture (11) on the upper side (10a) and with the at least on aperture (12, 13) on the lower side (10b) of said annuloplasty ring (10), such that said tension members (21, 22, 23, 24, 25) are extendable through said apertures (12, 13) on the lower side (10b) through said channel and through said aperture (11) on the upper side (10a).

4. A system (1) according to any one of claims 1-3, characterized in that at least one anchor of said first set of papillary anchors (30) is adapted to be fixed on a papillary muscle (170, 171).

5. A system (1) according to any one of claims 1-4, characterized in that at least one anchor of said first set of anchors (30) is adapted to be fixed to an exterior side (170b) of an exterior wall (111) of a ventricle (110) of the heart (100), and that said tension members are adapted to be extendable through a papillary muscle (170).

6. A system (1) according to claim 5, characterized in that a second end (21b, 22b, 23b, 24b, 25b) of at least one of said annulus-papillary tension members (21, 22, 23, 24) and/or said inter-papillary tension member (25) is provided with piercing means (26).

7. A system (1) according to any of claims 1-6, characterized in that said annuloplasty ring (10) is provided with integrated attachment means for fixing the annuloplasty ring (10) to the upper side (180a) of the annulus (180).

8. A system (1) according to any of claims 1-7, characterized in that said system further comprises an atrial anchor (35) for anchoring said second ends (21a, 22a, 23a, 24a, 25a) of said annulus-papillary tension members (21, 22, 23, 24) and said inter-papillary tension member (25) at said exterior wall (151) of said atrium (150).

9. A system (1) according to any of claims 1-7, characterized in that said system 1 further comprises an annuloplasty ring fixating system (40) for fixing a portion (21c, 22c, 23c, 24c, 25c) of said annulus-papillary tension members (21, 22, 23, 24) and/or said inter-papillary tension member (25) to said annuloplasty ring (10), at and from the atrial side (10a) of the annuloplasty ring (10).

10. A system (1) according to claim 9, characterized in that said annuloplasty ring fixating system (40) is adapted to fixate the tension members (21, 22,23, 24, 25) between a tubular extension of annuloplasty ring (41) of said annuloplasty ring (10) and a plugging member (43).

11. A system (1) according to claim 10 characterized in that said annuloplasty ring fixating system (40) comprises a circular cutting edge (42) formed in the tubular extension (41) of the annuloplasty ring on the upper side (10a) of said annuloplasty ring (10) adapted for cooperating with a conical part (45) of said plugging member (43).

12. A system (1) according to any of claims 9-10, characterized in that said system (1) is further provided with means (50) for cutting said annulus-papillary tension members (21, 22, 23, 24) and/or said inter-papillary tension member (25) when adjusted, said means for cutting being provided on an auxiliary tool 400.

22. A system (1) according to claim 1 or 2 comprising the annuloplasty ring according to any one of claims 18-21.

23. A system (1) according to claim 22 further comprising a tightening tool (400) for fasting the fastening member (340) in order for locking/fixating tension members (21, 22, 23, 24, 25).

13. A system (201) for altering the geometry of a heart (100), comprising

an annuloplasty ring (210) for supporting the geometry of an annulus (180 of the heart (100), being attachable to said annulus (180), and having an upper side (210a) and a lower side (210b);

a set of elongate annulus-papillary tension members (221, 222, 223, 224), each of which tension members are adapted for forming a link between said annuloplasty ring (210) and a papillary muscle (170, 171) of the heart (100), each of said tension members (221, 222, 223, 224) having a first end (221a, 222a, 223a, 224a) and a second end (221b, 222b, 223b, 224b); and

a first set of papillary anchors (230) for connecting each of said annulus-papillary tension members (221, 222, 223, 224) to said papillary muscle (170, 171),

where the first end (221a, 222a, 223a, 224a) of each tension member is fixed to said annuloplasty ring (210), characterized in that the second end (221b, 222b, 223b, 224b) of each of the annulus-papillary tension members (221, 222, 223, 224) are extendable through a papillary muscle (170, 171) to an exterior side (170b) of an exterior wall (111) of a ventricle (110) of the heart (100), to a first set of papillary anchors (230) for adjustably connecting each of the second ends (221b, 222b, 223b, 224b) of said annulus-papillary tension members (221, 222, 223, 224) to said papillary muscle (170, 171).

14. A system (201) according to claim 13, characterized in that the system has one anchor (230) for each papillary muscle (170, 171).

15. A system (1) according to claim 13 or 14, characterized in each anchor (230) having means for individually fixing each of the second ends (221b, 222b, 223b, 224b) of said annulus-papillary tension members (221, 222, 223, 224).

16. A system (201) according to claim 13, characterized in that the system further comprises

an inter-papillary tension member (225) for forming a link between said papillary muscles (170), said inter-papillary tension member (225) having a first end (225a) and a second end (225b);

a third papillary anchor (237) for fixing the first end (225a) of said interpapillary tension member (225) to a papillary muscle (170); and

a second papillary anchor (238) through which the second end (225b) of said interpapillary tension member (225) is extendable,

said inter-papillary tension member (225) further being extendable through a papillary muscle (171) of said heart (100) such that the distance of the inter-papillary link between the papillary muscles (170, 171) is adjustable from a position exterior to the heart (100).

17. A system (1) according to claim 16 characterized in that the second end (225b) of the interpapillary tension member (225) is fixable to one anchor of said first set of anchors (230), and that this anchor (230) has means for individually fixating the second end (225b) of said inter-papillary tension member (225).

18. An annuloplasty ring (10) for supporting the geometry of an annulus (180) of the heart (100), being attachable to said annulus (180), and having an upper side (10a) and a lower side (10b), characterized in that said annuloplasty ring (10) has at least one aperture (12, 13) located on said lower side (10b) and at least one aperture (11) located on said upper side (10a) and wherein a set tension members (21, 22, 23, 24, 25) are extendable through said annuloplasty ring (10) through said apertures (11, 12, 13).

19. An annuloplasty ring (10) according to claim 18, wherein the annuloplasty ring further comprises a channel (14, 312) formed along the circumference of the annuloplasty ring (10), said channel connecting said upper aperture (11) located on said upper side (10a) to at least one aperture (12, 13) located on said lower side (10b), where the upper (11) and lower (12, 13) apertures are positioned diametrically across from each other on the circumference of the annuloplasty ring (10).

20. An annuloplasty ring (10) according to claim 19, wherein the annuloplasty ring further comprises a tension member hub (310) having a set of upper apertures (11) communicating with a set of lower apertures via a set of channels (312, 313), and where a set of tension members (21, 22, 23, 24, 25) may be locked to the annuloplasty ring (10) at said hub (310).

21. An annuloplasty ring (10) according to claim 20, wherein the hub (310) comprises a through hole (311), a locking part (330) mounted in said through hole (311) for locking/fixating tension members (21, 22, 23, 24, 25), and fastening means (340, 350) for locking/fixating the locking part (330) to the though hole (311) of the hub (310).