TRANSCATHETER VALVE PROSTHESIS

• US 20140277412A1
• Filed: 03/11/2014
• Published: 09/18/2014
• Est. Priority Date: 09/12/2011
• Status: Active Grant

• Current Assignee: HighLife SAS
• Original Assignee: HighLife SAS
• Inventors: BRTLEIN, Georg, NASR, Malek
• Granted Patent: US 8,956,404 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0033 made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0065 toroidal, e.g. ring-shaped, doughnut-shaped
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/006 modular
• CPC Class Codes: A61F 2250/0069 Sealing means
• CPC Class Codes: A61F 2250/007 O-rings

Abstract

A system for implanting a heart valve that includes a radially self-expandable tubular body having an inflow end and an outflow end, and a valve disposed within and attached to the tubular body. A first end of a projection is located at a side surface of the tubular body, and a second free end of the projection defines a groove between the projection and the tubular body. The groove has an opening between the tubular body and the second free end of the projection. Additionally, an elongate outer member is configured to move into the groove and to move heart tissue into the groove, such that the heart tissue is disposed between the tubular body and the projection.

Claims

1. A system for implanting a heart valve, comprising:

a radially self-expandable tubular body having an inflow end and an outflow end;

a valve disposed within and attached to the tubular body;

a projection having a first end located at a side surface of the tubular body and a second free end and configured to define a groove between the projection and the tubular body, the groove having an opening between the tubular body and the second free end of the projection; and

an elongate outer member configured to be moved into the groove and to move heart tissue into the groove such that the heart tissue is disposed between the tubular body and the projection.

2. The system according to claim 1, further including a trapping member configured to be disposed along the elongate outer member and trap the heart tissue in the groove.

3. The system according to claim 1, wherein a cross-sectional shape of the trapping member is larger than the opening of the preformed groove.

4. The system according to claim 3, wherein a cross-sectional shape of the trapping member is smaller than a maximum width of the groove.

5. The system according to claim 2, wherein the projection is rigid.

6. The system according to claim 1, wherein the projection includes a plurality of projections extending from the tubular body toward the inflow end of the tubular body.

7. The system according to claim 6, wherein the plurality of projections comprise struts forming rounded corner triangle configurations.

8. The system according to claim 1, wherein the projection includes a plurality of first projections extending from an outflow-end side of the groove toward an inflow-end side of the groove and a plurality of second projections extending from the inflow-end side of the groove toward the outflow-end side of the groove.

9. The system according to claim 1, wherein the second end of the projection includes a substantially flat end extending in a direction parallel to a tangent to the tubular body.

10. The system according to claim 1, wherein the first end of the projection includes first apertures substantially aligned with second apertures disposed between struts of the tubular body.

11. The system according to claim 2, wherein the trapping member is configured to form at least a partial loop around the tubular body.

12. The system according to claim 2, wherein the trapping member has substantially no shape memory.

13. The system according to claim 1, wherein the trapping member has shape memory configured to compress native valve leaflet tissue and/or chords radially outward toward the projection.

14. The system according to claim 1, wherein the trapping member has shape memory configured to compress a native valve leaflet and/or chords radially inward toward the tubular body.

15. A method for implanting a replacement valve in a patient'"'"'s heart, comprising:

deploying from a delivery catheter a radially self-expandable tubular body having a valve disposed within a lumen of the tubular body and a projection that forms a groove between the tubular body and the projection, such that, when the tubular body is deployed, the tubular body is aligned with a native valve of the patient; and

guiding portions of native valve leaflets and/or chords into the groove with an elongate outer member disposed radially outward of the native valve leaflets.

16. The method according to claim 15, further including trapping the portions of the native valve leaflets and/or chords within the preformed groove with a trapping member such that the portions of the native valve leaflets and/or chords are disposed between the tubular body and the trapping member.

17. The method according to claim 15, further including trapping the portions of the native valve leaflets or chords within the preformed groove with a trapping member such that the portions of the native valve leaflets and/or chords are disposed between the trapping member and the projection.

18. The method according to claim 16, wherein:

the projection includes a first end attached to the tubular body and a second free end; and

trapping the portions of the native valve leaflets and/or chords within the groove with the trapping member includes wrapping the portions of the native valve leaflets and/or chords around the trapping member and around the second free end of the projection.

19. The method according to claim 16, wherein trapping the portions of the native valve leaflets and/or chords with the trapping member includes advancing the trapping member between at least two projections of the tubular body and into the groove.

20. The method according to claim 16, wherein trapping the portions of the native valve leaflets and/or chords with the trapping member includes applying a radially outward force on the portions of the native valve leaflets with the trapping member.

21. The method according to claim 16, wherein trapping the portions of the native valve leaflets and/or chords with the trapping member includes applying a radially inward force on the portions of the native valve leaflets and/or chords with the trapping member.

22. The method according to claim 16, wherein trapping portions of the native valve leaflets and/or chords with the trapping member includes applying a longitudinal force on the portions of the native valve leaflets with the trapping member.

23. The method according to claim 16, wherein the trapping member includes a delivery configuration and a deployment configuration and is biased to the deployment configuration.

24. The method according to claim 16, wherein a cross-sectional shape of the trapping member is larger than an opening of the groove.

25. The method according to claim 15, wherein the native valve is a mitral valve or a tricuspid valve.

26. The method according to claim 15, further comprising removing the elongate outer member from the patient.