TRANSCATHETER VALVE PROSTHESIS

• US 20150257880A1
• Filed: 03/11/2014
• Published: 09/17/2015
• Est. Priority Date: 03/11/2014
• Status: Active Grant

• Current Assignee: HighLife SAS
• Original Assignee: HighLife SAS
• Inventors: BRTLEIN, Georg, NASR, Malek
• Granted Patent: US 9,889,003 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• 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 2002/8483 Barbs
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2230/008 paraboloidal
• CPC Class Codes: A61F 2250/006 modular

Abstract

A system for implanting a heart valve that includes a radially self-expandable tubular body having an inflow end and a preformed groove disposed at an outer surface of the tubular body between the inflow end and the outflow end, wherein the preformed groove extends at least partially around the tubular body and having a circumferential opening facing radially outward of the tubular body. A valve may be disposed within and attached to the tubular body. Additionally, a trapping member may be configured to form at least a partial loop encircling the preformed groove so as to trap portions of native valve leaflets and/or chords in the preformed groove, the trapping member including one or more barbs.

Claims

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

a radially self-expandable tubular body having an inflow end and an outflow end and a preformed groove disposed at an outer surface of the tubular body between the inflow end and the outflow end, the preformed groove extending at least partially around the tubular body and having a circumferential opening facing radially outward of the tubular body;

a valve disposed within and attached to the tubular body; and

a trapping member configured to form at least a partial loop encircling the preformed groove so as to trap portions of native valve leaflets and/or chords in the preformed groove, the trapping member including one or more barbs.

2. The system according to claim 1, wherein the barbs extend away from the trapping member, when the barbs are deployed, and the barbs are configured to secure the system to the portions of native valve leaflets and/or chords.

3. The system according to claim 2, wherein the trapping member includes a first set of barbs configured to be oriented toward an inflow side of the groove when the trapping member encircles the preformed groove, and the trapping member includes a second set of barbs configured to be oriented toward an outflow side of the groove when the trapping member encircles the preformed groove.

4. The system according to claim 2, wherein the barbs are configured in a helical shape to secure a first portion of the native valve leaflets and/or chords and a second portion of the native valve leaflets and/or chords together when the helical barb is rotated about its longitudinal axis.

5. The system according to claim 1, wherein the trapping member includes an inner member and an outer tube, the outer tube including a plurality of openings, and the barbs being disposed on the inner member.

6. The system according to claim 5, wherein the inner member is configured to move relative to the outer tube to substantially align the openings with the barbs so as to deploy the barbs through the openings.

7. The system according to claim 6, further including a pusher tube releasably attached to the inner member, the pusher tube configured to push the inner member to move the inner member relative to the outer tube in a longitudinal direction of or rotationally to the inner member.

8. The system according to claim 1, wherein the barbs are configured to assume a first delivery configuration and a second deployment configuration, the delivery configuration being substantially perpendicular to the deployment configuration.

9. The system according to claim 8, wherein the barbs are configured to be arcuate when in the second deployment configuration.

10. The system according to claim 1, further including an elongate outer member configured to form a loop encircling the preformed groove so as to guide the portions of native valve leaflets and/or chords into the preformed groove.

11. The system according to claim 1, further including a projection having a first end located at a side surface of the tubular body and a second free end and configured to define the preformed groove between the projection and the tubular body, the preformed groove having an opening between the tubular body and the second free end of the projection.

12. The system according to claim 11, wherein at least one barb is configured to attach to the projection to secure the system to the portions of native valve leaflets and/or chords.

13. The system according to claim 11, further including a fabric configured to form a pouch between the tubular body and the projection.

14. The system according to claim 1, wherein the preformed groove is defined by an indent in a side surface of the tubular body.

15. The system according to claim 14, wherein the circumferential opening of the preformed groove is larger than a maximum outer diameter of the trapping member.

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

at least partially deploying from a delivery catheter a radially self-expandable tubular body having an inflow end and an outflow end, a valve disposed within a lumen of the tubular body, and a preformed groove disposed at an outer surface of the tubular body between the inflow end and the outflow end, the preformed groove having a circumferential opening facing radially outward of the tubular body;

advancing a trapping member to form at least a partial loop encircling the preformed groove and trapping portions of native valve leaflets and/or chords in the preformed groove; and

at least partially piercing the portions of native valve leaflets and/or chords with one or more barbs on the trapping member to secure the tubular body to the portions of native valve leaflets and/or chords.

17. The method according to claim 16, further including securing the barbs through one or more projections on the stent when the barbs at least partially pierce the portions of native valve leaflets and/or chords.

18. The method according to claim 16, further including moving an inner member relative to an outer tube in a longitudinal direction of or rotationally to the inner member to deploy the barbs.

19. The method according to claim 18, wherein moving the inner member substantially aligns the barbs with a plurality of openings on the outer tube so that the barbs extend through the openings when deployed.

20. The method according to claim 16, further including pushing the inner member with a pusher tube to move the inner member relative to the outer tube in a longitudinal direction of or rotationally to the inner tube.

21. The method according to claim 20, further including:

selectively releasing a connection between the pusher tube and the inner member; and

removing the pusher tube from the patient.

22. The method according to claim 16, further including advancing an elongate outer member and forming a loop around the portions of native valve leaflets and/or chords with the elongate outer member.

23. The method according to claim 22, further including advancing the trapping member along the elongate outer member.

24. The method according to claim 22, wherein the trapping member includes an inner member and an outer tube, and further including advancing a pusher tube over the elongate outer member and pushing the inner member so that the inner member moves relative to the outer tube in a longitudinal direction of or rotationally to the inner tube to deploy the barbs.

25. The method according to claim 16, further including deploying the barbs, such that the barbs at least partially pierce the portions of native valve leaflets and/or chords, before fully deploying the stent.

26. The method according to claim 16, further including deploying the barbs, such that the barbs at least partially pierce the portions of native valve leaflets and/or chords, after the stent is fully deployed.

27. The method according to claim 16, wherein the tubular body includes a fabric on an outer surface of the tubular body, and further including deploying the barbs such that the barbs pierce through the fabric when the barbs at least partially pierce the portions of native valve leaflets and/or chords.

28. The method according to claim 27, further including securing the barbs through one or more projections on the tubular body when the barbs pierce through the fabric.

29. The method according to claim 16, wherein at least one barb extends from an outflow side of the preformed groove toward an inflow side of the preformed groove such that the at least one barb at least partially pierces through a first portion of the native valve leaflets and/or chords and a second portion of the native valve leaflets and/or chords.

30. The method according to claim 16, further including:

deploying the barbs, such that a helical needle at least partially pierces through the portions of native valve leaflets and/or chords;

advancing a suture from the helical needle; and

securing a first portion of the native valve leaflets and/or chords and a second portion of the native valve leaflets and/or chords together with the suture.