Transcatheter valve prosthesis

• US 9,358,108 B2
• Filed: 03/11/2014
• Issued: 06/07/2016
• Est. Priority Date: 09/12/2011
• Status: Active Grant

• Current Assignee: HighLife SAS
• Original Assignee: HighLife SAS
• Inventors: Brtlein, Georg, Nasr, Malek
• Primary Examiner(s): Manahan, Todd E
• Assistant Examiner(s): Herbermann, Erich
• Application Number:
  US14/204,171
• Publication Number:
  US 20140277409A1
• Time in Patent Office: 819 Days
• Field of Search: 623/2.11, 623/2.18
• 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 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 includes a radially self-expandable tubular body having a preformed groove disposed at an outer surface of the tubular body, and a valve disposed within the tubular body. The preformed groove extends at least partially around the tubular body, and has a circumferential opening facing radially outward. A trapping member is configured to be disposed within the preformed groove on the outer surface of the tubular body and form at least a partial loop around the tubular body. The circumferential opening of the preformed groove is relatively larger when an outflow end of the tubular body has been deployed from a catheter and an inflow end of the tubular body is disposed within the catheter, and the circumferential opening of the preformed groove is relatively smaller when both the outflow end and the inflow end are fully deployed from the catheter.

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 be disposed within the preformed groove on the outer surface of the tubular body, the trapping member configured to form at least a partial loop around the tubular body, wherein

(i) the circumferential opening of the preformed groove is in a first state when the outflow end of the tubular body has been deployed from a catheter and the inflow end of the tubular body is disposed within the catheter,

(ii) the circumferential opening of the preformed groove is in a second state when both the outflow end and the inflow end are fully deployed from the catheter, the circumferential opening of the second state being relatively smaller that the circumferential opening of the first state, and

(iii) a cross-sectional dimension of the trapping member is smaller than the circumferential opening of the first state and larger than the circumferential opening of the second state.

2. The system according to claim 1, wherein the trapping member is configured to trap heart tissue between the circumferential opening and the trapping member.

3. The system according to claim 1, further including an elongate outer member configured to form a loop encircling the preformed groove.

4. The system according to claim 1, wherein the trapping member forms a partial loop around the tubular body.

5. The system according to claim 1, wherein the trapping member forms a full loop around the tubular body.

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

advancing an elongate outer member from a first delivery catheter to form a loop around native valve leaflets and/or chords with the elongate outer member;

partially deploying from a second 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 extending at least partially around the tubular body and having a circumferential opening facing radially outward of the tubular body, such that, when the tubular body is partially deployed, the outflow end but not the inflow end is deployed from the second delivery catheter and the circumferential opening of the preformed groove is relatively larger than when both the outflow end and the inflow end are fully deployed from the second delivery catheter;

moving the loop and native valve leaflet tissue and/or chords into the preformed groove through the opening;

moving a trapping member into the preformed groove while the tubular body is partially deployed, the trapping member having a cross-sectional shape smaller than the opening of the groove when the outflow end but not the inflow end is deployed from the second delivery catheter; and

deploying a remainder of the tubular body from the second delivery catheter after moving the trapping member into the preformed groove, and allowing the opening of the groove to become smaller than the cross-sectional shape of the trapping member.

7. The method according to claim 6, wherein moving the trapping member into the preformed groove includes guiding the trapping member along the loop within the preformed groove.

8. The method according to claim 6, further including forming at least a partial loop within the preformed groove with the trapping member.

9. The method according to claim 8, further including removing the elongate outer member.

10. The method according to claim 6, wherein the native valve leaflet tissue and/or chords is a portion of a mitral valve or a tricuspid valve.

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

advancing an elongate outer member from a first delivery catheter to form a loop around native valve leaflets and/or chords with the elongate outer member;

deploying from a second 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 extending at least partially around the tubular body and having a circumferential opening facing radially outward of the tubular body, such that, when the tubular body is partially deployed from the second delivery catheter, the outflow end but not the inflow end is deployed from the second delivery catheter and the circumferential opening of the preformed groove is relatively larger than when both the outflow end and the inflow end are fully deployed from the second delivery catheter;

moving the loop and native valve leaflet tissue and/or chords into the preformed groove through the opening; and

moving a trapping member into the preformed groove after the tubular body is fully deployed from the second delivery catheter, the trapping member having a cross-sectional shape smaller than the opening of the groove when the outflow end but not the inflow end is deployed from the second delivery catheter.

12. The method according to claim 11, wherein the cross-sectional shape of the trapping member is larger than the opening of the groove when both the outflow end and the inflow end are fully deployed from the second delivery catheter.

13. The method according to claim 11, wherein moving the trapping member into the preformed groove includes advancing the trapping member between at least two struts of the tubular body.

14. The method according to claim 11, wherein moving the trapping member into the preformed groove includes guiding the trapping member along the loop within the preformed groove.

15. The method according to claim 11, further including removing the elongate outer member.

16. The method according to claim 11, wherein the native valve leaflet tissue and/or chords is a portion of a mitral valve or a tricuspid valve.

17. The method according to claim 11, further including forming at least a partial loop within the preformed groove with the trapping member.