Transcatheter valve prosthesis

• US 10,080,651 B2
• Filed: 03/11/2014
• Issued: 09/25/2018
• Est. Priority Date: 09/12/2011
• Status: Active Grant

• Current Assignee: HighLife SAS
• Original Assignee: HighLife SAS
• Inventors: Bortlein, Georg, Nasr, Malek
• Primary Examiner(s): Templeton, Christopher L
• Assistant Examiner(s): Jamialahmadi, Majid
• Application Number:
  US14/204,293
• Publication Number:
  US 20140277410A1
• Time in Patent Office: 1,659 Days
• Field of Search: 623 238, 623 21
• 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 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 extends at least partially around the tubular body and has a circumferential opening facing radially outward of the tubular body. A valve is disposed within and is attached to the tubular body, and an elongate outer member is configured to form a loop encircling the preformed groove so as to guide portions of native valve leaflets and/or chords into the preformed groove. The outflow end of the tubular body includes a frustoconical shape that slopes radially outward from the preformed groove toward the outflow end when the outflow end but not the inflow end has been released from a delivery catheter.

Claims

1. A method for implanting a replacement valve in a 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 having a circumferential opening facing radially outward of the tubular body, such that, when the tubular body is partially deployed;

(i) the tubular body is inside the loop, (ii) the outflow end but not the inflow end is deployed from the second delivery catheter, and (iii) the tubular body includes a frustoconical shape that slopes radially outward from the preformed groove toward the outflow end; and

when the tubular body is partially deployed, moving the loop into the preformed groove through the opening by sliding the loop along an outer surface of the tubular body.

2. The method according to claim 1, wherein moving the loop into the preformed groove includes tightening the loop around the native valve leaflets and/or chords and guiding portions of the native valve leaflets and/or chords into the preformed groove.

3. The method according to claim 2, wherein guiding the portions of the native valve leaflets and/or chords into the preformed groove includes sliding the loop in a direction moving radially inward along the slope of the tubular body from the outflow end toward the inflow end and into the preformed groove.

4. The method according to claim 3, further comprising trapping the portions of the native valve leaflets and/or chords within the preformed groove with a trapping member that is dimensioned or shaped to fit within the preformed groove but is too large to pass through the opening of the preformed groove when the tubular body is fully deployed.

5. The method according to claim 1, wherein the opening of the preformed groove is relatively larger when (i) the outflow end but not the inflow end has been released from the second delivery catheter than (ii) when both the outflow end and the inflow end are fully deployed from the second delivery catheter.

6. The method according to claim 1, wherein the native valve leaflets and/or chords form a portion of a mitral valve or a tricuspid valve.

7. A method for implanting a replacement valve in a 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 target area for the elongate outer member disposed between the inflow end and the outflow end, such that, when the tubular body is partially deployed;

(i) the tubular body is inside the loop, (ii) the outflow end but not the inflow end is deployed from the second delivery catheter, and (iii) the tubular body includes a frustoconical shape that slopes radially outward from the target area toward the outflow end; and

when the tubular body is partially deployed, moving the loop into the target area by sliding the loop along an outer surface of the tubular body.

8. The method according to claim 7, wherein moving the loop into the target area includes tightening the loop around the native valve leaflets and/or chords and guiding portions of the native valve leaflets and/or chords into the target area.

9. The method according to claim 7, wherein guiding portions of the native valve leaflets and/or chords into the target area includes sliding the loop in a direction moving radially inward along the slope of the tubular body from the outflow end toward the inflow end and into the target area.

10. The method according to claim 7, further comprising trapping portions of the native valve leaflets and/or chords within the target area with a trapping member that is dimensioned or shaped to fit within the target area but is too large to pass into the target area when the tubular body is fully deployed.

11. The method according to claim 7, wherein an opening of the target area is relatively larger when (i) the outflow end but not the inflow end has been released from the second delivery catheter than (ii) when both the outflow end and the inflow end are fully deployed from the second delivery catheter.

12. The method according to claim 7, wherein the native valve leaflets and/or chords form a portion of a mitral valve or a tricuspid valve.

13. A method for implanting a replacement valve in a 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 outflow end of the tubular body having a larger outer diameter when expanded than a diameter of the loop, such that, when the tubular body is partially deployed;

(i) the tubular body is inside the loop, (ii) the outflow end but not the inflow end is deployed from the second delivery catheter, and (iii) the tubular body includes a frustoconical shape that slopes radially outward from the preformed groove toward the outflow end; and

when the tubular body is partially deployed, moving the loop towards the native valve leaflets and/or chords by moving the partially deployed tubular body such that the loop slides along an outer surface of the tubular body.

14. The method according to claim 13, further comprising trapping portions of the native valve leaflets and/or chords within the preformed groove with a trapping member that is dimensioned or shaped to fit within the preformed groove but is too large to pass through an opening of the preformed groove when the tubular body is fully deployed.

15. The method according to claim 13, wherein an opening of the preformed groove is relatively larger when (i) the outflow end but not the inflow end has been released from the second delivery catheter than (ii) when both the outflow end and the inflow end are fully deployed from the second delivery cathete.