Transcatheter atrio-ventricular valve prosthesis

• US 9,375,312 B2
• Filed: 06/30/2011
• Issued: 06/28/2016
• Est. Priority Date: 07/09/2010
• Status: Active Grant

• Current Assignee: HighLife SAS
• Original Assignee: HighLife SAS
• Inventors: Weber, Josef
• Primary Examiner(s): Prone, Christopher D
• Assistant Examiner(s): Diop, Rokhaya
• Application Number:
  US13/808,838
• Publication Number:
  US 20130116779A1
• Time in Patent Office: 1,825 Days
• Field of Search: 623/2.1, 623/2.11, 623/2.14, 623/2.15, 623/2.17, 623/2.18, 623/2.19, 623/2.36, 623/2.37
• US Class Current: 1/1
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/1227 Spring clips
• CPC Class Codes: A61B 17/1285 for minimally invasive surgery
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/0403 Dowels
• CPC Class Codes: A61B 2017/0427 having anchoring barbs or pins extending outwardly from the anchor body
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/0475 using sutures having a slip knot
• 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 2/2442 Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
• 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 2/2475 Venous valves
• CPC Class Codes: A61F 2210/0057 stretchable
• 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 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0066 stapled
• CPC Class Codes: A61F 2230/0067 : conical
• CPC Class Codes: A61F 2230/0091 : helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61F 2250/001 : for adjusting a diameter
• CPC Class Codes: A61F 2250/006 : modular
• CPC Class Codes: A61F 2250/0063 : Nested prosthetic parts
• CPC Class Codes: A61F 2250/0069 : Sealing means
• CPC Class Codes: A61F 2250/007 : O-rings

Abstract

A transcatheter atria-ventricular valve prosthesis for functional replacement of an atrio-ventricular valve in a connection channel, having a circumferential connection channel wall structure, between atrial and ventricular chambers of a heart, including an inner device to be disposed in the interior of the connection channel, the inner device having a circumferential support structure which is radially expandable and having a valve attached to the circumferential support structure, and an outer device to be disposed on the exterior of the connection channel, wherein the outer device at least partly extends around the inner device at a radial distance to the inner device, wherein the inner and outer devices form a securing mechanism for securing the circumferential connection channel wall structure therebetween.

Claims

1. A transcatheter atrio-ventricular valve prosthesis for functional replacement of an atrio-ventricular valve adapted to be disposed in a connection channel, having a circumferential connection channel wall structure, configured to be placed between an atrial chamber and a ventricular chamber of a heart,

the transcatheter atrio-ventricular valve prosthesis comprising:

an inner device configured to be disposed in an interior of the connection channel,

the inner device having a circumferential support structure which is radially expandable, and having a valve attached to the circumferential support structure,

wherein the circumferential support structure of the inner device has a tubular funnel portion, extends along an axis, and has two axial ends, and

an outer device configured to be disposed on an exterior of the connection channel,

wherein the outer device is configured to at least partly extend around the inner device at a radial distance from the inner device and at an axial distance from the tubular funnel portion of the inner device, the outer device dimensioned so as to be loosely fit around the inner device such that there is no substantial radial compressive force on the inner device by the outer device,

wherein;

the inner and outer devices are configured to form a securing mechanism for securing the circumferential connection channel wall structure therebetween,

the outer device is configured to form a ring, for extending circumferentially around the circumferential connection channel wall structure, between and at a distance from the axial ends of the inner device, and

the circumferential support structure of the inner device comprises an outer circumferential groove, and the ring of the outer device is configured to be aligned with the outer circumferential groove.

2. The transcatheter atrio-ventricular valve prosthesis according to claim 1, wherein the circumferential groove, in cross-section, has a width corresponding to a cross-sectional dimension of the ring or slightly greater than the cross-sectional dimension of the ring so that the circumferential connection channel wall structure can be clamped by the ring against opposing lateral walls of the circumferential groove.

3. The transcatheter atrio-ventricular valve prosthesis according to claim 1, wherein the outer device further comprises an anchor member having one or more anchor parts to penetrate into the circumferential connection channel wall structure at a position at or close to the ring, the anchor member comprising an eye, through which the ring extends to thereby be anchored on the circumferential connection channel wall structure at the position at or close to the ring by the anchor member.

4. The transcatheter atrio-ventricular valve prosthesis according to claim 1, wherein the circumferential support structure is made of a mesh-like structure.

5. The transcatheter atrio-ventricular valve prosthesis according to claim 1, wherein the circumferential support structure is provided with a compressible material arranged on and around an outer periphery of the circumferential support structure.

6. The transcatheter atrio-ventricular valve prosthesis according to claim 1, wherein the ring of the outer device is one of an open ring or a closed ring.

7. The transcatheter atrio-ventricular valve prosthesis according to claim 1, wherein the ring is made of an elastic wire material.

8. The transcatheter atrio-ventricular valve prosthesis according to claim 1, wherein the outer device is formed as a clamp in the form of an open ring.

9. The transcatheter atrio-ventricular valve prosthesis according to claim 1, wherein the tubular funnel portion of the inner device corresponds to a funnel shape of the connection channel.

10. The transcatheter atrio-ventricular valve prosthesis according to claim 9, wherein the tubular funnel portion is provided at one of the axial ends of the circumferential support structure of the inner device.

11. The transcatheter atrio-ventricular valve prosthesis according to claim 1, wherein an outer surface of the circumferential support structure of the inner device is free of projections, with the circumferential groove being formed as a radially inwardly deepened recess in the circumferential support structure.

12. The transcatheter atrio-ventricular valve prosthesis according to claim 1, wherein the circumferential support structure is radially expandable to be able to exert an active outward radial force against an inner periphery of the circumferential connection channel wall structure and/or wherein the outer device is contractible to be able to exert an active inward radial force against an outer periphery of the circumferential connection channel wall structure.

13. The transcatheter atrio-ventricular valve prosthesis according to claim 1, wherein the circumferential support structure and/or the outer device are formed from a shape-memory material.

14. The transcatheter atrio-ventricular valve prosthesis according to claim 1, wherein the outer device further comprises a plurality of staples arranged around a periphery of the inner device, each staple having a base member configured to extend at a radial distance to the inner device at a radial outer side of the inner device to thereby clamp the circumferential connection channel wall structure radially between the base member and the inner device, and each staple having penetration legs for radially penetrating the circumferential connection channel wall structure and engaging the inner device.

15. The transcatheter atrio-ventricular valve prosthesis according to claim 1, wherein the outer device further comprises a plurality of clips arranged around a periphery of the inner device, each clip being of U-shape with a U-base portion and two U-leg portions, wherein an outer leg portion of the U-leg portions is configured to extend along and at a radial distance to the inner device at an outer side thereof, and an inner leg portion of the U-leg portions is configured to extend along and on an inner side of the inner device, wherein the U-leg portions are configured to radially clamp the circumferential connection channel wall structure and the inner device therebetween, wherein the clips may be arranged at an axial end of the circumferential support structure, and wherein the clips may be arranged at the other axial end of the circumferential support structure.

16. The transcatheter atrio-ventricular valve prosthesis according to claim 1, wherein the outer device further comprises a plurality of arms extending around an outer periphery of the inner device at a radial distance thereto, to clamp the circumferential connection channel wall structure radially between the arms and the inner device, each arm, starting from a free end thereof, is configured to extend in parallel and at a radial distance to the inner device to thereby form a corresponding radial gap therebetween for receiving the circumferential connection channel wall structure therein for clamping the circumferential connection channel wall between the respective arm and the inner device, and each arm is configured to extend towards the inner device and is fixedly connected to the inner device, for example at an axial end of the circumferential support structure of the inner device, wherein the arms may be arranged at the other axial end of the circumferential support structure.

17. The transcatheter atrio-ventricular valve prosthesis according to claim 1, wherein the circumferential support structure is a stent.

18. The transcatheter atrio-ventricular valve prosthesis according to claim 17, wherein the stent is a self-expanding stent.

19. The transcatheter atrio-ventricular valve prosthesis according to claim 1, wherein the circumferential groove is pre-formed in the circumferential support structure.

20. The valve prosthesis according to claim 1, wherein the outer device is loosely positionable within the circumferential groove to ensure proper positioning of the valve prosthesis until the inner device is secured to the circumferential connection channel wall structure.

21. The valve prosthesis according to claim 1, wherein the outer device is loosely secured to the inner device.

22. The valve prosthesis according to claim 1, wherein the outer device is configured to at least partly extend around the inner device so that a gap is disposed between the outer device and the inner device and so that the outer device does not overlap the funnel portion of the inner device.

23. The valve prosthesis according to claim 1, wherein an inner diameter of the outer device is greater than an outer diameter of the outer circumferential groove and less than an outer diameter of the inner device.

24. A transcatheter atrio-ventricular valve prosthesis for functional replacement of an atrio-ventricular valve adapted to be disposed in a connection channel, having a circumferential connection channel wall structure, configured to be placed between an atrial chamber and a ventricular chamber of a heart,

the transcatheter atrio-ventricular valve prosthesis comprising:

an inner device configured to be disposed in an interior of the connection channel,

the inner device having a circumferential support structure which is radially expandable, and having a valve attached to the circumferential support structure,

wherein the circumferential support structure of the inner device has a tubular funnel portion, extends along an axis, and has two axial ends, and

an outer device configured to be disposed on an exterior of the connection channel,

wherein the outer device is configured to at least partly extend around the inner device at a radial distance from the inner device and at an axial distance from the tubular funnel portion of the inner device,

wherein;

the inner and outer devices are configured to form a securing mechanism for securing the circumferential connection channel wall structure therebetween,

the outer device is configured to form a ring, for extending circumferentially around the circumferential connection channel wall structure, between and at a distance from the axial ends of the inner device so that a gap is disposed between the outer device and the inner device and so that the outer device does not overlap the tubular funnel portion of the inner device, and

the circumferential support structure of the inner device comprises an outer circumferential groove, and the ring of the outer device is configured to be aligned with the outer circumferential groove.

25. A transcatheter atrio-ventricular valve prosthesis for functional replacement of an atrio-ventricular valve adapted to be disposed in a connection channel, having a circumferential connection channel wall structure, configured to be placed between an atrial chamber and a ventricular chamber of a heart,

the transcatheter atrio-ventricular valve prosthesis comprising:

an inner device configured to be disposed in an interior of the connection channel,

the inner device having a circumferential support structure which is radially expandable, and having a valve attached to the circumferential support structure,

wherein the circumferential support structure of the inner device has a tubular funnel portion, extends along an axis, and has two axial ends, and

an outer device configured to be disposed on an exterior of the connection channel,

wherein the outer device is configured to at least partly extend around the inner device at a radial distance from the inner device and at an axial distance from the tubular funnel portion of the inner device, the radial distance configured so as to have a gap between the outer device and inner device that is substantially equal to or larger than a thickness of the circumferential connection channel wall structure,

wherein;

the inner and outer devices are configured to form a securing mechanism for securing the circumferential connection channel wall structure therebetween,

the outer device is configured to form a ring, for extending circumferentially around the circumferential connection channel wall structure, between and at a distance from the axial ends of the inner device, and

the circumferential support structure of the inner device comprises an outer circumferential groove, and the ring of the outer device is configured to be aligned with the outer circumferential groove.