TRANSCATHETER VALVE PROSTHESIS

• US 20140214157A1
• Filed: 06/13/2012
• Published: 07/31/2014
• 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 9,662,206 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• 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 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2002/8483 Barbs
• 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 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
• CPC Class Codes: A61F 2250/0069 Sealing means

Abstract

A transcatheter atrio-ventricular valve prosthesis for functional replacement of an atrio-ventricular heart valve in a connection channel, the prosthesis comprising a radially expandable tubular body extending along an axis, and a valve arranged within and attached to the tubular body. The tubular body is provided with an outer circumferential groove which is open to the radial outside of the tubular body, whereby the tubular body is separated by the outer circumferential groove into first and second body sections. The tubular body is provided with a first plurality of projections which extend from the first or second body section in an axial direction of the tubular body and each of which has a free end arranged to overlap the outer circumferential groove. An elongate outer member may be disposed at the exterior of the connection channel wall structure at a level of the circumferential groove.

Claims

1. A transcatheter atrio-ventricular valve prosthesis for functional replacement of an atrio-ventricular heart valve in a connection channel, having a circumferential connection channel wall structure, between the atrial chamber and the ventricular chamber of a heart, comprising:

a radially expandable tubular body configured to be disposed in the interior of the connection channel and extending along an axis, and

a valve arranged within and attached to the tubular body, wherein the tubular body is provided with an outer circumferential groove which is open to the radial outside of the tubular body and which defines a groove bottom, whereby the tubular body is separated by the outer circumferential groove into first and second body sections, and wherein

the tubular body is provided with a first plurality of projections which extend from the first or second body section in an axial direction of the tubular body and each of which has a free end arranged to overlap the outer circumferential groove,

further comprising an elongate outer member to be disposed at the exterior of the connection channel wall structure at a level of the circumferential grove, wherein the elongate outer member is configured to at least partially extend around the tubular body with valve tissue of the connection channel wall structure being correspondingly circumferentially arranged between the tubular body and the outer member and in such a radial distance to the axis of the tubular body that the valve tissue of the connection channel wall structure can be radially forced into the outer circumferential groove so as to be at least partially located radially below the projections.

2. The transcatheter atrio-ventricular valve prosthesis according to claim 1, wherein the first body section is adapted to be arranged on a side of the atrial chamber in the connection channel and the second body section is adapted to be arranged on a side of the ventricular chamber in the connection channel, and wherein the first plurality of projections extends from the second body section.

3. The transcatheter atrio-ventricular valve prosthesis according to claim 1, wherein the elongate outer member comprises a tubular structure having a central longitudinal axis so as to extend in the circumferential groove in a circumferential direction of the tubular body, wherein the elongate outer member has a cross-sectional diameter transverse to its central longitudinal axis and wherein the cross-sectional diameter is either larger than 2 mm or smaller than 15 mm.

4. The atrio-ventricular valve prosthesis according to claim 1, wherein the elongate outer member comprises an inflatable member which is adapted to be inflated by a substance so as to expand the elongate outer member.

5. The transcatheter atrio-ventricular valve prosthesis according to claim 1, wherein the elongate outer member is configured to be expandable and/or compressible in a radial direction of its cross-sectional diameter.

6. The atrioventricular valve prosthesis according to claim 4, wherein the substance is a curable substance that is adapted to be cured in the inflatable member so as to give the elongate outer member rigidity.

7. The atrio-ventricular valve prosthesis according to claim 1, wherein the elongate outer member extends partially around the tubular body at least 180°

, and has spaced and non-abutting free ends.

8. The atrio-ventricular valve prosthesis according to claim 1, wherein the elongate outer member is made from a mesh-type structure.

9. The transcatheter atrio-ventricular valve prosthesis according to claim 1, wherein the tubular body comprises a mesh-type body having elongate mesh elements crossing each other at crossings, wherein the plurality of projections is formed monolithically integrally with the tubular body.

10. The transcatheter atrio-ventricular valve prosthesis according to claim 1, wherein a diameter of the first body section in a radial direction of the axis is larger than any diameter of the second body section in a radial direction of the axis.

11. The transcatheter atrio-ventricular valve prosthesis according to claim 1, wherein

the tubular body is provided with a first and a second plurality of projections which extend from the first and the second body sections, respectively, in opposite axial directions of the tubular body and each of which has a free end arranged to overlap the outer circumferential groove.

12. The transcatheter atrio-ventricular valve prosthesis according to claim 11, wherein at least one of the first and the second plurality of projections is provided in a rectilinear shape.

13. The transcatheter atrio-ventricular valve prosthesis according to claim 11, wherein the first and the plurality of projections extend from the first and the second body sections, respectively, at a radial distance to the groove bottom so as to define a hollow chamber between the projections and the groove bottom.

14. The transcatheter atrio-ventricular valve prosthesis according to claim 11, wherein the first and the second plurality of projections extend from the first and the second body sections, respectively, at an area adjacent to the radial outer circumference of the outer circumferential groove.

15. The transcatheter atrio-ventricular valve prosthesis according to claim 11, wherein the first and the second pluralities of projections extend at an angle (β

) to the axis of the tubular body radially inwardly into the outer circumferential groove, wherein the angle (β

) may be equal to or smaller than 45°

.

16. The transcatheter atrio-ventricular valve prosthesis according to claim 11, wherein the first and the second pluralities of projections substantially extend in planes including the axis of the tubular body.

17. The transcatheter atrio-ventricular valve prosthesis according to claim 11, wherein the free ends of the first and the second pluralities of projections are either acute or sharpened ends.

18. The transcatheter atrio-ventricular valve prosthesis according to claim 11, wherein the free ends of the first and the second pluralities of projections are provided with barbs or hooks.

19. The transcatheter atrio-ventricular valve prosthesis according to claim 11, wherein the tubular body is a mesh type body having elongated mesh elements crossing each other at crossings, and wherein the first and the second pluralities of projections extend from crossings adjacent to the outer circumferential groove.

20. The transcatheter atrio-ventricular valve prosthesis according to claim 1, wherein, when seen in an axial section along the tubular body, the direction of a curvature or bend in the axial profile between the groove and the first body section and/or between the groove (45) and the second body section changes from a concave curvature of the groove to a convex curvature at the transition between the groove and first and or second body section.

21. The transcatheter atrio-ventricular valve prosthesis according to claim 1, wherein the elongate outer member comprises one or more clamping members, where each clamping member comprises a tubular clamping member body which extends along an axis in a circumferential direction of the tubular member and which is radially expandable with respect to the axis of the clamping member so as to force the tissue of the circumferential connection channel wall structure inwardly in radial direction of the tubular body into the outer circumferential groove.

22. The transcatheter atrio-ventricular valve prosthesis according to claim 11, further comprising one or more clamping members configured to be disposed within the circumferential groove radially below the first and/or the second plurality of projections with valve tissue of the connection channel wall structure between the first and/or second plurality of projections and the respective clamping member, wherein the respective clamping member applies a radial clamping force against the groove bottom and the valve tissue, so as to radially force the valve tissue towards the groove bottom.

23. The transcatheter atrio-ventricular valve prosthesis according to claim 1, wherein the transcatheter atrio-ventricular valve prosthesis is a sub-annularly anchoring prosthesis adapted to be implanted with the circumferential groove being located on a side of a ventricular chamber of a valve annulus of the heart valve and the circumferential groove having a distance to the valve annulus.

24. The transcatheter atrio-ventricular valve prosthesis according to claim 1, wherein the elongate outer member comprises an angularly shaped cross section with a first angular leg, extending with respect to the axis generally radially into the circumferential groove, and a second angular leg extending generally parallel to the axis of the tubular body on an outside of the tubular body so as to be disposed between the second body section of the tubular body and a ventricular chamber wall of the heart.

25. Method for implanting a transcatheter atrio-ventricular valve prosthesis comprising:

a tubular body having a longitudinal axis, a circumferential groove and a plurality of projections each having a free end arranged so as to partially overlap the groove, and an elongate outer member, the method comprising the steps of;

positioning the tubular body inside a connection channel between an atrial and a ventricular chamber of a heart,

positioning the elongate outer member on an outside of the connection channel at an axial level of the circumferential groove, and fixating the prosthesis relative to the heart by reducing a distance between the elongate outer member and the tubular body so that tissue of the connection channel is inserted into the groove so as to at least partially be radially inside of the projections with respect to axis.

26. Method for implanting a transcatheter atrio-ventricular valve prosthesis according to claim 25, further comprising positioning the tubular body such that the groove is positioned adjacent to the annulus of a native mitral valve towards the ventricular chamber, so that when the elongate outer member is inserted into the groove, a sub-annular prosthesis anchoring is achieved by the engagement of the elongate outer member in the groove.

27. The method according to claim 25, wherein the step of positioning the tubular body comprises entering the heart cavity using an arterial retrograde approach and/or using a venous access and a puncture through the inter-atrial septum and/or using a trans-apical approach by puncturing through the apex of the heart and or puncturing an atrial wall from an outside of the heart and or using an femoral-arterial access through a puncture in the groin.

28. The method according to claim 25, wherein the elongate outer member comprises a cross-sectional diameter and wherein the step of fixating the prosthesis comprises changing the cross-sectional diameter of the elongate outer member so as to reduce the radial distance between the elongate outer member and the tubular body.

29. The method according to claim 28, wherein the elongate outer member comprises an inflatable member and wherein changing the cross-sectional diameter of the elongate outer member comprises inflating the inflatable member.

30. The method according to claim 29, wherein inflating is achieved by infilling a curable substance into the inflatable member, and wherein the curable substance is cured in an inflated condition of the inflatable member.

31. The method according to claim 25, wherein the prosthesis comprises a plurality of projections, and wherein the step of fixating the prosthesis comprises (i) placing the elongate outer member at least partially radially inwards of the projections with respect to axis, and (ii) comprises piercing the elongate outer member with the plurality of projections, so that the elongate outer member is held by the plurality of projections.

32. 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

an elongate outer member configured to form a loop encircling the preformed groove, wherein

the outflow end of the tubular body includes a funnel shape that tapers inward toward a center of the tubular body such that a diameter of the outflow end is less than a maximum diameter of the tubular body when the tubular body is fully deployed within the patient.

33. The system according to claim 32, further including a trapping member configured to be moved into the preformed groove to form at least a partial loop around the tubular body.

34. 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 portions of native valve leaflets and/or chordae 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 deployed, the outflow end of the tubular body includes a funnel shape that tapers inward toward an axis of the tubular body and a diameter of the outflow end is less than a maximum diameter of the tubular body; and

moving the loop into the preformed groove through the opening.

35. The method according to claim 34, further including trapping the portions of the native valve leaflets and/or chordae within the preformed groove with a trapping member.

36. The method according to claim 34, wherein at least one of the inflow end and the outflow end has a non-circular cross-section.

37. The method according to claim 36, wherein the at least one of the inflow end and the outflow end has an oval-shaped or a D-shaped cross-section.

38. The method according to claim 37, wherein the cross-section has a major axis and a minor axis, and the minor axis is arranged in the septo-lateral direction.

39. The method according to claim 34, wherein the portions of native valve leaflets and/or chordae form a portion of a mitral valve or a tricuspid valve.

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

a radially self-expandable tubular body having an inflow end, an outflow end, and a preformed groove (a) disposed in outer surface of the tubular body between the inflow end and the outflow end, (b) extending at least partially around the tubular body, and (c) having a circumferential opening facially 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 around the preformed groove when the tubular body is fully expanded, wherein

the inflow end of the tubular body is self-expandable to a shape that constrains movement of the tubular body in an outflow direction by contact in a flow direction between the inflow end of the tubular body and an annulus of a native heart valve when the tubular body is deployed within a heart and aligned with the native heart valve, and

the trapping member is configured to extend around portions of chordae and/or leaflets of the native heart valve within the groove when the tubular body is deployed within the patient and aligned with the native heart valve, and constrain movement of the tubular body in a direction opposite the flow direction.

41. The system according to claim 40, wherein the tubular body is a stent.

42. The system according to claim 40, wherein the trapping member includes a partial loop.

43. The system according to claim 40, wherein the trapping member includes a closed loop.

44. The system according to claim 40, wherein the trapping member and the tubular body are configured to leave a radial gap between (a) at least one of the trapping member and the tubular body and (b) chordae or valve leaflets, when the trapping member is deployed around portions of chordae and leaflets of the native valve within the groove and the tubular body is fully expanded.

45. The system according to claim 40, wherein the trapping member is not configured to apply a radial force inward when deployed.

46. The system according to claim 40, further comprising a projection having a first end located at a side surface of the tubular body and a second free end, the groove defined between the projection and the side surface of the tubular body.

47. The system according to claim 40, wherein an outer diameter of the inflow end is greater than an outer diameter of the outflow end.

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

deploying at least a partial loop around portions of chordae and/or leaflets of a native heart valve at a downstream portion of the native heart valve such that movement of the loop in an upstream direction relative to an annulus of the native heart valve is limited by the portions of chordae and/or leaflets;

deploying a radially self-expandable tubular body, having (a) a valve disposed within a lumen of the tubular body and (b) a preformed groove located at an outer surface of the tubular body between an inflow end and an outflow end of the tubular body and having a circumferential opening facing radially outward of the tubular body, within the at least partial loop such that the at least partial loop and portions of the chordae and/or leaflets are located at least partially within the groove and movement of the tubular body relative to the at least partial loop in an upstream direction is limited; and

allowing an inflow end portion of the tubular body to expand beyond the annulus of the native heart valve upstream of the native heart valve so that downstream movement of the tubular body through the native heart valve is limited.

49. The method according to claim 48, wherein the native heart valve is a mitral valve, and expansion of the inflow end portion of the tubular body prevents the tubular body from moving out of alignment with the native heart valve and toward the patient'"'"'s ventricle apex.

50. The method according to claim 49, wherein interaction between the at least the partial loop, the groove, and the chordae and/or leaflets prevents the tubular body from moving out of alignment with the native heart valve and toward the patient'"'"'s atrium.

51. The method according to claim 48, wherein the at least partial loop is formed by passing an elongate outer member around the chordae and/or leaflets, and moving a trapping member along the elongate outer member to form the at least partial loop.

52. The method according to claim 48, wherein the at least partial loop is formed around portions of both the chordae and the leaflets.

53. The method according to claim 48, further comprising leaving a radial gap between the at least partial loop and the tubular body.

54. The method according to claim 48, wherein the loop is a closed loop.