Cardiac anchoring stent, valve system and a method for deploying same

Abstract

A prosthetic cardiac valve system is disclosed comprising a stent comprising a flexible tubular element having an upstream mesh section, a downstream mesh section, and a radially deformable intermediate section extending therebetween. The upstream mesh section is configured with a plurality of upstream tissue engaging spikes, and / or the downstream mesh section is configured with a plurality of downstream tissue engaging spikes. The upstream tissue engaging spikes and the downstream tissue engaging spikes are made of memory shape material and are configured, at a closed position to be coplanar with an outside surface of the stent, and at an expanded deployed position of the stent, after being introduced in situ and reaching a predefined temperature to deform to their memory shape to project radially outwards from an outside surface of the stent to their radially outwards deformed position, controlled by the inflation of the downstream inflatable tubular element. An upstream elastic sleeve may extend over at least a portion of the upstream mesh section. The upstream elastic sleeve can have an upstream inflatable tubular element disposed axially upstream of the upstream mesh section or downstream of the upstream mech section. A prosthetic cardiac valve can be configured to be secured within the upstream elastic sleeve after the stent is positioned in situ and the upstream inflatable tubular element of the upstream elastic sleeve is inflated. The prosthetic valve leaflets can be integrated as one piece within the prosthetic cardiac valve system.

Description

A prosthetic heart valve system is disclosed, comprising a stent including a flexible tubular element having an upstream grid segment, a downstream grid segment, and a radially deformable intermediate segment extending therebetween. The upstream grid segment is configured with a plurality of upstream tissue-engaging spines, and / or the downstream grid segment is configured with a plurality of downstream tissue-engaging spines. The upstream and downstream tissue-engaging spines are made of a shape-memory material and are configured to be coplanar with the outer surface of the stent in a closed position and, in the expanded position of the stent, deform into their shape after the stent is introduced in situ and reaches a predetermined temperature, protruding radially outward from the outer surface of the stent to their radially outward deformed position, controlled by the expansion of the downstream expandable tubular element. An upstream resilient sleeve may extend over at least a portion of the upstream grid segment. The upstream resilient sleeve may have an upstream expandable tubular element axially disposed upstream of or downstream of the upstream grid segment. Prosthetic heart valves can be configured for in-situ positioning within a stent, with the upstream expandable tubular element of the upstream elastic sleeve expanding and securing within the upstream elastic sleeve. The prosthetic valve leaflets can be integrated as a single unit within the prosthetic heart valve system. Abstract

Claims

CLAIMS:

1. A prosthetic cardiac valve system, comprising: a stent comprising a flexible tubular element having an upstream mesh section, a downstream mesh section, and a radially deformable intermediate section extending therebetween, wherein the upstream mesh section is configured with a plurality of upstream tissue engaging spikes, and / or the downstream mesh section is configured with a plurality of downstream tissue engaging spikes; wherein said upstream tissue engaging spikes and said downstream tissue engaging spikes are made of memory shape material and are configured, at a closed position to be coplanar with an outside surface of the stent, and at an expanded deployed position of the stent, after being introduced in situ and reaching a predefined temperature to deform to their memory shape to project radially outwards from an outside surface of the stent to their radially outwards deformed position; an upstream elastic sleeve extending over at least a portion of said upstream mesh section, said upstream elastic sleeve having an upstream inflatable tubular element disposed axially upstream of said upstream mesh section; and a prosthetic cardiac valve secured within one or more of the mesh sections of said stent, after said stent is positioned in situ and the upstream and downstream inflatable tubular elements of said upstream and downstream elastic sleeves are inflated.

2. The prosthetic cardiac valve system of claim 1, wherein the prosthetic cardiac valve is integrated with the stent.

3. The prosthetic cardiac valve system of claim 1, comprising valve leaflets attached to the upstream elastic sleeve and / or one or more of the mesh sections.

4. The prosthetic cardiac valve system of any one of the preceding claims, wherein the stent is configured for positioning and securing within a cardiac valve cavity, wherein at its deployed, expanded position the upstream inflatable tubular element is configured for bearing over the annulus of a native cardiac valve, to thereby seal and prevent blood flow external to the sleeve.

5. The prosthetic cardiac valve system of any one of the preceding claims, wherein the stent is configurable for positioning and securing within a cardiac valve cavity, and wherein when the stent assumes its expanded shape and bears against the native annulus, the inflated upstream inflatable tubular element bears over the annulus of a native cardiac valve, and functions as a seal to prevent blood flow external to the sleeve.

6. The prosthetic cardiac valve system of claim 5, wherein at the deployed position, when the upstream inflatable tubular element is inflated, it serves as an annular seal disposed radially, surrounding the prosthetic cardiac valve, to restrict blood flow only through said prosthetic cardiac valve.

7. The prosthetic cardiac valve system according to any one of the preceding claims, wherein the upstream mesh section and a downstream mesh section define between them a flow path in direction from the upstream mesh section to the downstream mesh section, in correspondence with normal hemodynamics.

8. The prosthetic cardiac valve system according to any one of the preceding claims, wherein a prosthetic cardiac valve is secured within the upstream mesh section of the stent, said cardiac valve being configured and operable for blood flow administration along the flow path, in direction from the upstream mesh section to the downstream mesh section in direction corresponding with normal hemodynamics.

9. The prosthetic cardiac valve system according to any one of the preceding claims, wherein the stent further comprises a downstream elastic sleeve extending over at least a portion of an inside face of the intermediate mesh section, said downstream elastic sleeve having a downstream inflatable tubular element axially and radially disposed in overlap over at least an inside portion of the intermediate mesh section and the portion of the downstream mesh section.

10. The prosthetic cardiac valve system of claim 9, wherein the upstream elastic sleeve and the downstream elastic sleeve are a homogeneous sleeve or independent sleeves.

11. The prosthetic cardiac valve system of claim 9 or 10, wherein each of the upstream elastic sleeve and the downstream elastic sleeve are secured to either an inside face of stent, or to an outside face thereof.

12. The prosthetic cardiac valve system of any one of claims 9 to 11, wherein the sleeve member is a continuous sleeve member comprising an intermediate portion extending between the upstream elastic sleeve and the downstream elastic sleeve.

13. The prosthetic cardiac valve system according to any one of the preceding claims, wherein the inflatable tubular element is configured with an inflating mechanism for inflating and pressure regulating of the volume and pressure within the inflatable tubular element.

14. The prosthetic cardiac valve system according to any one of the preceding claims, wherein the inflatable tubular element is associated with an inflation / deflation port.

15. The prosthetic cardiac valve system according to any one of the preceding claims, wherein the inflatable tubular element is disposed within an annular pouch of the sleeve.

16. The prosthetic cardiac valve system according to any one of the preceding claims, wherein the inflatable tubular element is inflatable with a fluid comprising a puncture sealing agent.

17. The prosthetic cardiac valve system according to any one of claims 9 to 16, wherein the upstream inflatable tubular element and the downstream inflatable tubular element are received within an enveloping portion of the upstream elastic sleeve and a downstream elastic sleeve, respectively.

18. The prosthetic cardiac valve system according to any one of claims 9 to 17, wherein the upstream inflatable tubular element and the downstream inflatable tubular element are configured as an annular pocket of the sleeve, accommodating an inflatable supra and sub-annular balloon.

19. The prosthetic cardiac valve system according to any one of the preceding claims, wherein the upstream tissue engaging spikes face towards a downstream side of the stent and the downstream tissue engaging spikes face towards an upstream side of the stent.

20. The prosthetic cardiac valve system according to any one of the preceding claims, wherein the intermediate mesh section is configured and operable as an undulating section, axially extending between the upstream mesh section and the downstream mesh section.

21. The prosthetic cardiac valve system according to any one of the preceding claims, wherein the intermediate mesh section integrally extends with the upstream mesh section and the downstream mesh section.

22. The prosthetic cardiac valve system according to any one of the preceding claims, having one of the following configurations: the upstream mesh section extends in proximity below the upstream inflatable tubular element; the upstream mesh section extends in proximity above the upstream inflatable tubular element.

23. The prosthetic cardiac valve system according to any one of claims 9 to 22, wherein the downstream inflatable tubular element extends opposite at least a portion of the intermediate mesh section and a portion of the downstream mesh section.

24. The prosthetic cardiac valve system according to any one of the preceding claims, wherein the projecting downstream spikes have a pointed end facing an upstream end of the stent.

25. The prosthetic cardiac valve system according to any one of the preceding claims, wherein the stent and the elastic sleeve and the prosthetic cardiac valve are configured and operable as drug-eluting.

26. The prosthetic cardiac valve system according to any one of the preceding claims, wherein a nominal diameter of the stent of the prosthetic valve, at its deployed position, is greater than a nominal diameter of the stent at its deployed position, hence once deployed, the prosthetic valve is engageable within the elastic sleeve.

27. The prosthetic cardiac valve system according to any one of the preceding claims, wherein the prosthetic cardiac valve is secured to the upstream elastic sleeve.

28. The prosthetic cardiac valve system according to any one of the preceding claims, wherein the prosthetic cardiac valve is secured at an inside face of the elastic sleeve.

29. The prosthetic cardiac valve system according to any one of the preceding claims, further comprising an inflating mechanism for inflating one or both of an upstream inflatable tubular element and a downstream inflatable tubular element.

30. The prosthetic cardiac valve system according to any one of the preceding claims, further comprising a detachable inflation tube detachably articulated with each of the upstream inflatable tubular element and the downstream inflatable tubular element.

31. A support structure for supporting a prosthetic cardiac valve, wherein said support structure comprising a flexible tubular stent having an upstream mesh section and a downstream mesh section, with a radially deformable intermediate mesh section extending therebetween, and wherein the upstream mesh section is configured with a plurality of upstream tissue engaging spikes and / or the downstream mesh section is configured with a plurality of downstream tissue engaging spikes; wherein at an expanded position of the stent, said upstream tissue engaging spikes and said downstream tissue engaging spikes project radially outwards from an outside surface of the stent; and an upstream elastic sleeve extending over at least a portion of an inside / outside face of said upstream mesh section; said upstream elastic sleeve having an upstream inflatable tubular element disposed axially and radially upstream of said upstream mesh section.

32. The support structure of claim 31, being configured and operable between a constricted, deploying position at which it is at a closed position, and an expanded, openposition at which it assumes a radially expanded position, and wherein at the closed position the upstream tissue engaging spikes and the downstream tissue engaging spikes are coplanar with an outside surface of the stent.

33. The support structure of claim 31 or 32, being configured and operable for use as a cardiac valve support for any one of the following: mitral valve, aortic valve, tricuspid valve and pulmonary valve.

34. The support structure of any one of claims 31 to 33, for use in conjunction with a prosthetic cardiac valve system, wherein the support structure is a valve support for a prosthetic valve in the mitral position, and wherein the upstream inflatable tubular element is configurable for supra-annular positioning and inflating within the left atrium.

35. The support structure of any one of claims 31 to 34, for use in conjunction with a prosthetic cardiac valve system, wherein the support structure is a valve support for a prosthetic aortic valve, and wherein the upstream inflatable tubular element is configurable for sub-annular positioning and inflation.

36. The support structure of any one of claims 31 to 35, for use in conjunction with a prosthetic cardiac valve system, wherein the support structure is a valve support for a prosthetic tricuspid valve, wherein the upstream inflatable tubular element is configured and operable for supra-annular positioning and inflating within the right atrium.

37. The support structure of any one of claims 31 to 36, for use in conjunction with a prosthetic cardiac valve system, wherein the support structure is a valve support for a prosthetic pulmonary valve, wherein the upstream inflatable tubular element is configurable for sub-annular positioning and inflating within the right ventricle.

38. The support structure of any one of claims 31 to 37, further comprising a temporary valve positioned between the upstream and downstream mesh section at a non- deformable section of the support structure thereof, for temporarily regulating blood flow, in the direction corresponding with the normal hemodynamics, during a procedure of positioning and deploying the support structure, whereby upon positioning and deploying the prosthetic valve within the support structure, said temporary valve is over-ridden by the prosthetic valve.

39. A stent member for supporting a prosthetic cardiac valve, the stent member being a flexible tubular element having an upstream mesh section, a downstream mesh section and a radially deformable intermediate section extending therebetween, wherein the upstream mesh section is configured with a plurality of upstream tissue engaging spikes,and / or the downstream mesh section is configured with a plurality of downstream tissue engaging spikes, wherein said upstream tissue engaging spikes and said downstream tissue engaging spikes are made of memory shape material and are configured, at a closed position to be coplanar with an outside surface of the stent, and at an expanded deployed position of the stent, after being introduced in situ and reaching a predefined temperature to deform to their memory shape to project radially outwards from an outside surface of the stent to their radially outwards deformed position.

40. The stent member according to claim 39, wherein at its deployed, expanded position, the stent assumes a frustoconical shape wherein a narrow portion thereof is the upstream section of the stent.

41. The stent member according to claim 39 or 40, wherein the projecting spikes can be equally distributed about a perimeter of the stent.

42. The stent member according to any one of claims 39 to 40, wherein the projecting spikes have a triangle / teardrop or elongated loop shape.

43. The stent member according to any one of claims 39 to 42, wherein at an initial, unstressed position, the stent is cylindric.

44. A support structure for supporting a prosthetic mitral valve, said support structure having an elastic sleeve member comprising an inflatable supra annular member and an inflatable sub annular member defining therebetween a flow space; and a flexible tubular mesh structure articulated at an inside face of the sleeve, the mesh structure having an atrial section and a ventricular portion, with a radially deformable section extending therebetween, and wherein the atrial portion is configured with a plurality of annular / supra annular tissue engaging spikes and / or the ventricular portion is configured with a plurality of annular / sub annular tissue engaging spikes, whereby inflating the supranuclear portion entails radial deformation of the of annular / supra annular tissue engaging spikes, and inflating the sub annular portion entails radially outwards deformation of the deformable section and the sub annular portion, and radial deformation of the annular / sub annular tissue engaging spikes, wherein a prosthetic mitral valve is secured within the elastic sleeve thereof.

45. A prosthetic cardiac valve kit comprising: a support structure comprising a flexible tubular stent having an upstream mesh section and a downstream mesh section, with a radially deformable intermediate mesh section extending therebetween, and wherein the upstream mesh section is configuredwith a plurality of upstream tissue engaging spikes and / or the downstream mesh section is configured with a plurality of downstream tissue engaging spikes; wherein at an expanded position of the stent said upstream tissue engaging spikes and said downstream tissue engaging spikes project radially outwards from an outside surface of the stent; an upstream elastic sleeve extending over at least a portion of an inside / outside face of said upstream mesh section; said upstream elastic sleeve having an upstream inflatable tubular element disposed axially and radially upstream of said upstream mesh section; a prosthetic cardiac valve secured within the upstream elastic sleeve and downstream of the upstream inflatable tubular element.

46. The prosthetic cardiac valve kit of claim 45, further comprising an inflating mechanism for inflating one or both of an upstream inflatable tubular element and a downstream inflatable tubular element.

47. The prosthetic cardiac valve kit of claim 45 or 46, further comprising a detachable inflation tube detachably articulated with each of the upstream inflatable tubular element and the downstream inflatable tubular element.

48. A method of deploying a prosthetic cardiac valve support system, or a fully functional prosthetic cardiac valve, the method comprising the following steps:A. introducing a guide wire with a distal capsule containing the prosthetic cardiac valve system, or the fully functional prosthetic cardiac valve, at a compressed position, visualized under imaging;B. exposing the downstream inflatable element with the downstream mesh section of the stent at the sub annular level of the native valve, distal to the native leaflets coaptation line;C . inflating the downstream inflatable element, while an upstream inflatable element is still crimped in the capsule;D. retrieving the capsule towards the upstream portion of the valve, allowing the downstream spikes to engage downstream of the native valve;E. unsheathing the upstream inflatable element under imaging;F. inflating the upstream inflatable element;G. withdrawing the capsule.

49. The method of claim 48 further comprising: introducing and guiding a compressed prosthetic valve over the guide wire;positioning the prosthetic valve within the inflated prosthetic cardiac valve system, between the upstream inflatable element and the downstream inflatable element; deploying the prosthetic valve.

50. A method of deploying a prosthetic cardiac valve support system, or a prosthetic cardiac valve system, the method comprising the following steps: introducing over a guide wire a distal capsule containing the prosthetic cardiac valve system at a compressed position; splitting a proximal portion of the capsule for exposing an upstream inflatable element above native leaflets of a native valve while maintaining downstream portions and a stent of the prosthetic cardiac valve in a portion of said distal capsule distal to said upstream inflatable element; inflating the upstream inflatable element; distally advancing the inflated upstream inflatable element and said portion of the capsule to place said inflated upstream inflatable element over an annulus of said native valve and introducing said portion of the capsule below the native leaflets of said native valve; distally advancing said portion of the capsule for unsheathing said downstream portions of the prosthetic cardiac valve under imaging; inflating the downstream inflatable element for anchoring said stent inside said native valves by upstream and / or downstream tissue engaging spikes of said stent; withdrawing the capsule.

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