INJECTABLE HEART VALVE PROSTHESIS FOR LOW-INVASIVE IMPLANTATION

• US 20090248149A1
• Filed: 06/11/2009
• Published: 10/01/2009
• Est. Priority Date: 09/12/2000
• Status: Abandoned Application

• Current Assignee: Shlomo Gabbay
• Original Assignee: Shlomo Gabbay
• Inventors: GABBAY, SHLOMO
• Application Number:
  US12/482,781
• Publication Number:
  US 20090248149A1
• Time in Patent Office: Days
• US Class Current: 623/2.370
• 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 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• CPC Class Codes: G01N 2800/52 Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis
• CPC Class Codes: Y10S 623/904 Heart

Abstract

A heart valve prosthesis may include a cylindrical support extending between axially spaced apart ends thereof, the cylindrical support including a plurality of support features extend generally axially between the opposed ends of the support, adjacent pairs of the support features being interconnected so as to bias the cylindrical support radially outwardly. A valve is mounted within the support to define a supported valve. The supported valve can include a sidewall portion extending between inflow and outflow ends thereof, the inflow and outflow ends of the valve sidewall portion being mounted within the cylindrical support such that ends of the sidewall portion are spaced axially apart from the spaced apart ends of the cylindrical support. The supported valve can also include a valve portion residing within the sidewall portion and configured to provide for substantially unidirectional flow of blood through the supported valve, the supported valve being deformable between a reduced cross-sectional condition and an expanded cross-sectional condition, whereby implantation of the supported valve is facilitated when in the reduced cross-sectional condition.

Claims

1. A heart valve prosthesis comprising:

a cylindrical support extending between axially spaced apart ends thereof, the cylindrical support including a plurality of support features extend generally axially between the axially spaced apart ends of the cylindrical support, adjacent pairs of the support features being interconnected so as to bias the cylindrical support radially outwardly; and

a valve mounted within the cylindrical support to define a supported valve, the supported valve comprising;

a sidewall portion extending between inflow and outflow ends thereof, the inflow and outflow ends of the valve sidewall portion being mounted within the cylindrical support such that ends of the sidewall portion are spaced axially apart from the spaced apart ends of the cylindrical support; and

a valve portion residing within the sidewall portion and configured to provide for substantially unidirectional flow of blood through the supported valve, the supported valve being deformable between a reduced cross-sectional condition and an expanded cross-sectional condition, whereby implantation of the supported valve is facilitated when in the reduced cross-sectional condition.

2. The prosthesis of claim 1, further comprising biasing elements that interconnect each adjacent pair of the support features, each biasing element urging support features that are interconnected by respective biasing element apart from each other as to bias the cylindrical support radially outwardly.

3. The prosthesis of claim 2, the biasing elements further comprising springs arranged in a generally circular array at the axially spaced apart ends of the cylindrical support, the springs interconnecting adjacent support features to bias the cylindrical support radially outwardly.

4. The prosthesis of claim 3, the support features and the springs being formed of a continuous length of a resilient material to provide a cage-like support.

5. The prosthesis of claim 3, further comprising projections biased to extend radially outwardly from at least one of the axially spaced apart ends of the cylindrical support.

6. The prosthesis of claim 5, the projections further comprising a plurality of triangular projections interconnected at the axially spaced apart ends of the cylindrical support at the biasing elements, each of the triangular projections being configured to extend axially and radially outwardly from the respective opposed ends beyond a radially outer extent of the cylindrical support.

7. The prosthesis of claim 1, further comprising a flexible connecting element attached to the cylindrical support to inhibit radial outward expansion of at least part of the cylindrical support beyond a predetermined amount.

8. The prosthesis of claim 1, the cylindrical support further comprising at least two generally cylindrical support portions having adjacent ends connected substantially coaxially together, the axially spaced apart ends of the cylindrical support define axially opposed inflow and outflow ends of the cylindrical support, the valve including an inflow end and an outflow end spaced apart from each other on axially opposed sides of a juncture between the at least two support portions.

9. The prosthesis of claim 8, further comprising an intermediate connecting element that connects the support portions at the juncture between the at least two support portions.

10. The prosthesis of claim 8, further comprising a plurality of biasing elements that interconnect adjacent support features in each of the support portions, the biasing elements urging the interconnected support features apart from each other to provide radial outward expansion of the respective at least two sidewall portions.

11. The prosthesis of claim 10, the biasing elements being connected by flexible connecting elements in a generally circular arrangement at the axially spaced apart ends of each respective support portion, the connecting elements inhibiting radial expansion of the cylindrical support at the respective ends of the support portions beyond a predetermined amount.

12. The prosthesis of claim 8, further comprising projections extending axially and radially outwardly from the axially opposed inflow and outflow ends of the cylindrical support.

13. The prosthesis of claim 12, the projections further comprising triangular-shaped projections connected at each of the axially opposed inflow and outflow ends of the cylindrical support in a circular arrangement and configured to extend axially and radially outwardly from the respective axially opposed inflow and outflow ends of the cylindrical support.

14. The prosthesis of claim 1, further comprising an outer sheath of a substantially biocompatible material that covers at least a substantial portion of an exposed part of the cylindrical support.

15. The prosthesis of claim 1, wherein the valve portion has an axial length defined by a distance between the spaced apart ends of the valve portion, the axial length of the valve portion being less than the axial length of the cylindrical support and the valve portion is connected to remain near a central axial position of the cylindrical support such that the ends of the valve portion are spaced axially apart from respective ends of the cylindrical support.

16. The prosthesis of claim 15, wherein, in the expanded cross-sectional condition, a cross-sectional dimension of the cylindrical support at an axial position between an outflow end of the valve and an outflow end of the cylindrical support is less than a cross-sectional dimension of the cylindrical support and the valve portion at an axial position where the valve portion resides.

17. The prosthesis of claim 16, wherein, in the expanded cross-sectional condition, a cross-sectional dimension of the cylindrical support at an axial position between an inflow end of the valve portion and an inflow end of the cylindrical support is less than a cross-sectional dimension of both the cylindrical support and the valve portion at an axial position where the valve portion resides.

18. The prosthesis of claim 1 in combination with an implanter, the combination comprising:

the implanter comprising;

a body portion; and

an elongated cylindrical member extending from the body portion to terminate in a distal end thereof that is spaced apart from the body portion, the distal end having an opening to a passage that extends through at least a portion of the cylindrical member, at least a distal end portion of the cylindrical member proximal the distal end thereof being flexible to permit flexing or bending of the distal end portion; and

the prosthesis being mounted within the cylindrical member in the reduced cross-sectional condition.

19. A heart valve prosthesis comprising:

a cylindrical support extending between axially spaced apart inflow and outflow ends thereof, the cylindrical support including a plurality of support features extend generally axially between the axially spaced apart inflow and outflow ends of the cylindrical support, adjacent pairs of the support features being interconnected so as to bias the cylindrical support radially outwardly; and

a valve mounted within the cylindrical support to define a supported valve, the supported valve being configured to provide for substantially unidirectional flow of blood through the supported valve, the valve having inflow and outflow ends that are spaced axially apart from the respective inflow and outflow ends of the cylindrical support, the supported valve being deformable between a reduced cross-sectional condition and an expanded cross-sectional condition,

wherein, in the expanded cross-sectional condition, a cross-sectional dimension of the cylindrical support at an axial position between an outflow end of the valve and an outflow end of the cylindrical support is less than a cross-sectional dimension of the cylindrical support and the valve at an axial position where the valve resides. 20. The prosthesis of claim 19 in combination with an implanter, the combination comprising;

the implanter comprising;

a body portion; and

an elongated cylindrical member extending from the body portion to terminate in a distal end thereof that is spaced apart from the body portion, the distal end having an opening to a passage that extends through at least a portion of the cylindrical member, at least a distal end portion of the cylindrical member proximal the distal end thereof being flexible to permit flexing or bending of the distal end portion; and

the prosthesis being mounted within the cylindrical member in the reduced cross-sectional condition.