APPARATUS AND METHOD FOR REPLACING A DISEASED CARDIAC VALVE

• US 20110178597A9
• Filed: 07/01/2010
• Published: 07/21/2011
• Est. Priority Date: 02/18/2006
• Status: Active Grant

• Current Assignee: Cleveland Clinic Foundation
• Original Assignee: Cleveland Clinic Foundation
• Inventors: Navia, Jose L., Gao, Shengqiang, Davis, Brian L., Stucke, Samantha, Chen, Ji-Feng
• Granted Patent: US 8,685,086 B2
• Time in Patent Office: Days
• US Class Current: 623/2.18
• CPC Class Codes: A61F 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• 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 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped

Abstract

An apparatus for replacing a diseased cardiac valve is movable from a radially collapsed configuration to a radially expanded configuration. The apparatus comprises an expandable support member and a prosthetic valve secured therein. The main body portion extends between first and second end portions and includes an outer circumferential surface, a circumferential axis extending about the circumferential surface, and a plurality of wing members spaced apart from one another by an expandable region. Each of the wing members includes first and second end portions and a flexible middle portion extending between the end portions. The second end portion is integrally formed with the main body portion. The first end portion is adjacent the circumferential axis and substantially flush with the outer circumferential surface in the radially collapsed configuration. The first end portion extends substantially radial to the outer circumferential surface in the radially expanded configuration.

Claims

1. An apparatus for replacing a diseased cardiac valve, said apparatus being movable from a radially collapsed configuration to a radially expanded configuration, said apparatus comprising:

an expandable support member having a first end portion, a second end portion, and a main body portion extending between said first and second end portions, said main body portion including an outer circumferential surface and a circumferential axis extending about said outer circumferential surface; and

a prosthetic valve secured within said main body portion of said expandable support member;

said main body portion including a plurality of wing members spaced apart from one another by an expandable region, each of said wing members including a first end portion, a second end portion, and a flexible middle portion extending between said first and second end portions, said second end portion of each of said wing members being integrally formed with said main body portion;

said first end portion of each of said wing members being adjacent said circumferential axis and substantially flush with said outer circumferential surface when said apparatus is in the radially collapsed configuration;

said first end portion of each of said wing members extending substantially radial to said outer circumferential surface when said apparatus is in the radially expanded configuration.

2. The apparatus of claim 1, wherein said expandable support member has a saddle-shaped, three-dimensional (3D) configuration to mimic the shape of the diseased cardiac valve.

3. The apparatus of claim 1, wherein a first plurality of said wing members is circumferentially spaced around a lower portion of said expandable support member, and a second plurality of said wing members is circumferentially spaced around an upper portion of said expandable support member.

4. The apparatus of claim 3, wherein said first and second pluralities of said wing members are symmetrically aligned with one another with respect to said circumferential axis.

5. The apparatus of claim 3, wherein said first and second pluralities of said wing members are asymmetrically aligned with one another with respect to said circumferential axis.

6. The apparatus of claim 3, wherein each of said first plurality of said wing members has a size less than the size of each of said second plurality of said wing members.

7. The apparatus of claim 1, wherein said prosthetic valve is stentless.

8. The apparatus of claim 1, wherein said expandable support member is balloon-expandable.

9. The apparatus of claim 1, wherein said expandable support member is self-expandable.

10. The apparatus of claim 1, wherein said expandable region further includes at least one reinforcing strut member.

11. The apparatus of claim 1, wherein said expandable region obtains a trapezoidal configuration when said apparatus is in the radially expanded configuration.

12. The apparatus of claim 1, wherein said prosthetic valve comprises a substantially dehydrated bioprosthetic valve.

13. The apparatus of claim 1, wherein said prosthetic valve comprises a bioprosthetic valve.

14. The apparatus of claim 1, wherein said main body portion further includes at least one expandable ring securely disposed about said outer circumferential surface.

15. A method for replacing a diseased cardiac valve, said method comprising the steps of:

providing an apparatus, the apparatus comprising an expandable support member and a prosthetic valve secured within a main body portion of the expandable support member, the main body portion including an outer circumferential surface, a circumferential axis extending about the circumferential surface, and a plurality of wing members spaced apart from one another by an expandable region, each of the wing members including a first end portion, a second end portion, and a flexible middle portion extending between the first and second end portions, the second end portion of each of the wing members being integrally formed with the main body portion;

placing the expandable support member, in a radially collapsed configuration, about an inflatable member;

loading the apparatus into a delivery catheter;

advancing the delivery catheter to the diseased cardiac valve; and

deploying the apparatus, in a radially expanded configuration, so that the first end portion of each of the wing members extends substantially radial to the outer circumferential surface, thereby contacting cardiac tissue and securing the apparatus in place of the diseased cardiac valve.

16. The method of claim 15, wherein said step of advancing the delivery catheter to the diseased cardiac valve further comprises the step of positioning the delivery catheter so that the apparatus is adjacent the valve annulus.

17. The method of claim 15, wherein said step of providing an apparatus further comprises providing a substantially dehydrated bioprosthetic valve.

18. The method of claim 17, wherein blood re-hydrates the substantially dehydrated bioprosthetic valve before the apparatus is deployed.

19. The method of claim 17, wherein blood re-hydrates the substantially dehydrated bioprosthetic valve after the apparatus is deployed.

20. The method of claim 15, wherein said step of deploying the apparatus further comprises the steps of:

withdrawing the delivery catheter; and

inflating the inflatable member so that the apparatus obtains the radially expanded configuration.

21. A method for replacing a diseased cardiac valve, said method comprising the steps of:

providing an apparatus, the apparatus comprising an expandable support member and a prosthetic valve secured within a main body portion of the expandable support member, the main body portion including an outer circumferential surface, a circumferential axis extending about the circumferential surface, and a plurality of wing members spaced apart from one another by an expandable region, each of the wing members including a first end portion, a second end portion, and a flexible middle portion extending between the first and second end portions, the second end portion of each of the wing members being integrally formed with the main body portion;

placing the expandable support member in a radially collapsed configuration;

loading the apparatus into a delivery catheter;

advancing the delivery catheter to the diseased cardiac valve; and

deploying the apparatus, in a radially expanded configuration, so that the first end portion of each of the wing members extends substantially radial to the outer circumferential surface, thereby contacting cardiac tissue and securing the apparatus in place of the diseased cardiac valve.

22. The method of claim 21, wherein said step of deploying the apparatus further comprises progressively withdrawing the delivery catheter from the apparatus so that the expandable support member obtains the radially expanded configuration.

23. The method of claim 21, wherein said expandable support member is self-expandable.

24. An apparatus for replacing an indwelling bioprosthetic valve having at least two commissural portions spaced apart by a first distance, said apparatus being movable from a radially collapsed configuration to a radially expanded configuration, said apparatus comprising:

an expandable support member having a first end portion, a second end portion, and a main body portion extending between said first and second end portions, said main body portion including an outer circumferential surface and a circumferential axis extending about said outer circumferential surface; and

a prosthetic valve secured within said main body portion of said expandable support member;

said second end portion including at least two flexible arch members spaced apart by a second distance that is about equal to the first distance, each of said at least two arch members being substantially co-planar with said outer circumferential surface when said apparatus is in the radially collapsed configuration and substantially radial to said outer circumferential surface when said apparatus is in the radially expanded configuration;

said main body portion including a plurality of wing members spaced apart from one another by an expandable region, each of said wing members including a first end portion, a second end portion, and a flexible middle portion extending between said first and second end portions, said second end portion of each of said wing members being integrally formed with said main body portion;

said first end portion of each of said wing members being adjacent said circumferential axis and substantially flush with said outer circumferential surface when said apparatus is in the radially collapsed configuration;

said first end portion of each of said wing members extending substantially radial to said outer circumferential surface when said apparatus is in the radially expanded configuration.

25. The apparatus of claim 24, wherein said expandable support member has a saddle-shaped, 3D configuration.

26. The apparatus of claim 24, wherein said main body portion further includes at least one expandable ring securely disposed about said outer circumferential surface.

27. The apparatus of claim 24, wherein the indwelling bioprosthetic valve includes first, second, and third commissural portions spaced apart by third, fourth, and fifth distances, and said second end portion of said expandable support member includes first, second, and third arch members spaced apart by sixth, seventh, and eighth distances that are about equal to the third, fourth, and fifth distances, respectively.

28. The apparatus of claim 24 further comprising:

at least one secondary flexible arch member for contacting a non-commissural portion of the indwelling bioprosthetic valve, said at least one secondary flexible arch member being substantially flush with said outer circumferential surface when said apparatus is in the radially collapsed configuration and substantially radial to said outer circumferential surface when said apparatus is in the radially expanded configuration.

29. The apparatus of claim 27 further comprising:

first, second, and third secondary arch members for contacting different non-commissural portions of the indwelling bioprosthetic valve, said first, second, and third secondary arch members being located at said second end portion of said expandable support member in between said first, second, and third arch members.

30. A method for replacing an indwelling bioprosthetic valve in a subject, the indwelling bioprosthetic valve having at least two commissural portions spaced apart by a first distance, said method comprising the steps of:

providing an apparatus, the apparatus comprising an expandable support member and a prosthetic valve secured within a main body portion of the expandable support member, the expandable support member including oppositely disposed first and second end portions, an outer circumferential surface, a circumferential axis extending about the circumferential surface, and a plurality of wing members spaced apart from one another by an expandable region, the second end portion including at least two flexible arch members spaced apart by a second distance that is about equal to the first distance, each of the wing members including a first end portion, a second end portion, and a flexible middle portion extending between the first and second end portions, the second end portion of each of the wing members being integrally formed with the main body portion;

loading the apparatus into a delivery catheter;

advancing the delivery catheter to the indwelling bioprosthetic valve; and

deploying the apparatus, in a radially expanded configuration, so that each of the at least two arch members engages each of the at least two commissural portions and the first end portion of each of the wing members extends substantially radial to the outer circumferential surface to displace a valve portion of the indwelling bioprosthetic valve.

31. The method of claim 30, wherein said step of loading the apparatus further comprises the step of placing the expandable support member, in a radially collapsed configuration, about an inflatable member.

32. The method of claim 30, wherein said step of advancing the delivery catheter further comprises the step of positioning the delivery catheter so that the apparatus is situated within the indwelling bioprosthetic valve.

33. The method of claim 30, wherein said step of providing an apparatus further comprises the step of providing a substantially dehydrated bioprosthetic valve.

34. The method of claim 33, wherein blood re-hydrates the substantially dehydrated bioprosthetic valve before the apparatus is deployed.

35. The method of claim 33, wherein blood re-hydrates the substantially dehydrated bioprosthetic valve after the apparatus is deployed.

36. The method of claim 31 further comprising the steps of:

withdrawing the delivery catheter; and

inflating the inflatable member so that the apparatus obtains the radially expanded configuration.

37. The method of claim 30, wherein said step of deploying the apparatus further comprises the step of progressively withdrawing the delivery catheter from the apparatus so that the expandable support member obtains the radially expanded configuration.

38. The method of claim 30, wherein said step of providing an apparatus further comprises the step of providing an apparatus having a self-expandable expandable support member.

39. An apparatus for replacing an indwelling bioprosthetic valve having at least two commissural portions spaced apart by a first distance, said apparatus being movable from a radially collapsed configuration to a radially expanded configuration, said apparatus comprising:

a cork-shaped expandable support member having a first end portion, a second end portion, and a main body portion extending between said first and second end portions, said first end portion having a flared configuration and including a diameter that is greater than a diameter of said second end portion, said main body portion including an outer circumferential surface and a circumferential axis extending about said outer circumferential surface; and

a prosthetic valve secured within said first end portion of said expandable support member;

said main body portion including a plurality of wing members spaced apart from one another by an expandable region, each of said wing members including a first end portion, a second end portion, and a flexible middle portion extending between said first and second end portions, said second end portion of each of said wing members being integrally formed with said main body portion;

said first end portion of each of said wing members being adjacent said circumferential axis and substantially flush with said outer circumferential surface when said apparatus is in the radially collapsed configuration;

said first end portion of each of said wing members extending substantially radial to said outer circumferential surface when said apparatus is in the radially expanded configuration.

40. The apparatus of claim 39, wherein said second end portion includes at least two flexible arch members spaced apart by a second distance that is about equal to the first distance, each of said at least two arch members being substantially co-planar with said outer circumferential surface when said apparatus is in the radially collapsed configuration and substantially radial to said outer circumferential surface when said apparatus is in the radially expanded configuration.