Prosthetic valve for transluminal delivery

• US 10,219,901 B2
• Filed: 02/11/2008
• Issued: 03/05/2019
• Est. Priority Date: 11/17/1999
• Status: Expired due to Fees

• Current Assignee: Medtronic CV Luxembourg SARL (Medtronic Plc)
• Original Assignee: Medtronic CV Luxembourg SARL (Medtronic Plc)
• Inventors: Seguin, Jacques, Bortlein, Georg
• Primary Examiner(s): Schall, Matthew
• Application Number:
  US12/029,031
• Publication Number:
  US 20080133003A1
• Time in Patent Office: 4,040 Days
• Field of Search: 623 124, 623 211, 623 238, 623 115, 623 21
• CPC Class Codes: A61B 17/0218 for minimally invasive surgery A61B17/0281, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2210/0023 operated at different temperatures whilst inside or touching the human body, heated or cooled by external energy source or cold supply
• 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 2220/0075 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
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/0048 differing in mechanical expandability, e.g. in mechanical, self- or balloon expandability
• CPC Class Codes: A61F 2250/0069 Sealing means
• CPC Class Codes: Y10S 623/904 Heart

Abstract

A prosthetic valve assembly for use in replacing a deficient native valve comprises a replacement valve supported on an expandable valve support. If desired, one or more anchor may be used. The valve support, which entirely supports the valve annulus, valve leaflets, and valve commissure points, is configured to be collapsible for transluminal delivery and expandable to contact the anatomical annulus of the native valve when the assembly is properly positioned. The anchor engages the lumen wall when expanded and prevents substantial migration of the valve assembly when positioned in place. The prosthetic valve assembly is compressible about a catheter, and restrained from expanding by an outer sheath. The catheter may be inserted inside a lumen within the body, such as the femoral artery, and delivered to a desired location, such as the heart. When the outer sheath is retracted, the prosthetic valve assembly expands to an expanded position such that the valve and valve support expand within the deficient native valve, and the anchor engages the lumen wall.

Claims

1. A prosthetic cardiac valve assembly for use in replacing a deficient native cardiac valve, the valve assembly comprising:

a replacement cardiac valve having a plurality of commissure points;

a prosthetic cardiac valve support configured to be collapsible for transluminal delivery and support of the replacement cardiac valve, the prosthetic cardiac valve support comprising;

a first portion configured to expand to contact an anatomical annulus of the native valve when the prosthetic cardiac valve assembly is properly positioned, wherein the first portion includes a mesh that defines a first plurality of cells having a first size;

a second portion comprising a first section and a second section, the first section attached to the commissure points of the replacement cardiac valve and configured to be radially restrained to a preset diameter when the prosthetic cardiac valve support is in a deployed state, wherein the second section of the second portion includes a mesh that defines a second plurality of cells having a second size that are connected to form at least one circumferential ring, wherein the second size is different from the first size, and wherein when the prosthetic cardiac valve support is in a deployed state, the entire at least one circumferential ring of the second section is spaced a distance away from the replacement cardiac valve and is configured to expand to contact at a region of vascular anatomy spaced downstream of the native cardiac valve; and

a connection portion configured to connect the first portion and the second portion comprising sufficient length in the axial direction to enable deployment of the first portion at a distance away from the second portion and such that when the first portion is deployed at the annulus of the native cardiac valve, the at least one circumferential ring of the second portion is positioned at the region of vascular anatomy spaced downstream of the native cardiac valve.

2. The prosthetic cardiac valve assembly of claim 1, wherein the prosthetic cardiac valve support is self-expanding.

3. The prosthetic cardiac valve assembly of claim 2, wherein the configuration and radial force of the valve support substantially preclude any portion of the native cardiac valve from obstructing effective placement of said valve assembly.

4. The prosthetic cardiac valve assembly of claim 1, wherein at least one of the meshes of the first portion or the second portion comprises wires.

5. The prosthetic cardiac valve assembly of claim 1, wherein the at least one circumferential ring of the second portion comprises a fixation portion that is configured to exert sufficient radial forces against the region of vascular anatomy spaced downstream of the native cardiac valve to prevent substantial migration.

6. The prosthetic cardiac valve assembly of claim 5, wherein the fixation portion comprises at least one hook for engaging the region of vascular anatomy.

7. The prosthetic cardiac valve assembly of claim 1, wherein the first portion is positioned at a distance away from the deficient native cardiac valve which resists contact between the first portion and a coronary ostia.

8. The prosthetic cardiac valve assembly of claim 1, wherein the connection portion comprises wires.

9. The prosthetic cardiac valve assembly of claim 8, wherein the wires comprise portions configured to correspond to junctions formed by the replacement cardiac valve.

10. The prosthetic cardiac valve assembly of claim 8, wherein the connection portion comprises undulating wires.

11. The prosthetic cardiac valve assembly of claim 1, wherein the prosthetic cardiac valve assembly is configured to be expanded by a balloon catheter.

12. The prosthetic cardiac valve assembly of claim 1, wherein the first section is configured to substantially resist expansion beyond a preset diameter.

13. The prosthetic cardiac valve assembly of claim 1, wherein the first section is configured to substantially resist collapse below a preset diameter.

14. The prosthetic cardiac valve assembly of claim 1, wherein when the prosthetic cardiac valve support is in the deployed state the first section is configured to:

i) substantially resist expansion beyond the preset diameter, and ii) substantially resist collapse below the preset diameter.

16. The prosthetic cardiac valve assembly of claim 1, wherein the first section of the second portion includes a mesh that defines a third plurality of cells having a third size that are connected to form at least one circumferential ring.

17. The prosthetic cardiac valve assembly of claim 16, wherein each cell of the third plurality of cells is diamond-shaped.

18. The prosthetic cardiac valve assembly of claim 1, wherein the second size of the second plurality of cells is smaller than the first size of the first plurality of cells.

19. The prosthetic cardiac valve assembly of claim 18, wherein each cell of the first plurality of cells is diamond-shaped and each cell of the second plurality of cells is diamond-shaped.

20. The prosthetic cardiac valve assembly of claim 1, further comprising:

a second connection portion configured to connect the first section of the second portion and the second section of the second portion, the second connection portion comprising three wires of sufficient length in the axial direction to enable deployment of the first section at a distance away from the second section.

15. A prosthetic cardiac valve assembly comprising:

a collapsible and expandable support structure comprising;

a first expandable portion comprising a mesh that defines a first plurality of cells having a first size;

a second expandable portion downstream from the first portion comprising a mesh that defines a second plurality of cells having a second size larger than the first size that are connected to form at least one circumferential ring; and

a connection portion spaced between the first expandable portion and the at least one circumferential ring of the second expandable portion, the connection portion having an axial length such that when the first expandable portion is deployed at an annulus of a native aortic valve, the at least one circumferential ring of the second expandable portion is positioned at a region of vascular anatomy spaced downstream of a native cardiac valve; and

a replacement cardiac valve coupled to the collapsible and expandable support structure, wherein when the support structure is in a deployed state, the entire at least one circumferential ring of the second expandable portion is spaced a distance away from the replacement cardiac valve.