Prosthetic valve for transluminal delivery

• US 8,603,159 B2
• Filed: 12/11/2009
• Issued: 12/10/2013
• Est. Priority Date: 11/17/1999
• Status: Expired due to Fees

• Current Assignee: Medtronic Corevalve LLC (Medtronic Plc)
• Original Assignee: Medtronic Corevalve LLC (Medtronic Plc)
• Inventors: Seguin, Jacques, Bortlein, Georg
• Primary Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US12/636,563
• Publication Number:
  US 20100152840A1
• Time in Patent Office: 1,460 Days
• Field of Search: 623 116- 124, 623 21- 219
• US Class Current: 623/2.1
• 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 heart valve assembly comprising:

a heart valve having commissures;

a stent portion having a plurality of annularly spaced regions to which the commissures of the heart valve are attached, wherein the plurality of annularly spaced regions of the stent portion comprise a plurality of peaks extending circumferentially around the stent portion;

an axial holding portion that is concentric with the stent portion and downstream from the stent portion in the direction of blood flow when in use in a patient; and

a plurality of linking members connecting the stent portion to the axial holding portion, wherein each one of the plurality of linking members connects to one of the plurality of annularly spaced regions of the stent portion;

wherein the stent portion and the axial holding portion are configured to be annularly compressible to about a same compressed circumference for transluminal delivery using a catheter.

2. The prosthetic heart valve assembly of claim 1, wherein the stent portion, the axial holding portion, and the plurality of linking members are formed of one integral unit.

3. The prosthetic heart valve assembly of claim 1, wherein the axial holding portion is configured to be re-expandable to a re-expanded circumferential size that is greater than a re-expanded circumferential size of the stent portion when the stent portion is re-expanded.

4. The prosthetic heart valve assembly of claim 1, further comprising a plurality of hooks to engage with surrounding tissues when the prosthetic heart valve assembly is implanted into the patient.

5. The prosthetic heart valve assembly of claim 1, wherein the stent portion takes the form of a mesh structure having a plurality of diamond-shaped cells.

6. The prosthetic heart valve assembly of claim 1, wherein the axial holding portion takes the form of a mesh structure having a plurality of diamond-shaped cells.

7. A prosthetic heart valve assembly comprising:

a heart valve having commissures;

a stent portion having a plurality of annularly spaced regions to which the commissures of the heart valve are attached, wherein the stent portion takes the form of a mesh structure having a plurality of diamond-shaped cells;

an axial holding portion that is concentric with the stent portion and downstream from the stent portion in the direction of blood flow when in use in a patient; and

a plurality of linking members connecting the stent portion to the axial holding portion, wherein the plurality of linking members are aligned with the plurality of annularly spaced regions of the stent portion;

wherein the stent portion and the axial holding portion are configured to be annularly compressible to about a same compressed circumference for transluminal delivery using a catheter.

8. The prosthetic heart valve assembly of claim 7, wherein the stent portion, the axial holding portion, and the plurality of linking members are formed of one integral unit.

9. The prosthetic heart valve assembly of claim 7, wherein the axial holding portion is configured to be re-expandable to a re-expanded circumferential size that is greater than a re-expanded circumferential size of the stent portion when the stent portion is re-expanded.

10. The prosthetic heart valve assembly of claim 7 further comprising a plurality of hooks to engage with surrounding tissues when the prosthetic heart valve assembly is implanted into the patient.

11. The prosthetic heart valve assembly of claim 7, wherein the axial holding portion takes the form of a mesh structure having a plurality of diamond-shaped cells.

19. The prosthetic heart valve assembly of claim 7, wherein the plurality of annularly spaced regions of the stent portion comprise a plurality of peaks extending circumferentially around the stent portion.

12. A prosthetic heart valve assembly comprising:

a stent portion having a plurality of annularly spaced peaks extending circumferentially around the stent portion, wherein the stent portion takes the form of a mesh structure having a plurality of diamond-shaped cells;

an axial holding portion that is concentric with the stent portion and downstream from the stent portion in the direction of blood flow when the valve is in use in a patient; and

a plurality of linking members connecting the stent portion to the axial holding portion, wherein each one of the plurality of linking members connects to one of the plurality of annularly spaced peaks,

wherein the stent portion and the axial holding portion are configured to be annularly compressible to about a same compressed circumference for transluminal delivery using a catheter.

13. The prosthetic heart valve assembly of claim 12 further comprising a heart valve supported by the stent portion.

14. The prosthetic heart valve assembly of claim 12, wherein the axial holding portion is configured to be re-expandable to a re-expanded circumferential size that is greater than a re-expanded circumferential size of the stent portion when the stent portion is re-expanded.

15. The prosthetic heart valve assembly of claim 12, wherein the plurality of annularly spaced peaks comprise an undulating wire structure.

16. The prosthetic heart valve assembly of claim 12, wherein the axial holding portion takes the form of a mesh structure having a plurality of diamond-shaped cells.

17. A prosthetic heart valve assembly comprising:

a heart valve having commissures;

a stent portion having a plurality of annularly spaced regions to which the commissures of the heart valve are attached, the annularly spaced regions comprising a series of expandable diamond-shaped cells;

a holding portion that is concentric with the stent portion and downstream from the stent portion in the direction of blood flow when in use in a patient; and

a plurality of linking members connecting the stent portion to the holding portion, wherein each linking member connects to one of the plurality of annularly spaced regions of the stent portion between two diamond-shaped cells;

wherein the stent portion and the axial holding portion are annularly compressible to about the same circumference.

18. A prosthetic heart valve assembly comprising:

a heart valve;

an upstream mesh portion having an undulating upstream wire forming a plurality of peaks extending circumferentially around the upstream mesh portion, the upstream mesh portion supporting the heart valve;

a downstream mesh portion that is concentric with the upstream mesh portion, wherein the downstream mesh portion includes two undulating wires forming a diamond-shaped mesh extending circumferentially around the downstream mesh portion, wherein the two undulating wires of the downstream mesh portion are coupled to one another at a plurality of opposing peaks via at least one downstream linking wire; and

a plurality of upstream linking wires, each upstream linking wire connecting a peak from the upstream mesh portion with a peak from the downstream mesh portion;

wherein the upstream mesh portion and the downstream mesh portion are annularly compressible to about the same circumference.