One Piece Prosthetic Valve Support Structure and Related Assemblies

• US 20100174363A1
• Filed: 12/30/2009
• Published: 07/08/2010
• Est. Priority Date: 01/07/2009
• Status: Abandoned Application

• Current Assignee: Endovalve, Inc. (Micro Interventional Devices, Inc.)
• Original Assignee: Endovalve, Inc. (Micro Interventional Devices, Inc.)
• Inventors: Castro, Salvatore
• Application Number:
  US12/649,692
• Publication Number:
  US 20100174363A1
• Time in Patent Office: Days
• US Class Current: 623/2.110
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: Y10T 29/49995 Shaping one-piece blank by removing material

Abstract

Valve prostheses are disclosed that are adapted for secure and aligned placement relative to a heart annulus. The valve prostheses may be placed in a non-invasive manner, e.g., via trans-catheter techniques. The valve prosthesis may include a support ring, a plurality of leaflet membranes mounted with respect to the support ring, and a plurality of retention clip elements. The support structure is advantageously formed from a tubular member or flat stock of shape memory metal. A delivery system for delivery of a valve prosthesis embodying the disclosed support structure is also disclosed.

Claims

1. A one-piece support structure, comprising:

a substantially cylindrical structure that defines (a) a support ring;

(b) a mounting collar;

(c) a plurality of support struts extending from the mounting collar to the support ring; and

(d) a plurality of retention clip elements, wherein a retention clip element is defined adjacent each of the plurality of support struts;

wherein the supporting ring, mounting collar, plurality of support struts and plurality of retention clip elements are formed by applying cuts to a one-piece structure.

2. The one-piece support structure according to claim 1, wherein the one-piece structure is a tubular member.

3. The one-piece support structure according to claim 1, wherein the one-piece structure is flat stock that is processed to form a tubular member after the cuts are applied.

4. The one-piece support structure according to claim 1, wherein the one-piece structure is fabricated from a shape memory metal.

5. The one-piece support structure according to claim 1, wherein the retention clip elements define upper and lower regions.

6. The one-piece support structure according to claim 1, further comprising a plurality of leaflet members mounted with respect to the support ring.

7. The one-piece support structure according to claim 1, wherein the support structure is embodied in a replacement valve prosthesis.

8. The one-piece support structure according to claim 1, wherein the support structure is embodied in a mitral heart valve prosthesis.

9. A method for fabricating a support structure, comprising:

a. providing a tubular member or flat stock of shape memory metal;

b. applying predefined cuts to the tubular member or flat stock and, if working with flat stock, welding the flat stock into a tubular member; and

c. expanding the tubular member to an expanded configuration to define a support structure having a mounting collar, a plurality of support struts, a support ring and a plurality of retention clip elements.

10. The method according to claim 9, further comprising annealing the expanded tubular member to apply a memory effect thereto.

11. The method according to claim 10, further comprising mounting leaflet membranes to the support ring of the support structure.

12. A delivery system for delivering a support structure to a desired location, comprising:

a. a sheath system that includes a sheath advance housing, a sheath flange, an inner sheath, and an outer sheath, and

b. a valve retaining system that includes a body housing, a lock plunger, a sheath advance ferrule, a guide wire channel tube, a valve retaining collet, a retaining cam, a plurality of O-rings and a flex shaft,

wherein the sheath system and the valve retaining system cooperate to facilitate delivery of a support structure to a desired anatomical location.