Fluid flow prosthetic device

• US 7,442,204 B2
• Filed: 11/22/2006
• Issued: 10/28/2008
• Est. Priority Date: 07/08/2003
• Status: Active Grant

• Current Assignee: Medtronic Ventor Technologies LTD. (Medtronic Plc)
• Original Assignee: Ventor Technologies Ltd. (Medtronic Plc)
• Inventors: Tuval, Yosi, Benary, Raphael, Schwammenthal, Ehud
• Primary Examiner(s): SWEET, THOMAS
• Application Number:
  US11/603,912
• Publication Number:
  US 20070185565A1
• Time in Patent Office: 706 Days
• Field of Search: 623/1.24, 623/1.25, 623/1.26, 623/2.12, 623/2.13, 623/2.14, 623/2.15, 623/2.16, 623/2.17, 623/2.18, 623/2.19
• US Class Current: 623/1.24
• CPC Class Codes: A61F 2/06 Blood vessels
• 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 2/848 having means for fixation to the vessel wall, e.g. barbs
• CPC Class Codes: A61F 2002/068 Modifying the blood flow model, e.g. by diffuser or deflector
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2250/0039 differing in diameter

Abstract

A prosthetic device including a valve-orifice attachment member attachable to a valve in a blood vessel and including a fluid inlet, and a diverging member that extends from the fluid inlet, the diverging member including a proximal end near the fluid inlet and a distal end distanced from the proximal end, wherein a distal portion of the diverging member has a larger cross-sectional area for fluid flow therethrough than a proximal portion thereof. The diverging member may have a diverging taper that causes fluid to flow therethrough with pressure recovery at the distal end thereof.

Claims

1. Prosthetic apparatus comprising:

a support frame, configured for attachment to a native valve site of a patient, and shaped to define;

a converging frame inlet section, and

a diverging frame downstream section; and

an envelope shaped to define;

a converging envelope inlet, conforming generally to the converging frame inlet section, and

a diverging envelope section, conforming generally to the diverging frame downstream section, supported by the frame, and configured to open and close in accordance with a cardiac cycle of the patient.

2. The apparatus according to claim 1, wherein the frame is expandable.

3. The apparatus according to claim 1, wherein the envelope is positioned inside of the frame.

4. The apparatus according to claim 1, wherein the frame is configured so as to define a plurality of cells, respective configurations of which change as the frame expands.

5. The apparatus according to claim 1, wherein the envelope covers a proximal portion of the diverging frame downstream section, and does not cover a distal portion of the diverging frame downstream section, and wherein at least a portion of the distal portion is configured to come in contact with an inner surface of a blood vessel in a vicinity of the native valve site.

6. The apparatus according to claim 1, wherein the diverging envelope section is shaped so as to define a downstream outlet, and wherein the diverging envelope section is shaped so as to cause fluid to flow therethrough with pressure recovery at the outlet.

7. The apparatus according to claim 6, wherein the diverging envelope section widens with a widening angle alpha of approximately 5-8 degrees.

8. The apparatus according to claim 1, wherein the support frame defines an inner surface, and wherein the envelope lines the inner surface.

9. The apparatus according to claim 1, wherein the frame comprises clasping members configured to clasp opposite sides of a native valve of the native valve site near an orifice of the native valve.

10. The apparatus according to claim 1, wherein the frame comprises an annular clamp configured to engage native valve leaflets of the native valve.

11. The apparatus according to claim 1, wherein the diverging frame downstream section defines a downstream outlet, and wherein the apparatus further comprises an annular array of bracing elements at the outlet configured to engage with an inner surface of a blood vessel in a vicinity of the native valve site.

12. The apparatus according to claim 1, wherein the diverging envelope section is conical.

13. The apparatus according to claim 1, wherein the diverging envelope section is curved convexly.

14. The apparatus according to claim 1, wherein the diverging envelope section is curved concavely.

15. The apparatus according to claim 1, wherein the frame comprises a plurality of axially-extending struts pivotally mounted near the converging envelope inlet and extending along at least a portion of the diverging envelope section.

16. The apparatus according to claim 1, wherein the frame comprises a plurality of axially-extending struts, wherein the diverging envelope section comprises a plurality of portions thereof, each portion disposed between a respective pair of the struts, and wherein there is no structural member of the apparatus intervening between the portions of the diverging envelope section and blood of the patient within or outside the diverging envelope section, when the frame is attached to the native valve site.

17. The apparatus according to claim 1, wherein the converging inlet is configured to be positioned within a left ventricle of the patient when the frame is attached to the native valve site.

18. The apparatus according to claim 1, wherein the diverging envelope section is configured to function as a prosthetic valve by collapsing inwardly.

19. The apparatus according to claim 1, wherein the diverging envelope section defines three portions thereof, which are disposed to collapse inwardly toward each other.

20. The apparatus according to claim 1, wherein the diverging envelope section is shaped so as to define a downstream outlet, and wherein the diverging envelope section is shaped so as to produce a non-turbulent blood flow from the downstream outlet.

21. A method, comprising:

identifying a stenotic native valve site of a heart of a patient; and

implanting at the native valve site;

a support frame, configured for attachment to the native valve site, and shaped to define;

a converging frame inlet section, and

a diverging frame downstream section; and

an envelope shaped to define;

a converging envelope inlet, conforming generally to the converging frame inlet section, and

a diverging envelope section, conforming generally to the diverging frame downstream section, supported by the frame, and configured to open and close in accordance with a cardiac cycle of the patient.

22. The method according to claim 21, wherein the diverging envelope section is shaped so as to define a downstream outlet, and wherein implanting the envelope comprises placing the envelope in a manner that facilitates fluid to flow through the diverging envelope section with pressure recovery at the outlet.

23. The method according to claim 21, wherein implanting the support frame comprises positioning the converging inlet within a left ventricle of the patient when the frame is attached to the native valve site.