Surgical heart valves identifiable post-implant

Patent metadata

Field	Value
Publication number	US-9504566-B2
Application number	US-201514745287-A
Country	US
Kind code	B2
Filing date	Jun 19, 2015
Priority date	Jun 20, 2014
Publication date	Nov 29, 2016
Grant date	Nov 29, 2016

Abstract

A prosthetic heart valve configured to replace a native heart valve and for post-implant expansion and having a valve-type indicator thereon visible from outside the body post-implant. The indicator communicates information about the valve, such as the size or orifice diameter of the valve, and/or that the valve has the capacity for post-implant expansion. The indicator can be an alphanumeric symbol or other symbol or combination of symbols that represent information about the characteristics of the valve such as the valve size. The capacity for post-implant expansion facilitates a valve-in-valve procedure, where the valve-type indicator conveys information to the surgeon about whether the implanted valve is suitable for the procedure and informs the choice of the secondary valve.

First claim

What is claimed is:

1. A prosthetic heart valve, comprising:
an internal support frame defining a flow orifice therethrough, wherein the internal support frame is adapted for post-implant expansion;
a plurality of flexible leaflets attached to the support frame and extending across the flow orifice and coming together within the orifice to define one-way flow therethrough; and
a valve-type indicator that signifies the capability of the support frame for post-implant expansion of the orifice, the valve-type indicator readable using an external imager.

2. The heart valve of claim 1 , wherein the prosthetic heart valve has a labeled valve size, and the valve-type indicator further comprises a valve-size indicator that denotes the labeled valve size.

3. The heart valve of claim 2 , wherein the valve-size indicator comprises a numerical value that equals the labeled valve size in millimeters.

4. The heart valve of claim 1 , wherein the internal support frame comprises a structural component that shows up as a positive image on the external imager, and the valve-type indicator is formed by one or more voids integrated into the structural component which show up as negative images on the external imager.

5. The heart valve of claim 4 , wherein the structural component of the internal support frame comprises a generally tubular band with a diameter that is expandable post-implant.

6. The heart valve of claim 1 , wherein the valve-type indicator comprises an indicator element that shows up as a positive image on the external imager, the indicator element mounted to a structural component of the prosthetic heart valve that has a distinguishable appearance on the external imager so that the valve-type indicator contrasts with the structural component on the external imager.

7. The heart valve of claim 6 , wherein the structural component comprises a soft sealing ring surrounding an inflow end of the heart valve, and the valve-type indicator is mounted to the sealing ring.

8. The heart valve of claim 1 , wherein the valve-type indicator comprises a non-numeric symbol.

9. The heart valve of claim 1 , wherein the prosthetic heart valve further includes an expandable tubular frame attached to an inflow end of the internal support frame on which the valve-type indicator is located.

10. The heart valve of claim 9 , wherein the expandable tubular frame comprises a series of circumferential and axial struts, wherein an upper strut is shaped with peaks and valleys around its periphery, and a second indicator readable using an external imager is integrated into the frame below the upper strut and along one of the axial struts.

11. The heart valve of claim 9 , wherein the upper strut includes a series of distributed notches that enable expansion of the upper strut.

12. A prosthetic heart valve, comprising:
an internal support frame defining a flow orifice therethrough, the internal support frame defining a plurality of cusps that curve toward the inflow end separated by commissures, the support frame comprising an annular element disposed at an inflow end of the support frame that undulates so as to have peaks and valleys, with the peaks corresponding to the commissures of the support frame;
a plurality of flexible leaflets attached to the support frame and extending across the flow orifice and coming together within the orifice to ensure one-way flow therethrough, each of the leaflets attaching at a peripheral edge along the cusps and commissures of the support frame; and
an indicator comprising at least one feature located on the annular element, at least a portion of the indicator having a radiopacity different from the radiopacity of the annular element, the indicator being visible using an external imager wherein the prosthetic heart valve has a labeled valve size, and the indicator denotes the labeled valve size.

13. The heart valve of claim 12 , wherein at least a portion of the annular element is radiopaque and the indicator includes at least one opening extending through the at least one radiopaque portion of the annular element.

14. The heart valve of claim 12 , wherein the annular element has an implant diameter wherein the prosthetic heart valve is functional and is adapted for post-implant expansion to a larger diameter wherein the prosthetic heart valve is non-functional.

15. The heart valve of claim 12 , wherein the annular element includes at least one expandable segment formed by overlapping free ends located at one of the cusps of the support frame.

16. The heart valve of claim 12 , wherein an indicator is disposed at at least one of the peaks and the valleys of the annular element.

17. The heart valve of claim 12 , wherein the indicator comprises a numerical value that equals the labeled valve size.

18. The heart valve of claim 12 , wherein the indicator comprises a non-numeric symbol representative of the labeled valve size.

19. The heart valve of claim 12 , wherein the prosthetic heart valve further includes an expandable tubular frame attached to an inflow end of the internal support frame on which a second indicator visible using an external imager is located.

20. The heart valve of claim 19 , wherein the expandable tubular frame comprises a series of circumferential and axial struts, wherein an upper strut is shaped with peaks and valleys around its periphery, and the second indicator is integrated into the frame below the upper strut and along one of the axial struts.

Assignees

• Edwards Lifesciences Corp

Inventors

• Guttenberg Jessica
• Chang Da-Yu
• Johnson Derrick
• Conklin Brian S
• Zeng Qinggang
• Howanec Jr Myron
• Kim Grace M

Classifications

• A61F2/2472

  Devices for testing · CPC title

• A61F2/2418 Primary

  Scaffolds therefor, e.g. support stents · CPC title

• A61F2/2427

  Devices for manipulating or deploying heart valves during implantation · CPC title

• A61F2250/0089

  coded with symbols, e.g. dots, numbers, letters, words · CPC title

• A61F2/2412 Primary

  with soft flexible valve members, e.g. tissue valves shaped like natural valves · CPC title