Surgical heart valves identifiable post-implant

• US 9,504,566 B2
• Filed: 06/19/2015
• Issued: 11/29/2016
• Est. Priority Date: 06/20/2014
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Guttenberg, Jessica, Chang, Da-Yu, Johnson, Derrick, Conklin, Brian S., Zeng, Qinggang, Howanec, Myron Jr., Kim, Grace M.
• Primary Examiner(s): STEWART, JASON-DENNIS NEILKEN
• Application Number:
  US14/745,287
• Publication Number:
  US 20150366664A1
• Time in Patent Office: 529 Days
• US Class Current: 1/1
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• 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 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2472 Devices for testing
• CPC Class Codes: A61F 2250/0085 Identification means; Administration of patients
• CPC Class Codes: A61F 2250/0089 coded with symbols, e.g. dots, numbers, letters, words
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers

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.

Claims

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.