Limited expansion heart valve

• US 10,080,653 B2
• Filed: 09/08/2016
• Issued: 09/25/2018
• Est. Priority Date: 09/10/2015
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Conklin, Brian S., Chang, Da-Yu
• Primary Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US15/260,053
• Publication Number:
  US 20170071732A1
• Time in Patent Office: 747 Days
• Field of Search: 623 21- 219
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2220/0033 made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable

Abstract

A prosthetic heart valve configured to replace a native heart valve and having a support frame configured to be reshaped into an expanded form in order to receive and/or support an expandable prosthetic heart valve therein is disclosed, together with methods of using same. Interlocking members or flexible loops are included to limit expansion of the valve to one or two valve sizes, for example, with a 2-mm gap between each valve size. The valve may include an internal structural band with overlapped free ends having structure for limiting expansion, or external loops of suture may be added to the fabric covering which limits expansion.

Claims

1. A prosthetic surgical heart valve adapted for post-implant expansion and having an inflow end and an outflow end, comprising:

a valve member including a non-collapsible inner structural support stent having three upstanding commissure posts extending in an outflow direction and spaced evenly around a periphery of the support stent alternating with three arcuate inflow cusps midway between adjacent commissure posts, and three flexible leaflets attached along the commissure posts and inflow cusps of the support stent configured to ensure one-way blood flow through the valve member, the support stent periphery defining a non-collapsible delivery and implant circumference having a first diameter, wherein the support stent permits expansion of the periphery from the first diameter to a second diameter larger than the first diameter upon application of an outward dilatory force from within the support stent substantially larger than forces associated with normal physiological use, the support stent including a structural band extending around the periphery and having overlapping free ends such that relative sliding of the overlapping free ends permits expansion of the support stent, and further including an expansion limiting spacer interposed between the overlapping free ends that engages both free ends and prevents over-expansion of the stent past the second diameter, and a flexible sleeve which surrounds the free ends and holds them radially together.

2. The prosthetic heart valve of claim 1, wherein the overlapping free ends are located at a single one of the inflow cusps of the support stent.

3. The prosthetic heart valve of claim 1, wherein the expansion limiting spacer includes two fingers that are radially offset in opposite directions and extend through channels provided in respective structural band free ends.

4. The prosthetic heart valve of claim 3, wherein the fingers terminate in enlarged heads that are wider than the channels.

5. The prosthetic heart valve of claim 1, further including a unique identifier on the support stent visible from outside the body after implant that identifies the support stent as being expandable.

6. The prosthetic heart valve of claim 1, wherein the support stent includes the structural band concentrically disposed against a commissure band defining the three upstanding commissure posts of the support stent, the structural band being truncated at the commissure posts of the commissure band.

7. The prosthetic heart valve of claim 1, wherein the support stent includes the structural band concentrically disposed against a commissure band defining the three upstanding commissure posts of the support stent, the structural band being made of a metal and the commissure band being made of a polymer.

8. The prosthetic heart valve of claim 1, wherein the expansion limiting spacer is made of a lubricious material selected from the group consisting of polyester, polytetrafluoroethylene (PTFE), ultra-high-molecular-weight polyethylene (UHMWPE) and polyether ether ketone (PEEK).

9. The prosthetic heart valve of claim 1, wherein the sleeve is made of a material selected from the group consisting of polyester shrink wrap tubing and silicone rubber.

10. The prosthetic heart valve of claim 1, wherein the sleeve is biodegradable to maintain alignment of the two free ends for a period after implant and then degrade to permit even easier expansion of the band.

11. A prosthetic surgical heart valve adapted for post-implant expansion and having an inflow end and an outflow end, comprising:

a valve member including a non-collapsible inner structural support stent having three upstanding commissure posts extending in an outflow direction and spaced evenly around a periphery of the support stent alternating with three arcuate inflow cusps midway between adjacent commissure posts, and three flexible leaflets attached along the commissure posts and inflow cusps of the support stent configured to ensure one-way blood flow through the valve member, the support stent periphery defining a non-collapsible delivery and implant circumference having a first diameter, wherein the support stent permits expansion of the periphery from the first diameter to a second diameter larger than the first diameter upon application of an outward dilatory force from within the support stent substantially larger than forces associated with normal physiological use, the support stent including a structural band extending around the periphery and having overlapping free ends such that relative sliding of the overlapping free ends permits expansion of the support stent, and further including a loop of one or more filaments loosely threaded through holes in the structural band adjacent each free end such that slack in the loop permits the structural band to expand but prevents over-expansion of the stent past the second diameter.

12. The prosthetic heart valve of claim 11, wherein the loop comprises a single suture threaded at least three times through the holes and tied off on the outside of the band.

13. The prosthetic heart valve of claim 11, wherein the slack in the loop is located outside the band, and the loop and slack are hidden when the support stent is covered in cloth.

14. The prosthetic heart valve of claim 11, wherein the overlapping free ends are located at a single one of the inflow cusps of the support stent.

15. The prosthetic heart valve of claim 11, further including a lubricious spacer interposed between the overlapping free ends that engages both free ends.

16. The prosthetic heart valve of claim 15, wherein the spacer is made of a material selected from the group consisting of polyester, polytetrafluoroethylene (PTFE), ultra-high-molecular-weight polyethylene (UHMWPE) and polyether ether ketone (PEEK).

17. The prosthetic heart valve of claim 11, further including a unique identifier on the support stent visible from outside the body after implant that identifies the support stent as being expandable.

18. The prosthetic heart valve of claim 11, wherein the support stent includes the structural band concentrically disposed against a commissure band defining the three upstanding commissure posts of the support stent, the structural band being truncated at the commissure posts of the commissure band.

19. The prosthetic heart valve of claim 11, wherein the support stent includes the structural band concentrically disposed against a commissure band defining the three upstanding commissure posts of the support stent, the structural band being made of a metal and the commissure band being made of a polymer.

20. A prosthetic surgical heart valve adapted for post-implant expansion and having an inflow end and an outflow end, comprising:

a valve member including a non-collapsible inner structural support stent having three upstanding commissure posts extending in an outflow direction and spaced evenly around a periphery of the support stent alternating with three arcuate inflow cusps midway between adjacent commissure posts, and three flexible leaflets attached along the commissure posts and inflow cusps of the support stent configured to ensure one-way blood flow through the valve member, the support stent periphery defining a non-collapsible delivery and implant circumference having a first diameter, wherein the support stent permits expansion of the periphery from the first diameter to a second diameter larger than the first diameter upon application of an outward dilatory force from within the support stent substantially larger than forces associated with normal physiological use, the support stent including a structural band extending around the periphery and having overlapping free ends such that relative sliding of the overlapping free ends permits expansion of the support stent, and further including an expansion limiting spacer interposed between the overlapping free ends that engages both free ends and prevents over-expansion of the stent past the second diameter, wherein the expansion limiting spacer includes two fingers that are radially offset in opposite directions and extend through channels provided in respective structural band free ends.

21. The prosthetic heart valve of claim 20, wherein the fingers terminate in enlarged heads that are wider than the channels.

22. The prosthetic heart valve of claim 20, wherein the overlapping free ends are located at a single one of the inflow cusps of the support stent.

23. The prosthetic heart valve of claim 20, further including a unique identifier on the support stent visible from outside the body after implant that identifies the support stent as being expandable.

24. The prosthetic heart valve of claim 20, wherein the expansion limiting spacer is made of a lubricious material selected from the group consisting of polyester, polytetrafluoroethylene (PTFE), ultra-high-molecular-weight polyethylene (UHMWPE) and polyether ether ketone (PEEK).