Fixation device having a flexure portion

Patent metadata

Field	Value
Publication number	US-12138169-B2
Application number	US-202217732830-A
Country	US
Kind code	B2
Filing date	Apr 29, 2022
Priority date	Apr 30, 2021
Publication date	Nov 12, 2024
Grant date	Nov 12, 2024

Abstract

Fixation device for fixation of leaflets of a heart valve, the fixation device including a central element defining a central axis. The fixation device further includes a distal portion including at least one arm coupled to the central element, wherein the at least one arm is moveable to a selected position between a fully open position and a fully closed position. The distal portion further includes at least one leg operatively coupled to the at least one arm and configured to move the at least one arm to the selected position between the fully open position and the fully closed position. The at least one arm includes a contact portion configured to engage native heart valve tissue, the contact portion defining a contact portion axis. The distal portion includes a flexure portion configured to enable the contact portion in the selected position to move within a flex angle range between an undeformed contact portion angle relative to the central axis and a flexed contact portion angle relative to the central axis. The flexed contact portion angle is greater than the undeformed contact portion angle. The flex angle range is about 10 degrees to about 45 degrees. The fixation device further includes at least one gripping element moveable relative to the at least one arm to capture a native leaflet therebetween.

First claim

The invention claimed is:

1. A fixation device for fixation of leaflets of a heart valve comprising:
a central element defining a central axis;
a distal portion comprising:
at least one arm coupled to the central element, the at least one arm moveable to a selected position between a fully open position and a fully closed position, and
at least one leg operatively coupled to the at least one arm and configured to move the at least one arm to the selected position between the fully open position and the fully closed position,
wherein the at least one arm includes a contact portion configured to engage native heart valve tissue, the contact portion defining a contact portion axis,
wherein the distal portion includes a flexure portion configured to enable the contact portion in the selected position to move within a flex angle range between an undeformed contact portion angle relative to the central axis and a flexed contact portion angle relative to the central axis, wherein the flexed contact portion angle is greater than the undeformed contact portion angle, the flex angle range being about 10 degrees to about 45 degrees; and

at least one gripping element moveable relative to the at least one arm to capture a native leaflet therebetween.

2. The fixation device of claim 1 , wherein the at least one arm comprises the flexure portion.

3. The fixation device of claim 2 , wherein the at least one arm comprises a deformable frame comprising the flexure portion and having first and second deformable portions, each of the first and second deformable portions disposed along a respective lateral side of the deformable frame.

4. The fixation device of claim 3 , each of the first and second deformable portions having an undeformed condition wherein the contact portion is at the undeformed contact portion angle and a deformed condition wherein the contact portion is at the flexed contact portion angle.

5. The fixation device of claim 2 , wherein the flexure portion includes at least one slit configured to enable the contact portion to move between the undeformed contact portion angle and the flexed contact portion angle.

6. The fixation device of claim 5 , wherein the at least one slit comprises at least one transverse cut in opposing lateral sides of the at least one arm.

7. The fixation device of claim 5 , wherein the at least one slit comprises a plurality of transverse cuts extending from each opposing lateral side of the at least one arm.

8. The fixation device of claim 5 , wherein each of the at least one slit is between about 0.01 inch to about 0.03 inch wide.

9. The fixation device of claim 5 , wherein each of the at least one slit is filled with a polymer having a durometer less than a durometer of the at least one arm.

10. The fixation device of claim 5 , wherein the at least one slit is formed of a kerf cut.

11. The fixation device of claim 2 , wherein the at least one arm extends from a first end proximate the central element to an opposing second end, wherein the contact portion is proximate the opposing second end, and the flexure portion is adjacent the contact portion.

12. The fixation device of claim 2 , wherein the at least one gripping element comprises a mid-length portion disposed along the at least one gripping element and spaced from a free end of the at least one gripping element, and the at least one gripping element further comprises an end portion proximate the free end, wherein the end portion is biased towards the at least one arm relative to the mid-length portion.

13. The fixation device of claim 1 , wherein the at least one leg comprises the flexure portion.

14. The fixation device of claim 13 , wherein the flexure portion comprises a spring feature configured to deform elastically under a compressive load.

15. The fixation device of claim 13 , wherein the flexure portion comprises a C-shaped compression link configured to enable the flex angle range be up to about 15 degrees.

16. The fixation device of claim 13 , wherein the flexure portion comprises an S-shaped compression link configured to enable the flex angle range be up to about 30 degrees.

17. The fixation device of claim 13 , wherein the flexure portion comprises a trapezoidal-shaped compression link configured to enable the flex angle range be about 10 to 15 degrees.

18. The fixation device of claim 17 , wherein the trapezoidal-shaped compression link has a width dimension that increases from a proximal location to a distal location.

19. The fixation device of claim 13 , wherein the flexure portion comprises at least one stop configured to limit the flex angle range.

20. The fixation device of claim 19 , wherein the at least one stop limits the flex angle range to up to about 10 degrees.

21. The fixation device of claim 1 , wherein the flexure portion includes an arm flexure portion disposed on the at least one arm configured to enable an arm source flexion angle range, and the flexure portion further includes a leg flexure portion disposed on the at least one leg configured to enable a leg source flexion angle range, wherein the arm source flexion angle range and leg source flexion range combine to enable the flex angle range.

22. The fixation device of claim 21 , wherein the combined arm source flex angle range and leg source flex angle range is about 45 degrees or less.

23. The fixation device of claim 1 , wherein the central element comprises a base portion coupled to the at least one leg, wherein distal movement of the base portion moves the at least one leg to move the at least one arm towards the fully open position.

24. The fixation device of claim 23 , wherein the fixation device is configured to prevent distal movement of the base portion when the at least one arm is in the selected position.

25. The fixation device of claim 24 , wherein the fixation device further comprises a locking mechanism configured to prevent distal movement of the base portion.

Assignees

• Evalve Inc

Inventors

• Abunassar Chad
• Gonzales Gabriel
• Jain Samir
• Mccoy Jill

Classifications

• A61F2230/0026

  trapezoidal · CPC title

• A61F2220/0016

  with sharp anchoring protrusions, e.g. barbs, pins, spikes · CPC title

• A61F2250/0029

  differing in bending or flexure capacity · CPC title

• A61B17/122

  Clamps or clips, e.g. for the umbilical cord {(for the vas deferens A61F6/206)} · CPC title

• A61F2/2466 Primary

  Delivery devices therefor · CPC title