Balloon Expandable Leaflet Protection During Crimping

Patent metadata

Field	Value
Publication number	US-2023390055-A1
Application number	US-202318327144-A
Country	US
Kind code	A1
Filing date	Jun 1, 2023
Priority date	Jun 6, 2022
Publication date	Dec 7, 2023
Grant date	—

Abstract

According to one aspect of the disclosure, a prosthetic heart valve system includes a prosthetic heart valve including a stent, a cuff and a plurality of leaflets, the cuff and the plurality of leaflets forming a valve assembly, and an expandable balloon having a deflated state and an inflated state, the expandable balloon being configured and arranged to transition the prosthetic heart valve from a collapsed condition to an expanded condition and protect portions of the valve assembly during crimping and delivery.

First claim

1 . A prosthetic heart valve system, comprising:
a prosthetic heart valve including a stent, a cuff and a plurality of leaflets, the cuff and the plurality of leaflets forming a valve assembly; and an expandable balloon having a deflated state and an inflated state, the expandable balloon being configured and arranged to transition the prosthetic heart valve from a collapsed condition to an expanded condition and protect portions of the valve assembly during crimping and delivery.

2 . The prosthetic heart valve system of claim 1 , wherein the expandable balloon includes a plurality of pleats.

3 . The prosthetic heart valve system of claim 2 , wherein the plurality of pleats includes three pleats.

4 . The prosthetic heart valve system of claim 2 , wherein the plurality of pleats includes six pleats.

5 . The prosthetic heart valve system of claim 2 , wherein the plurality of pleats corresponds to the plurality of leaflets.

6 . The prosthetic heart valve system of claim 2 , wherein the plurality of pleats define a number of interior pockets configured and arranged to receive portions of the plurality of leaflets.

7 . The prosthetic heart valve system of claim 1 , wherein the expandable balloon is star-shaped and includes a plurality of arms in the deflated state.

8 . The prosthetic heart valve system of claim 7 , wherein the plurality of arms is configured and arranged to gather and wind portions of the plurality of leaflets.

9 . The prosthetic heart valve system of claim 8 , wherein the star-shaped balloon is wound in a first direction, and the plurality of leaflets is wound in a second direction, the first direction and the second direction being similar.

10 . The prosthetic heart valve system of claim 8 , wherein the star-shaped balloon is wound in a first direction, and the plurality of leaflets is wound in a second direction, the first direction and the second direction being different.

11 . The prosthetic heart valve system of claim 1 , further comprising a removable protective sleeve disposed between the valve assembly and the stent frame during delivery.

12 . The prosthetic heart valve system of claim 1 , wherein the prosthetic heart valve has a non-circular collapsed state.

13 . The prosthetic heart valve system of claim 12 , wherein the prosthetic heart valve has a substantially triangular collapsed state.

14 . A method of delivery a prosthetic heart valve system, comprising:
providing a prosthetic heart valve including a stent, a cuff and a plurality of leaflets, the cuff and the plurality of leaflets forming a valve assembly; placing an expandable balloon inside the prosthetic heart valve in a deflated state, the expandable balloon having features to protect the prosthetic heart valve during crimping and delivery; and crimping the prosthetic heart valve and the expandable balloon while the features protect portions of the valve assembly.

15 . The method of claim 14 , further comprising rotating the expandable balloon with respect to the stent of the prosthetic heart valve prior to, or during, crimping the prosthetic heart valve.

16 . The method of claim 14 , wherein placing an expandable balloon comprises placing an expandable balloon having a plurality of pleats inside the prosthetic heart valve.

17 . The method of claim 16 , wherein placing an expandable balloon comprises placing an expandable balloon having a plurality of pleats and a number of interior pockets, and further comprising placing portions of the plurality of leaflets in the interior pockets of the expandable balloon.

18 . The method of claim 14 , further comprising winding the expandable balloon into a spiral configuration.

19 . The method of claim 14 , further comprising winding the expandable balloon in a first direction, and winding the plurality of leaflets in a second direction, the first direction and the second direction being similar.

20 . The method of claim 14 , further comprising winding the expandable balloon in a first direction, and winding the plurality of leaflets in a second direction, the first direction and the second direction being different.

Assignees

• St Jude Medical Cardiology Div Inc

Inventors

• Eidenschink Tracee
• Morrissey Michael Shane
• Laplante Jeffrey Paul

Classifications

• A61F2/2418 Primary

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

• A61F2/2433

  using balloon catheter · CPC title

• A61F2220/0075

  sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable · CPC title

• A61F2230/0002

  Two-dimensional shapes, e.g. cross-sections · CPC title

• A61F2250/0069

  Sealing means · CPC title