Modular dis-assembly of transcatheter valve replacement devices and uses thereof

• US 10,543,078 B2
• Filed: 10/16/2014
• Issued: 01/28/2020
• Est. Priority Date: 10/16/2013
• Status: Active Grant

• Current Assignee: Cedars-Sinai Medical Center (Cedars Sinai Health System)
• Original Assignee: Cedars-Sinai Medical Center (Cedars Sinai Health System)
• Inventors: Al-Jilaihawi, Hasanian, Makkar, Rajendra
• Primary Examiner(s): Rosen, Eric J
• Assistant Examiner(s): Labranche, Brooke
• Application Number:
  US15/023,995
• Publication Number:
  US 20160228241A1
• Time in Patent Office: 1,930 Days
• 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 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2210/0071 thermoplastic
• CPC Class Codes: A61F 2220/0025 Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2250/0031 made from both resorbable and non-resorbable prosthetic parts, e.g. adjacent parts
• CPC Class Codes: A61F 2250/0071 breakable or frangible
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2310/00023 Titanium or titanium-based alloys, e.g. Ti-Ni alloys
• CPC Class Codes: A61F 2310/00041 Magnesium or Mg-based alloys
• CPC Class Codes: A61F 2310/00149 Platinum or Pt-based alloys
• CPC Class Codes: A61F 2310/00155 Gold or Au-based alloys

Abstract

The present invention provides modular transcatheter valve replacement devices and methods of using the same to treat valvular heart diseases. Disclosed is a bottom module that contains a heart valve replacement, and a top module connected to the bottom module. The top module may be bio-absorbable, or may contain one or more severable joints that allow the top module to be removed after implantation. The removable or absorbable top portion serves to add additional length the structure to add in orientation during implantation, but is removed or absorbed to minimize the metal and other foreign material in a patient'"'"'s body that could cause thrombosis or other reactions.

Claims

1. A device for replacement of a heart valve comprising a top module comprising a frame and having a first width that is constant along a longitudinal axis for the entire length of the top module when in an expanded configuration;

at least two retrieval cords attached to the top module;

a bottom module comprising a second width equivalent to the first width, wherein the bottom module comprises a replacement heart valve; and

a severable joint connecting the top module to the bottom module that is configured to release the top module from the bottom module after implantation of the bottom module.

2. The device of claim 1, wherein the top module is about 10-30 mm in length.

3. The device of claim 1, wherein the bottom module is about 10-20 mm in length.

4. The device of claim 1, wherein the bottom module is configured to replace aortic valve, mitral valve, pulmonary valve, or tricuspid valve.

5. The device of claim 1, wherein the frame comprises a nitinol or an alternative alloy.

6. The device of claim 1, wherein the bottom module comprises a nitinol or an alternative alloy frame.

7. The device of claim 1, wherein the replacement heart valve is a prosthetic valve or a bio-prosthetic valve.

8. The device of claim 1, wherein the top module is self-expandable or balloon expandable.

9. The device of claim 1, wherein the bottom module is self-expandable or balloon expandable.

10. The device of claim 1, wherein the severable joint is a mechanical release mechanism.

11. The device of claim 1, wherein the severable joint is an electrically activated mechanical release mechanism.

12. The device of claim 1, wherein the severable joint is electrolytically dissolvable through application of positive current.

13. The device of claim 1, wherein the at least two retrieval cords are made of nitinol.