Perivalvular Occlusion Device and Methods

• US 20180055627A1
• Filed: 08/31/2016
• Published: 03/01/2018
• Est. Priority Date: 08/31/2016
• Status: Active Grant

• Current Assignee: Drasler, William Joseph
• Original Assignee: Drasler, William Joseph
• Inventors: Drasler, William Joseph
• Granted Patent: US 10,238,492 B2
• Time in Patent Office: Days
• CPC Class Codes: A61F 2/246 Devices for obstructing a leak through a native valve in a closed condition
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas

Abstract

An occlusion device intended for blocking perivalvular leak channels that are found following heart valve implantation between the heart valve and the surrounding tissue. The occlusion device has a stent and a covering that is attached to the stent surface. A blocking fabric extends across the lumen of the stent to block blood flow. The stent pattern and wall structure provide for small radius of curvature bends to fill narrow channels that cause the perivalvular leaks.

Claims

1. An occlusion device for occluding a perivalvular leak channel located along the perimeter of an implanted valve of the heart, said occlusion device comprising;

A. an occlusion balloon having a first element of a holding assembly located at a proximal end of said occlusion balloon, said proximal end of said occlusion balloon having an open orifice,

B. a stent located on an outer surface of said occlusion balloon,

C. a delivery tube having a second element of said holding assembly located at a distal end of said delivery tube, said second element of said holding assembly being attachable to said first element of said holding assembly, said holding assembly holding said occlusion balloon into a sealing contact with said delivery tube for delivery of inflation fluid to said occlusion balloon to provide said occlusion balloon with an inflated volume, said first element of said holding assembly being detachable from said second element of said holding assembly,

D. said occlusion balloon able to provide passage for unrestricted removal of said inflated volume out of said open orifice with said occlusion balloon detached from said delivery tube.

2. The occlusion device of claim 1 wherein said occlusion balloon is formed from an elastic material having an areal strain capability of at least 200%.

3. The occlusion device of claim 1 wherein said stent is formed from a BE material.

4. The occlusion device of claim 1 wherein said stent has hinges in bent regions and struts providing linear elements connecting said hinges;

said hinges having a hinge width that is less than a strut width of said struts.

5. The occlusion device of claim 1 wherein said stent has hinges in bent regions and struts providing linear elements that join to said hinges, said hinges having a hinge radial dimension that is greater than a strut radial dimension of said struts.

6. The occlusion device of claim 4 wherein said hinges having a hinge radial dimension that is greater than a strut radial dimension of said struts.

7. The occlusion device of claim 4 wherein said hinges are formed from a plastically deformable material and said struts are formed from a self-expanding material.

8. The occlusion device of claim 4 wherein said hinges and said struts are formed from a plastically deformable material.

9. The occlusion device of claim 4 wherein said hinges and said struts are formed from a self-expanding elastic material.

10. The occlusion device of claim 1 wherein said holding assembly is formed from a thread and screw mechanism.

11. The occlusion device of claim 1 wherein said holding assembly comprises a balloon stop located on said occlusion balloon and a member stop located on said delivery tube;

said member stop having a larger diameter than said balloon stop during attachment of said occlusion balloon to said delivery tube;

said member stop having a smaller diameter than said balloon stop during detachment of said occlusion balloon from said delivery tube.

12. The occlusion device of claim 1 further comprising a check valve located within said occlusion balloon;

said check valve providing one-way entry of inflation medium from said delivery tube into said occlusion balloon, said check valve preventing passage for said inflation medium out of said open orifice following detachment of said occlusion balloon from said delivery tube.

13. The occlusion device of claim 1 wherein said occlusion balloon has a slidable seal located at a distal end of said occlusion balloon, said slidable seal providing for passage of a guidewire therethrough, said slidable seal preventing substantial leakage of inflation fluid out of said occlusion balloon during inflation of said occlusion balloon with inflation fluid.