Heart valve prosthesis for controlled thrombus development

Patent metadata

Field	Value
Publication number	US-10709554-B2
Application number	US-201715446381-A
Country	US
Kind code	B2
Filing date	Mar 1, 2017
Priority date	Mar 3, 2016
Publication date	Jul 14, 2020
Grant date	Jul 14, 2020

Abstract

The invention relates to a heart valve prosthesis including a heart valve a main body for supporting the heart valve. The heart valve includes a terminating material selected from material and configured to at least partially close a paravalvular leak by controlled thrombus development.

First claim

What is claimed is:

1. A heart valve prosthesis, comprising: a main body in the form of an expandable or self-expanding stent; an artificial heart valve secured in the interior of the main body and surrounded by the main body; and a thrombus production and thrombus immobilising terminating material in the form of textile-immobilised fibers within a blood-permeable bag on the outer side of the main body, or a thrombus production and thrombus immobilising terminating material in the form of interconnected multi-filament fibres on the outer side of the main body that mechanically separate from each other in response to blood flow, or a thrombus production and thrombus immobilising terminating material in the form of a permeable sponge-like structure.

2. The heart valve prosthesis according to claim 1 , wherein the thrombus production and thrombus immobilising terminating material comprises the textile-immobilised fibers within a blood-permeable bag on the outer side of the main body, wherein the blood-permeable bag comprises liquid permeable material.

3. The heart valve prosthesis according to claim 1 , wherein the terminating material comprises at least one of a polymer, a biological polymer, an artificial polymer, a cationic polymer, a polycation, or chitosan.

4. The heart valve prosthesis according to claim 1 , wherein the terminating material consists of a polymer, a biological polymer, an artificial polymer, a cationic polymer, a polycation, or chitosan.

5. The heart valve prosthesis according to claim 1 , wherein the thrombus production and thrombus immobilising terminating material comprises the textile-immobilised fibers within a blood-permeable bag on the outer side of the main body, wherein the blood-permeable bag comprises at least one of polyethylene, polyethylene terephthalate, polyethylene succinate, polybutylene succinate, polyester, polylactide, and polycaprolactone.

6. The heart valve prosthesis according to claim 1 , wherein the thrombus production and thrombus immobilising terminating material comprises the textile-immobilised fibers within a blood-permeable bag on the outer side of the main body, wherein the blood-permeable bag consists of one of polyethylene, polyethylene terephthalate, polyethylene succinate, polybutylene succinate, polyester, polylactide, and polycaprolactone.

7. The heart valve prosthesis according to claim 1 , wherein the thrombus production and thrombus immobilising terminating material comprises the interconnected multi-filament fibres on the outer side of the main body, wherein the interconnected multi-filament fibres are secured to the main body in an integrally bonded, force-fitting and/or form-fitting manner.

8. The heart valve prosthesis according to claim 1 , wherein the thrombus production and thrombus immobilising terminating material comprises the textile immobilised fibres or the interconnected multi-filament fibres, and the fibres are formed of material to that deforms upon contact with water from an elongate first state into a second state, wherein the fibres in the second state have a multiplicity of curvatures.

9. The heart valve prosthesis according to claim 1 , wherein the thrombus production and thrombus immobilising terminating material comprises the textile immobilised fibres or the interconnected multi-filament fibres, and the fibres comprise a polymer mixture, wherein the polymer mixture comprises chitosan and a water-insoluble polymer.

10. The heart valve prosthesis according to claim 9 , wherein the water-insoluble polymer comprises P(VP-co-VAc).

11. The heart valve prosthesis according to claim 1 , wherein the thrombus production and thrombus immobilising terminating material comprises the textile immobilised fibres or the interconnected multi-filament fibres, and individual fibres of the textile immobilised fibres or the interconnected multi-filament fibres are coated with a soluble polymer.

12. The heart valve prosthesis according to claim 11 , wherein the soluble polymer is selected from the group consisting of polyvinylpyrrolidone, polyethylene glycol, hyaluronic acid, and polysugars.

13. The heart valve prosthesis according to claim 11 , wherein the soluble polymer comprises polysugars that are selected from pullulan or dextrans.

14. The heart valve prosthesis according to claim 1 , wherein the thrombus production and thrombus immobilising terminating material comprises the textile immobilised fibres or the interconnected multi-filament fibres, and the textile immobilised fibres or the interconnected multi-filament fibres comprise polycation fibres and a surrounding shell formed of rigid supporting fibres.

15. The heart valve prosthesis according to claim 1 , wherein the heart valve prosthesis is configured to be implanted by a catheter.

16. The heart valve prosthesis according to claim 1 , wherein the heart valve is formed of biological tissue.

17. A heart valve prosthesis, comprising a main body in the form of an expandable or self-expanding stent; an artificial heart valve secured in the interior of the main body and surrounded by the main body; and a thrombus production and thrombus immobilising terminating material in the form of textile-immobilised fibers within a blood-permeable bag on the outer side of the main body, or a thrombus production and thrombus immobilising terminating material in the form of interconnected multi-filament fibres on the outer side of the main body that mechanically separate from each other in response to blood flow or a thrombus production and thrombus immobilising terminating material in the form of a permeable sponge-like structure, wherein the terminating material includes at least one of the following materials or is formed by at least one of the following materials: a polymer, a biological polymer, an artificial polymer, a cationic polymer, a polycation, in particular of biological origin, chitosan, chitosan chloride, or chitin.

18. The heart valve prosthesis according to claim 17 , wherein the terminating material comprises compounds (mixtures or also blends) with diethylaminoethyl dextran or diethylaminoethylated cellulose or which are directly produced by diethylaminoethylation of hydroxyl-rich polymer surfaces.

19. The heart valve prosthesis according to claim 17 , wherein the thrombus production and thrombus immobilising terminating material comprises the textile-immobilised fibers within a blood-permeable bag on the outer side of the main body, wherein the blood-permeable bag comprises or consists of one of the following materials: HDPE (high density polyethylene), UHMWPE (ultra-high-molecular-weight polyethylene), polyethylene terephthalate (PET), polyethylene succinate, polybutylene succinate, polyester, polylactide and polycaprolactone.

20. The heart valve prosthesis according to claim 17 , wherein the thrombus production and thrombus immobilising terminating material comprises the interconnected multi-filament fibres on the outer side of the main body, wherein the interconnected multi-filament fibres are secured to the main body in an integrally bonded, force-fitting and/or form-fitting manner.

21. The heart valve prosthesis according to claim 17 , wherein the thrombus production and thrombus immobilising terminating material comprises the interconnected multi-filament fibres on the outer side of the main body, wherein the interconnected multi-filament fibres are tied or glued to the main body.

22. The heart valve prosthesis according to claim 17 , wherein the thrombus production and th

Assignees

• Biotronik Ag

Inventors

• Quint Bodo

Classifications

• A61L2400/04

  Materials for stopping bleeding · CPC title

• A61L2430/20

  for reconstruction of the heart, e.g. heart valves · CPC title

• A61F2250/0069

  Sealing means · CPC title

• A61L27/26

  Mixtures of macromolecular compounds · CPC title

• A61F2/2418 Primary

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