Heart valve prosthesis for controlled thrombus development

• US 10,709,554 B2
• Filed: 03/01/2017
• Issued: 07/14/2020
• Est. Priority Date: 03/03/2016
• Status: Active Grant

• Current Assignee: Biotronik AG (Biotronik SE & Company KG)
• Original Assignee: Biotronik AG (Biotronik SE & Company KG)
• Inventors: Quint, Bodo
• Primary Examiner(s): Stewart, Jason-Dennis N
• Application Number:
  US15/446,381
• Publication Number:
  US 20170252155A1
• Time in Patent Office: 1,231 Days
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/246 Devices for obstructing a leak through a native valve in a closed condition
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61F 2250/0069 Sealing means
• CPC Class Codes: A61L 2400/04 Materials for stopping bleeding
• CPC Class Codes: A61L 2430/20 for reconstruction of the heart, e.g. heart valves
• CPC Class Codes: A61L 27/26 Mixtures of macromolecular compounds
• CPC Class Codes: C08L 5/08 Chitin; Chondroitin sulfate; Hyaluronic acid; Derivatives thereof

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.

Claims

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 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 consist of an absorbable, chitosan-containing or chitosan-based polymer.

23. 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 fibres are secured to the main body in an integrally bonded, force-fitting and/or form-fitting manner.

24. The heart valve prosthesis according to claim 17, 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 configured and of material to deform 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.

25. The heart valve prosthesis according to claim 17, wherein the thrombus production and thrombus immobilising terminating material comprises the textile immobilised fibres or the interconnected multi-filament fibres, and the fibres of the textile immobilised fibres or the interconnected multi-filament fibres comprise a polymer mixture, wherein the polymer mixture comprises chitosan and a water-insoluble polymer.

26. The heart valve prosthesis according to claim 17, wherein the heart valve is formed of biological tissue.

27. 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 terminating material on an outer side of the main body formed of material and configured to induce a thrombus, 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, wherein the terminating material is arranged in a blood-permeable bag, which is arranged on an outer side of the main body and is secured to the main body at a position of the main body that corresponds to the native heart valve, and wherein the bag comprises a filter structure with through-openings or pores which have a diameter greater than 10 μ

m and the terminating material is arranged loosely in the bag.