IP Library › Granted Patent US 9,987,130
Granted Patent B2
US 9,987,130 · App. 13/708,292 · Granted Jun 5, 2018

Decalcifying heart valve

Inventor: Jan Weber (Maastricht, NL)
Assignee: Boston Scientific Scimed, Inc.
A61F2/2412A61F2/2415A61F2/2418A61L31/10A61L31/145A61F2220/005A61F2220/0058A61F2220/0075
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Quick Facts
Patent No.
US 9,987,130
App. No.
13/708,292
Granted
Jun 5, 2018
Kind
B2
Abstract

Vascular valve systems for treating calcified vascular vessel valves by delivery of one or more calcium chelating agents are described. The vascular valve system includes an expandable stent; a valve with a plurality of leaflets, and a hydrogel layer disposed on an outer surface of the stent. The hydrogel layer includes a hydrogel, and a calcium-chelating agent and an acidifying agent disposed within the hydrogel. The calcium-chelating agent and the acidifying agent are covalently bonded to the hydrogel. The hydrogel layer is configured to capture loosened calcium deposits to form a calcium-chelating agent complex covalently bonded to the hydrogel layer. Methods of making the vascular valve systems are also described.

Claims (31)

1. A vascular valve system comprising:

an expandable stent comprising an outer surface and a lumen;

a valve comprising a plurality of leaflets, wherein the valve is disposed within the lumen and coupled to the expandable stent; and

a hydrogel layer disposed on at least a portion of the outer surface of the stent, the layer comprising a hydrogel, and a calcium-chelating agent and an acidifying agent disposed within the hydrogel, wherein the calcium-chelating agent and the acidifying agent are covalently bonded to the hydrogel; and

wherein the hydrogel layer is configured to capture loosened calcium deposits to form a calcium-chelating agent complex covalently bonded to the hydrogel layer.

2. The vascular valve system of claim 1 , wherein the valve comprises at least two leaflets.

3. The vascular valve system of claim 1 , wherein the valve comprises three leaflets.

4. The vascular valve system of claim 1 , wherein the valve comprises porcine pericardium or a polymeric material.

5. The vascular valve system of claim 1 , wherein the valve is attached to the stent with a plurality of sutures.

6. The vascular valve system of claim 1 , wherein the hydrogel layer is disposed around a circumference of the valve.

7. The vascular valve system of claim 6 , the hydrogel layer spanning up to 90% of the full length of the expandable stent.

8. The vascular system of claim 1 , wherein the hydrogel is in the form of a plurality of fibers, a coating, a sheet, a film, or a viscous liquid.

9. The vascular valve system of claim 1 , wherein the hydrogel is selected from the group consisting of oligo(amidoamine/β-amino ester), gelatin, methyl cellulose, collagen, gelatin, chitosan, hyaluronic acid, chondroitin sulfate, alginate, agar, agarose, fibrin, polyethylene glycol, polyethylene oxide, polyvinyl alcohol, poly(propylene fumarate), oligo(polyethylene glycol) fumarate, poly(N-isopropylacrylamide), polypropylene oxide, poly(aldehyde guluronate), polylactic acid, polyglycolic acid, poly(lactic-co-glycolic) acid, polyanhydride, combinations thereof, and copolymers thereof.

10. The vascular valve system of claim 1 , wherein the calcium-chelating agent is selected from the group consisting of ethylene diamine tetraacetic acid, phosphonates, 1,2-bis(2-aminophenoxy)ethane-N,N,N′,N′-tetraacetic acid, ethylene glycol-bis(2-aminoethylether)-N,N,N′,N′-tetraacetic acid, trans-1,2-cyclohexanediaminetetraacetic acid, N-hydroxyethylenediaminetriacetic acid, diethylenetriaminepentaacetic acid, and glycine.

11. The vascular valve system of claim 1 , wherein the hydrogel comprises from one percent to ten percent by weight of the calcium-chelating agent.

12. The vascular valve system of claim 1 , wherein the acidifying agent is selected from the group consisting of citric acid, ascorbic acid, acetic acid, lactic acid, and any combination thereof.

13. The vascular valve system of claim 1 , wherein the hydrogel comprises from 0.5 percent to 20 percent by weight of the acidifying agent.

14. The vascular valve system of claim 1 , wherein the hydrogel is crosslinkable.

15. The vascular valve system of claim 1 , wherein the hydrogel comprises polyethylene glycol diacrylate and poly(ethylene glycol) dimethacrylate.

16. The vascular valve system of claim 1 , the hydrogel layer comprising a network of electrospun fibers.

17. A vascular valve system comprising:

an expandable stent comprising an outer surface and a lumen;

a valve comprising a plurality of leaflets, wherein the valve is disposed within the lumen and coupled to the expandable stent;

a permeable housing disposed on one or more leaflets, or around a portion of the outer surface of the stent, or both, wherein a hydrogel is disposed within the housing; and

a calcium-chelating agent and an acidifying agent disposed within the hydrogel and covalently bonded thereto; and

wherein the hydrogel layer is configured to capture loosened calcium deposits to form a calcium-chelating agent complex covalently bonded to the hydrogel layer.

18. The vascular valve of claim 17 , wherein the permeable housing is disposed around a circumference of the valve.

19. The vascular valve system of claim 17 , wherein the hydrogel is selected from the group consisting of oligo(amidoamine/β-amino ester), gelatin, methyl cellulose, collagen, gelatin, chitosan, hyaluronic acid, chondroitin sulfate, alginate, agar, agarose, fibrin, polyethylene glycol, polyethylene oxide, polyvinyl alcohol, poly(propylene fumarate), oligo(polyethylene glycol) fumarate, poly(N-isopropylacrylamide), polypropylene oxide, poly(aldehyde guluronate), polylactic acid, polyglycolic acid, poly(lactic-co-glycolic) acid, polyanhydride, combinations thereof, and copolymers thereof.

20. The vascular valve system of claim 17 , wherein the calcium-chelating agent is selected from the group consisting of ethylene diamine tetraacetic acid, phosphonates, 1,2-bis(2-aminophenoxy)ethane-N,N,N′,N′-tetraacetic acid, ethylene glycol-bis(2-aminoethylether)-N,N,N′,N′-tetraacetic acid, trans-1,2-cyclohexanediaminetetraacetic acid, N-hydroxyethylenediaminetriacetic acid, diethylenetriaminepentaacetic acid, and glycine.

21. The vascular valve system of claim 17 , wherein the acidifying agent is selected from the group consisting of citric acid, ascorbic acid, acetic acid, lactic acid, and any combination thereof.

22. The vascular valve system of claim 17 , wherein the hydrogel comprises polyethylene glycol diacrylate and poly(ethylene glycol) dimethacrylate.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 6, 2013
From: WEBER, JAN
To: BOSTON SCIENTIFIC SCIMED, INC.
Reel/Frame 030560/0924 →
Continuity (2)
Provisional Application 61569961 · Dec 13, 2011
Related Publication 20130150957A1 · Jun 13, 2013