INFLATION MEDIA FOR IMPLANTS

• US 20120022629A1
• Filed: 05/18/2011
• Published: 01/26/2012
• Est. Priority Date: 05/19/2010
• Status: Active Grant

• Current Assignee: Speyside Medical, LLC
• Original Assignee: Direct Flow Medical, Inc.
• Inventors: Greenan, Trevor, Perera, Aruna, Rogers, Larry
• Granted Patent: US 9,433,501 B2
• Time in Patent Office: Days
• US Class Current: 623/1.11
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61F 2/24 Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• 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 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2210/0085 hardenable in situ, e.g. epoxy resins
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61F 2310/00005 The prosthesis being constructed from a particular material
• CPC Class Codes: A61L 27/18 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/50 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: A61M 2025/0046 Coatings for improving slidability
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 25/0009 Making of catheters or other medical or surgical tubes
• CPC Class Codes: A61M 25/0023 by the form of the lumen, e.g. cross-section, variable diameter
• CPC Class Codes: A61M 25/005 with embedded materials for reinforcement, e.g. wires, coils, braids
• CPC Class Codes: A61M 25/0054 with regions for increasing flexibility
• CPC Class Codes: B29C 48/11 : comprising two or more partially or fully enclosed cavities, e.g. honeycomb-shaped
• CPC Class Codes: B29L 2031/7542 : Catheters
• CPC Class Codes: C08G 59/5026 : cycloaliphatic
• CPC Class Codes: C08L 63/00 : Compositions of epoxy resins; Compositions of derivatives of epoxy resins
• CPC Class Codes: G01N 2203/0071 : Creep
• CPC Class Codes: G01N 2203/0073 : Fatigue

Abstract

An inflatable implant is disclosed. The inflatable implant comprises at least one inflation channel for forming an inflatable structure of the inflatable implant; and an inflation media disposed within the at least one inflation channel, wherein the inflation media comprises a mixture of an epoxy resin and a hardener, the mixture is configured to gel at about 37° C. in less than about 2.5 hours after mixing to form a gelled mixture.

Claims

1. A inflatable implant comprising

at least one inflation channel for forming an inflatable structure of the inflatable implant;

and

an inflation media disposed within the at least one inflation channel, wherein the inflation media comprises a mixture of an epoxy resin and a hardener, the mixture is configured to have an average viscosity of less than about 100 cps at about 37°

C. over the first 10 minutes after mixing, and gel at about 37°

C. in less than about 2.5 hours after mixing to form a gelled mixture.

2. The inflatable implant of claim 1, wherein the gelled mixture has a tensile strength of greater than about 20 MPa when fully hydrated.

3. The inflatable implant of claim 1, wherein the mixture reaches at least about 70% cure in less than 20 hours.

4. The inflatable implant of claim 1, wherein the mixture exhibits less than about 10% creep when it is substantially completely cured.

5. The inflatable implant of claim 1, wherein the mixture has a fatigue life longer than about 600 million cycles when loaded at 1.5 MPa.

6. The inflatable implant of claim 1, wherein the surface of the inflatable implant is maintained at a temperature below 42°

C.

7. The inflatable implant of claim 1, wherein

the epoxy resin comprising a first compound having at least one N,N-bis(oxiran-2-ylmethyl)aniline segment and a second compound having at least two oxirane groups on a backbone of no more than five carbons;

and

the hardener comprising at least one cycloaliphatic amine.

24. A prosthetic valve implant delivery system comprising:

a deployment catheter comprising an inflation tube and a prosthetic valve comprising an inflatable structure in communication with the inflation tube; and

an inflation media of claim 1 for inflating the inflatable structure through the inflation tube.

25. The prosthetic valve implant delivery system of claim 24, wherein the deployment catheter has an inner diameter of 18 French.

26. A method of implanting a prosthetic valve within the heart, the method comprising:

translumenally advancing a prosthetic valve comprising an inflatable structure to a position proximate a native valve of the heart;

mixing the epoxy resin and the hardener in the inflation media of claim 1 to form an epoxy mixture; and

inflating the inflatable structure with the epoxy mixture.

27. The method of claim 26, wherein the epoxy mixture is formed ex-vivo and delivered to the inflatable structure.

28. The method of claim 26, wherein the epoxy mixture has an initial viscosity of less than about 50 cps after mixing, and is soluble in an aqueous environment.

29. The method of claim 26, wherein the epoxy mixture has a tensile strength of greater than about 40 MPa after becoming fully hydrated.

30. The method of claim 26, wherein the epoxy mixture cures to a semi-solid gel in less than about 4 hours at about 37°

C.

31. A method of treating a patient, comprising:

advancing a deployment catheter to a position proximate a native valve of the heart, the deployment catheter comprising an inflation tube and a prosthetic valve comprising an inflatable structure in communication with the inflation tube;

deploying the prosthetic valve at the cardiovascular site;

inflating the inflatable structure with an epoxy mixture comprising the inflation media of claim 1 through the inflation tube; and

detaching the deployment catheter from the prosthetic valve and removing the deployment catheter from the patient.

8. An inflation media comprising:

an epoxy resin comprising a first compound having at least one N,N-bis(oxiran-2-ylmethyl)aniline segment and a second compound having at least two oxirane groups on a backbone of no more than five carbons; and

a hardener comprising at least one cycloaliphatic amine.

9. The inflation media of claim 8, wherein the first compound is N,N-diglycidyl-4-glycidyloxyaniline or 4,4′

-methylenebis(N,Ndiglycidylaniline).

10. The inflation media of claim 8, wherein the second compound is selected from the group consisting of 1,4-butanediol diglycidyl ether, 1,2-ethanediol diglycidyl ether, polyglycidyl ether, and 1,3-butadiene diepoxide.

11. The inflation media of claim 8, wherein the at least one cycloaliphatic amine is selected from the group consisting of isophorone diamine, 1,3-bis-aminocyclohexane, diamino cyclobenxane, n-aminoethylpiperazine, and n-aminopropylpiperazine.

12. The inflation media of claim 8, wherein the hardener comprises isophorone diamine and 1,3-bis-aminocyclohexane.

13. The inflation media of claim 8, wherein the first compound is N,N-diglycidyl-4-glycidyloxyaniline, the second compound is 1,4-butanediol diglycidyl ether, and the hardener comprises isophorone diamine and 1,3-bis-aminocyclohexane.

14. The inflation media of claim 8, wherein the first compound is about 40% to about 60% by weight and the second compound is about 40% to about 60% by weight of the epoxy resin.

15. The inflation media of claim 8, wherein the epoxy resin further comprises a third compound having at least one of the following group:

16. The inflation media of claim 15, wherein the third compound is selected from the group consisting of tris(4-hydroxyphenyl)methane triglycidyl ether, bisphenyl-A diglycidyl ether, bisphenyl-F diglycidyl ether and resorcinol diglycidyl ether.

17. The inflation media of claim 8, wherein the hardener further comprises an aliphatic amine selected from the group consisting of diethylene triamine, tri-ethylene tetraamine and tetraethylenepentamine.

18. The inflation media of claim 17, wherein the cycloaliphatic amine is about 75% to about 100% and the aliphatic amine is about 0% to about 25% by weight of the hardener.

19. The inflation media of claim 8, wherein the hardener further comprises a radio-opaque compound.

20. The inflation media of claim 19, wherein the radio-opaque compound is selected from the group consisting of 3,5-diiodosalicylic acid, 3-iodo-1-propanol, 2,3,5-triiodobenzoic acid, 3,5-diiodobenzoic acid, 4-iodophenol, 2,4,6-triiodophenol, iodo benzoic acid, iodo salicylic acid, iodobenzene and diiodobenzene.

21. The inflation media of claim 8, wherein the hardener further comprises a catalyst.

22. The inflation media of claim 21, where in the catalyst is water, polybenzoic acid or polyphenol.

23. The inflation media of claim 8, wherein a mixture of the epoxy resin and the hardener has an average viscosity of less than about 100 cps at about 37°

C. over the first 10 minutes of formation.