SELF-SEALING SHELL FOR INFLATABLE PROSTHESES

• US 20100049316A1
• Filed: 08/19/2009
• Published: 02/25/2010
• Est. Priority Date: 08/20/2008
• Status: Active Grant

• Current Assignee: Allergan, Inc. (Canada) (Abbvie Incorporated)
• Original Assignee: Allergan, Inc. (Canada) (Abbvie Incorporated)
• Inventors: Schuessler, David J.
• Granted Patent: US 8,690,943 B2
• Time in Patent Office: Days
• US Class Current: 623/8
• CPC Class Codes: A61B 90/02 Devices for expanding tissue, e.g. skin tissue implements for holding wounds open, surgical tractors A61B17/02; implantable mammary prosthesis A61F2/12; dilators A61M29/00
• CPC Class Codes: A61F 2/12 Mammary prostheses and implants
• CPC Class Codes: A61F 2210/0061 swellable
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61F 5/003 inflatable
• CPC Class Codes: A61F 5/0036 Intragastrical devices
• CPC Class Codes: B29C 41/003 characterised by the choice of material
• CPC Class Codes: B29C 41/06 about two or more axes
• CPC Class Codes: B29C 73/16 Auto-repairing or self-sealing arrangements or agents incorporating auto-repairing or self-sealing arrangements or agents on or into tyres B29D30/0685
• CPC Class Codes: B29C 73/163 Sealing compositions or agents, e.g. combined with propellant agents
• CPC Class Codes: B29C 73/18 the article material itself being self-sealing, e.g. by compression
• CPC Class Codes: B29C 73/20 the article material only consisting in part of a deformable sealing material
• CPC Class Codes: B29C 73/22 the article containing elements including a sealing composition, e.g. powder being liberated when the article is damaged
• CPC Class Codes: B29K 2083/00 Use of polymers having silicon, with or without sulfur, nitrogen, oxygen, or carbon only, in the main chain, as moulding material
• CPC Class Codes: B29K 2995/0062 water-soluble
• CPC Class Codes: B29L 2031/7532 Artificial members, protheses

Abstract

A self-sealing shell useful as a component of a soft fluid-filled prosthetic implant is provided. The shell is at least partly constructed of a wall made of a colloid of an elastomeric polymer matrix and particles of a water-swellable material distributed therein.

Claims

1. A shell for an inflatable implant, the shell comprising

a wall comprising an elastomer component and discontinuous particles of a swellable material dispersed in the elastomer component;

wherein, when the wall is contacted with an aqueous fluid, the particles of swellable material enlarge such that the wall becomes self-sealing to a needle puncture.

2. The shell of claim 1 wherein the wall is not self sealing when it is in a dry state.

3. The shell of claim 1 wherein the particles comprise hydrogel particles.

4. The shell of claim 1 wherein the particles comprise a hydrogel comprising polyethylene glycol.

5. The shell of claim 1 wherein the particles comprise a hydrogel comprising hydroxyethylcellulose.

6. The shell of claim 1 wherein the elastomer component comprises a silicone elastomer material.

7. The shell of claim 1 wherein the particles comprise hydrogel particles having a size of between about 50 microns to about 1000 microns.

8. The shell of claim 1 wherein the particles comprise hydrogel particles having a size of between about 200 microns to about 350 microns.

9. The shell of claim 1 wherein the water swellable particles make up between about 2% to about 40% by weight of the composition.

10. The shell of claim 1 wherein the water swellable particles make up between about 25% by weight of the composition.

15. The shell of claim 1 wherein the particles comprise a hydrogel comprising hydroxyethylcellulose.

11. An implantable article of manufacture useful as a component of an inflatable prosthesis, the article made by the steps of:

providing a curable polymer-based liquid;

distributing a plurality of solid, water swellable particles in the liquid to form a fluid mixture comprising a liquid polymer and solid, water swellable particles;

allowing the mixture to solidify to form a polymeric matrix having solid, water swellable particles occupying enclosed spaces in the matrix,

forming the mixture into a wall of an inflatable prosthesis;

wherein, when the wall is contacted with an aqueous fluid, the water swellable particles expand and the wall becomes self-sealing to a needle puncture.

12. The article of claim 11 wherein the wall is not self sealing when it is in a dry state.

13. The shell of claim 11 wherein the particles comprise hydrogel particles.

14. The shell of claim 11 wherein the particles comprise a hydrogel comprising polyethylene glycol.

16. A method of making an implantable article useful as a component of an inflatable prosthesis, the method comprising the steps of:

providing a curable polymer-based liquid;

distributing a plurality of solid, water swellable particles in the liquid to form a fluid mixture comprising a liquid polymer and solid, water soluble particles;

allowing the mixture to solidify to form a polymeric matrix having solid, water swellable particles occupying enclosed spaces in the matrix; and

forming the mixture into a wall of an inflatable prosthesis;

wherein, when the wall is contacted with an aqueous fluid, the water swellable particles expand and the wall becomes self-sealing to a needle puncture.

17. The method of claim 16 wherein the wall is not self sealing when it is in a dry state.

18. The method of claim 16 wherein the water swellable particles make up between about 2% to about 40% by weight of the mixture.

19. The method of claim 16 wherein the water swellable particles make up about 25% by weight of the mixture.

20. A method of making an implantable soft prosthesis, comprising:

providing a liquid polymer matrix;

distributing a particles of a water-swellable material in the polymer matrix to form a colloid;

allowing the colloid to solidify;

forming the colloid into a wall of a shell for an inflatable prosthesis; and

contact the wall with an aqueous fluid such that the particles swell and the wall becomes capable of self-sealing around a needle puncture.