Self-sealing shell for inflatable prostheses

• US 9,630,366 B2
• Filed: 07/11/2016
• Issued: 04/25/2017
• 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.
• Primary Examiner(s): Khare, Atul P.
• Application Number:
  US15/207,233
• Publication Number:
  US 20160317284A1
• Time in Patent Office: 288 Days
• Field of Search: 264310, 264311, 264343, 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 method of making an implantable and 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 the liquid polymer and the solid, water-swellable particles;

solidifying the mixture to form a matrix of the polymer having the solid, water-swellable particles occupying enclosed spaces in the matrix; and

forming the mixture into a wall of an inflatable prosthesis comprising the matrix and enclosed particles,

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.

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

3. The method of claim 1 wherein the water-swellable particles make up between about 2% to about 40% by weight of the mixture.

4. The method of claim 1 wherein the water-swellable particles make up about 25% by weight of the mixture.

5. The method of claim 1 wherein the water-swellable particles are a hydrogel or polyethylene glycol (PEG) material.

6. The method of claim 5 wherein the water-swellable particles have a molecular weight of between about 200 and about 10,000 Daltons.

7. The method of claim 1 wherein the forming is conducted by rotational molding.

8. The method of claim 1 wherein the prosthesis configured to be inserted into a breast cavity in an empty or partially-filled state before being filled with physiological saline via a needle, the empty or partially-filled state reducing a required size of an incision.

9. The method of claim 1 wherein the prosthesis is configured to be used as an inflatable member of a gastric balloon useful for treatment of obesity.

10. The method of claim 1 wherein the prosthesis comprises a single layer of the matrix around an entirety of the prosthesis.

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

providing a liquid polymer matrix;

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

solidifying the colloid into a solid matrix of the polymer entrapping the particles;

forming the colloid into a wall of a shell comprising the solidified matrix and entrapped particles for an inflatable prosthesis; and

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

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

13. The method of claim 11 wherein the water-swellable particles make up between about 2% to about 40% by weight of the colloid.

14. The method of claim 11 wherein the water-swellable particles make up about 25% by weight of the colloid.

15. The method of claim 11 wherein the water-swellable particles are a hydrogel or polyethylene glycol (PEG) material.

16. The method of claim 15 wherein the water-swellable particles have a molecular weight of between about 200 and about 10,000 Daltons.

17. The method of claim 11 wherein the forming is conducted by rotational molding.

18. The method of claim 11 wherein the prosthesis is configured to be inserted into a breast cavity in an empty or partially-filled state before being filled with physiological saline via a needle, the empty or partially-filled state reducing a required size of an incision.

19. The method of claim 11 wherein the prosthesis is configured to be used as an inflatable member of a gastric balloon useful for treatment of obesity.

20. The method of claim 11 wherein the prosthesis comprises a single layer of the matrix around an entirety of the prosthesis.