Inflatable prostheses and methods of making same

• US 8,636,797 B2
• Filed: 05/11/2011
• Issued: 01/28/2014
• Est. Priority Date: 02/05/2010
• Status: Active Grant

• Current Assignee: Allergan Incorporated (Abbvie Incorporated)
• Original Assignee: Allergan Incorporated (Abbvie Incorporated)
• Inventors: Chitre, Kaustubh S., Manesis, Nicholas J., Trilokekar, Nikhil S., Leslie, Dustin, Schuessler, David J.
• Primary Examiner(s): IWAMAYE, ANDREW MICHAEL
• Application Number:
  US13/105,715
• Publication Number:
  US 20110270391A1
• Time in Patent Office: 993 Days
• Field of Search: 623 7- 8, 606/192
• 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 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61F 2250/0004 adjustable

Abstract

An inflatable tissue expander or more permanent prosthesis, suitable for implantation in a breast, is provided. The tissue expander includes a puncturable, self-sealing anterior portion forming a fillable cavity, and posterior portion that is puncture resistant. The anterior portion includes a silicone-based elastomer material having a mesh embedded therein. The posterior portion includes a first composite guard and a second composite guard, each composite guard including an arrangement of puncture resistant members and a flexible substrate having a first side on which the puncture resistant members are disposed in a spaced apart fashion.

Claims

1. A flexible self-sealing prosthesis comprising:

a shell made of a flexible laminate defining a fillable chamber;

the laminate comprising a base layer formed from an elastomer, a top layer formed from an elastomer, and an intermediate layer disposed between the base layer and the top layer, the intermediate layer being a silicone elastomer of sufficient thickness for self-sealing of a needle hole therethrough;

a total thickness of the laminate enabling an internal chamber pressure of 2.5 psi with an exterior compressive force of 40 pounds;

wherein the intermediate layer comprises a material with a storage modulus at 0.1, 1 and 10 Hz of 4490, 8330 and 18800 Pa, respectively.

2. The prosthesis according to claim 1 wherein the intermediate layer material has a loss modulus at 0.1, 1 and 10 Hz of 1840, 4820 and 12400 Pa, respectively.

3. The prosthesis according to claim 2 wherein the intermediate layer material has a complex viscosity at 0.1, 1 and 10 Hz of 7720, 1520 and 358 Pa·

s, respectively.

4. The prosthesis according to claim 1 wherein the base layer has a thickness of 0.006 inches, the intermediate layer has a thickness of between 0.100 inches and 0.120 inches, and the top layer has a thickness of 0.006 inches.

5. The prosthesis according to claim 1 further comprising a polyester mesh layer adjacent the intermediate layer.

6. The prosthesis of claim 1 further comprising a puncture resistant guard coupled to the shell.

7. A flexible self-sealing prosthesis comprising:

a shell made of a flexible laminate defining a fillable chamber;

the laminate comprising a base layer formed from an elastomer, a top layer formed from an elastomer, and an intermediate layer disposed between the base layer and the top layer, the intermediate layer being a silicone elastomer of sufficient thickness for self-sealing of a needle hole therethrough;

a total thickness of the laminate enabling an internal chamber pressure of 2.5 psi with an exterior compressive force of 40 pounds;

wherein the intermediate layer has a thickness between 0.100 inches and 0.120 inches and comprises a material with a storage modulus at 0.1, 1 and 10 Hz of 4490, 8330 and 18800 Pa, respectively, a loss modulus at 0.1, 1 and 10 Hz of 1840, 4820 and 12400 Pa, respectively, and a complex viscosity at 0.1, 1 and 10 Hz of 7720, 1520 and 358 Pa·

s, respectively.