Implantable prosthetic devices

• US RE35,391 E
• Filed: 10/15/1992
• Issued: 12/03/1996
• Est. Priority Date: 08/30/1984
• Status: Expired due to Term

• Current Assignee: Mentor Corporation (Johnson & Johnson)
• Original Assignee: Daniel Brauman
• Inventors: Brauman, Daniel
• Primary Examiner(s): ISABELLA, DAVID J
• Application Number:
  US07/961,465
• Time in Patent Office: 1,510 Days
• Field of Search: 623/1, 623/2, 623/7, 623/8, 623/11, 623/12, 623/66
• US Class Current: 623/8
• CPC Class Codes: A61F 2/0077 Special surfaces of prostheses, e.g. for improving ingrowth A61F2/30767 takes precedence
• CPC Class Codes: A61F 2/12 Mammary prostheses and implants
• CPC Class Codes: A61L 27/14 Macromolecular materials
• CPC Class Codes: A61L 27/34 Macromolecular materials
• CPC Class Codes: C08L 23/22 Copolymers of isobutene; Butyl rubber ; Homo- or copolymers of other iso-olefins
• CPC Class Codes: C08L 7/00 Compositions of natural rubber
• CPC Class Codes: C08L 83/04 Polysiloxanes

Abstract

An improved implantable prosthetic device for use in the human body which comprises a flexible container having therein a soft gel or fluid filling and an outer plastic covering bonded or otherwise connected to the flexible container. The external surface of the outer plastic covering is rough textured, while the plastic covering itself has numerous pores or interstices. It substantially encases the flexible container. In one embodiment a barrier film is positioned between the flexible container and the outer plastic covering or between the soft gel or liquid filling and the internal of the flexible container. The outer plastic covering is made of Dacron or Teflon.

Claims

1. In an implantable prosthetic device for use in a human body including a flexible container and a soft gel or liquid filling the flexible container;

the improvement which comprises providing an outer plastic covering made of rough textured silicone and bonded to the flexible container, said outer plastic .[.convering.]. .Iadd.covering .Iaddend.having a rough textured external surface thereby providing a multiplicity of pores and/or interstices .Iadd.to permit tissue ingrowth, .Iaddend.said outer plastic covering encases the flexible container in order to prevent the contraction of scar tissue around the prosthetic device from pulling the prosthetic device into a hard, spherical shape.

2. In the implantable prosthetic device of claim 1 wherein a barrier film is positioned between the flexible container and the outer plastic covering having said rough, textured external surface or inside the flexible container.

3. In the implantable prosthetic device of claim 2 wherein said barrier film is a fluororubber.

4. In a breast prosthesis comprising a flexible container approximating the shape of the human breast and a soft gel or liquid filling said container;

the improvement which comprises providing an outer, rough textured plastic covering made of rough textured silicone and which encases the flexible container and has an outer surface having a multiplicity of pores and/or interstices .Iadd.to permit tissue ingrowth. .Iadd.5. In the breast prosthesis of claim 4, wherein said outer rough textured plastic covering and said flexible container comprise a single integral member..Iaddend..Iadd.6. In the implantable prosthetic device of claim 1, wherein said outer plastic covering and said flexible container comprise a single integral member..Iaddend.