Fluid filled prosthesis excluding gas-filled beads

• US 5,534,023 A
• Filed: 04/11/1994
• Issued: 07/09/1996
• Est. Priority Date: 12/29/1992
• Status: Expired due to Fees

• Current Assignee: Henley, Julian L.
• Original Assignee: Henley, Julian L.
• Inventors: Henley, Julian L.
• Primary Examiner(s): Prebilic, Paul B.
• Application Number:
  US08/225,507
• Time in Patent Office: 820 Days
• Field of Search: 623/7, 623/8, 623/11, 623/66
• US Class Current: 623/8
• CPC Class Codes: A61F 2/12 Mammary prostheses and implants

Abstract

An implantable prosthetic device having a biocompatible elastomeric shell and a polyphasic filler material consisting of gas-filled chambers or beads bathed in a biocompatible fluid. In a preferred embodiment the solid and gaseous phases of the filler comprise interconnecting flexible chains of small gas-filled beads. The gas-filled beads may be continuously extruded in a chain with a fiber of extrudate connecting the beads. In one embodiment, the extruded chains of beads are formed into a mass having the desired shape of the prostheses where they may be further crosslinked, then placed within an outer shell. The void space between the beads is filled with a biocompatible fluid such as saline. The polyphasic filler preferably has a density which is less than or equal to the density of the surrounding tissue thereby reducing microtrauma to the capsule associated tissue and the incidence and/or severity of capsular contracture. The prosthesis does not collapse, wrinkle or otherwise become deformed during use; even in the case of rupture. In another embodiment, gas-filled beads are injected endoscopically into a previously placed, fluid-filled implant to displace the liquid filler and alter the density of the filler. The effective density of the polyphasic filler can be adjusted by varying the ratio of the volume of encapsulated gas to the weight of the encapsulating solid phase.

Claims

1. A prosthesis for implantation beneath the skin of a patient thereafter to be surrounded by tissue, said prosthesis comprising:

(a) an elastomeric outer shell; and

(b) a filler enclosed by said elastomeric outer shell and wherein said filler further comprises, in combination, a fluid and a string comprising a plurality of interconnected beads, each bead of said plurality of interconnected beads comprising a gas filled chamber and wherein each said bead is free of gaseous communication with any other said bead.

2. The prosthesis of claim 1 wherein said filler has a density which is less than or equal to the density of said tissue.