Implantable prosthesis

• US 4,636,213 A
• Filed: 01/24/1985
• Issued: 01/13/1987
• Est. Priority Date: 01/24/1985
• Status: Expired due to Fees

• Current Assignee: Anthony I. Pakiam
• Original Assignee: Anthony I. Pakiam
• Inventors: Pakiam, Anthony I.
• Primary Examiner(s): Apley, Richard J.
• Assistant Examiner(s): Isabella, David J.
• Application Number:
  US06/694,651
• Time in Patent Office: 719 Days
• Field of Search: 128/92 E, 128/1 R, 128/654, 3/1, 3/36, 3/1 G, 623/7.8
• US Class Current: 623/8
• CPC Class Codes: A61B 2090/3925 ultrasonic
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61B 90/94 coded with symbols, e.g. text
• CPC Class Codes: A61F 2/12 Mammary prostheses and implants
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61L 27/50 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials

Abstract

A prosthesis for permanent implantation at a selected body location to establish a desired body contour has particular utility and advantages as a mammary implant. It comprises an outer medical grade elastomer closed envelope having a built-in anterior self-sealing valve and an inner like envelope secured to the posterior of the outer envelope and having an anterior injection receiving area with a self-sealing capability secured in a fixed position of registration to the self-sealing valve. A viscous gel is provided intermediate the envelopes for lubrication to minimize or eliminate the incidence of spontaneous rupture. Selected materials are percutaneously injected into or withdrawn from the inner envelope through the registering injection receiving area and the valve with radiopaque indicia associated with the valve to delineate precisely the perimeter of the valve and the precise center thereof for accurate identification from outside the body by means of X-ray or ultrasound whereby the needle can be inserted at an accurate perpendicular attitude to the valve to eliminate the danger of piercing the envelope wall. In a second embodiment, a self-sealing capability is provided only in the valve and in a third embodiment, only a single envelope is used.

Claims

1. A prosthesis for permanent implantation in a body cavity, comprising:

a closed flexible envelope of medical grade elastomer for containing selected materials defining an anterior area for orientation towards the outer skin surface and an opposed posterior area,

a self-sealing valve fixedly disposed on the inner surface of said anterior area and adapted to be pierced by a hypodermic needle after implantation of said prosthesis,

a band of radiopaque material circumscribing said valve so that the precise perimeter of said valve can be delineated by means of X-ray and by means of ultrasound,

a pair of opposed half-shell shaped members of medical grade elastomer disposed within said envelope,

each one of said members secured at one end to the posterior area of said envelope and secured at its other end to a portion of the perimeter of said valve to form a compartment in said envelope in registration with said valve defining the material receiving area of said envelope and further forming respective chambers intermediate said respective members and said envelope, and

a lubricating gel disposed in each chamber.

2. A prosthesis as defined in claim 1 including a bullseye-like dot of radiopaque material disposed on said anterior area axially of said band so that the precise center of said valve can be delineated by means of X-ray and by means of ultrasound.

3. A prosthesis for permanent implantation in a body cavity, comprising:

a closed flexible envelope of medical grade elastomer for containing selected materials defining an anterior area for orientation towards the outer skin surface and an opposed posterior area,

a self-sealing valve fixedly disposed on the inner surface of said anterior area and adapted to be pierced by a hypodermic needle after implantation of said prosthesis,

a bullseye-like dot of radiopaque material disposed on said anterior area axially of said valve so that the precise center of said valve can be delineated by means of X-ray fluoroscopy and by means of ultrasound,

a pair of opposed half-shell shaped members of medical grade elastomer disposed within said envelope,

each one of said members secured at one end to the posterior area of said envelope and secured at its other end to a portion of the perimeter of said valve to form a compartment in said envelope in registration with said valve defining the material receiving area of said envelope and further forming respective chambers intermediate said respective members and said envelope, and

a lubricating gel disposed in each chamber.

4. A prosthesis for permanent implantation in a body cavity, comprising:

a closed flexible envelope of medical grade elastomer for containing selected materials defining an anterior area for orientation towards the outer skin surface and an opposed posterior area,

a self-sealing valve fixedly disposed on the inner surface of said anterior area and adapted to be pierced by a hypodermic needle after implantation of said prosthesis,

a pair of opposed half-shell shaped members of medical grade elastomer disposed within said envelope,

each one of said members secured at one end to the posterior area of said envelope and secured at its other end to a portion of the perimeter of said valve to form a compartment in said envelope in registration with said valve defining the material receiving area of said envelope and further dorming respective chambers intermediate said respective members and said envelope, and

a lubricating gel disposed in each chamber.

5. A breast prosthesis for permanent implantation in a body breast cavity, comprising:

a first closed flexible envelope of medical grade elastomer defining an anterior area for orientation towards the outer skin surface and an opposed posterior area,

a self-sealing valve fixedly disposed on the inner surface of said anterior area and adapted to be pierced by a hypodermic needle after implantation of said prosthesis,

a second closed flexible envelope of medical grade elastomer disposed within said first envelope,

a portion of said second envelope bonded to the posterior area of said first envelope and the opposed portion of said second envelope bonded to the perimeter of said valve to provide a pocket member in juxtaposition with said valve and in permanent registration therewith so that when a hypodermic needle is inserted through said valve, it can enter said second envelope through said pocket member, and

a band of radiopaque material circumscribing said valve so that the precise perimeter of said valve can be delineated by means of X-ray fluoroscopy and by means of ultrasound.

6. A prosthesis as defined in claim 5 including a lubricating gel intermediate said first and second envelopes.

7. A prosthesis as defined in claim 5 including a bullseye-like dot of radiopaque material disposed on said anterior area axially of said band so that the precise center of said valve can be delineated by means of X-ray fluoroscopy and by means of ultrasound.

8. A prosthesis as defined in claim 7 including a lubricating gel intermediate said first and second envelopes.

9. A breast prosthesis for permanent implantation in a body breast cavity, comprising:

a first closed flexible envelope of medical grade elastomer defining an anterior area for orientation towards the outer skin surface and an opposed posterior area,

a self-sealing valve fixedly disposed on the inner surface of said anterior area and adapted to be pierced by a hypodermic needle after implantation of said prosthesis,

a second closed flexible envelope of medical grade elastomer disposed within said first envelope,

a portion of said second envelope bonded to the posterior area of said first envelope and the opposed portion of said second envelope bonded to the perimeter of said valve to provide a pocket member in juxtaposition with said valve and in permanent registration therewith so that when a hypodermic needle is inserted through said valve, it can enter said second envelope through said pocket member, and

a bullseye-like dot of radiopaque material disposed on said anterior area axially of said valve so that the precise center of said valve can be delineated by means of X-ray fluoroscopy and by means of ultrasound.

10. A prosthesis as defined in claim 9 including a lubricating gel intermediate said first and second envelopes.