Method and apparatus for packaging a fluid containing prosthesis

• US 4,597,765 A
• Filed: 12/27/1984
• Issued: 07/01/1986
• Est. Priority Date: 12/27/1984
• Status: Expired due to Term

• Current Assignee: Ams Research Corporation (Endo International PLC)
• Original Assignee: American Medical Systems Incorporated (Endo International PLC)
• Inventors: Klatt, William M.
• Primary Examiner(s): Apley, Richard J.
• Assistant Examiner(s): Prizant, James
• Application Number:
  US06/686,644
• Time in Patent Office: 551 Days
• Field of Search: 206/63.3, 206/438, 206/210, 206/570, 206/5.1, 3/1, 3/36, 604/895, 128/79
• US Class Current: 623/23.67
• CPC Class Codes: A61F 2/0095 Packages or dispensers for prostheses or other implants for intraocular lenses A61F2/1691; for dental surgery A61C19/02
• CPC Class Codes: A61F 2/26 Penis implants

Abstract

A method and apparatus for packaging a fluid containing prosthesis adapted to be implanted in a sterile condition involves filling a closable, permeable fluid containing housing within the prosthetic device with a fluid. The prosthetic device is then enclosed within a substantially fluid impenetrable enclosure that is filled with a fluid with activities which substantially match the activities of the fluid within the prosthetic device. Thus, even where the prosthetic device contains a physiological solution, by incorporating a solution of equal solute concentration within the enclosure that surrounds the prosthetic device, the tendency for osmosis to occur across the barrier defined by the walls of the prosthetic device can be adequately controlled. The enclosure may then be enclosed within an outer bag which may be handled by a non-sterile nurse, preparatory to implantation by a surgeon. In this way, it is possible to ship a prosthetic device in a fluid filled state despite the tendency for migration through the walls of the device by establishing mass transfer equilibrium within the package.

Claims

1. A packaged fluid containing prosthesis adapted to be implanted in a sterile condition, said prosthesis comprising:

a prosthetic device having a closed, permeable housing defining a fluid containing chamber;

a sealed, substantially fluid impenetrable enclosure surounding said housing and defining a liquid retaining space between said enclosure and said housing, said enclosure adapted for separation from said device prior to implantation of said device; and

said enclosure containing a liquid in said space with activities that substantially match the activities of the fluid in said chamber such that the mass transfer gradient acoss the permeable housing is insubstantial.

2. The prosthesis of claim 1 wherein said prosthetic device is an inflatable penile prosthesis.

3. The prosthesis of claim 1 wherein the liquid in said space and the fluid in said chamber are both saline solutions of substantially the same salt concentrations.

4. The prosthesis of claim 1 wherein said fluid in said chamber is a liquid.

5. The prosthesis of claim 1 wherein said enclosure is itself enclosed within a container adapted to exclude micro-organisms.

6. The prosthesis of claim 5 wherein said container is a peel open bag.

7. The prosthesis of claim 1 wherein the fluid within said enclosure is filled sufficiently that it bulges discernably.

8. The prosthesis of claim 1 wherein said prosthetic device and said enclosure are sterilizable by autoclaving.

9. The prosthesis of claim 1 wherein said enclosure includes a weakening to facilitate tear opening.

10. The prosthesis of claim 9 wherein said enclosure is made of a laminate including aluminum foil and a heat sealable plastic sheet material.

11. The prosthesis of claim 1 wherein said enclosure is formed of flexible sheet material.

12. The prosthesis of claim 1 wherein the liquid in said space and the fluid in said chamber are of substantially the same osmolality as body fluids.

13. The prosthesis of claim 1 wherein the liquid in said space and the fluid in said chamber are of controlled osmolality different from that of body fluids.

14. A method of packaging a fluid containing prosthesis adapted to be implanted in a sterile condition, said method comprising the steps of:

filling a closable permeable housing within a prosthetic device with a fluid;

enclosing said prosthetic device within an enclosure which contains a liquid with activities that substantially match the activities of the fluid within the housing, thereby rendering insubstantial the mass transfer gradient across the permeable housing; and

sealing said enclosure about said prosthetic device to define a sealed substantially fluid impenetrable barrier to fluid migration.

15. The method of claim 14 including the step of enclosing said enclosure within an outer bag.

16. The method of claim 15 including the step of opening said outer bag 12 in a nonsterile fashion while opening said enclosure in a sterile fashion to expose said prosthetic device.

17. The method of claim 16 including the step of peeling open said outer bag and said enclosure.

18. The method of claim 15 including the step of sterilizing said prosthetic device in a liquid filled state within said enclosure and said outer bag.

19. The method of claim 14 including the steps of filling said device with a solution and enclosing said prosthetic device within an enclosure filled with a solution having a solute concentration substantially equal to the solute concentration of the solution in said device.

20. The method of claim 14 including the step of enclosing said enclosure within a container that excludes micro-organisms.

21. A packaged fluid containing prosthesis adapted to be implanted in a sterile condition, said prosthesis comprising:

a prosthetic device having a closed, permeable housing defining a fluid containing chamber, such that a mass transfer gradient would exist across said housing once said housing is exposed to atmospheric conditions;

a sealed, substantially fluid impenetrable enclosure surrounding said housing and defining a fluid retaining space between said enclosure and said housing, said enclosure adapted for separation from said device prior to use of said device; and

said enclosure containing a fluid in said space with activities that substantially match the activities of the fluid in said chamber such that the mass transfer gradient across the permeable housing is insubstantial.

22. The prosthesis of claim 21 wherein said prosthetic device is an inflatable penile prosthesis.

23. The prosthesis of claim 21 wherein the fluid in said space and the fluid in said chamber are both saline solutions of substantially the same salt concentrations.

24. The prosthesis of claim 21 wherein said fluid in said space and said fluid in said chamber are liquids.