Container for the packaging of a hollow endoprosthesis

• US 5,385,229 A
• Filed: 11/05/1993
• Issued: 01/31/1995
• Est. Priority Date: 12/04/1992
• Status: Expired due to Term

• Current Assignee: Centerpulse Orthopedics Incorporated
• Original Assignee: Sulzer Medizinaltechnik AG
• Inventors: Muller-Glauser, Tanner, Fredy, Bittmann, Peter
• Primary Examiner(s): ACKUN, JACOB K
• Application Number:
  US08/147,760
• Time in Patent Office: 452 Days
• Field of Search: 206/210, 206/438, 206/439, 206/363, 206/828, 206/370
• US Class Current: 206/210
• CPC Class Codes: A61B 2050/0065 Peelable cover
• CPC Class Codes: A61B 50/33 Trays
• 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 2/062 Apparatus for the production of blood vessels made from natural tissue or with layers of living cells prostheses made from natural tissue or living cells A61L27/507
• CPC Class Codes: A61L 2/26 Accessories or devices or components used for biocidal treatment
• CPC Class Codes: A61L 27/507 for artificial blood vessels apparatus for applying cells on a blood vessel prosthesis A61F2/062

Abstract

The container for packing hollow endoprostheses (8) comprises two germ-proof wrappings (1, 2). In accordance with the invention the inner wrapping (1) consists of a water-tight wall (10, 11) and various connection points (40, 50, 60). At least two of the connection points (40) are provided as access into the cavity of the prosthesis (8) and one is provided as an outlet (50) for liquids for treating the prosthesis. The outer wrapping (2) comprises through-pieces (42, 52, 62), which are associated with the connection points of the inner wrapping. The two wrappings are permeable to gas at least some regions. In accordance with the invention the container has a second application apart from its protective function: for example, in the case of a hybrid prosthesis for vascular replacement, to perform the charging of the prosthesis with the patient'"'"'s own endothelial cells in the container.

Claims

1. A container for packing a prosthesis comprising:

a sterile inner wrapping surrounding a chamber shaped for receiving the prosthesis, the inner wrapping having a fluid-tight wall with at least one gas-permeable region;

a sterile outer wrapping substantially enclosing the inner wrapping and having at least one gas-permeable region; and

first and second inner ports in the inner wrapping fluidly coupled to first and second outer ports, respectively, in the outer wrapping for providing fluid access to the chamber.

2. The container of claim 1 wherein the wrappings each comprise a molded tray and a gas-permeable lid, the inner and outer ports extending through the trays.

3. The container of claim 2 wherein the lids are removably attached to the trays.

4. The container of claim 2 wherein the trays each comprise a hot formed sheet of thermoplastic material.

5. The container of claim 1 further comprising an overflow port in the inner wrapping, a third outer port in the outer wrapping, and a connection plug fluidly coupling the overflow port to third outer port and tubes fluidly coupling the first and second inner ports to the first and second outer ports.

6. The container of claim 5 wherein the inner and outer ports comprise an elastomeric seal and a hollow tube extending through the seal.

7. The container of claim 1 further comprising holding means, positionally fixed within the inner wrapping, for securing the prosthesis within a fixed area in the inner wrapping.

8. The container of claim 1 wherein the inner and outer wrappings have a generally rectangular shape with first and second ends, the inner and outer ports being disposed on one of the first and second ends.

9. The container of claim 1 wherein the inner wrapping further comprises a sump fluidly coupled to the third inner port for collecting overflow fluid exiting the third inner port.

10. The container of claim 9 wherein the inner wrapping further comprises channels fluidly coupling the sump to the third inner port.

11. A storage system comprising:

a vascular prosthesis charged with a patient'"'"'s endothelial cells; and

a container for housing the prosthesis comprising;

a sterile inner wrapping enclosing the prosthesis and having a fluid-tight wall with portions that are gas-permeable and at least one inner opening providing fluid access to the prosthesis; and

a sterile outer wrapping enclosing the inner wrapping and having at least one outer opening coupled to the inner opening, the outer wrapping having portions that are gas-permeable.

12. A method for preparing a hybrid prosthesis for implantation into a patient'"'"'s body comprising the steps of:

(a) housing the prosthesis in a chamber enclosed by an inner wrapping having a fluid-tight wall with at least one gas-permeable region and having first and second inner ports, the inner wrapping being enclosed by an outer wrapping having at least one gas-permeable region and first and second outer ports fluidly coupled to the inner ports;

(b) connecting at least the first outer port to a fluid delivery source;

(c) sealing the second inner port;

(d) pumping water through the first inner and outer ports to force the water through an outer wall of the prosthesis into a hollow bore within the prosthesis, the water displacing air from the chamber through the gas-permeable regions of the inner and outer wrappings;

(e) securing the prosthesis to a fixed position within the inner wrapping so that the prosthesis is enveloped by the water;

(f) pumping a suspension of endothelial cells from the patient through the first inner and outer ports to force the endothelial cells into the outer wall of the prosthesis; and

(g) opening an overflow port to allow the water to exit the chamber.

13. The method of claim 12 further comprising the steps of:

(h) closing the overflow port;

(i) pumping water through the first inner and outer ports to direct water in a radial direction through the outer wall of the prosthesis, the water removing substances dissolved in the endothelial cell suspension from the outer wall of the prosthesis;

(j) opening the overflow port to allow the water to exit the chamber;

(k) repeating steps (h), (i) and (j) until the substances are substantially removed from the prosthesis;

(l) opening the second inner port; and

(m) pumping water through the second inner and outer ports into the chamber, the water flowing past the prosthesis in an axial direction and exiting through the first inner and outer ports to further remove the substances from the prosthesis.

14. A container for packing a prosthesis comprising:

a sterile inner wrapping surrounding a chamber that is adapted for the prosthesis, the inner wrapping having a water-tight wall with inner and outer surfaces and at least one gas-permeable region;

a sterile outer wrapping completely enclosing the inner wrapping so that the outer surface of the inner wrapping remains sterile, the outer wrapping being removable from the inner wrapping and having at least one gas-permeable region; and

at least one opening in the inner wrapping fluidly coupled to at least one opening in the outer wrapping for providing fluid access to the chamber.