Packaged prosthetic device

• US 4,011,947 A
• Filed: 05/22/1975
• Issued: 03/15/1977
• Est. Priority Date: 05/22/1975
• Status: Expired due to Term

• Current Assignee: Philip Nicholas Sawyer
• Original Assignee: Philip Nicholas Sawyer
• Inventors: Sawyer, Philip Nicholas
• Primary Examiner(s): Lipman, Steven E.
• Application Number:
  US05/579,791
• Time in Patent Office: 663 Days
• Field of Search: 3/1, 3/1.5, 3/13, 3/303 R, 128/172, 128/272, 128/274, 128/334 R, 206/.6, 206/45.34, 206/205, 206/209-209.1, 206/210, 206/361, 206/362.2-362.3, 206/363, 206/438, 206/498, 206/525, 206/527, 220/4 E, 220/4 B
• US Class Current: 206/363
• 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 2/2427 Devices for manipulating or deploying heart valves during implantation

Abstract

A prosthetic device is packaged for surgical use by detachably coupling a support to the device, cleaning substantially all of the foreign material from the device, and encapsulating the thusly cleaned device in an openable capsule with the support extending therethrough. The encapsulated device and support attached thereto are further encased in a bag or other like protective device and this packaged assembly is further encased in a box. Sterilization of the whole is effected by means of radiation. In use, the bagged device is subsequently removed from the box and delivered to an operating room or other antiseptic environment whereat the bag is removed and the device handled by means of the support attached thereto. A solution containing, for example, heparin and an antibiotic is injected into the capsule for treating the prosthetic device. Afterwards, the capsule is opened and the prosthetic device is juxtaposed to an installation zone by means of the support.

Claims

1. A protected prosthetic device comprising a sterilized and cleaned prosthetic structure, a support detachably engaging said structure and adapted to constitute a handle for the same, and hermetically sealed protective means encapsulating said structure, said support extending hermetically through said means, said means being openable to render said structure accessible, said means including at least two parts, one of which is mounted on said support and the other of which is detachably mounted on the first part whereby said structure can be cleaned and then encapsulated while being maneuverable by the use of said support.

2. A device as claimed in claim 1 wherein said structure is a heart valve.

3. A device as claimed in claim 1 comprising a filter between said port and said means.

4. A device as claimed in claim 2 wherein said support is a mandrel adapted for radial dimension changes for engaging and disengaging said structure.

5. A device as claimed in claim 2 comprising an inert gas in said means.

6. A device as claimed in claim 1 wherein said means is supported on said support and is spaced in entirety from said structure.

7. A device as claimed in claim 6 wherein said protective means is a rigid capsule.

8. A device as claimed in claim 6 comprising a syringe-penetrable port in said means for the injection of fluid into said means.

9. A device as claimed in claim 6 wherein said means is X-ray radiation penetrable for the sterilization of said structure.

10. A device as claimed in claim 6 comprising shielding means encasing said structure, support and protective means.

11. A device as claimed in claim 10 comprising an openable box housing said structure, means and support encased in said shielding means.

12. A device as claimed in claim 11 wherein said box, protective means and shielding means are penetrable to X-ray radiation.

13. A device as claimed in claim 10 wherein the shielding means is a collapsible plastic bag.

14. A device as claimed in claim 10 wherein the shielding means is a rigid plastic shield.

20. A device as claimed in claim 13 wherein said means is X-ray radiation penetrable for the sterilization of said structure.

15. A protected prosthetic device comprising a sterilized and cleaned prosthetic structure, a support detachably engaging said structure and adapted to constitute a handle for the same, sealed protective means encapsulating said structure, said support extending in sealed relation through said means, said means being openable to render said structure accessible, and a syringe-penetrable port in said means for the injection of fluid into said means.

16. A device as claimed in claim 15 wherein said structure is a heart valve.

17. A device as claimed in claim 15 comprising a filter between said port and said means.

18. A device as claimed in claim 15 wherein said means is supported on said support and is spaced in entirety from said structure and wherein said sealed protective means is hermetically sealed.

19. A device as claimed in claim 18 wherein said protective means is a rigid capsule.

21. A device as claimed in claim 18 wherein said means includes at least two parts, one of which is mounted on said support and the other of which is detachably mounted on the first part whereby said structure can be cleaned and then encapsulated while being maneuverable by the use of said support.

22. A device as claimed in claim 18 wherein said support is a mandrel adapted for radial dimension changes for engaging said disengaging said structure.

23. A device as claimed in claim 18 comprising an inert gas in said means.

24. A device as claimed in claim 18 comprising shielding means encasing said structure, support and protective means.

25. A device as claimed in claim 24 wherein the sheilding means is a collapsible plastic bag.

26. A device as claimed in claim 24 wherein the shielding means is a rigid plastic shield.

27. A device as claimed in claim 24 comprising an openable box housing said structure, means and support encased in said shielding means.

28. A device as claimed in claim 24 wherein said box, protective means and shielding means are penetrable to X-ray radiation.