Surgical method of using a sterile packaged prosthesis

• US 4,065,816 A
• Filed: 11/12/1976
• Issued: 01/03/1978
• 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): Frinks, Ronald L.
• Application Number:
  US05/741,476
• Time in Patent Office: 417 Days
• Field of Search: 3/1, 3/1.5, 128/303 R, 128/334 R, 206/363, 206/438, 220/4 B, 220/4 E, 53/21 FC, 53/21 R
• US Class Current: 206/438
• 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
• CPC Class Codes: Y10S 623/91 Heart

Abstract

A method is provided for packaging a prosthetic device for surgical use. The method includes 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. As to cleaning of the prosthetic device, this is effected by electropolishing, chemical polishing, electrochemical polishing or cathodic cleaning or the like. For 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 method comprising mounting a prosthetic device on a support and removing at least substantially all foreign substance from the device and support, encapsulating the prosthetic device in a capsule, encasing said device and support in a removable shield, boxing the thusly encased device and support, irradiating the thusly boxed and encased device and support to sterilize the same, sequentially removing the box and shield, injecting a fluid into the capsule to treat the prosthetic device, opening the capsule to expose the device, and maneuvering the device by the use of the support to locate the device proximate a site of installation.

2. A method as claimed in claim 1 wherein said fluid is a liquid with an anti-biotic therein.

3. A method as claimed in claim 1 wherein the foreign substance is removed by electrochemical cleaning, chemical polishing, electropolishing or cathodic polishing.

4. A method as claimed in claim 1 wherein the shield is removed in a sterilized atmosphere.

5. A method as claimed in claim 1 wherein the prosthetic device is a heart valve including a ring, comprising suturing the ring in position in a cardiac system and detaching the support from the device.