Method for treating a prosthesis having an apertured structure and associated devices

• US 6,572,642 B2
• Filed: 04/30/2002
• Issued: 06/03/2003
• Est. Priority Date: 12/10/1997
• Status: Expired due to Fees

• Current Assignee: Sorin Biomedica Cardio Srl (LivaNova Plc)
• Original Assignee: Sorin Biomedica Cardio Srl (LivaNova Plc)
• Inventors: Giannetti, Arnaldo, Pasquino, Enrico, Rinaldi, Stefano
• Primary Examiner(s): Beck, Shrive P.
• Assistant Examiner(s): Michener, Jennifer Kolb
• Application Number:
  US10/135,639
• Publication Number:
  US 20020117264A1
• Time in Patent Office: 399 Days
• Field of Search: 427/2.1, 427/2.24, 427/2.3, 427/2.31, 427/238, 427/243-245, 427/294-296, 623/1.1, 623/1.39, 623/1.49, 623/2.1, 623/2.42
• US Class Current: 623/1.1
• CPC Class Codes: A61F 2/0077 Special surfaces of prostheses, e.g. for improving ingrowth A61F2/30767 takes precedence
• 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 2/02 Prostheses implantable into the body closure means for urethra or rectum or for artificial body openings therefor A61F2/0004
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61L 27/00 Materials for grafts or prostheses or for coating grafts or prostheses dental prostheses A61C13/00; shape or structure of prostheses A61F2/00; use of preparations for artificial teeth A61K6/80; artificial kidneys A61M1/14
• CPC Class Codes: A61L 33/0005 Use of materials characterised by their function or physical properties
• CPC Class Codes: Y10T 156/1744 Means bringing discrete articles into assembled relationship

Abstract

A prosthesis having an apertured structure is located in a chamber (11) which is taken to sub-atmospheric pressure. Once sub-atmospheric pressure has been reached, a liquid, optionally containing pharmacological agents, is introduced into the chamber. Drawn by the sub-atmospheric pressure, the liquid saturates the apertured structure of the prosthesis. In this way, the invention eliminates the risk of air being trapped in the apertured structure that could give rise to the formation of blood clots after implantation of the prosthesis. The liquid can contain drugs that penetrate the prosthesis, performing their therapeutic action locally and over time after implantation.

Claims

1. A cardiac valve prosthesis having an apertured structure produced by a method comprising:

placing a cardiac valve prosthesis having an apertured structure into a holding chamber;

producing sub-atmospheric pressure in the holding chamber;

introducing physiological saline into the holding chamber;

allowing the physiological saline to saturate the cardiac valve prosthesis; and

removing the cardiac valve prosthesis from the holding chamber;

to form a physiological saline-containing cardiac valve prosthesis suitable for implantation.

2. A cardiac valve prosthesis according to claim 1, wherein the sub-atmospheric pressure is selected so that after the introduction of the physiological saline into the holding chamber, the cardiac valve prosthesis is substantially free of air.

3. A cardiac valve prosthesis according to claim 1, wherein

the step of producing sub-atmospheric pressure comprises connecting the holding chamber to a vacuum line; and

the step of introducing physiological saline into the holding chamber comprises connecting the holding chamber to a liquid supply line, the liquid supply line being provided with a cut-off element.

4. A cardiac valve prosthesis according to claim 1, wherein the sub-atmospheric pressure of the holding chamber is approximately −

850 mbar.

5. A cardiac valve prosthesis according to claim 3, wherein the holding chamber is connected to the vacuum line for less than about 60 seconds.

6. A cardiac valve prosthesis according to claim 1, wherein the physiological saline flows into the chamber for less than about 60 seconds.