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

• US 20020117264A1
• Filed: 04/30/2002
• Published: 08/29/2002
• Est. Priority Date: 12/10/1997
• Status: Active Grant

• Current Assignee: Sorin Biomedica Cardio Srl (LivaNova Plc)
• Original Assignee: Sorin Biomedica Cardio Srl (LivaNova Plc)
• Inventors: Pasquino, Enrico, Giannetti, Arnaldo, Rinaldi, Stefano
• Granted Patent: US 6,572,642 B2
• Time in Patent Office: Days
• US Class Current: 156/382
• 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 method for the treatment of a prosthesis having an apertured structure, comprising:

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

producing sub-atmospheric pressure in the holding chamber; and

introducing a liquid into the holding chamber to saturate the prosthesis.

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

3. A method according to claim 1, wherein the liquid is substantially inert.

4. A method according to claim 3, wherein the liquid is physiological saline.

5. A method according to claim 1, wherein the liquid comprises a drug.

6. A method 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 a liquid 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.

7. A method according to claim 1, wherein the sub-atmospheric pressure of the holding chamber is approximately −

850 mbar.

8. A method according to claim 6, wherein the holding chamber is connected to the vacuum line for less than about 60 seconds.

9. A method according to claim 1, wherein the liquid flows into the chamber for less than about 60 seconds.

10. A device for the treatment of a prosthesis having an apertured structure comprising:

a casing defining a holding chamber for a prosthesis, the casing including an opening sized to allow for the introduction of the prosthesis into the chamber and a sealing element disposed around the opening to allow a sub-atmospheric pressure to be drawn within the casing;

a first fluid line leading to the casing for connecting the chamber to a source of sub-atmospheric pressure;

a second fluid line for connecting the chamber to a source of liquid; and

a valve acting on the first and second fluid line to connect the chamber in succession with the source of sub-atmospheric pressure and the source of liquid.

11. A device according to claim 10, wherein the source of liquid is a container.

12. A device according to claim 11, wherein the liquid is a substantially inert liquid.

13. A device according to claim 12, wherein the liquid is physiological saline.

14. A device according to claim 11, wherein the liquid comprises a drug.

15. A device according to claim 10, further comprising a vacuum pump as a source of sub-atmospheric pressure.

16. A device according to claim 10, wherein a safety cutoff element is interposed in the second fluid line, selectively activatable to open or close the second fluid line.

17. A device according to claim 10, wherein a filtration element comprising a sterile, fluid-permeable barrier is interposed in the first fluid line.

18. A device according to claim 10, wherein the casing carries a connector defining a common part of the first and said second fluid lines.

19. A device according to claim 18, wherein the connector is a luer connector.

20. A device according to claim 10, wherein the casing has two complementary parts connectable together with the interposition of a sealing element.

21. A device according to claim 20, wherein the two complementary parts of the casing are sealingly connected together by locking means.

22. A kit for the treatment of a prosthesis having an apertured structure, comprising:

a casing defining a holding chamber for a prosthesis, the casing including an opening sized to allow for the introduction of the prosthesis into the chamber and a sealing element disposed around the opening to permit sub-atmospheric pressure to be drawn within the casing;

a first fluid line leading to the casing for connecting the chamber to a source of sub-atmospheric pressure;

a second fluid line for connecting the chamber to a source of liquid; and

a valve acting on the first and second fluid lines to connect the chamber in succession with the source of sub-atmospheric pressure and the source of liquid, wherein the casing, the first fluid line, the second fluid line, and the valve are packaged in a sterile envelope.

24. A container according to claim 23, wherein the connector is one of a luer connector or a perforable membrane.

25. A container according to claim 23, wherein the connector is a luer connector integral with a perforable membrane.

23. A container for a prosthesis having an apertured structure used to saturate the prosthesis with a liquid, the container comprising:

a casing defining a holding chamber for the prosthesis;

at least one connector associated with the casing and configured to enable the connection of the prosthesis holding chamber to a source of sub-atmospheric pressure, the casing being sealably closable and having a structure that retains the substantial integrity of the prosthesis in the presence of sub-atmospheric pressure within the prosthesis holding chamber, and

a liquid reservoir connected to the prosthesis holding chamber, such that the liquid from the reservoir saturates the apertured structure of the prosthesis as a result of the liquid being drawn into the holding chamber due to the sub-atmospheric pressure.