Two-Part Package For Medical Implant

• US 20070061008A1
• Filed: 02/02/2006
• Published: 03/15/2007
• Est. Priority Date: 09/13/2005
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Sadra Medical, Inc. (Boston Scientific Corporation)
• Inventors: Hildebrand, Daniel, Salahieh, Amr, Dueri, Jean-Pierre, Saul, Tom, Morejohn, Dwight, Geshlider, Robert, Johnson, Andrea
• Granted Patent: US 7,712,606 B2
• Time in Patent Office: Days
• US Class Current: 623/2.110
• 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: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: B65B 5/04 Packaging single articles
• CPC Class Codes: B65B 55/16 by irradiation
• CPC Class Codes: B65D 25/04 Partitions
• CPC Class Codes: B65D 41/04 Threaded or like caps or cap-like covers secured by rotation
• CPC Class Codes: B65D 81/22 in moist conditions or immersed in liquids

Abstract

The invention provides a two-part package and method of use for a pre-attached medical implant and delivery tool system. The package includes a wet compartment and a dry compartment and allows a pre-attached implant and delivery tool system to be at least partially stored immersed in a fluid in the wet compartment and at least partially stored in the dry compartment. In one embodiment the implant comprises a replacement heart valve, and the heart valve is stored inside the wet compartment while the heart valve delivery tool remains dry in the dry compartment.

Claims

1. A medical implant and delivery tool package comprising:

a wet compartment containing a fluid;

a dry compartment;

an implant at least partially stored inside the wet compartment; and

a delivery tool connected to the implant at least partially stored inside the dry compartment.

2. The package of claim 1 wherein the implant comprises a heart valve.

3. The package of claim 2 wherein the heart valve is stored inside the wet compartment.

4. The package of claim 1 further comprising an interface between the dry compartment and the wet compartment.

5. The package of claim 4 wherein the interface comprises a seal to prevent fluid from entering the dry compartment.

6. The package of claim 5 wherein the seal comprises a compression component and a compressing component.

7. The package of claim 5 wherein the delivery tool comprises a device to create a seal.

8. The package of claim 7 wherein the device comprises an inflatably expanding member.

9. The package of claim 7 wherein the device comprises a compression driven expanding member.

10. The package of claim 9 wherein the compression driven expanding member comprises a wedging component.

11. The package of claim 4 wherein the interface comprises a strain relief mechanism.

12. The package of claim 1 wherein the wet compartment comprises at least one component to allow passage of fluid from the wet compartment.

13. The package of claim 1 wherein the implant is substantially centered within the wet compartment.

14. The package of claim 1 wherein the wet compartment comprises an upper housing and a lower housing.

15. The package of claim 14 wherein the wet compartment further comprises a gasket between the upper housing and the lower housing.

16. The package of claim 14 wherein the wet compartment further comprises at least two gaskets between the upper housing and the lower housing.

17. The package of claim 1 wherein the wet compartment has a variable cross-section adapted to control transmission of sterilizing radiation from outside the wet compartment to the medical implant.

18. A medical implant and delivery tool comprising:

an implant at least partially stored in fluid; and

a delivery tool connected to the implant at least partially stored dry.

19. A method of packaging a medical implant and delivery tool comprising:

providing an implant connected to a delivery tool, a wet compartment, and a dry compartment; and

loading the implant at least partially into the wet compartment wherein the delivery tool is at least partially stored in the dry compartment.

20. The method of packaging of claim 19 wherein the implant is loaded into the wet compartment in a first configuration and then reconfigured to a second configuration.

21. The method of packaging of claim 20 wherein the implant is sheathed in the first configuration and unsheathed in the second configuration.

22. The method of packaging of claim 19 further comprising sealing the wet compartment from the dry compartment.

23. The method of packaging of claim 22 wherein the sealing comprises compressing a seal ring by compression fitting.

24. The method of packaging of claim 22 wherein the sealing at least comprises inflatably expanding a member of the delivery tool.

25. The method of packaging of claim 22 wherein the sealing comprises at least expanding a wedge driven member.

26. The method of packaging of claim 19 further comprising sterilizing at least part of the implant.

27. The method of packaging of claim 26 wherein the wet compartment has a variable cross-section adapted to control transmission of sterilizing radiation from outside the wet compartment to the medical implant.

28. The method of packaging of claim 19 further comprising centering the implant in the wet compartment.

29. A method of unpacking a medical implant and delivery tool comprising:

providing an implant connected to a delivery tool wherein the implant is at least partially stored in a wet compartment;

removing fluid from the wet compartment;

altering the configuration of the implant from a first configuration to a second configuration; and

removing the implant from the wet compartment.

30. The method of unpacking of claim 29 wherein the implant is unsheathed in the first configuration and sheathed in the second configuration.

31. The method of unpacking of claim 29 further comprising washing/rinsing the implant in the wet compartment after removing fluid from the wet compartment.