Two-part package for medical implant

• US 10,370,150 B2
• Filed: 06/30/2016
• Issued: 08/06/2019
• Est. Priority Date: 09/13/2005
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Salahieh, Amr, Saul, Tom, Geshlider, Robert, Johnson, Andrea, Morejohn, Dwight, Hildebrand, Daniel, Dueri, Jean-Pierre
• Primary Examiner(s): Ackun, Jacob K
• Application Number:
  US15/197,938
• Publication Number:
  US 20160376063A1
• Time in Patent Office: 1,132 Days
• Field of Search: 206438, 206210, 206363
• 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;

a replacement heart valve implant at least partially stored inside the wet compartment; and

a delivery tool at least partially stored inside the dry compartment;

wherein the replacement heart valve implant is configured to transition between a compressed configuration within the delivery tool and an expanded configuration within the wet compartment.

2. The medical implant and delivery tool package of claim 1, wherein the wet compartment is configured to maintain the replacement heart valve implant immersed in fluid regardless of orientation of the wet compartment.

3. The medical implant and delivery tool package of claim 1, wherein an interface between the wet compartment and the dry compartment stores the replacement heart valve implant in the wet compartment and keeps at least a portion of the delivery tool dry.

4. The medical implant and delivery tool package of claim 1, wherein the wet compartment is stored inside the dry compartment.

5. The medical implant and delivery tool package of claim 1, wherein a shape of the wet compartment is non-cylindrical.

6. The medical implant and delivery tool package of claim 5, wherein a cross-section of the wet compartment is triangular in shape.

7. The medical implant and delivery tool package of claim 1, further comprising a seal cap threadably engaged with the wet compartment, thereby preventing the fluid from entering the dry compartment.

8. The medical implant and delivery tool package of claim 7, wherein the seal cap engages a seal member against an exterior surface of the delivery tool when the seal cap is threadably engaged with the wet compartment.

9. The medical implant and delivery tool package of claim 1, wherein the delivery tool is attached to the replacement heart valve implant.

10. The medical implant and delivery tool package of claim 9, wherein the delivery tool includes a seal disposed within the delivery tool configured to prevent the fluid inside the wet compartment from escaping into a dry portion of the delivery tool.

11. A method of storing a medical implant, comprising:

attaching a medical implant to a delivery tool;

translating the medical implant into a compressed configuration within the delivery tool;

inserting a distal end of the delivery tool into a wet compartment;

unsheathing the medical implant within the wet compartment; and

placing the delivery tool and the wet compartment into a dry compartment.

12. The method of storing a medical implant of claim 11, wherein the wet compartment is filled with fluid.

13. The method of storing a medical implant of claim 11, wherein inserting the delivery tool into the wet compartment includes inserting the delivery tool through a seal cap.

14. The method of storing a medical implant of claim 11, wherein the medical implant is stored within the wet compartment in an expanded configuration.

15. The method of storing a medical implant of claim 12, further comprising forming a seal to prevent the fluid from escaping the wet compartment.

16. The method of storing a medical implant of claim 15, wherein the seal is formed after the medical implant is completely removed from the delivery tool.

17. The method of storing a medical implant of claim 11, further comprising irradiating the dry compartment to sterilize the delivery tool.

18. The method of storing a medical implant of claim 17, wherein the wet compartment masks the medical implant from radiation.

19. The method of storing a medical implant of claim 11, wherein the medical implant is a replacement heart valve.