Packaging for dry tissue prosthetic heart valve

Patent metadata

Field	Value
Publication number	US-11969329-B2
Application number	US-202217735248-A
Country	US
Kind code	B2
Filing date	May 3, 2022
Priority date	May 2, 2017
Publication date	Apr 30, 2024
Grant date	Apr 30, 2024

Abstract

A “dry” packaging in which a prosthetic heart valve is packaged within a container with hydrogel that can be provided in many forms. Certain embodiments include hydrogel that is preloaded with glycerol or the like. The hydrogel regulates the humidity within the container through a diffusion-driven mechanism if a gradient of humidity between the inside and the outside of the hydrogel exists. Humidity regulation is important to prevent the tissue of the valve structure from drying out. When the partially-hydrated hydrogel is present within container, which is saturated with air of a predefined humidity, the water molecules from the air will be absorbed by the hydrogel if the air humidity is high (i.e. when the thermodynamics favor hydrogel hydration) or vice versa. Various embodiments are configured to also house at least a portion of a delivery device for delivering the prosthetic heart valve.

First claim

What is claimed is:

1. A method comprising:
providing a packaged implant including:
an implant,
a container having a first portion and a second portion, the first and second portions being made of a non-porous material, wherein the first and second portions are sealed together to form a pouch around the implant,
at least one tether secured to the implant and at least partially extending out of the container, and
a hydrogel within the container; and

connecting the at least one tether to a delivery device.

2. The method of claim 1 , wherein the implant is a prosthetic heart valve.

3. The method of claim 1 , further comprising sterilizing the packaged implant prior to connecting the tether to the delivery device.

4. The method of claim 3 , further comprising again sterilizing the packaged implant after the tether is connected to the delivery device.

5. The method of claim 1 , wherein each tether includes a fastener that is connected to a corresponding fastener on the delivery device.

6. The method of claim 5 , wherein the corresponding fastener is positioned on an inner shaft of the delivery device.

7. The method of claim 1 , wherein the packaged implant further includes a pad positioned between the first and second portions.

8. The method of claim 7 , wherein the hydrogel is glycerol and the pad is soaked with the glycerol.

9. A method of preparing a packaged implant, the method comprising:
providing a prosthetic heart valve, wherein at least one tether is secured to the prosthetic heart valve;
providing a container having a first portion and a second portion; the first and second portions being made of a non-porous material;
positioning a pad including a hydrogel between the first and second portions; and
sealing the first and second portions together to form a pouch containing the prosthetic heart valve and the pad,
wherein at least a portion of the at least one tether extends out of the container after the step of sealing the first and second portions together.

10. The method of claim 9 , further comprising connecting the at least one tether to a delivery device.

11. The method of claim 10 , wherein each tether of the at least one tether includes a fastener and each fastener is connected to the delivery device.

12. The method of claim 9 , wherein the pad is positioned on the first and second portions to surround the prosthetic heart valve.

13. The method of claim 9 , wherein the prosthetic heart valve comprises a stent frame and a valve structure.

14. A method comprising:
providing a packaged implant including:
an implant positioned on a delivery device, wherein a portion of the delivery device extends out of a container, and
the container including a first compartment housing the implant and a second compartment housing a hydrogel, wherein a semi-permeable membrane separates the first and second compartments and the semi-permeable membrane further separates the hydrogel from the first compartment; and

sterilizing the packaged implant with at least one of a gas and radiation.

15. The method of claim 14 , wherein the implant is a prosthetic heart valve.

16. The method of claim 14 , wherein the gas includes ethylene oxide.

17. The method of claim 16 , wherein the container includes a vent and the ethylene oxide passes through the vent during the sterilizing.

18. The method of claim 14 , wherein the hydrogel is in the form of one or more of beads, a soaked pad, or a sheet.

19. The method of claim 15 , wherein the prosthetic heart valve comprises a stent frame and a valve structure.

Assignees

• Medtronic Vascular Inc

Inventors

• Ryan Raymond
• Clarke David
• Garde Kshitija
• Guo Ya
• Wong Benjamin
• Darekar Yogesh
• Lehmann Luke
• Wang Wei
• Mckinley Laura
• Devereux Paul
• Dudney Joshua
• Tien Tracey
• Olney Karl

Classifications

• A61L2103/05

  Living organisms or biological materials · CPC title

• A61F2/0095 Primary

  Packages or dispensers for prostheses or other implants (for intraocular lenses A61F2/1691; for dental surgery A61C19/02) · CPC title

• A61F2/2412

  with soft flexible valve members, e.g. tissue valves shaped like natural valves · CPC title

• A61L2/206

  Ethylene oxide · CPC title

• A61L2/26

  Accessories · CPC title