PACKAGED HYDROPHILIC MEDICAL PRODUCTS THAT ARE HYDRATED WITHIN THE PACKAGE AND METHODS OF MAKING THE SAME

Abstract

Ready to use packaged medical products that include hydrated hydrophilic medical devices and methods of making the same.

Claims

1. A packaged medical product, comprising: a package defining a cavity; a hydrophilic medical device contained within the cavity; and a container containing a hydration liquid, the container contained within the cavity, wherein the container is configured to open upon exposure to radiation.

2. The packaged medical product of claim 1, wherein the container is configured to burst upon exposure to e-beam radiation.

3. The packaged medical product of claim 1, wherein the hydration liquid includes a dissolved gas.

4. The packaged medical product of claim 3, wherein the dissolved gas comprises at least one of carbon dioxide and nitrogen.

5. The packaged medical product of claim 3, wherein upon radiation, the hydration liquid releases the gas, the released gas increasing a gas pressure within the container and the increase in gas pressure causing the container to open.

6. The packaged medical product of claim 1, wherein a gas pressure increases within the container upon exposure to radiation, and the increase in gas pressure causes the container to open.

7. The packaged medical product claim 1, wherein the container includes a weakened portion that is configured to open.

8. The packaged medical product of claim 7, wherein the weakened portion is configured to open when gas pressure increases within the container.

9. The packaged medical product of claim 7, wherein the weakened portion comprises at least one of a weak seal and a partial cut in a material of the container.

10. The packaged medical product of claim 1, wherein the hydrophilic medical device comprises a urinary catheter.

11. A method of making a packaged medical product, comprising: placing a hydrophilic medical device within a cavity of a package; placing a liquid filled container within the cavity of the package, wherein the liquid filled container is configured to open upon exposure to radiation; closing the package; and exposing the package to radiation, thereby opening the container and releasing the liquid.

12. The method of claim 11, wherein exposing the package to radiation comprises exposing the package to E-Beam radiation.

13. The method of claim 11, wherein the liquid includes a dissolved gas.

14. The method of claim 13, wherein the dissolved gas comprises at least one of carbon dioxide and nitrogen.

15. The method of claim 13, wherein upon radiation, the liquid releases the gas, the gas increasing a gas pressure within the container and the increase in gas pressure causes the container to open.

16. The method of claim 11, wherein a gas pressure increases within the container upon exposure to radiation, and the increase in gas pressure causes the container to open.

17. The method of claim 11, wherein the container includes a weakened portion that is configured to open.

18. (canceled)

19. The method of claim 17, wherein the weakened portion comprises at least one of a weak seal and a partial cut in a material of the container.

20. The method of claim 11, wherein the hydrophilic medical device comprises a urinary catheter.

21. A packaged medical product, comprising: a sleeve; a hydrophilic medical device contained within the sleeve; and a container containing a hydration liquid, the container contained within the sleeve wherein the container is configured to open upon exposure to radiation.

22.-30. (canceled)

Description

BRIEF DESCRIPTION OF DRAWINGS

[0010] FIG. 1 is a top plan view of one embodiment of a packaged medical device product in accordance with the present disclosure; and

[0011] FIG. 2 is a top plan view of the packaged medical device product of FIG. 1 shown with the container in an open condition.

DETAILED DESCRIPTION OF THE EMBODIMENTS

[0012] The present disclosure is generally directed to packaged hydrophilic medical device products 10 that are ready to use right out of the package. Referring to FIGS. 1 and 2, the packaged hydrophilic medical device product 10 includes a sleeve, such as package 12 or a non-touch sleeve (not-shown) that surrounds that catheter and is used to grip the catheter for insertion. In the embodiment illustrated in FIGS. 1 and 2, the package 12 is formed from a front sheet 14 and back sheet 16 that are sealed together to form a peripheral seal 18 and define an internal cavity 20. At the top of the package 12, the front and back sheets 14 and 16 may be unattached above top seal 22. The package 12 may be opened by grasping these unattached portions and pulling the front sheet 14 and back sheet 16 away from each other to peal open the package 12 along seal 18. Optionally, the package 12 may be any other suitable package for containing a medical device. For example, the package may be a tear open package. Additionally, the material of the package, optionally, may be made from a gas impermeable material.

[0013] A hydrophilic medical device is contained within cavity 20. In the illustrated embodiment, the hydrophilic medical device is a hydrophilic catheter 24. The hydrophilic catheter 24 may be any suitable hydrophilic catheter that includes a hydrophilic outer surface that becomes lubricous when hydrated with a hydration medium, such as water. For example, the catheter 24 may include a lubricious hydrophilic coating on the outer surface of the catheter.

[0014] A container 26 of hydration liquid 28 also may be located within the cavity 20. The container 26 may be a sachet or pouch containing the hydration liquid 28. The container 26 is configured to open or burst upon exposure to radiation, thereby releasing the hydration liquid 28 into the cavity 20. The released liquid 28 comes into to contact with the hydrophilic material of the catheter 24 to hydrate the material, and thereby active the lubricous characteristics of the hydrophilic material.

[0015] The hydration liquid 28 may be any suitable hydration liquid, such as water or an aqueous solution. The hydration liquid 28 may also include any suitable additives. The hydration liquid 28 also includes a gas, such as carbon dioxide or nitrogen, dissolved in the liquid. Optionally, the hydration liquid 28 may be super saturated with the gas. During exposure to sterilizing radiation, such as e-beam or gamma sterilization, energy impinges on the materials of the product (e.g., package, container, liquid), resulting in heat generation. The container 26 containing the liquid 28 utilizes this heating phenomenon to burst the container 26 containing the liquid. In one embodiment, a container 26 contains carbonated water, which includes dissolved carbon dioxide gas. When the packaged product is exposed to radiation, the hydration liquid 28 heats up, thereby releasing the carbon dioxide gas. The released gas increases the pressure within the container 26, and this increased pressure causes the container to burst. The liquid 28 is then released from the burst container 26 into the cavity 20. Optionally, the liquid 28 may include a foaming agent, such as a surfactant. The surfactant may be, for example, sodium dodecyl sulphate or sodium methyl cocoyl taurate. When a foaming agent is included, the hydration liquid will foam upon opening of the container and release of gases from the hydration liquid.

[0016] The container 26 may be made form a liquid impermeable material, such a polymer/metal laminate. For example, the laminate may a sheet or film that includes layers of polyethylene and aluminum. Optionally, the container 26 may have a weak portion configured to burst due to the increase of gas pressure within the container. The weak portion may be a weak seal or a weakened portion of the container material. For example, the container material may be partially cut through some of the layers. For instance, the container material may include a layer cut through the top layers or bottom layers of the materials.

[0017] When the sleeve containing the catheter and container 26 is a no-touch sleeve, the sleeve may have an introducer at one end and may be attached to the funnel of the catheter.

[0018] It should be understood that various changes and modifications to the presently preferred embodiments described herein will be apparent to those skilled in the art. Such changes and modification can be made without departing from the spirit and scope of the invention disclosed herein.