Patent Publication Number: US-2022233808-A1

Title: Packaged hydrophilic medical products that are hydrated within the package and methods of making the same

Description:
The present application claims the benefit of and priority to U.S. Provisional Application No. 62/851,376, filed May 22, 2019, which is hereby incorporated herein by reference. 
    
    
     DESCRIPTION 
     Field of the Disclosure 
     The present disclosure generally relates to packaged hydrophilic medical devices that are hydrated within the package and methods of hydrating medical devices within the package. Even more particularly, the present disclosure relates to packaged hydrophilic catheter assemblies and methods of hydrating the same. 
     Background 
     One method of sterilization includes exposing an item or product to radiation to kill the microbes and sterilize the item/product. There are items/products wherein the conditions under which the radiation sterilization occurs can cause damage to the items/products. For example, there are certain items that are required to be radiation sterilized in dry or substantially dry conditions. If such items are radiation sterilized in a wet or hydrated condition, the exposure to radiation may lessen one or more qualities of the item or will damage the item. For example, some types of hydrophilic materials may become damaged by exposure to sterilizing radiation while the hydrophilic materials are in a hydrated state. 
     It is known to coat medical devices, such as urinary catheters, with a hydrophilic coating. When the hydrophilic coating is wetted or hydrated with a wetting fluid, such as water, it becomes extremely lubricous which eases introduction of the device into the body and aids in reducing pain and discomfort associated with such introduction. 
     In some applications, the hydrophilically coated medical device is provided in a “dry” state wherein the user is required to wet the hydrophilic coating with a wetting fluid immediately prior to insertion into the body. In other applications, it is desirable to provide a hydrophilically coated medical device that is in a ready-to-use condition right out of the package. In the field of urinary catheters, a hydrophilically coated catheter may be provided in a catheter package wherein the catheter is stored in the package in contact with water so that the hydrophilic coating is wetted within the package and the catheter is ready for use right out of the package. 
     For various reasons, including but not limited to efficiency, effectiveness and cost, it is desirable to radiation sterilize packaged medical device assemblies. In some instances, the hydrophilically coated medical device and water are placed in the package and the package is sealed. After the package is sealed, the package having the hydrophilically coated medical device and water therein is exposed to radiation, such as gamma or E-Beam radiation, to sterilize the medical device. It has been found, however, that sterilization of hydrophilic coatings in the hydrated state or while in contact with a wetting fluid can result in degradation of the coating or excessive crosslinking of the coating which can lead to an increase of coefficient of friction (decrease in lubricity) of the coating and/or cause instability of coating which may result in the coating undesirably detaching from the medical device prior to or during use. 
     Therefore, there remains a need for sterilized ready-to-use hydrophilic medical devices and methods of sterilizing and hydrating the hydrophilic medical devices. 
     SUMMARY 
     In one aspect, a packaged medical device product includes a package defining a cavity. The product also includes a hydrophilic medical device contained within the cavity and a container containing a hydration liquid within the cavity. The container is configured to open upon exposure to radiation, thereby releasing the liquid into the cavity. 
     In another aspect, a method of making a packaged medical device product includes placing a hydrophilic medical device in a cavity of a package and placing a liquid filled container within the cavity of the package. The liquid filled container is configured to open upon exposure to radiation. The package is closed and exposed to radiation, thereby opening the container. 
    
    
     
       BRIEF DESCRIPTION OF DRAWINGS 
         FIG. 1  is a top plan view of one embodiment of a packaged medical device product in accordance with the present disclosure; and 
         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 
     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. 
     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. 
     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. 
     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. 
     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. 
     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. 
     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.