Patent Publication Number: US-2022226602-A1

Title: Packaged hydrophilic medical devices

Description:
The present application claims the benefit of and priority to U.S. Provisional Application No. 62/851,425, 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 products and methods of hydrating medical products within the package. Even more particularly, the present disclosure relates to packaged hydrophilic catheter assemblies and methods of hydrating the same. 
     Background 
     It is desirable for medical devices that are inserted into the body to have a lubricated or lubricious outer surface to facilitate insertion into and/or removal of the medical device from the body. Such devices may include, for example, urinary catheters, endoscopes, cardiovascular catheters, syringes, vascular stents, etc. Such medical devices may have a hydrophilic coating or layer disposed on an outer surface thereof. Hydrophilic coatings are becoming the preferred method of providing lubricious surfaces because of their high lubricity and ease of use. Hydrophilic coatings become slippery or lubricous when wetted with a hydration medium, such as saline or liquid or vapor water. The hydrated lubricous hydrophilic coating eases insertion and removal of the device, which can result in minimizing soft tissue damage and reducing overall discomfort during use of the medical device. 
     When a hydrophilically coated medical device is used, the hydrophilic coating is hydrated with a hydration medium prior to use to activate the hydrophilic coating. It is advantageous for the hydrophilic coating to be hydrated within the package so that the device is ready-to-use right out of the package without the user having to activate the hydrophilic coating prior to use. 
     Therefore, there remains a need for improved packaged hydrophilic medical devices. 
     SUMMARY 
     In one aspect, a packaged medical device product includes a package defining a cavity. The cavity includes a first compartment and a second compartment wherein the first and second compartments are separated by a vapor permeable, liquid impermeable barrier. The product also includes a hydrophilic medical device contained within the first compartment. The hydrophilic medical device including a hydrophilic material that becomes lubricious when hydrated. A liquid is contained in the second compartment. The liquid produces a vapor that migrates through the vapor permeable, liquid impermeable barrier into a first compartment, whereby the vapor hydrates the hydrophilic material. The pressure in the second compartment is greater than the pressure in the first compartment. 
     A method of making a package medical device product including placing hydrophilic medical device in first compartment of package. A vapor producing liquid is placed in a second compartment of the package. The first compartment and the second compartment are separated by a vapor permeable, liquid impermeable barrier. The package is closed and the pressure is increased in the second compartment. 
    
    
     
       BRIEF DESCRIPTION OF DRAWINGS 
         FIG. 1  is a top plan view of one embodiment of a packaged medical device in accordance with the present disclosure; and 
         FIG. 2  is cross-sectional view of the packaged medical device of  FIG. 1 , taken along lines  2 - 2 . 
     
    
    
     DETAILED DESCRIPTION OF THE EMBODIMENTS 
     The present disclosure is generally directed to packaged hydrophilic medical products  10  that are ready to use right out of the package. Referring to  FIGS. 1 and 2 , the packaged hydrophilic medical product  10  includes a package  12 . In the illustrated embodiment, 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 may be opened by grasping these unattached portions and pulling the front sheet  14  and back sheet  16  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 such as a tear open package. Additionally, the material of the package, optionally, may be made from a gas impermeable material. 
     As shown in  FIG. 2 , the cavity  20  of the package is divided into a first compartment  24  and a second compartment  26 . The first and second compartments  24  and  26  are separated by a vapor permeable, liquid impermeable barrier  28 , such as a sheet or film. Optionally, the barrier may be a vapor permeable calcium carbonate film. The barrier  28  may be adhered to or sealed to the back sheet  16  such that the second compartment is defined between the barrier  28  and the back sheet  16 . 
     A hydrophilic medical device is contained within the first compartment  24 . In the illustrated embodiment, a hydrophilic catheter  30  is contained within the first compartment  24 . The hydrophilic catheter  30  may be any suitable hydrophilic catheter that includes a hydrophilic outer surface  32  that becomes lubricous when hydrated with a hydration medium, such as water. For example, the catheter  30  may include a lubricious hydrophilic coating on the outer surface of the catheter  30 . 
     The second compartment  26  contains a liquid  34 , such as liquid water or an aqueous solution, which produces or donates a vapor (such as water vapor). The vapor produced in the second compartment  28  by the liquid  34  migrates through the vapor permeable, liquid impermeable barrier  28  and moves into the first compartment  24 . In the first compartment  24 , the vapor contacts the hydrophilic material  32  of the catheter  30  to hydrate the hydrophilic material  32 . 
     Referring to  FIG. 2 , the second compartment  26  includes a mechanism for increasing gas pressure within the second compartment  26 . This increase in gas pressure in the second compartment  26  results in the gas pressure of the second compartment  26  being greater than the gas pressure in the first compartment  24 , thereby creating a pressure gradient across the vapor permeable, liquid impermeable barrier  28  and a gas pressure differential between the first and second compartments  24  and  26 . This pressure gradient assists in increasing the rate of migration of the vapor from the second compartment  26  into the first compartment  24 . That is, when the pressure in the second compartment  26  is greater than that of the first compartment  24 , the flow of the vapor from the second compartment  26  to the first compartment  24  is increased. Thus, more vapor enters the first compartment  24  in a shorter period of time than if there was no pressure gradient between the compartments  24  and  26 . With more vapor entering the first compartment  24  in a shorter period of time, the hydrophilic material  32  hydrates faster than when there is no pressure gradient between the compartments  24  and  26 . 
     The mechanism for creating a pressure gradient includes a mechanism that produces a pressure increasing gas in the second compartment  26 . The mechanism may produce carbon dioxide, oxygen, nitrogen, etc. Optionally, the pressure increasing mechanism may include mixing of two or more components that react to produce the gas. For example, the components may be acid and a carbonate that react to produce a carbon dioxide. In one example, the mechanism may include mixing sodium bicarbonate and citric acid. As explained in more detail below, the components may be in solution and/or in solid form. For example, the acid and carbonate may be water soluble components that are included in the vapor producing liquid  34 . Referring to  FIG. 2 , one of the acid or carbonate may be placed in the package in solid form  36 , such as in tablet or powder form. The other of the components may be included in the liquid  34 . When the packaged device assembly  10  is formed, the solid form  36  is placed in the second compartment  26  along with the liquid  34  that contains the other of the components. 
     Alternately, again referring to  FIG. 2 , both the acid and carbonate may be placed in the package in solid form  36 , such as in tablet or powder form. When the packaged device assembly  10  is formed, the solid form  36  is placed in the second compartment  26  along with the liquid  34 . When the solid form  36  is wetted by the liquid  34  the reaction between the acid and carbonate proceeds, thereby producing a gas. 
     The catheter  30  is placed in the first compartment  24  and the package  10  is closed and sealed. The two components react with one another to produce a gas, thereby increasing the pressure within the second compartment  26 . 
     In another embodiment, the first component is included in a first liquid to form a first solution and the second component is included in a second liquid to form a second solution. During packaging, the first and second solutions are placed in the second compartment  24  and the catheter  30  is sealed within the package in a similar manner as described above. When the solutions come into contact with each other, the first and second components react to produce a gas, thereby increasing the pressure in the second compartment  24 . With a gas pressure gradient formed, the vapor produced by the liquid  34  will migrate at a faster rate across the barrier  28 , than if there was no pressure gradient. 
     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.