Patent Publication Number: US-2022226605-A1

Title: Reusable urinary catheter products

Description:
The present application claims the benefit of and priority to U.S. Provisional Application No. 62/866,339, filed Jun. 25, 2019, which is hereby incorporated herein by reference. 
    
    
     FIELD OF THE DISCLOSURE 
     The present disclosure generally relates to urinary catheters. More particularly, the present disclosure relates to reusable urinary catheter products. 
     BACKGROUND 
     Catheters are used to treat many different types of medical conditions and typically include an elongated shaft that is inserted into and through a passageway or lumen of the body. Catheters, and in particular intermittent catheters, are commonly used by those who suffer from various abnormalities of the urinary system, such as urinary incontinence. With the advent of intermittent catheters, individuals with urinary system abnormalities can self-insert and self-remove intermittent catheters several times a day. 
     Urinary catheters are frequently provided as disposable, single-use items. A user will remove the catheter from a package, use the catheter once, and then dispose of the catheter and the package. Reusable urinary catheters could, thus, be advantageous in reducing the amount of waste created by the use of disposable catheters, but there are various challenges associated with the use of reusable catheters (including storage, transport, and sterilization) that must be overcome before widespread acceptance and use of reusable catheters. 
     There is a need for reusable catheter products and methods of sterilizing the same. 
     SUMMARY 
     There are several aspects of the present subject matter which may be embodied separately or together in the devices and systems described and claimed below. These aspects may be employed alone or in combination with other aspects of the subject matter described herein, and the description of these aspects together is not intended to preclude the use of these aspects separately or the claiming of such aspects separately or in different combinations as set forth in the claims appended hereto. 
     In one aspect, the reusable catheter product includes a catheter and a case. The case includes a distal section, a proximal section, and a middle section therebetween. The case also includes a cavity configured to receive the catheter. The reusable catheter includes a distal end and a proximal end. The reusable catheter includes a hydrophilic coating. The case also includes a hydration fluid contained within the cavity. The hydration fluid includes a sterilization medium. The product allows the catheter to be repeatedly inserted and removed from the case, and yields a sterile and re-usable catheter. 
     In another aspect, the reusable catheter product further includes the case having a flexible middle section, and rigid proximal and distal sections. The flexible middle section may have grooves and/or ridges. The case may also include at least one grip, and the distal section of the case may define at least one cutout configured to mate with a catheter cap. Moreover, the catheter further includes the catheter cap configured to mate with the cutout. 
     In another aspect, a method for sterilizing the reusable catheter product is disclosed. The method includes inserting the hydration fluid comprising the sterilization medium into the cavity and inserting the catheter into the case by pushing the proximal end of the catheter into the proximal section of the case. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a side view of a reusable catheter product. 
         FIG. 2  is a cross-sectional view of the reusable catheter product of  FIG. 1 , showing a catheter positioned in a case. 
         FIG. 3  is a cross-sectional view of the reusable catheter product of  FIG. 1 , showing the case without the catheter. 
         FIG. 4  is a perspective view of the reusable catheter product of  FIG. 1 , showing the case in a bent configuration. 
         FIG. 5  is a perspective view of a multiuse catheter contained within a package. 
     
    
    
     DESCRIPTION 
     The embodiments disclosed herein are for the purpose of providing a description of the present subject matter, and it is understood that the subject matter may be embodied in various other forms and combinations not shown in detail. Therefore, specific embodiments and features disclosed herein are not to be interpreted as limiting the subject matter as defined in the accompanying claims. 
     Reusable urinary catheter products according to the present disclosure and their individual components may be variously configured without departing from the scope of the present disclosure, but in one embodiment, a reusable urinary catheter product  10  is configured as shown in  FIG. 1 . 
       FIG. 1  shows a reusable urinary catheter product  10 . The product  10  includes a storage and sterilization device, such as a case  12 . Referring to  FIGS. 2 and 3 , the case  12  defines a cavity  16  configured to hold a hydration fluid  18 . The case  12  includes a proximal section  30 , a distal section  32 , and a middle section  40  therebetween. The middle section  40  may be bendable or flexible. In the illustrated embodiment the middle section  40  includes grooves  42  and ridges  44  that assist in allowing the middle section  40  to bend. In one embodiment, the proximal section  30  and the distal section  32  are both comprised of rigid materials. The materials include but are not limited to PVC plastics and high density polyethylene (HDPE). Optionally, the middle section  40  comprises flexible material, including but not limited to elastomers. 
     The case  12  is configured to accommodate a multiuse urinary catheter  14 . In an embodiment, the cavity  16  is configured to accept and store the urinary catheter  14 . The catheter  14  includes a shaft  20  which has a hydrophilic coating thereon. The hydrophilic coating becomes lubricous when hydrated with a hydration fluid, which assists in easing insertion and withdrawal of the catheter  14  from the urethra. 
     The hydration fluid  18  comprises a sterilization medium for sterilizing the catheter  14  in between uses. The sterilization medium in the hydration fluid  18  contacts the catheter  14 , when the catheter  14  is located within the cavity  16 . The sterilization medium in the hydration fluid  18  can include any suitable antiseptic component such as iodine, oligodynamic metals, etc. In one embodiment, the hydration fluid  18  may include a water-based solution of a complex of polyvinyl pyrrolidone (PVP) and iodine. The hydration fluid  18  is capable of activating or refreshing the hydrophilic coating of the urinary catheter  14 , and capable of sterilizing the catheter  14  when the coating contacts the hydration fluid  18 . In one embodiment, when a user inserts the catheter  14  into the case  12 , the catheter  14  may be immersed in the hydration fluid  18 , which sterilizes and hydrates the hydrophilic coating of the catheter  14 . In another embodiment, the catheter  14  may not be immersed in the hydration fluid  18  but the fluid  18  may slosh around within the case  12  due to shaking and/or natural movement of the user. 
     In an embodiment, the hydration fluid  18  comprises a water based solution of chlorhexidine (e.g., dihydrochloride, diacetate, and digluconate). 
     In another embodiment the sterilization medium of the hydration fluid  18  comprises FimH inhibitors that hinder bacterial adhesion to cells, tissues and synthetic material surfaces, thus preventing bacterial colonization and proliferation. The FimH inhibitors include, but are not limited to, mannose based molecules. Among these mannose based molecules are alkyl alfa-D-mannopyranosides (e.g. heptyl alfa-D-mannopyranoside) and aryl alfa-D-mannopyranosides, having different degrees of relative inhibitory potency. In an embodiment, the sterilization medium of the hydration fluid  18  includes antibacterial materials. These antibacterial materials include peptidomimetic antimicrobials (synthetic peptides that attack the prokaryotic membrane and destroy it). Examples of these are: Lys-Leu or klotho (KL) peptide known as (KLAKLAK)2, D-(KLAKLAK)2, brilacidin (PMX-30063) and POL7080. 
     In one embodiment the sterilization medium of the hydration fluid  18  comprises antibacterial materials including aminoglycosides and derivatives (bactericidal antibiotics tolerant to enzymatic inactivation). Examples of these include but are not limited to Plazomicin. 
     In another embodiment the sterilization medium of the hydration fluid  18  comprises nanoparticles with bactericidal effects. Examples of these include, but are not limited to, zinc oxide and copper oxide. 
     In another embodiment the sterilization medium of the hydration fluid  18  comprises oxazolidinones capable of inhibiting bacterial protein synthesis. These oxazolidinones include, but are not limited to, Tedizolid, Solithromycin, cethromycin, Omadacycline, fusidic acid, GSK1322322, Radezolid, Tedizolid S and Eravacycline. 
     In another embodiment the sterilization medium of the hydration fluid  18  comprises antibacterial proteins that inactivate bacterial DNA. These anti-bacterial proteins include, but are not limited to, SASPject technology. In another embodiment the sterilization medium of the hydration fluid  18  comprises a water solution with honey. In one embodiment the sterilization medium of the hydration fluid  18  comprises glucose oxidase. 
     In addition to the hydration fluid  18  having features which may sterilize the product  10 , the catheter  14  and/or case  12  may also have features that facilitate sterilization. For example, an antimicrobial compound may be incorporated into the material of the catheter  14  and/or case  12 . The antimicrobial compound may include, but is not limited to, zinc oxide, zinc sulphates, and zero valence silver. 
     In one embodiment zinc oxide is incorporated into the material of the catheter  14  and/or case  12 . For instance, zinc oxide (ZnO) powder may be compounded using a twin screw extruder with the polymer material of the case, which may be a thermoplastic elastomer (TPE). This ZnO compound is then extruded to produce a case  12  and/or catheter  14  loaded with antimicrobial ZnO. 
     In one embodiment, when making the catheter  14 , a polymer loaded with ZnO is formed into a catheter tube. The tube is tipped and a funnel is attached to the catheter  14 . The catheter  14  is subsequently coated with a hydrophilic coating such as a polyvinylpyrrolidone (PVP) based coating. Once the catheter  14  is coated, at least one catheter “eye”  22  is cut into the tube ( FIG. 2 ). Thus, the catheter  14  has an outer portion with a hydrophilic coating and an inner portion including a polymer-ZnO composite. Due to the antibacterial properties of the ZnO-polymer composite the inner surface will resist bacterial colonization. Similarly, the case  12  may be made from a loaded polymer, such as TPE, which inhibits bacterial colonization in the cavity  16  of the case  12 . Furthermore, the outer surface of the catheter  14  and the inner surface of the case  12  may be UV irradiated to kill bacteria. 
     In another embodiment the hydrophilic coating of the catheter  14  is loaded with ZnO to provide an antibacterial hydrophilic surface. Alternatively, the catheter  14  and/or coating, comprises zinc sulphates (ZnSO4) and zero valence silver. 
     In another embodiment, the catheter  14  includes a silicone based coude tip/straight tip. The catheter  14  also may include zero valence silver attached to its exterior and interior walls. When metallic silver is deposited inside and outside of the catheter  14 , the catheter  14  may remain bacteria free and be useable for a years-long time period. 
     In one embodiment, the case  12  includes a wall that is lined with silver and the case 12  is filled with water. The silver lining helps kill bacteria both inside and outside the catheter  14 . 
     In one embodiment, the case  12  includes a pouch that is lined with silver. The pouch is filled with water and is configured to hold the catheter  14 . The silver lining helps kill bacteria both inside and outside of the catheter  14 . 
     In one embodiment the hydration fluid  18  may include water containing a surfactant to loosen biofilm from the catheter  14 . 
     In one embodiment the case  12  includes an agitator to agitate the hydration fluid  18  during sterilization of the catheter  14 . 
     In one embodiment the catheter  14  is placed in a catheter pack capable of irradiating the catheter with antibacterial UV light  64  for sterilization (illustrated in  FIG. 3 ). Optionally, the hydration fluid  18  may include a hydrophilic polymer, such as PVP. When the hydration fluid  18  contacts the hydrophilic coating, the hydrophilic polymer also contacts the coating. During exposure to UV light, the hydrophilic polymer of the hydration fluid  18  crosslinks with the hydrophilic coating so as to refresh the hydrophilic coating with additional polymer chains. 
       FIG. 2  is a cross sectional view of an embodiment of the product  10 , showing the catheter  14  inside the case  12 . As shown in  FIG. 2 , the case  12  is configured to accommodate the catheter  14 . When a user inserts the catheter  14  inside the case  12 , the hydration fluid  18  inside the case  12  sterilizes the catheter  14 , allowing for multiple safe and sterile uses of the catheter  14 . Moreover, the catheter eye  22  is visible at the proximal end  60  of the catheter  14 , near the proximal section  30  of the case  12 . The catheter eye  22  is configured to receive the hydration fluid  18 . The catheter eye  22  allows the hydration fluid  18  to travel inside the catheter  14  so that the hydration fluid  18  sterilizes the inside of the catheter  14 . 
       FIGS. 2 and 3  show the case  12  in a straightened configuration. The straightened configuration allows the catheter  14  to be fully inserted into the case  12 . When in the straightened configuration, the flexible middle section  40  is planar and aligned with both the proximal section  30  and the distal section  32  of the case  12 . Optionally, the case  12  may include a UV light  64  that may be used to sterilize the product  10  and refresh the hydrophilic coating when the hydration fluid  18  includes a hydrophilic polymer. 
       FIG. 4  shows an embodiment of the case  12  in a bent configuration. The bent configuration allows a user to more easily store and carry the case  12 . In the bent configuration the middle section  40  is flexed so that the distal section  32  and the proximal section  30  sit approximately opposed to each other. In the embodiment shown, the middle section  40  is bent at an acute angle. However, the flexible material comprising the middle section  40  allows for a range of angles; a user may choose the angle he or she prefers for added convenience. 
       FIG. 4  also shows grips  34 ,  36  attached to the outside of the case  12 . The case  12  includes a lower grip  34  that surrounds the lower portion of the case  12 . The lower grip  34  comprises a smooth elastomeric material, such as rubber. In the embodiment shown in  FIG. 4 , the lower grip  34  extends from the bottom of the middle section  40  to approximately ⅔ of the way to the proximal section  30 .  FIG. 4  also shows an upper grip  36 . The upper grip  36  shown in  FIG. 4  comprises a partially grooved elastomeric material (for example, rubber) and/or plastic. The upper grip  36  at least partially surrounds the upper portion of the case  12 . In  FIG. 4  the upper grip  36  extends from the distal section  32  to approximately the halfway point between the distal section  32  and the top of the middle section  40 . The grips  34 ,  36  make it easier for the user to grasp and hold the product  10 . 
     Furthermore, the distal section  32  comprises a cutout  38  configured to accommodate a cap  50  on the distal end  62  of the catheter  14  (the cap is shown as  50  in  FIG. 5 ). The cap  50  and the cutout  38  fit together to help keep the catheter  14  in place while inserted into the case  12 . This cap  50  and cutout  38  coupling may help keep the catheter  14  stable for traveling, sterilization, and/or for when the case  12  is in the bent configuration with the catheter  14  inside. 
     Additionally,  FIG. 4  shows an embodiment wherein the distal section  32  has a wider section at the upper most portion of the case  12  that tapers distally from the bottom of the upper grip  36 . The wider section of the upper portion of the case  12  extends from the bottom of the cutout  38  to the bottom of the upper grip  36 . The narrower section of the upper portion extends from the bottom of the upper grip  36  to the top of the middle section  40 . The case  12 , the cavity  16 , and the tapered upper portion may be configured to accommodate the shape of the catheter  14 . 
     Referring to  FIG. 5 , the catheter  14  may be provided to a user in a disposable package  52 . The catheter  14  comprises a proximal end  60  and a distal end  62  with a tubular section  54  therebetween. The tubular section  54  may comprise a shaft  20 . The reusable catheter  14  may be used multiple times and then may be discarded for a new catheter  14 . The catheter  14  shown in  FIG. 5  also comprises a removable cap  50  configured to mate with the cutout  38  (shown in  FIG. 4 ). The cap  50  includes a lower section  58  configured to engage the cutout  38  on the case  12 . 
     As shown in  FIG. 5 , the removable cap  50  surrounds the distal end  62  of the catheter  14  and comprises a substantially rigid polymeric material including but not limited to plastic. The cap  50  closes off the distal end  62  of the catheter  14  so that when it is stored in the case  12 , hydration fluid  18  does not leak from the distal end  62  of the catheter  14 . Moreover, the cap  50  shown includes a portion with at least one groove  56 . The at least one groove  56  spans the circumference of the cap  50 . 
     It will be understood that the embodiments described above are illustrative of some of the applications of the principles of the present subject matter. Numerous modifications may be made by those skilled in the art without departing from the spirit and scope of the claimed subject matter, including those combinations of features that are individually disclosed or claimed herein. For these reasons, the scope hereof is not limited to the above description but is as set forth in the following claims, and it is understood that claims may be directed to the features hereof, including as combinations of features that are individually disclosed or claimed herein.