Patent Publication Number: US-2021178117-A1

Title: Self-intermittent urinary catheter extension with infection detection, a catheter assembly having an extension with infection detection and a catheter assembly having infection detection

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
     This application claims priority from U.S. Provisional Patent Application Ser. No. 62/948,304, filed Dec. 12, 2019, entitled “Self-Intermittent Urinary Catheter Extension With Infection Detection And A Catheter Assembly Having An Extension With Infection Detection” and also U.S. Provisional Patent Application Ser. No. 63/042,770 filed Jun. 23, 2020, entitled “Self-Intermittent Urinary Catheter Extension With Infection Detection And A Catheter Assembly Having An Extension With Infection Detection”. The entire disclosure of each of these applications is hereby incorporated by reference in their respective entirety. 
     This application is also related to, but does not claim priority from, U.S. patent application Ser. No. 16/405,961 filed May 7, 2019, entitled “Monolithic Self-Intermittent Catherization System with Attached Extension”. The disclosure of this application is hereby incorporated by reference in its entirety. 
    
    
     BACKGROUND OF THE DISCLOSURE 
     1. Field of the Disclosure 
     The disclosure relates in general to self-intermittent urinary catheters, and more particularly, to a self-intermittent urinary catheter extension with infection detection. It will be understood that the system of the present disclosure is not limited to self-intermittent catheters, but can be utilized in association with, among other structures, indwelling catheter systems, without limitation. 
     2. Background Art 
     The urinary tract consists of the kidneys, bladder, ureters, and urethra. Urine in the bladder is normally sterile. This means it does not contain any bacteria or other germs (such as fungi). But bacteria can enter the urinary tract through the urethra. This can cause a urinary tract infection (UTI). A UTI can happen anywhere in your urinary tract, including your bladder, ureters, kidneys, and urethra. Most UTIs are easy to cure with antibiotics. But an untreated infection can become more severe as it spreads toward the kidneys. An infection in the upper urinary tract is much more challenging to treat. Eventually, the infection can spread into your blood, causing sepsis and frequently, death. 
     Individuals with spinal cord injuries or other maladies that preclude them from sensation in their lower body have Neurogenic bladders, which necessitates them to void their bladder 5 to 7 times a day through use of a self-intermittent urinary catheter. Because of limited sensation, UTIs are not sensed right away and therefore, treatment is late. There is an extremely high incidence of UTIs and subsequent complications in this population due to these issues, frequently resulting in complications, other medical issues, hospital stays, and often—sepsis and death. 
     SUMMARY OF THE DISCLOSURE 
     The disclosure is directed an extension assembly for a catheter. The extension assembly comprises an extension tube, an extension connector and an indicator assembly. The extension tube has a proximal end and a distal end, and, an inner bore. The extension connector has a body with a central bore, with the proximal end of the extension tube coupled to a first end of the body. The extension connector further includes at least one slot and at least one radial passage. The at least one slot is disposed in the body defined by lower end wall and upstanding walls extend axially outwardly therefrom, terminating at an upper opening. The at least one radial passage extends from the central bore to the at least one slot. The indicator assembly has an indicator and a wicking member. The indicator has a top surface, a bottom surface and an edge. The indicator is structurally configured to change color in the presence of a chemical indicative of a bladder infection. The wicking member has an indicator contact portion and a flow contact portion. The flow contact portion is in fluid communication with the at least one radial passage and the indicator contact portion is in contact with one of the top surface, the bottom surface and the edge of the indicator. The wicking member is positioned between the radial passage and the indicator. 
     In some configurations, the at least one slot comprises a pair of slots that are positioned on opposite sides of the body of the extension connector. The at least one radial passage further has a radial passage extending to each of the pair of slots. 
     In some configurations, the at least one slot further comprises a substantially rectangular lower end wall. The upstanding walls further comprise a catheter side wall, an extension side wall spaced apart from the extension side wall, with a first joining wall spanning therebetween and a second joining wall spanning therebetween spaced apart from the first joining wall. 
     In some configurations, the upstanding walls define a substantially rectangular upper opening. 
     In some configurations, the radial passage extends through the lower end wall spaced apart from the upstanding walls. 
     In some configurations, the radial passage comprises at least one of a centrally positioned, and an offset substantially circular opening, thereby defining a substantially cylindrical opening. 
     In some such configurations, the wicking member overlies the lower end wall and overlies the radial passage. The indicator extends over the wicking member so as to sandwich the wicking member between the lower end wall and the indicator. 
     In some configurations, a liner is positioned between the lower end wall and the wicking member. The liner is positioned such that the wicking member maintains direct fluid communication with the radial passage. 
     In some configurations, the wicking member overlies the lower end wall and overlies the radial passage. A portion of the wicking member extends over the top surface of the indicator. A liner is positioned between the lower end wall and the indicator, such that a portion of the lower end wall is overlayed with the liner, and a portion of the lower end wall is overlayed with the wicking member. 
     In some configurations, the radial passage comprises a slot positioned adjacent to one of the catheter side wall, the extension side wall, the first joining wall and the second joining wall. 
     In some configurations, at least a portion of the wicking member extends into the radial passage. 
     In some configurations, a liner positioned between the wicking member and the lower end wall, the liner being sandwiched therebetween. 
     In some configurations, the wicking member extends to an inner end of the radial passage. 
     In some configurations, the wicking member further extends over the top surface of the indicator. 
     In some configurations, a cover member extends over the slot. The cover member is at least partially transparent. 
     In some configurations, a bag coupling connector is positioned at the distal end thereof. 
     In some configurations, a plurality of ribs extend longitudinally along the central bore between the radial passage and the first end of the extension connector. 
     In another aspect of the disclosure, the disclosure is directed to a catheter comprising a catheter tube, a connector and an indicator assembly. The catheter tube has a proximal end and a distal end, and, an inner bore. The connector has a body with a central bore, with the proximal end of the catheter tube coupled to a first end of the body. The connector further includes at least one slot and at least one radial passage. The at least one slot is disposed in the body defined by lower end wall and upstanding walls extend axially outwardly therefrom, terminating at an upper opening. The at least one radial passage extends from the central bore to the at least one slot. The indicator assembly has an indicator and a wicking member. The indicator has a top surface, a bottom surface and an edge. The indicator is structurally configured to change color in the presence of a chemical indicative of a bladder infection. The wicking member has an indicator contact portion and a flow contact portion. The flow contact portion is in fluid communication with the at least one radial passage and the indicator contact portion is in contact with one of the top surface, the bottom surface and the edge of the indicator. The wicking member is positioned between the radial passage and the indicator. 
     In some configurations, the at least one slot comprises a pair of slots that are positioned on opposite sides of the body of the connector, with the at least one radial passage further comprising a radial passage extending to each of the pair of slots. 
     In some configurations, the at least one slot further comprises a substantially rectangular lower end wall, and wherein the upstanding walls further comprise a catheter side wall, an extension side wall spaced apart from the extension side wall, with a first joining wall spanning therebetween and a second joining wall spanning therebetween spaced apart from the first joining wall. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The disclosure will now be described with reference to the drawings wherein: 
         FIG. 1  of the drawings is a side elevational view of an extension assembly of the present disclosure, showing, the extension tube, the extension connector, the indicator assembly and the bag coupling connector; 
         FIG. 2  of the drawings is a cross-sectional view of the extension assembly of  FIG. 1 , taken about the longitudinal axis of the same; 
         FIG. 3  of the drawings is a partial perspective view of the extension assembly, showing, in particular, the extension connector and indicator assembly of the present disclosure; 
         FIG. 3A  of the drawings is a perspective view of the extension connector, showing, in particular ribs that extend radially inwardly within the central bore; 
         FIG. 4  of the drawings is a partial cross-sectional view of the extension assembly, showing, in particular, the central test portion having a plurality of slots therein, with a plurality of radial passages (one for each of the slots), with the indicator assembly having an indicator, a wicking member and a liner; 
         FIG. 5  of the drawings is a side elevational view of the extension connector of the present disclosure, showing, in particular, details pertaining to the slot and the radial passage of a configuration; 
         FIG. 6  of the drawings is an upper perspective view of a configuration of the indicator assembly; 
         FIG. 7  of the drawings is a lower perspective view of a configuration of the indicator assembly of  FIG. 6 ; 
         FIG. 8  of the drawings is a perspective view of an extension connector, showing, in particular, a configuration of the tube coupling assembly having an outer rim and a cavity; 
         FIG. 9  of the drawings is a cross-sectional view of the extension connector of  FIG. 8 ; 
         FIG. 10  of the drawings is a perspective view of an extension connector, showing, in particular, a configuration of the central test portion having a radial passage that is offset toward the catheter side wall, and, in the configuration shown, positioned between the first and second joining walls; 
         FIG. 11  of the drawings is a cross-sectional view of the extension connector of  FIG. 10 ; 
         FIG. 12  of the drawings is a perspective view of an extension connector, showing, in particular, a configuration of the central test portion having a slot passage that is positioned along the catheter side wall and which extends between the first and second joining walls; 
         FIG. 13  of the drawings is a cross-sectional view of the extension connector of  FIG. 12 ; 
         FIG. 14  of the drawings is a perspective view of a configuration of the indicator assembly of the present disclosure, which may be utilized with the extension connector shown in  FIGS. 12 and 13 ; 
         FIG. 15  of the drawings is a perspective view of a configuration of the indicator assembly of the present disclosure, which may be utilized with the extension connector shown in  FIGS. 10 and 11 ; 
         FIG. 16  of the drawings is a perspective view of a catheter having the central test portion of the present disclosure. 
     
    
    
     DETAILED DESCRIPTION OF THE DISCLOSURE 
     While this disclosure is susceptible of embodiment in many different forms, there is shown in the drawings and described herein in detail a specific embodiment(s) with the understanding that the present disclosure is to be considered as an exemplification and is not intended to be limited to the embodiment(s) illustrated. 
     It will be understood that like or analogous elements and/or components, referred to herein, may be identified throughout the drawings by like reference characters. In addition, it will be understood that the drawings are merely schematic representations of the invention, and some of the components may have been distorted from actual scale for purposes of pictorial clarity. 
     Referring now to the drawings and in particular to  FIGS. 1 and 2 , the self-intermittent urinary catheter extension assembly (herein referred to as “extension assembly”) is shown generally at  10 . As will be explained below, the extension assembly is configured for coupling to a self-intermittent urinary catheter. The extension assembly is not limited to use therewith, but can also be used with other types of catheters, and can also be used in closed systems, such as, for example indwelling catheters and Foley catheters, among others. For illustrative purposes only, and not for limiting purposes, the extension assembly will be described in the environment of a self-intermittent urinary catheter with the understanding that it is not so limited in use. 
     The extension assembly  10  is shown as comprising extension tube  12 , extension connector  14 , indicator assembly  16  and bag coupling connector  18 . The extension tube  12  is shown as comprising a tubular member formed from a polymer, such as a latex free polymer. In many configurations, the tubular member may be clear and transparent, while in other configurations, the tubular member may be translucent or opaque and in varying colors. The extension tube  12  extends between proximal end  20  and distal end  22 . The extension tube defines an outer surface  26  and an inner bore  24 , which, in the configuration shown, defines a substantially uniform cylindrical configuration with a substantially uniform wall thickness. Of course, variations are contemplated in the configuration and cross-sectional shape of the extension tube. 
     The extension connector  14  comprises body  30  and cover member  78 . The body  30  preferably comprises an injection molded rigid polymer component that is integrally formed and monolithic. Of course, multiple component constructions are likewise contemplated, wherein the multiple components can be co-molded, or separately molded and attached together mechanically through mechanical coupling, adhesive coupling and/or welding or the like. The body  30  extends from first end  32  to second end  34  and central bore  36 . In the configuration shown, the central bore is substantially circular in cross-sectional configuration while variations are contemplated. 
     The body  30  further defines a tube coupling assembly  40 , a catheter coupling assembly  50  and a central test portion  56 . In the configuration shown, the tube coupling assembly is configured to be attachable to the extension tube. The tube coupling assembly includes outer surface  42  and proximal stop  44 . In one configuration, the proximal stop defines a flange, such as flange  46  which provides a positive stop as the extension tube is extended over the outer surface of the tube coupling assembly. The outer surface  42 , in the configuration shown defines a plurality of barbs which are configured to sealingly engage the inner bore  24  of the extension tube in engagement. It will be understood that the relative sizes are such that the extension tube is both sealed against the outer surface of the tube coupling assembly and that it is also resistant to separation. In such a configuration, the extension tube is stretched over the barbs of the outer surface. 
     In another configuration, the outer surface may be substantially smooth and the extension tube may be slid over through stretching (wherein reliance is made on the inward biasing of the extension tube) or through an adhesive. In some configurations, such as the configuration shown in  FIGS. 8 and 9 , a cavity  48  may be created at the inner end of the tube coupling assembly which can be defined by an outer rim  47  that is concentric with and spaced apart from the outer surface  42  of the tube coupling assembly  40 . It will be understood that various combinations of outer surfaces and various couplings (mechanical through stretching, adhesive or the like) can be combined with each other to create variations on the different structures disclosed herein. 
     The catheter coupling assembly  50  is shown in  FIG. 3 through 5  as comprising outer surface  52  and proximal stop  54 . In the configuration shown, the proximal stop comprises a ridge  55  representing the proximal end of the catheter coupling assembly. The outer surface  52  comprises a barbed configuration of slightly increasing diameter. Such a configuration allows for the sealed engagement with a variety of catheters in a sealed arrangement. In other configurations, a fewer or greater amount of barbs as well as greater dimensional changes are contemplated. Furthermore, it is contemplated that in still other configurations, the outer surface may comprise a smooth surface, or a different configured surface for engagement in a sealed manner with the catheter (or another tubular member). With reference to  FIG. 3A , the central bore  36  thereof may include inwardly directed ribs  43  that extend along the central bore generally along the length thereof at least partially between a first and second end thereof. These ribs  43  increase the turbulence of the fluid within the central bore and provide improved contact between the fluid (urine) and the radial passage (so that the fluid can improve contact with the indicator assembly). In the configuration shown, a plurality of ribs  43  (in the configuration shown, three ribs spaced at 120° from each other) extend longitudinally along the central bore between the radial passage and the first end of the extension connector. 
     As to the central test portion, a plurality of central test portions  56  may be positioned radially separated from each other about the central portion  57  of the body  30 . In the configuration shown, two central test portions are positioned 180° apart from each other, or, on opposite sides of each other. In other configurations, a single central test portion may be utilized. In still other configurations, more than two central test portions may be disposed along the central portion of the body. It will be understood that in the configuration shown, the pair of central test portions are substantially identical to each other, while, in other configurations, the different test portions may have different configurations (which may be due to positioning, due to different testing structures positioned therein, among other variations). As such, one of the central test portions will be described with the understanding that the other test portion may be substantially the same in configuration. 
     The central test portion  56 , in the configuration depicted, comprises slot  58  and radial passage  59 . The slot  58  is defined by lower end wall  60  and upstand walls  62  which collectively define cavity  63  and upper opening  70 . In the configuration shown, the slot comprises a substantially rectangular slot having a substantially planar and rectangular lower end wall  60 , a catheter side wall  64 , an extension side wall  66 , a first joining wall  68  and a second joining wall  69 . The joining walls are generally perpendicular to the lower end wall  60 . The width and length of the resulting slot are dimensionally larger than the height thereof. 
     While a rectangular configuration is shown, the slot is not limited to such a configuration. For example, the slot may comprise a cylindrical configuration, with the lower end wall being substantially circular. Other polygonal configurations are contemplated, such as triangular or hexagonal lower end walls. Furthermore, it is contemplated that the base surface may be arcuate so as to be concentric with the inner bore  24  of the extension connector  14 . Additionally, it is contemplated that the upstanding joining walls may comprise walls that are perpendicular to the arcuate lower end wall, or, where the lower end wall is planar, the upstanding joining walls may be oblique thereto. Furthermore, it is contemplated that each wall may be disposed at a different angle relative to the lower end wall. It is likewise contemplated that the upstanding walls may be other than substantially planar. 
     The radial passage  59  is shown in  FIGS. 4 and 5  as comprising a passage that includes inner end  72  and outer end  74 . The radial passage places the cavity  63  in fluid communication with the central bore  36  of the extension connector. In the configuration shown, the radial passage may comprise a bore that extends through the lower end wall. Such an opening is dimensionally smaller than either the width or the length of the lower end wall. Such an opening may be centrally located, or may be offset to any one of the walls (typically, toward one of the catheter side wall  65  or the extension side wall  66 ,  FIGS. 10 and 11 ). In the configuration shown, the bore comprises a cylindrical configuration, while other configurations are contemplated. 
     In another configuration, as is shown in  FIGS. 12 and 13 , the radial passage may comprise a slot, that for example, extends between the first joining wall and the second joining wall proximate the catheter side wall, for example. In other configurations, the slot may be spaced apart from the catheter side wall or the extension side wall or adjacent either one (or both). In other configurations, such a slot may be positioned in alternate directions, such as for example, between the catheter side wall and the extension side wall, and along one of the first and second joining walls. 
     A cover member  78  ( FIG. 4 ) may span across a portion of the central test portion  56  that is on opposing sides of the slot  58  so as to provide a substantially (if not fully) fluid tight cover over the upper opening  70  of the central test portion. It is contemplated that at least a portion of the cover member will include a transparent portion so as to provide visual access to the slot for purposes of observing the indicator assembly. In the configuration shown, the cover member comprises a hoop-like structure having a catheter side seal  77  and an extension side seal  79  that seals against opposing surfaces that matingly engage with the same. In other configurations, the cover member may be coupled to the central test portion through an adhesive in place or in addition to a mechanical coupling. 
     With additional reference to  FIGS. 6, 7, 14 and 15 , the indicator assembly  16  includes an indicator  80 , a wicking member  90  and a liner  87 . In the configurations shown, the indicator includes a top surface  82 , a bottom surface  84  opposite the top surface  82  and edges  86  which define the shape of the indicator assembly. As will be understood, the indicator comprises a woven or non-woven material (such as an absorbent pad or the like) which includes a chemical that has a color reaction to a particular substance. That is, the presence of the substance triggers a color change providing a visual confirmation of the presence of the substance. The particular substance that is monitored can be varied, with the understanding that, for purposes of the present disclosure, the substance to be monitored provides an indication of a bladder infection. In the configuration contemplated, the indicator comprises a material that is available from Teco Diagnostics of Anaheim, Calif. Other materials are contemplated for use therewith. 
     The wicking member includes an upper surface  92 , a lower surface  94 , an indicator contact portion  96  and a flow contact portion  98 . The upper and lower surfaces generally are planar and define a wicking member, in the present configuration, that is substantially uniform in thickness, and substantially flexible. An edge defines the outer perimeter of the wicking member. The wicking member essentially provides for the delivery of fluid at a controlled rate or a controlled flow or volume from the flow of urine to the indicator  80 . In various configurations, a portion of the wicking member is in fluid communication with the flow of urine through the central bore, and that portion comprises the flow contact portion  98 . Additionally, a portion of the wicking member is in fluid communication with a surface and/or an edge of the indicator thereby defining the indicator contact portion  96 . In the configurations shown, the wicking material is in physical contact with the indicator. In the configuration shown, the wicking member comprises a material likewise available from Teco Diagnostics of Anaheim, Calif. 
     In some configurations, the wicking member remains within the slot, entirely. In other configurations, the wicking member is positionable within the slot, with a portion of the wicking member extending into the radial passage ( FIGS. 12, 13 , and the indicator assembly of  FIG. 14 ). For example, the wicking member may extend into the radial passage where, again, for example, and not to be deemed limiting, the radial passage comprises a slot extending from the first joining wall to the second joining wall along one or both of the catheter side wall and/or the extension side wall. It will be understood that, in other configurations as well, the wicking member may extend into the radial passage, and may be shaped so as to extend into the radial passage in a particular configuration and/or orientation. 
     The liner  87  includes an upper surface  88  and a lower surface  89  the upper and lower surfaces cooperate to define an outer perimeter. The liner is preferably utilized to preclude and/or limit the exposure and/or movement of fluid either to or from the indicator. In some configurations, the liner overlies a portion of or an entirety of a surface (such as the bottom surface) of the indicator when the indicator is positioned within the slot. In at least some configurations, the liner is sandwiched between the bottom surface of the indicator and the lower end wall  60  of the slot  58 . In some configurations, the liner may be continuous or may include openings. In one such configuration of  FIGS. 1 through 5 , the liner is sandwiched between the lower surface of the wicking member and the lower end wall of the slot of the central test portion. In such a configuration, the liner includes an opening so as to allow direct contact of fluid from within the central bore to communicate with the wicking member. 
     In the configurations shown, the indicator generally has a square configuration that matches the shape of the slot  58 . In other configurations, it will be understood that the shape of the slot may be varied, and according, the shape of the indicator. In other configurations, it will be understood that the shapes may not match, or may match. It will further be understood that in some configurations, the edges of each of the indicator, the wicking member and the liner may be identical, whereas in other configurations, the wicking member may extend along various surfaces and may extend as an appendage from the indicator and/or the liner. Various combinations of the same are contemplated. 
     It is also contemplated that the indicator assembly may extend fully around the entirety of the extension connector, and, may be positioned in the central test portion, or may be positioned elsewhere. For example, in some configurations, a slot may be provided in the tube coupling assembly as opposed to the central test portion, and an edge thereof may be exposed to the stream. 
     The bag coupling connector is shown in  FIGS. 1 and 2  as comprising outer end  100 , inner end  102 , outer surface face  104  and central bore  106 . The bag coupling connector can be extended over the distal end of the extension and may be coupled to a bag. In other configurations, the extension may be directed to a toilet, a urinal, or to a collection container and may be loosely associated with the same, in place of being coupled thereto by way of the bag coupling connector or the like. 
     In operation, as the catheter is utilized, there is flow of urine through the inner bore of the extension assembly, and then the central bore of the extension connector. The flow of urine through the central bore of the extension connector eventually directs at least some portion of urine through one of the radial passages  59  in the central test portion. As the urine passes through the radial passage, the urine contacts the wicking member  90 . The wicking member  90  through wicking action pulls the urine into the wicking member and directs the urine from the flow contact portion toward and into the indicator contact portion of the wicking member. Continued wicking eventually has urine reach the indicator. As the urine interacts with the indicator, if certain chemicals are present, then the indicator will experience a color change indicative of the presence of the chemical. The presence of the chemical is an indication that there is a high probability of a bladder infection. On the other hand, if there is no color change, there is indication that the bladder is free of infection. 
     By transferring the urine from the flow to the indicator through the wicking member, the amount of urine that reaches the indicator can be minimized. Such minimization precludes the inadvertent removal of the underlying test chemicals within the indicator and generally preclude the bleeding out of the chemical from the indicator. Additionally, the liner  87  further precludes the bleeding out of the chemical from the indicator, leaving sufficient chemicals to allow for the indicator to effectively point out, or, identify, the presence or absence of an infection. 
     It will be understood that the same principles that are in the extension connector can be applied to a catheter itself. That is, the body of the catheter can have the structural features of the central test portion of the body and the indicator assembly. One such configuration is shown in  FIG. 16 . In such a configuration, the catheter assembly  310  includes catheter tube  301 , and connector  314 . The central test portion  356 , and in particular the slot  358  and the radial passage  359  thereof (in addition to the cover) can be adapted to the body of the catheter. The structure of the central test portion  356  may be similar to, or identical to the central test portion of the extension connector ( FIGS. 1 through 14 ), as can the indicator assembly  16 . 
     As with the extension tube, the catheter tube  312  is similar to an extension tube, having a distal end  322  that allows for insertion into the body. As will be understood, the distal end is shaped so as to extend into the body, and includes openings that are placed in fluid communication with the urine in the bladder of a user. 
     The catheter tube  312  can be coupled to the body  330  in place of the catheter coupling assembly of the extension connector. The opposing end can be coupled to an extension  303  or the like, directly, or through other structures known to one of skill in the art. 
     The foregoing description merely explains and illustrates the disclosure and the disclosure is not limited thereto except insofar as the appended claims are so limited, as those skilled in the art who have the disclosure before them will be able to make modifications without departing from the scope of the disclosure.