Devices, systems, and methods for detecting a biomarker

Abstract

Devices, systems, and methods for detecting a biomarker. More particularly, a kit including a urinary catheter to obtain a sample to be tested for KRT5+ cells.

Description

Attorney Docket No. 3400-0355.01 (822PCT)DEVICES, SYSTEMS, AND METHODS FOR DETECTING A BIOMARKER The present application claims the benefit of and priority to U.S. Provisional Application 63 / 760,471, filed February 19, 2025, which is hereby incorporated by reference.FIELD OF THE INVENTION

[0001] This disclosure generally relates to devices, systems, and methods for detecting a biomarker. In particular, the disclosure relates to a urinary catheter configured to detect the presence of KRT5+ cells.BACKGROUND

[0002] Patients with spinal cord injuries (SCI) or other neurogenic bladder conditions typically need to empty their bladders by intermittent urinary catheterization. In some instances, intermittent catheterization is a good option for many users who suffer from various abnormalities of the urinary system. With the advent of intermittent urinary catheters, individuals with problems associated with the urinary system can conveniently self-catheterize to drain the individual’s bladder.

[0003] Although catheters are typically prepared in sterile environments and are provided with safe handling instructions, catheter users are at risk of contracting a urinary tract infection due to several different factors. For example, the catheters may become contaminated during use and introduce bacteria into the urethra. The catheter also may carry bacteria along the urinary tract.

[0004] Urinary tract infections pose significant health risks to the user and are often not detected early enough before symptoms develop. Symptoms of urinary tract infections may include abdominal pain, back pain, pain with catheterization, and fever. One way to prevent urinary tract infections is by detecting the characteristics of a user’s urine via a urodynamic evaluation done by a doctor. Such evaluations may be awkward for the individual and unrealistic for users that catheterize multiple times a day.

[0005] In addition to urinary tract infections, characteristics of urine can provide insights to other possible health issues. For instance, biomarkers present in a user’s urine can indicate a wide range of conditions, including kidney dysfunction and some types of cancer.

[0006] Certain proteins can be used as biomarkers. For instance, some proteins are expressed exclusively in particular regions of the uroepithelium. In particular,Attorney Docket No. 3400-0355.01 (822PCT)these proteins may be expressed / detected in only a particular region in healthy tissue and in other regions when in response to stress or trauma. The time of stress / injury / trauma also defines the expression of these proteins. This “local” and “global” expression of certain proteins can be used as biomarkers to diagnose and analyze the health of the tissue.

[0007] Keratin 5-expressing (KRT5+) cells play a fundamental role in maintaining and regenerating the uroepithelium, which constitutes the specialized epithelial lining of the urinary tract. These cells, positioned predominantly in the basal layer of the uroepithelium, function as progenitor cells capable of self-renewal and differentiation into various cell types necessary for urinary tract homeostasis. The presence and activity of KRT5+ cells are particularly relevant in tissue repair following injury, inflammation, or other pathological conditions affecting the urinary tract. KRT5+ cells can be identified through various analytical methods including, but not limited to, immunological and molecular techniques. The role of KRT5+ cells in urinary tract health, their involvement in tissue regeneration, and expression in the basal layer of healthy tissue make them a suitable target for diagnostic and therapeutic applications in the field of urology.

[0008] Therefore, there is a need for improved intermittent urinary catheter devices, products, and methods that allow users to obtain information about the characteristics of the user’s urinary tract.SUMMARY OF THE DISCLOSURE

[0009] There are several aspects of the present subject matter which may be embodied separately or together in the subject matter 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 combination as set forth in the claims appended hereto.

[0010] In one aspect, a urinary tract infection detection kit is provided. The kit includes an intermittent urinary catheter. The intermittent urinary catheter includes a catheter tube including a tube outer surface and a tube inner surface. The catheter tube includes a proximal insertion end, a tube distal drainage end, and a tube lumen defined by the tube inner surface, which extends from the proximal insertion end to the distal drainage end. The kit also includes a sample container configured to hold aAttorney Docket No. 3400-0355.01 (822PCT)sample to be tested for the presence of KRT5+ cells.

[0011] In another aspect, a method for detecting a biomarker is provided. The method includes inserting an intermittent urinary catheter into a urethra. The intermittent urinary catheter includes a catheter tube including a tube outer surface and a tube inner surface. The catheter tube includes a proximal insertion end, a tube distal drainage end, and a tube lumen defined by the tube inner surface, which extends from the proximal insertion end to the distal drainage end. The method also includes removing the urinary catheter from the urethra and collecting a sample in a sample container. The sample is to be tested for the presence of KRT5+ cells.

[0012] In yet another aspect, a urinary catheter product is provided. The urinary catheter product includes an intermittent urinary catheter. The catheter includes a tube outer surface and a tube inner surface. The tube includes a tube proximal insertion end, a tube distal drainage end, and a tube lumen defined by the tube inner surface, which extends from the proximal insertion end to the distal drainage end. The catheter product also includes at least one marking on the tube outer surface designating a location to cut the tube.BRIEF DESCRIPTION OF DRAWINGS

[0013] FIG. 1 is a perspective view of an example of a urinary catheter assembly.

[0014] FIG. 2 is a perspective view of another example of a urinary catheter assembly.

[0015] FIG. 3 is a front view of another example of a urinary catheter assembly including a urine collection container.

[0016] FIG. 4A is a perspective view of an example of a urinary catheter being prepared for sample collection.

[0017] FIG. 4B is a perspective view of the urinary catheter assembly of FIG. 3A after being prepared for sample collection.

[0018] FIG. 5 is an exploded perspective view of an example of a sample placed in a sample container.

[0019] FIG. 6 is a flow chart showing a method of detecting a biomarker.

[0020] FIG. 7 is a plan view of a system for detecting a biomarker.DETAILED DESCRIPTION

[0021] A more detailed description of the device in accordance with the present disclosure is set forth below. It should be understood that the description of theAttorney Docket No. 3400-0355.01 (822PCT)specific devices below is intended to be exemplary, and not exhaustive of all possible variations or applications. Thus, the scope of the disclosure is not intended to be limiting and should be understood to encompass variations or embodiments that would occur to persons of ordinary skill.

[0022] The present disclosure is generally directed to a urinary tract infection detection kit. The kit includes a urinary catheter assembly 10, such as, but not limited to an intermittent urinary catheter, and a sample container 60 configured to hold a sample to be tested for the presence of a biomarker. The biomarker can be used to assess the health of a user’s urinary system, including the urinary tract. In a particular example, the kit includes an intermittent urinary catheter and a sample container configured to hold a sample to be tested for the presence of KRT5+ cells. KRT5+ cells are present only in the basal (lowest) layer in healthy urinary tract tissue (and in tissue that has experienced an acute injury). However, when the urinary tract tissue has undergone long-term, or serial injury, KRT5+ cells may be present throughout the uroepithelium (e.g., from the basal layer to the superficial layer). A sample to be tested for the presence of KRT5+ cells can be obtained from the urinary catheter and placed into the sample container. In an example, the sample container containing the sample can be sent to a testing facility to detect the presence of KRT5+ cells on / in the sample. Additionally, in some examples, the kit may be obtained in an outer packaging and may optionally include instructions on how to use the kit.

[0023] Turning to FIGS. 1-3, the figures illustrate examples of a urinary catheter assembly 10 configured to receive a biomarker, such as KRT5+ cells. In particular, the urinary catheter assembly can be used to detect the presence of KRT5+ cells. The urinary catheter assembly 10 can be an intermittent urinary catheter. In some embodiments, the intermittent urinary catheter is a sleeved catheter (as shown in FIG. 2). In other embodiments, the urinary catheter assembly 10 can include a urine collection container 38 (as shown in FIG. 3). Other suitable urinary catheters can be used without departing from the scope of the disclosure. The intermittent urinary catheters illustrated in the figures may contain similar features. The same reference number will be used to identify similar features in the figures, whereas different features will be identified with a different reference number.

[0024] In an example, the urinary catheter includes a catheter tube 12 including aAttorney Docket No. 3400-0355.01 (822PCT)tube outer surface 14 and a tube inner surface (not shown). The tube 12 also includes a tube proximal insertion end 16 and a tube distal drainage end 18. A tube lumen defined by the tube inner surface extends from the tube proximal insertion end 16 to the tube distal drainage end 18. The tube proximal insertion end 16 includes one or more openings 20 for receiving urine. The one or more openings 20 is in fluid communication with the tube lumen. In an example, the one or more openings 20 for receiving urine may be an eyelet. The size, shape, and location of the one or more openings 20 for receiving urine may vary without departing from the scope of the disclosure.

[0025] The tube distal drainage end 18 includes a drainage opening for draining urine from the tube lumen. In an example, the tube distal drainage end 18 includes a drainage member 22. The drainage member 22 may be, for example, but not limited to, a funnel or a connector.

[0026] In some examples, the catheter tube 12 may include a hydrophilic outer surface. For example, the polymer of the catheter tube 12 may be a hydrophilic polymer or a hydrophilic polymer may be coated on the tube outer surface 14. The hydrophilic surface is configured to absorb a hydrating medium to lubricate the catheter tube 12 to aid in insertion into a urethra.

[0027] As shown in FIG. 1 , in an example, the urinary catheter can include an optional gripper 23. Gripper 23 can be located on the catheter tube 12 and is configured to move along the longitudinal length of the catheter tube 12. Gripper 23 can assist a user in handling and inserting the catheter into the urethra. For instance, a user can hold the gripper to align the tube proximal insertion end 16 with the urethra opening. The user may then slide the gripper 23 a distance towards the tube distal drainage end, squeeze the gripper 23 to grasp the catheter tube 12, and then advance the tube 12 further into the urinary tract. This can be repeated until the at least one or more openings 20 enters the bladder.

[0028] As shown in FIG. 2, in an example, the urinary catheter may be a sleeved intermittent urinary catheter. For instance, the urinary catheter can include a sleeve 24 and an insertion aid 26. The sleeve 24 may be a protective or barrier sleeve. The sleeve 24 has a sleeve proximal end 28 and a sleeve distal end 30. The sleeve 24 may define an internal cavity in which the catheter tube 12 may be located. In an example, the sleeve 24 surrounds at least a portion of the catheter tube 12. InAttorney Docket No. 3400-0355.01 (822PCT)another example, the sleeve 24 extends over and surrounds the length of the catheter tube 12.

[0029] The insertion aid 26 can be located at the sleeve proximal end 28. When an insertion aid 26 is present, the sleeve proximal end 28 may be attached to a distal portion 32 of the insertion aid 26 by, for example, welding or adhesive. The sleeve distal end 30 may be attached to the drainage member 22 (e.g., funnel or connector) or to a distal portion of the catheter tube 12. The sleeve distal end 30 may be attached to the drainage member 22 or to the tube distal drainage end 18 by, for example, welding or adhesive.

[0030] The sleeve 24 may be made of a transparent, flexible material which may be vapor permeable or vapor impermeable, depending on the desired use and packaging. The material of the sleeve 24 also may be liquid impermeable or liquid permeable. The sleeve 24 may be formed of any of a variety of thin, flexible polymeric film materials, such as polyethylene, plasticized PVC, or polypropylene, but elastomeric film materials such as polyurethane, and particularly elastomeric hydrogel materials, may be suitable. In some embodiments, the sleeve 24 may contain a hydration medium.

[0031] Optionally, the urinary catheter assembly 10 may include a cap 34 (shown in FIG. 2). The cap 34 includes a cavity configured to receive at least a portion of the insertion aid 26. The cap 34 may be attached to the insertion aid 26 via, for example, but not limited to, a friction fit. Additionally, the cap 34 can include a ring 36 configured to be gripped by a user to pull the cap 34 off the insertion aid 26.

[0032] Furthermore, urinary catheter assembly 10 can be associated with a urine collection container / bag 38, as shown in FIG. 3. The collection container 38 is configured to be placed in fluid communication with the urinary catheter and to receive urine flowing through the urinary catheter.

[0033] The collection container 38 can be made of a polymeric material. For example, the walls of the collection container can be made of EVA / polyethylene film. Other suitable polymeric material can be used without departing from the scope of the disclosure.

[0034] As shown in FIG. 3, the collection container can include a top edge 40, a bottom edge 42, a first side edge 44, and a second side edge 46. Additionally, the collection container 38 includes an inlet 39. Inlet 39 is configured to be coupled toAttorney Docket No. 3400-0355.01 (822PCT)the urinary catheter, placing the urinary catheter in fluid communication with a chamber defined by the walls of the collection container. For example, inlet 39 can be a port configured to receive the tube distal drainage end 18. In particular, the drainage member 22 at the tube distal drainage end 18 can be coupled to the port. Alternatively, the drainage member 22 can serve as the port. In an example, the inlet 39 can be sealed between the first flexible wall and the second flexible wall.

[0035] In an example, the collection container 38 can be formed of two separate sheets. For instance, the collection container 38 can include a first flexible sheet defining the first flexible wall and a second flexible sheet defining the second flexible wall. A perimeter seal 48 can join at least a portion of the first sheet to at least a portion of the second sheet. In particular, the first and second flexible sheets can be joined to one another at their perimeters by the perimeter seal 48. Alternatively, in another example, the first flexible wall and second flexible wall can be formed from a single sheet of flexible material that is folded over to define the first flexible wall and the second flexible wall. The first flexible wall and the second flexible wall are connected at a fold line and are sealed together along the remaining three sides.

[0036] In an example, the urinary catheter is separably coupled to the collection container 38. Alternatively, the urinary catheter is permanently coupled to the collection container 38. Additionally, in some examples, collection container 38 can be openable, such that urine collected therein can be drained from the collection container. For instance, collection container can be a collection container described in U.S. Patent Publication 2020 / 0360174, which is hereby incorporated by reference herein. It will be understood that any suitable urine collection container can be used, without departing from the scope of the disclosure.

[0037] As described herein, the urinary catheter assembly 10 can be used to obtain a sample to be tested for KRT5+ cells. In an example, the sample can be at least a portion of the catheter tube 12. For instance, after catheterization, the catheter tube can be tested for the presence of KRT5+ cells abraded on the tube outer surface 14. The sample can be the entire catheter tube 12, or alternatively, the sample to be tested can be a tube segment 50 of the catheter tube 12. The tube outer surface 14 can include a coating configured to preserve KRT5+ cells abraded on the catheter tube 12. The coating can include a preservative suitable for preventing the degradation of protein. For instance, the coating can include aAttorney Docket No. 3400-0355.01 (822PCT)preservative that is suitable for preventing the degradation of KRT5+ cells.

[0038] Turning to FIGS. 4A and 4B, the figures illustrate preparation of a sample, wherein the sample is a catheter tube segment 50. To prepare the sample, a portion of the catheter tube 12 can be separated from the remainder of the catheter tube 12. For instance, the catheter tube 12 can be cut and separated, or separated in any other suitable manner. In some examples, the tube 12 can be cut near the tube proximal insertion end 16, forming a tube segment 50 including the tube proximal insertion end 16. Alternatively, an intermediate segment can be formed by cutting the tube 12 at two locations between the tube proximal insertion end 16 and the tube distal drainage end 18.

[0039] In some examples the tube segment 50 can be at least about 0.5 cm long. In another example, the tube segment can be about 0.5-10 cm long. In a particular example, the tube segment 50 can be 6-8 cm long extending from the proximal insertion end 16 towards the tube distal drainage end 18 ( / .e., the catheter tube is separated at a single location distally from the proximal insertion end 16).Alternatively, the tube segment 50 can be the entire length of the catheter tube 12.

[0040] In some examples, the tube outer surface 14 can include markings 52 designating to a user where to cut the catheter tube 12 to form tube segment 50. For instance, as shown in FIG. 4A, the tube outer surface 14 can include a dotted line around the circumference of the tube 12, marking where a user should cut the catheter tube 12. In the instance that the sample is an intermediate segment, the tube outer surface 14 can include two such markings 52. The number and shape of the marking(s) 52 can vary without departing from the scope of the disclosure.

[0041] In another example, as described in greater detail below, the sample to be tested for KRT5+ cells is urine drained from the bladder. For instance, as urine travels from the bladder and through the catheter tube 12, KRT5+ cells that were present in the superficial layer of the urinary tract may travel with the urine through the urinary catheter assembly 10.

[0042] As described herein, the kit includes a sample container 60 configured to contain the sample. The sample container can be sized and shaped to contain the sample. Additionally, the sample container can be configured to be sent to a testing facility to detect the presence of KRT5+ cells.

[0043] As shown in FIG. 5, the sample container 60 can include a body 62 and aAttorney Docket No. 3400-0355.01 (822PCT)lid 64. The body 62 can be sized and shaped to contain the sample. For instance, as shown in FIG. 5, the body 62 is sized and shaped to contain tube segment 50. The body can also be configured to contain the entire catheter tube or a sample volume of urine drained from the bladder. The lid 64 can be coupled to the body with an airtight / fluid-tight seal. For example, the lid can contain a sealing element, such as, but not limited to, an O-ring, on the inner surface of the lid 64. The lid 64 can be attached to the body 62 in any suitable manner. For instance, the lid 64 can be attached to the body 62 with, but not limited to, a threaded coupling, a friction-fit, or an interference fit. Although the sample container 60 is shown as a cylinder in FIG.5, it will be understood, without departing from the scope of the disclosure, that the sample container 60 can be any suitable shape to hold a sample.

[0044] Turning to FIG. 6, the figure shows a flowchart showing an example of a method 70 for detecting KRT5+ cells with the kit described herein. For example, to use the kit, the urinary catheter is inserted into a user’s urethra, as shown in block 72. A user will insert the tube proximal insertion end 16 into their urethra and advance the catheter tube 12 through the urinary tract until the tube proximal insertion end 16 and the at least one or more openings 20 enter the user’s bladder.

[0045] In the instance urinary catheter assembly 10 includes a gripper 23, a user can hold the gripper 23 to align the tube proximal insertion end 16 with the urethra opening. The user may then slide the gripper 23 a distance towards the tube distal drainage end 18, squeeze the gripper 23 to grasp the catheter tube 12, and then advance the tube 12 further into the urinary tract. This can be repeated until the at least one or more openings 20 enters the bladder.

[0046] Alternatively, if the urinary catheter assembly is a sleeved catheter as described herein, a user may insert the insertion aid 26 into the urethra, grasp the catheter tube 12 through the sleeve 24, and advance the tube forward ( / .e., in the direction towards the insertion aid 26). The tube 12 may be advanced in this manner until the one or more openings 20 enter the user’s bladder.

[0047] Once the tube proximal insertion end 16 (including the at least one or more openings 20) enters the bladder, urine will drain from the bladder and into the catheter tube lumen through the at least one or more openings 20. In an example, a user may position the drainage member 22 such that urine draining from the bladder drains into a suitable receptacle, such as a toilet. Alternatively, the drainage memberAttorney Docket No. 3400-0355.01 (822PCT)may be coupled to a urine collection container 38, as described herein. Urine can be drained into the collection container 38 and disposed of or drained in a suitable receptacle.

[0048] After catheterization, the urinary catheter tube 12 is removed from the user’s urethra (block 74) and a sample to be tested for KRT5+ cells is placed into the sample container (block 76). In particular, the sample is placed into the sample container body 62.

[0049] In an example, as described herein, the sample is at least a portion of the catheter tube 12. As the catheter tube 12 is removed from the urinary tract, KRT5+ cells present in the superficial layer of the uroepithelial tissue may be abraded onto the tube outer surface 14. In a particular example, the sample can be the entire catheter tube 12. In this case, the urinary catheter assembly can be cut at the tube distal drainage end 18 ( / .e., separating the tube 12 from the drainage member 22) and placed into the sample container 60 or the entire urinary catheter assembly 10 can be placed into the sample container 60. In another example, the sample is a tube segment 50, as described herein. For instance, the tube 12 can be cut at one or more markings 52 to form tube segment 50.

[0050] Optionally, the kit can include gloves that a user may wear when removing the catheter and / or collecting the sample to prevent contaminating the sample and to maintain sterility for the user.

[0051] Alternatively, the sample to be tested for the presence of KRT5+ cells is a volume of urine drained from the bladder. During insertion of the catheter tube 12 through the urinary tract, KRT5+ cells may be exfoliated from the superficial layer of the uroepithelial tissue and suspended in urine present in the bladder / urinary tract. As the urine is drained, the suspended KRT5+ cells may travel with the urine through the urinary catheter assembly 10. In an example, the sample can be at least 0.5 ml_ of urine. In a particular example, the sample is about 0.5-1 mL of urine.

[0052] In one example, the urine sample to be tested for the presence of KRT5+ cells can be directly drained into the sample container 60. For instance, the drainage member 22 can be positioned such that urine exiting the tube distal drainage end 18 drains into the sample container body 62.

[0053] In another example, for instance when the urinary catheter assembly 10 includes a urine collection container 38, the urine sample to be tested for theAttorney Docket No. 3400-0355.01 (822PCT)presence of KRT5+ cells can be collected from the urine collection container 38. For instance, after urine has been drained into collection container 38, the urinary catheter assembly 10, including the collection container 38 can be placed into a sample container 60.

[0054] Alternatively, only the collection container 38 of the urinary catheter assembly 10 is placed into the sample container 60. For instance, the catheter tube 12 can be removed / separated from the collection container 38 and the collection container can be placed in the sample container 60. The collection container 38 can be torn open and drained, leaving residual urine (about 0.5-1 mL) in the collection container 38 before placing it in the sample container 60. In another instance, after catheterization, the urinary catheter tube 12 can be removed from the collection container 38, and the collection container 38 including drained urine can be sealed and placed into the sample container 60.

[0055] In yet another alternative, after urine has been drained into the collection container 38, a volume of urine from the collection container 38 can be drained into the sample container 60. For instance, in an example, the collection container 38 can be torn open and a volume of urine can be drained into the sample container 60. The remainder of the urine in the collection container can be drained into a suitable receptacle, such as a toilet.

[0056] Furthermore, in another example, the urine collection container 38 can be the sample container 60. In this instance, the catheter tube 12 can be removed / separated from the collection container 38, and the collection container can be sealed to prevent urine from leaking from the collection container 38. The sealed collection container 38 is then sent to a testing facility.

[0057] After placing the sample into the sample container body 62, the sample container 60 can be shut with the lid 64, and the sample container 60 can be sent to a testing facility (block 78), where the sample will be tested for the presence of KRT5+ cells (block 80). Alternatively, after the sample has been collected (block 76), a user can test the sample for the presence of KRT5+ cells (block 80) using an at-home testing kit configured to detect KRT5+ cells. For instance, the at-home testing kit can include, but is not limited to, a lateral flow assay kit, microfluidic kits, electrochemical biosensors, or other suitable at-home testing kits without departing from the scope of the disclosure.Attorney Docket No. 3400-0355.01 (822PCT)

[0058] Turning to FIG. 7, the figure illustrates an example of a health monitoring system 82 including sending a sample to be tested for KRT5+ cells to a testing facility 84. The health monitoring system 82 can be used to monitor catheterization data, including the presence of KRT5+ cells. It will be understood that the system 82 can also be used to monitor the detection of other biomarkers or to monitor other catheterization data, without departing from the scope of the disclosure.

[0059] After sending the sample container 60 with the sample to a testing facility 84, the testing facility 84 will test the sample for the presence of KRT5+ cells. The presence of KRT5+ cells can be detected by, but not limited to, immunological detection methods such as immunohistochemistry (IHC), flow cytometry, and immunocytochemistry (ICC), wherein specific antibodies are used to bind to the KRT5 protein; molecular detection methods including reverse transcription polymerase chain reaction (RT-PCR) and RNA sequencing for detection of KRT5 gene expression; protein analysis methods such as Western blot; immunofluorescence; and / or mass spectrometry-based techniques, such as LC-MS / MS (Liquid Chromatography-Tandem Mass Spectrometry). Additionally, suitable assays may be used to detect KRT5+ cells, including, but not limited to enzyme-linked immunosorbent assays (ELISA), fluorescence-based immunoassays, chemiluminescent immunoassays, and multiplex protein assays, wherein such assays may be configured to detect either the KRT5 protein directly or markers associated with KRT5+ cells in biological samples such as urine, tissue homogenates, or cell culture supernatants. After testing the sample for KRT5+ cells, the testing facility 84 can communicate the results with the user. For instance, in an example, the testing facility 84 can send the results to a user’s computing device 86. The computing device can be a mobile phone, smartphone, tablet, smartwatch, laptop, computer, or any other suitable computing device. Alternatively, the testing facility 84 can upload the results to a server 88, such as, but not limited to, a cloudbased server. A user can access the results from the server 88 using a computing device 86. Optionally, a user’s healthcare provider 90, such as a doctor, can access the results from the server 88. The user’s healthcare provider 90 can communicate the results with the user via a network accessing the server 88 or directly with the user (via, for instance, the user’s computing device 86). It will be understood that a user can access the test results in a variety of ways, including any suitableAttorney Docket No. 3400-0355.01 (822PCT)communication manner not described herein, without departing from the scope of the disclosure.

[0060] The kit, devices, and methods described herein are not limited to detecting only the presence of KRT5+ cells. The kit, devices, and methods can be used to determine the presence of any other suitable biomarker associated with the health of a user’s urinary system, including the urinary tract.

[0061] It will be understood that the embodiments and examples 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.

Claims

Attorney Docket No. 3400-0355.01 (822PCT)What is Claimed:

1. A urinary tract infection detection kit comprising:an intermittent urinary catheter includinga catheter tube including a tube outer surface and a tube inner surface, the catheter tube having a tube proximal insertion end, a tube distal drainage end, and a tube lumen defined by the tube inner surface and extending from the proximal insertion end to the distal drainage end; anda sample container configured to hold a sample to be tested for the presence of KRT5+ cells.

2. The kit of claim 1 , wherein the sample is at least a portion of the catheter tube.

3. The kit of claim 2, wherein the sample is the entire catheter tube.

4. The kit of claim 2, wherein the sample is a segment of the catheter tube.

5. The kit of claim 4, wherein the segment of the catheter tube is cut and separated from the catheter tube.

6. The kit of claim 5, wherein the tube outer surface includes at least one marking designating where to cut the catheter tube.

7. The kit of any one of claims 1 -6, wherein the tube outer surface includes a coating configured to preserve KRT5+ cells abraded on the catheter tube after catheterization.

8. The kit of claim 1 , wherein the sample is a sample volume of urine drained from a user through the intermittent urinary catheter.

9. The kit of claim 8, comprising a urine collection bag located at the tube distal drainage end.

10. The kit of claim 9, wherein the urine collection bag is the sample container. 11 . The kit of claim 9, wherein the sample container is configured to receive the sample volume of urine from the urine collection bag.

12. The kit of any one of claims 1-11 , wherein the sample container is configured to be transported to a testing facility.

13. A method of detecting a biomarker comprising:inserting an intermittent urinary catheter into a urethra, wherein the urinary catheter includesAttorney Docket No. 3400-0355.01 (822PCT)a catheter tube including a tube outer surface and a tube inner surface, the catheter tube having a tube proximal insertion end, a tube distal drainage end, and a tube lumen defined by the tube inner surface and extending from the proximal insertion end to the distal drainage end;removing the urinary catheter from the urethra; andcollecting a sample in a sample container, wherein the sample is to be tested for the presence of KRT5+ cells.

14. The method of claim 13, comprising sending the sample to a testing facility.

15. The method of any one of claims 13-14, wherein the sample is the entire catheter tube.

16. The method of any one of claims 13-14, wherein the sample is a segment of the catheter tube.

17. The method of claim 16, comprising cutting the catheter tube to provide the segment of the catheter tube.

18. The method of claim 17, wherein the tube outer surface includes at least one marking designating where to cut the catheter tube.

19. The method of any one of claims 13-18, wherein the tube outer surface includes a coating configured to preserve KRT5+ cells abraded on the catheter tube after catheterization.

20. The method of any one of claims 13-14, wherein the sample is a sample volume of urine drained from a user through the intermittent urinary catheter.21 . The method of claim 20, wherein the urinary catheter includes a urine collection bag located at the tube distal drainage end.

22. The method of claim 21 , wherein the urine collection bag is the sample container.

23. The method of claim 21 , comprising transferring the sample volume of urine from the urine collection bag to the sample container.

24. A urinary catheter product comprising:an intermittent urinary catheter, the catheter comprisinga tube including a tube outer surface and a tube inner surface, the tube having a tube proximal insertion end, a tube distal drainage end;Attorney Docket No. 3400-0355.01 (822PCT)a tube lumen defined by the tube inner surface and extending from the proximal insertion end to the distal drainage end; andat least one marking on the tube outer surface designating a location to cut the tube.

25. The product of claim 24, wherein the intermittent urinary catheter is configured to receive a biomarker.

26. The product of claim 25, wherein the biomarker is KRT5+ cells.

27. The product of any one of claims 25-26, wherein the tube outer surface receives the biomarker.

28. The product of any one of claims 25-27, wherein the tube outer surface includes a coating configured to preserve the biomarker.

29. The product of any one of claims 25-28, wherein the intermittent urinary catheter comprises a urine collection bag located at the tube distal drainage end.

30. The product of any one of claim 29, wherein the urine collection bag receives the biomarker.

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