Biomarker detection embedded on urinary catheter wall

Abstract

A urinary catheter assembly (10) for detecting characteristics of urine. More particularly, a urinary catheter assembly (10) including a catheter tube (12) with at least one microchannel (40c-e) in the tube wall (36) configured to contain a biomarker reagent, with an additional drainage member (20) which is located at the tube distal drainage end (16), opposite the tube proximal insertion end (14).

Description

Attorney Docket No. 3400-0352.01 (830PCT)BIOMARKER DETECTION EMBEDDED ON CATHETER WALLSThe present application claims the benefit of and priority to U.S.Provisional Application 63 / 727,856, filed December 4, 2024, which is hereby incorporated by reference.FIELD OF THE DISCLOSURE

[0001] This disclosure generally relates to devices, systems, and methods for monitoring urinary catheterization. In particular, the disclosure relates to a urinary catheter including microchannels containing biomarker reagents.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] Therefore, there is a need for improved urinary catheter devices, products,Attorney Docket No. 3400-0352.01 (830PCT) and methods that allow urinary catheter users to obtain information about the characteristics of the user’s urine.SUMMARY

[0007] 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.

[0008] In one aspect, a urinary catheter assembly is provided. The urinary catheter assembly includes a catheter tube including a tube wall. The catheter tube includes a tube proximal insertion end, tube distal drainage end, and a tube lumen defined by the tube wall that extends from the proximal insertion end to the distal drainage end. The urinary catheter assembly also includes at least one microchannel in the tube wall configured to contain a biomarker reagent and a drainage member located at the tube distal drainage end.

[0009] In another aspect, a method of detecting biomarkers with a urinary catheter is provided. The method includes inserting a urinary catheter into a urethra. The urinary catheter includes a catheter tube including a tube wall. The catheter tube includes a tube proximal insertion end, a tube distal drainage end, and a tube lumen defined by the tube wall that extends from the proximal insertion end to the distal drainage end. The urinary catheter also includes at least one microchannel containing a biomarker reagent and a drainage member located at the distal drainage end. The method further includes flowing urine through the at least one microchannel and detecting a biomarker via the biomarker reagent within the at least one microchannel.BRIEF DESCRIPTION OF DRAWINGS

[0010] FIG. 1 is a front perspective view of an example of a urinary catheter assembly.

[0011] FIG. 2 is a front perspective view of another example of a urinary catheter assembly.

[0012] FIG. 3 is a front perspective view of an example of a catheter tube proximal insertion end without a rounded tip.

[0013] FIG. 4A is a front perspective exploded view of an example of a catheterAttorney Docket No. 3400-0352.01 (830PCT) tube proximal insertion end and a rounded tip.

[0014] FIG. 4B is a front perspective exploded view of another example of a catheter tube proximal insertion end and a rounded tip.

[0015] FIG. 5 is a perspective view of a portion of an example of a catheter tube including an opening and a microchannel inlet.

[0016] FIG. 6 is a front view of an example of a catheter tube proximal insertion end with a rounded tip.

[0017] FIG. 7 is a plan view of an example of a distal drainage end of a urinary catheter assembly including a drainage member and catheter tube.

[0018] FIG. 8 is a plan view of an example of a first piece of a drainage member.

[0019] FIG. 9 is a plan view of an example of a second piece of a drainage member.

[0020] FIG 10. is a schematic view of another example of a distal drainage end of a urinary catheter including a drainage member and a catheter tube.

[0021] FIG. 11 is a plan view of an example of a distal drainage end of the urinary catheter assembly including an enlarged inset showing the drainage member in an open / loading configuration.

[0022] FIG. 12 is a cross-sectional view taken along line A-A of the drainage member of FIG. 11 in the open / loading configuration.

[0023] FIG. 13 is a plan view of an example of the distal drainage end of FIG. 11 and an enlarged inset showing the drainage member in a shut / non-loading configuration.

[0024] FIG. 14 is a cross-sectional view taken along line B-B of the drainage member of FIG. 13 in the shut configuration.

[0025] FIG. 15A is a cross-sectional view of another example of a drainage member in an open / loading configuration taken across the width of the drainage member and viewed from the distal end towards the proximal end.

[0026] FIG. 15B is a cross-sectional view of the drainage member of FIG. 15A in a shut configuration.

[0027] FIG. 16A is a cross-sectional view of another example of a drainage member in an open / loading configuration taken across the width of the drainage member and viewed from the distal end towards the proximal end.

[0028] FIG. 16B is a cross-sectional view of the drainage member of FIG. 16A inAttorney Docket No. 3400-0352.01 (830PCT) a shut configuration.

[0029] FIG. 17A is a plan view of an example of a urinary catheter assembly before containing a biomarker reagent.

[0030] FIG. 17B is a perspective view of the catheter tube proximal insertion end of the urinary catheter assembly of FIG. 17A.

[0031] FIG. 18A is a plan view of an example of a urinary catheter assembly being loaded with a biomarker reagent.

[0032] FIG. 18B is a perspective view of the catheter tube proximal insertion end of the urinary catheter assembly of FIG. 18A.

[0033] FIG. 19A is a plan view of an example of a urinary catheter assembly after being loaded with a biomarker reagent.

[0034] FIG. 19B is a perspective view of a catheter tube proximal insertion end of the urinary catheter assembly of FIG. 19A.

[0035] FIG. 20A is a plan view of an example of a urinary catheter assembly containing a biomarker reagent.

[0036] FIG. 20B is a perspective view of a catheter tube proximal insertion end of the urinary catheter assembly of FIG. 20A.

[0037] FIG. 21 is a plan view of an example of a urinary catheter assembly including multiple microchannels containing different biomarker reagents and an enlarged inset showing the microchannels containing different biomarker reagents.

[0038] FIG. 22 is a plan view of an example of a urinary catheter assembly in a shut configuration before draining urine from a user and an enlarged inset showing the microchannel with a biomarker reagent.

[0039] FIG. 23 is a plan view of the urinary catheter assembly of FIG. 22 in an open configuration as urine is draining from the user and an enlarged inset showing a color-change reaction of the biomarker reagent after draining urine from the user.DETAILED DESCRIPTION

[0040] 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 the 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.Attorney Docket No. 3400-0352.01 (830PCT)

[0041] Turning to FIGS. 1 -2, the figures illustrate examples of a urinary catheter assembly 10 including at least one microchannel 40 configured to contain a biomarker reagent therein. The biomarker reagent can be used to detect the presence of biomarkers in a user’s urine. In particular, the biomarker reagent may change colors after contacting urine that includes a biomarker.

[0042] 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 any other suitable urinary catheters. As will be discussed in greater detail herein, the urinary catheter assembly 10 includes at least one microchannel 40 within the catheter tube 12 which can be loaded with a biomarker reagent. In use, urine drained from a user’s bladder may enter a microchannel 40 including the biomarker reagent and may change color based on the presence of a biomarker in the urine.

[0043] As discussed above, the urinary catheter assembly 10 may be an intermittent urinary catheter, as shown in FIGS. 1 and 2. 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. In an example, the urinary catheter includes a catheter tube 12 having a tube proximal insertion end 14 and a tube distal drainage end 16. A tube lumen 38 (shown in FIGS. 3, 4A, and 4B) extends from the tube proximal insertion end 14 to the tube distal drainage end 16. The tube proximal insertion end 14 includes one or more openings 18 for receiving urine. The one or more openings 18 is in fluid communication with the tube lumen 38. In an example, the one or more openings 18 for receiving urine may be an eyelet. The size, shape, and location of the one or more openings 18 for receiving urine may vary without departing from the scope of the disclosure.

[0044] The catheter tube 12 can include an optional tip 13 located at the tube proximal insertion end 14. The optional tip 13 can be integrally formed at the tube proximal insertion end 14 during manufacturing of the catheter tube 12. Alternatively, the optional tip 13 can be attached to the tube proximal insertion end 14. For instance, the optional tip 13 can be attached to the tube proximal insertion end 14 by welding, adhesion, bonding, or any other suitable method of attachment, without departing from the scope of the disclosure. The optional tip 13 can include a rounded proximal endAttorney Docket No. 3400-0352.01 (830PCT) configured to aid with insertion of the catheter tube 12 into and through a urethra. In an embodiment, the at least one or more openings 18 for receiving urine can be located on the optional tip 13. In this instance, the at least one or more openings 18 are in fluid communication with the tube lumen 38 and microchannels 40 when the optional tip 13 is attached.

[0045] The tube distal drainage end 16 includes a drainage opening for draining urine from the tube lumen 38. Additionally, the tube distal drainage end 16 includes a drainage member 20. The drainage member 20 may be, for example, but not limited to, a connector or a funnel.

[0046] In some examples, the catheter tube 12 may include a hydrophilic outer surface. For example, the polymer forming the catheter tube 12 may be a hydrophilic polymer or a hydrophilic polymer may be coated on the tube’s outer surface. The hydrophilic surface is configured to absorb a hydrating medium to lubricate the catheter tube 12 to aid in insertion into a urethra.

[0047] The urinary catheter may optionally include a sleeve 22 and an insertion aid 24 (shown in FIG. 2). The sleeve 22 may be a protective or barrier sleeve. The sleeve 22 has a sleeve proximal end 26 and a sleeve distal end 28. The sleeve 22 may define an internal cavity in which the catheter tube 12 may be located. In an example, the sleeve 22 surrounds at least a portion of the catheter tube 12. In another example, the sleeve 22 extends over and surrounds the length of the catheter tube 12.

[0048] In an example, an insertion aid 24 may be located at the sleeve proximal end 26. When an insertion aid 24 is present, the sleeve proximal end 26 may be attached to a distal portion 30 of the insertion aid 24 by, for example, welding, adhesion, or any other suitable method of attachment. The sleeve distal end 28 may be attached to the drainage member 20 e.g.. connector or funnel) or to a distal portion of the catheter tube 12. The sleeve distal end 28 may be attached to the drainage member 20 or to the tube distal drainage end 16 by, for example, welding, adhesion, or any other suitable method of attachment.

[0049] The sleeve 22 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 22 also may be liquid impermeable or liquid permeable. The sleeve 22 may be formed of any of a variety of thin, flexible polymeric film materials, such as polyethylene, plasticized PVC, or polypropylene, butAttorney Docket No. 3400-0352.01 (830PCT) elastomeric film materials such as polyurethane, and particularly elastomeric hydrogel materials, may be suitable. In some embodiments, the sleeve 22 may contain a hydration medium.

[0050] Optionally, the urinary catheter assembly 10 may include a cap 32 (shown in FIG. 2). The cap 32 includes a cavity configured to receive at least a portion of the insertion aid 24. The cap 32 may be attached to the insertion aid 24 via, for example, but not limited to, a friction fit. Additionally, the cap 32 can include a ring 34 configured to be gripped by a user to pull the cap 32 off the insertion aid 24.

[0051] As shown in FIG. 3, catheter tube 12 includes at least one microchannel 40 configured to contain a biomarker reagent. In particular, the catheter tube 12 includes a catheter tube wall 36 defining the tube lumen 38 extending from the tube proximal insertion end 14 to the tube distal drainage end 16. The at least one microchannel 40 is located within the catheter tube wall 36. In an example, the catheter tube 12 can include multiple microchannels 40, as shown in FIG. 3. The catheter tube 12 can be made of a transparent material such that any color-change reaction of a biomarker reagent within a microchannel 40 is visible to a user. For example, the catheter tube can be formed of polyvinyl chloride, polyvinyl pyrrolidone (PVP), as well as other materials such as polyamide, polyanhydride, polyether, poly(ether imide), poly(ester imide), polyvinyl alcohol, polyvinyl chloride, polycarbonate, poly(s-caprolactone) with polymethylvinylsiloxane, poly(ethylene-co-(vinylacetate)) with dicumylperoxide, poly(D-lactide), poly(L-lactide), poly(DL-lactide) and poly(glycolide-co-(s- caprolactone))-segments, multiblock copolyesters from poly(s-caprolactone) and PEG and chain extender based on cinnamic acid groups, poly(s-caprolactone) dimethacrylate and n-butyl acrylate, oligo(s-caprolactone) diols, oligo (p-dioxanone) diols and diisocyanate, linear density polyethylene, linear low density polyethylene, high density polyethylene, polypropylene, thermoplastic elastomer (TPE), thermoplastic olefin (TPO), latex, silicone, rubber, polyolefin-based elastomer (POBE), thermoplastic polyurethane (TPU) and poly(ether-block-amide) (PEBA). It will be understood that the catheter tube 12 can be made of any suitable material, without departing from the scope of the disclosure.

[0052] The microchannels 40 can extend in a longitudinal direction parallel to the longitudinal axis of the tube lumen 38. In an example, the microchannels 40 can extend along a portion of the length of the catheter tube 12. In another example, theAttorney Docket No. 3400-0352.01 (830PCT) microchannels 40 can extend along the entire length of the catheter tube 12. If multiple microchannels 40 are included, the microchannels 40 can vary in length to one another without departing from the scope of the disclosure. The diameter of the microchannels 40 can be at least 0.1 mm and smaller than about 1.6 mm. The diameter of the microchannels 40 may vary based on the thickness of the catheter tube wall. For instance, a size 16 Ch catheter can include microchannels 40 with a diameter of smaller than 1.6 mm, a size 14 Ch catheter can include microchannels 40 with a diameter of smaller than 1 .5 mm, a size 1 Ch catheter can include microchannels 40 with a diameter of smaller than 1.4 mm, a size 10 Ch catheter can include microchannels 40 with a diameter of smaller than 1.1 mm, and a size 8 Ch catheter can include microchannels 40 with a diameter of smaller than 0.9 mm. The diameter of the microchannels 40 contributes to the capillary action used to load the microchannels 40 with a biomarker reagent.

[0053] The microchannels 40 can be formed during manufacturing of the catheter tube 12. For instance, microchannels 40 can be extruded during manufacturing of the catheter tube 12. Without departing from the scope of the disclosure, the microchannels 40 can also be formed by molding or any other suitable method during manufacturing of the catheter tube 12.

[0054] Additionally, microchannels 40 include a microchannel inlet 42 located at or near the catheter tube proximal end 14. During catheterization, microchannel inlet 42 receives urine such that urine can flow into the microchannels 40 and can contact the biomarker reagent within the microchannels 40.

[0055] FIG. 3 illustrates an example of the catheter assembly 10 including a catheter tube 12 without optional tip 13. As shown in FIG. 3, the tube proximal end 14 includes a flat end that is configured to be inserted into and through the urethra. In this example, microchannel inlets 42 can be located at the tube proximal end 14. The microchannel inlets 42 are configured to receive a biomarker reagent solution during loading of the catheter assembly 10 with a biomarker reagent, as described in greater detail below, and to receive urine during catheterization.

[0056] In other examples, as shown in FIGS. 4A and 4B, catheter tube assembly 10 can include optional tip 13. The microchannels 40 can be loaded with the biomarker reagent either before or after the optional tip 13 is present. The microchannels 40 have inlets 42 located at or near the proximal end of the tube 12. The microchannel inletsAttorney Docket No. 3400-0352.01 (830PCT)42 are configured to receive urine. Additionally, in some instances, microchannel inlets 42 can be configured to be used during loading of the microchannels 40 with biomarker reagents, as is described in greater detail below. In other instances, the microchannels 40 can be loaded with biomarker reagents using loading apertures 45.

[0057] Turning to FIG. 4A, the figure illustrates an example of a catheter assembly 10 with microchannels 40 including microchannel inlets 42 and loading apertures 45. For instance, as shown in FIG. 4A, microchannels 40 include microchannel inlets 42 located near the tube proximal end 14. The microchannel inlets 42 can extend from the inner surface of catheter tube 12 to the microchannels 40. The microchannel inlets 42 are in fluid communication with the tube lumen 38 such that when urine is drained from the bladder, some of the urine travelling through the tube lumen 38 can enter the microchannel inlets 42 and flow through the microchannels 40. The microchannels 40 can also include loading apertures 45 located at the catheter tube proximal end 14. The microchannels 40 can be loaded with the biomarker reagent using the loading apertures 45, as described in greater detail below. The optional tip 13 can be attached to the catheter tube proximal end 14 after loading the microchannels 40 with a biomarker reagent.

[0058] Turning to FIG. 4B, the figure illustrates another example of a catheter assembly 10 with optional tip 13. In this instance, the microchannels 40 include microchannel inlets 42 extending from the outer surface of the catheter tube 12 to the microchannels 40. The microchannel inlets 42 can be located at or near the tube proximal end 14 such that during catheterization, the microchannel inlets 42 are in fluid communication with the user’s bladder. After insertion into a bladder, urine can then enter the microchannel inlets 42 and flow through the microchannels 40. In this example, the microchannels 40 may optionally include loading apertures 45 located at the tube proximal end 14. In one alternative, the microchannels 40 can be loaded with a biomarker reagent via the loading apertures 45 and the optional tip 13 can be attached to the tube proximal end 14 after loading the microchannels 40 with biomarker reagents. In another alternative, the microchannels 40 do not include loading apertures 45 and the microchannels 40 can be loaded with biomarker reagents via the microchannel inlets 42. In this alternative, the optional tip 13 can be present before or after loading microchannels 40. In particular, the optional tip 13 can be attached to the tube proximal end 14 before or after loading the microchannels 40 withAttorney Docket No. 3400-0352.01 (830PCT) biomarker reagents, or the optional tip 13 can be integrally formed during manufacturing of the catheter tube and is thus present before loading the microchannels 40 with biomarker reagents.

[0059] FIGS. 5 and 6 illustrate other examples of the catheter assembly 10, which can include an optional tip 13. In particular, the figures illustrate examples of the catheter tube assembly 10 including microchannels 40 with a microchannel inlet 42 located in the catheter wall 36 defining the one or more openings 18 such that the one or more openings 18 is in fluid communication with the microchannels 40. As such, the microchannels 40 are also in fluid communication with the tube lumen 38 and urine can flow through the one or more openings 18 and into the microchannels 40 and tube lumen 38. As described above, the one or more openings 18 can be formed on the catheter tube 12 at or near the catheter tube proximal end 14. The one or more openings 18 can be punched, cut, or otherwise made through the catheter tube wall 36. Additionally, microchannel inlets 42 can be formed when forming the one or more openings 18.

[0060] Turning to FIG. 5, the microchannels 40 can be loaded with a biomarker reagent before or after formation of one or more opening 18 and microchannel inlets 42. For instance, in one alternative, the catheter assembly 10 can include loading apertures 45 at the tube proximal end 14 as described in FIGS. 4A and 4B, above. The microchannels 40 can be loaded with a biomarker reagent via the loading apertures 45 and the one or more openings 18 (and microchannel inlets 42) can be formed after loading the microchannels 40. An optional tip 13 can be attached after loading the microchannels 40 and before or after forming the one or more opening 18 and microchannel inlets 42. In another alternative, the catheter tube 12 does not include loading apertures 45 and the microchannels 40 are loaded via the microchannel inlets 42. In this instance, the one or more opening 18 is formed before loading the microchannels 40. Additionally, in this example, the optional tip 13 can be present before or after loading the microchannels 40.

[0061] As shown in FIG. 5, the one or more openings 18 can be formed at a location along the length of the microchannels 40. For instance, an opening 18 is formed through the longitudinal length of the microchannel 40, forming two microchannel segments 41 a and 41 b. In this manner, two inlets 42a and 42b are formed. Inlet 42a is associated with segment 41 a, which extends towards the tubeAttorney Docket No. 3400-0352.01 (830PCT) distal drainage end 16. Inlet 42b is associated with segment 41 b, which extends towards the tube proximal insertion end 14. The biomarker reagent can be loaded into microchannel segment 41 a through microchannel inlet 42a.

[0062] In another example, as shown in FIG. 6, the microchannels 40 can vary in length from one another. In this instance, the one or more openings 18 can be punched near the terminal proximal ends of the microchannels 40 such that the microchannel inlets 42 are located at a distal end of the one or more openings 18. As shown in FIG. 6, a first microchannel 40a and a second microchannel 40b include different longitudinal lengths, and their respective inlets 42 are located at different positions along the longitudinal length of the catheter tube 12. The first microchannel 40a is associated with a first opening 18a and a second microchannel 40b is associated with a second opening 18b. Opening 18a is formed at a location such that the inlet 42 of microchannel 40a is located at a distal portion of the first opening 18a and the second opening 18b is formed at a location such that the inlet 42 of microchannel 40b is located at a distal portion of the second opening 18b. By varying the length of the microchannels 40 and accordingly, varying the position of the microchannel inlets 42 along the longitudinal axis of the catheter tube 12, different biomarker reagents can be loaded into the microchannels 40a and 40b, as described in greater detail below. Although FIG. 6 shows two microchannels 40a and 40b and openings 18a and 18b, more or fewer microchannels 40 and associated openings 18 can be included without departing from the scope of the disclosure.

[0063] It will be understood that the microchannels 40 present in the catheter tube 12 can include a respective inlet 42 and / or loading aperture 45. Additionally, if the catheter tube 12 includes multiple microchannel inlets 42, the microchannel inlets 42 can be positioned in the same location as described above, or in varying locations (e.g., on the inner surface of the catheter tube, on the outer surface of the catheter tube, or in the one or more openings 18). In some examples, a single inlet 42 and / or aperture 45 can be associated with multiple microchannels 40, for instance, when multiple microchannels are configured to include the same biomarker reagent. Additionally, the microchannels 40, in any of the examples disclosed herein, may include an outlet 43 (shown in FIG. 10) at the tube distal drainage end 16.

[0064] Turning to FIG. 7, the figure illustrates an example of a drainage member 20 attached to a catheter tube 12. In particular, the drainage member 20 is a two-pieceAttorney Docket No. 3400-0352.01 (830PCT) drainage member including a first piece 50 and a second piece 52. The drainage member 20 is configured to control airflow to the microchannels 40. In an example, as shown in FIG. 7, the first piece 50 can be attached to the tube distal drainage end 16 and the second piece 52 can be located over a portion of the first piece 50 and tube distal drainage end 16.

[0065] As shown in FIG. 8, the first piece 50 includes connector portion 54 and a neck portion 56 extending from the connector portion 54. In an example, the connector portion 54 is a funnel. The funnel can taper from a first piece distal end 55 towards the neck portion 56. In an example, when the connector portion 54 is a funnel, the first piece distal end 55 can include a flange around the perimeter of the first piece drainage outlet 58. Alternatively, the first piece connector portion 54 can be any suitable coupling element configured to connect the urinary catheter assembly 10 to a urine collection container, such as a collection bag. A first piece drainage outlet 58 is located in the connector portion 54 at the first piece distal end 55 and a first piece drainage inlet 59 is located in the neck portion 56 at the first piece proximal end 57. A first piece lumen 60 (FIG. 10) extends between the first piece distal end 55 and the first piece proximal end 57.

[0066] Referring to FIGS. 7 and 10, the tube distal drainage end 16 is connected to the drainage member 20. In particular, the tube distal drainage end 16 can be connected to the first piece 50 of drainage member 20. For example, the neck portion 56 of the first piece 50 can include a slot 62 (FIGS. 8 and 10) within the wall 63 of the first piece 50 extending from the first piece proximal end 57 towards the connector portion 54. The slot 62 is configured to receive the tube distal drainage end 16. The slot 62 includes a width configured to accommodate the width of the catheter tube wall 36. In other words, the width of the slot 62 may be slightly larger than the catheter tube wall 36 such that the catheter tube wall 36 may fit into the slot 62. The slot 62 extends annularly parallel to the circumference of the neck portion 56. The slot 62 can be formed by molding the slot 62 during manufacture of the first piece 50, by cutting, or by any other suitable method of manufacturing.

[0067] Additionally, the first piece 50 includes a first piece air inlet 64. The first piece air inlet 64 is located on the neck portion 56 of the first piece 50 and extends from the outside surface 66 of the first piece 50 towards the first piece lumen 60. In particular, the first piece air inlet 64 extends to a point aligning with the wall 61 of theAttorney Docket No. 3400-0352.01 (830PCT) slot 62 such that the first piece air inlet 64 does not extend all the way to the first piece lumen 60. As such, the first piece air inlet 64 is in fluid communication with the slot 62, but not with the first piece lumen 60.

[0068] To couple the catheter tube 12 to the first piece 50, the tube distal drainage end 16 is inserted into the slot 62 and advanced a distance to leave a gap between the catheter tube 12 and a distal surface 65 of the slot 62. As shown in FIG. 10, the tube distal drainage end 16 does not protrude into the first piece air inlet 64, but the location of the tube distal drainage end 16 can vary within the slot 62 as long as a gap allowing air to enter the slot 62 is present.

[0069] Turning back to FIGS. 7-9, the second piece 52 can be a hollow collar located over the neck portion 56 of the first piece 50. For example, the second piece 52 includes a collar wall 70 with a collar outer surface 72 and a collar inner surface 74, a first collar opening 75 located at the collar distal end 76, and a second collar opening 77 located at the collar proximal end 78. A second piece lumen 80 is defined by the collar inner surface 74 and extends from the collar distal end 76 to the collar proximal end 78. The diameter of the second piece lumen 80 is sized to receive the neck portion 56 of the first piece 50. For instance, the diameter may be slightly larger than the diameter of the neck portion 56 such that the collar inner surface 74 abuts or nearly abuts the first piece outer surface 66.

[0070] The second piece 52 is connected to first piece 50 such that the first piece50 and second piece 52 are configured to rotate relative to one another. In an example, as shown in FIGS. 7-10, the first piece 50 and second piece 52 can be connected with a click-fit including a groove 51 and a protruding ring 53. The groove 51 can be located on the first piece 50 and the ring 53 can be located on the second piece 52 or vice versa. For instance, as shown in FIGS. 7-10, the first piece 50 can include a groove51 configured to accept a ring 53 protruding from the collar inner surface 74 of the second piece 52. The groove 51 and ring 53 can extend along the circumference of the respective piece 50 and 52 on which they are located, such that the pieces 50 and52 can rotate relative to one another when they are connected. In another example, the first piece 50 and second piece 52 can be connected with an interference or friction fit. In addition to being rotatable, in an example, the first piece 50 and second piece 52 are attached to one another to create an air-tight seal. As such, when the drainage member 20 is in a shut configuration, air does not travel between the first and secondAttorney Docket No. 3400-0352.01 (830PCT) piece 50 and 52.

[0071] Furthermore, second piece 52 includes a second piece air inlet 82 extending from the collar outer surface 72 to the collar inner surface 74. As such, the second piece air inlet 82 is in fluid communication with the second piece lumen 80. The second piece air inlet 82 is located on the second piece 52 in a position that can align with the first piece air inlet 64 as shown in FIG. 10. Accordingly, the drainage member 20 can be placed in an open / loading configuration by rotating the first piece 50 and / or second piece 52 to align first piece air inlet 64 and the second piece air inlet 82 or in shut configuration by rotating the first piece 50 and / or second piece 52 to a position where the first piece air inlet 64 and the second piece air inlet 82 are not aligned. As such, in the shut configuration, first piece air inlet 64 is closed by the second piece inner surface 74.

[0072] FIGS. 11 -14 show examples of a drainage member 20 in an open / loading configuration and a shut configuration. In particular, FIGS. 12 and 14 show crosssections of the drainage member 20 and catheter tube 12 along lines A-A and B-B, respectively ( / .e., across the drainage member 20 and viewed in a direction from the first piece distal end 55 towards the first piece proximal end 57). As shown in FIGS. 11 and 12, to place the drainage member 20 into the open / loading configuration, the first piece 50 and / or second piece 52 are rotated to align the first piece air inlet 64 with the second piece air inlet 82. In this configuration, the microchannel 40 is exposed to the ambient environment. Without being bound to theory, a capillary action effect caused by allowing airflow between the outside environment and the microchannel outlet 43 when the microchannel inlets 42 and / or loading openings 45 are submerged in a biomarker reagent solution can be used to load the microchannel 40 with a biomarker reagent. To place the drainage member 20 into a shut configuration, as shown in FIGS. 13 and 14, the first piece 50 and / or second piece 52 can be rotated such that the first piece air inlet 64 and the second piece air inlet 82 are not aligned.

[0073] As described herein, the catheter tube 12 can include multiple microchannels 40. FIGS. 15A-16B show examples of drainage members 20 configured to receive a catheter tube 12 including multiple microchannels 40. Turning to FIGS. 15A-15B, first piece 50 can include multiple first piece air inlets 64. For illustrative purposes, FIGS. 15A-15B show three microchannels 40, yet it will be understood that more or less microchannels 40 can be included without departing fromAttorney Docket No. 3400-0352.01 (830PCT) the scope of the disclosure. By providing multiple first piece air inlets 64, the microchannels 40 can be selectively loaded by aligning the second piece air inlet 82 with the different first piece air inlets 64. For example, as shown in FIG. 15A, the second piece air inlet 82 can be aligned with the first piece air inlet 64 in fluid communication with a first microchannel 40. In this configuration, the first microchannel 40 can be loaded with a biomarker reagent. To place the drainage member 20 in a shut configuration, the second piece 52 and / or first piece 50 can be rotated such that the second piece air inlet 82 does not align with any of the first piece air inlets 64, as shown in FIG. 15B. Accordingly, to load a different microchannel 40 with a biomarker reagent, the second piece 52 and or first piece 50 are rotated to align the second piece air inlet 82 with the first piece air inlet 64 in fluid communication with another microchannel 40.

[0074] Alternatively, the first piece 50 can include one first piece air inlet 64 in fluid communication with multiple microchannels 40 as shown in FIGS. 16A and 16B. In this instance, when the second piece air inlet 82 is aligned with the first piece air inlet 64, multiple microchannels 40 are exposed to the ambient environment. As illustrated in FIG. 16A, the catheter tube 12 can include three microchannels 40 and the first piece air inlet 64 extends at least partially along the circumference of the first piece 50 to include all of the microchannels 40. More or less microchannels 40 can be included and the first piece air inlet 64 extends around the circumference of the first piece 50 to include all of the microchannels 40. To place the drainage member 20 in a loading configuration, as shown in FIG. 16A, the second piece air inlet 82 is aligned with any part of the opening defined by the first piece air inlet 64. To place the drainage member 20 in a shut configuration, as shown in FIG. 16B, the second piece 52 and / or first piece 50 is rotated such that the second piece air inlet 82 does not align with any part of the first piece air inlet 64. In this manner, the second piece inner surface 74 covers the first piece air inlet 64.

[0075] Turning to FIGS. 17A-23, the figures illustrate examples of a urinary catheter assembly 10 being loaded with a biomarker reagent and use of the urinary catheter assembly 10.

[0076] Briefly referring to FIGS. 7 and 8, to assemble the urinary catheter assembly 10, the catheter tube 12 is inserted into the slot 62 of the first piece 50. The tube distal drainage end 16 is inserted into the slot 62 so as to leave a gap betweenAttorney Docket No. 3400-0352.01 (830PCT) the tube distal drainage end 16 and the slot distal surface 65. The catheter tube 12 can be attached to the first piece 50 by welding, adhesion, bonding, or any other suitable method of attachment.

[0077] After attaching the catheter tube 12 to the first piece 50, the second piece 52 can be attached to the first piece 50. For instance, the tube proximal insertion end 14 can be inserted into the first collar opening 75 of the second piece 52 and the second piece 52 can be slid along the length of the catheter tube 12 to the first piece 50. The second piece 52 is then attached to the neck portion 56 of the first piece 50 such that the second piece 52 and the first piece 50 (with the catheter tube 12, if previously attached) are rotatable in relation to one another. In a particular example, the ring 53 located on the second piece 52 engages with and is received in the groove 51 located on the neck portion 56 of the first piece 50, such that the first piece 50 and second piece 52 are attached via a click-fit. Alternatively, in an example, the drainage member 20 including the first piece 50 and the second piece 52 can be assembled before attaching the catheter tube 12 to the first piece 50.

[0078] Referring back to FIGS. 17A-23, after assembling the urinary catheter assembly 10, the microchannels 40 can be loaded with a biomarker reagent. The biomarker reagent can be a color-changing reagent. When the reagent contacts drained urine within a microchannel 40, the reagent may change color to indicate the presence of a biomarker within the drained urine. The reagent may be configured to detect, for example, but not limited to, urinary tract infections, urinary tract infection causative agents, the degree of urinary tract infection, proteases, ureases, pH, nitrite, leukocytes, urobilinogen, ketones, glucose, bilirubin, creatinine, and blood. Other urine characteristics and biomarkers can be detected without departing from the scope of the disclosure.

[0079] The biomarker reagent can be loaded into the microchannels 40 as a biomarker reagent solution 84 (FIGS. 17A, 18A, and 19A). The biomarker reagent solution 84 can include a biomarker reagent solute dissolved in a solvent. The biomarker reagent solute can be a reagent which changes color when it contacts urine including the biomarker. For example, the biomarker reagent can be, but is not limited to, tetrabromophenol sulphonephthalein, 2,6-dichlorophenol indophenol sodium salt, diazonium salt, peroxide, tetramethylbenzidine, dinitrobenzoic acid, and sodium nitroprusside. The solvent can include, but is not limited to, water, alcohol, or any otherAttorney Docket No. 3400-0352.01 (830PCT) water-miscible organic solvents.

[0080] FIGS. 17A-21 illustrate a method of loading a catheter assembly 10, including microchannel inlets 42 located at tube proximal insertion end 14 and without optional tip 13, as described in FIG. 3. As shown in FIG. 17A, urinary catheter assembly 10 includes a first microchannel 40c, a second microchannel 40d, and a third microchannel 40e. Although FIGS. 17A-21 illustrate an example of a urinary catheter assembly 10 including multiple microchannels 40, it will be understood that the method of loading the microchannels 40 with a biomarker reagent, as described herein, applies to urinary catheter assemblies 10 including a single microchannel 40.

[0081] The microchannels 40 can be loaded via microchannel inlets 42. When multiple microchannels 40 are included, all the microchannels 40 can contain the same biomarker reagent or, alternatively, each microchannel 40 can be loaded with a different biomarker reagent. Accordingly, each microchannel 40 can be configured to detect the presence of a different biomarker. To selectively load the microchannels 40 with different biomarker reagents, the microchannel inlets 42 that are not being loaded can be closed. For instance, the microchannel inlets 42 associated with the microchannels 40 that are not being loaded can be closed with a plug, a cap, a covering, or any other suitable closing. After loading the intended microchannel 40, the inlet 42 associated with the loaded microchannel 40 can be closed and the microchannel inlet 42 associated with the next microchannel 40 to be loaded would be opened and loaded.

[0082] Turning to FIGS. 17A-20B, the figures illustrate the first microchannel 40c being loaded with a biomarker reagent. Accordingly, as shown in FIGS. 17B, 18B, 19B, and 20B the microchannel inlet 42 associated with microchannel 40c is open while the other two microchannels inlets (associated with microchannels 40d and 40e) are closed with a closing as described herein. For illustrative purposes only, the closed microchannel inlets 42 are shown with an “X” over the microchannel inlet.

[0083] As shown in FIG. 17A, to load microchannel 40c with a biomarker reagent, the drainage member is placed in the shut configuration and the proximal insertion end 14 of the catheter tube 12 (and microchannel inlets 42) are submerged in the biomarker reagent solution 84. After submerging the tube proximal insertion end 14 in the biomarker reagent solution 84, the second piece 52 and / or first piece 50 can be rotated (as illustrated by the arrow near the first piece distal end 55) to align the secondAttorney Docket No. 3400-0352.01 (830PCT) piece air inlet 84 with the first piece air inlet 64 associated with the microchannel 40c, placing the drainage member 20 in the open / loading configuration and exposing microchannel 40c to the ambient environment. Without being bound to theory, via capillary action, the biomarker reagent solution 84 travels into the open microchannel inlet 42 and through the microchannel 40c towards the drainage member 20, as shown in FIGS. 18A and 18B.

[0084] T urning to FIGS. 19A and 19B, the proximal end 14 of the catheter tube 12 can remain submerged in the biomarker solution until the microchannel 40c is sufficiently loaded. For instance, a microchannel 40 can be sufficiently loaded once the biomarker reagent solution 84 travels to a predetermined distance within the microchannel 40 or when the biomarker reagent solution 84 stops travelling further up the microchannel 40. Once the microchannel 40c is sufficiently loaded with the biomarker reagent solution 84, as shown in FIGS. 19A and 19B, the drainage member 20 is placed in the closed configuration (as shown by the arrow near the first piece distal end 55). By placing the drainage member 20 in the closed configuration, airflow to the microchannel 40c is stopped and the biomarker reagent solution 84 is retained within the microchannel 40c.

[0085] After placing the drainage member 20 in the closed configuration after loading the microchannel 40c, the proximal insertion end 14 can be removed from the biomarker solution 84, as shown in FIGS. 20A and 20B, and the microchannel 40c can be dried by leaving the urinary catheter assembly 10 in the ambient environment for a period of time to let the solvent of the biomarker reagent solution 84 evaporate. By placing the drainage member 20 in the shut configuration, the solution 84 is retained inside the microchannels 40 by capillary action. As the solvent evaporates, the biomarker reagent remains attached to the inner wall of the microchannel 40c. In one alternative, to dry the microchannel 40c, the tube proximal insertion end 14 can be left submerged in the biomarker reagent solution 84 and the drainage member 20 is left in the loading ( / .e., open) configuration. In this manner, the biomarker reagent solution 84 remains in the microchannel 40c for a longer time, providing the biomarker reagent more time to attach to the microchannel wall. In some examples, the urinary catheter assembly 10 can be placed in a temperature-controlled and / or humidity-controlled environment to promote drying. For instance, after loading the microchannel 40c, the urinary catheter assembly can be dried at a temperature of about 25-60° C.Attorney Docket No. 3400-0352.01 (830PCT)Additionally, the urinary catheter assembly 10 can be dried in an environment with humidity levels of about 30-50%.

[0086] As discussed above, to load the other microchannels 40d and 40e, the microchannel inlet 42 associated with loaded microchannel 40c can be closed, the microchannel inlet 42 associated with either 40d or 40e can be opened, and the method of loading the microchannels 40 can be repeated until all the microchannels 40 are loaded. Turning to FIG. 21 , the figure illustrates the urinary catheter assembly 10 including loaded microchannels 40c-e, each loaded with a different biomarker reagent.

[0087] To prepare a urinary catheter assembly 10 with multiple microchannels 40 including different biomarker reagents, each microchannel 40 can be loaded and dried one-by-one or they can be loaded separately and then dried simultaneously. For example, to load and dry each microchannel 40 individually, one microchannel 40 will be loaded and dried as described herein and the process would be repeated for each microchannel 40. Alternatively, as described herein, each microchannel 40 can be loaded individually and dried simultaneously. For instance, after loading a microchannel 40, before letting the loaded microchannel 40 dry, a subsequent microchannel 40 is loaded. This is repeated until each microchannel 40 has been loaded. After all of the microchannels 40 are loaded, the urinary catheter assembly 10 is dried.

[0088] It will be understood that the method of loading the microchannels 40, as described above, applies to other examples of the catheter assembly 10 described herein. For instance, as described in FIGS. 4A and 4B, the catheter assembly can include microchannel inlets 42 and loading apertures 45. In one alternative, the microchannels 40 can be loaded via the inlets 42 or apertures 45 by submerging both the inlets 42 and the apertures 45 into a biomarker reagent solution. In another alternative, if the microchannels 40 are to be loaded via the apertures 45, the inlets 42 can be closed with plugs, covers, or other suitable closings during loading, or vice versa. The microchannels 40 can then be loaded with a biomarker reagent as described herein.

[0089] In another example, such as when the microchannel inlets 42 are located at different locations along the longitudinal length of the catheter tube 12, as described in FIG. 6, the microchannels 40 can be selectively loaded by dipping the tube proximalAttorney Docket No. 3400-0352.01 (830PCT) insertion end 14 into a biomarker reagent solution 84 up to a first depth to submerge the first opening 18a, thus submerging the microchannel inlet 42 associated with the first opening 18a. The first microchannel 40a can then be loaded as described herein. After the biomarker reagent has been loaded in the first microchannel 40a, the inlet 42 associated with microchannel 40a can be closed (e.g., with a plug, a cap, a covering, or any other suitable closing) and the catheter tube 12 can be dipped into another biomarker reagent solution 84 to a depth to submerge another opening 18b and the microchannel 40b can be loaded as described herein. This process can be repeated for each microchannel 40 included in the catheter tube 12.

[0090] In some examples, if the urinary catheter assembly 10 was loaded without an optional rounded tip 13, the rounded tip 13 can be attached to the tube proximal insertion end 14 after loading or drying. The rounded tip 13 can be added by welding, adhesion, bonding, adhesive curing, overmolding, RF induction, laser bonding, or any other suitable attachment method. Additionally, the one or more openings can be formed on the catheter tube 12 after drying the microchannels 40.

[0091] Turning to FIGS. 22-23, the figures illustrate how to use the urinary catheter assembly 10. Although urinary catheter assembly 10 in FIGS. 22 and 23 does not include an optional rounded tip 13, it will be understood that a tip 13 could be present to aid in insertion of the tube proximal insertion end 14 into a urethra. Additionally, for illustrative purposes, FIGS. 22 and 23 illustrate a catheter tube 12 with one microchannel 40. It will be understood that the catheter tube 12 can include multiple microchannels 40 without departing from the scope of the disclosure. To use the urinary catheter assembly 10, the drainage member 20 is placed in the loading ( / .e. open) configuration (as illustrated with the arrow near first piece distal end 55) to allow airflow through the microchannel 40. The user will insert the tube proximal insertion end 14 through the urethra until the tube proximal insertion end 14 is in the bladder.

[0092] Once properly inserted, urine will then flow from the bladder and through the catheter assembly 10. For instance, as illustrated with the arrows near the proximal insertion end 14 in FIG. 22, urine may flow through the catheter tube lumen 38 and through the microchannels 40 by entering the microchannel inlets 42. In another example, when the catheter assembly 10 includes an optional rounded tip 13 and one or more openings 18 on the tube proximal insertion end 14, urine may enter the tube lumen 38 via the one or more openings 18 and urine can enter the microchannels 40Attorney Docket No. 3400-0352.01 (830PCT) via the microchannel inlets 42. For instance, when the microchannel inlet 42 is located on the inner surface of the catheter tube 12, as shown in FIG. 4A, urine can enter the tube lumen 38 via the one or more openings 18 and then into the microchannel inlets 42. In another example, when the microchannel inlets 42 are located on the outer surface of the catheter tube 12, as shown in FIG. 4B, urine may enter the microchannels 40 directly via the microchannel inlets 42. In a further example, when the catheter assembly 10 includes microchannel inlets 42 in the one or more openings 18, as shown in FIGS. 5 and 6, as urine enters the tube lumen 38 through the one or more openings 18, urine will enter the microchannel inlets 42 and travel through the microchannels 40, thus contacting the biomarker reagent on the microchannel wall.

[0093] During catheterization, the drainage member 20 can be aimed towards a suitable receptacle, such as a toilet, and drained urine exits the urinary catheter assembly 10 through the first piece drainage outlet 58. In another example, when the drainage member 20 includes a connector, a urine collection container can be attached to the connector before catheterization and voided urine is collected in the collection container.

[0094] After the user has voided the bladder, the user may remove the catheter tube 12 from the urethra and view the microchannel(s) 40 to assess the characteristics of the urine. For illustrative purposes, FIG. 23 shows a different shading within the microchannel 40 from the shading in the microchannel 40 in FIG. 22 to show that the biomarker reagent underwent a color-change reaction. The user may assess the characteristics of the urine based on color change of the biomarker reagents. The user may use a key card indicating what a color identifies to interpret any color change in the microchannel(s) 40. Optionally, the user may interpret the color change in the microchannel(s) 40 using an electronic means. For instance, but not limited to, color change may be interpreted using an app. In one example, the user may use a smart device (such as a cellphone or tablet) to take a photo or scan of the catheter tube 12. The smart device may include software, an application or connection via the internet to a software that analyzes the photo / scan and provides the analysis to the user or a healthcare provider. The analysis or other data may also be stored and readably retrievable for future viewing.

[0095] It will be understood that the embodiments and examples described above are illustrative of some of the applications of the principles of the present subjectAttorney Docket No. 3400-0352.01 (830PCT) 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. 3400-0352.01 (830PCT)What is Claimed:1 . A urinary catheter assembly comprising: a catheter tube including a tube wall, the catheter tube having a tube proximal insertion end and a tube distal drainage end; a tube lumen defined by the tube wall and extending from the proximal insertion end to the distal drainage end; at least one microchannel in the tube wall configured to contain a biomarker reagent; and a drainage member located at the tube distal drainage end.

2. The urinary catheter assembly of claim 1 , wherein the at least one microchannel includes a plurality of microchannels.

3. The urinary catheter assembly of any one of claims 1 -2, wherein the at least one microchannel extends parallel to the tube lumen.

4. The urinary catheter assembly of any one of claims 1 -3, wherein the biomarker reagent is loaded into the at least one microchannel via capillarity.

5. The urinary catheter assembly of any one of claims 1 -4, wherein the drainage member includes a first piece and a second piece located over a portion of the first piece.

6. The urinary catheter assembly of claim 5, wherein the first piece and second piece are rotatable in relation to one another.

7. The urinary catheter assembly of any one of claims 5-6, wherein the second piece includes a second piece air inlet and the first piece includes a first piece air inlet and wherein the drainage member is placed in an open configuration when the second piece air inlet and the first piece air inlet are aligned, thereby placing the first piece air inlet and second piece air inlet in fluid communication with the at least one microchannel, and a shut configuration when the second piece air inlet and first piece air inlet are not aligned.

8. The urinary catheter assembly of claim 7, wherein the microchannel is configured to be loaded with a biomarker when the first piece air inlet and second piece air inlet are aligned.

9. The urinary catheter assembly of any one of claims 1 -8, comprising at least one opening at the tube proximal insertion end.Attorney Docket No. 3400-0352.01 (830PCT)10. The urinary catheter assembly of claim 9, wherein the at least one opening is in fluid communication with the tube lumen and the at least one microchannel.

11. A method of detecting biomarkers with a urinary catheter comprising: inserting a urinary catheter into a urethra, wherein the urinary catheter comprises a catheter tube including a tube wall, the catheter tube having a tube proximal insertion end and a tube distal drainage end; a tube lumen defined by the tube wall and extending from the tube proximal insertion end and the tube distal drainage end; at least one microchannel containing a biomarker reagent; and a drainage member located at the tube distal drainage end; flowing urine through the at least one microchannel; and detecting a biomarker via the biomarker reagent within the at least one microchannel.

12. The method of claim 11 , wherein the at least one microchannel includes a plurality of microchannels.

13. The method of any one of claims 11 -12, wherein the at least one microchannel extends parallel to the tube lumen.

14. The method of any one of claims 11 -14, wherein the drainage member includes a first piece and a second piece located over a portion of the first piece.

15. The method of claim 14, wherein the first piece and the second piece are rotatable in relation to one another.

16. The method of any one of claims 14-15 , wherein the second piece includes a second piece air inlet and the first piece includes a first piece air inlet and wherein the drainage member is placed in an open configuration when the second piece air inlet and the first piece air inlet are aligned, thereby placing the first piece air inlet and second piece air inlet in fluid communication with the at least one microchannel, and a shut configuration when the second piece air inlet and first piece air inlet are not aligned.

17. The method of any one of claims 11 -16, wherein the urinary catheter includes at least one opening at the tube proximal insertion end.

18. The method of claim 17, wherein the at least one opening is in fluid communication with the tube lumen and the at least one microchannel.Attorney Docket No. 3400-0352.01 (830PCT)19. The method of any one of claims 16-18, further comprising loading the at least one microchannel with a biomarker reagent.

20. The method of claim 19, wherein loading the at least one microchannel with a biomarker reagent comprises dipping the proximal insertion end into a biomarker reagent solution.21 . The method of claim 20, wherein loading the at least one microchannel with a biomarker reagent comprises placing the drainage member in the open configuration to draw the biomarker reagent solution into the at least one microchannel via capillarity.

22. The method of claim 21 , wherein loading the at least one microchannel with a biomarker reagent comprises drying the at least one microchannel such that the biomarker reagent remains within the at least one microchannel.

23. The method of claim 22, wherein drying the at least one microchannel includes placing the drainage member in a shut configuration and removing the tube proximal insertion end from the biomarker reagent solution.

24. The method of any one of claims 22-23, comprising placing the drainage member in the open configuration during catheterization.

25. The method of claim 24, comprising checking the at least one microchannel for a color change of the biomarker reagent after catheterization.

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