WO2011163448A1

WO2011163448A1 - A device for monitoring a patient for a urinary tract infection

Info

Publication number: WO2011163448A1
Application number: PCT/US2011/041581
Authority: WO
Inventors: Chad A. Hanson; Geoff H. Gorres; Tom Brust
Original assignee: Superior Medical, Llc
Priority date: 2010-06-25
Filing date: 2011-06-23
Publication date: 2011-12-29

Abstract

The invention provides a UTI-monitoring urinary catheter system for monitoring the presence or absence of one or more markers in urine that are indicative of a UTI. The UTI-monitoring system includes a catheter portion, a collection tubing portion, and a collection bag portion. At least one of those portions includes a UTI indicator substrate that detects and signals the presence or absence of the one or more markers in urine that are indicative of a UTI. The UTI indicator substrate is found within a urinary screening device that is then placed somewhere along the UTI-monitoring system. In certain embodiments, the catheter portion contains the UTI indicator substrate; in certain embodiments, the collection tubing portion contains the UTI indicator substrate; and in certain embodiments, the collection bag portion contains the UTI indicator substrate.

Description

A DEVICE FOR MONITORING A PATIENT FOR A

URINARY TRACT INFECTION

[0001] This application claims the benefit of United States Provisional Application No. 61/358,500, filed June 25, 2010.

TECHNICAL FIELD

[0002] This invention relates to medical devices, and more particularly to a device for monitoring a patient for a urinary tract infection (UTI).

BACKGROUND

[0003] Urinary tract infections are a major cause of morbidity and mortality in healthcare, especially in hospitalized and otherwise debilitated patients. Catheter-associated UTI (CAUTI) is the most common nosocomial infection, accounting for more than 40% of all hospital-acquired infection. The risk of infection is substantially increased in patients having a urinary catheter. In addition, many afflicted patients are unable to verbalize their symptoms and their infections may not be recognized until they are in advanced stages such as life- threatening sepsis.

[0004] CAUTI is the second most common cause of nosocomial sepsis after pneumonia. More than 750,000 patients in the United States develop severe sepsis each year, which is characterized by acute organ system dysfunction. The mortality rate from severe sepsis, at 28.6%, leaves 215,000 Americans dead annually at an estimated cost of about $16.7 billion. This is nearly 600 patients per day, which means that as many patients in the United States die from severe sepsis each day as die from acute myocardial infarction.

[0005] It is desirable to discover CAUTIs as early as possible. Urine "dipsticks" are available (e.g., Multistix®, Bayer, Leverkusen, Germany; Chemstrip®, Roche Diagnostics, Indianapolis, IN; Multistix® 10 SG, Miles Laboratories, Inc., Elkhart, IN; and Combur- Test®, Boehringer Mannheim Corp., Indianapolis, IN), but require an index of suspicion, are labor-intensive for nursing staff, and usually require incident- specific physician orders. More commonly, urine specimens are sent to a hospital or central laboratory when certain indicators such as cloudiness, a change in color, or blood are observed.

[0006] Current procedures can result in a significant lapse of time before the UTI is clinically diagnosed and treatment initiated. Ultimately, the cost of these infections in both dollars and human life is substantial. The present disclosure provides systems and devices that monitor a patient for a UTI as well as methods of using such systems and devices. Using the disclosed systems and devices, particularly on catheterized patients, can significantly reduce or completely eliminate the current delays in diagnosis and treatment of UTIs.

SUMMARY OF THE INVENTION

[0007] In one aspect, the invention provides a UTI-monitoring urinary catheter system for monitoring the presence or absence of one or more markers in urine that are indicative of a UTI. Such a UTI-monitoring system generally includes a catheter portion, a collection tubing portion, and a collection bag portion. At least one of those portions includes a UTI indicator substrate that detects and signals the presence or absence of the one or more markers in urine that are indicative of a UTI. The UTI indicator substrate is found within a urinary screening device that is then placed somewhere along the UTI-monitoring system. In certain embodiments, the catheter portion contains the UTI indicator substrate; in certain

embodiments, the collection tubing portion contains the UTI indicator substrate; and in certain embodiments, the collection bag portion contains the UTI indicator substrate.

[0008] In another aspect, the invention provides a UTI monitoring device for monitoring the presence or absence of one or more markers in urine that are indicative of a urinary tract infection (UTI). Such a UTI-monitoring device can be configured for placement in-line in a urinary catheter system. Such a UTI-monitoring device generally includes a tubular portion that has a first port on one end and a second port on the other end that are configured for inline placement at a position along a urinary catheter system. The tubular portion of such a device also includes a UTI indicator substrate for detecting and signaling the presence or absence of the one or more markers in urine that are indicative of a UTI.

[0009] The UTI indicator substrate can be attached (e.g., releasably attached) to an inside surface of the at least one portion of the UTI-monitoring system or device. In some embodiments, a UTI-monitoring system or device contains more than one UTI indicator substrate. Representative markers in urine that are indicative of a UTI include leukocyte esterase and nitrites. The UTI-monitoring system can provide a colorimetric change and can be coupled with a digital read-out.

[0010] In still another aspect, the invention provides methods of monitoring a catheterized patient's urine for the presence or absence of one or more markers indicative of a UTI. Such a method comprises catheterizing the patient with the UTI-monitoring urinary catheter system as described herein or placing a UTI-monitoring device as described herein in a urinary catheter system, and monitoring the patient's urine for the presence or absence of one or more markers indicative of a UTI.

[0011] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, suitable methods and materials are described below. In addition, the materials, methods, and examples are illustrative only and not intended to be limiting. All publications, patent applications, patents, and other references mentioned herein are incorporated by reference in their entirety. In case of conflict, the present specification, including definitions, will control.

[0012] Other patents and patent applications related to the technology of this patent application include U.S. Patent 7,727,206 and U.S. patent application 2010/0120073 entitled, METHODS AND DEVICES FOR DETECTING ORGANISMS CAUSING URINARY TRACT INFECTIONS

filed on, October 30, 2009 and naming inventors Geoffrey Gorres and Chad Hanson, both of which, are incorporated in reference in their entirety, as are all patents and applications referenced herein.

[0013] The details of one or more embodiments of the invention are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the invention will be apparent from the drawings and detailed description.

BRIEF DESCRIPTION OF THE DRAWINGS

[0014] FIG. 1 is a perspective view of the front side of an embodiment of a UTI-screening device that can be incorporated into a urinary catheter system.

[0015] FIG. 2 is a perspective view of the back side of an embodiment of a UTI-screening device that can be incorporated into a urinary catheter system. [0016] FIG. 3 is a cross section of an individual piercing member and substrate well that illustrates an embodiment of the inventions shown herein.

[0017] FIG. 4 is a front view of an embodiment of a UTI-screening device that can be incorporated into a urinary catheter system.

[0018] FIG 5 is cross section of FIG. 4 along A-A.

[0019] FIG. 6 is a cross section of FIG. 4 along B-B.

[0020] FIG. 7 is a back view of an embodiment of a UTI screening device that can be incorporate into a urinary catheter system.

[0021] FIG. 8 is a front view of a substrate holder that can be incorporated into various embodiments of the UTI screening devices disclosed herein.

[0022] FIG. 9 is a side view of FIG. 8.

[0023] FIG. 10 is a side view of FIG. 8.

[0024] FIG. 11 is a perspective view of a substrate holder that can be incorporated into various embodiments of the UTI screening devices disclosed herein.

[0025] FIG. 12 is a front view of an embodiment of a UTI-screening device that has its substrate holders in a V orientation.

[0026] FIG. 13 is a back view of the embodiment of FIG. 12 that shows the piercing members and urine reservoir.

[0027] FIG. 14 is an exploded perspective view of the embodiment of FIG. 12 showing the relative locations of the front and back and substrate holders juxtaposed the piercing members.

[0028] FIG. 15 is a front view of an embodiment of the inventions showing a carousel arrangement of the substrate holders.

[0029] FIG. 16 is a rear view of the embodiment of FIG. 15 that shows a serpentine urine path and urine reservoir.

[0030] Persons of ordinary skill are familiar with interpreting such figures and will recognize the variations set forth in the aforementioned figures.

[0031] Like reference symbols in the various drawings indicate like elements. Computer- generated figures are drawn to scale. DETAILED DESCRIPTION OF A PREFERRED EMBODIMENT

Nomenc ture

1 Urinary Screening Device

2 Front Side

3 Back Side

4 Inlet

5 Outlet

7 Trigger

8 Holes

9 Serpentine Path

10 Substrate Wells

12 Retaining Snap Hole

13 Retaining Snap (Could Weld or Crush)

14 Retaining Snap

15 Passage

16 Sloping End

17 Collar

18 Flare

19 Tubing Receiver

25 Passage

26 Passage

27 Passage

28 Passage

29 Passage

30 Passage

31 Passage

32 Passage

33 Urine Reservoir

35 Suction Break

41 Piercing Connector

45 Piercing Member

46 Sloping Side 47 Side Wall

48 Piercing Base

49 Piercing Top

50 Foil

55 Substrate Holder

56 Substrate Wells

60 UTI Substrate

Construction

[0032] UTI-screening systems and devices are disclosed herein. The systems and devices provide timely, sensitive, and specific information regarding the presence or absence of markers in urine that are indicative of a UTI. The systems and devices disclosed herein provide timely information regarding UTIs. These systems are specifically valuable in patients who have a urinary catheter system in place.

[0033] Urinary catheter systems are known, and often generally include a catheter portion, a collection tubing portion, and a collection bag portion. See, for example, U.S. Patent 4,575,371; 4,579,554; 4,813,935; 4,936,837; 5,295,979; 5,300,051; 5,785,694;

5,919,170; 6,117,120; 6,162,201; and 6,837,868. Such catheter systems may also incorporate valves to prohibit back flow of urine within the catheter system. See, for example, U.S. Patents 6,682,503 and 4,227,533.

[0034] This patent describes a variety of UTI-monitoring systems that can screen for the presence or absence of one or more markers in urine that are indicative of a UTI.

[0035] FIG. 1 shows a urinary screening device 1 with a front 2. Urinary screening device 1 can be constructed with plastic such as a thermoformable plastic. Useful plastics include PVC, PETG, and PE. Urinary-screening device 1 has substrate wells 10 that can contain UTI indicator substrates. Preferably, substrate wells 10 are clear so that when UTI indicator substrates contained within substrate wells 10 change color, that color change can be visualized from outside urinary-screening device 1.

[0036] Visualization can occur via a medical professional viewing the device or an electronic color detector can be adapted to fit over or next to or in any arrangement that allows a detector to detect the color change that can occur within the one or more of the substrate wells 10. The technology to build color detectors in general are known and can be adapted to manufacture the electronic color detectors disclosed herein.

[0037] Urinary-screening device 1 can be incorporated into a urinary catheter system. Tubing of the catheter system may be placed into inlet 4 and outlet 5. Tubing may be connected to the Urinary-screening device 1 in any manner. It may be glued, welded, or otherwise connected directly to the tubing. Alternatively, stepped tubing connectors, sometimes referred to as Christmas-tree connectors can be used. The inlet and outlets are the starting and ending passage for urine passing through passage 15 of urinary- screening device 1. Passage 15 may have a sloping end 16 that alters the urine path from being part of both the front 2 and back 3 (not shown in FIG. 1) to being primarily formed by the back 3. Front 2 and back 3 may be held together with snaps 13 and 14. Snaps 13 and 14 nest within each other to form a functional snap. Designing and implementing snaps in thermoformed plastics are known in the art. The snaps may be any shape or form, including round, oblong, rectangular, linear, angled, or any other shape. The snaps may be asymmetric. The snaps 13 and 14 are used to hold front 2 and back 3 more closely together. For certain embodiments it may be useful to remove the snaps and allow the front 2 and back 3 to bow out from each other more than would occur with snaps 13 and 14. Eliminating snaps 13 and 14 may facilitate increased urine volume held within urinary- screening device 1.

[0038] The urine passage may remain in both the front 2 and back 3. Further, a urine passage may be configured anywhere within urinary- screening device 1. A flare or flange 18 may be used to facilitate assembly of tubing to the urinary-screening device 1. Tubing can be inserted into tubing receiver 19 up to collar 17. Tubing may be secured using any acceptable method, e.g., glue, epoxy, RF welding, curable resins, and the like.

[0039] FIG. 2 shows the back 3 side of a urinary-screening device 1. It depicts the urine passage that begins at inlet 4 and exits at outlet 5. The urine passage includes passages 25,

26, 27, 28, 29, 30, 31, and 32. The urine path may also include space between passages 26,

27, 28 and parts of passages 25 and 29. In use with inlet 4 placed above outlet 5, passages 26, 27, 28 and parts of passages 25 and 29 create a urine reservoir. Preferably, the volume of the reservoir is about the volume expected to be excreted by the intended patient in an hour, e.g., amount for an adult patient in one hour, or less. Some embodiments of the inventions herein have a urine reservoir 33 of about 12 ml or less as shown in FIGS. 13, 14, and 16. [0040] A break passage 35 can connect urine passages 25 and 29. The break passage 35 functions as a suction break. That is, when passages 30, 31, or 32 are full and draining, break passage 35 breaks the suction that may occur along passages 25-28 thus preventing urine present in the urine reservoir from being siphoned out of the urinary-screening device 1. It may be useful to make passage 29 larger in cross-sectional area than the passages that precede passage 29.

[0041] In use, urine flows generally along the urine path. Urine can also enter the piercing member 45 through a passage created by one of piercing connectors 41. As depicted, urinary-screening device 1 in FIG. 2 has ten piercing members 45 and ten piercing connectors 41 that are surrounded by the urine path. The piercing members may also be configured to encircle the urine passage. The number of piercing members 45 and piercing connectors 41 may vary. There may be more or fewer piercing connectors 41 than piercing members 45. In a preferred embodiment, the number of piercing members 45 is 7, 10, or 30. Multiple urinary- screening devices 1 can be connected together in series or parallel to provide additional UTI indicator substrates.

[0042] FIG. 3 shows a detailed cross section of an individual piercing member 45 and the substrate wells 10 in an assembled urinary-screening device 1. Piercing member 45 has sloping side 46, side walls 47, piercing base 48, and a piercing top 49. Foil 50 is sealed against either the top of a substrate holder 55 or directly to substrate well 10. When foil 50 is sealed against substrate holder 55, it is expected that substrate holder 55 will be sized to fit snuggly into substrate well 10 with the expectation that the fit will be liquid tight or close thereto. Alternatively, a bonding solvent or adhesive can be placed between substrate well 50 and substrate holder 55. Preferably, the solvent or adhesive will cure clear. In use, piercing force applied to piercing top 49 can force the piercing base 48 to against foil 50 and when enough pressure is applied, foil 50 will break to the inside of substrate well 10 or substrate holder 55. While foils are the preferred material to sequester the substrate from urine until the user wants to test the urine, other materials can be used. For example thin PVC or Aclar or other materials that are moisture impervious and breakable may be sealed to the substrate holder 55. The main point is to have a material that prevents moisture from wetting the substrate until the user pierces to other wise breaks the seal between the substrate and the urine. Alternatively, designs using a carrousel wheel that holds substrate and is pressed against a gasket can also be used to sequester the substrate away from urine. Such design involve more moving parts as it is necessary to move the substrate holder around in a circle to juxtapose the substrate to be tested in front of the viewing window. . This movement can be achieved with a trigger-ratchet mechanism 7 as shown in FIG. 15. Examples of these designs are seen in FIG. 16 (exposed backside showing a serpentine urine path 9) and FIG. 15 (showing front side). The embodiment of FIG. 15 also shows optional holes 8 that can be used to secure the device in an upright fashion to a bed or sheets or the like. The embodiment of FIG. 16 also shows Christmas tree connectors configured on the inlet 4 and outlet 5. Other designs can include stacking individual substrates where each substrate is removed or accessed from the stack as needed. For example, stacked like in a Pez® dispenser.

[0043] In one embodiment, the electronic detector opens to accept at least one of the urinary- screening devices 1 of the present invention. The electronic detector can be manual, hard wired, or programmed. Further, the electronic device may have a piston, plunger, or other actuating member that can activate piercing member 45 to pierce foil 50. It may be advantageous to place the actuating member so that it presses upon piercing base 48. The actuating member can be oriented straight on or at an angle. It may press on piercing base 48 or perhaps piercing top 49 or any other location that, when actuated, causes the piercing member 45 to pierce foil 50. The electronic detector or its individual parts such as the actuating member can be caused to provide a slight vibration or movement to the piercing member to facilitate urine movement within a urinary- screening device 1. The actuating member may be oriented so as to push against only a portion of piercing member 45 so as to concentrate piercing pressure against a smaller portion of piercing member 45 and thus translating into a more concentrated pressure against foil 50. This may facilitate more efficient piercing of foil 50. The electronic device then would then measure the color change, if any, of the UTI indicator substrates at an appropriate time point following the piercing of foil 50. The electronic device would then provide an indication of the presence or absence of markers that would be indicative of a UTI. For example, the device may provide an indication to a medical professional of the result of the testing for the presence or absence of markers by an indicator light on the device or at the nurse's station or doctor's office, or a buzzer or periodic chime, email, etc.

[0044] Piercing member 45 may take on a variety of shapes though somewhat circular or oval is a preferred shape. Preferably, the area of the piercing base 48, when circular in design, is about 45% of the overall diameter of the opening of the substrate holder 55 or substrate well 10 and the piercing base 48 is generally flat as shown in FIG. 3. There are other ratios that are useful, such as greater than 30%, less than 40%, less than 50%, less than 60%, less than 70% and combinations thereof. Alternatively, piercing base 48 can be pointed, concave, convex, or an irregular shape. Piercing base 48 can be configured to accept an additional piercing structure that is separate and apart from piercing base 48. Such structures can be spheres, cubes, springs, crushable structures, and the like. In such instances, piercing base 48 may form a structure or space that accepts the additional piercing structure such as a plastic ball, pin, spring or the like.

[0045] When the urinary-screening device 1 is manufactured with thermoforming techniques, the molds can be arranged so that the thermoforming process thins sloping side 46 or side wall 47. This can be useful when the starting thickness of the thermoformed plastic, such as PETG or PVC, is about 0.010 inches thick. The thinning can result in a sloping side 46 or side wall 47 that is thinner. The thickness of the sloping side 46 and side wall 47 can affect the force necessary to push piercing base 48 through foil 50. Thinning the sloping side 46 and side wall 47 can create a structure that more easily crushes around the piercing base 48. This may lead to a more uniform pierce of foil 50.

[0046] Preferred foils are unsupported foils but other foils such as those used in blister sealing will work. Suitable foils are known and available from companies such as Tekni-Plex Inc. in Pennsylvania and Wincare Health Packaging in Quebec, Canada. Preferred foils include the Tekni-Plex 1250 and 1252 foils and the Wincare DF08HJ712A, DF10J712A, and DF10HJ712A foils. Suitable foils are in the range of 20-25 micron foil thickness, useful foils may range from below 15 to 40 micron or more. Depending on the piercing member design, different thickness foils may be preferred. The suitability of a foil may depend on its adhesive, which must be appropriate for the polymer used to make the substrate holder 55 or back side 3.

[0047] Foil 50, when pierced will allow a small amount of urine to enter or wick into UTI substrate 60. Preferably urine wets the UTI substrate. The urine is supplied by the space between piercing base 48 and foil 50 before foil 50 was pierced. Urine is also supplied by urine residing in the space created on the underside of sloping side 46 and side wall 47 and other surrounding spaces created as urine fills the urinary- screening device 1. Foil 50 also prevents substrate 60 from entering the urine passage, instead keeping it within substrate well 10 or substrate holder 55. If the urine wetting substrate 60 contains markers evidencing a UTI, substrate 60 will change color. Suitable substrates are substrates that, when they give a positive result, are indicative of the presence of a UTI. Known substrates include those measuring leukocyte esterase and nitrites. These substrates are available form companies such as Teco Diagnostics, Roche Diagnostics, and Bayer Corporation. Alternatively, such substrates can be manufactured using known methods. See, for example, U.S. Patent 5,663,044 and UK Patent 1,128,371.

[0048] FIGS. 4, 5, 6, and 7 provide a top view and two cross sectional views of a urinary- screening device 1.

[0049] FIGS. 8, 9, 10, and 11 show various views of a substrate holder 55. It has ten substrate wells 56 and two holes 12. Holes 12 can be arranged to line up with snaps 13.

[0050] FIGS. 12, 13, and 14 show another embodiment of a UTI-monitoring system or device. In this embodiment the is a front side 2 where the results of the substrates, when exposed to urine, can be viewed, and a backside 3 that contains a plurality of piercing members 45 that can be connected by piercing connectors 41. Substrate holders 55 contain substrate wells 56 that can receive a diagnostic material. The substrate holders 55 are sealed with a suitable foil 50 or other materials to sequester the diagnostic material away from urine and moisture until each diagnostic is exposed to urine for testing. The USD diagnostic device can be connected to urinary catheter tubing by the tubing receivers 19. Tubing receiver 19 located at the wider portion of FIG. 12 is the top side of the USD diagnostic device. In use, urine flows into the device at this location. A urine reservoir 33 can be placed in the space between the substrate holders 55. In use urine flowing through the tubing of a urinary catheter system enters the UTI-monitoring device it is deposited in the urine reservoir 33. When urine reservoir 33 becomes full excess urine spills out over the top of the reservoir sides. This opening at the top also functions as a suction break. Urine then passes along, for example, passage 26 to the bottom of the UTI-monitoring device and out tubing connected to the bottom tubing receiver 19. In use, urine can flow along the side wall of the passages among and around the substrate holders 55. Urine may flow along the passages closest to the urine reservoir 33. This can be facilitated in this embodiment by orienting the substrate holders 55 and the corresponding passages in a V shape as shown in FIGS. 12, 13, and 14.

[0051] To test a sample of urine, the UTI-monitoring device of FIGS. 12, 13, and 14 may be turned on its side so that urine in the urine reservoir 33 spills into and fills the passages surrounding one or more of the substrate wells 56 of the substrate holder 55. A medical professional then squeezes one of the piercing members 45 to pierce the foil covering one of the substrate wells 56. Alternatively, the medical professional may pierce the foil before turning the device on its side. This piercing allows urine to enter the substrate well and react with the diagnostic materials contained therein. Upon an appropriate time period, often 2 minutes, the diagnostic can be read through the front side 2 of the UTI-monitoring device. To facilitate an adequate aliquot of urine, urine reservoir 33 can retain a volume of urine greater than the volume of the passages among and around one of the substrate holders 55. This volume can be any multiple of the volume of the space around the substrate holders 55, such as 1.5X, 2X, 3X, etc of the volume of around the substrate holders 55.

[0052] The use of a UTI-monitoring system or device such as that disclosed herein can detect a UTI or a potential UTI very early in its course and allow for prompt treatment. A positive result may indicate an undiagnosed pre-existing condition of a patient. Additionally, the device works in a way so as to avoid exposing medical professionals to bodily fluids. The UTI-monitoring systems and devices described herein can significantly reduce the risks associated with indwelling urinary catheters and improve the standard of care for such patients. The UTI-monitoring systems and devices described herein are of particular value to patients that are at high risk of developing a UTI (e.g., patients requiring a long-term urinary catheter) such as head injury patients, patients having a broken spinal cord or a broken pelvis, or comatose patients and may be the difference between life and death for an

immunocompromised high-risk patient such as a burn patient. The UTI-monitoring systems and devices, however, can be used by any catheterized patient (e.g., a woman in labor, or a patient undergoing outpatient surgery).

[0053] The UTI-monitoring systems and devices described herein can result in a significant decrease in the morbidity and mortality of catheter-associated UTIs, which are usually very responsive to treatment once identified. Use of a UTI-monitoring system or device also can result in substantial financial savings by cost-effectively treating UTIs at an early stage, thereby preventing the progression to more life threatening and costly systemic infections. Use of a UTI-monitoring system or device may uncover asymptomatic infections in their early stages allowing for early treatment and mitigate the risk of sepsis.

OTHER EMBODIMENTS

[0054] It is to be understood that while the invention has been described in conjunction with the detailed description thereof, the foregoing description is intended to illustrate and not limit the scope of the invention. Other aspects, advantages, and modifications are within the scope of the invention.

Claims

We claim:

1. A UTI monitoring device comprising

(a) an inlet and an outlet, said inlet and said outlet configured for in-line placement along a collection tubing portion of a urinary catheter system so that in use urine exiting a patient can pass in through said inlet and out through said outlet;

(b) a serpentine passage connecting said inlet to said outlet;

(c) a substrate well covered with a breakable seal and positioned along said serpentine passage, said breakable seal capable of being exposed to urine passing through said serpentine passage;

(d) a piercing member capable of breaking said breakable seal; and

(d) a UTI indicator substrate contained within said substrate well, wherein said UTI substrate is capable in use of monitoring urine for the presence or absence of one or more markers in urine that are indicative of a urinary tract infection when said piercing member has broken said breakable seal and urine has been allowed to contact said UTI indicator substrate.

2. A UTI monitoring device comprising a piercing member having

(a) a piercing base having a surface and configured to pierce the seal of a substrate well;

(b) a side wall connected to said piercing base and extending away from said surface of said piercing base;

(c) a sloping side connected to said side wall.

3. The piercing member of claim 2 wherein said piercing base is circular.

4. The piercing member of claim 2 wherein said piercing base is oval.

5. The piercing member of claim 2 wherein said piercing base is about 45% of the overall diameter of an opening of a substrate holder.

6. The piercing member of claim 2 wherein said piercing base if substantially flat.

7. The piercing member of claim 6 wherein the area of said piercing base is greater than 50% of the area of the opening of a substrate well.

8. The piercing member of claim 2 wherein piercing member is selected from the group consisting of spheres, cubes, springs, and crushable structures.

9. The piercing member of claim 2 wherein piercing base is configured to accept additional piercing structures selected from the group consisting of balls, pins, and springs.

10. A UTI monitoring device comprising

(b) a urine reservoir configured to retain a sample of urine in use;

(c) a substrate well covered with a breakable seal and positioned between said inlet and said outlet, said breakable seal capable of being exposed to urine when said urine reservoir is turned onto its side;

(d) a piercing member capable of breaking said breakable seal; and

(d) a UTI indicator substrate contained within said substrate well, wherein said UTI substrate is capable in use of monitoring urine for the presence or absence of one or more markers in urine that are indicative of a urinary tract infection when said piercing member has broken said breakable seal and urine is allowed to contact said UTI substrate.

11. The piercing member of claim 10 further comprising a piercing base wherein said piercing base is circular.

12. The UTI monitoring device of claim 10 wherein said piercing member further comprises

(c) a sloping side connected to said side wall.

13. The piercing member of claim 12 further comprising a piercing base wherein said piercing base is circular.

14. The piercing member of claim 12 wherein said piercing base is oval.

15. The piercing member of claim 12 wherein said piercing base is about 45% of the overall diameter of an opening of a substrate holder.

16. The piercing member of claim 12 wherein said piercing base if substantially flat.

17. The piercing member of claim 16 wherein the area of said piercing base is greater than 50% of the area of the opening of a substrate well.

18. The piercing member of claim 12 wherein piercing member is selected from the group consisting of spheres, cubes, springs, and crushable structures.

19. The piercing member of claim 12 wherein piercing base is configured to accept additional piercing structures selected from the group consisting of balls, pins, and springs.