SYSTEM FOR DETECTING AND COMBATING URINARY CATHETER-DWELLING BACTERIA

One embodiment is a urinary catheter system comprising an optical flow tube for connecting a catheter tube to a collection tube; and a disinfection and detection device configured to enclose the optical flow tube for detecting and destroying bacteria within the optical flow tube.

FIELD OF THE DISCLOSURE

This disclosure relates generally to the field of urinary catheters and, more particularly, to a system for detecting and combating urinary catheter-dwelling bacteria.

DESCRIPTION OF EXAMPLE EMBODIMENTS OF THE DISCLOSURE

FIG. 1Aillustrates a conventional catheter system100with which a patient may be catheterized. As shown inFIG. 1A, catheter system100includes a urine drainage bag102for collecting urine, a spout104for emptying urine from the drainage bag102, a catheter tube106for transporting urine to the urine drainage bag102, a connection adapter108, and a connector110between the catheter (connection adapter108) and catheter tube106. It will be recognized that catheterized patients are highly susceptible to developing urinary tract infections (“UTIs”) as a result of bacteria that colonize in a catheter system, such as the system100. UTIs are harder to diagnose in catheterized patients because the patients do not exhibit typical symptoms. When a UTI is suspected in a patient, laboratory tests may be performed.

Bacteria diffuse within a catheter through urine or travel through biofilm that forms inside the catheter, leading to decreased antibiotic efficacy. Biofilms that form inside the catheter block the light, thus impeding detection of bacteria as well as protecting the bacteria from ultraviolet C irradiation (“UVC”) that might otherwise be effective in ridding the catheter of bacteria.

A urinary catheter may be “urethral,” in which case it is inserted through the urethra into the bladder of the patient, or “suprapubic,” in which case it is inserted through the stomach directly into the bladder of the patient. Often, catheters are inserted to prevent blockages of urine flow. The catheter extends into the bladder and urine flow is expected to be lower flow and have a larger duty cycle than under normal (non-catheterized) circumstances. It will be recognized that urine flow back into the bladder should be avoided. Bacteria likely migrate by diffusion through the catheter. The catheter system should be closed to prevent infection.FIG. 1Bis a representative illustration of a catheter120inserted into a bladder122of a patient124through the patient's urethra125. In the embodiment illustrated inFIG. 1B, a urethral sphincter126of the patient124may be defeated by the catheter120, allowing free flow of urine from the bladder122through the catheter120.

A goal of embodiments described herein is to provide a system that continuously detects and combats bacteria growth in a urinary catheter system. In one embodiment, the system includes two primary subsystems: (1) an optical flow tube; and (2) a disinfection/detection instrument (e.g., a spectrometer). In accordance with embodiments described herein, as illustrated inFIG. 2, a urinary catheter system200includes an optical flow tube202, which replaces the catheter-collection tube connector110shown inFIG. 1A. More particularly, and as will be described in greater detail hereinbelow, the optical flow tube202connects a catheter tube204to a collection tube206and provides an optimized spectral environment and an acoustic coupler. The optical flow tube202prevents air bubble formation and provides flow and temperature measurement via sensors. In certain embodiments, the optical flow tube202is disposable. As will also be described in greater detail hereinbelow, a disinfection/detection instrument208encloses the optical flow tube202and disrupts biofilm formation and irradiates and monitors bacteria. More particularly, the disinfection/detection instrument208inhibits biofilm formation, kills bacteria, performs spectral urinalysis, and collects urine flow and temperature data. Additionally, the disinfection/detection instrument208may transmit data to cloud services and provide a basic user interface. Unlike the optical flow tube202, the disinfection/detection instrument208is designed to be reusable.

FIG. 3is a perspective view of an embodiment the optical flow tube202, including a collection tube connector300, an optical cell302, and a catheter connector306.FIG. 4illustrates a more detailed schematic view of an embodiment of the optical flow tube202. As shown inFIG. 4, in addition to the collection tube connector300, optical cell302, and catheter connector306, the optical flow tube202includes a permeable membrane402, a bubble trap404, an acoustic coupler406, a near infrared (“NIR”) antireflective coating410, and a UVC antireflective coating412. In accordance with features of embodiments described herein, the optical flow tube is optically transparent at critical wavelengths of 255-275 nm (disinfection), 740-1100 nm (detection) and 1500-2500 nm (detection). UVC light is known to inhibit and/or destroyE. coliand other bacteria, which can be detected in the visible spectrum (VIS)-NIR range. The permeable membrane402comprises a bubble trap404for preventing air bubble formation. The acoustic coupler406captures and propagates acoustic energy to inhibit biofilm formation. In certain embodiments, the optical flow tube202is constructed of low-cost materials (e.g., PVC or PET) and is disposable.

FIG. 5illustrates a more detailed schematic view of the optical flow tube202. In accordance with alternative embodiments described herein, as shown inFIG. 5, the optical flow tube202may optionally include optional urine flow and temperature measurement system500. The flow and temperature measurement system500includes sensors for gauging the flow rate and temperature of urine flow through the optical flow tube202, which may be useful in cases in which the flow rate affects detection scans and also enables the optical flow tube202to be used in monitoring kidney health. The flow and temperature measurement system202may be queried and powered by a radio frequency identification (RFID) reader included with a disinfection/detection system, as described below.

As shown inFIG. 6, in certain embodiments, the optical flow tube202may be inserted into and/or enclosed within disinfection/detection system208comprising a clamshell spectrometer602having a reflective interior. The spectrometer602performs spectral measurement over the VIS-NIR band and provides an optimized optical environment for the optical flow tube202by blocking ambient light and integrating excitation light sources. As shown inFIG. 7, the spectrometer602includes an ultraviolet-C (UVC) light emitting diode (LED)700for disinfecting the optical flow tube202, thereby protecting the patient from infection and increasing the apparent detection limit. The spectrometer602further includes an ultrasound transmitter for inhibiting biofilm growth and orientation measurement for bubble prevention and detection. Referring also toFIG. 8, the spectrometer602also provides a gateway to cloud services800via a wireless connection802and an RFID reader702for collecting flow and temperature measurement data from and powering the sensors of the flow and temperature measurement system500(FIG. 5). The clamshell device blocks ambient light and provides VIS-NIR light integration, provides an accelerometer for orientation measurement (including bubble avoidance and detection), deters biofilm growth via ultrasound, and provides a UVC light source to disinfect the catheter.

As shown inFIG. 7, in addition to the RFID flow and temperature reader702and the UVC LED700, the spectrometer602further includes an accelerometer704, a piezoelectric or microelectromechanical system (“MEMS”) speaker706, a VIS LED and photodetector (PD)708, and IR LEDs and PD710. The spectrometer602may be a dual spectrometer system providing energy in wavelength ranges of 740-1100 nm and 1500-2500 nm for bacterial detection. In certain embodiments, UVC LED700covers 275 nm and may be implemented using an Inolux IN-C33DTDU1 for bacterial disinfection. In certain embodiments, the piezoelectric or MEMS speakers may operate706at 70 KHz and the accelerometer704may be a 1 axis accelerometer for providing orientation information. The RFID flow and temperature reader702is optional and may include an antenna and may power and read the flow and measurement sensors of the optical flow tube202.

FIG. 8illustrates interaction between the spectrometer602and cloud services800via wireless connection802. In certain embodiments, cloud services800perform spectrometer calibration, store spectral scan and sensor data, run chemometric models on the data to perform urine analysis, perform sensor fusion algorithms to amend and complement insights from NIR, accelerometer, and flow and temperature measurement sensors, and provide remote access to all collected data in compliance with HIPPA regulations.

Although embodiments have been described herein with reference to urine, the embodiments may be applied to any liquids. Additionally, a gravity system may be included to manage urine (or other liquid) flow. The optical flow tube202may be implemented using a simple flow tube or no flow tube at all, in which case the spectrometer602may be implemented as a clip-on case. A camera may be provided in some embodiments and analytics may be cloud-based or local. Moreover, a chemical sensor array may be provided and a fiber optic surface plasmon resonance (“SPR”) system may be provided at the catheter tip.

FIGS. 9A and 9Billustrate graphs of example UV dosages for destroying bacteria in the catheter system.

FIG. 10illustrates another view of the optical flow tube202of catheter system200described herein. As previously described, in the system200, catheter connecter304connects optical cell302to catheter tubing1000. The optical cell302includes flow and temperature measurement sensors500, a syringe luer lock1002, bubble trap404, collection tube connector300for connecting optical cell302to connection tubing1004. The optical flow tube202is optically transparent in NIR range, rejects bubble formation, and is low cost and therefore disposable. The flow tube202may also measure flow rate and temperature to gauge urine flow and may be queried and powered by an RFID reader included within the spectrometer.

FIG. 11illustrates another view of the spectrometer602as connected to the optical flow tube202. As previously noted, the spectrometer602includes an interior reflective coating with an optical window. The spectrometer602performs spectral measurement over the NIR band, blocks ambient light, and provides NIR reflectivity for light collection. The spectrometer602also provides a gateway to cloud services and an RFID reader thereof collects flow and temperature data and powers flow and temperature sensors of the optical flow tube. The spectrometer602includes an accelerometer for measuring orientation and may be battery powered in some embodiments.

EXAMPLE 1 is a fluid catheter system including an optical flow tube for connecting a catheter tube to a collection tube; and a disinfection and detection device configured to enclose the optical flow tube for detecting and destroying bacteria within the optical flow tube.

In EXAMPLE 2, the fluid catheter system of EXAMPLE 1 may include the optical flow tube being disposable and the disinfection and detection device being reusable.

In EXAMPLE 3, the fluid catheter system of any of EXAMPLES 1 and 2 may include the disinfection and detection device comprising a clamshell spectrometer.

In EXAMPLE 4, the fluid catheter system of any of EXAMPLES 1-3 may include the optical flow tube comprising at least one sensor for measuring at least one of a flow rate of urine within the system and a temperature of the urine within the system.

In EXAMPLE 5, the fluid catheter system of any of EXAMPLES 1-4 may further include the disinfection and detection device comprising a radio frequency identification (RFID) reader for powering the at least one sensor.

In EXAMPLE 6, the fluid catheter system of any of EXAMPLES 1-5 may further include the disinfection and detection device comprising a radio frequency identification (RFID) reader for reading the at least one sensor.

In EXAMPLE 7, the fluid catheter system of any of EXAMPLES 1-6 may further include the disinfection and detection device being wirelessly connected to cloud services.

In EXAMPLE 8, the fluid catheter system of any of EXAMPLES 1-7 may further include the cloud services comprising at least one of performing spectrometer calibration, storing spectral scan and sensor data, performing urinalysis; performing a sensor fusion algorithm; and providing remote access to collected data.

In EXAMPLE 9, the fluid catheter system of any of EXAMPLES 1-8 may further include the disinfection and detection device comprising a dual spectrometer system and an ultraviolet-C light emitting diode (UVC LED).

In EXAMPLE 10, the fluid catheter system of any of EXAMPLES 1-9 may further include the optical flow tube being optically transparent at a range of wavelengths.

In EXAMPLE 11, the fluid catheter system of any of EXAMPLES 1-10 may further include the range of wavelengths comprising at least one of 255-275 nm, 740-1100 nm, and 1500-2500 nm.

In EXAMPLE 12, the fluid catheter system of any of EXAMPLES 1-11 may further include the optical flow tube comprising a permeable membrane to reject air bubble formation.

In EXAMPLE 13, the fluid catheter system of any of EXAMPLES 1-12 may further include the optical flow tube comprising an acoustic coupler for capturing and propagating acoustic energy to inhibit biofilm formation.

In EXAMPLE 14, the fluid catheter system of any of EXAMPLES 1-13 may further include the optical flow tube comprising an ultraviolet-C (UVC) antireflective coating.

In EXAMPLE 15, the fluid catheter system of any of EXAMPLES 1-14 may further include the optical flow tube comprising a near infrared (NIR) antireflective coating.

In EXAMPLE 16, the fluid catheter system of any of EXAMPLES 1-15 may further include the clamshell spectrometer comprising a reflective interior.

In EXAMPLE 17, the fluid catheter system of any of EXAMPLES 1-16 may further include the clamshell spectrometer blocking ambient light and provides visual spectrum (VIS)-near infrared (NIR) light integration.

In EXAMPLE 18, the fluid catheter system of any of EXAMPLES 1-17 may further include the clamshell spectrometer deterring biofilm growth via ultrasound and providing an ultraviolet-C (UVC) light source to disinfect the fluid catheter system.

EXAMPLE 19 is an optical flow tube for use in a fluid catheter system, the optical flow tube for connecting a catheter tube to a collection tube and including at least one sensor for measuring at least one of a flow rate of urine within the system and a temperature of the urine within the system; a permeable membrane to reject air bubble formation; an acoustic coupler for capturing and propagating acoustic energy to inhibit biofilm formation; and at least one of an ultraviolet-C (UVC) antireflective coating and a near infrared (NIR) antireflective coating; wherein the optical flow tube is optically transparent at certain wavelengths.

EXAMPLE 20 is a fluid catheter system including a disinfection and detection device configured to enclose an optical flow tube for detecting and destroying bacteria within the optical flow tube, the disinfection and detection device further including a dual spectrometer system; and a radio frequency identification (RFID) reader for reading at least one sensor disposed in the optical flow tube, the at least one sensor for measuring at least one of a flow rate of urine within the system and a temperature of the urine within the system; wherein the disinfection and detection device is wirelessly connected to cloud services, the cloud services comprising at least one of performing spectrometer calibration, storing spectral scan and sensor data, performing urinalysis; performing a sensor fusion algorithm; and providing remote access to collected data.

It should be noted that all of the specifications, dimensions, and relationships outlined herein (e.g., the number of elements, operations, steps, etc.) have only been offered for purposes of example and teaching only. Such information may be varied considerably without departing from the spirit of the present disclosure, or the scope of the appended claims. The specifications apply only to one non-limiting example and, accordingly, they should be construed as such. In the foregoing description, exemplary embodiments have been described with reference to particular component arrangements. Various modifications and changes may be made to such embodiments without departing from the scope of the appended claims. The description and drawings are, accordingly, to be regarded in an illustrative rather than in a restrictive sense.

It should also be noted that the functions related to circuit architectures illustrate only some of the possible circuit architecture functions that may be executed by, or within, systems illustrated in the FIGURES. Some of these operations may be deleted or removed where appropriate, or these operations may be modified or changed considerably without departing from the scope of the present disclosure. In addition, the timing of these operations may be altered considerably. The preceding operational flows have been offered for purposes of example and discussion. Substantial flexibility is provided by embodiments described herein in that any suitable arrangements, chronologies, configurations, and timing mechanisms may be provided without departing from the teachings of the present disclosure.

Numerous other changes, substitutions, variations, alterations, and modifications may be ascertained to one skilled in the art and it is intended that the present disclosure encompass all such changes, substitutions, variations, alterations, and modifications as falling within the scope of the appended claims.

Note that all optional features of the device and system described above may also be implemented with respect to the method or process described herein and specifics in the examples may be used anywhere in one or more embodiments.

Note that with the example provided above, as well as numerous other examples provided herein, interaction may be described in terms of two, three, or four network elements. However, this has been done for purposes of clarity and example only. In certain cases, it may be easier to describe one or more of the functionalities of a given set of flows by only referencing a limited number of network elements. It should be appreciated that topologies illustrated in and described with reference to the accompanying FIGURES (and their teachings) are readily scalable and may accommodate a large number of components, as well as more complicated/sophisticated arrangements and configurations. Accordingly, the examples provided should not limit the scope or inhibit the broad teachings of the illustrated topologies as potentially applied to myriad other architectures.

Although the present disclosure has been described in detail with reference to particular arrangements and configurations, these example configurations and arrangements may be changed significantly without departing from the scope of the present disclosure. For example, although the present disclosure has been described with reference to particular communication exchanges, embodiments described herein may be applicable to other architectures.