Patent Description:
The various embodiments herein relate to systems and devices for monitoring bladder health of a patient, including real-time monitoring of bladder health of patients who require daily catheterization, including, in some cases, clean, intermittent catheterization up to <NUM> times each day depending on the patient bladder size, function and/or urine production.

Approximately <NUM> million people in the United States and <NUM> million worldwide suffer from neurogenic bladder - a condition in which an individual lacks normal bladder functionality due to an underlying brain, spinal cord, or pelvic nerve condition. When the nerves that innervate the bladder and urinary sphincters are compromised, the bladder and urinary sphincter fail to function in a normal way. For example; atonic bladder, overactive bladder, detrusor sphincter dysynergia, poorly compliant bladder and the like. In such cases, patients can have difficulty expelling urine and thus are reliant on intermittent bladder catheterization - including clean catheterization up to <NUM> times a day as discussed above - to empty the bladder of urine and relieve the pressure within the bladder. The passage of such a catheter can both prevent the bladder from becoming chronically over distended with weakened muscle wall or contracted with a tense and thickened wall. By improving bladder drainage, the risk of bladder and kidney infections can be reduced and harm to the kidney from high pressures urinary storage in the bladder can be prevented.

In a normal bladder, the bladder wall will be compliant, meaning that it will relax or stretch with filling (or increasing volume), thereby keeping the bladder at a low pressure. Accordingly, as used herein, "compliance" relates to the change in volume divided by the change in pressure. With the ensuing increase in urinary volume constrained in the bladder, the pressure within the bladder rises. When the pressure reaches a critically elevated level, such as above <NUM> H<NUM>O, transmission of high pressures to the kidneys can occur, thereby potentially resulting in subsequent permanent kidney damage and/or failure that may require a kidney transplant or hemodialysis treatment for the remainder of their lives - a costly expense and grueling treatment that is necessary to control the condition of their failing/failed kidneys, including the electrolyte and fluid imbalances associated with kidney failure.

The current, known procedure utilized by clinicians to monitor the state of patients' bladders and the concomitant changes in bladder pressure with urinary volume readings is called Urodynamic Testing (UDS). This technique involves placing catheters in the bladder and/or rectum, and filling the bladder while measuring the compliance, pressure, and volume in the bladder. Drawbacks of UDS are that it requires an extensive amount of capital equipment, is not readily available in all clinics, is long in duration (a typical test requires <NUM> - <NUM> hours for completion), is expensive (around $<NUM> for testing and interpretation) and is contingent on factors related to the administration and interpretation of the test by the healthcare team. Another disadvantage is that the test is very invasive for patients, as patients have catheters placed in the bladder and rectum, the bladder is filled with fluid at a set rate while the pressure is continuously monitored, and the patients may be asked to urinate on command in front of the team administering the test. A further disadvantage is that it fails to provide a comprehensive summary of the bladder's condition - UDS only provides a snapshot of a single point in time (i.e. the time of test administration). Since UDS is normally done approximately once a year (though can be performed more or less frequently depending on the severity of the patient's disease), bladder pressure can increase between tests and thus bladder and/or kidney damage can go undetected by both physician and patient for prolonged periods of time. It is not uncommon for physicians to see patients with bladders and kidneys that have 'deteriorated' between their visits. This makes the initiation of any intervention for worsening bladder pressure (whether behavioral, medical, or surgery) a reactive intervention, rather than proactive. <CIT> describes a urinary catheter j oint, a urine drainage device and a urine drainage method that can monitor the intravesical pressure in real time and accurately judge whether the intravesical pressure reaches the safe pressure. <CIT> describes an analysis, measurement, and data reduction system for carrying out a noninvasive urodynamic analysis of the human male or female urogenital tract. <CIT> describes a device for measuring the urine volume and the pressure intensity of a bladder and a measurement and control method thereof, thereby providing the advantages of convenience in operation and control, low cross infection risk and small potential safety hazard. <CIT> describes an apparatus for monitoring the intra-abdominal pressure of a patient includes a urinary catheter connected to a urine valve providing selectable communication between a discharge end of the urinary catheter and either a drain or a fluid source.

There is a need in the art for improved systems, methods, and devices for monitoring bladder health of a patient.

Discussed herein are various bladder health monitoring systems and devices that can be coupled to existing urinary catheters.

A system of one or more computers can be configured to perform particular operations or actions by virtue of having software, firmware, hardware, or a combination of them installed on the system that in operation causes or cause the system to perform the actions. One or more computer programs can be configured to perform particular operations or actions by virtue of including instructions that, when executed by data processing apparatus, cause the apparatus to perform the actions.

The various embodiments disclosed herein relate to methods, systems, and devices for monitoring bladder health, especially in a patient with a catheterized bladder. In certain implementations, the patient can be intermittently catheterized. As used herein, "bladder health" can include monitoring in real-time the pressures, volumes, and compliance of urinary bladders, as well adherence to catheterization schedules, in patients who require catheterization, including intermittent catheterization from <NUM>-<NUM> times per day depending on the patient's bladder underlying condition, bladder structure, bladder function, urine volume production and/or fluid consumption. The various embodiments provide for noninvasively monitoring bladder pressure and volume readings in real time. Further, various implementations promote faster fluid flow from the bladder than by gravitational urinary flow.

In certain implementations, the various methods, systems, and devices herein will permit data collection, including bladder pressure at catheter insertion, volume of expelled urine, bladder compliance calculation, the time and date and other relevant information (collectively "data"). Some embodiments provide for this digital information to be recorded and transmitted to an electronic device. In various implementations, the electronic device is configured to store the data and synchronize the data with a secured server or electronic health record system. Using pre-set thresholds, the identification of harmful pressures, volumes, or catheter frequencies can then be addressed by clinicians through therapeutic interventions to prevent bladder injury. The various implementations can speed up the time required for patients to empty their bladders, for example, by way of a pump.

Prior to the invention of the various embodiments disclosed herein, there was no similar portable, handheld, in-home, or other non-UDS device available for patients to monitor their own "bladder health. " As described above, known methods to assess bladder health involve the use of invasive, expensive, and time-consuming techniques that are completed on an annual basis in a hospital or clinic setting and therefore do not provide real-time monitoring. The various implementations disclosed herein provide patients and clinicians with a device that will regularly monitor the bladder in a non-invasive, time-efficient, and inexpensive manner while providing patients and their caregivers with a faster way to eliminate urine, freeing up time for both parties.

As shown in <FIG> and <FIG>, various embodiments relate to a system <NUM> having a physical device component <NUM> and a digital component <NUM>. The physical device component <NUM> is a bladder monitoring device <NUM> that can couple to a patient's urinary catheter and thereby measures the pressure in the bladder (shown at box <NUM> in <FIG>) at the time of urinary catheter insertion as well as the volume obtained from catheterization and the time and date of each catheterization. The digital component <NUM> is a separate system or processor running a software application <NUM> such as a mobile device application, electronic medical health records system, or other electronic database or records system that is configured to interface with the digital component <NUM>. This software application <NUM> (also referred to herein as an "algorithm" or "module") that has flexible function settings for extracting information for compiling, packaging, processing, evaluating the various bladder health readings of the system <NUM> for analysis and display.

In various implementations, the physical device component <NUM> and digital component <NUM> can consist of multiple components distributed variously. For example, the device component may be distributed over multiple separate components (as shown in <FIG>). Likewise, the digital component <NUM> can also consist of multiple components and be housed with portions of the device component <NUM> or elsewhere. As shown in <FIG>, the physical device component <NUM> and digital component <NUM> are operationally integrated around a CPU <NUM>, such that readings from the device component <NUM> are processed, stored and displayed by way of the digital component <NUM>.

In <FIG>, the digital component <NUM> is depicted as a mobile device <NUM> that contains an appropriate application for use in the system <NUM>. As such, as shown variously in the drawings, the device <NUM> can record and store the digital information (pressure, volume, and time and date readings) and wirelessly transmit the information to the digital component <NUM> through paired communications components <NUM>, <NUM>. In one embodiment, the mobile device application is an iPhone® app and the wireless transmission occurs via Bluetooth™ or WiFi. In alternate embodiments, such as those depicted in <FIG>, the digital component <NUM> can comprise physical storage media, such as an SD card, as discussed below.

As shown in the embodiments of <FIG>, the device <NUM> has a catheter coupling component <NUM> at a distal end of the device <NUM>. In one implementation, the catheter coupling component <NUM> is coupleable directly to the end of a urinary catheter (not shown). For example, in one specific embodiment, the coupling component <NUM> is a tapered coupling component <NUM> that can be positioned in the catheter, as would be apparent to a skilled artisan. In this implementation, the coupling component <NUM> is coupled to a tube <NUM> having a lumen <NUM>. When the component <NUM> is coupled to a catheter, the lumen <NUM> is in fluid communication with the lumen of the catheter (not shown).

In this embodiment, the device <NUM> has a pressure sensor component <NUM> that is positioned in and through the wall of the tube <NUM> such that a portion of the sensor component <NUM> is positioned within the lumen <NUM> of the tube <NUM>. As such, the sensor component <NUM> can come into contact with fluid in the lumen <NUM> and thus is in fluid communication with the urinary catheter tubing via the catheter coupling component <NUM>. According to one embodiment, the pressure sensor component <NUM> is configured to detect pressure - for example static or dynamic fluid pressure - and transmit the data relating to the pressure readings to the processor <NUM> (discussed further below). In exemplary embodiments, and as described below in relation to Table <NUM>, the pressure sensor component <NUM> can collect dynamic relative pressures in the catheter.

As shown in <FIG>, the device <NUM> also has a pump <NUM> in fluid communication with the lumen <NUM> of the tube <NUM>. The pump <NUM> is configured to urge the fluid proximally along the lumen <NUM> of the tube <NUM>. In one specific example of a pump <NUM>, the tube <NUM> is positioned through the pump <NUM> and the pump <NUM> is configured to repeatedly compress and expand the tube <NUM>, thereby creating a suction action that urges the fluid proximally along the lumen <NUM>. According to one embodiment, the fluid is urged proximally in the lumen <NUM> until it is expelled from a proximal end <NUM> of the tube <NUM> into a collection vessel or container (shown in <FIG> at box <NUM>) for removal.

As shown in <FIG> and <FIG>, the pressure sensor component <NUM>, pump <NUM>, and processor <NUM> are disposed within a container or housing <NUM>. The housing <NUM> can help prevent damage to these components <NUM>, <NUM>, <NUM> during use and further can help to maintain structural integrity of the overall device <NUM>. The housing <NUM> can be opened to replace the batteries held within the bladder health monitoring system <NUM>. Alternatively, as shown in the embodiments of <FIG>, various aspects of the system <NUM> may be distributed separately in a first housing <NUM> and a second housing <NUM>. These implementations can provide certain advantages in terms of form and installation, as would be apparent to one of skill in the art. Other configurations are possible.

As shown in <FIG>, in an example that is not covered by the claims of the present application, the physical device <NUM> may not have a pump, but instead simply be a pressure sensing device <NUM>. In various implementations, the pressure sensing device <NUM> has a coupling component <NUM>, an elongate tube <NUM> with a lumen <NUM> in fluid communication with a pressure sensor component <NUM>. A processor or CPU <NUM>, battery <NUM> and communications component <NUM> are also disposed within the housing <NUM>, so as to allow the patient to take pressure readings from a catheter (not shown) as described in detail herein. These readings can be transmitted out to a digital device <NUM> having another communications component <NUM> and used to monitor patient bladder health. As would be appreciated by one of skill in the art, these implementations can be used with any of the other components discussed herein.

Returning to the implementation of <FIG>, a second tube <NUM> and second lumen <NUM> are provided and may be adjoined to the first tube <NUM> by way of a valve <NUM>, such as a stopcock. The first tube <NUM> is in fluidic communication with the pump <NUM>, and may be in hermetic communication with the pump, and the second tube <NUM> may be in hermetic and fluidic communication with the pressure sensor component <NUM>, such that the communication with the coupling component <NUM> can be controlled by the valve <NUM>. A power source <NUM> such as a battery or outlet power can be used to provide electricity to the device <NUM>.

In these embodiments, after attaching the coupling component <NUM> to the catheter (not shown), the valve <NUM> can be set in a "closed" position, such that the pressure sensor component <NUM> is in hermetic and fluidic communication with the catheter through the coupling <NUM>, such that the pressure of the bladder can be assessed. In a subsequent step, the valve <NUM> can be toggled to an "open" position to put the coupling <NUM> in communication with the first tube <NUM> and lumen <NUM>. Contemporaneously, the pump <NUM> can be activated, as described further below.

Accordingly, as shown in <FIG>, in certain implementations, the patient's bladder (box <NUM>) is in fluidic communication with the pump (box <NUM>) and sensor (box <NUM>) by way of the first tube (line <NUM>) and second line (line <NUM>), respectively, as dictated by the valve (junction <NUM>). In these implementations, the sensor (box <NUM>) is in electronic communication with a processor, or CPU (box <NUM>), which in turn is in communication with a mobile unit (box <NUM>). The mobile unit (box <NUM>) can have a storage unit (box <NUM>) and a display unit (box <NUM>), Further, in these implementations, the pump (box <NUM>) is also in electronic communication with the CPU (box <NUM>) to transmit data (line <NUM>) such as volume data to the CPU (box <NUM>) and mobile unit (box <NUM>). As discussed above, the data transmission (line <NUM>) can occur wirelessly through paired communications components <NUM>, <NUM> - such as by Bluetooth™ or WiFi - or by way of a physical connection, such as a wired connection (not shown) or digital storage media, such as an SD card (shown in <FIG> at <NUM>) or jump drive. Further, in exemplary embodiments, the time and date of each time the device system <NUM> is connected to a catheter and is in use is recorded by way of the CPU (box <NUM>).

In operation, and as shown in <FIG>, in certain implementations, after the system is initiated (box <NUM>) and the catheter connected (box <NUM>), the pressure can be detected and recorded (box <NUM>). As a next step, the pump is turned on (box <NUM>), thereby accelerating urination (box <NUM>). Optionally, the flow rate can be detected and recorded (box <NUM>), and the pressure and flow rates relayed to the processor (box <NUM>). After urination has completed, the pump is stopped (box <NUM>) and the volume of expelled urine can be calculated (box <NUM>). Recorded data, such as pressure, flow, volume, time and the like, can be transmitted to the digital device (box <NUM>).

In various embodiments, the pump <NUM> is used to accelerate the evacuation time of catheterization, maintain a constant negative pressure, and contribute to an almost constant flow rate of the fluid moving through the lumen.

As shown in <FIG>, the data is received by the digital device (box <NUM>). Optionally, additional calculations - such as compliance and trending - can be performed (box <NUM>). The digital device is also able to generate output (box <NUM>), which can be viewed by the patient, physician, or other interested party, such as by way of a mobile application or display device (not shown). In exemplary embodiments, the data can be transmitted by way of a secure connection over WiFi, Bluetooth™, or other known connection means to a third party at another location, such as a hospital, clinic, research or records institution, as has been previously described above. In certain implementations, this transmission is encrypted and can be achieved by way of cloud storage, the internet, and other known information transmission and storage methods. As would be apparent to one of skill in the art, the digital device <NUM> through a software application <NUM> can implement various steps to assist in obtaining, converting, packaging, and sending the resulted measurements to various users, as described elsewhere herein.

Returning to the implementations of <FIG>, in certain embodiments, a driver switch <NUM> can be provided to start the pump <NUM>. For example, in certain embodiments, the driver switch <NUM> can be a chip switch driven by a small change in voltage and be configured to detect changes in light to detect the presence of fluid in the first lumen <NUM>. In further embodiments, the driver switch <NUM> can be configured to interface with the processor and be capable of being toggled on and off based on pressure readings. In further examples, the driver switch can be operationally integrated with the valve <NUM>, so as to operate the pump <NUM> in conjunction with opening the valve relative to the first lumen <NUM>.

In further embodiments, and as shown in <FIG>, the pressure sensor component <NUM> can include a known pressure sensor <NUM>, such as an AMS <NUM>-<NUM>-D pressure sensor or other similar devices known to the skilled artisan. The pressure sensor <NUM> allows for high precision measurements and excellent drift and long-term stability. In various implementations, the pressure sensor component <NUM> and pressure sensor <NUM> can combine micro-machined, high quality piezoresistive measuring cells with a signal conditioning mixed-signal ASIC on a ceramic substrate. In exemplary embodiments, the pressure sensor <NUM> has physical storage media <NUM> such as an SD card reader and a clock <NUM> can also be in electronic communication with the pressure sensor <NUM> for recording and time-stamping the sensor readings. In various implementations, the clock <NUM> is a real time clock ("RTC") component configured to keep true time even when the CPU is asleep or shut down. In these embodiments, the CPU <NUM> is thus able to obtain true date and time data from the RTC <NUM> every time the device <NUM> is used.

In exemplary embodiments, other electronic components <NUM> such as printed circuit boards ("PCB") and a signaling mechanism <NUM>, which can be an LED light, a buzzer, a LCD screen or other known device used to communicate to the user that a reading has been taken. These other electronic components <NUM> can be operationally integrated into the sensor component <NUM> as would be apparent to one of skill in the art.

In various embodiments, the pressure sensor component <NUM> and sensor <NUM> are specifically configured for applications with static and dynamic pressure measurements, barometric pressure measurement, vacuum monitoring, gas flow, fluid level measurement, and medical instrumentation. Accordingly, as shown in the implementation of <FIG>, the sensor component <NUM> is sensitive and reliable within the range of about <NUM> - to about <NUM> cmH<NUM>O, using a differential pressure measurement between current atmosphere and pressure detected within the lumen <NUM> (<NUM> cmH2O is equal to <NUM> Pa). As would be apparent to a skilled artisan, this is the range associated with urinary bladder pressures for the assessment of bladder health, and can accommodate the measurement of fluid pressure. It is also advantageous because the necessary components are durable and inexpensive. Further, in certain implementations, the sensor component <NUM> can have signal amplification circuitry configured to amplify the pressure output signal and clear the background noise from the signal. In these embodiments, a sensor battery <NUM> may also be provided. The battery can be a lithium-ion battery, though other types of battery are of course possible, such as powering the pressure sensor by way of the battery <NUM>.

The pump <NUM> according to certain embodiments is also configured to calculate the volume that is expelled from the device <NUM> by detecting the volumetric flow rate and the elapsed time that the fluid is within the tube <NUM>. Further, the pump <NUM> is configured to transmit the data relating to the volumetric flow rate and time to the CPU <NUM>. In various embodiments, the volumetric flow rate the of pump <NUM> can be determined by power source testing, such as calculating the pump's <NUM> volumetric flow rate for different power source characteristics by measuring the amount of time required for a certain standard of volume to pass through the device, as would be apparent to one of skill in the art.

Bladder compliance can accordingly be calculated using the measured pressure and volume values obtained from the pressure and volume sensing components (such as the pressure sensor <NUM> and pump <NUM>) of the device <NUM>, respectively. In these embodiments, a function within the CPU <NUM> or an attached computer terminal can calculate bladder compliance by comparing the volume to the pressure and accounting for any calibrations, as discussed further below, in relation to Tables <NUM>-<NUM>.

In certain implementations, the pump <NUM> has a flow meter to calculate volume. The flow meter calculated volumetric flow rate. Using the measured volumetric flow rate from the flow meter as well as the amount of elapsed time (the amount of time the device was in operation) measured by the CPU <NUM>, to calculate the volume expelled from the device <NUM>. This would be apparent to a skilled artisan. The pump <NUM> can be used to accelerate the evacuation time of catheterization, maintain a constant negative pressure, and contribute to an almost constant flow rate of the fluid moving through the lumen <NUM>.

In exemplary implementations, and as shown in <FIG>, the pump <NUM> is a peristaltic pump configured to measure volume expelled from the bladder. As is known in the art, the mechanism of the peristaltic pump hinges on a set of rollers <NUM>, <NUM> that compress the tubing <NUM> within the pump <NUM> to maintain a constant volumetric flow rate of the fluid <NUM> (shown by reference arrows A and B). In these implementations, the volumetric flow rate can be measured and used in conjunction with the amount of elapsed time (again, the amount of time the device was in operation) measured by the CPU <NUM> to calculate the total volume expelled from the device. In these implementations, the use of the peristaltic pump <NUM> provides a durable, low cost, and reliable measurement of volumetric flow rate. Further, the peristaltic pump <NUM> enables the propulsion of fluid from the catheter into the external environment (collection vessel) in a faster manner compared to catheter drainage by gravity.

To this end, and as shown in <FIG>, the pump <NUM> in certain implementations is configured to accelerate the catheterization process. That is, the power (electrical or otherwise) to the pump <NUM> can be increased to increase the volumetric flow rate of the pump <NUM>, thereby increasing the flow rate of the fluid in the lumen <NUM>. In those embodiments in which the pump <NUM> compresses and expands the tube <NUM> as described above, the increased action of the pump <NUM> causes the pump <NUM> to exert a more powerful suction on the fluid in the lumen <NUM>. Regardless of the type of pump <NUM>, the increased action of the pump <NUM> causes the pump to increase the flow rate of the fluid in the lumen <NUM>, thereby applying greater suction to the fluid held in the bladder and urinary catheter. This suction will speed up the process by which the urine leaves the bladder via the urinary catheter. As such, in certain embodiments, the pump <NUM> can reduce the amount of time needed for urine to pass through the catheter and be eliminated into a collection vessel (not shown).

According to one embodiment, the pump <NUM> can be configured to decrease the amount of time needed to expel urine between about <NUM> and about <NUM> of urine to less than about <NUM> minutes. Alternatively, the pump <NUM> can be configured to decrease the amount of time to less than about <NUM> minutes. In a further alternative, the pump <NUM> can be configured to decrease the amount of time to about <NUM> minutes.

The pump <NUM> in certain implementations can have a safety mechanism (not shown) in the form of a power switch that allows the patient or caregiver or another user) to turn the pump on or off as needed. Alternate embodiments include an automated switch to prevent power supply to the pump when the pressure sensor <NUM> detects certain pressures indicative of lumen <NUM> blockages or any indication that the flow of fluid through the device <NUM> has become impeded. An additional embodiment includes an automated switch to prevent power supply to the pump when there is any an indication that the lumen <NUM> is void of fluid (i.e. the bladder is empty). A further embodiment includes an automated switch that becomes activated and thus powers the bladder health monitoring system off with the passage of five minutes.

As discussed previously, in various implementations the device <NUM> also has a processor, or CPU <NUM>. In one embodiment, the CPU <NUM> is an Arduino board. In one embodiment, the CPU <NUM> is a computer processing unit <NUM> or a central processing unit <NUM>. Alternatively, the processor <NUM> can be a microprocessor, a computer, or any other known type of processor or processing unit that can be configured to assist with the operation of a medical device such as the device disclosed or contemplated herein. As shown in <FIG>, in this embodiment, the processor <NUM> is operably coupled to both the pressure sensor component <NUM> and the pump <NUM> via wires <NUM> or other know types of physical connections. In further embodiments, and as shown in <FIG>, a plurality of CPUs <NUM>, <NUM> can be provided and operationally integrated with one another and the various components. More specifically, as shown in <FIG>, the pump <NUM> is coupled to a first processor <NUM> directly, while the pressure sensor component <NUM> is coupled to a second processor <NUM> via more wires <NUM>. Alternatively, the pressure sensor component <NUM> and pump <NUM> can be coupled to the processor <NUM> or processors <NUM>, <NUM> wirelessly. <FIG> also show a voltage driver <NUM>, which can also be operationally integrated with the CPU <NUM>.

The processor <NUM> is configured to store the pressure data from the pressure sensor component <NUM>, along with date and time data relating to the pressure data. Further, the processor <NUM> is also figured to calculate the volume expelled from the device <NUM> based on the volumetric flow rate and time data received from the pump <NUM>, and further can store this volume data. In certain embodiments, the processor <NUM> is also configured to transmit the compliance, pressure, volume and other data wirelessly, or by direct connection, to the digital component <NUM> as discussed in further detail below. In one embodiment, the device <NUM> or the processor <NUM> has a transceiver (not shown) configured to communicate wirelessly, or by direct connection, with the digital component <NUM> such as a mobile device <NUM> or other separate system <NUM> as described above, thereby allowing for transmission of the data from the processor <NUM> to the system <NUM>.

In certain embodiments, the processor <NUM> has software <NUM> (either integrated into the processor <NUM> or connectable with the processor <NUM> via a connection of some type) that can accomplish the various steps described herein, including saving pressure and volume, compliance measurements, such as volume and pressure, date, and time data on the processor <NUM> and outputting corresponding data or readings to the digital component <NUM> in real-time. A software application <NUM> can also be provided on the digital component <NUM>. The processor <NUM> may also display the outputting pressure, volume, compliance, date, and time readings on a digital display <NUM> as part of the processor <NUM> and device <NUM>. In a further embodiment, instead of a physical switch as described above, the software <NUM> can serve as an automated safety feature in the form of an automated switch that powers the pump on and off when, for example, fluid has ceased flowing through the first lumen <NUM>, when certain pressure changes such as negative pressure is sensed by the pressure sensing component <NUM> and software <NUM>, when the bladder health monitoring system has been in use for five minutes, when the device is inserted properly to a urinary catheter, or upon the satisfaction of other conditions, as would be apparent to one of skill in the art.

Further, it is understood that the CPU <NUM> can be configured via programming or software <NUM> to control and coordinate the operation of the sensor component <NUM> and the pump <NUM> to optimize operation of the system <NUM>.

The digital component <NUM> of the system <NUM> is configured to communicate wirelessly with the processor <NUM>. In one implementation, as mentioned above, the wireless communication utilizes Bluetooth™ technology through the communications components <NUM>, <NUM>. In one exemplary embodiment in which the digital component <NUM> is mobile device <NUM>, the appropriate application in the device <NUM> can be configured to output the pressure and/or volume readings in any known form. Further, the digital component <NUM> can also be configured to store any of the pressure and/or volume, compliance, time, and date data as well.

As discussed above in relation to <FIG>, in certain embodiments the software application <NUM> is configured to output the time and date of each catheterization as well as a bladder pressure and bladder volume readings and bladder compliance. In addition, the application can also have an alarm function, providing feedback to the patient, caregiver, physician, or other person when a threshold is exceeded. For example, in one embodiment, if bladder pressure, volume and compliance readings worsen such that any or all of those parameters increase to the point of reaching a critical pressure or volume threshold indicative of bladder damage, then the mobile device application will trigger an alarm or notification of some kind, thereby causing the patient to consult his or her physician or take other appropriate steps. In addition, the alarm or notification of some kind can trigger the generation of an automatic electronic message to the treating physician, as well as upload a similar electronic message to the patient's file in a hospital's electronic medical record system. Alternatively, the application can be configured to trigger an alarm when one or more catheterizations are not performed in a timely fashion. This application can also permit the physician, caregiver, or patient to make adjustments to various settings, such as pump speed, catheterization thresholds and schedules, as well as pressure, volume, or compliance thresholds with the mobile device application.

Not only do the aforementioned neurogenic bladder patients benefit from this solution, but health care professionals, caregivers, and catheter distributing companies also reap advantages from such a device. The real-time measurement and data storage capabilities of the embodiments enable health care professionals such as physicians to have a means of regularly monitoring the patient's current bladder status without having to complete the invasive and time consuming office, hospital or clinical UDS test. For this same reason, patients benefit in having a system that monitors their condition so that if abnormal readings occur, they can consult their health care provider before irreversible damage to the bladder or renal system results. In addition, the amount of time that patient caregivers require to take patients to hospital clinics for appointments can be substantially decreased. Also, the amount of time that caregivers take to assist patients with catheterizing can be significantly decreased. Further, utilization of UDS testing by way of the present implementations can be reduced, thus reducing routine use of clinical UDS testing and reducing the overall treatment cost.

According to one embodiment, the various system embodiments described herein provide for measurement of pressure in the bladder at the time of catheter insertion. In accordance with other embodiments, the system <NUM> as described herein provides for earlier detection of harmful changes in bladder pressure, volume and compliance than known technologies, thereby triggering earlier intervention and protection of the kidney and bladder. In further implementations, the system can be used to assess the patient's compliance with a specified catheterization schedule by examination of the digital record of the timing of catheterization, or alert sent to the health care professional (such as a physician, physician assistant or nurse) when catheterization threshold does not fall within the optimal range set in the mobile device application. Further, adjustments in the frequency or timing of catheterization could also be made based on patterns of urine output and pressures. In additional implementations, this system is configured to permit patient self-monitoring of the patient's bladder health similar to a patient's home monitoring of blood pressure or blood sugars. The system <NUM> in certain embodiments is configured to notify a patient, caregiver, and/or physician about the status of a patient's bladder health, including whether the health of the bladder is improving, worsening, or staying the same. In this implementation, based on the information provided via the system <NUM>, the physician or patient can intervene and adjust the patient's treatment regime to prevent bladder damage, if needed.

Below are examples of specific embodiments relating to the calibration and operation of the disclosed bladder monitoring devices, systems and methods. They are provided for illustrative purposes only, and are not intended to limit the scope of the various embodiments in any way.

<FIG> depict various examples and implementations of the disclosed system <NUM> being calibrated. One example of the device <NUM> involves the use of the aforementioned AMS <NUM>-<NUM>-D pressure sensor. Calibration testing can be performed to ensure that the pressure values read from the sensor component <NUM> are within a predetermined level of accuracy. For example, the accuracy threshold can be set at about <NUM> percent of the true pressure reading.

As shown in Table <NUM>, and Chart <NUM>, a water column apparatus (from <NUM> to about <NUM> H<NUM><NUM>) can be used to compare the actual true reading of pressure (as measured via the column, shown as "Tested Pressure") with the raw value obtained from the pressure sensor component <NUM>.

In this example, the pressure sensor component <NUM> is used to obtain dynamic relative pressures between the measuring nozzle and the baseline nozzle of the catheter. The CPU <NUM> obtained an average initial raw pressure reading from the pressure sensor component <NUM> by reading the raw output from the pressure sensor component <NUM> every <NUM> second for <NUM> pressure readings. This raw pressure reading is then converted to a cmH<NUM>O scale using a function described by calibration testing of the device <NUM> using three different catheter sizes, a water column, and experimental cmH<NUM>O water column values between <NUM>-<NUM> cmH<NUM>O. From these results, a person skilled in the art can readily derive a calibration equation to address reading variability created by varying catheter sizes.

To this end, as shown in Tables <NUM>-<NUM>, ten trials were conducted on a variety of catheter types (male/female, catheter length, catheter lumen diameter): <NUM> French ("Fr") <NUM> inch male catheter, <NUM> Fr <NUM> inch female catheter, <NUM> Fr <NUM> inch female catheter, and <NUM> Fr <NUM> inch male catheter. From the observed pressure readings for each trial, it was possible to establish calibration equations for the various catheter sizes and lengths. Since there can be slight differences in the pressure readings between different catheter lengths and diameters, an equation was determined for each catheter type listed above, as would be apparent to one of skill in the art.

Accordingly, in order to improve accuracy of the pressure sensing unit, the raw data acquired during the calibration testing in tandem with the actual true readings obtained from the water column can be used to construct a mathematical equation with a correction factor to further improve the accuracy of the system <NUM> in various implementations. As would be apparent to one of skill in the art, these calibration equations can be programmed into the processing unit <NUM> that communicates with the pressure sensing component <NUM>.

As shown in Tables <NUM>-<NUM>, in the present examples, the results when analyzed from the calibration testing showed that the constructed pressure sensing unit (the AMS <NUM>-<NUM>-D pressure sensor and the associated circuitry) was able to reliably detect pressure readings within the desired range (<NUM>-<NUM> H<NUM><NUM>) within five percent of the actual value.

The total expelled volume is calculated by the CPU <NUM> using the total time elapsed multiplied by a function representing the constant pump <NUM> flow rate, this function was described by pump <NUM> and power source testing where the constant flow rate of the pump <NUM> was tested against many different power source characteristics.

Therefore, in various implementations, shown variously in <FIG>, in one example the processor or processors (shown at <NUM> and <NUM>) collect data values from the various components - such as the pressure sensor <NUM>, pump <NUM> and clock <NUM>. In these embodiments, the CPU <NUM> or CPUs <NUM>, <NUM> can collect true date and time data from the clock component <NUM>, dynamic pressure readings from the pressure sensor component <NUM> and flow from the pump <NUM>.

In one exemplary implementation, the CPU <NUM> has software configured to record date and time values within the software application <NUM> on the digital device <NUM> as data points. In this implementation, the pressure sensor component <NUM> is used to obtain dynamic relative pressures between the second lumen <NUM>, which is in fluid communication with the first lumen <NUM>, thereby collecting a pressure reading directly from the catheter via the catheter coupling <NUM>, and the measured atmospheric pressure. The CPU <NUM> obtains an average initial RAW pressure reading from the sensor component <NUM> by reading the RAW output from the pressure sensor component <NUM> every <NUM> second for <NUM> pressure readings. This RAW pressure reading is then converted to a cmH<NUM>O scale using a function described by calibration testing of the device using three different catheter sizes, a water column, and many experimental cmH2O water column values between <NUM>-<NUM> cmH<NUM>O shown in Tables <NUM>-<NUM>.

Claim 1:
A portable intermittent catheterization bladder health monitoring device comprising:
(a) a first elongate tube (<NUM>) comprising a first lumen (<NUM>);
(b) a catheter coupling component (<NUM>) disposed at a distal end of the first elongate tube, the catheter coupling component comprising an opening in fluid communication with the first lumen, wherein the catheter coupling component is configured to be coupleable to a urinary catheter such that the opening is in fluid communication with a lumen of the urinary catheter;
(c) a housing (<NUM>);
(d) a pressure sensor (<NUM>) disposed within the housing and in fluid communication with the catheter coupling component via a proximal end of the first elongate tube;
(e) a pump (<NUM>) disposed within the housing and in fluid communication with the catheter coupling component wherein the pump is configured to urge fluid proximally along the lumen of the urinary catheter;
(f) a processor (<NUM>) disposed within the housing and operably coupled to the pressure sensor and the pump;
(g) a communications component (<NUM>) operably coupled to the processor; and
(h) a second elongate tube (<NUM>) comprising a second lumen (<NUM>) in fluidic communication with the catheter coupling component, the second elongate tube being in fluid communication with the pump; wherein:
(i) the pressure sensor is constructed and arranged to detect bladder pressure at the time of catheterization;
(ii) the pump is configured to detect a volumetric flow rate of fluid within the second lumen and to transmit data relating to the volumetric flow rate to the processor;
(iii) the processor is configured to calculate volume data indicating a volume of fluid expelled from the device based on the volumetric flow rate received by the pump, and to store the volume data alongside detected bladder pressure; and
(iv) the communications component is constructed and arranged to wirelessly transmit the detected bladder pressure and the volume data.