WO2014160517A1 - Deployable and retrievable objective data acquistion unit - Google Patents

Abstract

A device (150C) for measuring physiological parameters in a bladder and a tissue orifice includes an elongate body having a proximal end and a distal end. The device includes two arms (154A, B). Each arm has a first end and a free end. Each arm has a natural configuration in which the free end is cantilevered in a radial direction relative to the body (164A) axis and has a collapsed configuration in which each free end can be independently and resiliently deflected to align with the body axis. The device includes sensors (156A, 157A, 160A) and a data telemetry unit (159). The telemetry unit is configured to wirelessly communicate data corresponding to a volume signal, a first pressure signal, and a flow signal to a remote device. The device includes a power supply coupled to the telemetry unit.

Description

DEPLOYABLE AND RETRIEVABLE OBJECTIVE DATA ACQUISTION UNIT

CLAIM OF PRIORITY

This patent application claims the benefit of priority of US Provisional

Patent Application serial number 61/780,810 filed March 13, 2013 and US Provisional Patent Application serial number 61/874,100 filed September 5, 2013 both of which are hereby incorporated by reference herein in their entirety. BACKGROUND

Lower urinary tract dysfunction (LUTD) can encompass a plethora of symptoms with various underlying causes within a urinary tract. Symptoms can be expressed as problems with storage, voiding, and post-micturition. Storage symptoms can include frequency, urgency, nocturia, and incontinence. Voiding symptoms can include hesitancy, intermittency, residual urine sensation, straining to void, and poor stream. Post-micturition symptoms can include incomplete emptying and terminal dribbling.

On a pathophysiology level, lower urinary tract symptoms (LUTS) and dysfunction can be the result of bladder dysfunction, bladder outlet obstruction, or a combination of these. Bladder dysfunction can include symptoms such as bladder hypersensitivity, detrusor overactivity, and detrusor underactivity.

Bladder outlet obstruction can include symptoms such as bladder neck dysfunction, prostatic obstruction, urethral stricture, poorly relaxed urethral sphincter, and urethral sphincter dyssynergia.

Patients presented to an urologist with any of the aforementioned symptoms will usually be prescribed a series of diagnostic tests and treatments.

OVERVIEW

The present subject matter relates to diagnosis of a lower urinary tract dysfunction (LUTD) and can also be applied to other organs in the human body, such as, but not limited to, the heart.

Patients with LUTD face considerable decreases in quality of life as well as a high economic burden of dealing with their dysfunction. Current diagnostic tests, including non-invasive and minimally-invasive procedures, are often inadequate and can require a patient to undergo multiple rounds of healthcare provider visits before an appropriate diagnosis is achieved. This places an unnecessary economic, physical, and mental strain on the patients and healthcare providers, which can be diminished using better monitoring or diagnosis systems, such as disclosed herein.

An example includes a device for measuring physiological parameters in a bladder and a tissue orifice includes an elongate body having a proximal end and a distal end. The device includes two arms. Each arm has a first end and a free end. Each arm has a natural configuration in which the free end is cantilevered in a radial direction relative to the body axis and has a collapsed configuration in which each free end can be independently and resiliently deflected to align with the body axis. The device includes sensors and a data telemetry unit. The telemetry unit is configured to wirelessly communicate data corresponding to a volume signal, a first pressure signal, and a flow signal to a remote device. The device includes a power supply coupled to the telemetry unit.

These and other examples and features of the system and method will be set forth in part in the following Detailed Description. This Overview is intended to provide non-limiting examples of the present subject matter— it is not intended to provide an exclusive or exhaustive explanation. The Detailed Description below is included to provide further information about the present system and method.

This overview is intended to provide an overview of subject matter of the present patent application. It is not intended to provide an exclusive or exhaustive explanation of the invention. The detailed description is included to provide further information about the present patent application.

BRIEF DESCRIPTION OF THE DRAWINGS

The drawings illustrate generally, by way of example, but not by way of limitation, various embodiments discussed in the present document. FIG. 1 illustrates an example of a system including an internal and external device.

FIG. 2 illustrates a device in a bladder.

FIG. 3A illustrate a view of a device.

FIG. 3B illustrate a view of a device.

FIG. 3C illustrate a view of a device.

FIG. 4A illustrates a view of a device.

FIG. 4B illustrates a view of a device.

FIG. 5 illustrates a view of a device.

FIG. 6A illustrates a device.

FIG. 6B illustrates a device.

FIG. 7A illustrates a volume sensor.

FIG. 7B illustrates a volume sensor.

FIGS. 8A and 8B illustrate views of a subjective data input device.

FIG. 9 illustrates a view of a flowchart.

FIG. 10 illustrates an example of data collection.

FIG. 11 illustrates a flow chart.

DETAILED DESCRIPTION

The present inventors recognize an opportunity for an improved diagnostic system and method for lower urinary tract dysfunction. The system and method can include patient subjective inputs, such as pain, pressure or urgency, and can include objective bladder contractile activity recording through systems such as EMGs or MEMS. The present system and method can provide patients with the opportunity to input their feelings into a user-interface to strengthen a healthcare provider's understanding of the patient's LUTD. The system and method can provide the healthcare providers with a detailed patient report, with numerical and graphical outputs combining subjective and objective data.

This disclosure describes a system and a method for obtaining subjective and objective ambulatory patient urinary tract information by utilizing both internal and external data acquisition units. The system and method can generally employ external and internal components.

FIG. 1 illustrates an example a patient fitted with system 100A. System 100A includes sensor 140A configured as a wearable belt. Sensor 140A detects can include a contractile activity sensor. Sensor 140A is coupled to telemetry unit 142. Telemetry unit 142 can communicate wirelessly with an implanted device or an externally located remote device. Telemetry unit 142 can include a Bluetooth transceiver. The belt coupled to sensor 140A is coupled to subjective data input unit 160 A. Subjective data input unit 160A can receive user inputs.

The patient is fitted with an internal objective data device 150A. Device

150A can have a variety of configurations as shown elsewhere in this document. Device 150A is positioned in bladder 120 and is configured to wirelessly telemeter data to an external device (such as data input unit 160A), as shown by radiofrequency signal 130. Bladder 120 is coupled to ureter 110.

FIG. 2 illustrates device 150B positioned in ureter 110 and retained by retention device at one end. In the example illustrated, the retention device includes a pair of barbs, one of which is denoted as barb 152.

In the example shown, device 150B includes two retention arms 154A. Retention arms are disposed radially from an elongate body of device 150B and retain device 150B in position within bladder 120. Device 150B includes a sensor and a telemetry unit. The telemetry unit is configured to wirelessly communicate with a remote device, as shown by radiofrequency signal 130.

FIG. 3 A illustrates device 150C according to one example. Device 150C includes radially extending arms 154B. Arms 154B are coupled to elongate body 164A at a point referred to herein as a proximal end. In addition, device 150C includes volume sensor 156A. Volume sensor 156 A, also affixed at the proximal end, is configured to provide an electrical signal corresponding to a volume of a vessel, such as a bladder. Device 150C includes pressure sensor 157 A. Pressure sensor 157A is configured to provide an electrical signal corresponding to a fluid pressure of a physical pressure. Sensor 157A can include a piezoelectric element and provide an electrical signal based on a mechanical deformation. Elongate body 164A is coupled to power supply 158A. Power supply 158 A is electrically coupled to one or more sensors, transducers or a telemetry unit of device 150C. Telemetry unit 159 is coupled to elongate body 164A. Device 150C includes distally disposed pressure sensor 157B also affixed to elongate body 164A. In addition, device 1150C includes flow sensor 160A coupled to elongate body 164A and magnetic element 162A. Flow sensor 160A provides an electrical signal corresponding to fluid flow proximate a sense element of sensor 160A. Magnetic element 162A can include a ferrous component configured to engage with a corresponding magnetic component of a placement instrument. The placement instrument, not shown in this view, can be manipulated to place device 150C in an orifice of a patient and selectively engage or disengage from magnetic element 162A.

FIG. 3B illustrates device 150D. Device 150D includes arms 154C and includes volume sensor 156B. Volume sensor 156B is illustrated as a circular disk. In one example, volume sensor 156B includes an acoustical or ultrasonic transducer configured to emit energy along an axis (generally normal to the surface of sensor 156B). The time of flight for reflected energy from the transducer can be correlated with a distance and on the basis of the distance measurement, a volume can be determined. In one example, the volume corresponds to a volume of a bladder.

Device 150D includes power supply 158B coupled to elongate body 164B. Elongate body 164B is coupled to pressure sensor 157C, flow sensor 160B, and magnetic element 162B.

FIG. 3C illustrates device 150E having volume sensor 156D, 156E and 156C. In addition device 150E includes arms 154D. Volume sensor 156D,

156E and 156C are configured with sensing elements aligned to detect a volume of a bladder.

FIG. 4 A illustrates a top view of device 150F. Device 150F includes arms 154E disposed radially. Volume sensor 156F is disposed at the center of device 150F and aligned to project energy and detect energy on axis normal to the page (parallel with elongate body, not shown in this view). FIG. 4B illustrates a top view of device 150G. Device 150G includes arms 154F disposed radially. Volume sensors 156G, 156H, 156J, and 156K are disposed at the center of device 150G and each is aligned to project energy and detect energy on axis aligned substantially radially with respect to an axis of the elongate body (not shown in this view).

FIG. 5 illustrates a view of device 150H in a collapsed configuration. In this view, device 150H is within a lumen of catheter 210 and configured for deployment and retrieval. Device 150H includes arms 154G in a collapsed configuration in contrast to the deployed, or natural configuration, of the arms shown in FIG. 4B, for example. Volume sensor 156L is configured to emit and detect energy in a direction aligned with the elongate body. Magnetic element 162C facilitates deployment and retrieval of device 150H.

FIG. 6 A illustrates an example of external leakage monitor 610A. Monitor 610A is configured for attachment to a penis. Monitor 610A includes attachment member 620 configured to retain sheath 615 in position. Sensor 625A includes a moisture sensor or fluid sensor. When sensor 625A detects presence of fluid 605, a signal is generated and emitted, as shown at 630. The emitted signal can include a radio frequency signal for reception and processing by a remote device.

FIG. 6B illustrates an example of internal leakage monitor 610B.

Monitor 610B is configured for placement in urethra 110. Monitor 610B includes sensor 625 B configured to detect presence of moisture or fluid. When sensor 625B detects presence of fluid, a signal is generated and emitted, as shown at 630. The emitted signal can include a radio frequency signal for reception and processing by a remote device. Element 635 includes a stent-like device and is coupled to sensor 625B.

FIGS. 7 A and 7B illustrate side views of a rotating element for volume sensor positioning. In FIG. 7A, volume sensor 156M is affixed to arms 154H and is configured to emit and detect energy aligned with axis 20A. Volume sensor 156M can be rotated or displaced as shown by arrow 5. In FIG. 7B, volume sensor 156M has emit and detect axis 20B aligned at angle 24 with respect to normal axis 22. A piezoelectric actuator coupled to volume sensor 156M can be controlled to modulate the alignment.

FIGS. 8A and 8B illustrate selected components of a subjective data input and recording unit with unit 81 OA depicting external elements and unit 810B depicting internal elements. In FIG. 8 A, unit 810 A includes components 805 to attach to a patient. Components 805 can include a strap, a buckle, or a Velcro fastener. Unit 810A illustrates, button 820 for indicating a level of pain perceived by a patient. The pain level is a subjective determination. Button 825 is configured to indicate a perceived level of pressure and button 830 is configured to indicate a perceived sense of urgency. A patient can manipulate buttons 820, 825, and 830, and trigger 835, to store subjective data. In one example, buttons 820, 825, and 830 are configured to allow a patient to indicate subjective data using a gradient for assessing intensity.

Data communication port 840 allows stored data to be transferred to a remote device.

FIG. 8B illustrates selected internal components of unit 810B.

Components 805 are configured to attach device 810B to a patient. Subjective data recorder 845 is coupled to module 850 which is configured to compile objective and subjective data. In addition, module 850 receives data from module 870 which is configured to receive and record objective data. Module 870 also provides data to module 865 configured to assess objective data.

Module 860 is coupled to module 865 and is configured to provide an alert. In addition, module 860 is coupled to module 850. Module 855 is configured to receive data from module 850 and provide objective and subjective data output. Module 870 is configured to receive wireless signals from internal objective data unit sensor as shown elsewhere in this document.

FIG. 9 illustrates process 900 according to one example. Process 900 includes, at 910, subjective data collection in time. This can include data corresponding to pressure, pain, and urgency. At 915, process 900 includes objective data collection in time. Data can include pressure as a function of time, volume as a function of time, contractile activity, leakage, and other data. At 925, process 900 includes compiling the subjective and objective data. At 920, process 900 includes generating an alert if leakage is detected, if high pressure is detected, or if too much volume is detected. At 930, an alert is provided to the patient. In one example, an alert is also provided to a health care provider. At 935, process 900 includes outputting the subjective and objective data. This can include numerical and graphical data.

FIG. 10 illustrates diagram 1000 showing occurrences for subjective data collection. At 1010, subjective data is collected. At 1020, the data corresponds to a baseline normal. At 1030, the data corresponds to when feeling pain, pressure, or urgency. At 1040, the data corresponds to an alert condition associated with leaking, high pressure or high volume.

FIG. 11 illustrates flow chart 1100 corresponding to a method. At 1100, method 1100 includes providing an elongate body. At 1115, method 1100 includes affixing at least two arms to the proximal end of the elongate body. At 1120, method 1100 includes coupling a first volume sensor to the proximal end of the elongate body. At 1125, method 1100 includes coupling a first pressure sensor to the elongate body. The first pressure sensor can be affixed to the proximal end. At 1130, method 1100 includes attaching a flow sensor to the distal end of the elongate body. At 1135, method 1100 includes coupling a telemetry unit to the elongate body. At 1140, method 1100 includes coupling a power supply to the telemetry unit. In other examples, the power supply is coupled to other sensors of the device.

An external component of the present subject matter can be configured for subjective data sensing and recording. The external unit can include a bladder contractile activity sensor unit.

The subjective data input and recording unit can include at least four components: (i) a patient-controllable component that the patient can manipulate when he/she is having sensations relating to his/her urinary tract; (ii) a receiving and recording unit that receives and records data from the other external and internal system data-transmitting components; (iii) a data compiling component; and (iv) a data output component.

The patient-controllable component of the subjective data input and recording unit can comprise a digital input and recording means configured to enable the patient to input temporal subjective data related to the patient's feeling of his/her urinary tract such as the onset of pressure, pain, and/or urgency. The patient-controllable component of the subjective data input and recording unit can be further configured to enable the patient to input varying degrees of subjective data such as the intensity of the pressure, pain, and/or urgency the patient is subjectively feeling. The varying degrees of subjective data can be input using analog means such as a turn-able knob, or using digital means such as up/down buttons. The patient-controllable component of the subjective data input and recording unit can be further configured to prevent unintentional data input by the patient through confirmation means/steps such as an on/off switch before and after data input that the patient must press before and after inputting his/her subjective data.

The receiving and recording unit can comprise a receiver configured to pick up on and record the temporal data being transmitted to the system from various points throughout the body. Temporal data can be time-stamped data, or data associated with time at which the received events occurred. Such data can include, but is not limited to, those transmitted by a bladder contractile activity sensor unit, pressure sensor, volume sensor, and leakage monitor. More specifics of these sensors and monitors are described below. The receiving and recording unit can be configured to continuously monitor the sensors and record the data transmitted by the sensors. Alternatively, or additionally, the receiving and recording unit can be configured to monitor the sensors and record data upon a command triggered automatically by the sensor, or manually by the patient, care giver. The receiving and recording unit can be configured to alert the patient of an adverse event, such as excessively high pressures or volumes within the bladder or unwanted leaking from the urethra.

The subjective data input and recording unit can comprise a hardware and/or a software component configured to compile the subjective and objective data it records. This compiling can produce a variety of outputs including, but not limited to, graphical and numerical representations of the received data. This component can be further configured to process the received data into clinically relevant information such as generating pressure- volume curves/characteristics of the bladder (similar to those used to assess cardiac function/performance), elastic properties of the bladder, and possible clinical diagnoses.

The subjective data input and recording unit can comprise a component configured to output recorded, compiled data, or alerts. Methods of output can include, but are not limited to, a wired port, such as via a micro-USB connection, or wireless transmission, such as Bluetooth technology.

The function of the bladder contractile activity sensor unit can be to monitor bladder contractile movements. This can be accomplished in a variety of ways, such as through electromyography (EMG) sensors or

microelectromechanical systems (MEMS) sensors. Measuring bladder contractile movements can help provide a more thorough understanding of how the bladder and detrusor muscles are functioning as a whole. The bladder contractile activity sensor unit can combine data it records from various points near the bladder and then transmit this data to the subjective data sensing and recording unit described in this document. The bladder contractile activity sensor unit can be attached to the patient via a belt or alternative methods that can align with the technology being used to measure bladder contractile activity.

Internal components can include internal objective data sensors such as, but not limited to, pressure and volume sensors, a leakage monitor, and data transmitters.

The pressure and volume sensors can be configured with pressure and volume sensing capabilities.

In an example, an internal unit can include one or more volume measurement sensors including one or more rotating elements, one or more pressure sensors, one or more flow rate measurements sensors, one or more data acquisition/transfer units, one or more power sources to energize the

aforementioned components and an overall housing. The internal unit can include a proximal end and a distal end aligned on a central axis.

The volume measurement sensor (also referred to as a volume sensor) may be adapted to periodically measure the volume of the bladder. In an example, the volume sensor can measure bladder volume through the use of acoustic or electromagnetic waves. Acoustic waves can be used to measure volume by emitting a pulse at a specific frequency and then receiving the reflected pulses. The emitted pulse may be triggered by an external source. An external source can include a pulse generator, a physiological sensor, an external module or other device. The emitted pulses can reflect off the wall of the intended target, such as the inner surface of a bodily organ. The reflected waves can then be received by a receiver. The reflected waves will have a phase shift depending on the distance they traveled. This phase shift information can be used to determine the distance the waves traveled. Multiple waves can be emitted and distances measured to calculate the volume of the space in which an emitter, a receiver, or both an emitter and receiver (sometimes referred to as a transducer) is placed. A similar method of use may be applied to a variety of other waves including, but not limited to, electromagnetic waves.

The size of the volume measurement sensor or sensors can be on the micro scale. This sensor or sensors can be placed at the proximal end of the internal unit. Power for the internal unit may be supplied from stored energy, such as a battery, or generated locally. Data transmission and processing may occur at the site of data acquisition or be transmitted to an external component.

A rotating element can be attached to the volume measurement sensor in order to obtain more data points which may be used to generate a volume measurement. The means to rotate the rotating element can be mechanical, electrical or a combination of mechanical and electrical components. In an example, piezoelectric actuators can be used to articulate the distance transceiver. The rotating element can be incorporated into the proximal end of the internal unit and engage with the volume measurement sensor. The rotating element can adjust the angle of the volume measurement sensor to gather data from as many locations as possible. An illustrative example of this is shown in FIG. 7 A and 7B.

The pressure sensors can be adapted to measure hydrostatic pressure or hydrodynamic pressure capable of obtaining small changes in pressures. The size of the pressure sensors can be on the micro scale. An example can include one pressure sensor at the proximal end of the internal unit and another pressure sensor at the distal end of the internal unit. The flow rate sensor can be adapted for determining flows ranging from 0-lOOm/s with high accuracy. The size of the flow rate sensor can be on the micro scale. The flow rate measured can be output to either the local data collection component on the internal unit or be directly transmitted to an external device.

The flow rate sensor can be used to detect leakage events. A leakage event is defined by the presence of a liquid flowing through a space in which liquid is not expected to be flowing through. Upon a leakage event, this can trigger an alert to an external component as well as be recorded either locally or on an external component.

A data acquisition/transfer unit can be integrated into the aforementioned sensors obtaining objective data on volume, pressures, flow rate, and leakage events. This unit can incorporate a transmitter to directly transmit the obtained data to an external component that will be able to analyze and store the obtained data. The unit can transmit wirelessly through Bluetooth or alternative means, such as radiofrequency communication.

A battery can be used as a power source for the aforementioned sensors and data acquisition/transfer unit. In lieu of a battery, an example can include a reactive tank circuit (such as an inductor-capacitor or LC tank) self-powering mechanisms, or wireless power transmission methods may also be used.

A housing can be provided for the various components. The housing can be deployed and then retracted through one or multiple small orifice(s). The housing can remain reasonably stable in a desired location without generating excessive motion to obtain similar data during the duration of use. The housing can be made out of biocompatible polymer that minimizes unwanted bodily responses from the internal unit. The polymer can cover everything that does not need to be in direct contact with the body. The housing can have collapsible wings or arms that are able to fold into the midline of the internal unit and then expand upon insertion. The arms enable the internal unit to stay in its desired location, but be easy to insert and remove. An example of the internal unit in collapsed form is depicted in FIG. 5. This housing is able to withstand various elements subjected to it, such as those found within various locations in a living animal including human.

In order to insert and remove the internal unit, a magnetic element is incorporated into the distal end of the internal unit. As shown in FIG. 3A, the magnetic element can engage with the magnetic element of a means to deploy and retrieve the internal unit in the bladder.

The leakage monitor can be configured to monitor unwanted leaking from the urethra. The leakage monitor can be placed internally or externally, as shown at FIG. 6B and 6A, depending upon patient preference and/or physician recommendation.

An example of the internal leakage monitor is depicted in FIG. 6B. It can include a stent-like system that is deployed in a distal tip of a urethra without causing patient irritation. The stent-like system can be embedded with moisture sensors that can transmit an alert to the receiving and recording unit upon reaching a pre -determined threshold for moisture levels. One example for measuring urine leaking is to measure conductance as the urine flows through the distal end of the urethra.

An example of the external leakage monitor is depicted in FIG. 6A. It can include an attachment device for a penis in the case of a man with sensors that signal an alert when a pre-determined amount of moisture is sensed. An alternative configuration for both men and women can be similar to a sanitary pad with sensors that signal an alert upon reaching a pre-determined level of moisture. Both systems can be configured with patient comfort and leaking accuracy in mind.

The leakage monitor can serve as an additional component to the overall system intended for patients with leaking problems. When the monitor senses leaking, it can transmit this data to the external recording and receiving unit which can then alert the patient of the event and the patient can input the subjective data he/she is feeling at the moment of the leakage event.

The data transmitters can transfer the objective data from its original location within or near the bladder to the data recording unit. An example of the overall process for the present system is shown in the figures. The goal of the system can be to obtain both subjective and objective data, appropriately compile this data, and output the data in a desired format as well as alert the patient when an event, such as leaking, excessively high pressure, or too much volume being retained in the bladder, is happening that he/she might not be aware of. Example various occurrences when a patient can input subjective data to be compiled with objective data is depicted in FIG. 10.

An example of the device is configured for measuring physiological parameters in a bladder and a urethra. The device includes an elongate body, two arms, a first volume sensor, a first pressure sensor, a flow sensor, and a data telemetry unit coupled to a power supply. The elongate body includes a proximal end, a distal end and a body axis. The body can be formed from a polymer such as a flexible biocompatible polymer. In an example, the flexible biocompatible material can include polyethylene, polypropylene, nylon, polyurethane, silicone, and polyethylene terephthalate (PET).

The arm includes a first end attached to the proximal end of body and a free end. The arm can be formed from a polymer such as a flexible

biocompatible polymer. In an example, the flexible biocompatible material can include polyethylene, polypropylene, nylon, polyurethane, silicone, and polyethylene terephthalate (PET). Materials can be characterized by their physical properties including, but not limited to, a measure of stiffness or a measure of flexibility. As used here, measures of stiffness and measures of flexibility can include physical characteristics of a material such as Young's modulus, elastic modulus or compliance. In an example, the body can be formed from a first polymer material and the arm can be formed from a second polymer material where the first polymer material is different from the second polymer material. In an example, the body can be formed from a first polymer material and the arm can be formed from a second polymer material where the measure of flexibility or stiffness of the first polymer material is different from the measure of flexibility or stiffness of the second polymer material. In an example, a high molecular weight polyethylene can be used for the body and low molecular weight polyethylene for the arms. The arm can be attached to the proximal end of the of the body and can assume different configurations including a natural configuration and a collapsed configuration. In the natural configuration, the free end of arm can be cantilevered in a radial direction relative to the body axis. In an example, the body remains in a substantially stabilized orientation when the arms are in the natural configuration. In an example, the body with the arms in the natural configuration can be suspended in a stabilized orientation in a hollow organ of the body or in a tissue orifice of the body. In an example, the hollow organ of the body can be the bladder and the tissue orifice can be the trigone area of the bladder or the proximal urethra area.

In the collapsed configuration, the free end of arm can be independently and resiliently deflected to align with the body axis. In an example, the arms can be substantially deflected against and in intimate contact with the elongate body and other adjacent arms. In an example, the body with arms in the collapsed condition can be inserted into the proximal end of a tubular structure so that the body resides completely within the lumen of the tubular structure. In an example, the tubular structure can be, but is not limited to, a catheter, a cystoscope or other tubular-shaped structure. In an example, the catheter can be inserted into the urethra of a patient and advanced so that the proximal end of the catheter is located within the bladder.

The first distance sensor 130 can be attached to the proximal end of body and includes a detector face that can both generate and receive energy in the form of waves. In a generating mode, the detector face is made to vibrate thereby transferring energy to the transmitting medium to which the detector face is in contact. In an example, the medium can be a gas, a liquid or a solid. As energy waves travel in a medium, they can be reflected when encountering a medium with a different index of transmissibility, such as a physical structure, whereby some of the energy can be deflected back to the detector face. By measuring the time between the initiation of an energy wave generated by the detector face and the corresponding reflection of the energy wave from the physical structure, the distance from the face to the structure can be determined with knowledge of the transmitting medium's index of transmissibility. In an example, the detector face of the first sensor can generate a first energy wave in the direction of the body axis that can propagate through the transmitting medium until the wave encounters a structure whereby some of the energy wave is reflected back along the body axis to the detector face.

The first pressure transducer can be attached to the proximal end of body and detects local fluid pressure in the medium in which the transducer is immersed and thereafter creates and electrical signal corresponding to the fluid pressure. In an example, the medium can be a gas or a liquid.

The flow sensor can be attached to the distal end of body. The flow sensor detects fluid motion in the medium in which the sensor is immersed and thereafter creates and electrical signal corresponding to the fluid flow. In an example, the medium can be a gas or a liquid.

The data telemetry unit can be coupled to the body and electrically coupled to the first distance sensor 130, the first pressure transducer and the flow sensor. The telemetry unit can communicate wirelessly with other suitable devices using any applicable data transmission protocol. In an example, the telemetry unit can transmit data corresponding to measurements from the first distance sensor, the first pressure transducer and the flow sensor to another wireless device located remotely from the data telemetry unit. In an example, the telemetry unit can receive data from another wireless device located remotely from the data telemetry unit to initiate events such as sensor data query, sensor data download or signals to drive actuators.

The power unit can be coupled to the body and electrically coupled to the data telemetry unit. In an example, the power unit can energize the data telemetry unit. In another example, the power unit can energize the first distance sensor, the first pressure transducer and the flow sensor through direct electrical communication or through electrical communication with the data telemetry unit.

In one example, the first volume sensor is sensitive to distance and can be made to articulate about a body axis. In an example, the body axis intersects the first distance sensor at the centroid of the first sensor and the body axis is perpendicular to the first sensor. A sense axis can be an axis that is perpendicular to detector face and designates the primary direction of travel of wave energy emissions created by the first distance sensor. In one example, the body axis and the sense axis of detector face are parallel and co-linear.

In one example, the first distance sensor is articulated about the body axis. In an example, the sense axis can be articulated with respect to the body axis at any angle. In an example, the sense axis can be articulated with respect to the body axis where the angle is in a range of 0 degrees to 5 degrees.

In an example, the first distance sensor can be made to articulate about the body axis so as to direct energy waves generated by the detector face in a direction different from that of the body axis. In an example, the first sensor can be made to articulate with respect to the body axis with mechanical components, electrical components or a combination of mechanical and electrical components. In an example, a piezoelectric actuator can be mechanically connected between the first distance sensor and the body to generate force and thereby articulate the first distance sensor about a body axis. In an example, a piezoelectric actuator can be electrically coupled to the power unit to energize the actuator and to the data telemetry unit to receive command signals from a remote wireless device to actuate the actuator.

One example includes a retention feature attached to the distal end of an elongate body. The retention feature can be used to releasably couple the device to another instrument such as a surgical guidewire or flexible surgical rod. In an example, the feature can be a barb device that can removably couple to another instrument. In an example, the feature can be a magnetic surface or a magnetic interface.

Additional Notes

In an example, biocompatible, flexible materials including polymers such as polyethylene, polypropylene, nylon, polyurethane, silicone, and polyethylene terephthalate (PET) can be to construct the device.

In an example, more than two arms attached to the proximal end of the body and less flexible cylinder that houses the flow rate sensor, urethral pressure sensor, battery, and wireless data transmitter at the distal end of the body. In an example, a biocompatible coating can be applied to all surfaces of the device to reduce the risk of infection due to long term implantation in a patient's bladder. In an example, long term can mean introduction of the device into the body for 24-48 hours. In an example, some components of the device that contact bodily fluids can be left bare of a biocompatible coating, such as the flow sensor. In an example, an alternative to a biocompatible coating such as PET can be used to protect components of the device that would not otherwise be coated with a biocompatible coating.

In an example, hooks at the distal end of the device can secure the device to the urethra and prevent the device from traveling up from the urethra and then just floating around in the bladder. In an example, the hooks can be one-way barbs mechanisms that are released upon deployment of the device in the patient but are then easily retracted upon retrieval. Deployment

In an example, the device can be deployed from a catheter where the device would be housed. The straight (non-curved/wing-like) end of the device has a magnet in it which can interface with the magnet push/inner

pipe/'guidewire' of inside of the catheter. When the catheter magnet is activated, the device will attach to the magnet. The user (clinician) may push the catheter with the device and guidewire inside of it into the desired location in the trigone area of the bladder/proximal urethra. When the device is appropriately positioned, the user pushes the device out of the catheter enabling the wings of the device to expand and rest in the bladder. The user then pulls back the catheter and guidewire to allow the cylindrical portion of the device to rest in the patient's urethra. Once the entire device is unsheathed and in position, the user turns off the magnet (either by removing the power or some other method of disrupting the magnetic charge between two magnets). The user then pulls back the catheter with the guidewire still inside.

Retrieval In an example, when the user wants to retrieve the device from the patient's bladder after a 24-48 hour monitoring period, the user may insert another (sterile) catheter into the patient with another guidewire with magnet in it. The user will place the catheter and magnetic tip into the patient's urethra. Once inside the urethra in in the approximate location of retrieving the device, the user may push the magnet to unsheath it as well as on turn on the magnet to reactivate the magnetic field that will ultimately attract the device to be removed from the patient's bladder. Once the device has been relocated and attached with the magnets, the user pulls them back into the catheter and then removes the catheter and device from the patient.

Instead of a healthcare provider needing to utilize several tests to obtain an adequate diagnosis, he/she now has the opportunity to use the present system and method. In one testing period, the healthcare provider can obtain a comprehensive understanding of a patient's symptoms, and thereby more efficiently and effectively prescribe an appropriate course of treatment.

Additionally, the present system and method are believed to have the potential to significantly improve diagnostics and yield a dramatic reduction of patient time spent in a clinic. This can, in turn, enable healthcare providers to see more patients, reduce the waiting time for LUTD diagnostic testing, and provide patients with an overall more positive clinic visit.

To illustrate system and method disclosed herein, a non-limiting list of examples is provided here:

In Example 1, a system for monitoring or diagnosing urinary tract dysfunction can comprise an external unit and an internal unit. The external unit can be configured to receive subjective data from a user. The internal unit can be configured to measure objective data from the user. The external unit and the internal unit can be operatively coupled, thereby allowing the subjective data and the objective data to be combined and used to establish a health assessment output.

In Example 2, the system of Example 1 can optionally further comprises a processor configured to establish the health assessment output. In Example 3, the system of any one or any combination of Examples 1 or 2 can optionally further comprise an alarm.

In Example 4, the system of any one or any combination of Examples 1-3 can optionally further comprise a bladder contractility activity sensor.

In Example 5, the system of Example 4 can optionally be configured such that the bladder contractility activity sensor includes one or more EMG electrodes or one or more MEMS sensor.

In Example 6, the system of any one or any combination of Examples 1-5 can optionally be configured such that the external unit includes a recorder.

In Example 7, the system of any one or any combination of Examples 1-6 can optionally be configured such that the external unit is configured to receive subjective data selected from a group consisting of a pain, a pressure, and an urgency.

In Example 8, the system of any one or any combination of Examples 1-7 can optionally be configured such that the external unit includes a leakage monitor.

In Example 9, the system of Example 8 can optionally be configured such that the leakage monitor includes a condom, positionable over the user's penis, having one or more moisture sensors coupled thereto.

In Example 10, the system of any one or any combination of Examples 1-

9 can optionally be configured such that the external unit is configured to receive objective data from the user.

In Example 11 , the system of any one or any combination of Examples 1 -

10 can optionally be configured such that the external unit and the internal unit are wireless connected.

In Example 12, the system of any one or any combination of Examples 1-

11 can optionally be configured such that the external unit includes a belt, wearable around the user's waist.

In Example 13, the system of any one or any combination of Examples 1- 12 can optionally be configured such that the external unit includes an actuation switch that, when activated, allows receipt of the subjective data. In Example 14, the system of any one or any combination of Examples 1- 13 can optionally be configured such that the internal unit includes a sensor positionable within the user's bladder.

In Example 15, the system of Example 14 can optionally be configured such that the sensor is configured to monitor pressure or volume as a function of time.

In Example 16, the system of any one or any combination of Examples 1- 15 can optionally be configured such that the internal unit includes a leakage monitor.

In Example 17, the system of Example 16 can optionally be configured such that the leakage monitor includes a stent, positionable within the user's urethra, having one or more moisture sensors coupled thereto.

In Example 18, can method can comprise collecting subjective data from a user; collecting objective data from the user; combining the subjective data and the objective data; and establishing a health assessment output, indicative of a status of urinary tract dysfunction, based in part on the combed subjective data and objective data.

In Example 19, the method of Example 18 can optionally be configured such that collecting of the subjective data is triggered when the user experiences a pain, a pressure, or an urgency.

In Example 20, the method of any one or any combination of Examples 18 or 19 can optionally be configured such that collecting of the subjective data is triggered when a leakage event is sensed.

In Example 21 , the method of any one or any combination of Examples 18-20 can optionally be configured such that collecting the objective data includes sensing a pressure or a volume, as a function of time, within the user's bladder.

In Example 22, the method of any one or any combination of Examples 18-21 can optionally be configured such that collecting one or both of the subjective data or the objective data includes sensing as leakage event. In Example 23, the method of any one or any combination of Examples 18-22 can optionally be configured such that combining the subjective data and the objective data includes wirelessly communicating data.

In Example 24, the method of any one or any combination of Examples 18-23 can optionally further comprise sensing a bladder contractility activity of the user.

In Example 25, the method of any one or any combination of Examples 18-24 can optionally further comprise generating an alarm if the health assessment output is above a threshold and indicative of urinary tract dysfunction.

In Example 26, the system or method of any one or any combination of Examples 1-25 can optionally be configured such that all elements, operations, or other options recited are available to use or select from. The above Detailed Description includes references to the accompanying drawings, which form a part of the Detailed Description. The drawings show, by way of illustration, specific embodiments in which the present system and method can be practiced. These embodiments are also referred to herein as "examples."

The above Detailed Description is intended to be illustrative, and not restrictive. For example, the above-described examples (or one or more elements thereof) can be used in combination with each other. Other embodiments can be used, such as by one of ordinary skill in the art upon reviewing the above description. Also, various features or elements can be grouped together to streamline the disclosure. This should not be interpreted as intending that an unclaimed disclosed feature is essential to any claim. Rather, inventive subject matter can lie in less than all features of a particular disclosed embodiment. Thus, the following claims are hereby incorporated into the Detailed Description, with each claim standing on its own as a separate embodiment. The scope of the invention should be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled. In this document, the terms "a" or "an" are used to include one or more than one, independent of any other instances or usages of "at least one" or "one or more." In this document, the term "or" is used to refer to a nonexclusive or, such that "A or B" includes "A but not B," "B but not A," and "A and B," unless otherwise indicated.

In the appended claims, the terms "including" and "in which" are used as the plain-English equivalents of the respective terms "comprising" and

"wherein." Also, in the following claims, the terms "including" and

"comprising" are open-ended, that is, a system or method that includes elements in addition to those listed after such a term in a claim are still deemed to fall within the scope of that claim. Moreover, in the following claims, the terms "first," "second," and "third," etc. are used merely as labels, and are not intended to impose numerical requirements on their objects.

These non-limiting examples can be combined in any permutation or combination.

The above detailed description includes references to the accompanying drawings, which form a part of the detailed description. The drawings show, by way of illustration, specific embodiments in which the invention can be practiced. These embodiments are also referred to herein as "examples." Such examples can include elements in addition to those shown or described.

However, the present inventors also contemplate examples in which only those elements shown or described are provided. Moreover, the present inventors also contemplate examples using any combination or permutation of those elements shown or described (or one or more aspects thereof), either with respect to a particular example (or one or more aspects thereof), or with respect to other examples (or one or more aspects thereof) shown or described herein.

All publications, patents, and patent documents referred to in this document are incorporated by reference herein in their entirety, as though individually incorporated by reference. In the event of inconsistent usages between this document and those documents so incorporated by reference, the usage in the incorporated reference(s) should be considered supplementary to that of this document; for irreconcilable inconsistencies, the usage in this document controls.

In this document, the terms "a" or "an" are used, as is common in patent documents, to include one or more than one, independent of any other instances or usages of "at least one" or "one or more." In this document, the term "or" is used to refer to a nonexclusive or, such that "A or B" includes "A but not B," "B but not A," and "A and B," unless otherwise indicated. In this document, the terms "including" and "in which" are used as the plain-English equivalents of the respective terms "comprising" and "wherein." Also, in the following claims, the terms "including" and "comprising" are open-ended, that is, a system, device, article, or process that includes elements in addition to those listed after such a term in a claim are still deemed to fall within the scope of that claim. Moreover, in the following claims, the terms "first," "second," and "third," etc. are used merely as labels, and are not intended to impose numerical requirements on their objects.

Method examples described herein can be machine or computer- implemented at least in part. Some examples can include a computer-readable medium or machine-readable medium encoded with instructions operable to configure an electronic device to perform methods as described in the above examples. An implementation of such methods can include code, such as microcode, assembly language code, a higher-level language code, or the like. Such code can include computer readable instructions for performing various methods. The code may form portions of computer program products. Further, in an example, the code can be tangibly stored on one or more volatile, non- transitory, or non- volatile tangible computer-readable media, such as during execution or at other times. Examples of these tangible computer-readable media can include, but are not limited to, hard disks, removable magnetic disks, removable optical disks (e.g., compact disks and digital video disks), magnetic cassettes, memory cards or sticks, random access memories (RAMs), read only memories (ROMs), and the like.

The above description is intended to be illustrative, and not restrictive. For example, the above-described examples (or one or more aspects thereof) may be used in combination with each other. Other embodiments can be used, such as by one of ordinary skill in the art upon reviewing the above description. The Abstract is provided to allow the reader to quickly ascertain the nature of the technical disclosure. It is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. Also, in the above Detailed Description, various features may be grouped together to streamline the disclosure. This should not be interpreted as intending that an unclaimed disclosed feature is essential to any claim. Rather, inventive subject matter may lie in less than all features of a particular disclosed embodiment. Thus, the following claims are hereby incorporated into the Detailed Description, with each claim standing on its own as a separate embodiment, and it is contemplated that such embodiments can be combined with each other in various combinations or permutations.

Claims

THE CLAIMED INVENTION IS:

1. A device for measuring physiological parameters in a bladder and a tissue orifice, the device comprising:

an elongate body having a proximal end and a distal end along a body axis;

at least two arms, each arm having a first end and a free end, each first end attached to the proximal end and each arm having a natural configuration in which the free end is cantilevered in a radial direction relative to the body axis and having a collapsed configuration in which each free end can be

independently and resiliently deflected to align with the body axis, and wherein in the natural configuration, the elongate body remains in a substantially stabilized orientation in a tissue orifice;

a first volume sensor including a detector face and configured to provide a volume signal based on a linear distance between the detector face and a tissue surface aligned on a sense axis, the first volume sensor coupled to the proximal end;

a first pressure sensor attached to the elongate body, the first pressure sensor configured to provide a first pressure signal corresponding to a first fluid pressure;

a flow sensor attached to the distal end, the flow sensor configured to provide a flow signal corresponding to a fluid flow;

a data telemetry unit coupled to the elongate body and coupled to the first volume sensor, the first pressure sensor, and the flow sensor and configured to wirelessly communicate data corresponding to the volume signal, the first pressure signal, and the flow signal to a remote device; and

a power supply coupled to the telemetry unit.

2. The device of claim 1 wherein the device is configured for passage through a lumen of a catheter.

3. The device of claim 1 wherein the device includes a polymer configured for biocompatibility.

4. The device of claim 1 wherein an arm is made of a first polymer and the body is made of a second polymer different than the first polymer.

5. The device of claim 4 wherein a measure of stiffness of the first polymer is greater than a corresponding measure of stiffness of the second polymer.

6. The device of claim 1 wherein alignment of the sense axis relative to the body axis is remotely selectable.

7. The device of claim 1 wherein alignment of the sense axis relative to the body axis is selectable based on a wireless signal received by the data telemetry unit.

8. The device of claim 1 further comprising a retention feature affixed to the distal end.

9. The device of claim 8 wherein the retention feature includes a barb.

10. The device of claim 1 wherein the distal end includes a magnetic element.

11. The device of claim 1 wherein the data telemetry unit is configured to communicate with an external sensor.

12. The device of claim 11 wherein the external sensor includes a contractility activity sensor.

13. The device of claim 11 wherein the external sensor includes a fluid leakage sensor.

14. The device of claim 1 further including a second pressure sensor attached to the distal end, the second pressure sensor configured to provide a second pressure signal corresponding to a second fluid pressure, and further wherein the first pressure sensor is attached to the proximal end.

15. A method of manufacturing a device for measuring physiological parameters in a bladder and a tissue orifice, the method comprising:

providing an elongate body having a proximal end and a distal end along a body axis;

affixing at least two arms to the proximal end, each arm having a first end and a free end, each first end attached to the proximal end and each arm having a natural configuration in which the free end is cantilevered in a radial direction relative to the body axis and having a collapsed configuration in which each free end can be independently and resiliently deflected to align with the body axis, and wherein in the natural configuration, the elongate body remains in a substantially stabilized orientation in a tissue orifice;

coupling a first volume sensor to the proximal end, the first volume sensor having a detector face, the first volume sensor configured to provide a volume signal corresponding to a linear distance between the detector face and a tissue surface aligned on a sense axis;

coupling a first pressure sensor to the elongate body, the first pressure sensor configured to provide a first pressure signal corresponding to a first fluid pressure;

attaching a flow sensor to the distal end, the flow sensor configured to provide a flow signal corresponding to a fluid flow;

coupling a data telemetry unit to the elongate body, to the first volume sensor, to the first pressure sensor, and to the flow sensor and configuring the data telemetry unit to wirelessly communicate data corresponding to the volume signal, the first pressure signal, and the flow signal to a remote device; and coupling a power supply to the telemetry unit.

16. The method of claim 15 further comprising coating the device with a biocompatible polymer.

17. The method of claim 15 further comprising configuring the data telemetry unit to provide an alignment signal to the first volume sensor, the alignment signal corresponding to alignment of the sense axis relative to the body axis.

18. The method of claim 15 further comprising forming a retention feature at the distal end.

19. The method of claim 18 wherein forming the retention feature includes forming a barb.

20. The method of claim 15 further comprising providing a magnetic surface at the distal end.

21. The method of claim 15 further comprising configuring the data telemetry unit to communicate with an external sensor.

22. The method of claim 15 further comprising configuring the data telemetry unit to communicate with contractility activity sensor.

23. The method of claim 15 further comprising configuring the data telemetry unit to communicate with a fluid leakage sensor.

24. The method of claim 15 further attaching a second pressure sensor the distal end, the second pressure sensor configured to provide a second pressure signal corresponding to a second fluid pressure, and further wherein the first pressure sensor is attached to the proximal end.