Self-Learning and Non-Invasive Bladder Monitoring System and Method - Patent application

Abstract

Embodiments disclosed herein are directed to a self-learning bladder volume monitoring system. The system may include a bladder volume (BV) system configured to measure the electrical impedance of a patient's bladder region and determine the amount of fluid located in the bladder using an impedance versus bladder volume model (BV model). Additionally, the system may measure the patient's total body water (TBW) and modify the BV model to account for variations in TBW in the tissue surrounding the bladder to provide a more accurate bladder volume measurement. The system may include a "training unit." The training unit may include one of a user input interface, an automatic urine volume monitoring system, an ultrasound system, or an intravesical pressure system configured to verify the amount of fluid in or emptied from the bladder and train the BV model.

Description

Summary of the Invention

[0001] Briefly summarized, embodiments disclosed herein relate to a self-learning and non-invasive bladder volume (BV) monitoring, urination volume measurement, and total body water monitoring system and related methods. The embodiments may use bio-impedance spectroscopy (BIS) and may be standalone or worn by the patient.

[0002] Heart failure (HF) is one of the most common causes of hospitalization, with a weakened heart causing patients to experience edema and other symptoms of fluid overload. The most common treatment for these patients is diuretics to remove excess fluid through urination and reduce fluid burden on the heart. A patient's urine output (UO) and total body water (TBW) are important indicators for assessing a patient's response to diuretic therapy. However, collecting accurate UO and TBW data can be challenging.

[0003] HF and similar patients admitted to an ICU or similar critical care setting may be fitted with an indwelling urinary catheter (Foley catheter), the output of which may be used to measure UO. Similarly, external catheter systems may be used, the output of which may also be used to measure UO. Some patients may be managed by intermittent catheterization. In these patients, the provider periodically measures the patient's bladder volume using a portable ultrasound device or scanner. When the patient's bladder is sufficiently full, the provider performs an intermittent catheterization procedure to drain the bladder. This process reduces the risk of infection associated with indwelling urinary catheters, but requires regular evaluation by the provider with a portable ultrasound bladder scanner, which can be time-consuming for the provider and intrusive for the patient. Alternatively, HF and similar patients may be semi-ambulatory and admitted to a general ward, where accurate UO collection, measurement, and recording present a significant clinical challenge.

[0004] Current technology for the measurement of UO in semi-ambulatory patients uses a variety of devices, such as urine collection hats, portable commodes, graduated urinals, and bedpans. However, these solutions have several limitations. Urine collection hats and other collection devices present infection control challenges and are frequently tipped over by patients and nurses, which can result in the loss of several hours of UO data. Inaccurate urination directly into the collection device can also lead to the loss of some UO data and inaccurate results. Furthermore, hospital staff must rely on the ability and compliance of patients to help collect, measure, and sometimes even record their UO data. Furthermore, voiding times are often not obtained accurately, limiting the assessment of renal function by donors who want to know the volume of urine produced during a specific time interval. Thus, manual measurement and recording of UO data by either the patient or trained clinicians leaves opportunities for error and also a greater risk of cross-contamination. Furthermore, voided fluid does not always accurately represent a patient's UO because a residual amount of fluid remains in the bladder after a urination event (called post-void fluid volume). The amount of post-void fluid remaining can vary widely from patient to patient. Thus, a comparison of pre-void bladder volume with post-void fluid volume and voided fluid volume can provide improved UO data for a patient.

[0005] Gathering accurate TBW can also be a challenge. Most TBW measurement systems require additional information about the patient, such as age, weight, height, sex, ethnicity, demographics, etc., and therefore apply regression-based algorithms based on what is "normal" for these patient parameters. However, such systems cannot account for atypical patients, such as HF patients or patients in similar critical care settings. Furthermore, the need for a high level of accuracy is much more important for such atypical patients, since even small degrees of variation can have dramatic consequences compared to those seen in normal healthy individuals.

[0006] The embodiments described herein relate to self-learning, non-invasive UO and TBW measurement devices and associated methods that can be incorporated into a healthcare professional's workflow. These devices can use bioimpedance spectroscopy (BIS) to accurately determine a patient's TBW / UO values ​​without relying solely on population-specific assumptions or regression-based algorithms. The embodiments include devices that can be free-standing or wearable and can be used with bedridden, semi-ambulatory, or ambulatory patients.

[0007] Disclosed herein is a system for measuring the amount of fluid in a patient's bladder, the system including a bladder volume monitoring system including an impedance sensor in contact with a skin surface of the patient, the bladder volume monitoring system configured to measure the electrical impedance of a portion of the patient's bladder and to determine a bladder volume value of the patient using a model, the bladder volume value being an estimated amount of fluid in the bladder; a training system configured to receive a urine output value relating to the amount of fluid voided from the bladder; and logic configured to determine a difference between the pre-urination bladder volume value and the post-urination bladder volume and urine output values, and to iteratively modify the model to reduce the difference between the pre-urination bladder volume value and the post-urination bladder volume and urine output values ​​to increase accuracy of the model.

[0008] In some embodiments, the bladder volume monitoring system uses one of bioimpedance analysis, bioimpedance spectroscopy, bioimpedance plethysmography, or bioimpedance tomography to determine the bladder volume value.

[0009] In some embodiments, the bladder volume monitoring system is configured to measure a first electrical impedance value before a urination event and a second electrical impedance value after a urination event to determine a bladder volume value.

[0010] In some embodiments, the impedance sensor includes a first sensor array having a first electrode configured to generate an excitation signal and a second electrode configured to measure the electrical impedance of the excitation signal through a bladder portion of the patient.

[0011] In some embodiments, the bladder volume monitoring system further includes a second sensor array including a third electrode configured to generate a second excitation signal and a fourth electrode configured to measure a second electrical impedance of the second excitation signal through a second portion of the patient to determine a total body water value of the patient.

[0012] In some embodiments, the logic obtains a total body water value and further modifies the model to reduce the difference between the bladder volume value and the urine output value to increase the accuracy of the model.

[0013] In some embodiments, the automated urine output training system includes a flow sensor coupled to one of the catheter, the drainage tube, or the collection container and configured to determine a urine output value.

[0014] In some embodiments, the training system includes an automatic urinary output training system including a valve configured to control the flow of voided fluid from the bladder and train the patient's bladder to a natural bladder cycle.

[0015] In some embodiments, the training system includes an interface to a network or electronic health record system configured to receive an input of the amount of fluid voided. In some embodiments, the training system includes a user interface configured to receive an input of the amount of fluid voided.

[0016] In some embodiments, the impedance sensor is disposed on a belt that is configured to be secured around the patient's torso and align the impedance sensor with a bladder portion of the patient.

[0017] In some embodiments, the bladder volume monitoring system further includes an accelerometer or a gyroscope configured to detect patient movement, and the logic is configured to receive a signal from one of the accelerometer or gyroscope and modify the model to increase accuracy of the patient's bladder volume value.

[0018] In some embodiments, the bladder volume monitoring system further includes an electromyography sensor configured to contact a skin surface of the patient and detect one of a contraction of the patient's detrusor muscle or a relaxation of the urethral sphincter to determine the occurrence of a bladder voiding event.

[0019] In some embodiments, the system is communicatively coupled to one of a network, a remote database, an intranet, the Internet, a cloud-based network, or an electronic health record system.

[0020] In some embodiments, the impedance sensor is in wireless communication with the bladder volume monitoring system, and one of the bladder volume monitoring system, the training system, or the logic is located in a stand-alone unit.

[0021] In some embodiments, the standalone unit includes one of a base station, a portable computing device, a monitor, a handheld device, a wearable device, a smart watch, a laptop, or a tablet device.

[0022] In some embodiments, the training system further includes one or both of an ultrasound training system and a pressure-based training system. Also disclosed is a bladder volume measurement system including a first sensor array including electrodes in contact with a patient's skin surface, the first sensor array configured to determine an electrical impedance value of the patient's bladder, an ultrasound system including a transducer in contact with the patient's skin surface, the ultrasound system configured to determine a volume of fluid in the patient's bladder, and a bladder volume monitoring system including logic configured to determine the volume of fluid in the bladder from the electrical impedance values ​​using a bladder volume model, and configured to iteratively validate the bladder volume model with the volume of fluid in the bladder as determined by the ultrasound system.

[0023] In some embodiments, one of the first sensor array or transducer is disposed on a belt configured to encircle a torso portion of the patient and secure the one of the first sensor array or transducer to a skin surface of the patient.

[0024] In some embodiments, the urine volume monitoring system uses one of bioimpedance analysis, bioimpedance spectroscopy, bioimpedance plethysmography, or bioimpedance tomography to determine the amount of fluid in the bladder from electrical impedance values.

[0025] In some embodiments, the first sensor array includes a first electrode configured to generate an excitation signal and a second electrode configured to measure an electrical impedance of the excitation signal through the patient's bladder.

[0026] In some embodiments, the urine volume monitoring system further includes a second sensor array including a third electrode configured to generate a second excitation signal and a fourth electrode configured to measure a second electrical impedance of the second excitation signal through a second portion of the patient to determine a total body water value of the patient.

[0027] In some embodiments, the urine volume monitoring system logic obtains a total body water value and modifies the patient's bladder volume model to increase its accuracy. In some embodiments, the bladder volume measurement system further includes an accelerometer or a gyroscope configured to detect patient movement, and the urine volume monitoring system logic is configured to receive a signal from one of the accelerometer or gyroscope and modify the bladder volume model to increase the accuracy of the patient's bladder volume model.

[0028] In some embodiments, the bladder volume measurement system further includes an electromyography sensor configured to contact a skin surface of the patient and detect one of a contraction of the patient's detrusor muscle or a relaxation of the urethral sphincter to determine the occurrence of a bladder voiding event.

[0029] In some embodiments, the urine volume monitoring system logic is communicatively coupled to one of a network, a remote database, an intranet, the Internet, a cloud-based network, or an electronic health record system.

[0030] In some embodiments, the first sensor array is in wireless communication with the urine volume monitoring system, and one of the urine volume monitoring system or the ultrasound system is located in a stand-alone unit.

[0031] In some embodiments, the standalone unit includes one of a base station, a portable computing device, a monitor, a handheld device, a wearable device, a smart watch, a laptop, or a tablet device.

[0032] In some embodiments, the bladder volume system further includes a user interface configured to receive an input of the amount of voided fluid. In some embodiments, the ultrasound transducer or system may be removed from the system after fully training the electrical impedance element of the bladder volume system.

[0033] Also disclosed is a method of measuring the amount of fluid in a patient's bladder, the method including measuring a first electrical impedance value of the patient's bladder, determining the amount of fluid in the bladder from the electrical impedance value using a bladder volume model, measuring the amount of fluid voided from the bladder, and modifying the bladder volume model to minimize a difference between the amount of fluid in the bladder as determined by the electrical impedance value and the amount of fluid voided from the bladder.

[0034] In some embodiments, the method further includes measuring a first electrical impedance value before the amount of fluid is voided from the bladder and measuring a second electrical impedance value after the amount of fluid is voided from the bladder to determine the amount of fluid originally in the bladder.

[0035] In some embodiments, the method further includes using one of bioimpedance analysis, bioimpedance spectroscopy, bioimpedance plethysmography, or bioimpedance tomography to determine the amount of fluid in the bladder from the electrical impedance values.

[0036] In some embodiments, the method further includes measuring an electrical impedance value of the patient's body part, determining a total body water value of the patient, and modifying the bladder volume model to increase accuracy of the bladder volume model in determining the amount of fluid in the bladder.

[0037] In some embodiments, measuring an electrical impedance value of the patient's bladder includes a first sensor array including a first electrode configured to generate an excitation signal and a second electrode configured to measure the electrical impedance of the excitation signal through the patient's bladder.

[0038] In some embodiments, the method further includes detecting patient movement using one of an accelerometer or a gyroscope, and modifying the bladder volume model to increase accuracy of the bladder volume model in determining the amount of fluid in the bladder from the electrical impedance values.

[0039] In some embodiments, the method further includes detecting one of a contraction of the patient's detrusor muscle or a relaxation of the patient's urethral sphincter using an electromyography sensor in contact with a skin surface of the patient to determine the occurrence of a bladder voiding event.

[0040] In some embodiments, the method further includes communicating the value of the amount of fluid in the bladder or the amount of fluid voided from the bladder to one of a network, a remote database, an intranet, the Internet, a cloud-based network, or an electronic health record system.

[0041] In some embodiments, the method further includes controlling the flow of fluid voided from the bladder to improve the bladder volume model and train the patient's bladder to a natural bladder cycle.

[0042] In some embodiments, the method further includes a training system configured to determine a first volume of fluid in the bladder before the volume of fluid is voided from the bladder, and a second volume of fluid in the bladder after the volume of fluid has been voided from the bladder.

[0043] In some embodiments, the training system includes one of an ultrasound training system, an automated urinary output training system, or a bladder pressure training system, a network or electronic health record connected training system, or a user input training system.

[0044] Also disclosed is a device for measuring an amount of fluid in a patient's bladder, the device including an article of clothing secured around at least a torso portion of the patient, a sensor disposed on an interior surface of the article of clothing, and a computer device communicatively coupled to the sensor and including logic configured to determine an amount of fluid in the patient's bladder.

[0045] In some embodiments, the article of apparel comprises a t-shirt, briefs, disposable underwear, or a belt. The sensor comprises one of an electrical impedance modality, an ultrasound modality, or an optical laser modality. In some embodiments, the device further comprises a first sensor array including a first electrode and a second electrode positioned proximate to the patient's bladder and configured to determine the amount of fluid in the bladder using bioimpedance spectroscopy. In some embodiments, the device further comprises a second sensor array configured to determine a total body water index. In some embodiments, the computing device is communicatively coupled to one of a network or an electronic health record system.

[0046] Also disclosed is a cystometry device that includes a sensor array configured to detect electrical impedance values ​​of a patient's bladder, and BV logic configured to determine a volume of fluid in the bladder from the electrical impedance values ​​using bioimpedance spectroscopy.

[0047] In some embodiments, the bladder volume measuring device further includes a second sensor array configured to detect a second electrical impedance value of the patient's body part, and BV logic configured to determine a total body water value from the second electrical impedance value. In some embodiments, one of the first sensor array or the second sensor array is supported by an article of clothing and secured against a skin surface of the patient. In some embodiments, the article of clothing includes one of a belt, a T-shirt, pants, or underwear. In some embodiments, the bladder volume measuring device further includes one of an ultrasonic transducer or an optical laser sensor configured to measure the amount of fluid in the bladder. In some embodiments, the bladder volume measuring device further includes a computer device communicatively coupled thereto, the computer device also communicatively coupled to one of a network or an electronic health record system.

[0048] Also disclosed is a method of measuring the amount of fluid in a patient's bladder, the method including securing an article of clothing having a sensor disposed on an inner surface thereof around the torso, engaging the sensor with a skin surface of the patient, measuring an electrical impedance value of the patient's bladder, and using bioimpedance spectroscopy to determine the amount of fluid present in the bladder.

[0049] In some embodiments, the article of clothing includes one of a belt, a t-shirt, pants, or underwear. In some embodiments, the method further includes generating an excitation signal from the sensor at a first electrode and detecting the excitation signal at a second electrode to determine an electrical impedance value. In some embodiments, the method further includes determining a total body water value of the patient's body part. In some embodiments, the method further includes determining an amount of fluid present in the bladder using one of an ultrasound modality or an optical laser modality. In some embodiments, the method further includes communicating one of the electrical impedance value or the value of the amount of fluid present in the bladder to one of a computing device, a network, or an electronic health record system.

[0050] Also disclosed is a standing scale device including a step plate configured to support a standing patient and including a first electrode, a handle supported by a post extending from the step plate and configured to be grasped by both hands of the patient, the handle including a second electrode, and TBW logic configured to measure the patient's electrical impedance and determine a total body water value of the patient using bioimpedance spectroscopy.

[0051] In some embodiments, the standing scale device further includes a pressure sensor disposed within the footboard and configured to determine a weight measurement of the patient. In some embodiments, the standing scale device further includes a second sensor array including a third electrode and a fourth electrode configured to determine a bladder volume value of the patient. In some embodiments, the standing scale device further includes communications logic configured to transmit the total body water value of the patient to one of a network or an electronic health record system.

[0052] Also disclosed is a total body water measurement device including a first electrode configured to contact a skin surface proximate the patient's ankle, a second electrode configured to contact a skin surface proximate the patient's wrist, and TBW logic configured to determine an electrical impedance value between the first electrode and the second electrode and to determine a TBW value of the patient using bioimpedance spectroscopy.

[0053] In some embodiments, one of the first electrode or the second electrode is secured in place by a bracelet. One of the first electrode or the second electrode has a coating on its skin-facing surface, the coating comprising one of a hydrogel or a urethane material. In some embodiments, the total body water measurement device further comprises a second sensor array having a third electrode and a fourth electrode configured to detect a second electrical impedance value of the patient, and the TBW logic is configured to determine a bladder volume value from the second electrical impedance value. In some embodiments, the total body water measurement device further comprises communication logic configured to communicate the TBW value to one of a network or an electronic health record system.

[0054] Also disclosed is a method of measuring a total body water value of a patient, the method comprising coupling a first electrode to a first area of ​​the patient, coupling a second electrode to a second area of ​​the patient, measuring an electrical impedance value between the first electrode and the second electrode, and determining the total body water value of the patient using bioimpedance spectroscopy.

[0055] In some embodiments, the first region is one of a foot region or a hand region, and the second region is one of a foot region or a hand region. One of the first electrode or the second electrode is secured in place by a bracelet. One of the first electrode or the second electrode is provided with a coating on its skin-facing surface, the coating comprising one of a hydrogel or a urethane material.

[0056] In some embodiments, the method further includes communicating the TBW value to one of a network or an electronic health record system. In some embodiments, the method further includes detecting a second electrical impedance value of the patient and determining the bladder volume value from the second electrical impedance value.

[0057] A more particular description of the present disclosure will be made by reference to specific embodiments that are illustrated in the accompanying drawings. It should be understood that these drawings depict only typical embodiments of the invention and should not be considered as limiting its scope. Exemplary embodiments of the invention will be described and explained with additional specificity and detail through the use of the accompanying drawings. [Brief description of the drawings]

[0058] [Figure 1A] 1 illustrates a bladder volume monitoring (BVM) device in an exemplary environment of use, according to embodiments disclosed herein. [Figure 1B] 1 illustrates a bladder volume monitoring (BVM) device according to an embodiment disclosed herein. [Diagram 2] FIG. 1C shows a schematic diagram of the BVM device of FIG. 1B according to an embodiment disclosed herein. [Diagram 3] 1 shows a cross-sectional view of a patient wearing a BVM device according to an embodiment disclosed herein. [Figure 4] 1 illustrates a wearable BVM device according to an embodiment disclosed herein. [Diagram 5]1 shows a schematic diagram of a self-learning non-invasive bladder monitoring system in an exemplary environment of use according to embodiments disclosed herein. [Figure 6] 1 illustrates an exemplary urine collection system according to embodiments disclosed herein. [Figure 7] 1 shows a schematic diagram of a self-learning non-invasive bladder monitoring system including an automated urine volume-based training system according to an embodiment disclosed herein. [Figure 8] 1 shows a schematic diagram of a non-invasive bladder monitoring system including an ultrasound-based training system according to an embodiment disclosed herein. [Figure 9] 1 shows a schematic diagram of a non-invasive bladder monitoring system including a pressure-based training system according to an embodiment disclosed herein. [Figure 10A] 1 illustrates an example bio-impedance versus bladder volume model according to embodiments disclosed herein. [Figure 10B] 1 illustrates an example bio-impedance versus bladder volume model according to embodiments disclosed herein. [Figure 10C] 1 illustrates an example bio-impedance versus bladder volume model according to embodiments disclosed herein. [Figure 11A] 1 shows a perspective view of a non-invasive TBW measuring device according to an embodiment disclosed herein. [Figure 11B] 1 illustrates an exemplary use environment for a non-invasive TBW measurement device according to embodiments disclosed herein. [Figure 12] 1 shows a schematic diagram of a non-invasive TBW measurement device according to an embodiment disclosed herein. [Figure 13] 1 illustrates a perspective view of a wearable non-invasive TBW measurement device in an exemplary use environment, according to an embodiment disclosed herein. [Figure 14A] 14 illustrates a cross-sectional view of a sensor of the non-invasive TBW measurement device of FIG. 13 according to an embodiment disclosed herein. [Figure 14B]14 shows a perspective view of the sensor and bracelet assembly of the non-invasive TBW measurement device of FIG. 13 according to an embodiment disclosed herein. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0059] term Before some specific embodiments are disclosed in more detail, it should be understood that the specific embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that the specific embodiments disclosed herein can have features that can be easily separated from the specific embodiment and can be optionally combined with or substituted for features of any of the other numerous embodiments disclosed herein. With respect to the terms used herein, it should also be understood that the terms are for the purpose of describing some specific embodiments, and that the terms do not limit the scope of the concepts provided herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps within a group of features or steps, and do not provide sequential or numerical limitations. For example, "first", "second", and "third" features or steps do not necessarily have to appear in that order, and a particular embodiment that includes such features or steps is not necessarily limited to three features or steps. Labels such as "left", "right", "upper", "lower", "front", "rear", etc. are used for convenience and do not imply, for example, a specific fixed position, orientation, or direction. Instead, such designations are used, for example, to reflect relative positions, orientations, or directions. The singular forms "a", "one", and "said" also include plural references unless the context clearly dictates otherwise.

[0060] As used herein, the term "communication" generally refers to related data received, transmitted, or exchanged within a communication session. The data can include multiple packets, where "packet" generally means a series of bits or bytes having a defined format. Alternatively, the data may include individual or several packets carrying related payloads, such as, for example, a single web page received over a network. Additionally, as used herein, the terms "about," "approximately," or "substantially" for any numerical value or range indicate an appropriate tolerance that enables a portion or collection of components to function for its intended purpose as described herein.

[0061] In the following description, certain terms are used to describe features of the invention. For example, in certain contexts, the term "logic" refers to hardware, firmware, and / or software configured to perform one or more functions. As hardware, logic may include circuitry having data processing or storage capabilities. Examples of such circuitry may include, but are not limited to or restricted to, a microprocessor, one or more processor cores, a programmable gate array, a microcontroller, a controller, an application specific integrated circuit (ASIC), wireless receiver, transmitter and / or transceiver circuitry, semiconductor memory, or combinatorial logic.

[0062] Alternatively, logic may be software, such as executable code in the form of an executable application, an application programming interface (API), a subroutine, a function, a procedure, an applet, a servlet, a routine, source code, object code, a shared library / dynamic load library, or one or more instructions. The software may be stored on any type of suitable non-transitory storage medium, or on a transitory storage medium (e.g., an electrical, optical, acoustic, or other form of propagated signal, such as a carrier wave, an infrared signal, or a digital signal). Examples of non-transitory storage media include, but are not limited to, non-transitory storage, such as programmable circuits, semiconductor memory, volatile memory (e.g., any type of random access memory "RAM"), or transitory storage, such as non-volatile memory (e.g., read only memory "ROM", power backed RAM, flash memory, phase change memory, etc.), solid state drives, hard disk drives, optical disk drives, or portable memory devices. As firmware, the executable code may be stored on a persistent storage device. In one embodiment, the logic described herein may rely on heuristics, machine learning, artificial intelligence (AI), neural networks, or other data processing techniques to perform the functions described.

[0063] The term "computing device" may be interpreted as an electronic device having data processing and / or network interface capabilities, such as network connectivity to physical or virtual networks, such as a public network (e.g., the Internet), a private network (e.g., a wireless data telecommunications network, a local area network "LAN," etc.), a public cloud network, a virtual private cloud, etc. Examples of computing devices may include, but are not limited or restricted to, servers, end-point devices (e.g., notebook computers, smartphones, "wearable" devices, smart watches, tablets, desktop or laptop computers, netbooks, or any general-purpose or special-purpose user-controlled electronic device), mainframes, routers, etc.

[0064] The term "network" may include public and / or private networks in a centralized or distributed configuration, based on wired or wireless interconnections. A network may include, but is not limited or restricted to, a local area network (LAN), a wireless local area network (WLAN), a virtual private network (VPN), an intranet, the Internet, a "cloud"-based network, or similar network configuration. A "message" generally refers to information transmitted in one or more electrical signals that collectively represent data stored electronically in a predefined format. Each message may be in the form of one or more packets, frames, HTTP-based transmissions, or any other series of bits having a defined format.

[0065] The term "computerized" generally denotes that any corresponding operations are performed by hardware in combination with software and / or firmware.

[0066] The term "wireless" communication may include Bluetooth, WiFi, Near Field Communication (NFC), GSM, infrared, microwave, and the like. With respect to "proximal," for example, the "proximal portion" or "proximal end portion" of a catheter disclosed herein includes the portion of the catheter intended to be near the clinician when the catheter is used on a patient. Similarly, for example, the "proximal length" of a catheter includes the length of the catheter intended to be near the clinician when the catheter is used on a patient. For example, the "proximal end" of a needle includes the end of the catheter intended to be near the clinician when the catheter is used on a patient. The proximal portion, proximal end portion, or proximal length of a catheter can include the proximal end of the catheter, but the proximal portion, proximal end portion, or proximal length of a catheter need not include the proximal end of the catheter. That is, unless otherwise suggested by context, the proximal portion, proximal end portion, or proximal length of a catheter is not the terminal portion or terminal length of the catheter.

[0067] With respect to "distal," for example, the "distal portion" or "distal end portion" of a catheter disclosed herein includes the portion of the catheter that is intended to be near or in a patient when the catheter is used with the patient. Similarly, for example, the "distal length" of a catheter includes the length of the catheter that is intended to be near or in a patient when the catheter is used with the patient. For example, the "distal end" of a needle includes the end of the catheter that is intended to be near or in a patient when the catheter is used with the patient. The distal portion, distal end portion, or distal length of a catheter can include the distal end of the catheter, but the distal portion, distal end portion, or distal length of a catheter need not include the distal end of the catheter. That is, unless otherwise indicated by the context, the distal portion, distal end portion, or distal length of a catheter is not the terminal portion or terminal length of the catheter. Unless otherwise defined, all scientific and technical terms used herein have the same meaning as commonly understood by those of ordinary skill in the art.

[0068] A patient-wearable device for non-invasive measurement of bladder volume 1A-1B illustrate a Bladder Volume Monitor (BVM) device 100 in an exemplary environment of use. In one embodiment, the BVM 100 may be wearable and may non-invasively monitor the amount of fluid in the bladder 12 of the patient 10, referred to as the "BV value." In one embodiment, the BVM 100 may include one or more of a first sensor array 102 and a second sensor array 104 that contact a skin surface of the patient 10 and are communicatively coupled to a circuit 108, either wired or wirelessly. A "sensor array" as used herein may include one or more sensors configured to transmit and / or receive a signal output in a first modality and generate an output in a second modality. The first modality and the second modality may be the same or different. Exemplary modalities may include optical, electrical, acoustic, electro-impedance, etc.

[0069] 2, the circuitry 108 may include one or more of a processor 110, a data store 112, a power source 114, one or more logics 116, a user interface 118, or combinations thereof. In one embodiment, the BVM device 100 may include BV logic 116A communicatively coupled to one or more of the first sensors 102 and configured to accurately measure a BV value, i.e., the amount of fluid in the bladder 12 of the patient 10. In one embodiment, the BVM 100 may further include communication logic 116C configured to communicatively couple to a network 90 and / or a remote computing device or database 80.

[0070] Exemplary network 90 may include, for example, a local area network (LAN), a hospital network, an intranet, the Internet, a “cloud” based network, etc. Exemplary remote computing device or database 80 may include a computing device, a mobile device, a “smartphone,” a tablet, a laptop, a mainframe, a server, an electronic health record (EHR) system, etc. In one embodiment, remote computing device 80 may include a handheld device, etc. Handheld device 80 may include a user interface 118 configured to allow a user or clinician to input additional information. Exemplary additional information may include information about the patient (height, weight, age, sex, etc.), bladder voiding events (number, amount, date, time, etc.), fluid intake (number, amount, date, time, etc.), combinations thereof, etc. In one embodiment, as described in more detail herein, BVM 100 may obtain this additional information from remote database 80 or network 90 to further improve the accuracy of BV logic 116A.

[0071] In one embodiment, the first sensor 102 may be placed on the skin surface of the patient 10 and secured in place by adhesive, adhesive tape, etc. In one embodiment, the sensor 102 may be placed on a belt 120, or similar article of clothing, configured to secure the sensor 102 against the skin surface of the patient 10. Exemplary articles of clothing may include belts, t-shirts, pants, underwear, or similar form-fitting garments configured to hold the sensor securely against the skin surface of the patient 10.

[0072] As shown in FIGS. 1A-3, in one embodiment, a belt 120 may include a sensor 102 disposed on an inner surface thereof. The belt 120 may be worn around the torso of the patient 10 and may press the sensor 102 against and maintain contact with the skin surface of the patient 10. In one embodiment, one or more sensors 102 may be disposed within a lining such as underwear, a t-shirt, jogging pants, combinations thereof, and configured to press the sensor 102 against the skin surface of the patient 10, as described in more detail herein. Advantageously, the elastic nature of the article of clothing may ensure comfortable contact between the sensor 102 and the skin surface. In one embodiment, the sensor 102 may be attached directly to the patient's skin surface using a pressure-responsive adhesive or the like.

[0073] In one embodiment, as shown in FIG. 2, one or more of the components of the circuit 108, such as the processor 110, the data store 112, the power source 114, or the logic 116, may be located in a stand-alone unit separate from the belt 120 and the sensor 102 assembly and communicatively coupled thereto, for example, by wired or wireless communication. In one embodiment, the circuit 108 or one or more of its components may be located in a stand-alone computing device or a "base station" located in close proximity to the patient 10. In one embodiment, the circuit 108 or one or more of its components may be located in a handheld device, a "wearable" device (e.g., a smart watch), a tablet-type device, or a laptop computer. In one embodiment, the circuit 108 or one or more of its components may be carried by a user in a waist bag or "fanny pack" and communicatively coupled, either wired or wirelessly, to the sensor 102 located in the belt 120 or an article of clothing, as described herein. In one embodiment, the circuit 108 may be removable from the belt 120 and the sensor 102 assembly. This allows the belt 120 and sensor 102 assembly to be washed separately or allows the old belt 120 and sensor 102 assembly to be discarded while a new belt 120 and sensor 102 assembly is coupled to the BVM system 100 for the same patient or for a new patient.

[0074] FIG. 3 shows a cross-sectional view of a patient 10 wearing a BVM device 100 worn around the torso. In one embodiment, a belt 120 may be tightened around the patient 10 with a fastener at the back to prevent removal of the device 100 or non-compliance of the patient 10. In one embodiment, the belt 120 may be adjustable to accommodate patients 10 of different sizes. In one embodiment, the belt 120 may include one or more adjustable portions 124 disposed between the one or more sensors 102. The adjustable portions may be elasticated, slip lock buckles, ladder lock buckles, etc. The adjustable portions 124 of the belt 120 may be configured to adjust to accommodate patients of different sizes while maintaining the relative position of the sensors 102 around the torso of the patient 10.

[0075] In one embodiment, the belt 120 may include one or more markers 122 to facilitate alignment to anatomical features of the patient. For example, as shown in FIG. 2, a first marker 122A may align with the navel region and / or a second marker 122B may align with the spine region of the patient 10. Advantageously, the one or more markers 122 may facilitate alignment of the one or more sensors 102 with the correct location on the patient 10.

[0076] In one embodiment, the first sensor array 102 may use one or more modalities to measure the amount of fluid in the bladder and / or triangulate the position of the bladder 12. Advantageously, the BVM device 100 may triangulate the position of the bladder 12 to facilitate distinguishing fluid measurements of the bladder 12 from fluid measurements of the surrounding tissues, providing a more accurate measurement of the fluid present within the bladder 12. Exemplary modalities may include ultrasound, laser, electrical impedance, or a combination thereof.

[0077] In one embodiment, the BVM 100 may use an electrical impedance modality to determine the location of the bladder 12 and / or the amount of fluid present in the bladder 12. The electrical impedance modality BVM device 100 may include a first sensor array 102 including a first electrode 102A configured to generate an excitation signal and a second electrode 102B configured to detect the excitation signal of the first electrode 102A. The BVM 100 may determine a decrease in signal strength between the first electrode 102A and the second electrode 102B to determine the electrical impedance of body tissue disposed between the electrodes. In one embodiment, a hydrogel, urethane gel, or similar conductive gel may be disposed between the electrodes 102A, 102B and the skin surface to increase electrical conductivity therebetween. In one embodiment, the first sensor array 102 may include a single sensor 102A configured to both generate and detect the excitation signal. Similarly, the second sensor array 104 may include a single sensor 104A configured to both generate an excitation signal and detect an excitation signal.

[0078] In one embodiment, the first sensor array 102 may be positioned at the patient's navel region closest to the bladder 12, with the first electrode 102A positioned on the left side of the bladder 12 and the second electrode 102B positioned on the right side of the bladder 12. The excitation signal may travel through the bladder 12 from the first electrode 102A to the second electrode 102B. Different amounts of fluid in the bladder 12 may affect the electrical impedance of the excitation signal as it passes through the bladder 12.

[0079] In one embodiment, the second sensor array 104 may include a third electrode 104A and a fourth electrode 104B and may be communicatively coupled to the TBW logic 116B. The second sensor array 104 and the TBW logic 116B may be configured to detect and determine one or both of the location of the bladder 12 and the amount of fluid, i.e., total body water (TBW), within the body 14 of the patient 10, i.e., within tissues external to the bladder 12. The second sensor array 104 may be positioned at a body site other than the navel region. For example, as shown in FIG. 3, the second sensor array 104 may be positioned at a back portion of the patient 10, with the third electrode 104A and the fourth electrode 104B disposed on either side of the spine. However, it will be appreciated that the second sensor array 104 may be positioned at other regions of the patient 10 without departing from the spirit of the present invention. In one embodiment, the electrical impedance value determined by the second sensor array 104 and the TBW logic 116B may determine a total body water (TBW) value for the patient 10.

[0080] In one embodiment, the BVM 100 can detect both the amount of fluid accumulated in the bladder 12 as well as any changes in the TBW of the patient 10. In one embodiment, the BVM 100 can use a bioimpedance spectroscopy (BIS) model to determine one or both of the BV and TBW values ​​from the bioimpedance values. The BVM 100 can be configured to modify the BIS model to "learn" the individual patient 10. The BVM 100 can use additional information from the target patient or data aggregated from one or more other patients different from the target patient. The additional information can be UO data entered into the BVM 100 by the user interface 118 as described herein, automated UO data from an additional medical system, fluid intake from an additional medical system, etc. FIGS. 10A-10C provide an exemplary BIS model, e.g., a bladder volume model (BV model) 150, configured to determine BV values ​​from impedance measurements as described in more detail herein. Similarly, a TBW model can determine TBW values ​​from impedance values ​​in a similar manner. Additionally, a lung fluid volume (LFV) model may determine LFV values ​​from impedance values ​​in a similar manner, as described in more detail herein. In one embodiment, the BVM 100 may modify the BIS model to compensate for the TBW value of the tissue surrounding the bladder 12 to determine an accurate BV value. In one embodiment, the BV and TBW values ​​may be immediately communicated in real time to the network 80 or EHR 90 for further analysis.

[0081] In one embodiment, the BVM 100 may obtain additional information from either the remote database 80 or the network 90 to further refine the BIS model determined by the BV logic 116A. In one embodiment, the remote database or computer device 80 may include a handheld device or the like. The handheld device 80 may include a user interface 118 configured to allow the patient 10, a user, or a clinician to input additional information. Exemplary additional information may include information about the patient (e.g., height, weight, age, sex, etc.), bladder voiding events (e.g., number, amount, date, time, etc.), fluid intake (e.g., number, amount, date, time, etc.), combinations thereof, etc., by the patient 10, as described herein.

[0082] Advantageously, the BVM 100 may monitor and communicate changes in the patient's 10 BV, TBW, or water intake values ​​over time. Such data may be essential to clinicians, for example, in determining whether diuretic therapy is working for HF or similar patients. Additionally, the BIS model (e.g., BV model 150) used by the BVM 100 may accommodate different body compositions of different patients 10. This may be particularly important when measuring bladder volume in HF or similar patients who may have atypical body morphology and atypical body composition. Of note, some BV and TBW measurement systems rely on bio-impedance analysis (BIA), which requires a pre-determined assumption that the patient has a "normal" body morphology and body composition. However, these assumptions may not be as applicable to patients in critical care settings, leading to less accurate results.

[0083] In one embodiment, the BVM 100 may use an ultrasound acoustic modality to triangulate the location of the bladder 12 and determine the amount of fluid in the bladder 12. The ultrasound modality BVM 100 may include a first transducer 102A and a second transducer 102B configured to emit and detect reflected ultrasound signals within the patient 10. In one embodiment, the transducer 102A may be a transducer array that both emits and detects reflected ultrasound signals. In one embodiment, a hydrogel, urethane gel, or similar acoustically conductive gel may be placed between the sensor 102 and the skin surface to increase acoustic conductance therebetween.

[0084] The ultrasound modality BVM 100 may detect changes in density of the subcutaneous tissue closest to the first sensor 102A and the second sensor 102B to triangulate the location and dimensions of the bladder 12. Furthermore, changes in the reflected signal may further determine the amount of fluid in the bladder 12. For example, if there is relatively little fluid in the bladder 12, the reflected ultrasound signal will show little or no difference from the surrounding tissue. If the bladder 12 is relatively full of fluid, the reflected signal will show more difference from the surrounding tissue, allowing for an estimate of the bladder volume. In other words, the ultrasound bladder volume is based on edge detection, where the ultrasound determines changes in signal reflection to determine the bladder wall / urine boundary. A three-dimensional volume model is then calculated to estimate the bladder fluid volume.

[0085] In one embodiment, the ultrasound modality BVM 100 may include a first array transducer 102 and a second array transducer 104 configured to transmit and detect reflected ultrasound signals, respectively, into the body of the patient 10. The ultrasound modality BVM 100 may measure reflected signals from each of the first array transducer 102 and the second array transducer 104 to further refine the triangulation of the location of the bladder 12 and the determination of its size and volume.

[0086] In one embodiment, one or more sensors 102 may use an optical modality to determine one of the location of the bladder 12 or the amount of fluid therein. For example, a first sensor array 102A, 102B may direct a laser light signal into the patient 10 and detect a reflected light signal to determine one of the location of the bladder 12 or the amount of fluid therein. In one embodiment, multiple optical sensor arrays 102, 104 may increase the accuracy of the location of the bladder 12 and the amount of fluid therein.

[0087] 4, in one embodiment, the BVM 100 may be included in an article of clothing, such as a T-shirt 126. As will be appreciated, the T-shirt 126 is exemplary and embodiments of the present invention may be used with a variety of articles of clothing, including belts, T-shirts, pants, underwear, or similar form-fitting garments configured to securely apply the first sensor array 102 and / or the second sensor array 104 to the patient's skin surface. The first sensor array 102 and / or the second sensor array 104 may be disposed within the lining of the T-shirt 126, and the T-shirt 126 may be formed of a form-fitting material such that the sensors are secured securely against the patient's 10 skin surface.

[0088] In one embodiment, the T-shirt 126 may include a first sensor array 102 disposed about a torso portion of the T-shirt 126 and configured to determine a BV value, as described herein. The first sensor array 102 may include one or more sensors that may use the same or different modalities, as described herein. For example, the first sensor array 102 may include six sensors disposed about a torso portion of the T-shirt 126 and configured to contact a skin surface of the patient 10 about the location of the bladder 12 when the T-shirt 126 is worn by the patient 10. Each of the six sensors may use the same or different modalities to determine a BV value.

[0089] In one embodiment, as described herein, the T-shirt 126 may include a second sensor array 104 including one or more sensors that may use the same or a different modality. The second sensor array 104 may be positioned on a different portion of the T-shirt 126, such as the arm portion, and may be configured to determine a TBW value for the patient 10. Advantageously, the second sensor array 104 may be positioned spaced apart from the first sensor array 102 to distinguish BV data from TBW data.

[0090] In one embodiment, T-shirt 126 may further include one or more components of BVM 100 or circuitry 108, such as processor 110, data store 112, power source 114, one or more logics 116, user interface 118, or combinations thereof. These components may be sewn into the lining of the T-shirt and may be communicatively coupled to first sensor array 102 or second sensor array 104, either by wire or wirelessly.

[0091] In one embodiment, one or more components of the BVM 100 or circuitry 108 may be located remotely from and wirelessly coupled to the T-shirt 126. For example, one of the first sensor array 102 or the second sensor array 104 may be communicatively coupled to a computing device, handheld device, “base station,” or similar device, which may include one or more components of the BVM 100 or circuitry 108, i.e., processor 110, data store 112, power source 114, one or more logics 116, user interface 118, or a combination thereof.

[0092] A self-learning, non-invasive bladder monitoring system 5 illustrates an exemplary self-learning, non-invasive bladder monitoring system (system) 200, including a bladder volume monitoring system (BVM) 100 and a training system, such as an automated urinary output training system (AUO) 300. As illustrated, the AUO training system 300 may be directly coupled to the system 200, either by wired or wireless communication. In one embodiment, the AUO training system 300 may be indirectly coupled to the system 200, by one or both of a network 90 and a remote computing device 80.

[0093] The system 200 may be configured to non-invasively detect the amount of fluid in the bladder 12 of the patient 10. The system 200 may use one or more modalities to determine a bladder volume (BV) index of the patient 10. Exemplary modalities may include electrical impedance, ultrasound, optical modalities, or combinations thereof, as described herein. Additionally, the system 200 may determine a total body water (TBW) index of the patient 10, as described herein. In one embodiment, the system 200 may use the TBW value to improve the accuracy of the BV value of the patient 10.

[0094] In one embodiment, the system 200 may also include a training system configured to independently verify the amount of fluid in the bladder 12 and "train" the BVM 100 to improve accuracy. In one embodiment, the training system may include an automatic urine output training system (AUO) 300 configured to automatically determine the amount of fluid voided by the patient 10 (urinary output value or "UO" value). The system 200 may use the AUO value to modify the bioimpedance vs. bladder volume model (BV model) 150 to "learn" the particular patient 10 and provide improved, personalized BV and / or TBW data. Other training systems may include an ultrasound-based training system 400 or a pressure-based training system 500, as described in more detail herein.

[0095] In one embodiment, once the BVM 100 has been trained on a particular patient 10, the training system 300, 400, 500 may be removed from the system 200, and the system 200 non-invasively records the BV and / or TBW data. In one embodiment, one or more of the training systems 300, 400, 500 may be directly communicatively coupled to the system 200 by wired or wireless communication. In one embodiment, one or more of the training systems 300, 400, 500 may be indirectly communicatively coupled to the system 200 by the network 90 and / or remote computer device 80. The BV and / or TBW data may also be communicated to the network 90 and / or a remote database or remote computer device 80 (e.g., an electronic health record system, "EHR") for further analysis. Patient-specific BV or TBW data may be important for assessing renal function and determining the effectiveness of diuretic therapy in problem patients. Exemplary problem patients may include HF patients with various comorbidities or atypical body composition.

[0096] 6 illustrates an exemplary urine collection system 30 including a catheter 32, a drainage tube 34, and a collection container 36. The catheter 32 may be a Foley catheter, an indwelling urethral catheter, a balloon catheter, a non-balloon catheter, a suprapubic catheter, a ureteral catheter, a nephrostomy catheter, or a similar device configured to drain fluid from a patient, such as to drain urine from the bladder 12 of the patient 10. The drainage tube 34 may be configured to drain fluid from the catheter 32 to a collection container 36.

[0097] 7 shows a schematic diagram of a system 200 including a BVM 100 and an AUO-based training system 300. In one embodiment, the system 200 may include a processor 210, a data store 212, a power source 214, one or more logics 216 (e.g., communication logic 216C), a user interface 218, or a combination thereof. In one embodiment, the BVM 100 may include a processor 110, a data store 112, a power source 114, or a combination thereof. The processor 110, the data store 112, or the power source 114 of the BVM 100 may be in addition to or in place of the processor 210, the data store 212, or the power source 214 of the system 200. Thus, the BVM 100 may be a stand-alone unit communicatively coupled to and optionally removable from the system 200. Alternatively, the BVM 100, or components thereof, may be integrated with the system 200 as a single unit.

[0098] In one embodiment, the BVM 100 may further include one or more logics 116, as well as one or more sensor arrays, e.g., the first sensor array 102, the second sensor array 104, communicatively coupled thereto and configured to detect and determine one or both of a bladder volume (BV) value, a total body water (TBW) value, and a total body water (TBW) value. In one embodiment, the BVM 100 may measure one of the BV or TBW values ​​using one of bio-impedance analysis (BIA), bio-impedance spectroscopy (BIS), bio-impedance plethysmography (BIP), or bio-impedance tomography (BIT). However, it will be appreciated that other methods of measuring the BV or TBW values ​​using electrical impedance, ultrasound, or optical (e.g., laser) modalities are also considered to be within the scope of the present invention.

[0099] In one embodiment, the BIS uses electrical impedance to measure the hydration of the patient 10. An excitation signal is emitted by a first sensor, e.g., the first electrode 102A, and detected by a second sensor, e.g., the second electrode 102B. The first electrode 102A and the second electrode 102B can be positioned across the portion of the patient 10 to be measured. The amount of impedance to the signal between the first electrode 102A and the second electrode 102B can be correlated to the total hydration. It should be noted that bioimpedance spectroscopy is different from bioimpedance analysis (BIA). BIA relies on generalizations in the shape, size, composition, and demographics of patients. These generalizations may not be as applicable to critical care patients whose conditions are already different from the general population, e.g., HF patients or patients with hypervolemia.

[0100] In one embodiment, a first sensor array 102 including a first electrode 102A and a second electrode 102B may be placed on the abdomen of the patient 10 on either side of the navel region. The first sensor array 102 may be communicatively coupled, either wired or wirelessly, to the BV logic 116A and configured to transmit and receive electrical signals to determine the impedance of the bladder region 12 of the patient 10. Thus, the BV logic 116A may determine the amount of fluid in the bladder 12 of the patient 10.

[0101] In one embodiment, the second sensor array 104 may include a third electrode 104A and a fourth electrode 104B and may be positioned on a body portion 14 of the patient 10, such as the patient's back, on either side of the spine. The second sensor array 104 may be communicatively coupled, either wired or wirelessly, to the TBW logic 116B and configured to transmit and receive electrical signals to determine the impedance of the body portion 14 of the patient 10. Thus, the TBW logic 116B may determine the amount of fluid in the tissue of the patient 10.

[0102] In one embodiment, one or both of the first sensor array 102 and the second sensor array 104 may be in contact with the patient's skin to measure electrical impedance. In one embodiment, one or both of the first sensor array 102 and the second sensor array 104 may be adhered to the skin of the patient 10. In one embodiment, one or both of the first sensor array 102 and the second sensor array 104 may be disposed on a belt 120 that is secured around the patient's torso and configured to secure one or both of the first sensor array 102 and the second sensor array 104 to the skin surface.

[0103] It should be noted that different patients may have different amounts of biological tissue disposed between the skin surface and the bladder 12. The amount of water in the tissue disposed between the skin surface and the bladder 12 may affect the BV measurement of the first sensor array 102. Thus, the BVM 100 may include two sensor arrays 102, 104. The first sensor array 102 may be disposed over an upper side of the bladder 12 and configured to measure a BV index. The second sensor array 104 may be disposed over a different part of the patient, e.g., an upper side of the body part 14, and configured to determine a TBW index of the patient 10. The BVM 100 may then determine an accurate BV by compensating for the TBW of the tissue disposed between the skin surface and the bladder 12. Thus, the BVM 100 may accurately determine the BV of the patient 10.

[0104] In one embodiment, the system 200 may monitor either the BV or TBW values ​​of the patient 10 over a period of time. In one embodiment, as described herein, the system 200 may further include a date / time stamp of the BV, TBW, or urinary output (UO) values ​​recorded by the system 200. Thus, the system 200 may subsequently associate these events with additional data entered into the system 200, either directly by the user interface 118, or indirectly by the network 90 or remote database 80. This information may be stored locally, for example in the data store 114 or data store 214, or may be communicated by the network 90 or remote database 80, for example a hospital network or an electronic health record (EHR) system. It will be appreciated that the exemplary network 90 and remote database 80 may include one or more computing devices including electronics including data processing capabilities and / or network interface capabilities, for example an intranet, the Internet, a "cloud" based network, a server, a hospital network, an EHR system, or the like.

[0105] In one embodiment, the system 200 may include a user interface 218 configured to receive additional information. Exemplary information may include, but is not limited to, patient variables such as gender, age, height, weight, anatomical measurements, body composition, body mass index (BMI), measured post-void residual volume, date / time of voiding event, voided urinary output volume, automatic urinary output volume adjustment, etc. These variables may be entered by a clinician, the patient, or automatically queried from a remote database 80 by a network 90 (e.g., an EHR, a "cloud" based network, an intranet, the Internet, a LAN, etc.).

[0106] 10A-10C, the system 200 may apply the bioimpedance measurements to a bioimpedance versus bladder volume model (BV model) 150 to determine the amount of fluid in the bladder 12, i.e., the BV value. FIG. 10A shows an exemplary BV model 150 illustrating the correlation of change in bioimpedance to the amount of fluid in the bladder 12. It should be noted that the illustrated BV model 150 is a highly simplified example for ease of explanation, and it should be appreciated that the BV model may be linear, logarithmic, polynomial, multidimensional, time-varying, and / or may include one or more inflection points.

[0107] In one embodiment, a patient's TBW value may vary considerably between individuals, which may in turn affect the BV index from the first sensor array 102. Thus, the system may monitor the patient's 10 TBW value or changes thereto, and modify the BV model 150 to accommodate these changes. Advantageously, the system 200 may monitor one of the patient's 10 BV and TBW values ​​over a period of time to determine the effectiveness of the patient's diuretic therapy. In one embodiment, the BV logic 116 may continuously measure bioimpedance to determine changes in bladder volume, either by a steady build-up over time or a sudden drop in bladder volume indicating a bladder voiding event. In one embodiment, the BV logic 116 may determine changes in bladder volume and distinguish these from other artifacts, such as patient movement or patient position (sitting, standing, walking, lying, etc.).

[0108] In one embodiment, the system 200 may include an accelerometer 222, gyroscope, etc. configured to detect speed, direction, or change in movement of the patient 10. The system 200 may detect movement of the patient 10 to distinguish impedance changes resulting from redistribution and orientation of the patient's tissues or organs due to patient position, fluid movement within the bladder, or changes in geometric bladder shape from impedance changes due to bladder voiding events. For example, in women, the position of the uterus generally leads to the need for some compensation mechanism for ultrasound bladder scanning and / or bioimpedance measurements.

[0109] In one embodiment, the first sensor array 102 may be configured to detect bladder sphincter relaxation and / or detrusor contraction by surface electromyography. As such, the BVM 100 may directly detect when the muscles of the bladder 12 contract for a micturition event, and the system 200 may record these events. Thus, the BVM 100 may further distinguish changes in BV impedance caused by patient 10 movement or other artifacts (e.g., sensor or sensor array movement) from those associated with bladder micturition events.

[0110] Training System In one embodiment, the system 200 may further include an automated urine output (AUO) based training system 300 configured to automatically measure the volume of urine voided by the patient 10. The urinary output volume may be used to calibrate or "train" the BVM 100, or the logic 116 contained therein, to provide accurate BV measurements for each individual patient 10.

[0111] In one embodiment, the AUO 300 may include a processor 310, a data store 312, a power source 314, or a combination thereof. The processor 310, the data store 312, or the power source 314 may be in addition to or in place of the processor 210, the data store 212, or the power source 214 of the system 200. Thus, the AUO 300 may be a stand-alone unit communicatively coupled to and optionally removable from the system 200. Alternatively, the AUO 300 or components thereof may be integrated with the system 200 as a single unit.

[0112] In one embodiment, the AUO 300 may further include one or more logics 316 (e.g., AUO logic 316A) and one or more sensors 302 configured to detect the amount of fluid voided from the bladder 12. In one embodiment, the sensor 302 may be coupled to the catheter 32 or drainage tube 34 and configured to measure the amount of fluid passing therethrough. In one embodiment, the sensor 302 may be coupled to the collection reservoir 36 and configured to measure the amount of fluid received therein.

[0113] BV Model Training As shown in FIGS. 10A-10C and described in more detail herein, the system 200 may modify or calibrate the impedance measurements vs. bladder volume model (BV model) 150 based on urine output measurements from the AUO 300, or from patient or clinician input measurements from actual voided volume, or from other devices, such as, for example, a urodynamic monitor, pressure sensor, or ultrasound bladder scanner. For example, as shown in FIG. 10A, an initial BV model 150 may be provided by the system 200 and stored locally, such as in the data store 112 or data store 212. In one embodiment, the initial BV model 150 may be provided to the system 200 from a remote database 80 and / or a network 90. ​​In one embodiment, the initial BV model 150 may be obtained by the system 200 from a compilation of previous BV models from the patient or from different patients with similar patient variables (e.g., gender, age, height, weight, etc.). Some information about the patient 10 may be input into the system 200 using a user interface 218. Exemplary information may include age, sex, height, weight, body mass index (BMI), health status, etc. As such, the system 200 may compile previously trained BV models from other patients with similar information as the patient 10 to provide an initial BV model 150. The system 200 may then detect bioimpedance values ​​from the first sensor array 102 and use the initial BV model 150 to predict a first BV value 250A.

[0114] As shown in FIG. 10B, the system 200 may then compare the first BV value 250A to the first urine output measurement (e.g., 450 ml). The system 200, e.g., the BV logic, may then modify the initial BV model 150 to a second BV model 152 to improve accuracy. Subsequent bladder voiding events may further refine the BV model. For example, as shown in FIG. 10C, the second voiding event provided a second urine output measurement 250B (e.g., 150 ml), which may be used to further refine the trained BV model 152 to a third BV model 154. The system 200 may continue to iteratively refine the BV model and improve the BV model with each subsequent bladder voiding event to refine the patient's unique profile.

[0115] In one embodiment, the system 200 may go through a training period to "learn" or calibrate the system 200 on a particular patient 10 and provide an accurate estimate of the patient's BV value based on bioimpedance measurements. In one embodiment, the system 200 may go through a training period of a predetermined time window or a predetermined number of bladder voiding events. In one embodiment, the system 200 may continue the training period until the difference between the estimated BV value and the urinary output (UO) index falls below a threshold value. In one embodiment, the threshold value may be a predetermined value or may be obtained by the system 200.

[0116] In one embodiment, once the system 200 has been "trained" on the patient, the AUO 300 training system and / or urine collection system 30 may be detached and removed. Thus, the system 200 may continue to measure the BV values ​​of the patient 10 using the trained BV model 154. Advantageously, removal of the AUO training system 300 and urine collection system 30 may reduce the need for invasive urinary management equipment and may also increase the portability of the system 200, allowing greater freedom of movement for the patient 10. The system 200 may be contained within a portable pack worn by the patient 10, allowing greater freedom of movement for the patient 10.

[0117] In one embodiment, the trained BV model 154 may be used by the system 200 to improve the accuracy of the TBW value of the patient 10. Thus, the system 200 may determine an accurate TBW for each individual patient 10. Advantageously, the system 200 may monitor the TBW value of the patient 10 and determine any changes in the patient's TBW to indicate the patient's response to diuretic therapy, response to other therapies, or changes in the patient's condition. Such information may provide a more rapid and accurate indication of response to diuretic therapy than current methods of periodic weight measurement or bladder output measurement. This may be particularly important when a patient does not respond to diuretic therapy and an alternative therapy needs to be implemented quickly.

[0118] In one embodiment, either the BVM 100 or the AUO 300 may be a separate standalone system communicatively coupled to the system 200, either directly or indirectly, such as by a network. In one embodiment, one of the system 200, the BVM 100, or the AUO 300 may be a standalone "base station" located in close proximity to the patient, for example in a patient room, and wirelessly coupled to one of the first sensor array 102, the second sensor array 104, or the AUO sensor 302 located on the patient. Thus, less instrumentation may be "worn" by the patient 10, improving patient comfort. In one embodiment, the system 200 or components thereof may be located in a portable computing device, a monitor, a handheld device, a wearable device (e.g., a smart watch, etc.), a laptop, a tablet device, etc. In one embodiment, the system 200 or components thereof may be located in a self-contained unit that is water-resistant or waterproof, and may allow for a quick bath or shower without the need to disengage the system 200 from the patient 10. In one embodiment, the system 200 or components thereof may be contained within a pouch, or “fanny pack,” and worn by a user to facilitate carrying the system 200 .

[0119] Advantageously, electrical impedance sensors are relatively inexpensive and lightweight, and may require little pressure with the skin surface to establish conductive contact therebetween, allowing a user to wear the sensors 102, 104 with little or no impact on the user's movement or comfort. Additionally, the sensors may be discarded, and a new sensor may be coupled to the system 200 for each new patient, providing a more cost-efficient system, especially in short-term critical care settings.

[0120] Advantageously, system 200, including BVM 100 and AUO training system 300, may enable automated, "closed-loop" self-learning and calibration of system 200 for each individual patient 10, allowing for increased accuracy in "problematic" patients with comorbidities.

[0121] bladder training When the patient 10 is catheterized for an extended period of time, several problems may occur. For example, the bladder 12 may lose elasticity and compliance, causing incontinence, urgency, or other abnormal bladder and voiding functions after the catheter 32 is removed. The patient may often have a sensation of a full bladder and a need to urinate, even if the bladder only has a relatively small amount of urine. In one embodiment, the AUO logic 316A may be communicatively coupled to the valve 306 and may selectively open or close the valve 306 to control fluid flow through the urine collection system 30. The valve 306 may be disposed in one of the lumen of the catheter 32, or the lumen of the drainage tube 34, or any suitable location to control urine flow within the urine collection system 30. The AUO 300 may be configured to occlude the drainage lumen of the catheter 32 or the drainage tube 34 to allow urine to pool in the bladder 12. The AUO 300 may allow urine to accumulate until the bladder 12 is deemed "full," i.e., the urine volume is a percentage of the total bladder capacity. The system 200 may measure the BV value of the bladder 12, as described herein, and may determine when the bladder 12 is full enough to open the valve 306. The AUO logic 316A then moves the valve 306 from a closed position to an open position to allow the patient 10 to empty the bladder 12 before closing the valve 306 again in preparation for the next urination cycle.

[0122] The periodic closing of the valve and accumulation of urine after a micturition event may maintain or retrain bladder elasticity, compliance and natural bladder function. Additionally, periodic filling and voiding of the bladder 12 may further train the BV model 150 to determine the percentage of urine accumulation in the bladder 12, the percentage of bladder volume that needs to be voided, the amount of urine voided, and / or the amount of residual urine remaining in the bladder 12 after a micturition event. In one embodiment, the valve 306 may include a redundant pressure relief mechanism configured to open the valve to relieve pressure in the event that the pressure sensor, the valve, or the logic controlling the valve fails. Advantageously, in the event that the system 200 fails to open the valve 306 before a threshold is reached, the valve 306 may include a fail-safe mechanism that opens the valve 306 when a threshold is reached to allow fluid to flow therethrough. This may prevent inadvertent trauma to the patient in the event that the valve 306 fails to activate.

[0123] Safety features of collaborative systems Advantageously, system 200, including BVM 100 and AUO 300, may include one or more safety features. In one embodiment, system 200 may issue one or more alerts to the clinician, and the alerts may be communicated from system 200 directly to the clinician or indirectly over network 90 and / or to a remote computing device, such as EHR 80. The alerts may be visual, audible, or tactile alerts.

[0124] In one embodiment, if the AUO 300 sets the valve 306 open and the BVM 100 subsequently determines that there is little or no change in bladder volume, the system 200 may alert the clinician that an error has occurred, e.g., a blockage of the urine collection system 30, a malfunction of the valve 306, etc.

[0125] In one embodiment, the system 200 can determine when the bladder 12 is approaching maximum bladder volume capacity, which may be uncomfortable for the patient 10 or clinically unacceptable, and can issue a warning to the clinician. This can be particularly important when the patient is incapacitated and unable to indicate uncomfortable sensations to the clinician, which could lead to trauma to the patient 10. For example, a significant risk is reflux into the ureters and back pressure on the kidneys, which can lead to hydronephrosis.

[0126] In one embodiment, system 200 may determine when bladder 12 is approaching maximum or a predetermined bladder volume capacity and may alert the clinician, instead of the clinician having to perform a scheduled bladder ultrasound scan to assess the need for intermittent catheterization. This may be particularly important because it reduces the incidence of inefficient scans (i.e., no need for intermittent catheterization), which are time-consuming for the clinician and disruptive to the patient.

[0127] In one embodiment, the system 200 can determine when the bladder 12 is approaching a maximum or predetermined bladder volume capacity and can provide an alert to the patient. This can be particularly important for certain types of patients who are substantially independent but do not experience bladder fullness, such as spinal cord injured patients who rely on intermittent self-catheterization to empty their bladder. This can further reduce the incidence of unnecessary intermittent catheterization and the associated risk of urethral trauma and infection.

[0128] In one embodiment, as described in more detail herein, the system 200 may further include a pressure sensor 502 disposed distally of the catheter 32 for measuring the patient's bladder pressure directly within the patient's bladder 12. In one embodiment, as described in more detail herein, the pressure sensor 502 may be disposed within the lumen of the catheter 32, the lumen of the drainage tube 34, or within the collection container 36 and configured to measure the patient's bladder pressure. As such, the system 200 may determine the patient's bladder pressure value and determine when the bladder pressure is approaching an uncomfortable or clinically unacceptable level. As such, the system 200 may alert the clinician or move the valve 306 to an open position to relieve the pressure.

[0129] Ultrasound-based training system 8 , in one embodiment, system 200 may include an ultrasound-based training system (U / S system) 400 configured to train BVM 100 and BV model 150 as described herein. U / S system 400 may be configured to directly measure fluid volume in bladder 12 using ultrasound. In one embodiment, U / S system 400 may include a processor 410, a data store 412, a power source 414, or a combination thereof, in addition to or instead of processor 210, data store 212, or power source 214 of system 200.

[0130] In one embodiment, the U / S system 400 may further include one or more logics 416 (e.g., U / S logic 416A) communicatively coupled to the ultrasound transducer 402 and configured to generate an ultrasound acoustic signal. The U / S logic 416A may be configured to detect the reflected ultrasound signal and determine the amount of fluid in the bladder (BV value) either before or after a bladder voiding event. In one embodiment, the ultrasound transducer 402 may be held in place by a clinician to periodically measure the amount of fluid in the bladder 12 using a standalone portable bladder scanner U / S system 400. This may be done before and after an intermittent catheterization procedure, and may or may not include measuring the amount of urine collected during the procedure. In one embodiment, the ultrasound transducer 402 may be fixed, such as by adhesive, to the abdomen, around the bladder site, or just above the pubic bone. In one embodiment, the ultrasound transducer 402 may be located on the inside surface of the belt 120. The belt 120 may be configured to secure the transducer 402 around the navel area of ​​the abdomen. The belt 120 may be adjustable to maintain sufficient pressure between the transducer 402 and the skin surface to ensure sufficient acoustic conductance therebetween. In one embodiment, a hydrogel, urethane gel, or similar ultrasound conducting gel may be placed between the transducer and the skin surface to further ensure sufficient acoustic conductance therebetween.

[0131] Advantageously, as described herein, the U / S system 400 may calibrate or "train" the BVM system 200 without the need to collect and measure urine output from the patient 10. For example, even if the patient 10 does not need to be catheterized using the urine collection system 30, the system 200 may still be trained on an individual patient 10 using the U / S training system 400 to train the BV model 150. This may avoid indwelling catheterization and increase the freedom of movement of the patient 10, while still allowing the system 200 to be trained, for example, if the patient is semi-ambulatory.

[0132] In one embodiment, the U / S system 400 and transducer 402 may be removable from the system 200. Thus, once the system 200 has been trained on a particular patient 10, the U / S system 400 may be removed, allowing the patient greater freedom of movement and increased comfort, while the system 200 continues to monitor the BV value with high accuracy, as described herein.

[0133] In one embodiment, the system 200 may train the BVM 100 using one or more training systems, as described herein. For example, the BVM 200 may determine the BV value using electrical impedance and a BIS model (e.g., the BV model 150), as described herein. The U / S system 400 may then confirm the BV value using an ultrasound modality, and the system 200 may modify the BIS model if necessary. The patient 10 may then empty the bladder and record the amount of fluid voided, and input the value into the system 200, for example, by the user interface 218 or the remote computing device 80. The U / S system 400 may then measure the residual fluid left in the bladder after the urination event. Thus, the system 200 may combine the voided bladder value input into the system 200 with the residual bladder volume value determined by the U / S system 400 to provide an accurate BV value and improve the accuracy of the BV model 150.

[0134] System with Internal Bladder Pressure Sensor Calibration 9 , in one embodiment, system 200 may include BVM system 100 as described herein, and bladder pressure training system 500 configured to train BV model 150. Bladder pressure training system 500 may be configured to directly measure the amount of fluid in bladder 12 by measuring the fluid pressure in bladder 12.

[0135] In one embodiment, the bladder pressure system 500 may include a processor 510, a data store 512, a power source 514, or a combination thereof, in addition to or instead of the processor 210, data store 212, or power source 214 of the system 200 as described herein. In one embodiment, the bladder pressure system 500 may further include one or more logics 516 (e.g., pressure logic 516A) communicatively coupled to the pressure sensor 502. In one embodiment, the pressure sensor 502 may be positioned distal to the catheter 32, which may be positioned within the bladder 12 and may directly measure the pressure within the bladder 12 to determine its urine volume.

[0136] Advantageously, for patients who already need to be catheterized, the pressure system 500 can calibrate or "train" the BVM system 200 as described herein without the need to collect and measure urine output from the patient 10. For example, urine output measurements may vary depending on the amount of residual urine remaining in the bladder after a bladder voiding event. These variations may add "noise" to the training data and lead to a less accurate BV model. Furthermore, collecting and measuring urine voided from the bladder 12 can be cumbersome and time consuming. For example, urine may be trapped in a loop that relies on the drainage tube, which may affect the urine output measurements.

[0137] System with internal pressure sensor monitoring In one embodiment, system 200 may include BVM system 100 as described herein, and an internal pressure monitoring system, such as bladder pressure system 500 configured to optimize BV model 150. Internal pressure monitoring system 500 may be configured to measure intra-abdominal pressure and determine changes in internal pressure that may affect bioimpedance values ​​and the determination of BV or TBW values ​​by system 200. For example, abdominal compartment syndrome may cause changes in intra-abdominal pressure that may be detected by a pressure sensor placed in the bladder as described herein.

[0138] In one embodiment, the internal pressure monitoring system 500 may include a processor 510, a data store 512, a power source 514, or a combination thereof, in addition to or instead of the processor 210, data store 212, or power source 214 of the system 200 as described herein. In one embodiment, the internal pressure monitoring system 500 may further include one or more logics 516 communicatively coupled to the pressure sensor 502. In one embodiment, the pressure sensor 502 may be positioned distal to the catheter 32, which may be positioned within the bladder 12 and may directly measure the pressure within the bladder 12 to determine its intraperitoneal pressure.

[0139] Advantageously, for patients who already require being catheterized, the pressure system 500 may optimize the calibration or "training" of the BVM system 200. For example, ascites and other conditions that lead to abdominal fluid accumulation may affect bioimpedance measurements. These variations may add "noise" to the training data and lead to a less accurate BV model. Having the BVM system 200 generate a warning regarding the possible presence of excess fluid via intraperitoneal pressure measurements leads to a more robust BV model 150.

[0140] Total Body Water and Bladder Volume System 11A-11B show a freestanding, non-invasive TBW measurement device (instrument) 600 configured to measure a TBW value of a patient 10 and / or a BV value of a bladder 12 of a patient 10. In one embodiment, the device 600 may be a "standing scale" device 600 including a footboard 620 and a handle 622. The handle 622 may be supported by a post 624 extending from the footboard 620. The footboard 620 may be configured to support the patient 10 standing thereon. The handle 622 may be configured to be grasped by each hand of the patient while standing on the footboard 620. The post 624 may support the handle 622 at a height that is ergonomically comfortable for the patient 10, for example, 2 feet to 4 feet from the footboard 620. In one embodiment, the post 624 may be adjustable to allow the handle to be repositioned depending on the height of the patient 10.

[0141] In one embodiment, the footboard 620 may include a first sensor array 602 including left foot electrodes 602A and right foot electrodes 602B. In one embodiment, the handle 622 may include a second sensor array 604 including left hand electrodes 604A and right hand electrodes 604B. In one embodiment, the footboard 620 may further include a pressure sensor configured to determine a weight value of the patient 10. The device 600 may further include a user interface 618 configured to display information or allow a user to input information into the device 600. In one embodiment, the user interface 618 may be a touch screen, a keypad, or the like.

[0142] 12, in one embodiment, the device 600 may further include circuitry 108, which may include one or more of a processor 110, a data store 112, a power source 114, one or more logics 116 (e.g., BV logic 116A, TBW logic 116B, communication logic 116C, pulmonary fluid volume (LFV) logic 116D), a user interface 118, or combinations thereof, configured to measure BV or TBW values ​​of the patient 10 as described herein. In one embodiment, the device 600 may be communicatively coupled to a network 90 and / or a remote database 80, such as a local area network (LAN), a hospital network, an intranet, the Internet, a "cloud" based network, a computer device, an electronic health record (EHR) system, combinations thereof, or the like. In one embodiment, the device 600 may be communicatively coupled to additional medical systems 70, such as an ultrasound system, a fluid collection system, an automated urine output system, a pleural or other drainage system, an infusion system, an enteral feeding system, a ventilator and nebulizer system, or the like. It should be noted that the amount of fluid lost through breathing can be significant. These additional medical systems 70 can provide additional information to the device 600 to determine the amount of fluid to be infused into or removed from the patient 10. The additional medical systems 70 can be directly coupled to the device 600, communicatively coupled to the device 600 either wired or wirelessly, or communicatively coupled to the device 600 by either the network 90 or the remote database 80.

[0143] In one embodiment, the device 600 may include TBW logic 116B configured to measure electrical impedance values ​​of a patient and determine a TBW value using bioimpedance spectroscopy (BIS). Bioimpedance spectroscopy as used herein may also be referred to as bioimpedance plethysmography or bioimpedance tomography. It should be noted that bioimpedance spectroscopy is distinct from bioimpedance analysis, which relies on generalizations of a patient's body shape, size, age, height, weight, sex, ethnicity, and / or demographics. While these generalizations may be applicable to "normal" patients, such generalizations may not be applicable to critical care patients. Furthermore, critical care patients also require much greater precision in their values. For example, HF patients may be overweight due to excess fluid, leading to fluid overload in the heart. Thus, generalizations that rely on a BIA-based system provide less accurate TBW or BV measurements. Furthermore, HF patients require much greater precision in TBW and BV measurements to provide more rapid confirmation that their diuretic treatment is working. When diuretic therapy is ineffective, clinicians must move quickly to alternative treatments.

[0144] In an exemplary method of use, a standing scale device 600 as described herein is provided. A patient 10 may stand on a step 620 and place a bare foot on each of the foot electrode sensors 602, e.g., the left foot on the left foot electrode 602A and the right foot on the right foot electrode 602B. In one embodiment, the patient 10 may also grasp the handle 622 with both hands, grasping the left hand electrode 604A with his bare left hand and the right hand electrode 604B with his bare right hand. It should be noted that the patient touches the electrodes 602, 604 with bare skin to provide electrical contact between them.

[0145] Thus, an excitation signal may be provided by a first electrode, for example, by one of the foot electrodes 602 or the hand electrodes 604. Thus, a second electrode may detect the excitation signal. In one embodiment, the second electrode may be one of the foot electrodes 602 or the hand electrodes 604 that is different from the first electrode. For example, the excitation signal may be provided by the right foot electrode 602B and detected by one of the left foot electrode 602A, the left hand electrode 604A, the right hand electrode 604B, or a combination thereof. In one embodiment, the excitation signal may be provided by one or more of the left foot electrode 602A, the right foot electrode 602B, the left hand electrode 604A, the right hand electrode 604B, or a combination thereof. In one embodiment, the second detection electrode may be one or more of the left foot electrode 602A, the right foot electrode 602B, the left hand electrode 604A, the right hand electrode 604B, or a combination thereof. It will be appreciated that these and other combinations of excitation and detection electrodes are contemplated without limitation.

[0146] The TBW logic 116B may be configured to both measure the excitation signal provided at the first electrode as well as detect the excitation signal received at the second electrode. Thus, the TBW logic 116B may determine an electrical impedance value for the patient 10. Thus, the TBW logic 116B may apply the electrical impedance value to a BIS model (e.g., BV model 150 or TBW model) for the patient 10 to determine a TBW value for the patient 10. It should be noted that the TBW model is used similarly to the BV model 150 (see FIGS. 10A-10C), except that it is used to determine the patient's TBW value instead of the BV value. The model may convert impedance values ​​to TBW values ​​and may be modified by the system 600 as determined by the logic 116 to be personalized to the individual patient 10, as described herein.

[0147] In one embodiment, the first pair of electrodes may be configured to measure a TBW value using the BIS, and the second pair of electrodes may be configured to measure a BV value using the BIS. For example, the first pair of foot electrodes 602A, 602B may be configured to pass an excitation signal through the bladder 12 of the patient 10 to determine a BV value of the patient 600. The second pair of hand electrodes 604A, 604B may be configured to pass an excitation signal through the torso region 14 of the patient 10 to determine a TBW measurement of the patient's 10 biological tissue. Advantageously, the device 600 may determine a TBW value of the patient 10 and modify the BIS model to account for the TBW of the tissue surrounding the bladder 12. Thus, the device 600 may determine an accurate BV measurement of the patient 10 without relying on assumptions on populations or demographics. In one embodiment, the second pair of hand electrodes 604A, 604B may be configured to pass an excitation signal through the torso region 14 to determine the amount of fluid present in the lungs 16. Thus, the device 600 can determine the amount of fluid present in the lungs 16 (ie, the LFV value).

[0148] In one embodiment, the footboard 620 may further include a pressure sensor configured to detect pressure applied thereto when the patient 10 is standing on the footboard 620. As a result, the TBW logic 116B may determine a weight value of the patient 10. In one embodiment, the TBW value, the BV value, the weight value, the LFV value, or a combination thereof may be displayed to the clinician on the user interface 618. In one embodiment, the device 600 may further include communication logic 116C configured to communicate one of the TBW value, the BV value, the weight value, or the LFV value to the network 90 and / or the remote database 80, such as an EHR system.

[0149] In one embodiment, the additional information may be entered into the device 600 by the user interface 618 or may be provided by the remote database 80 or the network 90. ​​Exemplary variables may include, but are not limited to, patient variables such as gender, age, height, weight, circumference measurement, date / time of voiding event, urinary volume output, adjustment for automatic urinary volume output, etc. These variables may be entered by a clinician, the patient, or automatically queried from the remote database 80 by a network 90, such as an electronic medical record, a "cloud" based network, an intranet, the Internet, a LAN, etc.

[0150] As shown in FIGS. 13-14B, in one embodiment, a TBW device 700 is provided including circuitry 108 as described herein, communicatively coupled to a sensor 702 disposed on a bracelet 720. In one embodiment, the circuitry 108 may be included in a single stand-alone unit, handheld computing device, or "base station," and communicatively coupled to the sensor 702, either by wire or wireless communication. The "base station" may be located in close proximity to the patient, i.e., coupled to the patient's bed, or located in the same room. In one embodiment, the circuitry 108 may be carried by the patient 10, for example, in a bag or pouch or "fanny pack," and the circuitry 108 may be located on a belt secured around the patient's torso.

[0151] In one embodiment, the sensor 702 may be an electrode configured to generate or detect an excitation signal. The sensor 702 may be disposed on a bracelet 720 configured to encircle the wrist or ankle portion of the patient 10 and support the electrode 702 against the skin surface of the patient 10. In one embodiment, the bracelet 720 may be adjustable or stretchable to fit patients of different sizes. In one embodiment, the bracelet 720 may include one or more markers to facilitate proper alignment of the electrode 702. For example, the markers may be aligned with anatomical fiducial marks of the patient 10, such as the talus or carpal bone, to properly align the sensor with the patient 10.

[0152] In one embodiment, TBW device 700 may include a left foot bracelet 720A, a right foot bracelet 720B, a left hand bracelet 720C, a right hand bracelet 720D, or a combination thereof. In one embodiment, each of bracelets 720A-720D may include a sensor 702. In one embodiment, each of bracelets 720A-720D may include an array of sensors 702.

[0153] The sensor 702 may be communicatively coupled to the circuit 108, either wired or wirelessly. The circuit 108 may include logic 116, such as BV logic 116A, TBW logic 116B, LFV logic 116D, etc., configured to generate and / or detect excitation signals and use the BIS to determine the BV, TBW, LFV values ​​of the patient 10, as described herein. Advantageously, the one or more bracelets 720 and the one or more electrode sensors 702 are worn by the patient 10 while the patient is in a prone or sitting position, for example if the patient is bedridden and / or unable to stand.

[0154] In one embodiment, as shown in FIG. 13, the device 700 may further include a chest strap 722 that extends around the lung region 16 of the patient 10 and includes one or more sensors 702 as described herein. The chest strap 722 and sensor 702 assembly may be communicatively coupled to a pulmonary fluid volume (LFV) logic 116D. The LFV logic 116D may be configured to measure an electrical impedance value of the patient's lungs 16 and determine the amount of fluid therein, i.e., the LFV value. In one embodiment, the LFV logic 116D may use bioimpedance spectroscopy (BIS) to determine the amount of fluid in the lungs 16. In one embodiment, the device 700 may use a TBW value to compensate for fluid that is in the tissue surrounding the lungs 16 to provide an accurate LFV value.

[0155] As shown in FIG. 14A, in one embodiment, the sensor 702 may include an electrode having a coating 708 disposed thereon. The coating may be disposed between a surface of the electrode 702 and a skin surface of the patient 10. The coating 708 may include a hydrogel, a urethane gel, or a combination thereof. The coating 708 may be configured to improve electrical contact between the electrode 702 and the skin surface of the patient 10. Advantageously, the electrode 702 with the coating 708 may require less pressure between the electrode 702 and the skin surface to maintain electrical contact therebetween. Thus, the electrode may be worn for extended periods of time without discomfort.

[0156] In one embodiment, the coating 708 may include a pressure-responsive adhesive configured to hold the electrode against the skin surface of the patient 10. Advantageously, the adhesive allows the electrode 702 to be secured to the patient 10 without the need for a bracelet 720. Pressure from the bracelet 720 may be uncomfortable for the patient over an extended period of time and may lead to an increased risk of skin infections, dermatitis, and damage to the skin.

[0157] Advantageously, the device 700 may be worn by the patient 10 for an extended period of time and may periodically measure impedance levels to determine changes in the TBW, BV, or LFV values ​​of the patient 10. Thus, the embodiments described herein may provide time-based BV, TBW, or LFV data. Such time-based BV, TBW, or LFV data may be communicated to the network 90 or remote database 80, and may be important in quickly determining whether a therapy, such as diuretic therapy in a HF patient, is working.

[0158] Advantageously, the embodiments disclosed herein may use a BIS to determine a patient's TBW, BV, and / or LFV values. In contrast to bioimpedance analysis (BIA) systems that rely on assumptions about age, sex, and other demographics, a BIS system may adapt to each patient, account for "abnormal" conditions, and provide accurate TBW, BV, and LFV data. Thus, accurate TBW values ​​can be determined for all patients with different body compositions.

[0159] Advantageously, the embodiments disclosed herein can be integrated into a clinician's existing workflow and communicatively coupled to a network 80 and / or a remote database 90, such as an EHR. Thus, TBW and / or BV measurements can be determined by the device and communicated to the EHR in real time with no extra work or inconvenience to the clinician or patient. This can provide accurate and direct information regarding TBW, BV, and / or LFV values ​​to determine the effectiveness of diuretic or other therapeutic measures. Furthermore, this can reduce the clinician's workload and reduce data entry errors.

[0160] Although some specific embodiments have been disclosed herein, and the specific embodiments have been disclosed in some detail, the specific embodiments are not intended to limit the scope of the concepts provided herein. Additional adaptations and / or modifications may occur to those skilled in the art, and the broader interpretation includes these adaptations and / or modifications. Thus, departures may be made from the specific embodiments disclosed herein without departing from the scope of the concepts provided herein.

Claims

1. 1. A system for measuring a volume of fluid in a patient's bladder, comprising: a bladder volume monitoring system including an impedance sensor in contact with a skin surface of the patient, the bladder volume monitoring system configured to determine an electrical impedance of a portion of the patient's bladder and configured to determine a bladder volume value of the patient using a model, the bladder volume value being an estimated amount of fluid in the bladder; a training system configured to receive a urine output value relating to an amount of fluid voided from the bladder; logic configured to determine a difference between the bladder volume value and the urine output value, and configured to iteratively modify the model to reduce the difference between the bladder volume value and the urine output value to increase accuracy of the model; A system comprising:

2. 10. The system of claim 1, wherein the bladder volume monitoring system uses one of bioimpedance analysis, bioimpedance spectroscopy, bioimpedance plethysmography, or bioimpedance tomography to determine the bladder volume value.

3. 3. The system of claim 1 or 2, wherein the bladder volume monitoring system is configured to measure a first electrical impedance value before a urination event and a second electrical impedance value after a urination event to determine the bladder volume value.

4. 4. The system of claim 1, wherein the impedance sensor includes a first sensor array having a first electrode configured to generate an excitation signal and a second electrode configured to measure the electrical impedance of the excitation signal through the bladder portion of the patient.

5. 5. The system of claim 1, wherein the bladder volume monitoring system further comprises a second sensor array including a third electrode configured to generate a second excitation signal and a fourth electrode configured to measure a second electrical impedance of the second excitation signal through a second portion of the patient to determine a total body water value of the patient.

6. 6. The system of claim 5, wherein the logic takes the total body water value and modifies the model to reduce a difference between the bladder volume value and the urine output value to increase accuracy of the model.

7. 7. The system of claim 1, wherein the training system includes an automated urinary output training system, the automated urinary output training system including a flow sensor coupled to one of a catheter, a drainage tube, or a collection container and configured to determine the urinary output value.

8. 8. The system of claim 7, wherein the automated urinary output training system includes a valve configured to control the flow of voided fluid from the bladder and train the patient's bladder to a natural bladder cycle.

9. 9. The system of claim 1, wherein the impedance sensor is disposed on a belt configured to be secured around the patient's torso and to align the impedance sensor with the bladder portion of the patient.

10. 10. The system of claim 1, wherein the bladder volume monitoring system further comprises an accelerometer or a gyroscope configured to detect movement of the patient, and the logic is configured to receive a signal from one of the accelerometer or the gyroscope and to modify the model to increase accuracy of the bladder volume value for the patient.

11. 11. The system of claim 1, further comprising an electromyography sensor configured to contact a skin surface of the patient and configured to detect one of a contraction of the patient's detrusor muscle or a relaxation of the patient's urethral sphincter to determine the occurrence of a bladder voiding event.

12. 12. The system of claim 1, wherein the system is communicatively coupled to one of a network, a remote database, an intranet, the Internet, a cloud-based network, or an electronic health record system.

13. 13. The system of claim 1, wherein the impedance sensor is in wireless communication with the bladder volume monitoring system, and wherein one of the bladder volume monitoring system, the training system, or the logic is located in a stand-alone unit.

14. 14. The system of claim 13, wherein the standalone unit comprises one of a base station, a portable computing device, a monitor, a handheld device, a wearable device, a smart watch, a laptop, or a tablet device.

15. The system of claim 1 , wherein the training system further comprises one or both of an ultrasound training system and a pressure-based training system.

16. 1. A bladder volume measurement system, comprising: a first sensor array including electrodes in contact with a skin surface of the patient, the first sensor array configured to measure an electrical impedance value of the patient's bladder; an ultrasound transducer system including a transducer in contact with the skin surface of the patient, the ultrasound transducer system configured to determine a volume of fluid in the bladder of the patient; a bladder volume monitoring system including logic configured to determine a volume of fluid in the bladder from the electrical impedance values ​​using a bladder volume model, the bladder volume monitoring system being configured to iteratively validate the bladder volume model with the volume of fluid in the bladder as determined by the ultrasound system; A system comprising:

17. 17. The system of claim 16, wherein one of the first sensor array or the transducer is disposed on a belt configured to encircle a torso portion of the patient and secure the one of the first sensor array or the transducer to the skin surface of the patient.

18. 18. The system of claim 16 or 17, wherein the urine volume monitoring system uses one of bioimpedance analysis, bioimpedance spectroscopy, bioimpedance plethysmography, or bioimpedance tomography to determine the volume of fluid in the bladder from the electrical impedance values.

19. 19. The system of claim 16, wherein the first sensor array includes a first electrode configured to generate an excitation signal and a second electrode configured to measure an electrical impedance of the excitation signal through the bladder of the patient.

20. 20. The system of claim 16, wherein the urine volume monitoring system further comprises a second sensor array including a third electrode configured to generate a second excitation signal and a fourth electrode configured to measure a second electrical impedance of the second excitation signal through a second portion of the patient to determine a total body water value of the patient.

21. 21. The system of claim 20, wherein logic of the urine volume monitoring system obtains the total body water value and modifies the bladder volume model to increase accuracy of the bladder volume model for the patient.

22. 22. The system of claim 16, wherein the bladder volume measurement system further includes an accelerometer or gyroscope configured to detect movement or position of the patient, and the logic of the urine volume monitoring system is configured to receive a signal from one of the accelerometer or gyroscope and to modify the bladder volume model to increase accuracy of the bladder volume model for the patient.

23. 23. The system of claim 16, wherein the bladder volume measurement system further comprises an electromyography sensor configured to contact a skin surface of the patient and detect one of a contraction of the patient's detrusor muscle or a relaxation of the patient's urethral sphincter to determine the occurrence of a bladder voiding event.

24. 24. The system of any one of claims 16 to 23, wherein the logic of the urine volume monitoring system is communicatively coupled to one of a network, a remote database, an intranet, the Internet, a cloud-based network, or an electronic health record system.

25. 25. The system of claim 16, wherein the first sensor array is in wireless communication with the urine volume monitoring system, and one of the urine volume monitoring system or the ultrasound system is located in a stand-alone unit.

26. 26. The system of claim 25, wherein the standalone unit is selected from the group consisting of a base station, a portable computing device, a monitor, a handheld device, a wearable device, a smart watch, a laptop, and a tablet device.

27. 25. The system of any one of claims 16 to 24, further comprising a user interface configured to receive urination volume input.

28. 1. A method for measuring a volume of fluid in a patient's bladder, comprising: Measuring a first electrical impedance value of the bladder of the patient; determining a volume of fluid in the bladder from the electrical impedance values ​​using a bladder volume model; measuring the amount of fluid voided from the bladder; modifying the bladder volume model to minimize the difference between the amount of fluid in the bladder as determined by the electrical impedance values ​​and the amount of fluid voided from the bladder; The method includes:

29. 30. The method of claim 28, comprising measuring the first electrical impedance value before the amount of fluid is voided from the bladder and measuring a second electrical impedance value after the amount of fluid is voided from the bladder to determine the amount of fluid originally in the bladder.

30. 30. The method of claim 28 or 29, further comprising using one of bioimpedance analysis, bioimpedance spectroscopy, bioimpedance plethysmography, or bioimpedance tomography to determine the amount of fluid in the bladder from the electrical impedance values.

31. 31. The method of claim 28, further comprising measuring an electrical impedance value of the patient's body part, determining a total body water value of the patient, and modifying the bladder volume model to increase accuracy of the bladder volume model in determining the amount of fluid in the bladder.

32. 32. The method of any one of claims 28 to 31, wherein measuring an electrical impedance value of the patient's bladder comprises a first sensor array including a first electrode configured to generate an excitation signal and a second electrode configured to measure the electrical impedance of the excitation signal passing through the patient's bladder.

33. 33. The method of any one of claims 28 to 32, further comprising detecting movement or position of the patient using one of an accelerometer or a gyroscope, and modifying the bladder volume model to increase accuracy of the bladder volume model in determining the amount of fluid in the bladder from the electrical impedance values.

34. 34. The method of any one of claims 28 to 33, further comprising detecting one of a contraction of the patient's detrusor muscle or a relaxation of the patient's urethral sphincter to determine the occurrence of a bladder voiding event using an electromyography sensor in contact with a skin surface of the patient.

35. 35. The method of any one of claims 28 to 34, further comprising communicating the value of the amount of fluid in the bladder or the value of the amount of fluid voided from the bladder to one of a network, a remote database, an intranet, the Internet, a cloud-based network, or an electronic health record system.

36. 36. The method of any one of claims 28 to 35, further comprising controlling the flow of fluid voided from the bladder to improve the bladder volume model and to train the patient's bladder to a natural bladder cycle.

37. 34. The method of any one of claims 26 to 33, further comprising a training system configured to determine a first volume of fluid in the bladder before the volume of fluid is voided from the bladder and a second volume of fluid in the bladder after the volume of fluid has been voided from the bladder.

38. 38. The method of claim 37, wherein the training system comprises one of an ultrasound training system, an automated urinary output training system, or a bladder pressure training system.

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