Bladder monitoring device, system, and method

Abstract

A bladder monitoring device is provided. The bladder monitoring device includes a housing operable to be implanted within a bladder of a patient, one or more sensors disposed within the housing, and a controller communicatively coupled with the sensors. The sensors are operable to capture data regarding the bladder. The controller is operable to: transition the sensors to an activated mode to capture the data, wirelessly transmit the data to an external device outside of a body of the patient, and transition the one or more sensors to a standby mode.

Description

Attorney Docket No. 106546-846816 (3995)TITLEBLADDER MONITORING DEVICE, SYSTEM, AND METHODCROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 681 ,023, filed in the U.S. Patent and Trademark Office on August 8, 2024, which is incorporated herein by reference in its entirety for all purposes.TECHNICAL FIELD

[0002] The disclosure is directed to a bladder monitoring device operable to be implanted into a bladder for noninvasive monitoring.BACKGROUND

[0003] Patients with bladder cancer are at risk for cancer recurrence within the bladder and undergo many repeat cystoscopy procedures for cancer surveillance, often as frequently as 3 months. Approximately one out of three patients experience major discomfort during office cystoscopy. Over 40% have substantially anxiety associated with the procedure. This can impact the patient experience and impact adherence with recommended follow ups leading to delays in diagnosis.

[0004] The decision on how frequently to perform cystoscopy is arbitrary and mostly is created for convenience and to avoid too many invasive procedures. However, there is risk for recurrence and progression prior to the conventional 3-month intervals, and earlier detection can improve cancer outcomes.1104616696Attorney Docket No. 106546-846816 (3995)BRIEF SUMMARY

[0005] The disclosure provides a bladder monitoring device and system. The bladder monitoring device is operable to be implanted (e.g., deposited) into a bladder of a patient such that the bladder monitoring device can remain within the bladder for an extended period of time, for example 1-6 months. The bladder monitoring device is operable to periodically capture data regarding the bladder, for example images, video, etc. The bladder monitoring device transitions between an activated mode and a standby mode to save power such that the bladder monitoring device can remain in the bladder longer. The bladder monitoring device can be operable to transmit the data to an external device (e.g., mobile device, reader, server, etc.), and the data can be analyzed to determine whether there is cancer and / or whether the cancer has any developments. Based on the analysis, the bladder monitoring device can be instructed to activate again to capture more data. This can prevent the need for multiple cystoscopy procedures.

[0006] The aforementioned may be achieved in at least one aspect of the present disclosure by a bladder monitoring device. The bladder monitoring device may include a housing operable to be implanted within a bladder of a patient. One or more sensors may be disposed within the housing. The one or more sensors may be operable to transition to an activated mode to capture data regarding the bladder and transition to a standby mode. A controller may be communicatively coupled with the one or more sensors. The controller may be operable to wirelessly transmit the data to an external device outside of a body of the patient.

[0007] The one or more sensors may be operable to transition to the activated mode based on a scheduled time and / or a day. The one or more sensors may be operable to transition to the activated mode based on a command. The command may be received from the external device. The command may be based on input from the patient. The one or more sensors may be operable to transition to the activated mode when the bladder is filled a threshold amount. The threshold amount may be greater than 50% of the volume of the bladder.

[0008] The one or more sensors may include one or more cameras operable to capture one or more images and / or videos. The one or more cameras may be operable to capture an image angle equal to or greater than 90 degrees.

[0009] The one or more sensors may be operable to transition to the activated mode for a period of time before transitioning the one or more sensors to the standby mode. The period of time may be between about 1 second and about 30 seconds. The period of time may be between about 5 seconds and about 25 seconds. The one or more sensors may be operable to transition2104616696Attorney Docket No. 106546-846816 (3995) to to the activated mode a predetermined number of times within 24 hours. The predetermined number of times within 24 hours may be greater than 3 times. The controller may be operable to transition the one or more sensors to the activated mode intermittently.

[0010] The housing may be buoyant within the bladder. The housing may be resistant to a pH of between about 5.0 and about 7.5. The housing may be resistant to treatment, such as chemotherapy and / or other vesical treatments. The housing may include a retrieve portion operable to be coupled with a retrieving tool to extract the bladder monitoring device from the bladder. The housing may have a length less than about 20 millimeters. The housing may have a width less than about 12 millimeters.

[0011] The bladder monitoring device may further include one or more movement components operable to adjust the orientation and / or position of the bladder monitoring device within the bladder.

[0012] The aforementioned may be also achieved in at least one aspect of the present disclosure by a method. The method may include transitioning one or more sensors of a bladder monitoring device implanted within a bladder of a patient to an activated mode; capturing, by the one or more sensors, data regarding the bladder; wirelessly transmitting the data to an external device outside of a body of the patient; and transitioning the one or more sensors to a standby mode.

[0013] A signal may be received from the external device to transition the one or more sensors of the bladder monitoring device to the activated mode. The data may be stored by the external device and / or the bladder monitoring device. The data may be displayed by the external device to a user. An instance of a tumor within the bladder may be identified based on the data from the one or more sensors. Changes within the bladder may be tracked based on the data from the one or more sensors. A retrieval signal may be transmitted to the external device to indicate to retrieve the bladder monitoring device from the bladder. The retrieval signal may be transmitted based on a predetermined amount of time. The predetermined amount of time may be greater than about 60 days. The retrieval signal may be transmitted based on a power threshold for a battery of the bladder monitoring device. The power threshold may be less than 10% of battery capacity.

[0014] Additional aspects, advantages, and utilities of the present disclosure will be set forth, in part, in the description which follows and, in part, will be obvious from the description, or may be learned by practice of the present disclosure.

[0015] The foregoing is intended to be illustrative and is not meant in a limiting sense. Many3104616696Attorney Docket No. 106546-846816 (3995) features and sub-combinations of the present disclosure may be made and will be readily evident upon a study of the following specification and accompanying drawings comprising a part thereof. These features and sub-combinations may be employed without reference to other features and sub-combinations.4104616696Attorney Docket No. 106546-846816 (3995)BRIEF DESCRIPTION OF THE DRAWINGS

[0016] Embodiments of the present disclosure are illustrated by way of example in which like reference numerals indicate similar elements and in which:

[0017] FIG. 1A is a diagram of a bladder monitoring system;

[0018] FIG. 1 B is a diagram of a bladder monitoring device of the bladder monitoring system, implanted in a bladder of a patient;

[0019] FIG. 2 is a block diagram of components of the bladder monitoring system and flow of data;

[0020] FIG. 3A is a perspective view of a bladder monitoring device;

[0021] FIG. 3B is a front perspective view of the bladder monitoring device of FIG. 3A;

[0022] FIG. 3C is a side view of the bladder monitoring device of FIG. 3A;

[0023] FIG. 3D is a front view of the bladder monitoring device of FIG. 3A;

[0024] FIG. 3E is a rear view of the bladder monitoring device of FIG. 3A;

[0025] FIG. 3F is an exploded view of the bladder monitoring device of FIG. 3A;

[0026] FIG. 3G is a diagram showing an exploded view of the bladder monitoring device of FIG.3A and an external device;

[0027] FIG. 4A is a perspective view of another bladder monitoring device;

[0028] FIG. 4B is a side view of the bladder monitoring device of FIG. 4A;

[0029] FIG. 4C is an exploded view of the bladder monitoring device of FIG. 4A;

[0030] FIG. 5 is a diagram showing the bladder monitoring device in comparison with a conventional pill camera;

[0031] FIG. 6 is a diagram of a controller which may be employed as shown in FIGS. 1A-5;

[0032] FIG. 7 is a flow chart of a method for operation of the bladder monitoring device; and

[0033] FIG. 8 is a flow chart of a method for operation of the external device.

[0034] The drawing figures do not limit the present inventive concept to the specific embodiments disclosed and described herein. The drawings are not necessarily to scale, emphasis instead being placed on clearly illustrating principles of certain embodiments of the present inventive concept.5104616696Attorney Docket No. 106546-846816 (3995)DETAILED DESCRIPTION

[0035] Aspects of the presently disclosed technology relate to systems and methods for monitoring a bladder of a patient In at least one example, the systems and methods can be utilized to monitor the inside of a bladder, such as the walls of the bladder. To monitor the inside of the bladder, a bladder monitoring device can be deposited into the bladder such that the bladder monitoring device can stay inside the bladder for an extended period of time (e.g., at least 1 week, at least 1 month, at least 3 months, at least 6 months, etc). By being able to be deposited within the bladder for an extended period of time, the bladder monitoring device greatly reduces the need for cystoscopy procedures which can be painful or uncomfortable, which can lead to the patient avoiding checkups. While within the bladder, the bladder monitoring device can be activated to capture data regarding the bladder. The data can include images, videos, parameters of the fluid in the bladder, tissue samples, etc. For example, the patient may be at risk for bladder cancer, and the bladder monitoring device can capture data regarding the inside of the bladder which can be used to determine whether cancer is present, track the progress of the cancer, determine the needed steps to address the cancer, etc. In at least one example, the bladder monitoring device can also capture the data more frequently than the standard 3-month time frame for cystoscopy procedures.

[0036] The size of the bladder monitoring device is small enough to be implanted into the bladder and removed from the bladder via a cystoscopy procedure. For example, the battery needs to be small enough to allow for the disposal of bladder monitoring device to be implanted into the bladder while also providing enough energy storage so that the bladder monitoring device can capture the data and remain within the bladder for the extended period of time. One method to manage battery usage is by transitioning the bladder monitoring device between an activated mode and a standby mode. In the activated mode, the bladder monitoring device can capture data, move around, etc. In the standby mode, the components of the bladder monitoring device utilize little to no energy from the battery. For example, in the standby mode, the bladder monitoring device may only utilize enough battery power to receive instructions to transition to the activated mode.

[0037] The bladder monitoring device can wirelessly communicate with an external device located outside of the body of the patient. The external device can receive the data that was captured by the bladder monitoring device. The external device can then analyze and / or present the data so that determinations regarding the status of the bladder can be made. In some examples, a user such as a doctor or a nurse can review the data and determine whether the6104616696Attorney Docket No. 106546-846816 (3995) bladder has cancer, the cancer is developing, etc. In some examples, the external device can analyze the data and make such determinations without the need of user input.

[0038] In some examples, the external device can then send signal(s) to the bladder monitoring device, in a feedback loop. For example, the external device can send signals to the bladder monitoring device to capture more data. In some examples, the external device can send signals to the bladder monitoring device to move to capture data for a specific area of the bladder.

[0039] To begin a detailed description of wireless charging systems and methods, reference is made to FIGS. 1A and 1 B, where a bladder monitoring system 10 is illustrated. The bladder monitoring system 10 includes a bladder monitoring device 100 and an external device 50. The bladder monitoring device 100 is operable to be disposed within a bladder 14 of a patient 12. The external device 50 is operable to be disposed external to the body of the patient 12. For example, the external device 50 can include a mobile device, a reader, a server, a hard drive, etc. The external device 50 is operable to be in wireless communication with the bladder monitoring device 100 disposed within the bladder 14 of the patient 12. In at least one example, as illustrated in FIG. 1A, the external device 50 can include a device that is worn or disposed on the patient 12. In some examples, the external device 50 can include a device that is one, two, three, or more devices separated from the bladder monitoring device 100. For example, the external device 50 can include a computer at a doctor’s facilities, which has received data from the bladder monitoring device 100 via a device worn on the patient which sends the data to a server which is then accessed by the computer at the doctor’s facilities.

[0040] The bladder monitoring device 100 is operable to implanted within the bladder 14 of the patient 12, for example, via a retrieving tool 30. In at least one example, the bladder monitoring device 100 can be implanted within the bladder 14 during a cystoscopy procedure (e.g., via the urethra). In some examples, the bladder monitoring device 100 can be disposed within the bladder 14 (e.g., the cavity 18 formed by the bladder walls 16) such that the bladder monitoring device 100 floats and / or can move within the bladder 14 when fluid is received in the bladder 14. In some examples, as shown in FIG. 3C, the retrieving tool 30 can also be operable to couple with the bladder monitoring device 100 to extract the bladder monitoring device 100 from the bladder 14.

[0041] When the bladder monitoring device 100 is disposed within the bladder 14, the bladder monitoring device 100 is operable to capture data regarding the bladder 14. The data regarding the bladder 14 can include the bladder 14, such as bladder walls 16 or other portions of the bladder 14, and / or contents in the bladder. For example, the bladder monitoring device 100 can be operable to capture data regarding the bladder walls 16 of the bladder 14 over a predetermined7104616696Attorney Docket No. 106546-846816 (3995) amount of time (e.g., about 1 month to about 6 months, or in some cases, longer than 6 months). During that predetermined amount of time, the bladder monitoring device 100 can be configured to stay within the bladder 14 without the need to extract the bladder monitoring device 100. This can reduce the number of in-office cystoscopy procedures that the patient 12 needs to endure. Conventionally, patients 12 with bladder cancer have cystoscopy procedures every 3 months. However, the procedures can be uncomfortable, and in some cases, painful. The patients 12 may then not keep up with their procedures, in fear of the discomfort or pain. Even with conventional cystoscopy procedures every 3 months, the patients 12 may be at high-risk of re-occurrence and can benefit from being surveilled more frequently.

[0042] The bladder monitoring device 100 can be operable to capture the data regarding the bladder 14 periodically, for example once a week, once a day, and / or multiple times a day. Accordingly, with the bladder monitoring device 100, the bladder monitoring system 10 can identify an instance of a tumor within the bladder based on the data and / or track changes within the bladder 14 with more frequency than conventional cystoscopy procedures - while vastly reducing the number of cystoscopy procedures and thus discomfort or pain for the patient 12.

[0043] The bladder monitoring device 100 is operable to wireless communicate with the external device 50 such that the bladder monitoring device 100 sends the data to an external device 50 - whether that external device 50 is the final destination for the data or one in a chain of external devices, as discussed above - while the bladder monitoring device 100 is still disposed within the bladder 14 of the patient 12. Accordingly, the initial transmission from the bladder monitoring device 100 is wireless from within the patient’s bladder 14 to a device outside of the patient’s body. However, the data can then be transmitted to other external device(s) 50 via wired and / or wireless connection. In at least one example, any number of external devices 50 can be included in the bladder monitoring system 10. Any number and / or any combination of external devices 50 can be utilized to perform any of the functions or steps disclosed herein.

[0044] The external device 50 can be operable to receive the data from the bladder monitoring device 100 (directly and / or indirectly) and store the data. In some examples, the external device 50 can analyze the data, for example identifying an instance of a tumor within the bladder and / or track changes within the bladder. In some examples, the external device 50 can transmit (directly and / or indirectly) signals (e.g., instructions) to the bladder monitoring device 100. For example, the external device 50 can send signals to the bladder monitoring device 100 to capture more data before the previously planned time. In some examples, the external device 50 can send signals to the bladder monitoring device 100 to move location and / or orientation to capture data8104616696Attorney Docket No. 106546-846816 (3995) in a different location within the bladder 14. Accordingly, the bladder monitoring system 10 can have a feedback mechanism.

[0045] FIG. 2 illustrates a diagram 200 of an example bladder monitoring system 10 which includes the bladder monitoring device 100 and the external device 50. The bladder monitoring device 100 can include one or more sensors 104 that can be operable to capture data regarding the bladder 14. In some examples, as illustrated in FIG. 2, the one or more sensors 104 can include one or more cameras 104 operable to capture one or more images and / or videos. While the disclosure discusses the sensors 104 including cameras, in some examples, the one or more sensors 104 can include infrared sensors, sonar sensors, etc. so long as the sensors 104 can capture data regarding the bladder 14. In at least one example, the one or more sensors 104 can include pressure sensors that can assist in determining when the bladder 14 is filled a threshold amount of the fluid. In some examples, the one or more sensors 104 can include a distance sensor which can detect a distance from the bladder wall 16. For example, the distance sensor can include sonar. In some examples, when the bladder monitoring device 100 is a distance (e.g., 4 centimeters) away from the bladder wall 16, the bladder 14 may be determined to be filled a threshold amount. In some examples, the sensor(s) 104 can include GPS to indicate the orientation and / or position of the bladder monitoring device 100 within the bladder 14. Any combination and / or number of sensors 104 can be included without deviating from the scope of the disclosure.

[0046] In at least one example, the bladder monitoring device 100 can include a lens diffuser filter 102 operable to work with the one or more cameras 104 to improve the images and / or videos captured. In at least one example, the bladder monitoring device 100 can include one or more light sources 106 (e.g., LED) operable to illuminate a portion of the bladder 14 for the camera(s) 104 to capture the images and / or videos clearly.

[0047] A communication component 112 can be operable to transmit data and / or signals (e.g., captured by the sensor(s) 104) from the bladder monitoring device 100 to the external device 50. In some examples, the communication component 112 receives data and / or signals (e.g., instructions) from the external device 50 that is transmitted to the bladder monitoring device 100. In at least one example, the communication component 112 can include a transceiver 113 operable to receive and / or transmit data and / or signals. In some examples, the communication component 112 can include one or more antennae 1122 operable to convert electrical signals into radio waves for transmission and vice versa for reception.

[0048] A controller 108 can be communicatively coupled with the communication component 112,9104616696Attorney Docket No. 106546-846816 (3995) the one or more sensors 104 and / or the one or more light sources 106. The controller 108 can be operable to cause the one or more sensors 104 to transition between an activated mode to capture data and a standby mode to save energy. The controller 108 can be operable to receive the data from the one or more sensors 104 and, in some examples, cause the communication component 112 to transmit the data to the external device 50. In some examples, the controller 108 can be operable to store the data. In some examples, the controller 108 can be operable to transition the one or more light sources 106 between an on state and an off state. In some examples, the controller 108 can change the intensity of the light illuminated from the one or more light sources 106. In some examples, the controller 108 can be communicatively coupled with the one or more light sources 106 via a current control component 110. The current control component 110 can be operable to regulate the amount of electrical current supplied to each of the light source 106, ensuring the light sources 106 receive a steady and safe amount of current to operate efficiently and prevent damage from overcurrent conditions.

[0049] The bladder monitoring device 100 can include one or more batteries 114 that is operable to provide power to the light source(s) 106, sensor(s) 104, controller 108, and / or the communication component 112. The number and / or size of the one or more batteries 114 can be configured so that the size of the bladder monitoring device 100 remains in the desired range (to be discussed further below). Additionally, the number and / or size of the one or more batteries 114 can be configured so that the bladder monitoring device 100 can remain within the bladder 14 for the predetermined amount of time (e.g., about 1 month to about 6 months, or in some cases longer than 6 months). The controller 108 can be operable to monitor the status of the one or more batteries 114 to determine the amount of power left. The controller 108 can determine, based on the amount of power left in the one or more batteries 114, how to operate the components (e.g., the light source(s) 106, the sensor(s) 104, and / or the communication component 112) so that the bladder monitoring device 100 can function as efficiently as possible.

[0050] For example, the controller 108 can be operable to transition the sensor(s) 106 to an activated mode to capture the data. The controller 108 can receive the data from the sensor(s) 104, and then wirelessly transmit the data to the external device 50 outside of the body of the patient 12. In some examples, the controller 108 can be operable to cause the data to be stored within storage media included in the bladder monitoring device 100. In some examples, the controller 108 can be operable to transition the sensor(s) to a standby mode. By transitioning the sensor(s) 104, and in some examples the light source(s) 106, to an activated mode only when needed and to a standby mode otherwise, the one or more batteries 114 can be more efficiently10104616696Attorney Docket No. 106546-846816 (3995) used which can lead to the bladder monitoring device 100 remaining within the bladder 14 for a longer amount of time. That can further reduce the number of cystoscopy procedures that are needed and also increase the amount of time that the bladder 14 can be monitored without needing retrieval and / or implantation of the bladder monitoring device 100.

[0051] In at least one example, the one or more sensors 104 can be transitioned to the activated mode based on a scheduled time and / or day. For example, the sensors 104 can be transitioned to the activated mode Monday, Wednesday, and Friday at 12am, 8am, and 4pm. Different combinations of time and / or day can be programmed without deviating from the scope of the disclosure.

[0052] In at least one example, the one or more sensors 104 can be transitioned to the activated mode based on a command. For example, the command can be transmitted by the controller 108. In some examples, the command can be received from the external device 50 to the controller 108. In some examples, the command can be programmed into the controller 108, so that the controller 108 automatically transitions the sensor(s) 104 between the activated mode and the standby mode as desired. In some examples, the command can be based on input from the patient 12. For example, the patient 12 may have notice blood in their urine, which can be a sign of bladder cancer or a worsening of the bladder cancer. The patient 12 may notify the doctor or operator of the blood, and the command can be sent to the bladder monitoring device 100 to capture more data - in some examples overriding the scheduled time for activated mode. In some examples, the patient 12 may provide input to the external device 50 to cause the bladder monitoring device 100 to transition to activated mode to capture data.

[0053] In at least one example, the sensor(s) 104 can transition to the activated mode when the bladder 14 is filled a threshold amount. In some examples, the threshold amount can be greater than 50% of the volume of the bladder 14.

[0054] In at least one example, the controller 108 can be operable to transition the one or more sensors 104 to the activated mode for a period of time before transitioning the sensor(s) 104 to the standby mode. In some examples, the period of time can be between about 1 second and about 30 seconds. In some examples, the period of time can be between about 5 seconds and about 25 seconds. In some examples, the period of time can be about 15 seconds. The period of time can be programmed or adjusted to maximize the battery life.

[0055] The controller 108 can be operable to transition the one or more sensors 104 to the activated mode intermittently. In at least one example, the controller 108 can be operable to11104616696Attorney Docket No. 106546-846816 (3995) transition the sensor(s) 104 to the activated mode a predetermined number of times within 24 hours. In some examples, the predetermined number of times within 24 hours can be greater than 3 times.

[0056] As an example, the predetermined amount of time for the bladder monitoring device 100 to be utilized in the bladder 14 may be about 90 days, or in some examples more than 90 days. The bladder monitoring device 100 may be transitioned to the activated mode for about 15 seconds at a time, and the bladder monitoring device 100 may be transitioned to the activated mode 3 times per day. In at least one example, the bladder monitoring device 100 with the one or more sensor(s) 104 in the activated mode may utilize between about 15 milliWatts (mW) to about 30 mW, while the bladder monitoring device 100 with the one or more sensor(s) 104 in the standby mode may utilize between about 20 microWatts to about 60 microWatts. This can greatly increase the usage of the power from the batteries 114 (e.g., the bladder monitoring device 100 can be utilized in the bladder 14 for a longer amount of time). In some examples, this can lessen the size and / or number of batteries 114 needed, which can decrease the size of the bladder monitoring device 100. In such an example, over the 90 days, about 450 Joules may be used with data captured 3 times per day over the 90 days. However, in a conventional device where it is utilized continuously, over 600 Joules may be used over an amount of time of between 90 minutes and 8 hours.

[0057] As illustrated in FIG. 2, the external device 50 can include a communication component 52, which can include a transceiver 56 and, in some examples, one or more antennae 54. In at least one example, the communication component 53 can be operable to communicate with the communication component 112 of the bladder monitoring device 100. In some examples, the communication component 53 can be operable to communicate with another external device that is in the communication line from the bladder monitoring device 100. In some examples, the external device 50 can include a communication component 52 that includes an outward transceiver 60. The outward transceiver 60 can be operable to communicate (e.g., transmit and / or receive data and / or signals) with another device, such as a server, the Internet, and / or another external device.

[0058] In at least one example, as illustrated in FIGS. 1A and 2, the external device 50 can include a display 64. The display 64 can be utilized to show data, such as images and / or video, or analysis of the data. An operator, such as a doctor, a nurse, and / or a technician, can then review the data or the analysis of the data and determine next steps (e.g., cause the bladder monitoring device 100 to capture more data, transmit a notification such as an alert to the patient or a medical12104616696Attorney Docket No. 106546-846816 (3995) provider so that the patient receives treatment or surgery, etc.). In some examples, the external device 50 can automatically, without user input, determine and / or cause the next steps to occur. In some examples, the bladder monitoring device 100 can conduct the analysis of the data and automatically, without user input, determine and / or cause the next steps to occur.

[0059] In at least one example, the external device 50 can include storage 62 operable to store the data and / or analysis of the data. In some examples, the storage 62 can be included in the external device 50. In some examples, the storage 62 may be wired and / or wirelessly coupled with the external device 50.

[0060] In some examples, the external device 50 can include one or more batteries 68 to provide power to the external device 50.

[0061] In at least one example, a controller 58 can be included to control the components (e.g., communication component(s) 52, storage 62, display 64, battery 68) of the external device 50. In some examples, the controller 58 can receive the data and conduct analysis on the data, and determine next steps. In some examples, the controller 58 can cause the next steps to occur by communicating with the needed personnel and / or device(s).

[0062] As illustrated in FIG. 2, the bladder monitoring system 10 can have an outward data flow 250 from the sensor(s) 104 capturing data regarding the bladder 14 to the controller 108. The controller 108 then transmits, via the communication component 112, the data to the external device 50 via the communication component 53. The controller 58 of the external device 50 can analyze the data and / or control the data, for example by transmitting the data to another device via the outward transceiver 60. Accordingly, the data can undergo post-processing for directive clinical feedback.

[0063] Once the data has been analyzed and actions have been determined (e.g., with or without user input), in some examples, signal(s) (e.g., command(s)) can be sent back from the external device 50 to the bladder monitoring device 100 via the inward data flow 260, shown by the dashed lines. The controller 58 can send the signal(s), via the communication component 53, to the bladder monitoring device 100 via the communication component 112. The controller 108 can then receive the signal(s) and determine next steps, which can include transitioning the one or more sensor(s) 104 to the activated mode for the period of time and / or move the bladder monitoring device 100 to a different location and / or orientation.

[0064] FIGS. 3A-3G illustrate an example bladder monitoring device 100. The bladder monitoring device 100 can include a housing 302, 310 which can encompass the components of the bladder13104616696Attorney Docket No. 106546-846816 (3995) monitoring device 100. The housing 302, 310 can be operable to be implanted within the bladder 14 of the patient 12. For example, the housing 302, 310 can be buoyant within the bladder 12 so that the bladder monitoring device 100 can float at the surface of the fluid and / or within the fluid. In some examples, to achieve buoyancy, the bladder monitoring device 100 can include a balloon and / or bladder system. In some examples, the housing 302, 310 can be resistant to a pH of between about 5.0 and about 7.5, so that the bladder monitoring device 100 does not deteriorate or become damaged within the environment of the bladder 14. In some examples, the housing 302, 310 can be resistant to treatment, as the patient 12 may be undergoing treatment such as chemotherapy and / or other vesical treatments, and the bladder monitoring device 100 needs to function and remain within the bladder 14 during that time.

[0065] The housing 302, 310 can include a transparent portion 302 and a base 310. In at least one example, as illustrated in FIGS. 3A-3G, the transparent portion 302 can be positioned to correspond with the one or more sensors 104 that are disposed within the housing 302, 310. For example, when the sensor(s) 104 include a camera 104, the transparent portion 302 can be positioned so that the camera 104 can take images and / or videos of the bladder 14 through the transparent portion 302. FIGS. 3A-3G illustrate a dome-shaped transparent portion 302 so that the camera 104 can capture images and / or video of the bladder 14 substantially unrestricted by the housing 302, 310 of the bladder monitoring device 100. In some examples, the camera(s) 104 can be operable to capture an image angle equal to or greater than 90 degrees. In some examples, the image angle can be equal to or greater than 180 degrees. In some examples, the image angle can be equal to or greater than 250 degrees. In some examples, the image angle can be equal to or greater than 300 degrees.

[0066] Similarly, the transparent portion 302 can be positioned to correspond with the one or more light sources 106 so that the light source(s) 106 can illuminate portion of the bladder 14 for the sensor(s) 104 to be able to capture the data. As illustrated in FIGS. 3A-3G, the bladder monitoring device 100 can include four light sources 106 disposed equally about the circumference of the sensor 104. In some examples, the bladder monitoring device 100 can include one, two, three, or more than four light sources 106 as needed. The number of light sources 106 can correspond with the number of sensors 104.

[0067] In at least one example, as shown in FIGS. 3A-3G and in particular FIGS. 3F and 3G, the communication component 112 of the bladder monitoring device 100 can include one or more transceivers 113 and one or more antennae 1122. As shown in FIGS. 3F and 3G, the communication component 112 can include a transmitter 1130 and a receiver 1132. In some14104616696Attorney Docket No. 106546-846816 (3995) examples, the transmitter 1130 and / or the receiver 1132 can communicate via radio frequency. In some examples, the transmitter 1130 and / or the receiver 1132 can communicate via infrared, ultrasonic, Bluetooth, etc. without deviating from the scope of the disclosure. The antenna 1122 can be formed in a substantially hollow cylindrical shape so that components (e.g., the batteries 114, transmitter 1130, and / or receiver 1132) can be received therein. This can save space so that the size of the bladder monitoring device 100 is as desired to be able to be inserted and / or retrieved via the urethra by cystoscopy procedure.

[0068] In at least one example, the bladder monitoring device 100 can include one or more batteries 114. As illustrated in FIGS. 3F and 3G, the bladder monitoring device 100 can include and / or utilize a plurality of batteries 114 that can be stacked to provide the desired amount of power for the predetermined amount of time. For example, as illustrated, the bladder monitoring device 100 includes four batteries 114. The number and / or configuration of batteries 114 can vary based on the energy supply for each battery 114 and the size of each battery 114. In some examples, the one or more batteries 114 can be rechargeable. In some examples, the one or more batteries 114 can be recharged wirelessly via a wireless charger positioned outside of the body of the patient 12. This can increase the amount of time that the bladder monitoring device 100 can remain in the bladder 14 while decreasing the number of times for a cystoscopy procedure.

[0069] As illustrated in FIG. 3C, the bladder monitoring device 100 has a length 100L and a width 100D that is configured to fit and traverse through the urethra, so that the bladder monitoring device 100 can be implanted and / or retrieved during a cystoscopy procedure. Additionally, the size of the bladder monitoring device 100 must allow for movement within the bladder 14 so that the sensor(s) 104 can capture data regarding the desired portion of the bladder 14. In some examples, the housing 302, 310 can have a length 100L less than about 20 millimeters. In some examples, the housing 302, 310 can have a length 100L less than about 18 millimeters. In some examples, the housing 302, 310 can have a width 100D that is less than about 12 millimeters. In some examples, the housing 302, 310 can have a width 100D that is less than about 10 millimeters. In some examples, the housing 302, 310 can have a width 100D that is less than about 8 millimeters. In some examples, the housing 302, 310 can have a width 100D that is about 7 millimeters.

[0070] In at least one example, the bladder monitoring device 100 can include one or more movement components 315 that are operable to adjust the orientation and / or position of the bladder monitoring device 100 within the bladder 14. For example, the movement component(s)15104616696Attorney Docket No. 106546-846816 (3995)315 can move the bladder monitoring device 100 within the fluid of the bladder 14 so that the sensor(s) 104 are oriented to capture the data regarding the desired portion of the bladder 14. In some examples, the movement component(s) 315 can include one or more motors, one or more fins, one or more blades, one or more pumps, and / or any other suitable mechanism to move the bladder monitoring device 100 within the fluid of the bladder 14.

[0071] As shown in FIGS. 3A, 3C, and 3E, the housing 302, 310 can include a retrieve portion 350 operable to be coupled with the retrieving tool 30 to insert and / or extract the bladder monitoring device 100 within and / or from the bladder 14. In at least one example, the retrieve portion 350 can be configured so that the retrieving tool 30 can couple with the retrieve portion 350. The retrieving tool 30 can maintain the coupling with the retrieve portion 350 while the bladder monitoring device 100 traverses through the urethra into and / or out of the bladder 14. In at least one example, as illustrated herein, the retrieve portion 350 can be included in the base 310 of the housing 302, 310. The retrieve portion 350 can extend from the base 310 and form one or more coupling portions 3502, 3510 which the retrieving tool 30 can couple with.

[0072] In some examples, the retrieve portion 350 can include a foot 3500 and the coupling portion 3502. The coupling portion 3502 can extend from the base 310 and have a narrower width or diameter than the foot 3500 that extends or is coupled with the end of the coupling portion 3502. Accordingly, when the retrieving tool 30 grasps onto the coupling portion 3502 using the tool coupling component(s) 32, the retrieving tool 30 is securely coupled with the coupling portion 3502. The larger width or diameter of the foot 3500 and the larger width or diameter of the base 310 in relation to the coupling portion 3502 provides stops for the retrieving tool 30 so that the retrieving tool 30 does not slip off of an end of the coupling portion 3502.

[0073] In some examples, the base 310 can include a rear coupling portion 3510 that is positioned at an end of the base 310 or at an end of the foot 3500 (e.g., facing outward away from the bladder monitoring tool 100) for easy access by the retrieving tool 30. The rear coupling portion 3510 can extend outwardly from the base 310 or the foot 3500. The rear coupling portion 3510 can be substantially in a rectangular shape to be grasped on either side thereof by the tool coupling component(s) 32. In some examples, the base 310 or the foot 3500 can include recesses 3512 on either side of the rear coupling portion 3510 to form a pocket for the retrieving tool 30 to be securely received therein while coupled with the rear coupling portion 3510, so that the retrieving tool 30 does not slip off of an end of the rear coupling portion 3510 while traversing through the urethra and the bladder 14.

[0074] In some examples, the retrieve portion 350 can include only one of the coupling portions16104616696Attorney Docket No. 106546-846816 (3995)3502, 3510. In some examples, the retrieve portion 350 can include both of the coupling portions 3502, 3510 to provide different options to couple with the retrieving tool 30, regardless of the orientation of the bladder monitoring tool 100.

[0075] In some examples, the retrieve portion 350 can include magnet(s) so that the retrieving tool 30 can magnetically couple with the retrieve portion 350. In some examples, at least a portion of the retrieve portion 350 can include rubber to assist with grip for the retrieving tool 30.

[0076] FIGS. 4A-4C illustrate another example of the bladder monitoring device 100, 400 with a different configuration of the transparent portion 302, the communication component 112, and the sensors 104, 404. The bladder monitoring device 400 includes two sensors 104 (e.g., two cameras 104) facing opposite directions. Each sensor 104 can be coupled with a receiver 1132. The transmitter 1132 can be disposed within the base 310. The transparent portion 302 can be substantially cylindrical to correspond with the positioning of the sensors 104 on opposite sides. In some examples, the transparent portion 302 can include the dome tip as in FIGS. 3A-3G. The sensors 104 facing opposite directions allow for more of the bladder 14 to be captured at one time, without the need to move and / or reorient the bladder monitoring device 100 as much if at all. With the configuration as illustrated in FIGS. 4A-4C, the combined image angle can be up to about 360 degrees. For example, the combined image angle can be between about 90 degrees and about 360 degrees. In some examples, the combined image angle can be between about 180 degrees and about 360 degrees. In some examples, the combined image angle can be between about 250 degrees and about 360 degrees. In some examples, the combined image angle can be between about 300 degrees and about 360 degrees. In some examples, the combined image angle can be between about 330 degrees and about 360 degrees.

[0077] As illustrated in FIG. 4B, the bladder monitoring device 400 has a length 400L and a width 400D that is configured to fit and traverse through the urethra, so that the bladder monitoring device 400 can be implanted and / or retrieved during a cystoscopy procedure. Additionally, the size of the bladder monitoring device 400 must allow for movement within the bladder 14 so that the sensors 404 can capture data regarding the desired portion of the bladder 14. In some examples, the housing 302, 310 can have a length 400L less than about 20 millimeters. In some examples, the housing 302, 310 can have a length 400L less than about 19 millimeters. In some examples, the housing 302, 310 can have a length 400L that is about 18 millimeters. In some examples, the housing 302, 310 can have a width 400D that is less than about 14 millimeters In some examples, the housing 302, 310 can have a width 400D that is less than about 12 millimeters. In some examples, the housing 302, 310 can have a width 400D that is less than17104616696Attorney Docket No. 106546-846816 (3995) about 10 millimeters. In some examples, the housing 302, 310 can have a width 400D that is less than about 8 millimeters. In some examples, the housing 302, 310 can have a width 400D that is about 7 millimeters.

[0078] FIG. 5 illustrates a comparison of the size between the bladder monitoring device 100 and a conventional device 1 , for example a device used for endoscopy of the intestinal tract. The conventional device can have a width 1 D of about 11 millimeters and a length 1 L of about 25 millimeters. Accordingly, the size of the bladder monitoring device 100 is much smaller so that the bladder monitoring device 100 can traverse through the urethra during a cystoscopy procedure.

[0079] FIG. 6 is a block diagram of an exemplary controller 108, 58. Controller 108, 58 is configured to perform processing of data and communicate with the sensors 104, for example as illustrated in FIGS. 1A-5. In operation, controller 108, 58 communicates with one or more of the components discussed herein and may also be configured to communication with remote devices / systems.

[0080] As shown, controller 108, 58 includes hardware and software components such as network interfaces 610, at least one processor 620, sensors 660 and a memory 640 interconnected by a system bus 250. Network interface(s) 210 can include mechanical, electrical, and signaling circuitry for communicating data over communication links, which may include wired or wireless communication links. Network interfaces 610 are configured to transmit and / or receive data using a variety of different communication protocols, as will be understood by those skilled in the art.

[0081] Processor 620 represents a digital signal processor (e.g., a microprocessor, a microcontroller, or a fixed-logic processor, etc.) configured to execute instructions or logic to perform tasks. Processor 620 may include a general-purpose processor, special-purpose processor (where software instructions are incorporated into the processor), a state machine, application specific integrated circuit (ASIC), a programmable gate array (PGA) including a field PGA, an individual component, a distributed group of processors, and the like. Processor 620 typically operates in conjunction with shared or dedicated hardware, including but not limited to, hardware capable of executing software and hardware. For example, processor 620 may include elements or logic adapted to execute software programs and manipulate data structures 645, which may reside in memory 640.

[0082] Sensors 660, which may include sensors 104 as disclosed herein, typically operate in18104616696Attorney Docket No. 106546-846816 (3995) conjunction with processor 620 to perform measurements, and can include special-purpose processors, detectors, transmitters, receivers, and the like. In this fashion, sensors 660 may include hardware / software for generating, transmitting, receiving, detection, logging, and / or sampling parameters.

[0083] Memory 640 comprises a plurality of storage locations that are addressable by processor 620 for storing software programs and data structures 645 associated with the embodiments described herein. An operating system 642, portions of which may be typically resident in memory 640 and executed by processor 620, functionally organizes the device by, inter alia, invoking operations in support of software processes and / or services 644 executing on controller 108, 58. These software processes and / or services 644 may perform processing of data and communication with controller 108, 58, as described herein. Note that while process / service 644 is shown in centralized memory 640, some examples provide for these processes / services to be operated in a distributed computing network.

[0084] It will be apparent to those skilled in the art that other processor and memory types, including various computer-readable media, may be used to store and execute program instructions pertaining to the bladder evaluation techniques described herein. Also, while the description illustrates various processes, it is expressly contemplated that various processes may be embodied as modules having portions of the process / service 644 encoded thereon. In this fashion, the program modules may be encoded in one or more tangible computer readable storage media for execution, such as with fixed logic or programmable logic (e.g., software / computer instructions executed by a processor, and any processor may be a programmable processor, programmable digital logic such as field programmable gate arrays or an ASIC that comprises fixed digital logic. In general, any process logic may be embodied in processor 620 or computer readable medium encoded with instructions for execution by processor 620 that, when executed by the processor, are operable to cause the processor to perform the functions described herein.

[0085] Additionally, the controller 108, 58 can apply machine learning, such as a neural network or sequential logistic regression and the like, to determine relationships between the data from the sensors 104 and the bladder. For example, a deep neural network may be trained in advance to capture the complex relationship between the images and / or video captured by the sensors 104 and the status of the bladder. This neural net can then be deployed in the estimation of cancer development. As such, the determination of bladder cancer and development can be more accurate.19104616696Attorney Docket No. 106546-846816 (3995)

[0086] Referring to FIG. 7, a flowchart is presented in accordance with an example embodiment. The method 700 is provided by way of example, as there are a variety of ways to carry out the method. The method 700 described below can be carried out using the configurations illustrated in FIGS. 1A-6, for example, and various elements of these figures are referenced in explaining example method 500. Each block shown in FIG. 7 represents one or more processes, methods, or subroutines, carried out in the example method 700. Furthermore, the illustrated order of blocks is illustrative only and the order of the blocks can change according to the present disclosure. Additional blocks may be added, or fewer blocks may be utilized, without departing from this disclosure. The example method 700 can begin at block 702.

[0087] At block 702, one or more sensors of a bladder monitoring device implanted within a bladder of a patient is transitioned to an activated mode. In at least one example, the bladder monitoring device can receive, from an external device, a signal to transition the one or more sensors to the activated mode.

[0088] At block 704, the one or more sensors capture data regarding the bladder. In some examples, the one or more sensors can include one or more cameras operable to capture images and / or videos of the bladder. In some examples, one or more light sources can be transitioned to an on state to illuminate a portion of the bladder for the camera(s). In at least one example, the one or more sensors can include pressure sensors that can assist in determining when the bladder is filled a threshold amount of the fluid. In some examples, the one or more sensors can include a distance sensor which can detect a distance from the bladder wall. For example, the distance sensor can include sonar. In some examples, when the device is a distance (e.g., 4 centimeters) away from the bladder wall, the bladder may be determined to be filled a threshold amount. In some examples, the sensor(s) can include GPS to indicate the orientation and / or position of the bladder monitoring device within the bladder.

[0089] At block 706, the data is wireless transmitted to the external device outside of a body of the patient.

[0090] At block 708, the one or more sensors is transitioned to a standby mode. The sensor(s) can be transitioned to the standby mode after a period of time from transitioning to the activated mode. In some examples, the period of time can be between about 1 second and about 30 seconds.

[0091] In at least one example, the external device and / or the bladder monitoring device can store the data. In at least one example, the external device can display the data to a user. In at20104616696Attorney Docket No. 106546-846816 (3995) least one example, an instance of a tumor within the bladder can be identified based on the data from the one or more sensors. In at least one example, changes within the bladder can be tracked based on the data from the one or more sensors.

[0092] In at least one example, a retrieval signal can be transmitted to the external device to indicate to retrieve the bladder monitoring device from the bladder. In some examples, the retrieval signal can be transmitted by the bladder monitoring device. In some examples, the retrieval signal can be transmitted based on a predetermined amount of time. In some examples, the predetermined amount of time can be greater than about 60 days. In some examples, the retrieval signal can be transmitted based on a power threshold of the bladder monitoring device. In some examples, the power threshold can be less than 10% of battery capacity.

[0093] Referring to FIG. 8, a flowchart is presented in accordance with an example embodiment. The method 800 is provided by way of example, as there are a variety of ways to carry out the method. The method 800 described below can be carried out using the configurations illustrated in FIGS. 1A-6, for example, and various elements of these figures are referenced in explaining example method 800. Each block shown in FIG. 8 represents one or more processes, methods, or subroutines, carried out in the example method 800. Furthermore, the illustrated order of blocks is illustrative only and the order of the blocks can change according to the present disclosure. Additional blocks may be added, or fewer blocks may be utilized, without departing from this disclosure. The example method 800 can begin at block 802.

[0094] At block 802, data regarding a bladder of a patient is received from a bladder monitoring device. The data can be received by an external device. The external device can be directly or indirectly communicatively coupled with the bladder monitoring device. The external device is disposed outside of the body of the patient.

[0095] At block 804, the data can be processed. The data can be post-processed to identify instances of cancer and / or track progress of the bladder. The post-processing can be done manually and / or automatically by a computing system. The post-processing can provide clinical feedback.

[0096] At block 806, one or more signals can be transmitted to the bladder monitoring device to transition one or more sensors to an activated mode. For example, the post-processing may indicate a possibility of cancer in the bladder. The signal(s) can be transmitted, for example by the external device, to the bladder monitoring device to activate the sensor(s) to capture more data. In some examples, the signal(s) can include moving the bladder monitoring device to obtain21104616696Attorney Docket No. 106546-846816 (3995) the desired data.

[0097] In the present disclosure, it is understood that the specific order or hierarchy of steps in the methods disclosed are instances of example approaches. Based upon design preferences, it is understood that the specific order or hierarchy of steps in the method can be rearranged while remaining within the disclosed subject matter. The accompanying method claims present elements of the various steps in a sample order and are not necessarily meant to be limited to the specific order or hierarchy presented.

[0098] While the present disclosure has been described with reference to various implementations, it will be understood that these implementations are illustrative and that the scope of the present disclosure is not limited to them. Many variations, modifications, additions, and improvements are possible. More generally, implementations in accordance with the present disclosure have been described in the context of particular examples. Functionality may be separated or combined in blocks differently in various examples of the disclosure or described with different terminology. These and other variations, modifications, additions, and improvements may fall within the scope of the disclosure as defined in the claims that follow.22104616696

Claims

Attorney Docket No. 106546-846816 (3995)CLAIMSWhat is claimed is:1 . A bladder monitoring device comprising: a housing operable to be implanted within a bladder of a patient; one or more sensors disposed within the housing, the one or more sensors operable to transition to an activated mode to capture data regarding the bladder and transition to a standby mode; a controller communicatively coupled with the one or more sensors, the controller operable to wirelessly transmit the data to an external device outside of a body of the patient.

2. The bladder monitoring device of claim 1 , wherein the one or more sensors are transitioned to the activated mode based on a scheduled time and / or day.

3. The bladder monitoring device of claim 1 , wherein the one or more sensors are transitioned to the activated mode based on a command.

4. The bladder monitoring device of claim 3, wherein the command is received from the external device.

5. The bladder monitoring device of claim 3, wherein the command is based on input from the patient.

6. The bladder monitoring device of claim 1 , wherein the one or more sensors are transitioned to the activated mode when the bladder is filled a threshold amount.

7. The bladder monitoring device of claim 6, wherein the threshold amount is greater than 50% of the volume of the bladder.

8. The bladder monitoring device of claim 1 , wherein the one or more sensors includes one or more cameras operable to capture one or more images and / or videos.

9. The bladder monitoring device of claim 8, wherein the one or more cameras are operable to capture an image angle equal to or greater than 90 degrees.23104616696Attorney Docket No. 106546-846816 (3995)10. The bladder monitoring device of claim 1, wherein the controller is operable to transition the one or more sensors to the activated mode for a period of time before transitioning the one or more sensors to the standby mode.

11. The bladder monitoring device of claim 10, wherein the period of time is between about 1 second and about 30 seconds.

12. The bladder monitoring device of claim 10, wherein the period of time is between about 5 seconds and about 25 seconds.

13. The bladder monitoring device of claim 1 , wherein the one or more sensors are operable to transition to the activated mode a predetermined number of times within 24 hours.

14. The bladder monitoring device of claim 1 , wherein the predetermined number of times within 24 hours is greater than 3 times.

15. The bladder monitoring device of claim 1 , wherein the one or more sensors are operable to transition to the activated mode intermittently.

16. The bladder monitoring device of claim 1 , wherein the housing is buoyant within the bladder.

17. The bladder monitoring device of claim 1 , wherein the housing is resistant to a pH of between about 5.0 and about 7.5.

18. The bladder monitoring device of claim 1 , wherein the housing is resistant to treatments.

19. The bladder monitoring device of claim 1 , wherein the housing includes a retrieve portion operable to be coupled with a retrieving tool to extract the bladder monitoring device from the bladder.

20. The bladder monitoring device of claim 1 , wherein the housing has a length less than about 20 millimeters.24104616696Attorney Docket No. 106546-846816 (3995)21. The bladder monitoring device of claim 1 , wherein the housing has a width less than about 14 millimeters.

22. The bladder monitoring device of claim 1 , further comprising: one or more movement components operable to adjust the orientation and / or position of the bladder monitoring device within the bladder.

23. A method comprising: transitioning one or more sensors of a bladder monitoring device implanted within a bladder of a patient to an activated mode; capturing, by the one or more sensors, data regarding the bladder; wirelessly transmitting the data to an external device outside of a body of the patient; and transitioning the one or more sensors to a standby mode.

24. The method of claim 23, further comprising: receiving, from the external device, a signal to transition the one or more sensors of the bladder monitoring device to the activated mode.

25. The method of claim 23, further comprising: storing, by the external device and / or the bladder monitoring device, the data.

26. The method of claim 23, further comprising: displaying, by the external device, the data to a user.

27. The method of claim 23, further comprising: identifying an instance of a tumor within the bladder based on the data from the one or more sensors.

28. The method of claim 23, further comprising: tracking changes within the bladder based on the data from the one or more sensors.

29. The method of claim 23, further comprising: transmitting a retrieval signal to the external device to indicate to retrieve the bladder monitoring device from the bladder.25104616696Attorney Docket No. 106546-846816 (3995)30. The method of claim 29, wherein the retrieval signal is transmitted based on a predetermined amount of time.

31. The method of claim 30, wherein the predetermined amount of time is greater than about 60 days.

32. The method of claim 29, wherein the retrieval signal is transmitted based on a power threshold for a battery of the bladder monitoring device.

33. The method of claim 32, wherein the power threshold is less than 10% of battery capacity.26104616696

Images