KR-20260062726-A - DATA COLLECTION DEVICE AND METHOD FOR CONSTRUCTING A BLADDER MONITORING ALGORITHM

Abstract

The embodiments disclosed in this disclosure relate to a data collection process for constructing a bladder monitoring algorithm. The purpose is to provide a method for clinically implementing various bladder volumes to construct an algorithm used in a bladder monitoring device that non-invasively measures the bladder urine volume of patients requiring bladder urine volume management. Furthermore, the embodiments disclosed in this disclosure aim to simulate and implement bladder irrigation—a routine prescription for patients requiring bladder urine volume management—by injecting physiological saline into the bladder through a catheter to flush the bladder. The purpose is to construct a bladder monitoring algorithm based on accurate clinical bladder volume information derived from the measured signals by injecting physiological saline into the bladder in stages and measuring signals at each injection stage.

Inventors

• 강병일
• 김세환
• 김아람

Assignees

• (주)메디띵스

Dates

Publication Date

20260507

Application Date

20241029

Claims (10)

1. Memory for storing at least one instruction for collecting data required to build a bladder monitoring algorithm; and It includes a processor that performs an operation according to the above instruction, The above processor is, A data collection device in which a data collection system is mounted on the lower abdomen around the bladder, and when a Foley catheter is inserted into the urethra with a syringe containing physiological saline connected to the bladder, the physiological saline is injected into the bladder in stages, and a signal regarding the clinical bladder volume is collected at each stage of the injection of the physiological saline.
2. In paragraph 1, the processor A data collection device that collects signals for clinical bladder volume at each injection step of physiological saline and clinically implements a bladder of volume for each injection step.
3. In paragraph 1, the processor A data acquisition device that determines the volume of physiological saline to be injected based on a urodynamic study (UDS) or a routine voiding diary.
4. In paragraph 3, the processor A data collection device that determines the maximum bladder volume of a subject and injects a certain proportion of physiological saline relative to the maximum bladder volume.
5. In paragraph 1, the processor A data acquisition device that labels the volume of injected physiological saline as a bladder volume and measures a signal for the labeled bladder volume.
6. In paragraph 1, the data collection system A data collection device including a bladder monitoring device and an application.
7. In paragraph 6, the above application is A data collection device that communicates with a monitoring device to visually output monitoring data.
8. In paragraph 1, the processor When the intravesical volume is 0 ml, collect a signal for clinical bladder volume, and after infusing physiological saline to an intravesical volume of 1/4 of the maximum bladder volume, collect a signal for clinical bladder volume, and After infusing physiological saline solution until the intravesical volume reaches 2/4 of the maximum bladder capacity, collect signals regarding clinical bladder volume, and After infusing physiological saline solution to the extent that the intravesical volume becomes 3/4 of the maximum bladder capacity, collect signals regarding clinical bladder volume, and A data acquisition device that collects a signal regarding clinical bladder volume after injecting physiological saline into the bladder to the extent that the bladder volume becomes the maximum bladder volume.
9. In paragraph 5, the above processor A data acquisition device for labeling clinical bladder volume when the bladder volume is 0 ml, when the bladder volume is 1/4 of the maximum bladder volume, when the bladder volume is 2/4 of the maximum bladder volume, when the bladder volume is 3/4 of the maximum bladder volume, and when the bladder volume is the maximum bladder volume, respectively.
10. In a method for collecting data necessary for establishing a bladder monitoring algorithm using a data collection device, A data collection system is mounted on the lower abdomen around the bladder, and when a Foley catheter is inserted into the urethra with a syringe containing physiological saline connected to the bladder, the physiological saline is injected into the bladder in stages; and The method comprises the step of collecting a signal for clinical bladder volume at each of the above physiological saline injection steps; and The volume of physiological saline injected in each of the above steps is A data collection method determined based on a urodynamic study (UDS) or a routine voiding diary.

Description

Data Collection Device and Method for Constructing a Bladder Monitoring Algorithm The present disclosure relates to a data collection device and method for constructing a bladder monitoring algorithm, and specifically, to a device and method for collecting data that clinically implements various bladder volumes in order to construct a bladder monitoring algorithm used in a bladder monitoring device that non-invasively measures the amount of urine in the bladder of patients who need to manage the amount of urine in the bladder. Unless otherwise indicated in this specification, the contents described in this section are not prior art for the claims of this application, and are not to be recognized as prior art simply because they are included in this section. Most conventional bladder monitoring products are based on ultrasound technology. However, there is a problem in that the algorithms applied to conventional ultrasound technology are built upon artificially created bladder phantoms and are commercialized without considering clinical performance. In addition to ultrasound technology, there are bladder monitoring products based on non-invasive technologies such as bio-impedance and near-infrared (NIR). These non-invasive monitoring products measure signals from immediately after urination until the next, and provide data based on algorithms constructed from the urine output volume and the measured time. However, non-invasive bladder monitoring products have limitations in terms of urine output variability, and the reliability of bladder volume information from signals measured during the interim is low. Furthermore, non-invasive bladder monitoring products suffer from the problem of requiring a long time to collect data. FIG. 1 is a drawing showing a data collection system for constructing a bladder monitoring algorithm according to an embodiment. FIG. 2 is a diagram showing the change in bladder volume upon physiological saline infusion according to an embodiment. FIG. 3 is a block diagram of a data collection device according to an embodiment. FIG. 4 is a drawing for explaining the labeling process according to an embodiment. FIG. 5 is a diagram illustrating a data collection method required for establishing a bladder monitoring algorithm according to an embodiment. Hereinafter, various embodiments of the present disclosure are described in conjunction with the accompanying drawings. As various embodiments of the present disclosure may be subject to various modifications and may have various forms, specific embodiments are illustrated in the drawings and described in detail. However, this is not intended to limit the various embodiments of the present disclosure to specific forms, and it should be understood that they include all modifications and/or equivalents and substitutions that fall within the spirit and scope of the various embodiments of the present disclosure. In relation to the description of the drawings, similar reference numerals have been used for similar components. In various embodiments of the present disclosure, terms such as “comprising” or “having” are intended to indicate the existence of the features, numbers, steps, actions, components, parts, or combinations thereof described in the specification, and should be understood as not precluding the existence or addition of one or more other features, numbers, steps, actions, components, parts, or combinations thereof. In various embodiments of the present disclosure, expressions such as “or” include any and all combinations of the words listed together. For example, “A or B” may include A, may include B, or may include both A and B. Expressions such as "first," "second," "first," or "second" used in various embodiments of the present disclosure may modify various components of the various embodiments, but do not limit such components. For example, such expressions do not limit the order and/or importance of such components and may be used to distinguish one component from another. When it is mentioned that a component is "connected" or "joined" to another component, it should be understood that the component may be directly connected or joined to the other component, but that a new component may also exist between the component and the other component. In the embodiments of the present disclosure, terms such as "module," "unit," "part," etc. are used to refer to a component that performs at least one function or operation, and such component may be implemented in hardware or software, or in a combination of hardware and software. Additionally, a plurality of "modules," "units," "parts," etc. may be integrated into at least one module or chip and implemented as at least one processor, except where each needs to be implemented in specific individual hardware. Terms such as those defined in commonly used dictionaries should be interpreted as having meanings consistent with their meanings in the context of the relevant technology, and sho