Detection and rehabilitation training system for urinary control related pelvic floor muscle group

Abstract

The application discloses a detection and rehabilitation training system for urinary control related pelvic floor muscle groups, which comprises a pelvic floor muscle electrical regulation catheter and an extracorporeal monitoring and regulation system. The pelvic floor muscle electrical regulation catheter is used for monitoring the electromyographic signals (EMG) of the muscles corresponding to urinary control related muscles. The extracorporeal monitoring and regulation system is in communication connection with the pelvic floor muscle electrical regulation catheter and is configured to generate a targeted electrical stimulation treatment scheme in response to the processing result of the electromyographic signals, and release an electrical stimulation signal to the urinary control related muscles through the pelvic floor muscle electrical regulation catheter according to the electrical stimulation treatment scheme, so as to implement electrical stimulation rehabilitation training on patients with abnormal muscle groups. The system is also configured to detect the pressure of the prostate and the bladder cavity, and further adopts a combined treatment design of drug administration and heating for the prostate. Through one aspect of the application, multiple electromyographic signals can be monitored at the same time, and through the other aspect of the application, precise rehabilitation intervention and training treatment can be realized.

Description

Technical Field

[0001] This application relates to the technical fields of the urinary system and the pelvic floor muscle system, and in particular to a detection and rehabilitation training system for the pelvic floor muscle group related to urinary control. Background Technology

[0002] Urinary dysfunction is a common symptom of urinary system diseases, with an incidence rate of 15-20% in ordinary adults. The incidence rate increases with age, reaching more than 50% in people over 65 years of age.

[0003] Normal urination is accomplished through the coordinated action of the bladder detrusor muscle, the bladder neck and internal urethral sphincter, the external urethral sphincter, and other pelvic floor muscles, including the levator ani and puborectalis muscles. Abnormal behavior of these muscles, or a lack of coordination between them, can lead to urinary abnormalities.

[0004] Among related technologies, urodynamic testing is currently the most important detection method for urinary abnormalities. The main detection indicators include bladder pressure, rectal pressure, and electromyography of the external anal sphincter. Summary of the Invention

[0005] This application provides a detection and rehabilitation training system for pelvic floor muscles related to urinary control, which can realize real-time monitoring and intelligent electrical stimulation regulation of urinary control muscles.

[0006] The embodiments of this application adopt the following technical solutions:

[0007] In a first aspect, embodiments of this application provide a detection and rehabilitation training system for pelvic floor muscles related to urinary control. The system includes a pelvic floor electromyography (EMG) catheter and an external monitoring and control system. The EMG catheter is used to monitor the electromyographic (EMG) signals corresponding to the muscles related to urinary control. The external monitoring and control system is electrically connected to the EMG catheter via electrodes and is configured as follows:

[0008] In response to the processing results of the electromyographic signals, a targeted electrical stimulation treatment plan is generated; and

[0009] According to the electrical stimulation treatment plan, electrical stimulation signals are released to the urinary control-related muscles through the pelvic floor muscle electromodulation catheter to perform electrical stimulation rehabilitation training for patients with abnormal muscle groups.

[0010] The urinary control-related muscles are combined with the balloon assembly and electrode assembly on the pelvic floor muscle electro-regulation catheter. The abnormal muscle groups are determined by comparing the test data of the patient's muscle groups with those of normal muscle groups in normal individuals.

[0011] The at least one technical solution adopted in this application embodiment can achieve the following beneficial effects: by establishing a detection and rehabilitation training system for the pelvic floor muscles related to urinary control, the system includes a pelvic floor electromyography (EMG) control catheter and an external monitoring and control system. The pelvic floor EMG control catheter is used to monitor the electromyographic (EMG) signals corresponding to the urinary control-related muscles. The external monitoring and control system is communicatively connected to the pelvic floor EMG control catheter and configured to generate a targeted electrical stimulation treatment plan in response to the processing results of the EMG signals; and according to the electrical stimulation treatment plan, electrical stimulation signals are released to the urinary control-related muscles through the pelvic floor EMG control catheter to perform electrical stimulation rehabilitation training for patients with abnormal muscle groups. The urinary control-related muscles cooperate with the balloon assembly and electrode assembly on the pelvic floor EMG control catheter to target and output electrical stimulation under physiological adaptation conditions, relying on the electrodes and balloon assembly integrated in the catheter, thus completing an integrated closed loop of monitoring-diagnosis-individualized electrical stimulation rehabilitation. The abnormal muscle groups are determined by comparing the patient's muscle groups with normal muscle groups in healthy individuals, enabling objective quantitative assessment and adaptive rehabilitation training of the urinary control muscle groups. Precise targeted therapy using a composite field formed by multi-electrode stimulation within the pelvic cavity effectively improves dysfunction of urination-related muscle groups, enhancing rehabilitation efficiency and treatment suitability. Attached Figure Description

[0012] The accompanying drawings, which are included to provide a further understanding of this application and form part of this application, illustrate exemplary embodiments and are used to explain this application, but do not constitute an undue limitation of this application. In the drawings:

[0013] Figure 1 This is a schematic diagram of the internal structure of the urinary incontinence-related pelvic floor muscle group detection and rehabilitation training system in an embodiment of this application;

[0014] Figure 2 This is a schematic diagram of the male pelvic floor myoelectric modulation catheter in an embodiment of this application;

[0015] Figure 3 This is a schematic diagram of the female pelvic floor myoelectric modulation catheter in an embodiment of this application;

[0016] Figure 4 This is a schematic diagram of the connection relationships in the urinary incontinence-related pelvic floor muscle group detection and rehabilitation training system in this application embodiment;

[0017] Figure 5 This is one of the schematic diagrams of the urinary tract in the urinary incontinence-related pelvic floor muscle group detection and rehabilitation training system in the embodiments of this application;

[0018] Figure 6 This is the second schematic diagram of the urinary tract in the urinary control-related pelvic floor muscle group detection and rehabilitation training system in the embodiments of this application;

[0019] Figure 7This is a schematic diagram of the airbag wall in the urinary incontinence-related pelvic floor muscle group detection and rehabilitation training system in the embodiments of this application;

[0020] Figure 8 This is a schematic diagram of the balloon and urinary catheter in the urinary incontinence-related pelvic floor muscle group detection and rehabilitation training system in the embodiments of this application;

[0021] Figure 9 This is a schematic diagram of the outer wall electrode of the airbag of the urinary incontinence-related pelvic floor muscle group detection and rehabilitation training system in the embodiments of this application;

[0022] Figure 10 This is a schematic diagram of the comprehensive detection signal of the male urinary tract in the urinary control-related pelvic floor muscle group detection and rehabilitation training system in the embodiments of this application;

[0023] Figure 11 This is a schematic diagram of the comprehensive detection signal of the female urinary tract in the urinary control-related pelvic floor muscle group detection and rehabilitation training system in the embodiments of this application;

[0024] Figure 12 This is a schematic diagram of the internal structure of the external monitoring and control system in the urinary control-related pelvic floor muscle group detection and rehabilitation training system in this application embodiment. Detailed Implementation

[0025] To make the objectives, technical solutions, and advantages of this application clearer, the technical solutions of this application will be clearly and completely described below in conjunction with specific embodiments and corresponding drawings. Obviously, the described embodiments are only a part of the embodiments of this application, and not all of them. Based on the embodiments in this application, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this application.

[0026] The current routine clinical methods for testing urinary control muscle groups and lower urinary tract function are as follows:

[0027] During the test, the subject's bladder is first emptied of any remaining urine. Then, saline solution is artificially instilled into the bladder through an indwelling catheter to induce a urination response. The subject is guided to perform a series of simulated urination actions, including detrusor muscle contraction and relaxation. Using body fluid pressure in conjunction with a pressure transducer or measuring device, bladder pressure data is indirectly collected. Simultaneously, the expelled fluid is introduced into a uroflowmeter. By combining the dynamic changes in bladder pressure and urine flow rate, overall bladder function is indirectly assessed.

[0028] Similarly, in clinical practice, fluid irrigation combined with catheter insertion is often used to complete the functional testing of the urethral sphincter and urethral passage.

[0029] For the functional testing of the terminal pelvic floor sphincter and pelvic floor muscle group, rectal electrodes and vaginal electrodes are routinely inserted to collect electromyographic signals of the rectal sphincter group and vaginal pelvic floor muscle group, respectively, to achieve local electrophysiological assessment of the pelvic floor muscles.

[0030] Existing traditional testing methods have many obvious technical shortcomings:

[0031] First, the testing procedure is cumbersome, highly invasive, and results in a poor patient experience.

[0032] Traditional fluid-infused pressure monitoring relies on long-term catheterization and continuous fluid infusion, resulting in a complex and time-consuming procedure. Bladder and urethral pressure monitoring, rectal electromyography (EMG) acquisition, and pelvic floor and vaginal muscle EMG acquisition are independent processes with incompatible equipment, requiring testing to be performed in segments. Repeated insertion and removal of catheters and electrodes increases the frequency of invasive procedures, easily causing patient discomfort, foreign body sensation, and physical pain, leading to low clinical compliance.

[0033] Second, multiple parameters cannot be collected synchronously, lack temporal correlation, and cannot be used to assess muscle group coordination.

[0034] In traditional methods, bladder pressure, urethral pressure, and urine flow parameters are detected and recorded separately from the electromyographic signals of the rectum and pelvic floor muscles. The time axes of these physiological parameters cannot be aligned, preventing synchronous sampling of signals across the entire range. It is impossible to establish a temporal correspondence between pressure indicators and electromyographic signals from multiple muscle groups, making it difficult to accurately analyze the coordination patterns between the bladder, urethra, and pelvic floor muscles during urine storage and voiding. Consequently, it is impossible to objectively assess voiding dysfunction caused by multi-muscle group dyscodynamics.

[0035] Third, the visualization of pressure monitoring is low and the data continuity is poor.

[0036] Traditional liquid pressure testing mostly records values ​​intermittently, making it difficult to present the dynamic fluctuations of pressure inside the bladder and urethra in a real-time, continuous, and intuitive manner. It cannot capture the details of short-term and transient abnormal pressure fluctuations, resulting in one-sided test data and a tendency to miss or misjudge.

[0037] Fourth, the lack of detection of core target muscle groups leads to significant diagnostic limitations.

[0038] Currently, only external or end-cavity electrodes can be used to collect superficial electromyographic signals of the rectal sphincter and pelvic floor vaginal muscles. Direct acquisition of in-situ electromyographic activity of the bladder detrusor muscle and internal / external urethral sphincters is not possible; urinary tract function can only be indirectly inferred from signals of peripheral muscle groups. For complex and multifaceted lower urinary tract dysfunctions, neurogenic voiding disorders, and prostatic secondary voiding disturbances, there is a lack of direct and objective diagnostic evidence, resulting in insufficient accuracy in screening and diagnosis.

[0039] Fifth, it has limited functionality, possessing only detection and assessment capabilities but lacking simultaneous intervention and treatment methods.

[0040] Traditional testing involves multiple independent tests, increasing patient discomfort, and the data is difficult to analyze jointly over a time scale. Traditional testing equipment only has the functions of physiological signal acquisition and data detection and evaluation. After the test is completed, patients need to be referred to other hospitals and have their equipment changed to carry out rehabilitation interventions such as electrical stimulation and drug therapy. It cannot achieve an integrated closed loop of real-time monitoring, data analysis and targeted treatment. The diagnosis and treatment process is fragmented, and the rehabilitation intervention is less targeted and timely.

[0041] Sixth, the stimulation used in traditional urodynamic testing is single-catheter, single-electrode stimulation, which is difficult to effectively stimulate target points inside the pelvic cavity and at the same time generates unnecessary stimulation to surrounding tissues, causing side effects.

[0042] Seventh, traditional urodynamic testing presents significant challenges in diagnosing and treating the prostate, and oral medications are inefficient and cannot effectively reach the affected area.

[0043] 1. Traditional testing involves multiple independent tests, increasing patient discomfort, and the data is difficult to analyze together over a time scale; 2. Traditional testing uses single-catheter, single-electrode stimulation, which is difficult to effectively stimulate targets within the pelvic cavity and causes unnecessary stimulation to surrounding tissues, leading to side effects; 3. Prostate diagnosis and treatment are challenging, and oral medications are inefficient and cannot effectively reach the affected area.

[0044] To address the aforementioned shortcomings, the urinary control-related pelvic floor muscle group detection and rehabilitation training system in this application embodiment integrates the functional catheter, detection electrode, and pressure regulating balloon into a single design. Operators only need a single insertion operation to simultaneously complete multiple detection items that previously required multiple instruments and steps, while also integrating electrical stimulation modulation function.

[0045] The urinary control-related pelvic floor muscle group detection and rehabilitation training system in this embodiment can simultaneously collect bladder pressure signals and electromyographic signals of multiple urinary tract muscle groups, and output targeted electrical stimulation intervention signals; in conjunction with the external monitoring and control system, it can realize real-time dynamic monitoring and intelligent closed-loop control of urinary control-related muscle groups.

[0046] The urinary control-related pelvic floor muscle group detection and rehabilitation training system in this application embodiment can accurately delineate the area of ​​action through a flexible and free pelvic floor electrode circuit configuration method, assisting medical staff in treating various urinary abnormalities, and thus completing individualized and targeted precise rehabilitation intervention and training treatment.

[0047] The technical solutions provided by the various embodiments of this application are described in detail below with reference to the accompanying drawings.

[0048] This application provides a system for detecting and rehabilitating pelvic floor muscles related to urinary incontinence, such as... Figure 1The diagram shows the internal structure of a pelvic floor muscle group detection and rehabilitation training system according to an embodiment of this application. The system includes a pelvic floor electromyography (EMG) control catheter 100 and an external monitoring and control system 200. The EMG control catheter 100 is used to monitor the electromyographic (EMG) signals corresponding to the urinary control-related muscles 300. The external monitoring and control system 200 is communicatively connected to the EMG control catheter 100 and is configured to: generate a targeted electrical stimulation treatment plan in response to the processing results of the EMG signals; and release electrical stimulation signals to the urinary control-related muscles through the EMG control catheter according to the electrical stimulation treatment plan, so as to perform electrical stimulation rehabilitation training on patients with abnormal muscle groups. The urinary control-related muscles cooperate with the balloon assembly and electrode assembly on the EMG control catheter, and the abnormal muscle groups are determined by comparing the patient's muscle groups with normal muscle groups in normal individuals.

[0049] The pelvic floor electromyography (EMG) control catheter 100 includes a catheter inserted into the patient's body, which can acquire EMG signals from muscles related to urinary control. Furthermore, the catheter can also provide corresponding electrical stimulation signals to these muscles. In other words, the pelvic floor EMG control catheter 100 functions to acquire EMG signals and output electrical stimulation signals.

[0050] The external monitoring and control system 200 can be wiredly connected to the pelvic floor electromyography (EMG) control catheter 100. In addition to displaying monitoring results, the external monitoring and control system 200 can also generate an electrical stimulation protocol corresponding to the current patient. Based on the processing results of the EMG signals, the external monitoring and control system 200 generates a targeted electrical stimulation treatment plan. Considering that the pelvic floor EMG control catheter 100 can be inserted at different locations and that patients may be of different genders, the electrical stimulation treatment plan generated by the external monitoring and control system 200 can be adaptively adjusted for different urinary control-related muscles and for patients of different genders, thereby meeting the needs of different scenarios.

[0051] Furthermore, the external monitoring and control system 200 will also release electrical stimulation signals to the urinary control-related muscles through the pelvic floor myoelectric control catheter according to the electrical stimulation treatment plan (including but not limited to stimulation frequency, stimulation pulse width, stimulation current, stimulation duration, electrode circuit configuration, stimulation mode type, and synchronization control threshold) to perform electrical stimulation rehabilitation training for patients with abnormal muscle groups.

[0052] Understandably, the stimulation frequency of the system is usually designed to be adjustable within a fixed range, typically 1~1000Hz or higher. This corresponds to different pathological states of muscle groups; high-frequency parameters are used for interventions to relax urinary muscles, while low-frequency, high-energy parameters are used for interventions to strengthen muscle contraction.

[0053] The aforementioned stimulation pulse width, controlling the duration of a single electrical pulse, adapts to the tolerance thresholds of different soft tissue muscle groups such as the urethral sphincter, detrusor muscle, pelvic floor muscles, and anal sphincter, ensuring both stimulation effectiveness and safety. The aforementioned stimulation current allows for graded adjustment of the electrical stimulation output energy, distinguishing between low-intensity adaptive stimulation and high-intensity functional activation stimulation to improve various abnormal conditions such as muscle weakness and excessive muscle tension / spasm. The aforementioned stimulation duration includes the duration of a single stimulation, the interval period, and the overall duration of the rehabilitation training course; it supports multiple working modes such as short-term pulse intermittent output and continuous rhythmic stimulation. The aforementioned electrode circuit configuration allows for customizable selection of the combination of stimulation electrodes and circuit electrodes, limiting the area of ​​electrical stimulation and achieving precise stimulation of single-point or multi-area targeted muscle groups. The aforementioned stimulation mode types include muscle relaxation mode, muscle contraction strengthening mode, and rhythmic alternating training mode, matching the physiological movement patterns of relaxation and contraction of the urinary control muscles. The aforementioned synchronous control thresholds include real-time thresholds for binding electromyographic signals, using detection data such as bladder neck electromyography, detrusor muscle electromyography, and intravesical pressure as triggering conditions to adaptively start, stop, and switch electrical stimulation schemes.

[0054] The urinary control-related muscles 300 are different muscle sites in the patient's body related to (normal) urination function. Because the pelvic floor electromyography control catheter 100 is equipped with a "balloon assembly" and an "electrode assembly," and the "balloon assembly" is equipped with an "electrode assembly," it can not only collect electromyographic signals but also apply electrical stimulation. It is understood that the "balloon assembly" and "electrode assembly" can be placed at different sites within the urinary control-related muscles 300.

[0055] The system allows for real-time monitoring of electromyographic (EMG) signals. Abnormal muscle groups are identified by comparing the patient's muscle groups (feedback) with pre-saved normal muscle groups (feedback) from healthy individuals. For example, by inputting the patient's age, gender, and physical characteristics, standard muscle group physiological parameters corresponding to healthy individuals are matched. Threshold comparisons and temporal correlation analyses are performed on the EMG signals and bladder pressure indicators of various parts of the body under resting and urination dynamic conditions, compared with normal parameters. Based on differences in signal amplitude, muscle relaxation / contraction response characteristics, and differences in muscle group synergy, abnormal muscle groups are identified and determined. Those skilled in the art will understand that the above implementation is merely an example and is not intended to limit the scope of protection in this application's embodiments. This application provides a detection and rehabilitation training system for pelvic floor muscle groups related to urinary control. It can not only complete multiple traditional tests at once, thus more accurately determining muscle group coordination, but also provides a more intelligent auxiliary diagnostic and treatment system.

[0056] The pelvic floor muscle group detection and rehabilitation training system in this embodiment breaks through the long-standing technical inertia and design bias in the field. It enables the pelvic floor electromyography (EMG) catheter 100 to capture the raw EMG signals of the urinary control muscles in real time and simultaneously transmit them back to the external monitoring and control system 200. The external monitoring and control system 200 dynamically calculates real-time signal data and intelligently generates a customized electrical stimulation treatment plan, which is then reversed through the pelvic floor EMG catheter 100 to complete targeted electrical stimulation output. Through the bidirectional linkage of catheter-end sensing and external-end intelligent analysis and closed-loop control, a complete closed loop of "in vivo real-time monitoring - intelligent signal analysis - individualized plan generation - in situ synchronous intervention" is achieved. This differs from the conventional design approach in the field, which only uses a cavity catheter to collect physiological signals or uses external devices for isolated electrical stimulation. It establishes real-time communication and linkage between the invasive pelvic floor EMG catheter 100 and the external monitoring and control system 200, forming an integrated closed-loop collaborative working mode.

[0057] The pelvic floor electromyography (EMG) control catheter 100 integrates a balloon and electrodes, enabling it to monitor bladder pressure and EMG signals from the detrusor muscle, internal urethral sphincter, external urethral sphincter, and external anal sphincter, and transmit the monitored signals to an external monitoring and control system 200. The external monitoring and control system 200 receives and processes the signals, displaying the results in real-time on a monitor. Simultaneously, the system compares the results with data from healthy individuals to develop an electrical stimulation treatment plan, releasing electrical stimulation to provide rehabilitation training for abnormal muscle groups. By integrating the catheter, electrodes, and balloon into a single component, medical personnel can perform tests that previously required multiple steps with a single operation. Furthermore, it features EMG control functionality, enabling the acquisition and regulation of bladder pressure and urinary tract muscle EMG data.

[0058] In one embodiment of this application, the pelvic floor electromyography (EMG) catheter includes a urinary catheter inserted into the urinary tract and a rectal catheter inserted into the rectum. The rectal catheter is configured to: collect EMG signals of the anal sphincter group during the monitoring phase and apply electrical stimulation signals to the anal sphincter group during the rehabilitation phase. The urinary catheter is configured to: collect intravesical pressure EMG signals, internal urethral sphincter EMG signals, external urethral sphincter EMG signals, and intravesical detrusor muscle EMG signals during the monitoring phase and apply electrical stimulation signals to the bladder and / or urethra during the rehabilitation phase. The urinary catheter integrates a prostate-specific tubular balloon, which is specifically used for monitoring prostate physiological parameters and targeted prostate therapy. During the monitoring phase, pressure signals at the prostate are accurately collected, and during the rehabilitation phase, therapeutic drugs can be precisely delivered to the prostate lesion site, achieving local targeted drug delivery intervention for the prostate.

[0059] like Figure 4 and 5As shown, exemplarily, the distal end of the urinary catheter has a retractable balloon 5, with a sheet electrode 6 embedded in the outer wall of the balloon. This electrode can collect electromyographic signals from the bladder detrusor muscle and can also apply electrical stimulation to the bladder detrusor muscle. A miniature pressure sensor 7 is located inside the balloon to monitor the balloon pressure in real time. The sheet electrode has two specific implementations:

[0060] The first implementation method is to design the sampling electrode and the stimulation electrode as independent physical electrodes, so that acquisition and stimulation can be performed simultaneously. Since the stimulation amplitude, frequency and pulse width are known, the stimulation pulse is mixed with real electromyography data to simulate and calculate a digital filter, which is then applied to the electromyography acquisition algorithm. This can effectively remove the signal interference generated by the stimulation and extract the effective electromyography signal.

[0061] The second implementation method is to use a single physical electrode for both sampling and stimulation. Acquisition and stimulation need to be performed alternately. Since stimulation can produce artifacts in the acquisition, it is necessary to control the time interval between the acquisition action after stimulation to reduce the interference of stimulation on the acquisition. At the same time, a digital filter algorithm for high-frequency stimulation is designed to reduce stimulation artifacts and improve the fidelity of the acquired signal.

[0062] like Figure 5 and Figure 6 As shown, exemplarily, the urinary catheter has ring electrodes (8, 18) or directional electrodes (19, 20, 21) embedded at different positions in the tubing to collect electromyographic signals from the bladder neck and internal and external urethral sphincters, and to apply electrical stimulation to these muscles. A retractable tubular balloon 9 is also placed on the urinary catheter, containing a miniature pressure sensor 10 to monitor the balloon pressure in real time. It is understood that the functional state of the female vagina has a significant impact on the formulation of pelvic floor surgery plans; therefore, an electrode is added to the mid-urethra of the female catheter to collect electromyographic signals from that area. Due to the high complexity of the female pelvic floor muscle group and the different physiological orientations of key muscles in different parts of the urethra, the electrodes are designed as directional electrodes (19, 20, 21), divided into four directions: three o'clock, six o'clock, nine o'clock, and twelve o'clock.

[0063] like Figure 4 As shown, exemplarily, a rectal catheter has a ring electrode 11 embedded in the tube for collecting electromyographic signals of the muscles around the rectum and anus, and can also apply electrical stimulation to the muscles around the rectum and anus. The other end of the pelvic floor electromyographic control catheter has three interfaces, two of which are tracheal interfaces 12, used to adjust the contraction of the two balloons respectively; the other interface is a multi-way plug 13 formed by the convergence of all the ring electrode wires, the electrode wires embedded in the balloons, and the barometric pressure sensor wires.

[0064] like Figure 5As shown, exemplarily, the pelvic floor electromyography (EMG) control catheter includes a urinary tract catheter inserted into the urinary tract and a rectal catheter inserted into the rectum. One end of the urinary tract catheter contains a contractile balloon with electrodes embedded in it, capable of collecting EMG signals from the detrusor muscle of the bladder. The balloon is connected to the gas interface of the external monitoring and control system's inflation / deflation module via a trachea-15 inside the catheter. The inflation / deflation module can dynamically adjust the output gas pressure, causing the balloon to inflate and fill the bladder. Simultaneously, the inflating balloon deploys multiple sheet-like electrodes embedded in different areas of the bladder surface, allowing them to adhere to the bladder surface. It can be understood that the sheet-like electrodes consist of acquisition electrodes and stimulation electrodes. The acquisition electrodes are used to collect EMG signals from the detrusor muscle in different bladder regions of the subject, while the stimulation electrodes are used to stimulate the detrusor muscle in different bladder regions.

[0065] The acquisition electrode is connected to a multi-way connector at the other end via a wire inside the catheter. The electromyography (EMG) signal is then output to the EMG acquisition module through the female connector of the multi-way connector. For example... Figure 5 As shown, in the catheter used by men, a tubular balloon is set at the prostate position after insertion. The trachea 2 16 inside the tubular balloon is connected to the airway interface of the inflation and deflation module of the external monitoring and control system, which can be used for inflation and deflation adjustment. The miniature pressure sensor 2 inside the tubular balloon can reflect the pressure at the prostate in real time.

[0066] After insertion into the urinary tract, a urinary catheter has ring electrodes (8, 18) embedded at the locations corresponding to the bladder neck, internal urethral sphincter, and external urethral sphincter. These electrodes consist of a acquisition electrode and a stimulation electrode. The acquisition electrode collects electromyographic (EMG) signals from the bladder neck and urethral sphincter. It connects to a multi-way connector at the other end via a wire inside the catheter, and outputs the EMG signals to the EMG acquisition module through the female connector. The stimulation electrode stimulates the bladder neck and urethral sphincter. It connects to a multi-way connector at the other end via a wire inside the catheter, and receives the electrical stimulation signal from the electrical stimulation module through the male connector. Similarly, a rectal catheter, after insertion into the anus, has ring electrodes embedded at the locations corresponding to the muscles around the anus. These electrodes consist of an acquisition electrode and a stimulation electrode. The acquisition electrode collects EMG signals from the muscles around the anus, while the stimulation electrode stimulates them. The acquisition electrode connects to a multi-way connector at the other end via a wire inside the catheter, and outputs the EMG signals to the EMG acquisition module through the female connector. The stimulation electrode is connected to a multi-way plug at the other end via a wire inside the catheter, and receives the electrical stimulation signal from the electrical stimulation module through the male part of the multi-way plug.

[0067] Before the urinary tract catheter is inserted, the external monitoring and control system's inflation / deflation module deflates the terminal balloon and tubular balloon via trachea one and trachea two, respectively, causing the balloon wall 22, along with the sheet electrode and wires, to be tightly compressed around the support guide rod 23. Figure 7As shown. The urinary catheter is inserted into the designated position, and the inflation / deflation module begins to inflate, causing the balloon to expand and fill the bladder. Simultaneously, sheet electrodes are attached to the inner surface of the bladder cavity, as... Figure 8 As shown. The support guide rod is made of polymer material, with a rounded head and a certain degree of elasticity, such as... Figure 7 As shown, for independent electrodes, to improve the overlap between acquisition and stimulation target sites, the ring-shaped electrode at the sphincter location adopts a cross design, and the sheet-like electrode in the bladder cavity adopts a concentric ring 17 or a cross wave design, such as... Figure 9 As shown.

[0068] In the specific embodiments of this application, the pelvic floor muscle electro-modulation catheter is divided into two independent interventional catheter structures: a urinary catheter that can be inserted into the human urinary tract and a rectal catheter that can be inserted into the human rectum. The two catheters are used in sync to complete the synchronous acquisition of multi-source signals of the entire urinary control muscle group and the regional targeted electrical stimulation rehabilitation treatment.

[0069] The rectal catheter is inserted directionally along the natural cavity of the rectum, with its insertion depth closely matching the physiological location of the anal sphincter muscles. Multiple sets of high-precision electromyography (EMG) acquisition electrodes and flexible stimulation electrodes are attached to the outer wall of the catheter. During system monitoring, the rectal catheter continuously and in real-time acquires raw EMG signals from the entire anal sphincter muscles via the attached electrodes, fully capturing the contraction amplitude, relaxation sequence, and muscle synergistic fluctuation characteristics of the posterior pelvic floor muscles. During system rehabilitation training, the external monitoring and control system precisely matches and outputs corresponding electrical stimulation waveforms based on the muscle abnormality assessment results. The rectal catheter then applies targeted electrical stimulation to the anal sphincter muscles, specifically addressing abnormalities such as tension, weakness, and slow relaxation of the posterior pelvic floor muscles.

[0070] Simultaneously, a urinary catheter is inserted along the urethral cavity to reach key anatomical areas adjacent to the bladder and prostate. The main body of the urinary catheter integrates multi-channel electromyography (EMG) acquisition contacts, pressure sensing channels, and electrical stimulation output electrodes. During the monitoring phase, the urinary catheter simultaneously acquires piezoelectric signals from the bladder, in-situ EMG signals from the internal and external urethral sphincters, and EMG signals from the entire detrusor muscle region within the bladder. This comprehensively covers the physiological parameters of the core urinary control muscle groups throughout the entire process of urine storage and voiding, forming a multi-dimensional data source for muscle group function assessment. During the rehabilitation phase, based on the EMG signal comparison and analysis results, the urinary catheter can selectively output appropriate electrical stimulation signals to the bladder and urethral regions, specifically regulating the detrusor muscle contraction ability and the coordination of urethral sphincter opening and closing, thereby improving the overall function of the voiding pathway.

[0071] Because of significant differences in the physiological morphology of the bladder and urethra between women and men, prostate diseases in men can affect the pressure of the urinary system. For example... Figure 2As shown, the urinary catheter integrates a dedicated tubular balloon specifically designed to fit the anatomical location of the prostate. This balloon is precisely positioned around the periphery of the prostate urethra, closely conforming to the lateral wall of the prostate gland, without adding additional puncture trauma. During monitoring, the balloon incorporates a high-precision pressure sensor unit, directly contacting the prostate surface to collect real-time data on local pressure fluctuations. This data is simultaneously correlated with key physiological indicators such as changes in glandular tension and the degree of tension in surrounding soft tissues, enabling synchronized monitoring and assessment of prostate function and the coordinated state of the urinary tract muscles. During the rehabilitation treatment phase, the prostate-specific tubular balloon, combined with an integrated drug delivery microchannel structure, can directly and precisely deliver the appropriate therapeutic drug to the area surrounding the prostate lesion according to the targeted drug delivery instructions issued by the external monitoring and control system. This achieves minimally invasive, localized, and precise targeted drug delivery intervention for the prostate, with high drug utilization and good local effects. At the same time, it can be combined with subsequent thermotherapy and electrotherapy to improve blood circulation in the tissues surrounding the prostate, reduce glandular edema, and relieve urethral compression, thereby fundamentally improving clinical problems such as prostate-related urinary obstruction and related disorders of the urinary control muscle group.

[0072] This implementation method utilizes an integrated structure that combines dual-catheter placement, simultaneous monitoring of multiple muscle groups, and zoned electrical stimulation regulation with prostate pressure monitoring and targeted drug delivery. This structure can comprehensively assess the health status of the entire urinary control muscle group and also provide targeted treatment for local prostate lesions. The overall structure conforms to the body's natural cavities, making insertion convenient, minimally invasive, and highly safe, effectively improving the accuracy of urinary control muscle group detection and the overall effectiveness of rehabilitation treatment.

[0073] In one embodiment of this application, the prostate-specific tubular balloon integrates microneedles and is connected to a drug delivery tubing; the tubular balloon, in conjunction with the external monitoring and control system, can directly deliver the drug solution to the patient's prostate.

[0074] The prostate-specific tubular balloon attached to the urinary catheter is made entirely of flexible medical material. The balloon integrates a micro-drug delivery system, and its surface is uniformly covered with numerous micron-sized microneedles. These microneedles are small, flexible, and adaptable, conforming to the surrounding mucosa of the prostate with minimal trauma. One end of the drug delivery system connects to an external drug storage device, while the other end penetrates the balloon and connects to the microneedle delivery channel. In actual use, the prostate-specific tubular balloon, once inflated, conforms to the corresponding anatomical location of the prostate. The external monitoring and control system precisely controls the dosage and timing of drug delivery based on the patient's prostate condition and abnormal urination indicators, directly targeting the drug solution to the local prostate tissue via the delivery system and microneedles. Unlike traditional oral or systemic drug delivery methods, this structure enables targeted local drug delivery to the prostate, increasing drug concentration in the lesion area, reducing the side effects of systemic medication, and, combined with overall urinary tract monitoring data, achieving synergistic intervention and treatment of prostate symptoms and urinary continence disorders.

[0075] Preferably, the prostate-specific tubular balloon at the prostate site integrates microneedles and is connected to a drug delivery tube. Combined with an external control system, the drug solution can be directly delivered to the prostate. The microneedles are in a retracted state during catheter insertion. Once the catheter is in place, they are extended through a guidewire connected to the microneedles. After drug injection, the guidewire is used to pull them back, restoring the retracted state.

[0076] In one embodiment of this application, the prostate-specific tubular balloon is provided with at least two ultra-thin electrothermal films in different directions on its exterior. These ultra-thin electrothermal films are heated by electric current, which can apply heat to the patient's prostate.

[0077] At least two sets of ultra-thin electrothermal films, arranged in different directions, are fixedly installed on the outer wall of the prostate-specific tubular balloon. These ultra-thin electrothermal films are soft and conform to the tissue, adapting to the balloon's shape without affecting its inflation and pressure detection functions. The multi-directional arrangement of the electrothermal films covers different areas around the prostate, expanding the range of heat therapy. The electrothermal films are electrically connected to the external monitoring and control system's electrical control module. During operation, a low-voltage, safe current is used to achieve uniform heating, precisely controlling the heating temperature, duration, and frequency. During the rehabilitation intervention phase, the gentle heat generated by the electrothermal films continuously acts on the prostate area, effectively improving blood circulation around the prostate, relieving glandular tissue edema and muscle spasms, reducing pressure and stimulation of the urethra by the prostate, and synergistically improving complications such as urinary frequency, difficulty urinating, and pelvic floor muscle tension caused by prostate problems, achieving a physical thermotherapy-assisted rehabilitation effect.

[0078] Preferably, the external structure of the prostate-specific tubular balloon integrates four ultra-thin electrothermal films in different directions. These films can be heated by electric current and applied to the prostate to promote blood circulation. The stimulation electrodes are connected to a multi-way connector at the other end via wires inside the catheter. The male portion of the multi-way connector receives electrical stimulation signals from the electrical stimulation module. When the subject controls the bladder detrusor muscle to urinate, the balloon is squeezed. The pressure changes inside the prostate-specific tubular balloon are transmitted to the piezoelectric acquisition module via an electrical signal from a miniature pressure sensor.

[0079] In one embodiment of this application, the pelvic floor electromyography control catheter further includes a vaginal catheter, which is used to collect electromyographic signals of the vaginal muscle group during the monitoring phase and to stimulate the vaginal muscle group during the rehabilitation phase.

[0080] Because there are significant differences in the physiological morphology of the bladder and urethra between women and men, such as Figure 3 As shown, the pelvic floor electromyography (EMG) control catheter is also equipped with a dedicated vaginal catheter, adapted to the human physiological structure. The catheter surface integrates multiple sets of EMG acquisition electrodes and flexible electrical stimulation electrodes. During system monitoring, the vaginal catheter is inserted into the corresponding physiological position and stably conforms to the pelvic floor muscles surrounding the vagina. It continuously acquires raw EMG signals from the vaginal muscles, capturing physiological data such as resting tension, contraction amplitude, and activity rhythm, thus improving the signal acquisition dimensions of the entire female pelvic floor muscle group. During rehabilitation training, the external monitoring and control system, combined with the detected abnormal muscle data, outputs a suitable electrical stimulation signal through the stimulation electrodes of the vaginal catheter. This provides targeted stimulation and regulation of the vaginal muscles and surrounding pelvic floor muscles, improving issues such as pelvic floor muscle relaxation, weak contraction, and muscle coordination disorders, and specifically enhancing the rehabilitation training function of the female-specific pelvic floor urinary control muscles.

[0081] For women, in addition to vaginal and rectal electrodes, a vaginal electrode is integrated, similar to the rectal electrode, for collecting electromyographic signals from the vaginal muscles and stimulating them. Because the length and size of the urinary tract differ between men and women, the catheter is designed in two different sizes for men and women. The electrodes on the catheter located in the urinary tract, rectum, and vagina can be configured to use any one electrode as the stimulating electrode and another as the loop electrode. The stimulating and loop electrodes can form a specific transmission path within the pelvic floor muscles, applying a smaller current and a pre-defined path to the affected area.

[0082] In one embodiment of this application,

[0083] In the pelvic floor electromyography control catheter, one electrode is the stimulating electrode and the other electrode is the loop electrode, forming a single electrical stimulation loop inside the pelvic floor to achieve a deep-directed stimulation loop inside the pelvic floor.

[0084] Any number of electrodes in the pelvic floor electromyography control catheter are stimulating electrodes, and one or more other electrodes are loop electrodes, forming a deep-directional composite electrical stimulation circuit inside the pelvis; by adjusting the intensity of the stimulating electrodes and the acting electrodes in the composite electrical stimulation circuit, the 3D space of stimulation therapy can be accurately controlled.

[0085] The in vitro monitoring and control system also includes a display and interaction module; the display and interaction module is configured to display freely configured electrode circuits within the muscle group in real time, and to synchronize the electrode circuits with the acquired electromyographic signals on the time scale of stimulus release.

[0086] The relatively flexible configuration of pelvic floor electrode circuits can help doctors make accurate diagnoses and precise interventions for patients' urination abnormalities.

[0087] The in vitro monitoring and control system integrates a unified display and interaction module, which features human-computer interaction configuration, real-time data display, and signal synchronization control. Medical staff can use this module to independently configure any electrode on the pelvic floor electromyography (EMG) catheter as a stimulation electrode, while simultaneously matching another electrode as a loop electrode. This flexible combination creates a personalized electrode pathway, constructing a closed electrical stimulation circuit within the pelvic floor tissue. This overcomes the limitations of surface stimulation, achieving targeted and precise electrical stimulation of deep pelvic floor muscles. Simultaneously, the display and interaction module provides real-time visualization of the currently customized electrode circuit distribution, precisely aligning the electrical stimulation output timing with the EMG signal acquisition timing, ensuring complete synchronization of EMG data acquisition, muscle group status analysis, and electrical stimulation intervention in the time dimension. Based on the freely adjustable electrode circuit layout, stimulation plans can be customized according to the patient's lesion location and abnormal muscle areas, significantly improving the accuracy of urinary abnormality diagnosis and the effectiveness of targeted intervention treatment.

[0088] In one embodiment of this application, the display interaction module is further configured to: assist in judging the health status of the muscle groups at the tested location by observing individual test data laterally; and assist in judging the coordination of the test subject's muscle groups by observing the changes in intravesical pressure electromyography (IMP) signals, bladder neck electromyography (EMG) signals, internal urethral sphincter EMG signals, external urethral sphincter EMG signals, intravesical detrusor muscle EMG signals, and peripheral anal EMG signals over time, and by comparing and analyzing the correlation between the above parameters.

[0089] Longitudinal observation includes, but is not limited to, electromyographic (EMG) signals of intravesical pressure signals, internal urethral sphincter, external urethral sphincter, anal sphincter groups, and multiple detrusor muscles within the bladder. Due to differences in detection indicators between male and female catheters, charts are divided into male and female types, each containing its own unique detection signals. The male urinary tract comprehensive test chart displays pressure signals at the prostate. The female urinary tract comprehensive test signal chart displays EMG signals of the mid-urethral sphincter, with all urethral sphincter EMG signals exhibiting four directions. Additionally, the charts can be equipped with scales for measuring time and signal intensity, helping physicians assess the coordination of various urinary tract muscle groups, specifically as follows: Figure 10 , Figure 11 As shown.

[0090] The in vitro monitoring and control system is equipped with a dedicated display and interaction module. This module has built-in dual-channel data analysis logic, namely horizontal single-point data analysis and analysis logic and vertical multi-parameter time-series correlation analysis logic. Combined with the physiological signals synchronously collected by the pelvic floor myoelectric control catheter, it can realize a layered, graded, and precise comprehensive assessment of the urinary control muscle group. No manual secondary calculation is required throughout the process. The analysis is intuitive and meets the needs of the entire clinical voiding function testing process.

[0091] In the horizontal observation and analysis mode, the display and interaction module independently retrieves a single set of test data generated in real time at the test point, and independently compares and analyzes the core single indicators such as electromyographic amplitude, baseline tension, and instantaneous fluctuation amplitude of a single muscle group and at a single moment. It does not link other muscle group parameters or lengthen the observation time axis, but only focuses on the immediate physiological state of the muscle group at the current test point.

[0092] Generally, the test is conducted through a cycle, which consists of controlling the muscle to begin contracting (fast muscle) - continuously tightening (slow muscle) - relaxing (fast and slow muscle). The changes in electromyography (EMG) over one cycle can reflect the health status of the patient's fast and slow muscle groups.

[0093] Here, the monitoring point can be changed to the electromyographic changes of one of the above cycles.

[0094] Medical staff can use this horizontal single-item data to quickly screen whether there are independent functional defects in local muscle groups, such as weak muscle strength, abnormally high muscle tone, or sluggish local muscle response. They can directly determine the health status of the single muscle group being tested, quickly locate the injury point of the isolated local muscle group, and complete the initial screening of single muscle groups at the basic level.

[0095] The longitudinal temporal correlation analysis mode is the core collaborative analysis function of the module. Unlike the horizontal single-point static observation, this mode uses the complete urine storage and voiding physiological cycle as the time benchmark. It continuously and synchronously collects and pulls the complete curves of the dynamic changes of multiple core physiological parameters over time. Specifically, it includes six synchronous temporal signals: intravesical pressure electromyography signal, bladder neck electromyography signal, internal urethral sphincter electromyography signal, external urethral sphincter electromyography signal, intravesical detrusor muscle electromyography signal, and peripheral anal electromyography signal.

[0096] Among them, the electromyographic signal of the bladder neck mainly reflects the opening timing of the bladder outlet, while the electromyographic signal of the internal urethral sphincter focuses on the function of the urinary control valve at the proximal urethra. The two play different physiological roles in the urination pathway.

[0097] The module aggregates dynamic data across the entire lifecycle in real time, accurately recording the temporal characteristics of each parameter, such as the rise rhythm, fall duration, peak occurrence point, and duration of continuous action. It then cross-compares the activation sequence, synchronization amplitude, pressure and electromyographic matching compatibility, and start-stop coordination consistency among different muscle group signals, revealing multi-dimensional correlations. Based on multi-parameter temporal linkage analysis, it can accurately identify various muscle group coordination disorders during urination, such as detrusor and urethral sphincter misalignment, pelvic floor muscle group lag, bladder neck relaxation timing deviation, and abnormal compensation of peripheral anal muscles. It objectively quantifies and evaluates the overall synergistic working ability of the entire urinary control muscle group, effectively assisting in the identification of complex dysco-coordination-type urinary dysfunction. This provides complete, temporally aligned, and clearly correlated data support for the precise generation of subsequent personalized targeted electrical stimulation rehabilitation programs.

[0098] In one embodiment of this application, the in vitro monitoring and control system further includes an auxiliary diagnostic module, which is configured to: input patient characteristic information through the display interaction module, and fit detection data of healthy people that match the patient characteristic information; and generate a diagnostic report based on the calibration comparison results of the detection data of healthy people and the detection data of patients with abnormal muscle groups.

[0099] The in vitro monitoring and control system is equipped with a dedicated auxiliary diagnostic module. This module communicates with the display and interaction module, enabling integrated functions such as patient information entry, healthy population data matching, multi-source detection data calibration and comparison, and automated diagnostic report generation. During use, medical staff can enter multi-dimensional characteristic information such as patient age, gender, weight, past medical history, and abnormal urination symptoms through the display and interaction module. The module's built-in healthy population detection database pre-stores electromyographic signals of normal urinary control muscle groups, bladder pressure parameters, and temporal characteristics of various muscle groups for people of different ages, genders, and physiological characteristics. Based on the entered patient characteristic information, the auxiliary diagnostic module automatically filters and fits a healthy population reference data model that matches the patient's characteristics, constructing a personalized normal control benchmark.

[0100] Subsequently, the module automatically calibrates and compares the patient's bladder pressure, electromyographic signals from various sites, and multi-parameter time-series correlation data collected by the pelvic floor electromyography catheter with the matched data from healthy individuals. It quantifies and calculates the deviation values ​​of the patient's muscle group signals from the normal reference range, and identifies abnormal manifestations such as abnormal local muscle strength, abnormal muscle tone, and multi-muscle group dysco-coordination.

[0101] Based on the above comparison results, the auxiliary diagnostic module can automatically generate a structured diagnostic report. The report clearly marks the location of abnormal muscle groups, the type of abnormality (such as contractile weakness, spasmodic tension, and synergistic disorder), the degree of abnormality, and the possible corresponding type of urinary dysfunction. This provides objective, quantitative, and traceable reference for clinical diagnosis, significantly reducing human interpretation errors and improving diagnostic efficiency and accuracy.

[0102] In one embodiment of this application, the in vitro monitoring and control system further includes an intelligent control module; the intelligent control module is used to generate an electrical stimulation rehabilitation training program and control the electrical stimulation control module to generate electrical pulses to act on the patient, guiding the patient to perform repeated muscle relaxation or contraction training.

[0103] The aforementioned in vitro monitoring and control system is equipped with a dedicated intelligent control module. This module works in conjunction with the display and interaction module, the auxiliary diagnosis module, and the electrical stimulation control module to automatically generate and precisely execute electrical stimulation rehabilitation training programs based on individualized patient diagnostic results.

[0104] The module first receives abnormal information about the patient's muscle groups from the auxiliary diagnostic module, including the location, type, and severity of the abnormal muscle groups. Combined with a preset clinical rehabilitation training logic library, it automatically generates an individualized electrical stimulation rehabilitation training plan that is adapted to the patient's abnormal condition. The plan includes core parameters such as stimulation mode (muscle relaxation mode, muscle contraction strengthening mode, rhythm alternation training mode), stimulation frequency, pulse width, current intensity, duration of a single stimulation, interval period, and treatment schedule.

[0105] Once the stimulation protocol is generated, the intelligent control module sends control commands to the electrical stimulation control module, driving the module to output electrical pulse signals matching the protocol. These pulses are then applied to the patient's target muscle groups via electrode components on the pelvic floor electromyography (EMG) catheter, guiding the patient to perform repeated muscle relaxation or contraction exercises to specifically improve muscle dysfunction. During training, the module can receive real-time feedback from the patient's EMG signals and dynamically adjust stimulation parameters to ensure a safe and effective training process. This avoids the limitations of fixed-pattern stimulation and enhances the targeted and adaptable nature of rehabilitation training.

[0106] In one embodiment of this application, the intelligent control module is further configured to: when comparison reveals that the electromyographic signal of the bladder neck does not significantly decrease when the subject urinates, apply a higher frequency short pulse to induce relaxation of the muscle; when comparison reveals that the pressure inside the bladder is insufficient and the electromyographic signal of some areas does not significantly increase when the subject urinates, apply a lower frequency high energy pulse to induce contraction of the muscle.

[0107] The intelligent control module has built-in control logic for typical abnormalities of urinary dysfunction. It can automatically switch and execute corresponding electrical stimulation intervention strategies based on real-time detected electromyographic and pressure signals.

[0108] When the module comparison reveals that there is no significant attenuation of the electromyographic signal in the bladder neck during the subject's urination, it is determined that the bladder neck muscle group is in an abnormal state of continuous tension and inability to relax normally. At this time, the intelligent control module automatically triggers the muscle relaxation intervention logic, controls the electrical stimulation control module to apply higher frequency short pulses, acts on the bladder neck and surrounding related muscle groups, induces the muscles in this part to produce rhythmic relaxation response, relieves muscle spasm and tension, and promotes normal opening of the urination pathway.

[0109] When the module comparison reveals that the bladder pressure is insufficient during urination and the electromyographic signal in the corresponding detrusor muscle area does not increase significantly, it is determined that the detrusor muscle is in an abnormal state of weak contraction and insufficient muscle strength. At this time, the intelligent control module automatically triggers the muscle contraction strengthening intervention logic, controls the electrical stimulation control module to apply low-frequency high-energy pulses, which act on the detrusor muscle and related accessory muscle groups, induces the muscles to produce rhythmic contraction responses, strengthens muscle contraction ability, and improves bladder urination power.

[0110] The two control logics mentioned above can automatically switch according to the patient's real-time signal status without manual intervention, achieving dynamic and adaptive targeted electrical stimulation intervention, which greatly improves the accuracy and effectiveness of rehabilitation training.

[0111] like Figure 12 As shown, the in vitro detection and control system specifically includes 11 modules: an electromyography acquisition module, an electrical stimulation module, an electrical stimulation control module, an inflation / deflation module, an inflation / deflation control module, a piezoelectric acquisition module, a drug delivery module, an electrothermal control module, a main control module, a display and interaction module, and a power supply module.

[0112] The electromyography (EMG) acquisition module includes an external cable that is matched and connected to the multi-way plug of the pelvic floor EMG control catheter. The male end of the external cable is connected to the male end of the multi-way plug of the catheter for receiving EMG signals.

[0113] The electromyography (EMG) acquisition module converts the signals into digital signals through a sampling circuit and sends them to the main control module for processing. The main control module analyzes and processes the data sent by the EMG acquisition module and displays it in real time through the display and interaction module.

[0114] The interactive display module not only displays real-time changes in electromyographic signals but also real-time changes in bladder pressure. Medical staff can configure electrical stimulation parameters, pressure parameters, display signals, treatment methods, and treatment plans through the interactive interface and send these settings to the main control module. Upon receiving the interactive commands, the main control module generates electrical stimulation parameter commands and sends them to the electrical stimulation control module.

[0115] The electrical stimulation control module parses the instructions and controls the output of the electrical stimulation module according to the parameters in the instructions. The electrical stimulation module and the electromyography acquisition module share an external cable. The female end of the cable connects to the male end of the catheter plug, outputting electrical stimulation pulses, which are transmitted to each stimulation contact through the cable.

[0116] The piezoelectric acquisition module is connected to the electronic interface of the external piezoelectric converter for acquiring pressure data and sending it to the main control module for processing. The pressure data can be pressure monitoring data during the inflation and deflation of the airbag, or pressure data generated when the bladder detrusor muscle compresses the airbag.

[0117] The main control module analyzes and processes the data sent by the piezoelectric acquisition module and displays it in real time through the display interaction module. The main control module also sends the monitored pressure data to the pressure control module in real time. If the pressure data is generated during airbag inflation, when the pressure exceeds the preset inflation value, inflation is complete, and the pressure control module controls the inflation / deflation module to stop inflation. If the pressure data is generated during airbag deflation, when the pressure falls below the preset tightening value, the airbag is fully tightened, and the pressure control module controls the inflation / deflation module to stop deflation. Operators can set the preset inflation and tightening values, as well as inflation / deflation speeds, through the display interaction module, and send control commands to the inflation / deflation control module via the main control module, based on actual conditions.

[0118] The inflation / deflation control module parses the instructions and controls the inflation / deflation speed and on / off state of the module according to the parameters in the instructions. The inflation / deflation module is connected to the air valve of the pelvic floor electromyography control catheter, directly controlling the introduction and release of gas.

[0119] The drug delivery module delivers medication for prostate treatment directly to the prostate tissue via tubing and microneedles on the catheter. The electrothermal control module transmits current through cables in the catheter to an ultra-thin electrothermal film integrated into the surface of the balloon in the prostate, generating heat to enhance blood circulation and promote drug diffusion and action. The power supply module is connected to mains power to supply power to all modules of the system.

[0120] It is important to note that in order to prevent risks caused by incorrect inflation or deflation, a two-way safety valve is designed in the air circuit. Whether it is inflation or deflation, the shut-off valve will open when the internal air pressure is too high or too low to prevent the internal pressure from exceeding the safe range.

[0121] It is important to note that, to prevent incorrect connections, the external cable and multi-way connector use a dual-connector design. The male connector of the external cable connects to the female connector of the multi-way connector for transmitting EMG acquisition signals; the female connector of the external cable connects to the male connector of the multi-way connector for transmitting stimulation pulses. The use of a female connector on the external cable of the electrical stimulation module is also to prevent electric shock due to misuse.

[0122] Furthermore, to reflect the coordination of the entire urinary control system's muscle groups, piezoelectric and all electromyographic signals are simultaneously displayed on a coordinate system with time as the horizontal axis. Observing individual test data horizontally can help determine the health of the muscle groups at the tested location; observing and comparing the changes in intravesical pressure, bladder neck electromyography, external urethral sphincter electromyography, and peripheral anal electromyography over time can help determine the coordination of the test subject's muscle groups.

[0123] Preferably, to improve diagnostic efficiency and accuracy, the main control module includes auxiliary diagnostic and intelligent control functions. The system operator can input the patient's basic information such as age, gender, height, and weight through the interactive display module. Based on this information, the auxiliary diagnostic module uses big data to fit a set of test data for a healthy population that matches the basic information. This data is then synchronized, calibrated, and displayed with real-time monitoring data, generating a standard report for doctors' reference, helping them make more accurate diagnoses. The report includes all signal detection graphs, calibration of health data for reference, and a statement of comparison results. By observing the graphical comparison between the measured data and the health data, the operator can gain a more intuitive understanding of the subject's health status. The intelligent control function, building upon the auxiliary diagnostic function, automatically generates stimulation plans by comparing the test subject with healthy individuals. It controls the electrical stimulation module to generate electrical pulses to treat the patient. For example, if comparison reveals that the bladder neck electromyography (EMG) signal does not significantly decrease during urination, indicating that these muscles are not relaxed and cannot open the first valve of the urinary tract, a high-frequency, short-duration pulse is applied to induce relaxation in these muscles. Conversely, if comparison reveals that the bladder pressure is significantly insufficient during urination, and EMG results show no significant increase in EMG signals in certain areas, indicating insufficient muscle contraction in those areas, a low-frequency, high-energy pulse is applied to induce contraction. The system guides the patient through interactive graphics and text, allowing for repeated muscle relaxation or contraction exercises to ultimately achieve rehabilitation.

[0124] Preferably, the operator can set the treatment plan through the interactive display module. During the treatment, the interactive display module will provide graphic prompts for the subject to periodically perform actions such as urination and bladder contraction, and apply electrical stimulation pulses to the corresponding areas according to the set plan based on the action cycle; alternatively, the intelligent control function can be activated to automatically generate a treatment plan and apply electrical stimulation. The acquisition of electromyographic signals and the release of electrical stimulation can be performed alternately to reduce interference, or simultaneously, depending on the characteristics of the electrodes, and filtering methods can be used to reduce interference from stimulation on the electromyographic acquisition.

[0125] Optionally, the operator can configure any one electrode of the pelvic floor electromyography catheter on the catheter as a stimulating electrode and the other electrode as a loop electrode through the display interaction module, forming a single electrical stimulation loop inside the pelvic floor to realize a deep-directed stimulation loop inside the pelvic floor.

[0126] The pelvic floor electromyography (EMG) control catheter contains multiple electrodes as stimulating electrodes and one or more other electrodes as loop electrodes, forming a deep-directional composite electrical stimulation circuit within the pelvis. By adjusting the intensity of the stimulating electrodes and the acting electrodes within the composite electrical stimulation circuit, the 3D space of stimulation therapy can be accurately controlled. The external monitoring and control system also includes a display and interaction module. This module is configured to display the freely configured electrode circuits within the muscle group in real time, and to synchronize the electrode circuits with the acquired EMG signals on the time scale of stimulation release. The freely configured electrode circuits within the muscle group can be simultaneously displayed in real time on the display and interaction module, and synchronized with the acquired signals on the time scale, increasing the accuracy of control on both spatial and temporal scales.

[0127] Optionally, the server is used to store data and run fitting algorithms to calculate standard data for healthy individuals, which is then returned to the main control module.

[0128] The above description is merely an embodiment of this application and is not intended to limit the scope of this application. Various modifications and variations can be made to this application by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of this application should be included within the scope of the claims of this application.

Claims

1. A system for detecting and rehabilitating pelvic floor muscles related to urinary incontinence, characterized in that, The system includes a pelvic floor electromyography (EMG) control catheter and an external monitoring and control system; the pelvic floor EMG control catheter is used to monitor the electromyographic (EMG) signals corresponding to muscles related to urinary continence, and the external monitoring and control system is electrically connected to the pelvic floor EMG control catheter and is configured as follows: Based on the processing results of the electromyographic signals, a targeted electrical stimulation treatment plan is generated; as well as According to the electrical stimulation treatment plan, electrical stimulation signals are released to the urinary control-related muscles through the pelvic floor muscle electromodulation catheter to perform electrical stimulation rehabilitation training for patients with abnormal muscle groups. The urinary control-related muscles are combined with the balloon assembly and electrode assembly on the pelvic floor myoelectric control catheter. The abnormal muscle groups are determined by comparing the electromyographic signals of the patient's muscle groups with those of normal muscle groups in normal individuals.

2. The system as described in claim 1, characterized in that, The pelvic floor electromyography control catheter includes a urinary catheter inserted into the urinary tract and a rectal catheter inserted into the rectum. The rectal catheter is configured to: collect electromyographic signals of the anal sphincter group during the monitoring phase, and apply electrical stimulation signals to the anal sphincter group during the rehabilitation phase; The urinary catheter is configured to: collect intravesical pressure electrical signals, internal urethral sphincter electromyographic signals, external urethral sphincter electromyographic signals and intravesical detrusor muscle electromyographic signals during the monitoring phase; and apply electrical stimulation signals to the bladder and / or urethra during the rehabilitation phase. The urinary catheter integrates a prostate-specific tubular balloon, which is specifically used for monitoring prostate physiological parameters and targeted prostate therapy. During the monitoring phase, pressure signals at the prostate are accurately collected; during the rehabilitation phase, therapeutic drugs can be precisely delivered to the prostate lesion site, achieving local targeted drug delivery intervention for the prostate.

3. The system as described in claim 2, characterized in that, The prostate-specific tubular balloon integrates microneedles and is connected to a drug delivery tubing; the tubular balloon, in conjunction with the external monitoring and control system, can directly deliver the drug solution to the patient's prostate.

4. The system as described in claim 3, characterized in that, The external part of the prostate-specific tubular balloon is provided with at least two ultra-thin electrothermal films in different directions. These ultra-thin electrothermal films are heated by electric current, which can apply heat to the patient's prostate.

5. The system as described in claim 4, characterized in that, The pelvic floor electromyography catheter also includes a vaginal catheter, which is used to collect electromyographic signals of the vaginal muscle group during the monitoring phase and to stimulate the vaginal muscle group during the rehabilitation phase.

6. The system as described in claim 1, characterized in that, In the pelvic floor electromyography control catheter, one electrode is the stimulating electrode and the other electrode is the loop electrode, forming a single electrical stimulation loop inside the pelvic floor to achieve a deep-directed stimulation loop inside the pelvic floor. Any number of electrodes in the pelvic floor electromyography control catheter are stimulating electrodes, and one or more other electrodes are loop electrodes, forming a deep-directional composite electrical stimulation circuit inside the pelvis; by adjusting the intensity of the stimulating electrodes and the acting electrodes in the composite electrical stimulation circuit, the 3D space of stimulation therapy can be accurately controlled. The in vitro monitoring and control system also includes a display and interaction module; the display and interaction module is configured to display freely configured electrode circuits within the muscle group in real time, and to synchronize the electrode circuits with the acquired electromyographic signals on the time scale of stimulus release.

7. The system as described in claim 6, characterized in that, The display interaction module is also configured to: By observing individual test data laterally, the health status of the muscle groups at the tested location can be assessed. By longitudinally observing the changes in intravesical pressure electromyography (IEMG), bladder neck electromyography (EMG), internal urethral sphincter EEMG, external urethral sphincter EEMG, intravesical detrusor muscle EEMG, and peripheral anal EEMG over time, and comparing and analyzing the correlation between these parameters, the coordination of the test subjects' muscle groups can be assessed.

8. The system as described in claim 6, characterized in that, The in vitro monitoring and control system also includes an auxiliary diagnostic module, which is configured as follows: Patient characteristic information is entered through the display interaction module, and detection data of healthy people that match the patient characteristic information are fitted. A diagnostic report is generated based on the calibration comparison results of the test data of healthy individuals and the test data of patients with abnormal muscle groups.

9. The system as described in claim 8, characterized in that, The extracorporeal monitoring and control system also includes an intelligent control module; the intelligent control module is used to generate an electrical stimulation rehabilitation training program and control the electrical stimulation control module to generate electrical pulses to act on the patient, guiding the patient to perform repeated muscle relaxation or contraction training.

10. The system as described in claim 9, characterized in that, The intelligent control module is also configured to: When comparison revealed that the electromyographic signal of the bladder neck did not significantly decrease during urination, a higher frequency short pulse was applied to induce relaxation of the muscles in that area. When comparison revealed that the bladder pressure was insufficient and the electromyographic signal in some areas did not increase significantly during urination, a low-frequency high-energy pulse was applied to induce contraction of the muscles in those areas.

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