Closed-loop synergistic electrical stimulation system for diabig dysfunction

Abstract

The application discloses a closed-loop synergistic electrical stimulation system for diuresis and defecation dysfunction. The closed-loop synergistic electrical stimulation system comprises an implantable nerve stimulator, a bladder puncture probe electrode, a pressure sensor integrated with a tip for real-time acquisition of intravesical pressure signals, a sacral nerve stimulation electrode for implantation of sacral foramen to regulate micturition reflex and defecation reflex, the implantable nerve stimulator adjusts the pulse electrical stimulation output to the sacral nerve stimulation electrode to assist the user in urination according to the intravesical pressure signals collected by the pressure sensor, and the implantable nerve stimulator outputs pulse electrical stimulation to the sacral nerve stimulation electrode to assist the user in defecation in response to a manual trigger instruction issued by the user through an external program control instrument. The application realizes the integration and synergy of automatic regulation of micturition and manual assistance of defecation, adopts a single nerve stimulator two-drag-two design which can be implanted for a long time, and provides a safe and effective solution for diuresis and defecation dysfunction.

Description

Technical Field

[0001] This application relates to the field of neuromodulation technology, and more specifically, to a closed-loop synergistic electrical stimulation system for bowel and bladder dysfunction. Background Technology

[0002] Spinal cord injury, diabetic neuropathy, multiple sclerosis, and other diseases often lead to the simultaneous development of neurogenic bladder and neurogenic bowel, a condition known as "bladder and bowel dysfunction." Neurogenic bladder can manifest as urinary retention or incontinence, and over time can lead to hydronephrosis, urinary tract infections, and even kidney failure. Neurogenic bowel dysfunction is primarily characterized by constipation or fecal incontinence, severely impacting patients' quality of life. Currently, commonly used sacral nerve stimulation methods are mostly open-loop or patient-controlled, unable to automatically adjust stimulation parameters based on real-time bladder pressure, resulting in incomplete urination or overstimulation. Furthermore, bladder pressure monitoring and electrical stimulation are typically performed by separate devices, lacking collaborative capabilities. Therefore, there is an urgent need for an integrated electrical stimulation system that can be implanted long-term, uses a closed-loop bladder pressure control system for urination, and simultaneously supports patient-assisted defecation. Summary of the Invention

[0003] One objective of this application is to provide a closed-loop coordinated electrical stimulation system for bowel and bladder dysfunction, which can at least solve the aforementioned technical problems in the prior art.

[0004] To achieve the above objectives, this application provides the following technical solutions.

[0005] A closed-loop coordinated electrical stimulation system for urinary and fecal dysfunction according to an embodiment of the first aspect of this application includes: an implantable neurostimulator; a bladder puncture probe electrode for implantation into the bladder wall muscle layer, the tip of which integrates a pressure sensor that collects intrabladder pressure signals in real time; the system further includes a sacral nerve stimulation electrode for implantation into the sacral foramen to regulate urination and defecation reflexes; wherein the implantable neurostimulator is electrically connected to the bladder puncture probe electrode and the sacral nerve stimulation electrode respectively; the implantable neurostimulator adjusts the first electrical stimulation parameter corresponding to the pulse electrical stimulation output to the sacral nerve stimulation electrode in real time according to the intrabladder pressure signal collected in real time by the pressure sensor to assist the user in urination; and, in response to a manual trigger command issued by the user through an external programmer, the implantable neurostimulator outputs a pulse electrical stimulation corresponding to a preset second electrical stimulation parameter to the sacral nerve stimulation electrode to assist the user in defecation.

[0006] Optionally, the bladder puncture probe electrode is a slender needle-shaped electrode, and the pressure sensor is a MEMS piezoresistive pressure sensor.

[0007] Optionally, the implantable neurostimulator includes a control unit, a stimulation output unit, a signal receiving unit, a communication unit, and a battery unit. The implantable neurostimulator is connected to the bladder puncture probe electrode and the sacral nerve stimulation electrode through a subcutaneous tunnel.

[0008] Optionally, the implantable neurostimulator continuously reads the intrabladder pressure signal collected by the pressure sensor at a preset sampling rate; wherein, when the intrabladder pressure signal exceeds a preset first pressure threshold and the duration reaches a first preset duration, the implantable neurostimulator initiates pulsed electrical stimulation corresponding to the first electrical stimulation parameter to the sacral nerve stimulation electrode; when the intrabladder pressure signal decreases to below a preset second pressure threshold and the duration reaches a second preset duration, the implantable neurostimulator stops outputting pulsed electrical stimulation to the sacral nerve stimulation electrode; wherein, the first pressure threshold is higher than the second pressure threshold.

[0009] Optionally, the initial stimulation parameters in the first electrical stimulation parameters are a stimulation frequency of 18 Hz, a stimulation pulse width of 200 μs, and a stimulation amplitude of 1.8 mA. During electrical stimulation, the implanted neurostimulator calculates the pressure change rate every 2 seconds and then automatically adjusts the stimulation frequency, stimulation pulse width, and stimulation amplitude according to the pressure change rate. The upper limit of the stimulation frequency is 40 Hz, and the upper limit of the stimulation amplitude is 6 mA.

[0010] Optionally, if the duration of the first electrical stimulation parameter exceeds 3 minutes and the intrabladder pressure signal is still not lower than the second pressure threshold, the implantable neurostimulator stops emitting electrical stimulation and issues a urination incomplete alarm signal; if the duration of the first electrical stimulation parameter exceeds 5 minutes and the intrabladder pressure signal is not lower than the third pressure threshold, the implantable neurostimulator issues a urination alarm signal and prompts for manual intervention, while limiting the stimulation parameter to not exceed a preset safety upper limit; wherein, the third pressure threshold is higher than the first pressure threshold.

[0011] Optionally, in response to a manual trigger command, the implantable neurostimulator immediately suspends the function of adjusting the first electrical stimulation parameter in real time according to the intrabladder pressure signal, and automatically resumes the function of adjusting the first electrical stimulation parameter in real time according to the intrabladder pressure signal after a 10-second delay following the end of the pulse electrical stimulation corresponding to the second electrical stimulation parameter.

[0012] Optionally, the stimulation frequency in the second electrical stimulation parameters is 14Hz, the stimulation pulse width is 210μs, the stimulation amplitude is 2.2mA, and the stimulation mode is continuous stimulation for 20 seconds. During the stimulation, the user can manually terminate the electrical stimulation in advance through an external programmer.

[0013] Optionally, the multiple pressure thresholds collected by the pressure sensor, the adjustment range of the first electrical stimulation parameter, and the preset value of the second electrical stimulation parameter are all wirelessly adjusted by the doctor through an external programmer on the doctor's end; and the user adjusts the various parameter values ​​or duration of the second electrical stimulation parameter within the safe range preset by the doctor through an external programmer on the user's end.

[0014] Optionally, the implantable neurostimulator emits an incomplete urination alarm signal or a urination alarm signal and wirelessly transmits it to an external programmer. The external programmer is also used to receive the incomplete urination alarm signal and the alarm signal and display the corresponding prompt information on the display screen.

[0015] This application discloses a closed-loop synergistic electrical stimulation system for bowel and bladder dysfunction, which offers the following advantages: It integrates automatic closed-loop regulation of urination with manual assistance of defecation; employs a single implantable neurostimulator to simultaneously drive both a bladder puncture probe electrode and a sacral nerve stimulation electrode in a dual-mode design, reducing implantation trauma; replaces the transurethral pressure catheter with an intrabladder wall probe electrode, preventing catheter-related infections at the source, and allows for long-term indwelling use; physicians can individually set pressure thresholds and stimulation parameters via an external programmer, and users can fine-tune the defecation stimulation intensity within a safe range, providing a safe, effective, and long-term implantable automated solution for patients with bowel and bladder dysfunction.

[0016] Other features and advantages of this application will become clear from the following detailed description of exemplary embodiments with reference to the accompanying drawings. Attached Figure Description

[0017] The accompanying drawings, which are incorporated in and form part of this specification, illustrate embodiments of the present application and, together with their description, serve to explain the principles of the present application.

[0018] Figure 1 This is a schematic diagram of a closed-loop co-stimulation system for bowel and bladder dysfunction according to an embodiment of this application; Figure 2 This is a block diagram of a closed-loop synergistic electrical stimulation system for bowel and bladder dysfunction according to another embodiment of this application. Detailed Implementation

[0019] Various exemplary embodiments of the present application will now be described in detail with reference to the accompanying drawings. It should be noted that, unless otherwise specifically stated, the relative arrangement, numerical expressions, and values ​​of the components and steps set forth in these embodiments do not limit the scope of the present application.

[0020] The following description of at least one exemplary embodiment is merely illustrative and is in no way intended to limit the scope of this application and its application or use.

[0021] Techniques, methods, and equipment known to those skilled in the art may not be discussed in detail, but where appropriate, such techniques, methods, and equipment should be considered part of the specification.

[0022] In all the examples shown and discussed herein, any specific values ​​should be interpreted as merely exemplary and not as limitations. Therefore, other examples of exemplary embodiments may have different values.

[0023] It should be noted that similar labels and letters in the following figures indicate similar items; therefore, once an item is defined in one figure, it does not need to be discussed further in subsequent figures.

[0024] The following describes in detail, with reference to the accompanying drawings, a closed-loop coordinated electrical stimulation system for bowel and bladder dysfunction according to an embodiment of this application.

[0025] like Figure 1 and Figure 2 As shown, a closed-loop coordinated electrical stimulation system for bowel and bladder dysfunction according to an embodiment of this application includes: an implantable neurostimulator; a bladder puncture probe electrode for implantation into the bladder wall muscle layer, the tip of which integrates a pressure sensor that collects intrabladder pressure signals in real time; the system further includes a sacral nerve stimulation electrode for implantation into the sacral foramen to regulate urination and defecation reflexes; wherein the implantable neurostimulator is electrically connected to the bladder puncture probe electrode and the sacral nerve stimulation electrode respectively; the implantable neurostimulator adjusts the first electrical stimulation parameter corresponding to the pulse electrical stimulation output to the sacral nerve stimulation electrode in real time according to the intrabladder pressure signal collected in real time by the pressure sensor to assist the user in urination; and, in response to a manual trigger command issued by the user through an external programmer, the implantable neurostimulator outputs a pulse electrical stimulation corresponding to a preset second electrical stimulation parameter to the sacral nerve stimulation electrode to assist the user in defecation.

[0026] Specifically, this embodiment provides a closed-loop synergistic electrical stimulation system for bowel and bladder dysfunction. The system includes a dual-channel output implantable neurostimulator (IPG), a bladder puncture probe electrode, and a sacral nerve stimulation electrode. In this embodiment, the bladder puncture probe electrode can be a 1.3mm diameter titanium alloy needle electrode, percutaneously implanted into the bladder wall muscle layer. The tip of the bladder puncture probe electrode can be encapsulated with a MEMS piezoresistive pressure sensor. In this embodiment, the sacral nerve stimulation electrode is implanted in the sacral foramen to regulate the urination and defecation reflexes. Simply put, the sacral nerve stimulation electrode in this embodiment can be a standard eight-contact platinum-iridium alloy electrode, implanted through the intervertebral foramen under X-ray guidance to stimulate the S3 nerve root. Alternatively, a longer sacral nerve stimulation electrode with denser contacts can be selected and inserted into the sacral canal through the caudal hiatus. The sacral nerve stimulation electrode is placed in the epidural space within the spinal canal, where it can contact multiple nerve roots corresponding to the S2, S3, and S4 nerves; this is not limited to specific electrodes. The implantable neurostimulator in this embodiment is equipped with dual channels that can be electrically connected to the leads of the bladder puncture probe electrode and the sacral nerve stimulation electrode respectively within the user's body, allowing for independent control of the two electrodes. The implantable neurostimulator in this embodiment has a built-in control circuit that can adjust the first electrical stimulation parameter corresponding to the pulse electrical stimulation output to the sacral nerve stimulation electrode in real time based on the bladder pressure signal collected in real time by the pressure sensor at the tip of the bladder puncture probe electrode. This provides corresponding pulse electrical stimulation to the sacral nerve, effectively regulating the coordinated activity of the bladder detrusor muscle and sphincter, thereby promoting urination. The pulse electrical stimulation parameters in this embodiment can include multiple parameters such as the stimulation frequency, pulse width, and stimulation amplitude. Furthermore, the user can issue a manual trigger command via an external programmer on the user's end. Upon receiving the manual trigger command, the implantable neurostimulator responds by outputting a preset second electrical stimulation parameter to the sacral nerve stimulation electrode to enhance colonic peristalsis and assist the user in completing defecation. This will be described in detail below and will not be repeated here.

[0027] In one embodiment of this application, the bladder puncture probe electrode is a slender needle-shaped electrode, and the pressure sensor is a MEMS piezoresistive pressure sensor.

[0028] Specifically, the bladder puncture probe electrode in this embodiment is a slender needle-shaped electrode with a diameter of 1.2 mm, using a polyurethane-coated stainless steel core. Its tip integrates a MEMS piezoresistive pressure sensor. To prevent air bubble adhesion and inflammatory reactions, the sensor surface is coated with a hydrophilic gel layer, and the entire sensor is encapsulated in biocompatible silicone, leaving only a pressure-sensitive window. It should be noted that the internal structural design of the sacral nerve stimulation electrode and the bladder puncture probe electrode in this application is not the focus of this application; conventional electrode designs available on the market can be used, as those skilled in the art will understand, and will not be elaborated upon here.

[0029] In another embodiment of this application, the implantable neurostimulator includes a control unit, a stimulation output unit, a signal receiving unit, a communication unit, and a battery unit. The implantable neurostimulator is connected to a bladder puncture probe electrode and a sacral nerve stimulation electrode through a subcutaneous tunnel.

[0030] In detail, the implantable neurostimulator of this embodiment may internally include a control unit, a stimulation output unit, a signal receiving unit, a communication unit, and a battery unit. Specifically, the control unit of the implantable neurostimulator may be composed of a microcontroller (MCU), a digital signal processor, or other circuits, used to execute closed-loop control algorithms, coordinate the timing of each unit, and adjust stimulation parameters according to the electrical stimulation output commands. The stimulation output unit may include multi-channel independent output units with pulse generation functions, responsible for generating pulse electrical stimulation with corresponding stimulation frequency, pulse width, and amplitude according to the electrical stimulation output commands and delivering them to the sacral nerve stimulation electrodes. The signal receiving unit may specifically include an instrumentation amplifier and an analog-to-digital converter, used to amplify and digitize the weak signals detected in real time by the pressure sensor of the bladder puncture probe electrode. The communication unit typically uses a radio frequency chip in the Medical Implantable Communication Service (MICS) band or a near-field communication (NFC) module to achieve bidirectional wireless data transmission with the user's external programmer. Furthermore, the battery unit in this embodiment may specifically be a built-in wireless rechargeable lithium-ion battery, used to provide stable power to the entire implantable neurostimulator. The user can charge the built-in wireless rechargeable lithium-ion battery using an external power source. All of the above units are integrated into the titanium alloy shell of the implantable neurostimulator. For example... Figure 1 As shown, the implantable neurostimulator in this embodiment can be positioned within a subcutaneous pouch above the user's buttock. The implantable neurostimulator is electrically connected to the bladder puncture probe electrode and the sacral nerve stimulation electrode via wires through a subcutaneous tunnel. More specifically, the control unit inside the implantable neurostimulator executes a closed-loop control algorithm and adjusts subsequent stimulation parameters based on the electrical stimulation output command. The signal receiving unit receives pressure data transmitted from the bladder puncture probe electrode and synchronizes the data in real time to the user's external programmer via the communication unit. The stimulation output unit generates corresponding pulsed electrical stimulation based on the electrical stimulation output command sent by the user's external programmer. The communication unit exchanges data bidirectionally with the user's external programmer, and the battery unit powers the motherboard of the implantable neurostimulator. This is an explanation that will be understood by those skilled in the art and will not be elaborated upon further.

[0031] In other embodiments of this application, the implantable neurostimulator continuously reads the intrabladder pressure signal collected by the pressure sensor at a preset sampling rate; wherein, when the intrabladder pressure signal exceeds a preset first pressure threshold and the duration reaches a first preset duration, the implantable neurostimulator initiates pulsed electrical stimulation corresponding to the first electrical stimulation parameter to the sacral nerve stimulation electrode; when the intrabladder pressure signal decreases to below a preset second pressure threshold and the duration reaches a second preset duration, the implantable neurostimulator stops outputting pulsed electrical stimulation to the sacral nerve stimulation electrode; wherein, the first pressure threshold is higher than the second pressure threshold.

[0032] Specifically, in this embodiment, the signal receiving unit of the implantable neurostimulator can continuously receive the intrabladder pressure signal collected by the pressure sensor at a sampling rate of 10Hz, and transmit the data synchronously to the user-end external programmer in real time through the communication unit. In this embodiment, the default preset first pressure threshold is 40 cm water columns, the preset second pressure threshold is 10 cm water columns, the first preset duration is 3 seconds, and the second preset duration is 5 seconds. Based on this, when the real-time detected intrabladder pressure signal continuously exceeds 40 cm water columns and the duration reaches 3 seconds, the display screen of the user-end external programmer pops up a prompt interface box, asking the user whether to start urination stimulation. After the user confirms, the user-end external programmer sends an electrical stimulation output command to the implantable neurostimulator. The electrical stimulation output command corresponding to urination stimulation includes the first electrical stimulation parameter. The implantable neurostimulator receives the electrical stimulation output command corresponding to urination stimulation, and the stimulation output unit of the implantable neurostimulator starts to output pulse electrical stimulation corresponding to the first electrical stimulation parameter to the sacral nerve stimulation electrode. During this electrical stimulation, the implanted neurostimulator continuously monitors the intrabladder pressure signal transmitted from the pressure sensor. When the intrabladder pressure signal drops below 10 cmH2O for a duration of 5 seconds, the implanted neurostimulator controls the stimulation output unit to stop outputting pulsed electrical stimulation. Simultaneously, the implanted neurostimulator transmits the stimulation status back to the user's external programmer via the communication unit, so that the display of the user's external programmer shows that the current urination stimulation is stopped. The first pressure threshold is set higher than the second pressure threshold. The advantage of this is that it ensures that urination assistance stimulation is only initiated when the bladder is sufficiently full, avoiding frequent stimulation, and that urination assistance stimulation is terminated promptly when the bladder is basically empty, thus avoiding overstimulation and improving the user experience.

[0033] In another embodiment of this application, the initial stimulation parameters in the first electrical stimulation parameters are a stimulation frequency of 18 Hz, a stimulation pulse width of 200 μs, and a stimulation amplitude of 1.8 mA. During electrical stimulation, the implantable neurostimulator calculates the pressure change rate every 2 seconds and then automatically adjusts the stimulation frequency, stimulation pulse width, and stimulation amplitude according to the pressure change rate. The upper limit of the stimulation frequency is 40 Hz, and the upper limit of the stimulation amplitude is 6 mA.

[0034] Specifically, in this embodiment, the initial stimulation frequency in the first electrical stimulation parameters can be set to 18Hz, the stimulation pulse width to 200μs, and the stimulation amplitude to 1.8mA. During electrical stimulation, the implantable neurostimulator can be configured to calculate and update the rate of change of the intrabladder pressure signal (dP / dt) every 2 seconds. Here, dP represents the pressure change, and dt represents the time change. Based on this, the control unit in the implantable neurostimulator can automatically adjust the stimulation frequency, stimulation pulse width, and stimulation amplitude according to the rate of change of the intrabladder pressure signal based on the initial stimulation parameters in the first electrical stimulation parameters. The specific adjustment method is as follows: In this embodiment, the upper limit of the stimulation frequency is 40Hz, and the upper limit of the stimulation amplitude is 6mA. Specifically, if the dP / dt ratio is not greater than 0.5 cmH2O per second for 4 seconds, indicating urinary obstruction, the stimulation frequency is automatically increased by 3 Hz per second, but not exceeding the upper limit of 40 Hz. Simultaneously, the stimulation amplitude is increased by 0.2 mA per second, but not exceeding the upper limit of 6 mA, until the pressure change rate (dP / dt) is greater than 0.5 cmH2O per second. If the pressure change rate (dP / dt) is within the threshold range of greater than 0.5 cmH2O per second but not greater than 2 cmH2O per second, the current electrical stimulation parameters remain unchanged. If the dP / dt ratio is greater than 2 cmH2O per second for 4 seconds, indicating excessive urination and overstimulation of the bladder, the stimulation frequency is automatically decreased by 3 Hz per second, but not lower than the lower limit of 15 Hz. Simultaneously, the stimulation amplitude is decreased by 0.2 mA per second, but not exceeding the lower limit of 1.0 mA, until the pressure change rate (dP / dt) is not greater than 2 cmH2O per second. The advantage of this approach is that it allows for precise closed-loop adjustment of stimulation parameters based on the rate of change in bladder pressure signals, improving the user's urination completion rate, effectively avoiding the risks of overstimulation and bladder overpressure, and enhancing user comfort. It is important to note that, as those skilled in the art know, low-frequency stimulation (5-10 Hz) inhibits bladder activity, while excessively high-frequency stimulation induces excitatory reflexes. Therefore, this embodiment selects a mid-frequency stimulation of 15-20 Hz as the initial value for urination stimulation, which effectively regulates the coordinated activity of the bladder detrusor muscle and sphincter to promote urination. All initial values ​​in the first electrical stimulation parameters mentioned above can be manually set according to actual conditions and are not limited here.

[0035] In other embodiments of this application, if the duration of the first electrical stimulation parameter exceeds 3 minutes and the intrabladder pressure signal is still not lower than the second pressure threshold, the implantable neurostimulator stops emitting electrical stimulation and issues an incomplete urination alarm signal; if the duration of the first electrical stimulation parameter exceeds 5 minutes and the intrabladder pressure signal is not lower than the third pressure threshold, the implantable neurostimulator issues a urination alarm signal and prompts for manual intervention, while limiting the stimulation parameter to not exceed a preset safety upper limit; wherein, the third pressure threshold is higher than the first pressure threshold.

[0036] Specifically, in this embodiment, if the duration of pulsed electrical stimulation corresponding to the first electrical stimulation parameter on the user's sacral nerve exceeds 3 minutes and the pressure signal in the user's bladder is still not lower than the second pressure threshold (i.e., 10 cmH2O), the implanted neurostimulator stops emitting pulsed electrical stimulation and issues a "voidance incomplete" alarm signal. If the duration of the first electrical stimulation parameter exceeds 5 minutes and the pressure signal in the bladder is not lower than the third pressure threshold, which can be preset to 45 cmH2O, indicating that the user's bladder pressure is increasing instead of decreasing under electrical stimulation, and the user is in a dangerous state of bladder overdistension and ineffective stimulation, the implanted neurostimulator issues a "voidance alarm" signal and prompts for manual intervention. At the same time, since the implanted neurostimulator always calculates the pressure change rate every 2 seconds during the electrical stimulation process, and then automatically adjusts the stimulation frequency, stimulation pulse width, and stimulation amplitude according to the pressure change rate, the stimulation parameters can be limited to not exceeding the preset safety upper limit (e.g., the upper limit of stimulation frequency is set to 40Hz, and the upper limit of stimulation amplitude is set to 6mA) while the implanted neurostimulator issues the "voidance alarm" signal. It is important to note that the third pressure threshold in this embodiment can be set higher than the first pressure threshold to detect the dangerous state of bladder overdistension and ineffective stimulation. The alarm signal is transmitted wirelessly to the user's external programmer, and can also be synchronously transmitted via network to the doctor's external programmer to remind the user or doctor to take measures such as artificial catheterization.

[0037] In one embodiment of this application, in response to a manual trigger command, the implantable neurostimulator immediately suspends the function of adjusting the first electrical stimulation parameter in real time according to the intrabladder pressure signal, and automatically resumes the function of adjusting the first electrical stimulation parameter in real time according to the intrabladder pressure signal after a 10-second delay following the end of the pulse electrical stimulation corresponding to the second electrical stimulation parameter.

[0038] Specifically, in response to a manual trigger command issued by the user via an external programmer (i.e., a user manually triggers a defecation stimulation command), the implanted neurostimulator receives the command and immediately pauses its function of adjusting the first electrical stimulation parameter in real time based on the bladder pressure signal; that is, the urination closed-loop control is temporarily stopped. Subsequently, the implanted neurostimulator outputs pulsed electrical stimulation corresponding to the second electrical stimulation parameter to the sacral nerve stimulation electrode, providing continuous pulsed electrical stimulation to the user's sacral nerve for a preset duration. After the output of the pulsed electrical stimulation corresponding to the second electrical stimulation parameter ends, the implanted neurostimulator automatically delays for 10 seconds before resuming its function of adjusting the first electrical stimulation parameter in real time based on the bladder pressure signal; that is, the urination closed-loop control is reactivated. The advantage of this is that the 10-second delay avoids accidental triggering of urination stimulation due to bladder pressure fluctuations immediately after defecation stimulation ends, ensuring that the two modes of defecation and urination do not conflict during switching, and ensuring the rationality and accuracy of sacral nerve electrical stimulation.

[0039] In another embodiment of this application, the stimulation frequency in the second electrical stimulation parameters is 14Hz, the stimulation pulse width is 210μs, the stimulation amplitude is 2.2mA, the stimulation mode is continuous stimulation for 20 seconds, and the user can manually terminate the electrical stimulation in advance through an external programmer during the stimulation period.

[0040] Specifically, in this embodiment, the stimulation frequency in the second electrical stimulation parameters used for user defecation stimulation can be preset to 14Hz, the stimulation pulse width to 210μs, and the stimulation amplitude to 2.2mA. The stimulation mode can be set to continuous stimulation for 20 seconds. Simply put, after the user triggers the stimulation via the "Defecation Stimulation" button on the user-end external programmer's screen, the implanted neurostimulator outputs the pulsed electrical stimulation corresponding to the second electrical stimulation parameters. During the 20-second continuous stimulation, if the user feels discomfort or perceives that defecation is complete, they can manually terminate the electrical stimulation early via the "Stop" button on the external programmer. It is important to note that, unlike the initial values ​​of the first electrical stimulation parameters used for urination stimulation, the default parameters used in the second electrical stimulation parameters for defecation stimulation in this embodiment, such as stimulation frequency, stimulation pulse width, and stimulation amplitude, effectively assist in the antegrade propulsion of the colon and improve the user's constipation symptoms. After 20 seconds of continuous stimulation, the user can again initiate the stimulation via a manual trigger command from the user-end external programmer to perform multiple consecutive defecation stimulations until defecation is completed. It is particularly important to note that the preset parameters for urination or defecation stimulation mentioned above can be manually set or adjusted according to actual conditions, and are not limited here.

[0041] In other embodiments of this application, the multiple pressure thresholds collected by the pressure sensor, the adjustment range of the first electrical stimulation parameter, and the preset value of the second electrical stimulation parameter are all wirelessly adjusted by the doctor through an external programmer on the doctor's end; and the user adjusts the parameter values ​​or duration of the second electrical stimulation parameter within the safe range preset by the doctor through an external programmer on the user's end.

[0042] Specifically, in this embodiment, the doctor can wirelessly adjust multiple pressure thresholds (first, second, and third pressure thresholds), the adjustment range of the first electrical stimulation parameter, and the preset value of the second electrical stimulation parameter, among other parameters, collected by the pressure sensor, via an external programmer on the doctor's end. This information is then transmitted to the user's external programmer via a wireless or mobile network. Based on this, the user can further fine-tune various parameters of the second electrical stimulation parameter (e.g., the stimulation amplitude can be adjusted by the user within the doctor's preset safety range) or the duration (e.g., the stimulation duration can be adjusted by the user within the range of 1.5-3.0 mA based on actual user experience) using the external programmer on the user's end. The advantage of this approach is that this tiered adjustment mode ensures the safety of electrical stimulation while giving the user the ability to adjust the settings autonomously based on their actual experience, thus meeting the user's requirements for a superior user experience.

[0043] In some other embodiments of this application, the implantable neurostimulator emits an incomplete urination alarm signal or a urination alarm signal and wirelessly transmits it to an external programmer. The external programmer is also used to receive the incomplete urination alarm signal and the alarm signal and display the corresponding prompt information on the display screen.

[0044] Specifically, in this embodiment, when the implanted neurostimulator issues a voiding incompleteness alarm signal or a voiding alarm signal, the implanted neurostimulator can wirelessly and synchronously transmit the alarm signal and its accompanying data (including current pressure value, stimulation duration, etc.) to the user's external programmer via its communication unit. Upon receiving the alarm signal, the user's external programmer can display corresponding prompts on its screen, including alarm type, current bladder pressure value, and suggested actions. Furthermore, the user's external programmer can transmit the alarm signal in real time via a wireless network or 4G network to notify the doctor's external programmer, thereby instructing the doctor to take appropriate countermeasures.

[0045] In summary, the closed-loop synergistic electrical stimulation system for bowel and bladder dysfunction according to embodiments of this application has the following beneficial effects: it achieves integrated synergy between closed-loop automatic regulation of urination and manual assistance of defecation; it employs a single implantable neurostimulator to simultaneously drive a bladder puncture probe electrode and a sacral nerve stimulation electrode in a one-to-two design, reducing implantation trauma; it replaces the transurethral pressure catheter with an intravesical probe electrode, avoiding catheter-related infections from the source, and allows for long-term indwelling use; doctors can individually set pressure thresholds and stimulation parameters through an external programmer, and users can fine-tune the intensity of defecation stimulation within a safe range, providing a safe, effective, and long-term implantable automated solution for patients with bowel and bladder dysfunction.

[0046] While specific embodiments of this application have been described in detail by way of examples, those skilled in the art should understand that the above examples are for illustrative purposes only and are not intended to limit the scope of this application. Those skilled in the art should understand that modifications can be made to the above embodiments without departing from the scope and spirit of this application. The scope of this application is defined by the appended claims.

Claims

1. A closed-loop coordinated electrical stimulation system for bowel and bladder dysfunction, characterized in that, include: An implantable neurostimulator; A bladder puncture probe electrode is implanted into the bladder wall muscle layer. The tip of the bladder puncture probe electrode integrates a pressure sensor, which acquires intrabladder pressure signals in real time. The system also includes... A sacral nerve stimulation electrode is implanted in the sacral foramen to modulate the micturition and defecation reflexes; The implantable neurostimulator is electrically connected to the bladder puncture probe electrode and the sacral nerve stimulation electrode, respectively. The implantable neurostimulator adjusts the first electrical stimulation parameter corresponding to the pulse electrical stimulation output to the sacral nerve stimulation electrode in real time according to the bladder pressure signal collected in real time by the pressure sensor, so as to assist the user in urinating. In addition, in response to a manual trigger command issued by the user via an external programmer, the implanted neurostimulator outputs pulsed electrical stimulation corresponding to a preset second electrical stimulation parameter to the sacral nerve stimulation electrode to assist the user in defecation.

2. The closed-loop synergistic electrical stimulation system according to claim 1, characterized in that, The bladder puncture probe electrode is a slender needle-shaped electrode, and the pressure sensor is a MEMS piezoresistive pressure sensor.

3. The closed-loop synergistic electrical stimulation system according to claim 2, characterized in that, The implantable neurostimulator includes a control unit, a stimulation output unit, a signal receiving unit, a communication unit, and a battery unit. The implantable neurostimulator is connected to the bladder puncture probe electrode and the sacral nerve stimulation electrode through a subcutaneous tunnel.

4. The closed-loop synergistic electrical stimulation system according to claim 3, characterized in that, The implantable neurostimulator continuously reads the intrabladder pressure signal collected by the pressure sensor at a preset sampling rate; wherein, when the intrabladder pressure signal exceeds a preset first pressure threshold and the duration reaches a first preset duration, the implantable neurostimulator initiates pulsed electrical stimulation corresponding to the first electrical stimulation parameter to the sacral nerve stimulation electrode; when the intrabladder pressure signal decreases to below a preset second pressure threshold and the duration reaches a second preset duration, the implantable neurostimulator stops outputting pulsed electrical stimulation to the sacral nerve stimulation electrode; wherein, the first pressure threshold is higher than the second pressure threshold.

5. The closed-loop synergistic electrical stimulation system according to claim 4, characterized in that, The initial stimulation parameters in the first electrical stimulation parameters are a stimulation frequency of 18 Hz, a stimulation pulse width of 200 μs, and a stimulation amplitude of 1.8 mA. During electrical stimulation, the implantable neurostimulator calculates the pressure change rate every 2 seconds and then automatically adjusts the stimulation frequency, the stimulation pulse width, and the stimulation amplitude according to the pressure change rate. The upper limit of the stimulation frequency is 40 Hz, and the upper limit of the stimulation amplitude is 6 mA.

6. The closed-loop synergistic electrical stimulation system according to claim 5, characterized in that, If the duration of the first electrical stimulation parameter exceeds 3 minutes and the intrabladder pressure signal is still not lower than the second pressure threshold, the implantable neurostimulator stops emitting electrical stimulation and issues an incomplete urination alarm signal; if the duration of the first electrical stimulation parameter exceeds 5 minutes and the intrabladder pressure signal is not lower than the third pressure threshold, the implantable neurostimulator issues a urination alarm signal and prompts for manual intervention, while limiting the stimulation parameter to not exceed a preset safety upper limit; wherein, the third pressure threshold is higher than the first pressure threshold.

7. The closed-loop synergistic electrical stimulation system according to claim 6, characterized in that, In response to the manual trigger command, the implantable neurostimulator immediately suspends the function of adjusting the first electrical stimulation parameter in real time according to the intrabladder pressure signal, and automatically resumes the function of adjusting the first electrical stimulation parameter in real time according to the intrabladder pressure signal after a 10-second delay after the output of the pulse electrical stimulation corresponding to the second electrical stimulation parameter ends.

8. The closed-loop synergistic electrical stimulation system according to claim 7, characterized in that, The second electrical stimulation parameters are a stimulation frequency of 14 Hz, a stimulation pulse width of 210 μs, a stimulation amplitude of 2.2 mA, and a stimulation mode of continuous stimulation for 20 seconds. During the stimulation, the user can manually terminate the electrical stimulation in advance through the external programmer.

9. The closed-loop synergistic electrical stimulation system according to claim 8, characterized in that, The multiple pressure thresholds collected by the pressure sensor, the adjustment range of the first electrical stimulation parameter, and the preset value of the second electrical stimulation parameter are all wirelessly adjusted by the doctor through the external programmer on the doctor's end; and the user can adjust the various parameter values ​​or duration of the second electrical stimulation parameter within the safe range preset by the doctor through the external programmer on the user's end.

10. The closed-loop synergistic electrical stimulation system according to claim 9, characterized in that, The implantable neurostimulator emits the incomplete urination alarm signal or the urination alarm signal and wirelessly transmits it to the external programmer. The external programmer is also used to receive the incomplete urination alarm signal and the alarm signal and display corresponding prompt information on the display screen.

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