An extracorporeal vibration and electrical stimulation combined ed stimulator

Abstract

This invention relates to the field of medical device technology and discloses an external vibration-electric stimulation device for erectile dysfunction (ED), comprising a shell, a fixing chamber fixedly connected to the top of the shell, a flexible heating layer fixedly connected to the inner diameter of the shell, multiple vibration motors fixedly connected inside the flexible heating layer, multiple ultrasonic transducers fixedly connected inside the flexible heating layer, a shape memory alloy support frame disposed within the inner diameter of the flexible heating layer, multiple micro-airbags disposed within the inner diameter of the shape memory alloy support frame, an inner bonding layer fixedly connected between the multiple micro-airbags, and an electrical stimulation electrode and a bioimpedance detection electrode disposed within the inner diameter of the inner bonding layer. By integrating multiple stimulation methods such as vibration stimulation, electrical stimulation, ultrasonic stimulation, and thermotherapy stimulation in the same external stimulation device and its corresponding method, and by having a controller uniformly schedule each stimulation component, multiple stimulation methods can be executed collaboratively in the same stimulation session.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to an external vibratory-electrical stimulation device for erectile dysfunction (ED). Background Technology

[0002] Erectile dysfunction (ED) is a common male sexual dysfunction, typically characterized by the inability to achieve or maintain an erection sufficient for sexual intercourse. The occurrence of ED is related to various factors, including vascular function, nerve conduction, and psychological factors. With changes in lifestyle and an aging population, the incidence of ED is on the rise. In some men with erectile dysfunction, ejaculatory dysfunction may also occur to varying degrees. Ejaculation is a complex neuroreflex process that relies on the coordinated action of the central and peripheral nervous systems, involving multiple neural pathways. Due to factors such as radical prostatectomy, pelvic trauma, neurological diseases, or congenital neurodevelopmental disorders, some patients may experience damage or dysfunction in the ejaculation-related neural pathways, resulting in difficulty achieving or completing ejaculation even when they have some erectile ability.

[0003] Most existing in vitro stimulation protocols still use single stimulation or simple combination stimulation as the basic application mode. There is a lack of coordinated management at the methodological and process level between various stimulation methods. The stimulation process is usually based on a single use, making it difficult to uniformly manage the stimulation initiation, execution and termination stages. This limits the application of in vitro stimulation technology in continuous use and multi-stage intervention scenarios. Summary of the Invention

[0004] To address the shortcomings of existing technologies, this invention provides an external electro-electro-vibration combined ED stimulator, which solves the problem that most existing external stimulation programs still use single stimulation or simple combination stimulation as the basic application mode, and lack collaborative management between various stimulation methods at the method and process level.

[0005] To achieve the above objectives, the present invention provides the following technical solution: an external electro-vibration stimulator for erectile dysfunction (ED), comprising a shell, a fixation chamber fixedly connected to the top of the shell, a flexible heating layer fixedly connected to the inner diameter of the shell, multiple vibration motors fixedly connected inside the flexible heating layer, multiple ultrasonic transducers fixedly connected inside the flexible heating layer, a shape memory alloy support frame disposed within the inner diameter of the flexible heating layer, multiple micro-airbags disposed within the inner diameter of the shape memory alloy support frame, an inner bonding layer fixedly connected between the multiple micro-airbags, an electrical stimulation electrode and a bioimpedance detection electrode disposed within the inner diameter of the inner bonding layer, a fixed connection between the inner bonding layer and the fixation chamber, a battery fixedly connected inside the fixation chamber, an air pump fixedly connected inside the fixation chamber, an output end of the air pump fixedly connected to the multiple micro-airbags, and a controller fixedly connected inside the fixation chamber.

[0006] By adopting the above-described implementation method, multiple external stimulation methods such as vibration stimulation, electrical stimulation, ultrasonic stimulation, and thermal stimulation are integrated into the same stimulator structure. The controller provides unified control over each stimulation component, enabling multiple stimulation methods to work in coordination within the same device according to a preset process. This avoids situations where different stimulation methods operate independently or are simply superimposed, achieving collaborative management of multiple external stimulation methods at the structural and control levels. The stimulation process is no longer limited to a single stimulation operation but can cover multiple stages such as stimulation initiation, stimulation execution, and stimulation termination.

[0007] Preferably, the battery is electrically connected to the controller, and the controller is electrically connected to the flexible heating layer, the vibration motor, the ultrasonic transducer, the electrical stimulation electrode, the bioimpedance detection electrode, and the air pump.

[0008] Preferably, an external electro-electro-optical stimulation method for erectile dysfunction (ED) includes the following steps: S1: When the controller receives the stimulation start command, it generates the stimulation session identifier corresponding to the current external ED stimulation and stores the stimulation session identifier in association with the current stimulation process; S2: Before executing the current stimulus session, determine whether there is a previous stimulus session. If there is a previous stimulus session, read the corresponding session closure status flag and determine whether the previous stimulus session is in a closed state. S3: When it is determined that the previous stimulus session is not in a closed state, the stimulus session closure compensation step is executed, and the current stimulus session is prohibited from entering the stimulus execution process until the compensation is completed. S4: After confirming that there is no previous stimulus session that has not been closed, bioimpedance signals are collected in multiple consecutive time slices through bioimpedance detection electrodes, and the controller performs a stimulus validity determination on the current stimulus session based on the collected bioimpedance signals. S5: When the current stimulation session is determined to be valid, the controller controls the vibration motor, electrical stimulation electrodes, ultrasonic transducer and flexible heating layer to stimulate, and sets a session validity flag for the current stimulation session; S6: After the stimulus ends, the controller generates and stores a session closure status identifier for the current stimulus session.

[0009] Preferably, in step S1, the step of generating the stimulation session identifier corresponding to the current external ED stimulation includes: When the controller receives a stimulus activation command, it acquires the current stimulus activation time information; Obtain the stimulation sequence number information corresponding to the current in vitro ED stimulation; Based on the stimulation initiation time information and the stimulation sequence number information, a unique stimulation session identifier corresponding to the current external ED stimulation is generated.

[0010] Preferably, in step S2, the step of reading the corresponding session closure state identifier includes: In the controller, based on the stimulus session identifier corresponding to the current stimulus session, the previous stimulus session identifier that is adjacent to the stimulus session identifier in time sequence is determined; After determining the previous stimulus session identifier, read the session closure status identifier stored in association with the previous stimulus session identifier; When reading the session closure status identifier, the integrity of the session closure status identifier is checked. If the session closure status identifier is missing or incomplete, the previous stimulus session identifier is determined to be an unclosed session identifier.

[0011] Preferably, in step S3, the step of performing stimulus session closure compensation includes: In the controller, the identifier of the previous stimulus session that is determined to be unclosed is set to the compensation processing state; Based on the previous stimulus session identifier, terminate the output of stimulus control instructions associated with the previous stimulus session. Update the session validity identifier stored in association with the previous stimulus session and mark it as invalid; After completing the termination and update steps, a corresponding session closure status identifier is generated for the previous stimulus session, and the session closure status identifier is associated with and stored with the previous stimulus session identifier.

[0012] Preferably, in step S4, the step of acquiring bioimpedance signals through bioimpedance detection electrodes over multiple consecutive time slices includes: In the controller, the acquisition time slice parameters of the bioimpedance signal are set, and the acquisition time slice parameters are used to limit the acquisition timing of the bioimpedance signal; During the current stimulation session, bioimpedance signals are sequentially acquired in multiple consecutive time slices according to the acquisition time slice parameters by using bioimpedance detection electrodes set in the inner diameter of the inner bonding layer. The bioimpedance signals collected in each time slice are stored separately and associated with the corresponding stimulus session identifiers.

[0013] Preferably, in step S4, the step of determining the validity of a stimulus session by the controller based on the acquired bioimpedance signal includes: In the controller, the bioimpedance signals collected in multiple consecutive time slices are arranged sequentially according to the time slice sequence corresponding to the bioimpedance signals. Based on sequentially arranged bioimpedance signals, a sequence of bioimpedance changes corresponding to the current stimulus session is generated. The bioimpedance change sequence is matched with the pre-stored stimulus validity rules to determine whether the bioimpedance change sequence meets the stimulus validity conditions. When the bioimpedance change sequence meets the stimulus establishment condition, the current stimulus session is determined to be in an established state; otherwise, the current stimulus session is determined to be in an inestablished state.

[0014] Preferably, in step S5, the step of setting a session validity identifier for the current stimulus session includes: In the controller, the session validity flag is initialized for the current stimulus session, and the session validity flag is set to the initial state; During stimulus execution, the session validity flag is updated based on the stimulus validity determination results corresponding to the bioimpedance signals collected in multiple consecutive time slices.

[0015] Preferably, in step S6, the step of generating and storing a session closure state identifier for the current stimulus session via the controller is performed by: In the controller, obtain the stimulus session identifier corresponding to the current stimulus session and the session validity identifier associated with the stimulus session; Based on the stimulus session identifier and session validity identifier, generate the session closure status identifier corresponding to the current stimulus session.

[0016] This invention provides an external electro-pneumatic stimulator for erectile dysfunction (ED). It has the following beneficial effects: 1. This invention integrates multiple stimulation methods such as vibration stimulation, electrical stimulation, ultrasonic stimulation and thermal stimulation in the same external stimulation device and its corresponding method, and the controller uniformly schedules each stimulation component, so that multiple stimulation methods can be executed in the same stimulation session. This breaks through the application mode of external stimulation devices acting independently in a single stimulation form, and constructs a multimodal stimulation execution process covering the entire process of stimulation initiation, stimulation execution and stimulation termination.

[0017] 2. This invention introduces stimulation session identifiers, session closure status identifiers, and session validity identifiers into the stimulation method to perform session-level management of each in vitro stimulation process. Before stimulation is executed, the closure status of the previous stimulation session is judged. When an unclosed stimulation session is detected, the status is corrected through a closure compensation process. This ensures that the current stimulation session only enters the execution stage when the status of the preceding session is clear, thereby achieving continuous management of multiple stimulation processes, avoiding logical overlap or confusion between stimulation sessions, and improving the integrity and consistency of the stimulation process.

[0018] 3. This invention collects bioimpedance signals in multiple consecutive time slices using bioimpedance detection electrodes, and determines the establishment and validity of the stimulus session based on the bioimpedance change sequence. This establishes a clear correspondence between the stimulus execution process and the physiological signal acquisition results, enabling objective determination and dynamic recording of the stimulus session status. This facilitates the formation of traceable stimulus session operation data, providing a reliable data foundation for subsequent stimulus process management and stimulus parameter scheduling. Attached Figure Description

[0019] Figure 1 This is a perspective view of an external electro-pneumatic stimulator according to the present invention; Figure 2 This is a schematic cross-sectional view of the outer shell of an external vibratory-electrical combined ED stimulator according to the present invention; Figure 3 This is a schematic cross-sectional view of the fixation chamber of an external vibratory-electrical combined ED stimulator according to the present invention; Figure 4 This is a schematic diagram of a micro-airbag for an external vibratory-electrical combined ED stimulator according to the present invention. Figure 5 This is a flowchart of an external electro-electro-optical stimulation method according to the present invention.

[0020] The components include: 1. Outer shell; 2. Fixing chamber; 3. Flexible heating layer; 4. Vibration motor; 5. Ultrasonic transducer; 6. Battery; 7. Controller; 8. Air pump; 9. Shape memory alloy support frame; 10. Micro airbag; 11. Inner bonding layer. Detailed Implementation

[0021] The technical solution of the present invention will now be clearly and completely described with reference to the accompanying drawings. Obviously, the described embodiments are merely some embodiments of the present invention, and not all embodiments. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without creative effort are within the scope of protection of the present invention.

[0022] Please see the appendix Figure 1 -Appendix Figure 4 This invention provides an external electro-electro-vibration stimulator, comprising a shell 1, a fixation chamber 2 fixedly connected to the top of the shell 1, a flexible heating layer 3 fixedly connected to the inner diameter of the shell 1, multiple vibration motors 4 fixedly connected inside the flexible heating layer 3, multiple ultrasonic transducers 5 fixedly connected inside the flexible heating layer 3, a shape memory alloy support frame 9 disposed within the inner diameter of the flexible heating layer 3, multiple micro airbags 10 disposed within the inner diameter of the shape memory alloy support frame 9, an inner bonding layer 11 fixedly connected between the multiple micro airbags 10, an electrical stimulation electrode and a bioimpedance detection electrode disposed within the inner diameter of the inner bonding layer 11, the inner bonding layer 11 being fixedly connected to the fixation chamber 2, a battery 6 fixedly connected inside the fixation chamber 2, an air pump 8 fixedly connected inside the fixation chamber 2, the output end of the air pump 8 being fixedly connected to the multiple micro airbags 10, and a controller 7 fixedly connected inside the fixation chamber 2.

[0023] Specifically, the user places the device on the target area. Battery 6 provides power for the entire device. Controller 7, as the core control unit, receives usage instructions and coordinates the operation of each functional component. Air pump 8, under the control of controller 7, supplies or expels air to micro airbag 10 to adjust the fit of the device. Flexible heating layer 3 is located inside the outer shell 1 and comes into direct or indirect contact with the target area to provide thermal stimulation during operation. Multiple vibration motors 4 and multiple ultrasonic transducers 5 are evenly distributed inside the flexible heating layer 3 and generate vibration and ultrasonic stimulation respectively under the control of controller 7, thereby achieving the synergistic effect of multiple stimulation methods at the same location. During the device bonding process, the shape memory alloy support skeleton 9 is set in the inner diameter of the flexible heating layer 3 to provide elastic support in different states and to work with the micro airbags 10 to adjust the shape of the inner diameter. Multiple micro airbags 10 undergo inflation and deflation under the action of the air pump 8, thereby pushing the inner bonding layer 11 to produce radial displacement, so that the inner bonding layer 11 can form a stable bonding relationship with the target part. The electrical stimulation electrode set in the inner diameter of the inner bonding layer 11 is used to output electrical stimulation signal under the control of the controller 7. The bioimpedance detection electrode is used to collect the bioimpedance information of the corresponding part and feed it back to the controller 7. The controller 7 manages the stimulation process based on the collected bioimpedance information and forms a complete workflow. In medical institutions, the stimulator can be operated under the guidance of medical staff or professionals. Its stimulation parameters, including electrical stimulation intensity, microcurrent waveform, heating temperature range, vibration frequency and ultrasound output parameters, can all be set to professional modes that meet the requirements of medical device specifications to meet the needs of clinical adjuvant therapy or rehabilitation intervention. In this application scenario, the stimulator can be used on users with ejaculatory dysfunction, which can be caused by nerve damage after radical prostatectomy, nerve dysfunction due to pelvic trauma, or incomplete nerve development. Through one or more synergistic effects of vibration stimulation, electrical stimulation, thermal stimulation, and ultrasound stimulation, non-invasive external stimulation is applied to nerve areas related to the ejaculation reflex to help activate ejaculation-related neural pathways, induce or enhance the ejaculation reflex process, thereby meeting the application needs of clinical adjunctive therapy or rehabilitation intervention. In home use scenarios, the stimulator can operate in home safety mode. The controller limits the output of microcurrent, electrical stimulation energy and heating temperature, so that the released microcurrent, electrical stimulation and thermal stimulation are all within a safe range suitable for home users to operate themselves, thereby achieving the effects of soothing, regulating and assisting in improvement while ensuring the safety of use. In this usage scenario, the stimulator can be used as an erection aid or an ejaculation aid. Home users can choose vibration stimulation, electrical stimulation or a combination of modes according to their own needs to externally stimulate the target area to enhance stimulation synergy, assist in completing the ejaculation process or for sexual function training and function adjustment. The flexible heating layer can generate continuous or intermittent heat output under the control of the controller to achieve the function of thermal stimulation; the electrical stimulation electrode can output microcurrent stimulation signal under the control of the controller. The microcurrent stimulation can be pulsed, continuous or combined to adapt to the needs of different application scenarios. The external electro-pneumatic stimulator also includes a communication module for communicating with external terminal devices. The communication module can use Bluetooth, wireless LAN or other short-range wireless communication methods. External terminal devices include mobile terminals such as smartphones and tablets. The controller can interact with the application on the external terminal device through the communication module. Through the application, users or medical staff can set or adjust stimulation parameters, including stimulation mode selection, stimulation duration setting, microcurrent intensity adjustment, heating temperature adjustment, and stimulation session start or end control. At the same time, the application can also be used to display stimulation session status information, bioimpedance detection results, and historical stimulation session records, thereby realizing visual management and remote interactive control of the stimulation process. The inner bonding layer and the electrostimulation electrodes and bioimpedance detection electrodes disposed thereon can be used as an integrated contact assembly, which can be assembled with the main structure through snap-fit ​​connection, magnetic connection, plug-in connection or other detachable connection methods. After one or more uses, the contact components can be completely removed from the main structure and replaced with new ones, thereby avoiding hygiene risks caused by cross-use and improving safety and convenience in home use scenarios. During disassembly and assembly, the controller can control the stimulator's operating status by identifying the assembly status or identification marks of the contact components, ensuring that the stimulation function is allowed to be activated only when the contact components are correctly installed.

[0024] See appendix Figure 1 -Appendix Figure 4 The battery 6 is electrically connected to the controller 7, and the controller 7 is electrically connected to the flexible heating layer 3, the vibration motor 4, the ultrasonic transducer 5, the electrical stimulation electrode, the bioimpedance detection electrode, and the air pump 8.

[0025] Specifically, battery 6 serves as the power source for the entire device and supplies power to controller 7 via electrical connection. After receiving power, controller 7 enters the working state and acts as the distribution and control center for electrical signals. After the user starts the device, controller 7 outputs heating control signals to flexible heating layer 3 according to the preset or input workflow, causing flexible heating layer 3 to generate a warming effect. At the same time, controller 7 outputs corresponding drive signals to vibration motor 4 and ultrasonic transducer 5, causing vibration motor 4 to generate mechanical vibration and ultrasonic transducer 5 to generate ultrasonic effect, thereby forming a synergistic output of multiple stimulation modes in the same working process. During stimulation, the controller 7 is also electrically connected to the electrostimulation electrodes and bioimpedance detection electrodes located on the inner diameter of the inner bonding layer. The electrostimulation electrodes output electrostimulation signals under the control of the controller 7, and the bioimpedance detection electrodes transmit the collected bioimpedance information to the controller 7 in the form of electrical signals. The controller 7 manages the stimulation process based on the received bioimpedance information. At the same time, the controller 7 is electrically connected to the air pump 8 and sends start / stop or operation control signals to the air pump 8 as needed, so that the air pump 8 can regulate the inflation and deflation of the micro airbags, thereby coordinating with the overall stimulation process to complete the adjustment of the bonding state.

[0026] See appendix Figure 5 An external electro-electro-optical stimulation method for erectile dysfunction (ED) includes the following steps: S1: When the controller 7 receives the stimulation start command, it generates the stimulation session identifier corresponding to the current external ED stimulation and stores the stimulation session identifier in association with the current stimulation process; Furthermore, in step S1, the step of generating the stimulation session identifier corresponding to the current external ED stimulation includes: When the controller 7 receives the stimulus activation command, it acquires the current stimulus activation time information; Obtain the stimulation sequence number information corresponding to the current in vitro ED stimulation; Based on the stimulation initiation time information and stimulation sequence information, a unique stimulation session identifier corresponding to the current external ED stimulation is generated.

[0027] Specifically, when the external ED stimulator is in standby mode, the controller 7 listens for stimulation start commands from the input interface. When the user issues a stimulation start command via a button, touch interface, or external control terminal, the controller 7 receives the command and enters the stimulation session initialization process. The controller 7 recognizes this start request as a new external ED stimulation session and begins generating a stimulation session identifier corresponding to the current external ED stimulation. During this generation process, the current stimulation start time information is first obtained. This time information can be provided by the controller 7's internal clock and denoted as [missing information]. , This is timestamp data, used to characterize the start time of this stimulation session. Simultaneously, controller 7 acquires the stimulation sequence number information corresponding to the current external ED stimulation, denoted as... , A non-negative integer, used to represent the sequential position in the session record sequence within the same device. Optionally, the controller 7 can incrementally generate the identifier in its internal storage unit based on previous session records, for example, after detecting the previous stimulus and generating a session closure status identifier. Add one and save it so that it can be directly read as the current stimulus number information the next time it is started; In acquiring and Subsequently, controller 7 generates a unique stimulation session identifier corresponding to the current external ED stimulation based on the stimulation initiation time information and stimulation sequence number information. The stimulation session identifier is denoted as SID. SID can be generated using reversible encoding or irreversible mapping. In one optional implementation, controller 7 will... Reference start time Perform differential quantization and time quantization to obtain the discrete-time index. The time quantization process can be represented by the following formula: ; in, To preset the reference start time, To preset the time quantization step size, the symbol... This indicates the floor function. The time index is a non-negative integer, and then the controller 7 will set the time index. With stimulus number Combination encoding is performed to generate the stimulus session identifier (SID). The combination encoding relationship can be represented in the following form: ; in, As a preset base constant, are positive integers and satisfy , To quantize the step size at any time The maximum possible range of stimulus numbers within the range, thus ensuring different Combining and mapping to different SIDs to avoid triggering session identifier conflicts; in other alternative implementations, controller 7 can also... and The stimulus session identifier is formed by concatenating the preset field format. However, when using numerical stimulus session identifiers, the above-mentioned combination encoding method based on time index and sequence number is more convenient for storage and retrieval. After generating the stimulus session identifier (SID), controller 7 writes the SID into its internal storage unit and establishes a relationship between the SID and the current stimulus process. This relationship can be achieved by creating a record in controller 7's session log table with the SID as the primary key and including the current stimulus initiation time information. Information related to stimulus sequence number As a field, it is written into the same record item so that the signal acquisition data and status data in the subsequent stimulation process can be collected and traced through the stimulation session identifier. When the controller 7 needs to access the data related to this stimulation session in the subsequent stimulation process, it can be indexed and read through the stimulation session identifier SID, thereby realizing session-level data organization and operation management with the stimulation session identifier as the core.

[0028] S2: Before executing the current stimulus session, determine whether there is a previous stimulus session. If there is a previous stimulus session, read the corresponding session closure status flag and determine whether the previous stimulus session is in a closed state. Furthermore, in step S2, the step of reading the corresponding session closure state identifier includes: In controller 7, the previous stimulus session identifier that is adjacent to the stimulus session identifier in time sequence is determined according to the stimulus session identifier corresponding to the current stimulus session; After determining the previous stimulus session identifier, read the session closure status identifier stored in association with the previous stimulus session identifier; When reading the session closure status identifier, the integrity of the session closure status identifier is checked. If the session closure status identifier is missing or incomplete, the previous stimulus session identifier is determined to be an unclosed session identifier.

[0029] Specifically, after the controller 7 completes the generation of the stimulation session identifier corresponding to the current external ED stimulation, and before entering the actual stimulation execution process, the controller 7 judges the continuity status of the stimulation session. The controller 7 first searches the stimulation session records stored in the device based on the stimulation session identifier corresponding to the current stimulation session to determine whether there is a historical stimulation session before the current stimulation session. The historical stimulation session is used as the previous stimulation session to participate in the subsequent judgment process. This judgment process is used to determine whether the current stimulation session needs to continue to be executed based on the existing stimulation session status. If a previous stimulus session is identified, controller 7 further determines the previous stimulus session identifier that is temporally adjacent to the current stimulus session based on the temporal order relationship between the current stimulus session identifier and historical stimulus session identifiers. In one possible implementation, controller 7 records the time index corresponding to the current stimulus session identifier as... The time indices corresponding to the historical stimulus session identifiers are recorded as follows: ,in Indicating the index number of the historical stimulus session, controller 7 calculates: ; in This indicates the time index that is closest in time sequence to and earlier than the current stimulus session. Historical stimulus sessions that meet the above conditions are identified as the previous stimulus session. This method ensures that the identification of the previous stimulus session is based on explicit time sequence rules, rather than arbitrary historical records. After determining the previous stimulus session identifier, controller 7 reads the session closure status identifier associated with that previous stimulus session identifier. The session closure status identifier is used to reflect whether the previous stimulus session has completed the closure process at the method flow level. This session closure status identifier can be a data field generated and stored by controller 7 when the previous stimulus session ends or the compensation process is completed. During the reading process, controller 7 verifies the integrity of the session closure status identifier. The integrity verification is used to determine whether the session closure status identifier has missing fields, illegal values, or incomplete writing. In one possible implementation, controller 7 determines whether the session closure status identifier contains an identifier field that corresponds one-to-one with the previous stimulus session identifier and a valid status value. When a missing or incomplete session closure status identifier is detected, controller 7 determines the corresponding previous stimulus session identifier as an unclosed session identifier and uses this determination result for the control judgment of the subsequent stimulus session flow, thereby ensuring that the previous session status has been clearly identified and included in the unified process management before the stimulus session enters the execution stage.

[0030] S3: When it is determined that the previous stimulus session is not in a closed state, the stimulus session closure compensation step is executed, and the current stimulus session is prohibited from entering the stimulus execution process until the compensation is completed. Furthermore, in step S3, the stimulus session closure compensation step includes: In controller 7, the identifier of the previous stimulus session that is determined to be unclosed is set to the compensation processing state; Based on the previous stimulus session identifier, terminate the output of stimulus control instructions associated with the previous stimulus session. Update the session validity identifier stored in association with the previous stimulus session and mark it as invalid; After completing the termination and update steps, a corresponding session closure status identifier is generated for the previous stimulus session, and the session closure status identifier is associated with and stored with the previous stimulus session identifier.

[0031] Specifically, when controller 7 completes the judgment of the previous stimulus session's closure state during the stimulus session initialization phase and determines that the previous stimulus session is not in a closed state, controller 7 prevents the current stimulus session from entering the stimulus execution process and enters the stimulus session closure compensation process. In this process, controller 7 first formally marks the session state of the previous stimulus session. Controller 7 maintains a session state variable for each stimulus session, denoted as... ,in This indicates the index number corresponding to the stimulus session identifier. The value of is used to represent the current state of the stimulus session in the method flow, when satisfies At that time, controller 7 will assign the session state variable corresponding to the previous stimulus session identifier. Set to compensation processing status ,in This indicates that the connection is closed. This indicates the state of the compensation process. This state transition is used at the methodological level to clarify that the previous stimulus session has entered the compensation process and serves as the state basis for subsequent processing. After the previous stimulus session is placed in the compensation processing state, the controller 7 terminates the output of the stimulus control instructions associated with that stimulus session based on the previous stimulus session identifier. In one possible implementation, the controller 7 maintains a set of stimulus control instructions for each stimulus session, denoted as... ,in This represents the set of stimulus control instructions associated with the previous stimulus session. When entering the compensation processing flow, controller 7 will use the execution enable state variable corresponding to this set. Set to the off state, formally represented as ,in This indicates that the stimulus control command is allowed to output. This indicates that stimulus control commands are prohibited from being output. In this way, controller 7 terminates the output of stimulus control commands related to the previous stimulus session at the method flow level. After the stimulus control command is terminated, controller 7 further updates the session validity identifier stored in association with the previous stimulus session. The session validity identifier is recorded as follows: ,in Used to characterize the validity status of a stimulus session in the method flow, during the compensation process, controller 7 identifies the session validity flag corresponding to the previous stimulus session. Updated to an invalid state, formally represented as: ;in This indicates that the stimulus session is in a valid state. This indicates that the stimulus session is in an invalid state. This update is used to clarify in subsequent process flows that the previous stimulus session is no longer considered a valid stimulus session for judgment and management. After terminating the stimulus control command and updating the session validity flag, controller 7 generates a corresponding session closure status flag based on the previous stimulus session flag. The session closure status flag is denoted as [symbol missing]. ,in Used to characterize whether the stimulus session has completed the closure process at the method flow level, the controller 7 identifies the session closure status corresponding to the previous stimulus session when the compensation process is completed. Set to a closed state, formally represented as: ,in This indicates that the stimulus session has been closed. This indicates that the stimulus session is not closed, and then controller 7 will indicate the session closure status. The previous stimulus session identifier is associated with the storage, so that the previous stimulus session is identified as having completed the compensation closure process in the subsequent stimulus session judgment process. Through the above state update and compensation process, the controller 7 completes the process convergence and unified state management of the previous stimulus session before the current stimulus session enters the execution stage.

[0032] S4: After confirming that there is no previous stimulus session that has not been closed, bioimpedance signals are collected in multiple consecutive time slices through bioimpedance detection electrodes, and the controller 7 performs a stimulus validity determination on the current stimulus session based on the collected bioimpedance signals. Furthermore, in step S4, the step of acquiring bioimpedance signals through bioimpedance detection electrodes over multiple consecutive time slices includes: In controller 7, the acquisition time slice parameters of bioimpedance signals are set. The acquisition time slice parameters are used to limit the acquisition timing of bioimpedance signals. In the current stimulation session, according to the acquisition time slice parameters, bioimpedance signals are sequentially acquired in multiple consecutive time slices through the bioimpedance detection electrode set in the inner diameter of the inner bonding layer 11. The bioimpedance signals collected in each time slice are stored separately and associated with the corresponding stimulus session identifiers.

[0033] Furthermore, in step S4, the step of the controller 7 performing a stimulus validity determination for the current stimulus session based on the acquired bioimpedance signal includes: In controller 7, the bioimpedance signals collected in multiple consecutive time slices are arranged sequentially according to the time slice order corresponding to the bioimpedance signals. Based on sequentially arranged bioimpedance signals, a sequence of bioimpedance changes corresponding to the current stimulus session is generated. The bioimpedance change sequence is matched with the pre-stored stimulus validity rules to determine whether the bioimpedance change sequence meets the stimulus validity conditions. When the bioimpedance change sequence meets the stimulus establishment condition, the current stimulus session is determined to be in an established state; otherwise, the current stimulus session is determined to be in an inestablished state.

[0034] Specifically, after the controller 7 completes the judgment of the previous stimulation session closure state and confirms that there is no previous stimulation session that is not closed, the controller 7 enters the current stimulation session state determination stage. In this stage, the controller 7 collects bioimpedance signals of the target area through bioimpedance detection electrodes set in the inner diameter of the inner bonding layer 11, and judges whether the current stimulation session is established based on the collected bioimpedance signals. The bioimpedance signals are used to reflect the changes in the electrical characteristics of the target area before and after stimulation, and are the basic data source for determining the state of stimulation session. Before acquiring bioimpedance signals, controller 7 pre-sets the acquisition time-slice parameters for the bioimpedance signals in the current stimulation session. These time-slice parameters define the acquisition sequence and interval of the bioimpedance signals. The time-slice parameters may include the time-slice length and time-slice sequence number. In one possible implementation, controller 7 records the acquisition time-slice length as... ,in This indicates the time interval between two adjacent bioimpedance acquisitions. During the stimulation session establishment determination phase, the controller 7 periodically triggers the bioimpedance detection electrode according to the acquisition time slice parameters, so that the bioimpedance detection electrode sequentially acquires bioimpedance signals in multiple consecutive time slices, forming bioimpedance data in the form of discrete time series. During the acquisition of bioimpedance signals over multiple consecutive time slices, controller 7 records the bioimpedance signal acquired in the k-th time slice as... ,in , This indicates the number of time slices used for establishing a condition in the current stimulus session. It can be represented in complex form or amplitude form. In one possible implementation, Represented as impedance amplitude data, this simplifies subsequent processing. After each acquisition, controller 7 will display the bioimpedance signal within the corresponding time slice. Stored in the internal storage unit and associated with the current stimulus session identifier, so that all bioimpedance signals can be uniformly managed and accessed at the session level; After acquiring bioimpedance signals across multiple consecutive time slices, controller 7 sequentially arranges the acquired bioimpedance signals according to the time slice order, forming an ordered data sequence. Subsequently, controller 7 generates a bioimpedance change sequence corresponding to the current stimulus session based on the sequentially arranged bioimpedance signals. This bioimpedance change sequence describes the relationship between bioimpedance signal changes within adjacent time slices. In one possible implementation, controller 7 denotes the bioimpedance change sequence as... And calculate according to the following relationship: ; in, Indicates the first Bioimpedance signals acquired within a time slice, This represents the change in bioimpedance between adjacent time slices. Using the method described above, controller 7 obtains the complete bioimpedance change sequence. This change sequence is used to reflect the dynamic changes in bioimpedance during the stimulus determination phase; This represents the bioimpedance signal acquired in the previous time slice, used to characterize the impedance change relationship between adjacent time slices; This indicates the number of time slices used for determination in the current stimulation session, and is used to limit the length of the bioimpedance signal acquisition and change sequence.

[0035] After generating the bioimpedance change sequence, controller 7 matches the bioimpedance change sequence with pre-stored stimulus validity rules to determine whether the current stimulus session meets the stimulus validity conditions. The stimulus validity rules are a set of pre-stored rules in controller 7, used to describe the determination logic of the bioimpedance change sequence in terms of temporal continuity and consistency of change. In one possible implementation, the stimulus validity rules may include the determination of the sign consistency of the bioimpedance change sequence, that is, the determination of the consistency of the sign within multiple consecutive time slices. Whether the same trend of change is met, when the bioimpedance change sequence meets the stimulus establishment judgment rule, the controller 7 will determine the current stimulus session as established, and when the bioimpedance change sequence does not meet the stimulus establishment judgment rule, the controller 7 will determine the current stimulus session as not established, and use the judgment result for the management and control of subsequent stimulus processes.

[0036] S5: When the current stimulation session is determined to be valid, the controller 7 controls the vibration motor 4, the electrical stimulation electrode, the ultrasonic transducer 5 and the flexible heating layer 3 to stimulate, and sets a session validity flag for the current stimulation session. Furthermore, in step S5, the step of setting a session validity flag for the current stimulus session includes: In controller 7, the session validity flag is initialized for the current stimulus session, and the session validity flag is set to the initial state; During stimulus execution, the session validity flag is updated based on the stimulus validity determination results corresponding to the bioimpedance signals collected in multiple consecutive time slices.

[0037] Specifically, when the controller 7 completes the stimulation establishment determination based on the continuous time slice acquisition results of the aforementioned bioimpedance signal and determines that the current stimulation session is in an established state, the controller 7 enters the stimulation execution stage. In this stage, the controller 7, as the unified scheduling unit for stimulation execution, outputs corresponding stimulation control signals to the vibration motor 4, the electrical stimulation electrode, the ultrasonic transducer 5, and the flexible heating layer 3 according to the preset stimulation execution process, so that the above-mentioned multiple stimulation components are activated and participate in the stimulation process in the current stimulation session. The vibration motor 4 generates mechanical vibration stimulation under the control of the controller 7, the electrical stimulation electrode outputs electrical stimulation signals under the control of the controller 7, the ultrasonic transducer 5 generates ultrasonic stimulation under the control of the controller 7, and the flexible heating layer 3 generates thermal stimulation under the control of the controller 7. The start and stop of each stimulation component are uniformly coordinated by the controller 7, so that the stimulation process is carried out continuously within the current stimulation session. At the start of stimulus execution, controller 7 synchronously initializes the session validity flag corresponding to the current stimulus session. The session validity flag characterizes the valid state of the stimulus session within the method flow. In one possible implementation, controller 7 maintains a session validity state variable for each stimulus session, denoted as . ,in This indicates the index number corresponding to the stimulus session identifier. When the current stimulus session is determined to be in an established state, the controller 7 will assign the session validity identifier corresponding to the stimulus session. Initialize to a preset initial state. The initial state can be represented as a valid candidate state or an initial valid state, which is used to indicate that the stimulus session has entered the stimulus execution phase and has the basis for subsequent state updates. During stimulus execution, controller 7 dynamically updates the session validity flag based on the stimulus validity determination results corresponding to the bioimpedance signals collected within multiple consecutive time slices. In one possible implementation, controller 7 continuously receives bioimpedance signals collected by bioimpedance detection electrodes during stimulus execution and processes the bioimpedance signals according to the same time slice parameters as the stimulus validity determination phase. Based on the updated bioimpedance changes, controller 7 confirms the validity status of the current stimulus session within the stimulus execution phase and updates the session validity flag accordingly. In formal expression, when the stimulus validity determination results within the stimulus execution phase meet the preset validity conditions, controller 7 maintains the session validity flag in a valid state, represented as... When the stimulus validity determination result during the stimulus execution phase no longer meets the preset validity conditions, controller 7 updates the session validity flag to an invalid state, indicating that... ,in, This indicates that the current stimulus session is in a valid state. This indicates that the current stimulus session is in an invalid state. Through the above method, the session validity identifier is updated in status during the stimulus execution process along with the stimulus validity determination result, and serves as an important status basis for subsequent stimulus session closure processing and process management, so that the current stimulus session has a clear and traceable validity status record at the method and process level.

[0038] S6: After the stimulus ends, the controller 7 generates and stores a session closure status identifier for the current stimulus session.

[0039] Furthermore, in step S6, the step of generating and storing a session closure state identifier for the current stimulus session via controller 7 is achieved through: In controller 7, the stimulus session identifier corresponding to the current stimulus session and the session validity identifier associated with the stimulus session are obtained; Based on the stimulus session identifier and session validity identifier, generate the session closure status identifier corresponding to the current stimulus session.

[0040] Specifically, when the controller 7 completes the stimulus execution process of the current stimulus session and detects that the stimulus process termination condition is met, the controller 7 enters the stimulus session closure processing stage. In this stage, the controller 7 summarizes the running status of the current stimulus session at the method flow level and generates a session closure status identifier to characterize the end status of the stimulus session. The session closure status identifier is used to indicate whether the current stimulus session has completed the closure processing in the subsequent stimulus session judgment process. It is an important status data for the stimulus session lifecycle management. When entering the session closure state identifier generation process, the controller 7 first obtains the stimulus session identifier corresponding to the current stimulus session. The stimulus session identifier is used to uniquely identify the identity of the current stimulus session in the system. At the same time, the controller 7 obtains the session validity identifier associated with the stimulus session. The session validity identifier is used to characterize the valid state of the current stimulus session during the stimulus execution phase. In one possible implementation, the controller 7 uses the stimulus session identifier as an index to retrieve the corresponding session validity identifier state in the internal storage unit, thereby forming a set of state data directly associated with the current stimulus session. After acquiring the stimulus session identifier and session validity identifier, controller 7 generates a session closure state identifier corresponding to the current stimulus session based on these two types of identifier data. In formal expression, the session closure state identifier is denoted as... ,in This represents the index number corresponding to the stimulus session identifier. The generation rule for the session closure status identifier is based on the combination relationship between the stimulus session identifier and the session validity identifier. In one possible implementation, the controller 7 generates the session closure status identifier according to the following logical relationship:

[0041] in, This indicates the stimulus session identifier corresponding to the current stimulus session. The function represents the session validity identifier associated with the current stimulus session. This represents a session closure state generation function, which maps the identity information and validity state of a stimulus session to a unified closure state result. In one specific implementation, when the session validity identifier... At that time, controller 7 will indicate the session closure status. Set to a closed and valid state when the session validity flag is displayed. At that time, controller 7 will indicate the session closure status. By setting it to a closed and invalid state, the session closure status indicator not only reflects whether the stimulus session has completed the closure process, but also carries status information related to the validity of stimulus execution. After generating the session closure status identifier, the controller 7 associates and stores the session closure status identifier with the current stimulus session identifier. This association can be achieved by creating a session record item indexed by the stimulus session identifier in the internal storage unit of the controller 7 and writing the session closure status identifier as the status field of the record item. In the subsequent stimulus session initialization phase, the controller 7 can accurately determine whether the historical stimulus session has completed the closure process by reading the corresponding session closure status identifier. Through the above process, the current stimulus session completes the generation and storage of the complete closure status after the stimulus ends, so that the stimulus session forms a clear life cycle endpoint at the method flow level and provides a reliable basis for the continuous management of subsequent stimulus sessions.

[0042] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. An external electro-electro-optical stimulator, comprising a housing (1), characterized in that: The top of the outer shell (1) is fixedly connected to a fixed chamber (2). The inner diameter of the outer shell (1) is fixedly connected to a flexible heating layer (3). Multiple vibration motors (4) are fixedly connected inside the flexible heating layer (3). Multiple ultrasonic transducers (5) are fixedly connected inside the flexible heating layer (3). A shape memory alloy support frame (9) is provided inside the flexible heating layer (3). Multiple micro airbags (10) are provided inside the shape memory alloy support frame (9). An inner bonding layer (11) is fixedly connected between the multiple micro airbags (10). An electrical stimulation electrode and a bioimpedance detection electrode are provided inside the inner bonding layer (11). The inner bonding layer (11) is fixedly connected to the fixed chamber (2). A battery (6) is fixedly connected inside the fixed chamber (2). An air pump (8) is fixedly connected inside the fixed chamber (2). The output end of the air pump (8) is fixedly connected to the multiple micro airbags (10). A controller (7) is fixedly connected inside the fixed chamber (2).

2. The ED stimulator combining external electro-pneumatic stimulation according to claim 1, characterized in that: The battery (6) is electrically connected to the controller (7), and the controller (7) is electrically connected to the flexible heating layer (3), the vibration motor (4), the ultrasonic transducer (5), the electrical stimulation electrode, the bioimpedance detection electrode, and the air pump (8).

3. A method for ED stimulation combining external electro-vibration, characterized in that, For an external electro-electro-optical stimulator according to any one of claims 1-2, the method comprises the following steps: S1: When the controller (7) receives the stimulation start command, it generates the stimulation session identifier corresponding to the current external ED stimulation and stores the stimulation session identifier in association with the current stimulation process; S2: Before executing the current stimulus session, determine whether there is a previous stimulus session. If there is a previous stimulus session, read the corresponding session closure status flag and determine whether the previous stimulus session is in a closed state. S3: When it is determined that the previous stimulus session is not in a closed state, the stimulus session closure compensation step is executed, and the current stimulus session is prohibited from entering the stimulus execution process until the compensation is completed. S4: After confirming that there is no previous unclosed stimulus session, bioimpedance signals are collected in multiple consecutive time slices through bioimpedance detection electrodes, and the controller (7) performs a stimulus validity determination on the current stimulus session based on the collected bioimpedance signals. S5: When the current stimulation session is determined to be valid, the controller (7) controls the vibration motor (4), electrical stimulation electrode, ultrasonic transducer (5) and flexible heating layer (3) to stimulate, and sets a session validity flag for the current stimulation session; S6: After the stimulus ends, the controller (7) generates and stores the session closure status identifier for the current stimulus session.

4. The method for external electro-pneumatic stimulation combined with ED stimulation according to claim 3, characterized in that, In step S1, the step of generating the stimulation session identifier corresponding to the current external ED stimulation includes: When the controller (7) receives the stimulus initiation command, it obtains the current stimulus initiation time information; Obtain the stimulation sequence number information corresponding to the current in vitro ED stimulation; Based on the stimulation initiation time information and the stimulation sequence number information, a unique stimulation session identifier corresponding to the current external ED stimulation is generated.

5. The method for external electro-pneumatic stimulation combined with ED stimulation according to claim 3, characterized in that, In step S2, the step of reading the corresponding session closure state identifier includes: In the controller (7), the previous stimulus session identifier that is adjacent to the stimulus session identifier in time sequence is determined according to the stimulus session identifier corresponding to the current stimulus session; After determining the previous stimulus session identifier, read the session closure status identifier stored in association with the previous stimulus session identifier; When reading the session closure status identifier, the integrity of the session closure status identifier is checked. If the session closure status identifier is missing or incomplete, the previous stimulus session identifier is determined to be an unclosed session identifier.

6. The method for external electro-pneumatic stimulation combined with ED stimulation according to claim 3, characterized in that, In step S3, the step of performing stimulus session closure compensation includes: In the controller (7), the previous stimulus session identifier that is determined to be unclosed is set to the compensation processing state; Based on the previous stimulus session identifier, terminate the output of stimulus control instructions associated with the previous stimulus session. Update the session validity identifier stored in association with the previous stimulus session and mark it as invalid; After completing the termination and update steps, a corresponding session closure status identifier is generated for the previous stimulus session, and the session closure status identifier is associated with and stored with the previous stimulus session identifier.

7. The method for external electro-pneumatic stimulation combined with ED stimulation according to claim 3, characterized in that, In step S4, the step of acquiring bioimpedance signals through bioimpedance detection electrodes over multiple consecutive time slices includes: In the controller (7), the acquisition time slice parameters of the bioimpedance signal are set, and the acquisition time slice parameters are used to limit the acquisition timing of the bioimpedance signal; In the current stimulation session, according to the acquisition time slice parameters, bioimpedance signals are sequentially acquired in multiple consecutive time slices through the bioimpedance detection electrode set in the inner diameter of the inner bonding layer (11); The bioimpedance signals collected in each time slice are stored separately and associated with the corresponding stimulus session identifiers.

8. The method for external electro-pneumatic stimulation combined with ED stimulation according to claim 3, characterized in that, In step S4, the step of the controller (7) performing a stimulus validity determination on the current stimulus session based on the acquired bioimpedance signal includes: In the controller (7), the bioimpedance signals collected in multiple consecutive time slices are arranged in sequence according to the time slice order corresponding to the bioimpedance signals; Based on sequentially arranged bioimpedance signals, a sequence of bioimpedance changes corresponding to the current stimulus session is generated. The bioimpedance change sequence is matched with the pre-stored stimulus validity rules to determine whether the bioimpedance change sequence meets the stimulus validity conditions. When the bioimpedance change sequence meets the stimulus establishment condition, the current stimulus session is determined to be in an established state; otherwise, the current stimulus session is determined to be in an inestablished state.

9. The method for external electro-pneumatic stimulation combined with ED stimulation according to claim 3, characterized in that, In step S5, the step of setting a session validity flag for the current stimulus session includes: In the controller (7), the session validity flag is initialized for the current stimulus session and the session validity flag is set to the initial state; During stimulus execution, the session validity flag is updated based on the stimulus validity determination results corresponding to the bioimpedance signals collected in multiple consecutive time slices.

10. The method for external electro-pneumatic stimulation combined with ED stimulation according to claim 3, characterized in that, In step S6, the step of generating and storing a session closure state identifier for the current stimulus session via the controller (7) is achieved through: In the controller (7), obtain the stimulus session identifier corresponding to the current stimulus session and the session validity identifier associated with the stimulus session; Based on the stimulus session identifier and session validity identifier, generate the session closure status identifier corresponding to the current stimulus session.

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