A pelvic floor muscle self-adapting guided repair wearable device

Abstract

This invention provides a wearable device for adaptive guidance and repair of pelvic floor muscles, comprising: a wearable main body with a wearable area corresponding to the pelvic floor muscle region of the human body, and a driving component fixed to the wearable area; the driving component includes two driving unit groups, multiple flexible sensing units, and a flexible encapsulation support component; the driving unit groups and flexible sensing units are arranged circumferentially with the central axis of the driving component as a reference, together forming a closed-loop annular structure with a central through hole; the flexible encapsulation support component is used to encapsulate and fix each shape memory driving unit and flexible sensing unit; the two driving unit groups have shape memory performance, and each independently responds to external stimuli to generate a preset deformation to apply an auxiliary contraction driving force or an anti-contraction resistance to the pelvic floor muscle region; a control component is used to identify the activity state of the pelvic floor muscles based on the electrical signals collected by the flexible sensing units, and adjust the deformation of the two driving unit groups accordingly based on the identification results. This solution can achieve precise guidance of the pelvic floor muscles and realize efficient training.

Description

Technical Field

[0001] This invention relates to the field of interdisciplinary technology of smart materials and medical devices, and in particular to a wearable device for pelvic floor muscle adaptive guided repair. Background Technology

[0002] Postpartum pelvic floor muscle dysfunction is a common problem for women after childbirth, mainly caused by prolonged increased abdominal pressure during pregnancy, excessive stretching of the pelvic floor muscles during delivery, or damage. Clinically, it often manifests as stress urinary incontinence and pelvic organ prolapse. Current mainstream repair techniques and devices have significant shortcomings: electrical stimulation therapy applies low-frequency electrical pulses to the skin surface or cavities to passively induce muscle contraction, but patients often experience stinging sensations, individual efficacy varies greatly, and it relies on specialized equipment, is costly, and cannot effectively train the patient's active contraction ability; magnetic stimulation therapy, while using high-intensity pulsed magnetic fields to achieve non-contact stimulation and avoid invasive electrodes, has extremely expensive equipment, is usually limited to medical institutions, has high treatment costs, and is also a passive treatment.

[0003] From a muscle physiology perspective, the repair and strengthening of any muscle requires active contraction and the ability to withstand a certain load, causing slight tears in the muscle fibers. The body then repairs these torn fibers, making the muscles stronger. The pelvic floor muscles also require active contraction and load stimulation. Existing passive methods such as electrical stimulation and magnetic therapy can only awaken the pelvic floor muscles and cannot truly achieve repair. Therefore, strengthening the active control of the pelvic floor muscles is key to rehabilitation. While some biomechanical training devices guide patients in Kegel exercises to achieve rehabilitation through active pelvic floor muscle contraction, many patients (especially in the early postpartum period) have difficulty accurately perceiving and locating their pelvic floor muscle groups. During training, they often mistakenly use abdominal muscles, gluteal muscles, or inner thigh adductors for compensation, leading to poor training results and potentially exacerbating the problem due to incorrect muscle compensation patterns. Furthermore, some patients find it difficult to maintain long-term adherence due to discomfort and inconvenience during use.

[0004] Therefore, there is an urgent need to provide a wearable device for pelvic floor muscle adaptive guidance and repair. Summary of the Invention

[0005] This invention provides a pelvic floor muscle adaptive guided repair wearable device, which can solve the problem that existing pelvic floor muscle biomechanical training devices are difficult to accurately guide and assist patients in pelvic floor muscle contraction training, resulting in poor pelvic floor muscle training effects.

[0006] In a first aspect, the present invention provides a pelvic floor muscle adaptive guided repair wearable device, the device comprising: The wearable main body has a wearable area corresponding to the human pelvic floor muscle area, and the driving component is fixed to the wearable area; The driving component includes a first driving unit group, a second driving unit group, a plurality of flexible sensing units, and a flexible packaging support component; wherein, the first driving unit group includes at least one first shape memory driving unit, and the second driving unit group includes at least one second shape memory driving unit; The first driving unit group, the second driving unit group, and the flexible sensing unit are arranged circumferentially with the central axis of the driving component as the reference, and extend radially along the driving component, together forming a closed-loop annular structure with a central through hole. The flexible encapsulation support components are respectively attached to the opposite two sides of the annular structure to encapsulate and fix each shape memory driving unit and flexible sensing unit. Both the first shape memory driving unit and the second shape memory driving unit have shape memory performance, and each of them independently responds to external stimuli to generate preset deformations in order to apply a driving force to assist contraction or an anti-contraction resistance to the pelvic floor muscle area. The flexible sensing unit is used to collect electrical signals during the contraction of the pelvic floor muscles and transmit the electrical signals to the control component. The control component is used to identify the activity state of the pelvic floor muscles based on the received electrical signals, and to adjust the deformation of the first shape memory drive unit or the second shape memory drive unit accordingly based on the identification results.

[0007] Preferably, the first shape memory driving unit, the flexible sensing unit, and the second shape memory driving unit are arranged alternately in a circumferential manner with the central axis of the driving component as the reference, and each of the flexible sensing units is located between adjacent first shape memory driving units and second shape memory driving units.

[0008] Preferably, both the first shape memory driving unit and the second shape memory driving unit are provided with miniature electrothermal resistors. Each miniature electrothermal resistor is grouped and arranged through wiring components, and forms an auxiliary mode excitation circuit and an anti-resistance mode excitation circuit that are isolated from each other with the first shape memory driving unit and the second shape memory driving unit, respectively.

[0009] More preferably, both the auxiliary mode excitation circuit and the impedance mode excitation circuit are equipped with an electronically controlled switch device, and the control terminal of the electronically controlled switch device is electrically connected to the control component.

[0010] More preferably, the control component is pre-programmed with a dual-mode control program to regulate the on / off state and working mode switching of the two excitation circuits.

[0011] Preferably, the dual-mode control program includes an auxiliary training mode; wherein, in the auxiliary training mode, the control component connects the auxiliary mode excitation circuit through an electronically controlled switch device, drives the first shape memory drive unit to generate a preset deformation, and drives the ring structure to form a contraction and convergence posture, so as to apply a contraction assistance force to the pelvic floor muscles.

[0012] Preferably, the dual-mode control program includes a resistance training mode; wherein, in the resistance training mode, the control component disconnects the auxiliary mode excitation circuit and connects the resistance mode excitation circuit through an electronically controlled switching device, driving the second shape memory driving unit to generate a preset deformation, thereby causing the annular structure to form a supporting tension posture to apply resistance to the pelvic floor muscles.

[0013] Preferably, the flexible encapsulation support component further extends to cover the central through-hole area formed by the annular structure.

[0014] More preferably, the driving component further includes a plurality of stretchable flexible electrode units arranged in an array in the area corresponding to the central through hole of the flexible encapsulation support component. Each electrode unit is electrically connected to the control component and is used to output a programmable electrical pulse signal based on the pelvic floor muscle mechanical signal collected by the flexible sensing unit, thereby inducing the human pelvic floor muscles to produce passive contraction movements.

[0015] More preferably, the control component is further preset with an electrical stimulation-assisted collaborative training mode. In this collaborative training mode, the control component controls the stretchable flexible electrode unit and the first shape memory driving unit to operate synchronously, so that the pelvic floor muscle contraction movement induced by the electrical pulse signal and the contraction assistance force provided by the first shape memory driving unit are coordinated and matched in timing and direction of movement.

[0016] Preferably, the flexible sensing unit is a nano-triboelectric flexible sensing unit.

[0017] Furthermore, the nano-triboelectric flexible sensing unit is electrically connected to the control component to convert the mechanical energy generated by the contraction of the human pelvic floor muscles into an induced electrical signal. The induced electrical signal is transmitted to the control component to characterize the contractile mechanical state of the pelvic floor muscles.

[0018] More preferably, the nano-triboelectric flexible sensing unit is also electrically connected to a micro-thermal resistor, and the induced electrical signal generated by the unit is used to provide working power to the micro-thermal resistor to drive the corresponding shape memory driving unit to produce a preset deformation.

[0019] Preferably, the first shape memory driving unit and the second shape memory driving unit are prepared using a highly cycle-stable shape memory polymer material; wherein, the shape memory polymer material is a cross-linked polymer containing dynamic reversible covalent bonds, and its molecular chain contains thiourethane bonds, imine bonds and diselenyl bonds simultaneously.

[0020] More preferably, the highly cycle-stable shape memory polymer material is prepared using the following method: (1) The first shape memory polymer is mixed with functional acrylate monomers and catalyst to obtain a functionalized first shape memory polymer; (2) Functionalized first shape memory polymer, aliphatic diamine and aromatic dialdehyde are added to solvent and mixed, and after condensation reaction, modified prepolymer is obtained; (3) The modified prepolymer is mixed with diselenic acid and diol and subjected to esterification reaction to obtain a ternary dynamic bond prepolymer. (4) The ternary dynamic bond prepolymer is mixed with the second shape memory polymer, photoinitiator, nucleating agent and biocompatibility and reacted, and then crosslinked, cured and annealed in sequence to obtain the high cycle stability shape memory polymer material.

[0021] Preferably, in step (1), the first shape memory polymer is thiol-modified polycaprolactone; the functional acrylate monomer is isocyanate methacrylate; and the catalyst is dibutyltin dilaurate.

[0022] Preferably, in step (1), the molar ratio of the first shape memory polymer to the functional acrylate monomer is 1:(1.05~1.1), and the amount of catalyst added is 0.1~0.5wt%.

[0023] Preferably, the aliphatic diamine is hexamethylenediamine, and the aromatic dialdehyde is terephthalaldehyde.

[0024] More preferably, the molar ratio of the first shape memory polymer to the aliphatic diamine is (3.2~3.5):1, and the molar ratio of the aliphatic diamine to the aromatic dialdehyde is 1:(2.1~2.2).

[0025] Preferably, in step (3), the diselenoic acid is 3,3'-diselenodipropionic acid, and the diol is 1,4-butanediol; preferably, the molar ratio of the first shape memory polymer to the diselenoic acid is (1.4~1.6):1; the molar ratio of the diselenoic acid to the diol is 1:(0.9~0.98).

[0026] More preferably, in step (4), the second shape memory polymer is polylactic acid, the photoinitiator is 2-hydroxy-2-methyl-1-phenyl-1-propanone, the nucleating agent is nano-silica, and the biocompatibility agent is polyethylene glycol diamine.

[0027] Preferably, the mass ratio of the first shape memory polymer to the second shape memory polymer is (5~7):(3~5); More preferably, the amount of photoinitiator added is 0.3-0.5 wt%, the amount of nucleating agent added is 1-1.5 wt%, and the amount of biocompatibility added is 0.2-0.3 wt%, calculated by mass percentage.

[0028] Compared with the prior art, the present invention has at least the following beneficial effects: The pelvic floor muscle adaptive guided repair device of this invention includes a wearable main body, a drive component, and a control component. The drive component, located within the wearable main body corresponding to the pelvic floor muscle region, comprises two drive unit groups, multiple flexible sensing units, and a flexible encapsulation support component. These components together form a closed-loop annular structure with a central through-hole, allowing for close contact with the target muscle group while maintaining sufficient flexibility during wear. Furthermore, each of the two drive unit groups consists of multiple shape memory drive units. By heating the two sets of drive units, they can be controlled in zones, causing them to undergo a shape memory effect and deform into two preset functional forms: one applying an auxiliary contraction driving force to the pelvic floor muscles to assist the user in Kegel exercises; the other providing resistance against contraction for subsequent overload resistance training. Simultaneously, the control component identifies the activity state of the pelvic floor muscles based on the electrical signals collected by the flexible sensing units and accordingly adjusts the deformation of different drive units. This controlled shape recovery behavior not only generates a gentle and adaptive auxiliary force but also avoids internal thermal fatigue caused by repeated phase transitions of large-volume drive units, improving the lifespan of the material after multiple deformations. Meanwhile, the device is preset with two reversible modes: assisted training and resistance training. As the user's muscle strength improves, the device can switch from assisted mode to load mode, thereby achieving precise guidance and efficient training of the pelvic floor muscles. Attached Figure Description

[0029] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0030] Figure 1 This is a schematic diagram of the overall structure of a pelvic floor muscle adaptive guided repair wearable device provided in an embodiment of the present invention; Figure 2 This is an initial structural schematic diagram of the driving component in a pelvic floor muscle adaptive guided repair wearable device provided in an embodiment of the present invention; Figure 3 This is a schematic diagram of the structure of the drive component in the auxiliary mode of a pelvic floor muscle adaptive guided repair wearable device provided in an embodiment of the present invention; Figure 4 This is a schematic diagram of the shape memory driving unit in the pelvic floor muscle adaptive guided repair wearable device provided in an embodiment of the present invention, in the initial state, in the auxiliary mode and in the resistance mode respectively; In the figure, 101 is the control component, 102 is the drive component, 103 is the wearable main body, 301 is the first shape memory drive unit, 302 is the second shape memory drive unit, 303 is the flexible sensing unit, and 304 is the miniature electrothermal resistor. Detailed Implementation

[0031] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are some embodiments of the present invention, but not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0032] like Figure 1 and Figure 2 As shown, an embodiment of the present invention provides a pelvic floor muscle adaptive guided repair wearable device, the device comprising: The wearable body 103 has a wearable area corresponding to the pelvic floor muscle area of ​​the human body, and the driving component is fixed to the wearable area; The driving component 102 includes a first driving unit group, a second driving unit group, a plurality of flexible sensing units 303, and a flexible packaging support component (not shown in the figure); wherein, the first driving unit group includes at least one first shape memory driving unit 301, and the second driving unit group includes at least one second shape memory driving unit 302. The first driving unit group, the second driving unit group, and the flexible sensing unit are arranged circumferentially with the central axis of the driving component as the reference, and extend radially along the driving component, together forming a closed-loop annular structure with a central through hole. The flexible encapsulation support components are respectively attached to the opposite two sides of the annular structure to encapsulate and fix each shape memory driving unit and flexible sensing unit. Both the first shape memory driving unit and the second shape memory driving unit have shape memory performance, and each of them independently responds to external stimuli to generate preset deformations in order to apply a driving force to assist contraction or an anti-contraction resistance to the pelvic floor muscle area. The flexible sensing unit is used to collect electrical signals during the contraction of the pelvic floor muscles and transmit the electrical signals to the control component. The control component 101 is used to identify the activity state of the pelvic floor muscles based on the received electrical signals, and to adjust the deformation of the first shape memory drive unit or the second shape memory drive unit accordingly based on the identification result.

[0033] The pelvic floor muscle adaptive guided repair device in this embodiment of the invention includes a wearable main body, a driving component, and a control component. The driving component is disposed in the wearable main body corresponding to the pelvic floor muscle region and includes two driving unit groups, multiple flexible sensing units, and a flexible encapsulation support component. These components together form a closed-loop annular structure with a central through-hole, allowing it to closely conform to the target muscle group while maintaining sufficient softness during wear. Furthermore, each of the two driving unit groups consists of multiple shape memory driving units. By heating the two groups of driving units, they can be controlled in zones to induce a shape memory effect, deforming into two preset functional forms: one applying an auxiliary contraction driving force to the pelvic floor muscles to assist the user in performing Kegel exercises; the other providing resistance against contraction for subsequent overload resistance training. Simultaneously, the control component identifies the activity state of the pelvic floor muscles based on the electrical signals collected by the flexible sensing units and accordingly adjusts the deformation of different driving units. This controlled shape recovery behavior not only generates a gentle and adaptive auxiliary force but also avoids internal thermal fatigue caused by repeated phase transitions of large-volume driving units, improving the lifespan of the material after multiple deformations. Meanwhile, the device is preset with two reversible modes: assisted training and resistance training. As the user's muscle strength improves, the device can switch from assisted mode to load mode, thereby achieving precise guidance and efficient training of the pelvic floor muscles.

[0034] According to some preferred embodiments, the first shape memory driving unit, the flexible sensing unit, and the second shape memory driving unit are arranged alternately in a circumferential manner with the central axis of the driving component as the reference, and each of the flexible sensing units is located between adjacent first shape memory driving units and second shape memory driving units.

[0035] In this embodiment of the invention, by alternating the first shape memory driving unit and the second shape memory driving unit, and placing the flexible sensing unit between the first shape memory unit and the second shape memory unit, it is beneficial to ensure a uniform and symmetrical distribution of the driving force assisting contraction and the resistance to contraction in the circumferential direction. This allows the annular structure to be subjected to balanced forces during bidirectional deformation and to conform to the target muscle group of the pelvic floor muscles. Simultaneously, sandwiching the flexible sensing unit between the two types of driving units facilitates the accurate acquisition of contractile mechanical signals from various circumferential regions of the pelvic floor muscles.

[0036] In some specific embodiments, the first shape memory driving unit, the second shape memory driving unit, and the flexible sensing unit in this invention are all trapezoidal strip structures. The narrow end of the trapezoidal strip structure connects to the periphery of the central through-hole of the annular structure, and the wide end extends to the outer periphery of the annular structure, perfectly adapting to the radial arrangement path of the annular structure. Furthermore, the first shape memory driving unit and the second shape memory driving unit are of the same number, totaling 6-10. This ensures full coverage of the circumferential driving of the pelvic floor muscles while maintaining the overall structure's flexibility and wearability. Simultaneously, the interval between two adjacent circumferential driving units is set to 10-15 mm, providing ample space for the bidirectional deformation of the driving units, preventing adjacent units from squeezing or interfering with each other during deformation, and ensuring the smoothness and controllability of the deformation action.

[0037] According to some preferred embodiments, such as Figure 3 As shown, both the first shape memory driving unit and the second shape memory driving unit are equipped with miniature electric heating resistors 304. Each miniature electric heating resistor is grouped and arranged through a wiring assembly, forming an isolated auxiliary mode excitation circuit and an anti-resistance mode excitation circuit with the first shape memory driving unit and the second shape memory driving unit, respectively. Both the auxiliary mode excitation circuit and the anti-resistance mode excitation circuit are equipped with electronically controlled switching devices, and the control terminals of the electronically controlled switching devices are electrically connected to the control component. The control component has a preset dual-mode control program, which is used to regulate the on / off state and working mode switching of the two excitation circuits.

[0038] In this embodiment of the invention, to achieve independent and interference-free control of the two types of driving units, as shown in the figure, miniature electrothermal resistors are correspondingly provided on the outer peripheral edges of both the first and second shape memory driving units. These resistors provide a uniform and controllable thermal excitation source for the thermally induced deformation of the shape memory polymer. All miniature electrothermal resistors are grouped and electrically connected via wiring components, forming auxiliary mode excitation circuits and resistance mode excitation circuits corresponding to the first and second shape memory driving units, respectively. The two circuits are electrically isolated from each other, ensuring that the deformation actions of the two types of driving units are completely independent and do not affect each other. Each auxiliary mode excitation circuit and resistance mode excitation circuit is equipped with an independent electrically controlled switching device, such as an N-channel metal-oxide-semiconductor field-effect transistor. The control terminals of all electrically controlled switching devices are electrically connected to the control component. The control component can precisely control the on / off state of the two circuits through the electrically controlled switching devices, flexibly adjusting the connection sequence and time of the circuits to adapt to different training modes and meet the personalized training needs of different users.

[0039] According to some preferred embodiments, the dual-mode control program includes an auxiliary training mode; wherein, in the auxiliary training mode, the control component connects the auxiliary mode excitation circuit through an electronically controlled switch device, drives the first shape memory drive unit to generate a preset deformation, and causes the ring structure to form a contraction and convergence posture, so as to apply a contraction assistance force to the pelvic floor muscles; the dual-mode control program includes a resistance training mode; wherein, in the resistance training mode, the control component disconnects the auxiliary mode excitation circuit, connects the resistance mode excitation circuit through an electronically controlled switch device, drives the second shape memory drive unit to generate a preset deformation, and causes the ring structure to form a support and tension posture, so as to apply resistance to the pelvic floor muscles.

[0040] In this embodiment of the invention, a dual-mode control program is preset in the control component, thereby enabling flexible switching between assisted training mode and resistance training mode. The assisted training mode is suitable for users with weak pelvic floor muscles who are unable to independently perform standard Kegel contractions. In this mode, the control component connects the assisted mode excitation circuit via an electronically controlled switch, while simultaneously keeping the resistance mode excitation circuit disconnected. After the circuit is activated, the first shape memory drive unit is heated and generates a preset deformation (e.g., ...). Figure 4 As shown), this causes the ring structure to form an inward contraction and convergence posture (as shown). Figure 3As shown), applying gentle and controllable contraction assistance to the pelvic floor muscle area can provide contraction assistance for users with insufficient muscle strength, and can also help users master the correct pelvic floor muscle contraction rhythm, force direction and sequence through standardized deformation guidance, correcting incorrect training habits. The resistance training mode is suitable for users who have mastered the correct contraction method and whose pelvic floor muscle strength has reached a certain level. In this mode, the control component first interlocks and disconnects the auxiliary mode excitation circuit to completely avoid deformation conflict and force cancellation caused by the simultaneous conduction of two circuits; then, the resistance mode excitation circuit is connected through the electronically controlled switch device, driving the second shape memory drive unit to be heated and excited to produce a preset deformation, causing the ring structure to form an outward supporting tension posture (such as...). Figure 4 As shown in the figure, this mode provides counter-resistance when the user actively contracts the pelvic floor muscles. This mode can convert the device into a pelvic floor muscle training carrier with controllable load. Through the principle of overload training, it can effectively improve the muscle strength, contraction endurance and control ability of the pelvic floor muscles, and achieve full-cycle coverage of pelvic floor muscle rehabilitation training.

[0041] It should be noted that, in the embodiments of the present invention, the preset deformation specifically refers to training and fixing the prepared SMP material into a preset reversible shape (such as an auxiliary training mode or a resistance training mode) by pressing it with a mold or mechanically pre-stretching it under conditions higher than its glass transition temperature.

[0042] According to some preferred embodiments, the flexible encapsulation support component further extends to cover the central through-hole area formed by the annular structure; the driving component also includes a plurality of stretchable flexible electrode units arranged in an array in the central through-hole area of ​​the flexible encapsulation support component, each electrode unit being electrically connected to the control component, for outputting programmable electrical pulse signals based on the pelvic floor muscle mechanical signals collected by the flexible sensing unit, thereby inducing the human pelvic floor muscles to produce passive contraction movements.

[0043] In this embodiment of the invention, the driving component further includes multiple stretchable flexible electrode units arranged in an array in the area corresponding to the central through-hole of the flexible encapsulation support component. These electrode units serve as targeted neuro-electrical stimulation units, forming a high-density, flexible, and stretchable electrode array in the middle of the annular structure. Their arrangement precisely corresponds to the surface projection area or neuromotor point of key pelvic floor muscle groups such as the pubococcygeus muscle, urethral sphincter, vaginal sphincter, and related smooth muscles. Each electrode unit is electrically connected to the control component and can output programmable electrical pulse signals based on the pelvic floor muscle mechanical signals collected by the flexible sensing unit. These signals can be programmable low-frequency bidirectional symmetrical or asymmetrical square wave pulses with a typical range of 20-50Hz. The current intensity, pulse width, and frequency can be adaptively adjusted according to the rehabilitation stage, which can induce muscle tetanic contraction without causing pain or discomfort, thereby inducing passive contraction of the human pelvic floor muscles.

[0044] The flexible encapsulation support component uses medical-grade liquid silicone with a Shore hardness of 30~40HA. Two circular silicone films with a thickness of 0.3~0.5mm are prepared by a casting process to serve as the flexible encapsulation support component. During encapsulation, medical-grade epoxy adhesive is first evenly applied to the predetermined position on the lower silicone film. The prepared first shape memory driving unit and second shape memory driving unit are alternately and evenly arranged and fixed on the surface of the lower silicone film, with the center distance between two adjacent shape memory driving units controlled at 10~15mm. Then, a nano-triboelectric flexible sensing unit is arranged between adjacent shape memory driving units, with the distance between the flexible sensing unit and the adjacent shape memory driving unit controlled at 5~8mm. After the arrangement is completed, the array busbar of the sensing unit is electrically connected to the energy distribution module through flexible wires to complete the initial docking of the sensing-driving circuit. Then, the upper silicone film is covered and pressed to form a closed-loop ring structure.

[0045] According to some preferred embodiments, the control component is further preset with an electrical stimulation-assisted collaborative training mode. In this collaborative training mode, the control component controls the stretchable flexible electrode unit and the auxiliary mode of the first shape memory driving unit to operate synchronously, so that the pelvic floor muscle contraction movement induced by the electrical pulse signal and the contraction assistance force provided by the first shape memory driving unit are coordinated and matched in timing and direction of movement.

[0046] Addressing the core challenge of weak voluntary contraction awareness and inability to accurately activate target muscle groups, especially in postpartum patients, this invention integrates a targeted neurostimulation unit formed by flexible, stretchable electrodes. This unit, in conjunction with a shape memory drive unit, establishes a closed-loop collaborative working mode encompassing neural arousal, mechanical guidance, and biofeedback. In this collaborative mode, the targeted neurostimulation unit and the first shape memory drive unit operate synchronously and collaboratively. The stimulation unit outputs rhythmic nerve impulses, guiding the nervous system to establish the correct pelvic floor muscle contraction initiation logic. Simultaneously, the first shape memory drive unit is precisely triggered in the corresponding area, producing a gentle contraction. The shape-restored deformation provides mechanical guidance that is synchronized with and consistent with the contraction movements induced by electrical stimulation. This greatly enhances the user's learning of the correct contraction path of the pelvic floor muscles, the development of contraction sensation, and the establishment of muscle memory. In addition, the control component can quantitatively assess the user's active contraction ability through data collected by the flexible sensing unit. As the user's active contraction ability gradually increases, the system will gradually reduce the intensity of the neural electrical stimulation and correspondingly increase the proportion of mechanical guidance from the shape memory driving unit. This helps the user smoothly transition to a training mode dominated by active contraction and with the shape memory driving unit providing auxiliary force or resistance, ultimately achieving the advancement to a resistance load training mode.

[0047] According to some preferred embodiments, the flexible sensing unit is a nano-triboelectric flexible sensing unit; the nano-triboelectric flexible sensing unit is electrically connected to the control component and is used to convert the mechanical energy generated by the contraction of the human pelvic floor muscles into an induced electrical signal, the induced electrical signal being transmitted to the control component to characterize the contractile mechanical state of the pelvic floor muscles; the nano-triboelectric flexible sensing unit is also electrically connected to a micro-thermal resistor, and the induced electrical signal generated by it is used to provide working power to the micro-thermal resistor to drive the corresponding shape memory driving unit to produce a preset deformation.

[0048] Since the deformation of the shape memory driving unit relies on thermal excitation (such as electrothermal or photothermal), local high temperatures are generated during operation. In this embodiment of the invention, the flexible sensing unit and the shape memory driving unit are arranged alternately. This effectively avoids problems such as signal drift and performance failure caused by the sensing unit being in a high-temperature cycling environment for a long time, and greatly improves the working stability and service life of the sensing unit. At the same time, considering that the device will generate multiple mechanical reciprocating deformations during pelvic floor muscle rehabilitation training, in order to make full use of this deformation characteristic, the flexible sensing unit is designed as a nano-triboelectric structure. This structure can not only convert the mechanical energy generated during the contraction and relaxation of the pelvic floor muscles into electrical energy, but also output a bio-pressure signal that characterizes the contraction state of the pelvic floor muscles, measure the pressure change generated on the sensing unit when the pelvic floor muscles actively contract in real time, and determine whether the user has correctly called the target muscle group by comparing the pressure data with a preset threshold range, and quantitatively evaluate the accuracy of the contraction action; but also can further convert the converted electrical energy into heat energy to provide a heat source for the micro-thermal resistor near the shape memory driving unit, realizing the thermal deformation driving of the shape memory driving unit.

[0049] According to some preferred embodiments, the first shape memory driving unit and the second shape memory driving unit are prepared using a highly cycle-stable shape memory polymer material; wherein, the shape memory polymer material is a cross-linked polymer containing dynamic reversible covalent bonds, and its molecular chain contains thiourethane bonds, imine bonds and diselenyl bonds simultaneously.

[0050] Shape memory polymers (SMPs) are a class of smart materials that combine programmable shape memory effect, excellent superelasticity, and good biocompatibility. In recent years, they have been widely used in the field of soft actuators. These materials can accurately recover a preset shape through external stimuli such as heat and light, and also have controllable recovery stress and excellent deformation ability, making them highly compatible with the application scenarios of pelvic floor muscle rehabilitation. However, the long-term application of SMPs in the field of medical rehabilitation still faces bottlenecks. The core problem lies in the insufficient long-term cycling stability and fatigue resistance of the material. Traditional SMPs are prone to problems such as molecular chain fatigue, internal stress accumulation, microcrack propagation, and significant decay of shape recovery performance during repeated thermo-mechanical coupling deformation cycles, making it difficult to meet the long-term reciprocating drive requirements of wearable rehabilitation devices.

[0051] To address the aforementioned technical problems, this invention employs a single-matrix dynamic covalent adaptive network structure to modify and optimize SMP materials. By introducing dynamically reversible thiourethane bonds, imine bonds, and diselenylene bonds into the polymer backbone as adaptive crosslinking points, these dynamic covalent bonds can dissipate internal stress through in-situ fracture-recombination during the repeated deformation and shape recovery cycles of the material. This achieves adaptive relaxation of molecular chain segments, effectively avoiding stress concentration and irreversible structural damage, suppressing fatigue failure at the molecular level, and significantly improving the cyclic service stability and fatigue resistance of SMP.

[0052] According to some preferred embodiments, the highly cycle-stable shape memory polymer material is prepared by the following method: (1) The first shape memory polymer is mixed with functional acrylate monomers and catalyst to obtain a functionalized first shape memory polymer; (2) Functionalized first shape memory polymer, aliphatic diamine and aromatic dialdehyde are added to solvent and mixed, and after condensation reaction, modified prepolymer is obtained; (3) The modified prepolymer is mixed with diselenic acid and diol and subjected to esterification reaction to obtain a ternary dynamic bond prepolymer. (4) The ternary dynamic bond prepolymer is mixed with the second shape memory polymer, photoinitiator, nucleating agent and biocompatibility and reacted, and then crosslinked, cured and annealed in sequence to obtain the high cycle stability shape memory polymer material.

[0053] According to some preferred embodiments, in step (1), the first shape memory polymer is a thiol-modified polycaprolactone with a number-average molecular weight Mn of 4000~8000 g / mol, and each molecular chain contains an average of 2 thiol groups; the functional acrylate monomer is isocyanate methacrylate, and the catalyst is dibutyltin dilaurate; the molar ratio of the first shape memory polymer to the functional acrylate monomer is 1:(1.05~1.1) (for example, it can be 1:1.05, 1:1.8 or 1:1.1), and the amount of catalyst added is 0.1~0.5 wt% of the total amount of the first shape memory polymer and the functional acrylate monomer (for example, it can be 0.1 wt%, 0.2 wt%, 0.3 wt%, 0.4 wt% or 0.5 wt%).

[0054] In this embodiment of the invention, the first shape memory polymer uses mercapto-modified polycaprolactone as the base material (which can be obtained commercially). Under the action of a catalyst, the mercapto-modified polycaprolactone and functional acrylate monomers are thoroughly mixed at a preset molar ratio and placed in an anhydrous atmosphere. The mixture is then reacted at a temperature of 50-70°C for 7-9 hours to prepare functionalized polycaprolactone with side-linked thiourethane bonds. This allows for dynamic bond exchange reactions to occur in the temperature range of 60-80°C (i.e., the shape memory glass transition temperature). During the active process of shape recovery of the material, the internal stress generated by large deformation can be effectively dissipated. At the same time, the preset shape memory effect is released by reconstructing the polymer network structure, providing the core shape recovery driving force for the material and providing excellent cyclic service stability for the polymer network.

[0055] According to some preferred embodiments, in step (2), the aliphatic diamine is hexamethylenediamine and the aromatic dialdehyde is terephthalaldehyde; preferably, the molar ratio of the first shape memory polymer to the aliphatic diamine is (3.2~3.5):1 (for example, it can be 3.2:1, 3.3:1, 3.4:1 or 3.5:1), and the molar ratio of the aliphatic diamine to the aromatic dialdehyde is 1:(2.1~2.2) (for example, it can be 1:2.1, 1:2.15 or 1:2.2).

[0056] In this embodiment of the invention, the prepared functionalized first shape memory polymer, aliphatic diamine, and aromatic dialdehyde are further added to anhydrous ethanol solvent and thoroughly mixed. The mixture is reacted at room temperature (25-30°C) for 10-14 hours. An imine bond dynamic structure is constructed through Schiff base condensation reaction between the aliphatic diamine and the aromatic dialdehyde, resulting in a modified prepolymer. This enables the quantitative introduction of a fast stress-dissipating component. The introduced imine bonds can undergo rapid and reversible bond exchange reactions in a temperature environment of 32-35°C on the human body surface and under simulated slightly acidic microenvironment conditions. This allows for the immediate dissipation of minute local stresses generated during the wearing process and the initial stage of deformation, preventing the initiation of microcracks within the material from the source and further improving the structural stability and fatigue resistance of the material.

[0057] It should be noted that the molar ratios of the first shape memory polymer to the aliphatic diamine, diselenide, and aliphatic diamine are all based on the molar amount of the polycaprolactone chain.

[0058] According to some preferred embodiments, in step (3), the diselenoic acid is 3,3'-diselenodipropionic acid, the diol is 1,4-butanediol; the molar ratio of the first shape memory polymer to the diselenoic acid is (1.4~1.6):1 (for example, it can be 1.4:1, 1.5:1 or 1.6:1), and the molar ratio of the diselenoic acid to the diol is 1:(0.9~0.98) (for example, it can be 1:0.9, 1:0.95 or 1:0.98).

[0059] In this embodiment of the invention, the imine-modified prepolymer prepared above is first pre-reacted with diselenic acid and diol at a low temperature of 75-80℃ for 2 hours, and then heated to 90-95℃ for isothermal esterification reaction, with a total reaction time of 10-12 hours. This esterification reaction further introduces diselenic bond dynamic crosslinking sites into the polymer dynamic network. The diselenic bond is a redox / photo-triggered dynamic reversible covalent bond, which can undergo reversible breakage and recombination under near-infrared light irradiation of a specific wavelength or in the physiological redox microenvironment of the human body, thereby realizing the self-healing performance of the material. After the material has undergone thousands of cycles of deformation, only non-invasive near-infrared light irradiation is needed to trigger the dynamic exchange of diselenic bonds and the rebalancing of the network topology, which can efficiently repair the deep and invisible cumulative structural damage of the material, and further improve the fatigue resistance and long-term service stability of the ternary dynamic covalent network.

[0060] According to some preferred embodiments, in step (4), the second shape memory polymer is polylactic acid with a number-average molecular weight Mn of 50,000-80,000 g / mol; the photoinitiator is 2-hydroxy-2-methyl-1-phenyl-1-propanone; the nucleating agent is nano-silica; and the biocompatibility agent is polyethylene glycol diamine; the mass ratio of the first shape memory polymer to the second shape memory polymer is (5~7):(3~5) (for example, it can be 5:5, 6:4, or 7:3); the amount of photoinitiator added is ternary dynamic by mass percentage. The amount of the ternary dynamic bond prepolymer and the second shape memory polymer is 0.3 to 0.5 wt% (e.g., 0.3 wt%, 0.4 wt%, or 0.5 wt%), the amount of the nucleating agent is 1 to 1.5 wt% (e.g., 1 wt%, 1.2 wt%, or 1.5 wt%), and the amount of the biocompatibility agent is 0.2 to 0.3 wt% (e.g., 0.2 wt%, 0.25 wt%, or 0.3 wt%).

[0061] In this embodiment of the invention, the ternary dynamic bond prepolymer, which has been constructed stepwise with thiourethane bonds, imine bonds, and diselenylene bonds, is blended with a second shape memory polymer. Simultaneously, a photoinitiator, a nucleating agent, and a biocompatibility agent are added. The mixture is melt-stirred at 120°C to 150°C under a nitrogen protective atmosphere for 1 to 2 hours to obtain a homogeneous and stable shape memory matrix prepolymer. An appropriate amount of nucleating agent enhances the crystallinity and shape memory fixation rate of the polymer matrix without affecting the breaking-recombination efficiency of the dynamic bonds. The addition of the biocompatibility agent ensures that the material has good skin affinity and biocompatibility.

[0062] In some specific embodiments, after the shape memory matrix prepolymer is prepared, an air-floating worktable with an air pressure of 0.3~0.5MPa is used to provide non-contact support for the prepolymer, which can effectively avoid the surface contamination, uneven cross-linking, and local stress concentration problems caused by traditional mold contact molding. At the same time, with the help of three sets of infrared laser positioning instruments with a positioning accuracy of ±0.02mm, the thickness of the prepolymer is monitored in real time and the air-floating pressure is dynamically adjusted, so that the thickness uniformity of the prepolymer can be stably controlled within ±0.05mm. In this embodiment of the invention, the thickness of the shape memory driving unit is preferably 1.5~3mm. After the prepolymer is spread and shaped, a polytetrafluoroethylene breathable membrane with a pore size of 0.1~0.3μm is laid on its surface as a protective layer. This protective layer can not only timely discharge trace amounts of volatiles in the system during the curing process, improving the density and breathability of the material, but also form a physical protection for the cured surface of the prepolymer, avoiding local overheating and excessive cross-linking problems during the curing process.

[0063] In some specific embodiments, the present invention employs a dynamic curing method that synergistically couples UV irradiation intensity and temperature field, thereby forming a shape memory polymer material with gradient crosslinking density. The specific curing process is divided into the following three stages: The first stage is the surface pre-curing stage, with a UV irradiation intensity of 15~20mW / cm². 2 The temperature is 38~40℃ and the time is 40~50s. When the irradiation intensity and temperature are within the above range, a low cross-linked skin-friendly layer can be formed on the surface of the material. If the irradiation intensity and temperature are too low, the surface cross-linking density will be insufficient, the material will become soft and sticky, and the initial stress during the wearing process will not be effectively dissipated. If the irradiation intensity and temperature are too high, the surface will be over-cured, the hardness will increase, and the skin-friendly properties of the material will be damaged.

[0064] The second stage is the transition layer co-curing stage, where the UV irradiation intensity is increased from 15~20 mW / cm². 2 Linear boost to 75~80mW / cm 2 The temperature is simultaneously increased from 38~40℃ to 41~43℃ for 60~70s. Through linearly gradual light intensity and temperature field, the imine bonds and thiourethane bonds in the polymer network can be activated sequentially and the crosslinking gradient can be matched, ultimately forming a continuous gradient transition layer. If the irradiation intensity and temperature increase are too slow, the crosslinking density gradient transition will be indistinct and the interlayer bonding force will be weak. If the increase is too fast, it will cause local crosslinking mutations, internal stress concentration, and damage to the continuity of the material structure.

[0065] The third stage is the inner layer deep curing stage, using 90~100mW / cm² curing. 2 The UV irradiation intensity is maintained at an ambient temperature of 44~45℃ for 80~90s. This can fully activate the thiourethane bonds and diselenyl bonds, realize the construction of a highly cross-linked network in the inner layer of the polymer, and finally form a highly cross-linked support layer, providing sufficient shape recovery driving force and structural support stiffness for the material. If the irradiation intensity and temperature are too low, it will lead to insufficient inner layer support stiffness and weak shape recovery force, and the self-healing performance of the material cannot be fully reflected. If it is too high, it will lead to excessive cross-linking density, increased brittleness of the material, and easy breakage during cyclic deformation.

[0066] In some preferred embodiments of the present invention, after the above-mentioned gradient crosslinking structure is cured and molded, a segmented vacuum annealing process is used to post-process the shape memory polymer material. This segmented annealing process can avoid dynamic bond thermal decomposition caused by single high-temperature annealing. The specific process settings are as follows: First, a low-temperature annealing process is performed, with the annealing temperature controlled within the range of 55~65℃, and the material is held in a vacuum environment for 1.5~2.5 hours. This temperature range can precisely activate the dynamic recombination of imine bonds, effectively dissipating the residual internal stress in the surface and transition layers of the material. If the annealing temperature is too low, the dynamic exchange efficiency of imine bonds will decrease significantly, and the internal stress will not be fully released, which is likely to cause deformation recovery deviation or microcrack initiation during subsequent cycles. If the annealing temperature is too high, the dynamic exchange of thiourethane bonds will be activated prematurely, destroying the stability of the constructed gradient cross-linked structure. After low-temperature annealing, the temperature is raised to 75-85℃ for high-temperature annealing, and then held in a vacuum environment at this temperature for 1.5-2.5 hours. This temperature range can simultaneously activate the synergistic dynamic reconstruction of thiourethane bonds and diselenide bonds, completing the release of residual internal stress and repair of microstructural defects in the inner highly cross-linked support network. If the annealing temperature is too low, the dynamic response of thiourethane bonds and diselenide bonds will be insufficient, and the residual internal stress in the inner layer cannot be completely released, which will affect the long-term cyclic service stability of the material. If the annealing temperature is too high, it will approach the thermal decomposition critical temperature of diselenide bonds, and at the same time, it will easily cause softening creep of the polycaprolactone matrix, destroying the material's preset structure and properties. After annealing, the shape memory polymer material is first slowly cooled to below 40°C in the furnace, and then removed and placed in a room temperature environment to cool naturally, avoiding sudden cooling that could cause new thermal stress accumulation. Subsequently, the polytetrafluoroethylene breathable membrane on the surface is removed, and its surface (i.e., the side with low cross-linking density) is subjected to plasma treatment. The plasma treatment power is controlled at 50W, and the treatment time is 30s~40s. This treatment can introduce hydroxyl groups into the surface of the material, further improving the material's skin-friendliness.

[0067] In summary, in this embodiment of the invention, by further performing gradient cross-linking and curing on the shape memory polymer material, a gradient distribution of cross-linking density is achieved in the thickness direction. The surface layer in contact with human skin has a low cross-linking density structure, ensuring that the material is soft, skin-friendly, low-irritant, and highly biocompatible. The internal region near the stress-supporting skeleton has a high cross-linking density structure, providing the material with stable shape memory recovery force and structural rigidity. Through the adaptive stress dissipation characteristics of dynamic covalent bonds and the synergistic effect of the gradient cross-linking structure, the material maintains excellent shape recovery rate after more than 1000 consecutive shape memory cycles, with no significant permanent deformation or mechanical attenuation. This fully meets the requirements of long-term wearable pelvic floor muscle training devices for high cycle stability, high safety, and long service life.

[0068] To more clearly illustrate the technical solution and advantages of the present invention, the following describes in detail a pelvic floor muscle adaptive guided repair wearable device through several embodiments.

[0069] Example 1: Preparation of highly cycle-stable shape memory polymer materials: (1) The first shape memory polymer (thiol-modified polycaprolactone, PCL-SH) with a molar ratio of 1:1.1 was mixed with a functional acrylate monomer (isocyanate methacrylate), and 0.2 wt% catalyst (dibutyltin dilaurate) was added and mixed. The mixture was reacted for 8 h in an anhydrous atmosphere at 60 °C to obtain the functionalized first shape memory polymer. (2) The functionalized first shape memory polymer, aliphatic diamine (hexamethylenediamine) and aromatic dialdehyde (terephthalaldehyde) were added to 13 mL of solvent (anhydrous ethanol) and mixed at room temperature (25 °C) for 12 h. After condensation reaction, the modified prepolymer was obtained; wherein the molar ratio of the first shape memory polymer to the aliphatic diamine was 3.3:1 and the molar ratio of the aliphatic diamine to the aromatic dialdehyde was 1:2.1. (3) The modified prepolymer was mixed with diselenic acid (3,3'-diselenic acid) and diol (1,4-butanediol) and pre-reacted at 77°C for 2 hours. Then, the temperature was raised to 93°C for constant-temperature esterification reaction. The total reaction time was 12 hours to obtain a ternary dynamic bond prepolymer. The molar ratio of the first shape memory polymer to diselenic acid was 1.5:1, and the molar ratio of diselenic acid to diol was 1:0.9. (4) Under a nitrogen atmosphere, the ternary dynamic bond prepolymer was melt-stirred and reacted with the second shape memory polymer (polylactic acid), photoinitiator (2-hydroxy-2-methyl-1-phenyl-1-propanone), nucleating agent (nano-silica), and biocompatibility agent (polyethylene glycol diamine) at 130°C for 2 hours to obtain a shape memory matrix prepolymer; wherein, the mass ratio of the first shape memory polymer to the second shape memory polymer was 7:3; the amount of photoinitiator added was 0.4wt%, the amount of nucleating agent added was 1.2wt%, and the amount of biocompatibility added was 0.2wt% by mass percentage; the prepolymer was supported by an air flotation worktable (air pressure 0.4MPa), and a polytetrafluoroethylene breathable membrane (pore size 0.1μm) was set on the surface for dynamic crosslinking and curing. The first stage used 15mW / cm 2 The UV irradiation intensity was set at 38°C for 40 seconds; the second stage reduced the UV irradiation intensity from 15 mW / cm². 2 Linearly increase to 75 mW / cm 2 The temperature increased linearly from 38℃ to 42℃, lasting a total of 65 seconds; the third stage used 95mW / cm². 2 The cross-linking and curing process was completed by applying UV irradiation intensity at 44℃ for 85 seconds. Then, the polymer was annealed by first treating it in a vacuum environment at 60℃ for 2.0 hours, followed by annealing it in a vacuum environment at 80℃ for 2 hours. Finally, the surface of the polymer was treated with plasma (power 50W) for 30 seconds to obtain a highly cycle-stable shape memory polymer material.

[0070] Comparative Example 1: A first shape memory polymer (polycaprolactone), a second shape memory polymer (polylactic acid), a photoinitiator (2-hydroxy-2-methyl-1-phenyl-1-propanone), a nucleating agent (nano-silica), and a biocompatibility agent (polyethylene glycol diamine) were melt-stirred at 130°C for 2 hours to obtain a shape memory matrix prepolymer. The mass ratio of the first shape memory polymer to the second shape memory polymer was 7:3. The photoinitiator was added at 0.4 wt%, the nucleating agent at 1.2 wt%, and the biocompatibility agent at 0.2 wt% by mass percentage. The prepolymer was then injected into a rigid metal mold and pressed into shape at 55°C and 90 mW / cm². 2 The polymer was cured by UV irradiation for 130 seconds. After curing, it was kept at 95°C for 0.8 hours in an atmospheric environment, and then naturally cooled to room temperature. Finally, the surface of the polymer was treated with plasma (power 50W) for 30 seconds. After demolding, a high cycle-stable shape memory polymer material was obtained.

[0071] Comparative Example 2: Comparative Example 2 is basically the same as Example 1, except that in step (4), 95mW / cm² is directly used. 2 At a UV irradiation intensity of 44℃ and a temperature of 44℃, the prepolymer was continuously irradiated for 3 minutes to complete cross-linking and curing.

[0072] Comparative Example 3: Comparative Example 3 is basically the same as Example 1, except that in step (4), no annealing treatment was performed. After crosslinking, the surface of the polymer was treated with plasma (power of 50W) for 30s to obtain a high cycle stability shape memory polymer material.

[0073] The high cycle-stable shape memory polymer materials obtained in the examples and comparative examples were subjected to performance tests, and the test results are shown in Table 1: Shape memory fixation rate test: Five trapezoidal strip samples (uniform dimensions: thickness 2 mm, height 70 mm, top width 7 mm, bottom width 12 mm) were prepared for each group of materials in the examples and comparative examples. Before the test, the samples were kept in an initial straight state, and the initial radius of curvature was recorded as r0. In the straight state, r0 tends to infinity. The samples were heated in an environment of 60°C (above the glass transition temperature) for 5 min until completely softened, and then bent to the preset target radius of curvature r using a standard arc mold. p After holding for 1 minute, rapidly cool to 25°C, remove the mold and let stand for 10 minutes. Measure the actual radius of curvature r of the sample after fixing using the above-described radius of curvature measurement method. f According to the formula, the shape fixation rate R f (%) = (1 / r) f−1 / r0) / (1 / r p The shape fixation rate was calculated as (−1 / r0)×100%; each sample was tested three times, and the average value of the sample was calculated; finally, the lowest to highest value (i.e., the range) of the five samples was taken as the shape fixation rate test result of the material group. Among them, the radius of curvature was measured by image acquisition and contour fitting method. The strip sample to be tested was placed horizontally on the test platform, and the contour image of the sample was acquired vertically downward using a high-definition camera. The image pixels and actual size were calibrated with a standard ruler, and the least squares method was used to fit the arc edge contour of the sample using image analysis software. The radius of curvature r of the sample was directly obtained from the fitted circle.

[0074] Shape memory recovery rate test: The fixed arc-shaped sample is placed again in a 60℃ environment for 5 minutes until the sample completely stops deforming. The radius of curvature r of the sample after recovery is measured using the above-mentioned radius of curvature measurement method. r According to the formula, the shape recovery rate R r (%) = (1 / r) r -1 / r f ) / (1 / r0−1 / r f The shape recovery rate is calculated by multiplying the result by 100%. Each sample is tested three times, and the average value is taken. The minimum to maximum value range of the five samples is then used as the shape recovery rate test result for the material group.

[0075] 1000-cycle shape memory recovery rate fluctuation test: The same arc-shaped sample was subjected to 1000 consecutive thermo-mechanical cycles of heating deformation, cooling fixation, and heating recovery. The shape recovery rate R of the first cycle was recorded. r1 With the shape recovery rate R of the 1000th time r1000 According to the formula, the volatility of the recovery rate (%) = |R r1 -R r1000 | / R r1 The recovery rate fluctuation rate is calculated by multiplying by 100%. Three samples from each embodiment and comparative example are independently subjected to 1000 cycles of testing. The fluctuation rate of each sample is calculated according to the above formula. Finally, the fluctuation rate range (minimum value to maximum value) of the three samples is taken as the result of the 1000-cycle shape memory recovery rate fluctuation rate test of the material group.

[0076] Table 1 Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, and not to limit them; although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some of the technical features; and these modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims

1. A pelvic floor muscle self-adapting guided repair wearable device, characterized in that, include: The wearable main body has a wearable area corresponding to the human pelvic floor muscle area, and the drive component is fixed to the wearable area; The driving component includes a first driving unit group, a second driving unit group, a plurality of flexible sensing units, and a flexible packaging support component; wherein, the first driving unit group includes at least one first shape memory driving unit, and the second driving unit group includes at least one second shape memory driving unit; The first driving unit group, the second driving unit group, and the flexible sensing unit are arranged circumferentially with the central axis of the driving component as the reference, and extend radially along the driving component, together forming a closed-loop annular structure with a central through hole. The flexible encapsulation support components are respectively attached to the opposite two sides of the annular structure to encapsulate and fix each shape memory driving unit and flexible sensing unit. Both the first shape memory driving unit and the second shape memory driving unit have shape memory performance, and each of them independently responds to external stimuli to generate preset deformations in order to apply a driving force to assist contraction or an anti-contraction resistance to the pelvic floor muscle area. The flexible sensing unit is used to collect electrical signals during the contraction of the pelvic floor muscles and transmit the electrical signals to the control component. The control component is used to identify the activity state of the pelvic floor muscles based on the received electrical signals, and to adjust the deformation of the first shape memory drive unit or the second shape memory drive unit accordingly based on the identification results.

2. The apparatus of claim 1, wherein, The first shape memory driving unit, the flexible sensing unit, and the second shape memory driving unit are arranged alternately in a circumferential manner with the central axis of the driving component as the reference, and each of the flexible sensing units is located between the adjacent first shape memory driving unit and the second shape memory driving unit.

3. The apparatus of claim 1, wherein, Both the first shape memory driving unit and the second shape memory driving unit are equipped with miniature electrothermal resistors. Each miniature electrothermal resistor is grouped and arranged through wiring components, and forms an auxiliary mode excitation circuit and an anti-resistance mode excitation circuit that are isolated from each other with the first shape memory driving unit and the second shape memory driving unit, respectively. Both the auxiliary mode excitation circuit and the impedance mode excitation circuit are equipped with electrically controlled switching devices, and the control terminals of the electrically controlled switching devices are electrically connected to the control component; and / or The control component is pre-programmed with a dual-mode control program, which is used to regulate the on / off state and working mode switching of the two excitation circuits.

4. The apparatus according to claim 3, characterized in that, The dual-mode control program includes an auxiliary training mode; wherein, in the auxiliary training mode, the control component connects the auxiliary mode excitation circuit through an electronically controlled switch, driving the first shape memory driving unit to generate a preset deformation, causing the annular structure to form a contraction and convergence posture, so as to apply a contraction assistance force to the pelvic floor muscles; and / or The dual-mode control program includes a resistance training mode; in the resistance training mode, the control component disconnects the auxiliary mode excitation circuit and connects the resistance mode excitation circuit through an electronically controlled switch device, driving the second shape memory drive unit to generate a preset deformation, thereby causing the ring structure to form a support tension posture to apply resistance to the pelvic floor muscles.

5. The apparatus according to claim 4, characterized in that, The flexible encapsulation support component also extends to cover the central through-hole area formed by the annular structure. The driving component also includes multiple stretchable flexible electrode units arranged in an array in the corresponding central through-hole area of ​​the flexible encapsulation support component. Each electrode unit is electrically connected to the control component and is used to output programmable electrical pulse signals based on the pelvic floor muscle mechanical signals collected by the flexible sensing unit, thereby inducing the human pelvic floor muscles to produce passive contraction movements. Preferably, the control component is further preset with an electrical stimulation-assisted collaborative training mode. In this collaborative training mode, the control component controls the stretchable flexible electrode unit and the auxiliary mode of the first shape memory driving unit to operate synchronously, so that the pelvic floor muscle contraction movement induced by the electrical pulse signal and the contraction assistance force provided by the first shape memory driving unit are coordinated and matched in timing and direction of movement.

6. The apparatus according to claim 1 or 3, characterized in that, The flexible sensing unit is a nano-triboelectric flexible sensing unit. The nano-triboelectric flexible sensing unit is electrically connected to the control component and is used to convert the mechanical energy generated by the contraction of the human pelvic floor muscles into an induced electrical signal. The induced electrical signal is transmitted to the control component to characterize the contractile mechanical state of the pelvic floor muscles. Preferably, the nano-triboelectric flexible sensing unit is also electrically connected to a micro-thermal resistor, and the induced electrical signal generated by the unit is used to provide working power to the micro-thermal resistor to drive the corresponding shape memory driving unit to produce a preset deformation.

7. The apparatus according to claim 1, characterized in that, The first shape memory driving unit and the second shape memory driving unit are prepared using a highly cycle-stable shape memory polymer material; wherein, the shape memory polymer material is a cross-linked polymer containing dynamic reversible covalent bonds, and its molecular chain contains thiourethane bonds, imine bonds and diselenyl bonds simultaneously.

8. The apparatus according to claim 7, characterized in that, The highly cycle-stable shape memory polymer material was prepared using the following method: (1) The first shape memory polymer is mixed with functional acrylate monomers and catalyst to obtain a functionalized first shape memory polymer; (2) Functionalized first shape memory polymer, aliphatic diamine and aromatic dialdehyde are added to solvent and mixed, and after condensation reaction, modified prepolymer is obtained; (3) The modified prepolymer is mixed with diselenic acid and diol and subjected to esterification reaction to obtain a ternary dynamic bond prepolymer. (4) The ternary dynamic bond prepolymer is mixed with the second shape memory polymer, photoinitiator, nucleating agent and biocompatibility and reacted, and then crosslinked, cured and annealed in sequence to obtain the high cycle stability shape memory polymer material.

9. The apparatus according to claim 8, characterized in that, In step (1), the first shape memory polymer is thiol-modified polycaprolactone; the functional acrylate monomer is ethyl isocyanate methacrylate; and the catalyst is dibutyltin dilaurate. Preferably, the molar ratio of the first shape memory polymer to the functional acrylate monomer is 1:(1.05~1.1), and the amount of catalyst added is 0.1~0.5wt%; and / or In step (2), the aliphatic diamine is hexamethylenediamine, and the aromatic dialdehyde is terephthalaldehyde; preferably, the molar ratio of the first shape memory polymer to the aliphatic diamine is (3.2~3.5):1, and the molar ratio of the aliphatic diamine to the aromatic dialdehyde is 1:(2.1~2.2).

10. The apparatus according to claim 8, characterized in that, In step (3), the diselenoic acid is 3,3'-diselenodipropionic acid, and the diol is 1,4-butanediol; preferably, the molar ratio of the first shape memory polymer to the diselenoic acid is (1.4~1.6):1, and the molar ratio of the diselenoic acid to the diol is 1:(0.9~0.98); and / or In step (4), the second shape memory polymer is polylactic acid, the photoinitiator is 2-hydroxy-2-methyl-1-phenyl-1-propanone, the nucleating agent is nano-silica, and the biocompatibility agent is polyethylene glycol diamine; Preferably, the mass ratio of the first shape memory polymer to the second shape memory polymer is (5~7):(3~5); More preferably, the amount of photoinitiator added is 0.3-0.5 wt%, the amount of nucleating agent added is 1-1.5 wt%, and the amount of biocompatibility added is 0.2-0.3 wt%, calculated by mass percentage.

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