A biomimetic gastrointestinal peristalsis stimulating abdominal belt

Abstract

This invention belongs to the field of medical device technology and discloses a biomimetic gastrointestinal motility stimulation abdominal binder. It includes a binder body with an inner air bladder area corresponding to the colon's surface projection zone, a control unit with a built-in air pump and heat conduction control module, and a transdermal patch containing a temperature-sensitive controlled-release membrane for traditional Chinese medicine. The control unit can synchronously regulate the inflation and deflation of the air bladder according to a preset sequence and the temperature of the heating layer, achieving a synergistic effect of mechanical stimulation and controlled drug release. The control unit can execute a phased synergistic treatment program. This invention achieves biomimetic stimulation of gastrointestinal motility and transdermal penetration enhancement of traditional Chinese medicine in a non-invasive manner, is easy to operate, and can significantly improve the treatment effect of gastrointestinal motility disorders.

Description

Technical Field

[0001] This invention belongs to the field of medical device technology and discloses a biomimetic gastrointestinal peristalsis stimulation abdominal binder. Background Technology

[0002] Gastrointestinal motility disorders are common digestive system diseases in clinical practice. They have a very high incidence rate in patients with stroke hemiplegia, spinal cord injury, postoperative bed rest, and elderly and frail patients. They can easily cause problems such as abdominal distension, constipation, and enteral nutrition intolerance, which not only seriously reduce the quality of life of patients, but may also induce secondary problems such as intestinal obstruction and intestinal flora imbalance. They are a key and difficult point in clinical rehabilitation and nursing work.

[0003] Current clinical interventions for this condition all have limitations to varying degrees. Drug treatment mainly involves prokinetic drugs and laxatives, but long-term use can easily lead to adverse reactions such as drug dependence, electrolyte imbalance, and intestinal mucosal damage. Furthermore, drug administration is limited for patients who are fasting or have difficulty swallowing after surgery. In addition, drugs undergo first-pass metabolism via the liver and kidneys, resulting in unstable bioavailability.

[0004] In terms of non-drug intervention, manual abdominal massage is labor-intensive, and its efficacy is highly dependent on the operator's experience, making it difficult to achieve standardized and routine treatment. Traditional abdominal physiotherapy equipment mostly uses synchronous full-abdomen inflation or simple vibration modes, which do not conform to the anatomical direction of the colon and the physiological peristalsis pattern. They cannot simulate the physiological wave-like propulsion stimulation, have insufficient targeting and biomimicry, and mostly have only single massage or heat therapy functions, resulting in limited efficacy.

[0005] While external therapies such as acupoint application in Traditional Chinese Medicine (TCM) avoid the drawbacks of oral administration, traditional patches suffer from low transdermal absorption efficiency, uncontrollable drug release, and a lack of precise matching between colonic segmental targeting and acupoints. TCM fumigation devices, on the other hand, are cumbersome to operate, prone to contamination, pose a high risk of hospital-acquired infections, and have limited application scenarios. Existing drug-device combination products also fail to achieve a synergistic effect between drug release and physical stimulation, and cannot simultaneously meet the multiple clinical needs for efficacy, safety, and convenience. Summary of the Invention

[0006] The purpose of this invention is to provide a biomimetic gastrointestinal peristalsis stimulation abdominal binder that achieves a synergistic effect of "timely drug release, mechanical penetration enhancement, and diffusion-enhanced drug efficacy" by precisely controlling the timing of drug release and mechanical massage.

[0007] A biomimetic gastrointestinal motility stimulation abdominal binder includes: The main body of the abdominal binder has an air sac area on its inner side, which corresponds to the surface projection area of ​​the ascending colon, transverse colon and descending colon in the human abdomen. The control unit has a built-in air pump, power supply, and heat conduction control module; A heating layer, sewn inside the abdominal binder and covering the entire airbag area, is electrically connected to the power supply and heat conduction control module of the control host via wires, and is used to contact the transdermal Chinese medicine patch. The transdermal Chinese medicine patch contains a temperature-sensitive controlled-release membrane, which has a non-linear response characteristic of drug permeability changing with temperature within a set temperature range. The control host is configured to: control the inflation and deflation of each airbag area according to a preset time sequence and frequency during the execution of the treatment program, and synchronously and dynamically adjust the temperature of the heating layer, so that the drug release rate of the transdermal Chinese medicine patch and the mechanical stimulation of the airbag area form a synergistic effect.

[0008] The heating layer is a multi-layered composite structure that conforms to the entire abdomen (including the right Tianshu and right Daheng acupoints, Zhongwan acupoint, left Tianshu and left Daheng acupoints). From the inside out, it comprises a heat-insulating and reflective layer, a heating layer, a heat-conducting and temperature-equalizing layer, and a skin-friendly layer. The heat-insulating and reflective layer can be made of aluminum foil composite film, which reflects heat, reduces heat loss to the outer side of the abdominal patch, improves heat utilization efficiency, and protects the control unit and airbag assembly from heat radiation. The heating layer uses a flexible carbon fiber heating film, which receives electrical energy through wires and generates Joule heat evenly. It is thin, flexible, and has high electrothermal conversion efficiency, enabling rapid response to temperature adjustment commands from the control unit. The heat-conducting and temperature-equalizing layer uses a graphene thermal conductive film with high in-plane thermal conductivity, which rapidly diffuses localized hot spots generated by the heating layer to the entire heating layer plane, eliminating temperature unevenness and ensuring uniform temperature distribution in the area in contact with the transdermal herbal patch. The skin-friendly layer is made of medical-grade silicone or high thermal conductivity cloth, which comes into direct contact with the backing layer of the transdermal patch of traditional Chinese medicine. While ensuring biocompatibility and comfort, it achieves efficient heat conduction. At the same time, its membrane surface is sewn and fixed to the main body of the abdominal binder.

[0009] The transdermal herbal patch is a consumable independent of the abdominal binder. After being applied to the corresponding area of ​​the abdomen, the abdominal binder is worn, ensuring precise contact between the heating layer and the back of the patch. During the treatment process, the control unit dynamically adjusts the temperature of the heating layer and controls the airbag area to inflate and deflate according to a preset sequence, thus achieving thermal penetration of the patch and mechanical massage of the abdominal tissue in a non-invasive manner. This structure allows the operator to complete only the simple steps of "applying, wearing, removing, and wiping," eliminating the need to handle medication or clean equipment, significantly simplifying the operation and reducing the workload.

[0010] Furthermore, the traditional Chinese medicine transdermal patch includes a right abdominal patch, an upper abdominal patch, and a left abdominal patch. The right abdominal patch covers the right Tianshu acupoint and the right Daheng acupoint, the upper abdominal patch covers the Zhongwan acupoint, and the left abdominal patch covers the left Tianshu acupoint and the left Daheng acupoint to achieve dual positioning of Western medicine targeting and traditional Chinese medicine acupoint stimulation. Among them, the Zhongwan acupoint is the collecting acupoint of the stomach and the meeting point of the fu-organs, and it is mainly used to treat stomachache, abdominal distension, and loss of appetite. The Tianshu acupoint is the collecting acupoint of the large intestine and is mainly used to treat abdominal pain, constipation, and diarrhea, and it is a key acupoint for regulating gastrointestinal function. The Daheng acupoint belongs to the Spleen Meridian of Foot Taiyin and is mainly used to treat abdominal pain, diarrhea, and constipation. Applying the patch to the above acupoints can, on the one hand, directly act on the acupoint area closely related to gastrointestinal function with the drug components, and on the other hand, stimulate the meridian qi and regulate qi and blood with the physical stimulation of airbag massage and heat therapy, so as to achieve comprehensive regulation of the functions of multiple zang-fu organs such as the stomach, intestines, and spleen in a single treatment process. Compared with ordinary abdominal application, the therapeutic effect on gastrointestinal motility disorder diseases is significantly improved. Among them, the traditional Chinese medicine components contained in the right abdominal patch have the core efficacy of promoting qi movement, including one or more of Fructus Aurantii Immaturus, Magnolia officinalis, and Aucklandia lappa. The traditional Chinese medicine components contained in the upper abdominal patch have the core efficacy of warming the middle-jiao and regulating the stomach, including one or more of Folium Artemisiae Argyi, Cinnamomum cassia, and Zingiber officinale. The traditional Chinese medicine components contained in the left abdominal patch have the core efficacy of moistening the intestines and relieving constipation, including one or more of Angelica sinensis, Trichosanthes kirilowii, and Cannabis sativa

[0011] Specifically, the thermosensitive controlled-release membrane is a composite membrane layer containing a thermosensitive polymer copolymer formed by the copolymerization of N-isopropylacrylamide and acrylamide, and the lower critical solution temperature of the copolymer is between 35.5°C and 36.5°C.

[0012] N-isopropylacrylamide is a typical thermosensitive polymer material, and its molecular chain has the characteristic of lower critical solution temperature in aqueous solution. When the environmental temperature is lower than its lower critical solution temperature, a large number of hydrogen bonds are formed between the poly-N-isopropylacrylamide (PNIPAM) molecular chain and water molecules, presenting a swollen and stretched open state; when the environmental temperature rises above the lower critical solution temperature, the intermolecular hydrogen bonds are broken, the polymer chain collapses and becomes hydrophobic, expelling the internal water, and the volume shrinks sharply. The lower critical solution temperature of pure PNIPAM is about 32°C, slightly lower than the human treatment temperature requirement, but through copolymer modification, such as introducing a hydrophilic monomer acrylamide for copolymerization, the lower critical solution temperature can be accurately regulated within the human treatment temperature range of 35.5°C to 36.5°C. In the traditional Chinese medicine transdermal patch of the present invention, it is a five-layer composite structure, which is successively a backing layer, a drug reservoir layer, a thermosensitive controlled-release membrane, a skin adhesive layer, and an anti-adhesive layer from the outside to the inside.

[0013] The backing layer, made of medical nonwoven fabric or polyurethane film, provides leak-proof, support, and moisture retention, offering mechanical strength to the patch. The drug reservoir layer uses a hydrogel or poultice matrix, composed of sodium polyacrylate, gelatin, sodium carboxymethyl cellulose, glycerin, and water. This layer is a highly hydrated three-dimensional network structure responsible for carrying the herbal extract and controlling the initial drug release. The thermosensitive controlled-release membrane is a composite membrane containing N-isopropylacrylamide copolymer. The skin adhesive layer uses medical acrylate pressure-sensitive adhesive for skin adhesion and may contain a small amount of fast-release drug for rapid onset of action. The anti-adhesive layer uses silicone release paper, which is removed before use. In this invention, although the backing layer 41 uses a material with generally low thermal conductivity, it is extremely thin and has minimal thermal resistance. During the stratum corneum opening phase, the heating layer heats up to 42°C~43°C, allowing heat to quickly penetrate the backing layer, easily exceeding the low critical dissolution temperature of the thermosensitive controlled-release membrane 43, thereby effectively triggering drug release.

[0014] The drug reservoir layer utilizes a hydrogel or patch matrix, containing sodium polyacrylate, gelatin, glycerin, and water to form a highly hydrated three-dimensional network structure, providing the necessary temperature-sensitive response medium for the N-isopropylacrylamide copolymer. In this hydrated environment, the copolymer exhibits typical low critical solution temperature characteristics. When the temperature is below the copolymer's phase transition temperature, the polymer chains form hydrogen bonds with water molecules, resulting in a swollen and expanded state, which blocks the pores of the porous support layer, closing or significantly restricting drug release pathways. When the temperature rises above the phase transition temperature, the hydrogen bonds are broken, the polymer chains collapse and become hydrophobic, and the volume shrinks rapidly, opening the pores of the porous support layer, unblocking the drug release pathways, and rapidly increasing the release rate. With this structural design, the drug release behavior of the patch is no longer a passive concentration diffusion but can respond to real-time temperature changes in the heating layer, achieving an on-demand drug delivery mode of low-temperature drug lock-in and high-temperature drug release. When this thermosensitive controlled-release patch is used in conjunction with a biomimetic peristaltic stimulation abdominal band, the control unit can dynamically adjust the temperature of the heating layer to precisely control the timing and rate of drug release at different stages of the multi-stage synergistic treatment curve. This allows the peak drug release and the mechanical massage wave peak to be superimposed in sequence. On the one hand, the dual permeation-promoting effect of heat and mechanical pressure significantly improves transdermal absorption efficiency. On the other hand, it avoids ineffective drug release during non-treatment periods, thereby improving bioavailability, prolonging the effective duration of action, and reducing drug waste.

[0015] Optionally, the control host is configured to perform multi-stage synergistic treatment, which includes a temperature regulation stage and a pressure stimulation stage. The temperature regulation and pressure stimulation work synergistically according to a preset timing sequence to promote transdermal drug absorption in stages. This configuration, by executing a multi-stage synergistic treatment curve through the control host, coordinates the temperature regulation of the heating layer and the pressure stimulation of the airbag area according to a preset precise timing sequence, thereby achieving a staged and programmed promotion of the transdermal drug absorption process. This timing coordination allows the permeation-enhancing needs at different stages, such as thermal expansion of skin channels, mechanical pressure-driven drug transport, and intra-tissue diffusion, to be specifically met, thereby significantly improving the transdermal rate and total absorption of the drug, enhancing the therapeutic effect, and optimizing the intelligence and controllability of the treatment process.

[0016] Furthermore, the multi-stage synergistic treatment curve includes: During the stratum corneum opening phase: control the heating layer to be heated to 42℃~43℃, keep the air sac area in a deflated state or vibrate slightly at low frequency, so that the drug can form a concentration gradient in the stratum corneum; Synergistic permeation promotion period: Control the temperature of the heating layer to drop and stabilize at 39℃~40℃, and at the same time start the airbag area to perform wave-like inflation and deflation in the order of ascending colon area, transverse colon area and descending colon area; Tissue diffusion phase: The heating layer is further cooled to 34℃~35℃, and the air sac area is switched to a high-frequency micro-amplitude vibration mode to promote the transdermal diffusion of the drug within the intestinal wall tissue.

[0017] By implementing a multi-stage synergistic treatment curve encompassing the stratum corneum opening phase, the synergistic penetration enhancement phase, and the tissue diffusion phase, the staged and programmed precise promotion of drug transdermal absorption is effectively achieved. Specifically, during the stratum corneum opening phase, the heating layer is heated to a high temperature of 42℃~43℃, exceeding the low critical dissolution temperature of the thermosensitive controlled-release membrane (preferably 36℃ in this invention). This causes the polymer chains of the thermosensitive controlled-release membrane to undergo phase transition and collapse, fully opening the drug release channels and allowing the drug to be rapidly released from the drug reservoir layer. Simultaneously, the thermal effect increases the lipid fluidity and intercellular spaces of the stratum corneum, reducing skin barrier resistance and enabling the released drug to quickly establish a concentration gradient in the stratum corneum, laying the foundation for subsequent penetration. During the synergistic penetration enhancement phase, the heating layer is cooled from the previous stage and stabilized at 39℃~40℃. In this stage, drug penetration is mainly driven by the mechanical pressure waves generated by the wave-like inflation and deflation of the air bladder area, with temperature serving only as an auxiliary heat therapy to maintain the skin's microcirculation expansion. Specifically, the control unit initiates wave-like inflation and deflation of the airbag area in the order of ascending colon, transverse colon, and descending colon, simulating physiological colonic peristalsis waves. The positive pressure generated by the airbag inflation on the abdominal tissue directionally pushes the drug, which has already penetrated the stratum corneum, towards the dermis and subcutaneous tissue. When the airbag deflates, the elastic rebound of the tissue creates a negative pressure suction effect, further enhancing interstitial fluid convection and drug transport. Simultaneously, the heating layer maintains a temperature of 39℃~40℃ for continuous heat application, keeping skin capillaries moderately dilated and reducing interstitial fluid viscosity, providing a favorable tissue microenvironment for the mechanical permeation-enhancing effect of the airbag massage. Since the target temperature of the heating layer is still higher than the low critical dissolution temperature of the temperature-sensitive controlled-release membrane during this stage, the drug release channels remain open, and the drug is continuously released from the drug reservoir layer. This sequential superposition with the mechanical permeation-enhancing wave peak of the airbag massage achieves mechanical pressure-driven permeation enhancement under the assistance of heat application. During the tissue diffusion phase, the temperature is slightly reduced to 34℃~35℃, which is below the low critical dissolution temperature of the thermosensitive controlled-release membrane. This causes the polymer chains of the membrane to re-swell, actively closing the drug release channels and stopping new drug release, thus avoiding ineffective drug loss. Simultaneously, the air sac area switches to a high-frequency micro-amplitude vibration mode, using mechanical vibration to promote the lateral diffusion of drug molecules already in the subcutaneous tissue into target tissues such as the intestinal wall. This expands the effective drug action area, optimizes drug distribution at the target site, and achieves on-demand drug delivery. The application of this phased synergistic treatment curve allows thermotherapy and massage to achieve targeted and sequential intervention at different penetration stages (stratum corneum penetration, dermal transport, and intra-tissue diffusion) based on skin physiology and transdermal drug dynamics. This results in a significant overall improvement in transdermal absorption efficiency, enhanced therapeutic effect, and optimized intelligent and controllable treatment process.

[0018] It should be noted that the concentration gradient refers to the phenomenon that, in the initial stage of treatment (the stratum corneum opening phase), by heating the heating layer to 42℃~43℃, a phase transition is triggered in the temperature-sensitive controlled-release membrane, fully opening the drug release channels. This allows the high concentration of drug in the drug reservoir to be rapidly released to the skin surface, forming a near-saturated drug concentration on the patch side, while the initial drug concentration on the inner side of the skin (the active epidermal side) is zero. This establishes a drug concentration difference across the stratum corneum, extending from the skin surface to the deeper tissues. This concentration difference is the fundamental thermodynamic driving force that propels drug molecules to overcome skin barrier resistance and continuously penetrate the body.

[0019] Specifically, the airbag area includes at least a first airbag area, a second airbag area, and a third airbag area; The first air sac area is located in the surface projection area of ​​the ascending colon in the human abdomen; The second air sac area is located in the transverse colon projection area of ​​the human abdomen; The third air sac area is located in the surface projection area of ​​the descending colon in the human abdomen; Each airbag zone consists of several airbags, each equipped with an inflation valve connected to an air pump. The airbag zone is specifically divided, defining it as including at least the first, second, and third airbag zones, precisely corresponding to the surface projection areas of the ascending colon, transverse colon, and descending colon in the human abdomen. This structural division lays the physical foundation for a highly physiologically biomimetic stimulation pattern. This division allows the mechanical stimulation of the abdominal binder to precisely match the anatomical direction and segmentation of the colon, providing the necessary hardware configuration for subsequent control programs to drive the airbags to inflate and deflate in a wave-like manner in the order of "ascending colon zone, transverse colon zone, descending colon zone." The design of each airbag zone consisting of several independent airbag units further increases the fit and uniformity of the stimulation. This structure ensures that mechanical stimulation can simulate the natural peristaltic waves of the colon, producing a more physiologically accurate and effective directional propulsion sensation, providing a crucial structural guarantee for improving the treatment effect of gastrointestinal motility disorders.

[0020] Optionally, the inflation valve includes a valve body, an inner core, and a spring. The valve body has an inner cavity with an annular boss. The inner core can slide axially within the inner cavity and includes a limiting platform and an air vent. The spring is coaxially sleeved on the outer periphery of the inner core and accommodated in the inner cavity. One end of the spring axially abuts against and is limited to the annular boss of the valve body, and the other end axially abuts against and is limited to the limiting platform. The spring is constrained within the axial space between the annular boss of the valve body and the limiting platform of the inner core.

[0021] Furthermore, The inner cavity is provided with a sliding groove, and the sliding groove is provided with a limit groove; The inner core is provided with protrusions, and the protrusions are provided with limit blocks; The protrusion is accommodated in the sliding groove, and when the limiting block is not inserted into the limiting groove, the protrusion can move along the axial direction of the sliding groove; The protrusion can also rotate by a set angle around the axis of the inner core within the sliding groove, causing the limiting block to insert into the limiting groove. At this time, the axial movement of the protrusion within the sliding groove is restricted. This axial locking action is performed when the inner core is in the working position where the air passage is open. After locking, it can completely counteract the spring's return force, forcibly maintaining the air passage between the airbag and the air pump open throughout the entire process. This provides a stable fluid channel for the air pump to perform forced negative pressure inhalation and expulsion of air from the airbag, ensuring the speed and thoroughness of the airbag deflation action.

[0022] The inner core has a through hole that communicates with the air pump, and the through hole has a rotating groove; The air pump has an air outlet that can rotate along its axis, and the air outlet has a rotating block that can mate with the rotating groove. Specifically, the transmission fit between the rotating block and the rotating groove adopts a clearance fit tolerance design commonly used in medical precision transmission scenarios, while strictly controlling key dimensional and positional tolerances such as the parallelism of the mating working surfaces and the coaxiality of the overall assembly structure. This tolerance design scheme, by reserving a stable and reasonable fit clearance, can completely avoid interference, motion jamming, and additional frictional resistance problems that occur during the axial pushing and resetting of the inner core, without imposing any restrictions on the stroke and smoothness of axial movement. At the same time, through precise dimensional and positional tolerance control, the cumulative effect of tolerances in the machining and assembly of parts can be effectively eliminated, avoiding the problem of off-center load resistance caused by dimensional and positional deviations, and ensuring smooth and stable axial reciprocating motion of the inner core throughout the entire process. The outer periphery of the inner core has an O-ring, and a sealing ring is placed in the O-ring. When the spring is not working, the sealing ring can abut against the annular boss to maintain the seal between the inner core and the valve body. Through the tension of the spring, its elastic restoring force continuously acts between the limiting platform of the inner core and the annular boss of the valve body, giving the inner core a constant tendency to move axially outward into the cavity. Under this tendency, the sealing ring, housed in the O-ring groove, tightly abuts against the end face or inner wall of the annular boss under the action of the spring force, forming a reliable radial and axial double sealing interface. This structural design ensures that, in the non-working state, the air passage between the airbag area and the external environment and the air pump is normally closed, effectively preventing gas leakage and ensuring the initial fit stability and hygiene safety when wearing the abdominal binder. When the air pump's outlet pushes the inner core axially, the applied external force overcomes the spring's preload, driving the inner core to slide axially inward along the valve body cavity. This action causes the sealing ring to disengage from the tight contact with the annular boss, and simultaneously, the air vent of the inner core crosses the sealing interface, establishing a through air passage between the air pump and the airbag. In this state, by precisely controlling the magnitude and frequency of the air pump's outlet pressure by the control unit, real-time, linear adjustment of the gas volume inside the airbag can be achieved. Because the air pump continuously exerts pressure to maintain airflow, the structure allows for high-frequency, small-amplitude inflation adjustments of the airbag, thereby generating a high-frequency, micro-amplitude vibration mode at the mechanical stimulation level. This significantly enhances the lateral drug diffusion effect and the local microcirculation promotion effect during the tissue diffusion phase.

[0023] A rotary locking structure consisting of a protrusion, a sliding groove, a limiting block, and a limiting groove enables precise control of the airbag's working state. When the airbag's inflation and pressure-holding state needs to be terminated, the rotating block at the air outlet, in conjunction with the rotating groove, drives the inner core to rotate at a set angle within the sliding groove, causing the limiting block to insert into the limiting groove. At this point, the axial freedom of the inner core is mechanically locked, overcoming the spring force to maintain airflow and providing a stable fluid channel for the air pump to execute the inhalation program. This ensures that the gas inside the airbag is forcibly and rapidly drawn back, achieving rapid airbag collapse—the final action of the airbag's operation. Compared to exhaust methods relying on natural exhalation, this forced inhalation mechanism offers advantages such as fast response, thorough emptying, and high repeatability, providing precise mechanical execution for simulating the relaxation phase of colonic peristalsis. A micro-sensor (such as a microswitch) is integrated within the limiting groove to monitor in real time whether the limiting block is inserted correctly. This sensor generates a precise electrical signal characterizing whether a specific airbag has completed its "inhalation reset" state and feeds it back to the control host. Based on this closed-loop feedback signal, the control host can accurately determine whether the working cycle of the previous airbag has ended, and then trigger the generation of the start command for the next airbag area. This "wave relay" control logic based on hardware status confirmation fundamentally ensures that the first, second, and third airbag areas can be inflated and deflated in an orderly manner according to the preset sequence of "ascending colon area → transverse colon area → descending colon area", realizing a true simulation of peristaltic waves that conforms to the physiological direction of the colon, and greatly improving the accuracy and reliability of multi-cavity sequential control.

[0024] Optionally, the heating layer is a flexible carbon fiber heating film. Using a flexible carbon fiber heating film as the heating element offers advantages such as thinness, softness, and flexibility, allowing it to perfectly conform to the physiological curves of the abdomen. This ensures large-area, uniform contact between the heating layer and the back of the transdermal herbal patch, avoiding uneven heat distribution or localized overheating caused by poor adhesion in traditional rigid heating pads. Simultaneously, the high electrothermal conversion efficiency of carbon fiber material results in rapid and uniform heating, enabling precise response to temperature adjustment commands from the control unit. This allows for rapid and stable temperature control within a multi-stage synergistic treatment curve, ensuring that the drug release behavior of the temperature-sensitive controlled-release membrane closely matches the preset timing. The heating film is encapsulated within a medical-grade silicone layer. The flexibility and elasticity of silicone further enhance the overall deformability of the heating layer, allowing it to adaptively conform to the abdominal contour under the pressure of the abdominal binder. This not only improves wearing comfort but also ensures a tight fit between the heating layer and the herbal patch, reducing thermal resistance and improving heat conduction efficiency.

[0025] Compared to existing gastrointestinal motility intervention technologies and devices, this invention possesses significant comprehensive advantages. Its partitioned airbag structure, designed based on the anatomical orientation of the human colon, precisely simulates the physiological peristaltic rhythms of the ascending, transverse, and descending colon, achieving sequential wave-like air pressure stimulation. This addresses the pain point of traditional devices' stimulation modes deviating from physiological patterns. It innovatively integrates three modules: biomimetic air pressure massage, intelligent thermotherapy, and targeted transdermal Chinese medicine. Through temporal synergy, it achieves dual penetration enhancement through heat and mechanical force, significantly improving the transdermal absorption efficiency of Chinese medicine and achieving synergistic effects between drugs and devices, breaking through the efficacy bottleneck of traditional single-treatment modes. The accompanying Chinese medicine patches utilize both anatomical sites and acupoints for dual positioning, allowing for drug delivery tailored to treatment needs. Simultaneously, the independent patch design achieves physical isolation between the drug and the device, eliminating the risk of cross-infection. The operation process is extremely simple, significantly reducing clinical nursing workload. The device also features precise pressure and temperature control protection, ensuring safe use and adaptability to various clinical scenarios and home rehabilitation needs. Attached Figure Description

[0026] To more clearly illustrate the embodiments of the present invention or the technical solutions in 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 merely exemplary, and those skilled in the art can derive other embodiments based on the provided drawings without creative effort.

[0027] Figure 1 This is a schematic diagram of the inner side of the abdominal binder body of the present invention.

[0028] Figure 2 This is a perspective view of the heating layer of the present invention.

[0029] Figure 3 This is a schematic diagram of the outer side of the abdominal belt body of the present invention.

[0030] Figure 4 This is a schematic diagram of the first airbag area, the second airbag area, and the third airbag area of ​​the present invention.

[0031] Figure 5 This is a schematic diagram of the transdermal patch structure of traditional Chinese medicine according to the present invention.

[0032] Figure 6 This is a schematic diagram of the air pump and air outlet of the present invention.

[0033] Figure 7 This is a schematic diagram of the connection between the air pump and the air outlet of the present invention.

[0034] Figure 8 This is an exploded view of the inflation valve of the present invention.

[0035] Figure 9 This is a schematic diagram of the sealing assembly of the air inflator valve of the present invention.

[0036] Figure 10 This is a schematic diagram of the bottom sealing ring of the air valve in the sealed state of the present invention.

[0037] Figure 11 This is a schematic diagram of the valve body of the present invention.

[0038] Figure 12 For the present invention Figure 11 A magnified view of a portion of the image.

[0039] Figure 13 This is a schematic diagram of the inner core of the present invention.

[0040] Figure 14 For the present invention Figure 13 A magnified view of a portion of the image.

[0041] Figure 15 This is a schematic diagram of the inflation valve of the present invention in the air-filled state.

[0042] Figure Descriptions: 1-Abdominal band body, 1a-Hook and loop fastener, 1b-Plug, 2-Airbag area, 3-Heating layer, 4-Transdermal herbal patch, 5-Control unit, 6-Inflation valve, 21-First airbag area, 22-Second airbag area, 23-Third airbag area, 24-Airbag, 31-Wire, 41-Backing layer, 42-Drug reservoir layer, 43-Temperature-sensitive controlled-release membrane, 44-Skin adhesive layer, 45-Anti-adhesive layer, 51-Air pump, 61- Valve body, 62-inner core, 63-spring, 61a-annular boss, 61b-inner cavity, 61c-sliding groove, 61d-limiting groove, 62a-protrusion, 62b-limiting platform, 62c-limiting block, 62d-through hole, 62e-rotating groove, 62f-O-ring groove, 62g-sealing ring, 62h-vent, 511-air outlet, 512-miniature direct-drive linear rotary actuator, 513-hose, 51a-rotating block. Detailed Implementation

[0043] 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 only some embodiments of the present invention, and 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.

[0044] The concepts involved in this application will first be described with reference to the accompanying drawings. It should be noted that the following descriptions of various concepts are only for the purpose of making the content of this application easier to understand and do not constitute a limitation on the scope of protection of this application; furthermore, the embodiments and features in the embodiments of this application can be combined with each other unless otherwise specified. This application will now be described in detail with reference to the accompanying drawings and embodiments.

[0045] Example 1: like Figure 1 As shown, a biomimetic gastrointestinal peristalsis stimulation abdominal binder includes a main body 1. The inner side of the main body 1 is attached to the outer side of the main body 1 via Velcro 1a and is installed on the user's abdomen. An air sac area 2 is provided on the inner side of the main body 1, which corresponds to the surface projection areas of the ascending colon, transverse colon, and descending colon in the human abdomen. Figure 4 As shown, specifically, the air sac area 2 may include a first air sac area 21 corresponding to the surface projection area of ​​the ascending colon, a second air sac area 22 corresponding to the surface projection area of ​​the transverse colon, and a third air sac area 23 corresponding to the surface projection area of ​​the descending colon.

[0046] like Figure 1 , Figure 2 , Figure 3 , Figure 5 As shown, the abdominal binder body 1 is also equipped with a control host 5, which has a plug 1b that can be connected to an external power supply device to power its internal power supply. The control host 5 has a built-in air pump 51 and power supply, which are used to provide air supply and power supply for the airbag area 2 and the heating layer. The inner side of the abdominal binder body 1 is also provided with a heating layer 3, which is connected to the power supply and heat conduction control module built into the control host 5 through wires 31. The layer near the airbag area 2 is a heat insulation and reflection layer, which is made of aluminum foil composite film with the aluminum foil side facing inward to reflect infrared radiation. The first layer in the middle is a heating layer, which uses a carbon fiber flexible heating film. Its resistance value is designed to obtain good heating power under the supply voltage. The heating layer has positive and negative terminals led out through wires 31. The second middle layer is a heat-conducting and temperature-equalizing layer, which uses a graphene heat-conducting film with a high horizontal thermal conductivity. It is tightly bonded to the heating layer. The outermost layer (the side in contact with the Chinese medicine patch) is a skin-friendly layer, which uses medical-grade silicone or soft heat-conducting cloth. The surface is flat and smooth, which facilitates seamless contact with the backing layer of the transdermal Chinese medicine patch 4. The film surface is sewn to the abdominal belt body, which is made of elastic and breathable fabric.

[0047] like Figure 5As shown, the transdermal herbal patch 4 contains a temperature-sensitive controlled-release membrane 43. This membrane exhibits a non-linear response characteristic of drug permeability changing with temperature within a set temperature range, enabling the regulation of drug release rate based on the temperature change applied by the heating layer 3. In practical applications, the transdermal herbal patch 4 is used as a consumable independent of the abdominal binder body 1. The operator first applies the patch to the corresponding area of ​​the abdomen, then wears the abdominal binder body 1, ensuring precise contact between the heating layer 3 and the back of the patch. The control unit 5 is configured to control the inflation and deflation of each airbag area 2 according to a preset sequence and frequency during the treatment procedure, while simultaneously dynamically adjusting the temperature of the heating layer 3. This allows the drug release rate of the transdermal herbal patch 4 to synergistically interact with the mechanical stimulation of the airbag areas 2, thereby achieving thermal penetration enhancement of the patch and mechanical massage of the abdominal tissue in a non-invasive manner. The operator only needs to complete the simple steps of "applying, wearing, removing, and wiping," eliminating the need to handle medication or clean equipment, significantly simplifying the operation process and reducing the workload.

[0048] Furthermore, the transdermal patch 4 is designed as three independent patches—a right abdominal patch, an upper abdominal patch, and a left abdominal patch—based on the distribution of acupoints on the human abdomen, in order to achieve dual targeting of drug action and stimulation of acupoints. The right abdominal patch covers the right Tianshu (ST25) and right Daheng (SP15) acupoints. Its core function is to promote the flow of Qi, and it contains one or more of the following Chinese herbal ingredients: Citrus aurantium, Magnolia officinalis, and Aucklandia lappa. The upper abdominal patch covers the Zhongwan (CV12) acupoint. Zhongwan is the Mu point of the stomach and the meeting point of the fu organs. It is mainly used to treat stomach pain, abdominal distension, and loss of appetite. Tianshu is the Mu point of the large intestine and is a key acupoint for regulating gastrointestinal function. The core function of the Chinese herbal ingredients in this patch is to warm the middle and harmonize the stomach. It contains one or more of the following of the following of the following: Artemisia argyi, Cinnamomum cassia, and Zingiber officinale. The left abdominal patch covers the left Tianshu (ST25) and left Daheng (SP15) acupoints. Daheng belongs to the Foot Taiyin Spleen Meridian and is mainly used to treat abdominal pain, diarrhea, and constipation. The core function of the Chinese herbal ingredients in this patch is to moisten the intestines and promote bowel movements. It contains one or more of the following of the following: Angelica sinensis, Trichosanthes kirilowii, and Cannabis sativa. By applying the patch to the aforementioned acupoints, the medicinal ingredients can directly act on the acupoint areas closely related to gastrointestinal function. On the other hand, the physical stimulation generated by the wave-like inflation and deflation massage of the airbag area 2 and the heat therapy of the heating layer 3 can stimulate the flow of Qi and harmonize Qi and blood. Thus, in a single treatment process, it can achieve comprehensive regulation of the functions of multiple organs such as the stomach, intestines, and spleen. Compared with ordinary abdominal patches, it significantly improves the treatment effect for gastrointestinal motility disorders.

[0049] Example 2: like Figure 1 As shown, a biomimetic gastrointestinal peristalsis stimulation abdominal band includes an abdominal band body 1, and an air sac area 2 is provided on the inner side of the abdominal band body 1. The air sac area 2 corresponds to the surface projection area of ​​the ascending colon, transverse colon and descending colon of the human abdomen.

[0050] like Figure 1 , Figure 3 , Figure 6As shown, the abdominal binder body 1 is also equipped with a control host 5, which has a built-in air pump 51 and a power supply. The inner side of the abdominal binder body 1 is also provided with a heating layer 3, which is connected to the power supply and heat conduction control module built into the control host 5 through wires 31.

[0051] The transdermal patch 4 contains a thermosensitive controlled-release membrane 43, which is a composite membrane layer containing N-isopropylacrylamide copolymer. N-isopropylacrylamide (NIPAM) is a typical thermosensitive polymer material, whose molecular chains have a low critical dissolution temperature in aqueous solution. When the ambient temperature is below its low critical dissolution temperature, a large number of hydrogen bonds are formed between the NIPAM polymer chains and water molecules, exhibiting a swollen and expanded open state; when the ambient temperature rises above the low critical dissolution temperature, the intermolecular hydrogen bonds are broken, the polymer chains collapse and become hydrophobic, expelling internal water and shrinking in volume rapidly.

[0052] In addition, the following explanation is provided: NIPAM is a recognized and mature thermosensitive polymer material in the biomedical field. Its molecular chains have typical low critical solution temperature (LCST) characteristics in aqueous solutions: when the ambient temperature is below its LCST, a large number of hydrogen bonds are formed between the poly(N-isopropylacrylamide) polymer chains and water molecules, exhibiting a swollen and expanded open state, which can block drug release channels to achieve drug lock-in; when the ambient temperature rises above the LCST, the intermolecular hydrogen bonds are broken, the polymer chains collapse and become hydrophobic, expelling internal water, and the volume shrinks sharply, thus opening up the drug release channels and achieving rapid drug release.

[0053] The LCST of pure PNIPAM is about 32°C, which is slightly lower than the regulation requirement of the treatment scheme of the present invention. However, the LCST of the copolymer can be precisely regulated by copolymerizing NIPAM monomer with hydrophilic acrylamide (hereinafter referred to as AA) monomer. This is a very mature existing technology in the field, and its regulation rules have been fully confirmed by extensive and repeated experimental studies. Among them, the "Preparation and Performance Study of Rapid Temperature-Sensitive Poly(N-isopropylacrylamide-co-acrylamide) Hydrogel" (Zhang Xianzheng and Zhuo Renxi, published in the Journal of Chemical Research of Chinese Universities, Vol. 8, 2000, hereinafter referred to as the prior art) is a classic research result in this field, which clearly discloses the core regulation law: the lower critical dissolution temperature of the hydrogel can be adjusted by changing the content of acrylamide. As the content of hydrophilic monomer AA increases, the LCST of the hydrogel gradually increases. The prior art verified the controllable regulation effect of the copolymerization ratio on LCST through gradient feeding experiments of AA with different molar masses. Its technical solution has been industrialized in the fields of controlled release of medical drugs and biological dressings. The technical maturity, experimental repeatability and medical device-grade biosafety have been fully verified by the industry.

[0054] Based on the mature regulatory rules disclosed in this existing technology, and combined with the experimental data published in core polymer journals and biomedical materials dissertations in this field that match transdermal drug delivery scenarios, the correspondence between the acrylamide copolymerization ratio and the copolymer LCST can be found in Table 1.

[0055] Table 1. Relationship between Acrylamide Feed Ratio and LCST of Copolymer (Reference Data Table)

[0056] In the hydrogel matrix environment of the transdermal herbal patch described in this embodiment, the temperature-sensitive controlled-release membrane 43 preferably uses a NIPAM / AA copolymer with an acrylamide (AA) molar ratio of 4.5 mol%, and the lower critical dissolution temperature of this copolymer in the matrix environment is 36.0℃. The lower critical dissolution temperature of this invention is measured using existing mature technology. The finished transdermal herbal patch is taken, the anti-adhesive layer is removed, and it is fixed between the supply and receiving chambers of a Franz diffusion cell. The receiving chamber is filled with pH 7.4 phosphate buffer. The system is heated from room temperature to 45℃ at a rate of 0.5℃ / min, and the membrane interface temperature is monitored in real time using a fiber optic temperature sensor. Samples are taken at each steady-state temperature point, and the cumulative drug permeation is determined by high-performance liquid chromatography (HPLC). The permeation rate and temperature data are recorded, and the inflection point temperature at which the permeation rate changes abruptly is taken as the effective phase transition temperature of the patch. This method can realistically simulate the actual mass transfer environment after patch application, and the obtained LCST reflects the phase transition behavior of the temperature-sensitive membrane under these conditions. The phase transition temperature of the same formulation membrane in pure water, buffer solution and the matrix of this invention differs by no more than 0.6℃, and the influence of excipients is negligible.

[0057] like Figure 5 As shown, the transdermal herbal patch 4 has a five-layer composite structure, consisting of a backing layer 41, a drug reservoir layer 42, a temperature-sensitive controlled-release membrane 43, a skin adhesive layer 44, and an anti-adhesion layer 45, from the outside in. The backing layer 41 uses medical non-woven fabric or polyurethane film, providing leak-proof, support, and moisture retention, and offering mechanical strength to the patch. The drug reservoir layer 42 uses a hydrogel or poultice matrix, composed of sodium polyacrylate, gelatin, sodium carboxymethyl cellulose, glycerin, water, etc. This layer has a highly hydrated three-dimensional network structure, responsible for carrying the herbal extract and controlling the initial drug release. The temperature-sensitive controlled-release membrane 43 is a composite membrane layer containing N-isopropylacrylamide copolymer. The skin adhesive layer 44 uses medical acrylate pressure-sensitive adhesive for skin adhesion and may contain a small amount of fast-release drug for rapid onset of action. The anti-adhesion layer 45 uses silicone release paper, which is removed before use.

[0058] In practical applications, the transdermal herbal patch 4, as a consumable independent of the abdominal binder body 1, is first applied to the corresponding area of ​​the abdomen by the operator. Then, the abdominal binder body 1 is worn, ensuring precise contact between the heating layer 3 and the back of the patch. Although the backing layer 41 is made of a material with generally low thermal conductivity, it is extremely thin and has minimal thermal resistance. During the stratum corneum opening phase, the heating layer heats up to 42℃~43℃, allowing heat to quickly penetrate the backing layer. This causes the temperature of the temperature-sensitive controlled-release membrane 43 to easily exceed its lower critical dissolution temperature, thereby effectively triggering drug release.

[0059] The drug reservoir layer 42 employs a hydrogel or patch matrix, containing sodium polyacrylate, gelatin, glycerin, and water to form a highly hydrated three-dimensional network structure, providing the necessary temperature-sensitive response medium for the N-isopropylacrylamide copolymer. In this hydrated environment, the copolymer exhibits typical low critical dissolution temperature characteristics. When the temperature is below the copolymer's phase transition temperature, the polymer chains form hydrogen bonds with water molecules, swelling and expanding, thus blocking the pores of the porous support layer and significantly restricting drug release pathways. When the temperature rises above the phase transition temperature, the hydrogen bonds are broken, the polymer chains collapse and become hydrophobic, and the volume shrinks rapidly, opening the pores of the porous support layer, unblocking the drug release pathways, and rapidly increasing the release rate. With this structural design, the drug release behavior of the patch is no longer a passive concentration diffusion but can respond to real-time temperature changes in the heating layer 3, achieving a low-temperature drug-locking and high-temperature drug-release on-demand delivery mode. When this thermosensitive controlled-release patch is used in conjunction with a biomimetic peristaltic stimulation abdominal band, the control unit 5 can dynamically adjust the temperature of the heating layer 3 to precisely control the timing and rate of drug release at different stages of the multi-stage synergistic treatment curve. This allows the peak drug release and the mechanical massage wave peak to be superimposed in sequence. On the one hand, the dual permeation-promoting effect of heat and mechanical pressure significantly improves transdermal absorption efficiency. On the other hand, it avoids ineffective drug release during non-treatment periods, thereby improving bioavailability, prolonging the effective duration of action, and reducing drug waste.

[0060] Example 3: The overall structure of this embodiment is the same as that of Embodiment 1, and the main focus is on the configuration of the control host 5. The control host 5 is configured to execute a multi-stage synergistic treatment curve, which includes a temperature regulation stage and a pressure stimulation stage. The temperature regulation and pressure stimulation work synergistically according to a preset time sequence to achieve phased promotion of transdermal drug absorption. Specifically, the multi-stage synergistic treatment curve includes a stratum corneum opening phase, a synergistic penetration enhancement phase, and a tissue diffusion phase. During the stratum corneum opening phase, the heating layer 3 is heated to 42°C~43°C, and the air bladder area 2 remains in a deflated state or only undergoes micro-amplitude low-frequency vibration. At this time, the temperature exceeds the low critical dissolution temperature of the temperature-sensitive controlled-release membrane 43, causing the polymer chains of the temperature-sensitive controlled-release membrane 43 to undergo phase transition and collapse, fully opening the drug release channel, and rapidly releasing the drug from the drug reservoir layer 42. At the same time, the thermal effect is used to increase the fluidity of stratum corneum lipids and intercellular spaces, reducing skin barrier resistance, so that the released drug can quickly establish a concentration gradient in the stratum corneum, laying the foundation for subsequent penetration. During the synergistic penetration enhancement phase, the temperature of the heating layer 3 is controlled to decrease from the previous stage and stabilize at 39℃~40℃. In this stage, drug penetration enhancement mainly relies on the mechanical pressure waves generated by the wave-like inflation and deflation of the airbag area 2. Temperature is only used as an auxiliary heat therapy to maintain the skin's microcirculation expansion. Specifically, the control unit 5 starts the airbag area 2 to inflate and deflate in a wave-like manner according to the ascending colon area, transverse colon area, and descending colon area, simulating physiological colonic peristalsis waves. The positive pressure generated on the abdominal tissue when the airbag is inflated pushes the drug that has penetrated the stratum corneum into the dermis and subcutaneous tissue. When the airbag is deflated, the tissue elastic rebound creates a negative pressure suction effect, further enhancing interstitial fluid convection and drug transport. At the same time, the heating layer 3 controls the temperature at 39℃~40℃ for continuous heat therapy, keeping the skin capillaries moderately dilated, reducing the viscosity of interstitial fluid, and providing a good tissue microenvironment for the mechanical penetration enhancement effect of the airbag massage. Since the target temperature of the heating layer 3 is still higher than the low critical dissolution temperature of the thermosensitive controlled-release membrane 43 during this stage, the drug release channel remains open, and the drug is continuously released from the drug reservoir layer 42. This superimposes with the mechanical permeation peak of the airbag massage, achieving mechanical pressure-driven permeation under the assistance of heat therapy. Subsequently, during the tissue diffusion phase, the heating layer 3 is further cooled to 34℃~35℃, and the airbag area 2 switches to a high-frequency micro-amplitude vibration mode. This temperature is lower than the low critical dissolution temperature of the thermosensitive controlled-release membrane 43, causing the polymer chains of the thermosensitive controlled-release membrane 43 to re-swell. The drug release channel actively closes, stopping new drug release and avoiding ineffective drug loss. At the same time, the airbag area 2 switches to a high-frequency micro-amplitude vibration mode, using mechanical vibration to promote the lateral diffusion of drug molecules that have entered the subcutaneous tissue in target tissues such as the intestinal wall, expanding the effective action area of ​​the drug, optimizing the distribution of the drug at the target site, and achieving on-demand drug delivery.By applying this phased synergistic treatment curve, this invention enables thermotherapy and massage to achieve targeted and sequential intervention at different penetration stages based on the principles of skin physiology and transdermal drug dynamics. This significantly improves the transdermal rate and total absorption of drugs, enhances the therapeutic effect, and optimizes the intelligence and controllability of the treatment process.

[0061] Example 4: like Figure 8 As shown, to achieve precise wave-like inflation and deflation timing of the airbag area 2, an inflation valve 6 with a specific structure can be used. The inflation valve 6 employs a unique mechanical structure. The inflation valve 6 includes a valve body 61, an inner core 62, and a spring 63. (As shown...) Figure 11 As shown, the valve body 61 has an inner cavity 61b, which has an annular boss 61a. The inner core 62 can slide axially within the inner cavity 61b. The inner core 62 includes a limiting platform 62b and a vent 62h. The spring 63 is coaxially sleeved on the outer periphery of the inner core 62 and accommodated in the inner cavity 61b. One end of the spring 63 axially abuts against and is limited to the annular boss 61a of the valve body, and the other end axially abuts against and is limited to the limiting platform 62b. The spring 63 is constrained within the axial space between the annular boss 61a of the valve body 61 and the limiting platform 62b of the inner core 62. After assembly, under the action of pre-compression force, the spring can output a stable axial elastic restoring force throughout the entire process, providing the core driving force for the normally closed sealing and reset action.

[0062] like Figure 10 , Figure 13 As shown, the inner core 62 has an O-groove 62f around its periphery, and a sealing ring 62g is placed inside the O-groove 62f. This sealing ring 62g is a medical-grade elastic O-ring seal, which simultaneously performs the dual core functions of axial travel limiting and end-face air passage sealing. When the spring 63 is not in operation, the sealing ring 62g tightly abuts against the annular boss 61a, maintaining the seal between the inner core 62 and the valve body 61, so that the air passage between the airbag 24 and the external environment and the air pump 51 is in a normally closed state, effectively preventing gas leakage. The spring is in a non-working state here, specifically referring to the normal state where the inflation valve is not working and the air pump has no pushing force. At this time, the elastic restoring force of the pre-compressed spring drives the inner core to push outward, so that the sealing ring and the rigid end face of the annular boss form a stable axial fit. The mechanical transmission link is: spring preload → limiting platform 62b of inner core 62 → groove wall of O-ring 62f of inner core 62 → sealing ring 62g → sealing end face of annular boss 61a. The entire process is axial rigid transmission with no additional torque loss. The elastic force of the spring can be completely converted into the contact pressure of the sealing surface. From the perspective of the sealing requirements of medical low-pressure air circuits, the clinical working air pressure of the airbag of this invention is an extremely low pressure condition, while the preload of conventional medical micro springs can generate a contact pressure of more than 0.2MPa on the sealing surface, which far exceeds the working pressure requirement.

[0063] like Figure 6 , Figure 7 , Figure 10 , Figure 14 As shown, when the air outlet 511 of the air pump 51 pushes the inner core 62 axially, the applied external force overcomes the preload of the spring 63, driving the inner core 62 to slide axially inward along the inner cavity 61b of the valve body. The sealing ring 62g disengages from the tight contact with the annular boss 61a, and at the same time, the air vent 62h of the inner core 62 crosses the sealing interface, establishing a through air passage between the air pump 51 and the airbag 24. At this time, by precisely controlling the magnitude and frequency of the air pressure and change of the air pump 51 by the control host 5, the real-time linear adjustment of the gas volume inside the airbag 24 can be achieved, including generating a high-frequency micro-amplitude vibration mode.

[0064] like Figures 8-15As shown, the inner cavity 61b is also provided with a sliding groove 61c, and the sliding groove 61c has a limiting groove 61d; the inner core 62 is provided with a protrusion 62a, and the protrusion 62a is provided with a limiting block 62c; the protrusion 62a is accommodatedly disposed in the sliding groove 61c, and when the limiting block 62c is not inserted into the limiting groove 61d, the protrusion 62a can move axially along the sliding groove 61c; the protrusion 62a can also rotate a set angle around the axis of the inner core 62 in the sliding groove 61c, so that the limiting block 62c is inserted into the limiting groove 61d, at which time the axial movement of the protrusion 62a in the sliding groove 61c is restricted. The inner core 62 is provided with a through hole 62d communicating with the air pump 51, and the through hole 62d is provided with a rotating groove 62e; the air pump 51 is provided with an air outlet 511 that can rotate along its axis, and the air outlet 511 is provided with a rotating block 51a that can cooperate with the rotating groove 62e. During the process of the air outlet 511 of the air pump 51 axially pushing the inner core 62, the control host only drives the air outlet 511 to perform pure axial linear motion without any circumferential rotation. The rotating block 51a only slides freely along the axis in the rotating groove 62e and will not cause any obstruction, jamming or additional resistance to the axial movement. When the inflation and pressure holding state of the airbag needs to be terminated, the air pump outlet 511 remains fixed in its axial pushing position, ensuring that the inner core 62 is always in a working position with the air passage fully open. The sealing interface remains in an unsealed state. Through the cooperation of the rotating block 51a of the outlet 511 and the rotating groove 62e, the inner core 62 is driven to rotate within the sliding groove 61c by a set angle, causing the limiting block 62c to insert into the limiting groove 61d. At this time, the axial degree of freedom of the inner core 62 is mechanically locked, overcoming the spring force to maintain the air passage open state, providing a stable fluid channel for the air pump 51 to execute the inhalation program, ensuring that the gas in the airbag 24 is forcibly and quickly drawn back, achieving rapid collapse of the airbag. Compared with the exhaust method that relies on the natural rebound of the airbag, this forced inhalation mechanism has the advantages of fast response speed, thorough emptying, and high repeatability, providing precise mechanical execution guarantee for simulating the relaxation phase of colonic peristalsis. A micro-sensor is integrated within the limiting groove 61d to monitor in real time whether the limiting block 62c is inserted into place. This sensor generates a precise electrical signal indicating whether a specific airbag has completed its inhalation and reset state, and feeds it back to the control host 5. Based on this closed-loop feedback signal, the control host 5 accurately determines whether the working cycle of the previous airbag has ended, and then triggers the generation of the start command for the next airbag area. This wave relay control logic based on hardware status confirmation fundamentally ensures that the first airbag area 21, the second airbag area 22, and the third airbag area 23 can be inflated and deflated in an orderly manner strictly according to the preset timing of the ascending colon, transverse colon, and descending colon areas. This achieves a true simulation of peristaltic waves that conforms to the physiological direction of the colon, significantly improving the accuracy and reliability of multi-cavity sequential control.

[0065] Optionally, the connection status between the air outlet 511 and the air pump 51 can be referenced. Figure 7The rotation and linear motion of the entire air outlet 511 can be driven and controlled by the micro direct-drive linear rotary actuator 512. The entire rotation angle and linear motion distance are controlled by the control host 5. The side of the air outlet 511 is connected to the hose 513, which is directly connected to the air source inside the air pump 51. The material of the hose 513 can be medical high-elasticity silicone tubing.

[0066] Example 5: This embodiment provides a traditional Chinese medicine preparation process for a transdermal patch 4 for a biomimetic gastrointestinal motility stimulation abdominal binder, including the following steps.

[0067] 1. Extraction of traditional Chinese medicine Take the prescribed amount of medicinal materials, grind them into powder, and pass them through a 20-mesh sieve. Add 8-12 times the amount of 60-80% ethanol, reflux and extract twice, 1.5 hours each time; Combine the extracts and concentrate under reduced pressure to a thick paste with a temperature ≤60℃ and a relative density of 1.20-1.30 (60℃), or spray dry to prepare a dry extract powder.

[0068] 2. Matrix preparation Sodium polyacrylate, gelatin, sodium carboxymethyl cellulose, etc. are added to glycerin, stirred evenly, and allowed to stand and swell for 12-24 hours to obtain the oil phase. Mix the prescribed amount of water, humectant, and penetration enhancer to obtain the aqueous phase; Add the aqueous phase to the oil phase and stir at 40-60℃ to mix evenly to obtain a blank gel matrix.

[0069] 3. Drug loading and shaping Add the thick paste or dry extract powder of traditional Chinese medicine to the blank gel matrix and stir well; The coating is applied to the backing layer 41 with a thickness of 0.5-1.5 mm. Covered with a temperature-sensitive controlled-release membrane 43 and an anti-sticking layer 45; It is cut into three independent patches, each with a shape suitable for the right abdomen, upper abdomen, and left abdomen; Seal the aluminum foil bag.

[0070] The embodiments and / or implementation methods described above are merely preferred embodiments and / or implementation methods for implementing the technology of the present invention, and are not intended to limit the implementation methods of the technology of the present invention in any way. Any person skilled in the art may make some modifications to other equivalent embodiments without departing from the scope of the technical means disclosed in the content of the present invention, but these should still be regarded as the technology or embodiments that are substantially the same as the present invention. This document uses specific examples to illustrate the principles and implementation methods of this application. The descriptions of the above embodiments are only for the purpose of helping to understand the methods and core ideas of this application. The above descriptions are only preferred embodiments of this application. It should be noted that due to the limitations of written expression, while there are objectively infinite specific structures, those skilled in the art can make several improvements, modifications, or changes without departing from the principles of this application, and can also combine the above technical features in an appropriate manner. These improvements, modifications, changes, or combinations, or the direct application of the inventive concept and technical solution to other situations without modification, should all be considered within the scope of protection of this application.

Claims

1. A biomimetic abdominal binder for stimulating gastrointestinal peristalsis, characterized in that, include: The abdominal binder body (1) has an air sac area (2) on its inner side, and the air sac area (2) corresponds to the surface projection area of ​​the ascending colon, transverse colon and descending colon of the human abdomen. The control host (5) has a built-in air pump (51), power supply and heat conduction control module. The air pump (51) is used to provide air source for the airbag area (2). A heating layer (3) is sewn inside the abdominal binder body (1) and covers the entire airbag area (2). The heating layer (3) is electrically connected to the power supply and heat conduction control module of the control host (5) through a wire (31) and is used to contact the transdermal patch (4) of traditional Chinese medicine. The transdermal patch (4) of traditional Chinese medicine contains a temperature-sensitive controlled-release membrane (43), which has a non-linear response characteristic of drug permeability changing with temperature within a set temperature range. The control host is configured to: control each of the airbag areas (2) to inflate and deflate according to a preset time sequence and frequency when performing the treatment procedure, and synchronously and dynamically adjust the temperature of the heating layer (3) so that the drug release rate of the transdermal patch (4) and the mechanical stimulation of the airbag area (2) form a synergistic effect.

2. The biomimetic gastrointestinal peristalsis stimulation abdominal binder according to claim 1, characterized in that, The transdermal patch (4) includes a right abdominal patch, an upper abdominal patch, and a left abdominal patch. The right abdominal patch covers the right Tianshu acupoint and the right Daheng acupoint, the upper abdominal patch covers the Zhongwan acupoint, and the left abdominal patch covers the left Tianshu acupoint and the left Daheng acupoint, so as to achieve dual positioning with the stimulation of acupoints in traditional Chinese medicine.

3. The biomimetic gastrointestinal peristalsis stimulation abdominal binder according to claim 1, characterized in that, The temperature-sensitive controlled-release membrane (43) is a composite membrane layer containing a temperature-sensitive polymer copolymer formed by copolymerizing N-isopropylacrylamide and acrylamide, wherein the lower critical dissolution temperature of the copolymer is between 35.5℃ and 36.5℃.

4. The biomimetic gastrointestinal peristalsis stimulation abdominal binder according to claim 1, characterized in that, The control host is configured to perform multi-stage synergistic therapy, which includes a temperature regulation stage and a pressure stimulation stage, wherein the temperature regulation and pressure stimulation work synergistically according to a preset time sequence to achieve phased promotion of transdermal drug absorption.

5. The biomimetic gastrointestinal peristalsis stimulation abdominal binder according to claim 4, characterized in that, The multi-stage synergistic treatment curve includes: During the stratum corneum opening period: control the heating layer (3) to heat up to 42℃~43℃, and keep the air sac area (2) in a deflated state or vibrate slightly at low frequency to make the drug form a concentration gradient in the stratum corneum; Synergistic permeation period: Control the heating layer (3) to cool down and stabilize at 39℃~40℃, and at the same time start the airbag area (2) to perform wave-like inflation and deflation in the order of ascending colon area, transverse colon area and descending colon area; During the tissue diffusion phase: the controlled heating layer (3) is further cooled to 34℃~35℃, and the air sac area (2) is switched to a high-frequency micro-amplitude vibration mode to promote the transdermal drug to diffuse laterally within the intestinal wall tissue.

6. The biomimetic gastrointestinal peristalsis stimulation abdominal binder according to claim 1, characterized in that, The airbag area (2) includes at least a first airbag area (21), a second airbag area (22), and a third airbag area (23); The first air sac area (21) is located in the surface projection area of ​​the ascending colon in the human abdomen; The second air sac area (22) is located in the transverse colon surface projection area of ​​the human abdomen; The third air sac area (23) is located in the surface projection area of ​​the descending colon in the human abdomen; Each airbag area (2) consists of several airbags (24), each of which is provided with an inflation valve (6) and the inflation valve (6) is connected to an air pump (51).

7. The biomimetic gastrointestinal peristalsis stimulation abdominal binder according to claim 6, characterized in that, The inflation valve (6) includes a valve body (61), an inner core (62) and a spring (63). The valve body (61) has an inner cavity (61b) with an annular boss (61a). The inner core (62) can slide axially within the inner cavity (61b). The inner core (62) includes a limiting platform (62b) and an air vent (62h). The spring (63) is coaxially sleeved on the outer periphery of the inner core (62) and housed in the inner cavity (61b). One end of the spring (63) axially abuts against and is limited to the annular boss (61a) of the valve body, and the other end axially abuts against and is limited to the limiting platform (62b). The spring (63) is constrained within the axial space between the annular boss (61a) of the valve body (61) and the limiting platform (62b) of the inner core (62).

8. The biomimetic gastrointestinal peristalsis stimulation abdominal binder according to claim 7, characterized in that, The inner cavity (61b) is provided with a sliding groove (61c), and the sliding groove (61c) is provided with a limiting groove (61d). The inner core (62) is provided with a protrusion (62a), and the protrusion (62a) is provided with a limit block (62c). The protrusion (62a) is accommodated in the sliding groove (61c). When the limiting block (62c) is not inserted into the limiting groove (61d), the protrusion (62a) can move axially along the sliding groove (61c). The protrusion (62a) can also rotate by a set angle around the axis of the inner core (62) within the sliding groove (61c) so that the limiting block (62c) is inserted into the limiting groove (61d). At this time, the axial movement of the protrusion (62a) within the sliding groove (61c) is restricted.

9. The biomimetic gastrointestinal peristalsis stimulation abdominal binder according to claim 7 or 8, characterized in that, The inner core (62) is provided with a through hole (62d) communicating with the air pump (51), and the through hole (62d) is provided with a rotating groove (62e). The air pump (51) is provided with an air outlet (511) that can rotate along its axis, and the air outlet (511) is provided with a rotating block (51a) that can cooperate with the rotating groove (62e).

10. The biomimetic gastrointestinal peristalsis stimulation abdominal binder according to claim 7 or 8, characterized in that, The inner core (62) is provided with an O-groove (62f) around its periphery. A sealing ring (62g) is placed in the O-groove (62f). The sealing ring (62g) can abut against the annular boss (61a) in the non-working state to maintain the seal between the inner core and the valve body.

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