Logic-gated responsive release system for activation of local protection by body fluids

Abstract

The application discloses a logic-gated responsive release system for body fluid activated local protection, comprising a body fluid contact layer, a trigger interface layer, a release reservoir, a local release path and a responsive gating structure; in normal conditions, the local release path is closed to block, delay or limit the release of functional materials, and in the case of receiving the trigger signal, dissolution, swelling, degradation, softening, wetting, pore opening, capillary bridge formation, hydrogel swelling, barrier rupture or permeability enhancement occur to open the local release path, and the released functional materials are transported to the target human contact area through the local release path; the drug release behavior is controlled by the body fluid trigger condition / logic positive state, and meanwhile, the drug release module can realize local targeted protection through physical layout, greatly reducing unnecessary exposure of the functional materials in the healthy state; and the technical defects that the existing local release system lacks body fluid driving, logic gating and condition selective drug release are solved.

Description

Technical Field

[0001] This invention relates to the field of medical devices, and more particularly to a logic-gated responsive release system for local protection against body fluid activation. Background Technology

[0002] Cervical secretions, menstrual blood, vaginal fluid, wound exudate, urine, sweat, saliva, whole blood, plasma, interstitial fluid, and other bodily fluids contain local physiological and pathological information about the human body, reflecting health issues such as infection, inflammation, flora imbalance, pH changes, enzyme activity, tissue damage, wound healing status, and metabolic abnormalities. Utilizing bodily fluid states for local protection / treatment is an important research and development direction for wearable health devices, wound care, women's health products, absorbable products, and immediate therapeutic adhesives.

[0003] Existing local protective technologies include passive antibacterial coatings, drug-loaded pads, medicated dressings, hydrogel patches, responsive biomaterial films, wound dressings, feminine hygiene products, sanitary napkins with added functional materials, and local delivery systems. These products can carry protective components such as antibacterial agents, anti-inflammatory functional materials, hydrogels, nanoparticles, chitosan, polyphenols, silver preparations, antimicrobial peptides, compatible probiotic materials, and pH adjusters.

[0004] However, existing products have significant drawbacks: most products continuously or semi-continuously release active materials regardless of whether a disease / risk state exists. This passive, gateless controlled-release drug delivery causes multiple problems: unnecessary drug exposure, shortened material lifespan, uncontrollable delivery of functional materials, local irritation, disruption of beneficial flora, and inability to distinguish between normal and abnormal physiological states.

[0005] Currently, there are stimulus-responsive materials that can respond to environmental signals such as pH, enzymes, redox reactions, humidity, temperature, and microbial metabolites. For example, pH-responsive hydrogels can swell in acidic or alkaline environments, enzyme-sensitive barriers can degrade upon contact with specific enzymes, and humidity-responsive materials can release active substances after wetting. However, most of these materials can only respond to a single stimulus, and a single biomarker cannot reliably distinguish between normal physiological fluctuations and true risk states.

[0006] Taking women's health as an example: vaginal / menstrual blood pH fluctuates naturally with individual changes and the menstrual cycle; leukocyte esterase, protease activity, glucose, inflammatory markers, and microbial metabolites also exhibit physiological fluctuations. Relying solely on a single marker release system can lead to problems such as premature drug release, delayed drug release, and drug release under no-risk conditions. Similarly, in wound care, pH, humidity, exudate volume, protease activity, and inflammation levels all change during normal healing and wound infection stages. Therefore, a highly selective release system that can respond to multiple sets of bodily fluid signals and logically positive states is urgently needed, rather than responding only to a single primitive stimulus.

[0007] Paper-based fluids and wearable diagnostic devices can detect bodily fluid signals and output risk-related results, but the sensing and drug delivery functions of existing devices are independent: when the diagnostic area detects an abnormal state, the protective material area remains passive and continuously effective, making it impossible to achieve state-based gating local protection.

[0008] Some responsive dressings and intelligent wound care systems can release functional materials based on pH / enzyme activity, but these products are only designed for wound scenarios and cannot be extended to other fluid-contacting interfaces such as sanitary napkins, vaginal collection pads, panty liners, urine pads, saliva testing kits, and wearable absorbent products. At the same time, most products do not have logical gating release rules, validity verification, physical separation between sensing and drug release areas, and cannot be linked with paper-based computing risk output signals.

[0009] In the field of menstrual and feminine hygiene, existing sanitary napkins and panty liners only provide absorption, comfort, and leak prevention. A few products add fragrances, antibacterial coatings, plant extracts, and functional fibers, all of which are passively effective and do not selectively release medication based on the type of infection or the biochemical conditions of microecological imbalance. Continuous passive antibacterial treatment can disrupt the normal microecology of the intimate area, causing unnecessary contact between the user and functional materials even in a healthy state.

[0010] Chitosan, quercetin, hydrogels, antimicrobial peptides, polyphenols, polysaccharides, and nanoparticle systems have been proven to have antibacterial, anti-inflammatory, antioxidant, anti-biofilm, and wound repair effects. However, current applications are mostly in the form of coatings, films, gels, and suspensions, without controlling the release through body fluid logic rules. The materials themselves have application value, but the release architecture lacks selective activation, targeted local drug release, and conditionally gated operation design.

[0011] Overall, existing technologies have the following shortcomings:

[0012] Passive drug release drawbacks: Most pads, dressings, coatings, and topical materials continuously release active functional materials, resulting in exposure even in a risk-free environment;

[0013] Limitations of single stimulus: Most response materials only respond to single signals such as pH and humidity, and cannot distinguish between physiological fluctuations and pathological states;

[0014] Lack of logical gating control: Existing release systems do not require multiple sets of body fluid signals and paper-based logical positives to be met simultaneously before drug release is initiated;

[0015] Poor integration of diagnostic output and drug release: The sensing area and the drug storage area are independent of each other, and there is no linkage between drug release behavior and disease risk stratification;

[0016] Lack of physical separation design: Most devices do not separate the drug release area from the reading / sensing area, which can easily lead to chemical, optical, and fluid interference;

[0017] Poor carrier compatibility: Most responsive release systems are only compatible with wound dressings and are difficult to extend to body fluid interfaces such as sanitary napkins, vaginal pads, urine pads, saliva boxes, and skin patches;

[0018] Uncontrolled exposure risks: Continuous, gateless controlled-release drugs may reduce biocompatibility, disrupt beneficial bacteria, cause unnecessary antimicrobial exposure, and shorten the storage stability period of active materials;

[0019] Insufficient local targeting capability: Most systems are unable to deliver the released functional materials in a targeted manner to the designated fluid contact surface, tissue adhesion surface, or wound protection interface. Summary of the Invention

[0020] The following is an overview of the topics described in detail in this article.

[0021] The purpose of this application is to at least partially solve one of the technical problems existing in the related art. The embodiments of this application provide a logic-gated responsive release system for local protection against body fluid activation.

[0022] An embodiment of this application provides a logic-gated responsive release system for local protection against body fluid activation, comprising:

[0023] Body fluid contact layer, used to guide the fluid to the trigger interface layer;

[0024] The trigger interface layer is used to detect, identify, or respond to one or more bodily fluid trigger information, and generate trigger signals according to preset threshold rules, preset logic combination rules, or upstream paper-based fluid logic operation results.

[0025] Release the storage tank, which contains one or more protective, nursing, or therapeutic functional materials;

[0026] A local release pathway is a conduit connecting the release reservoir to the area in contact with the human body.

[0027] The responsive gating structure closes the local release pathway under normal conditions to block, delay, or limit the release of functional materials. Upon receiving the trigger signal, it undergoes dissolution, swelling, degradation, softening, wetting, pore opening, capillary bridge formation, hydrogel expansion, barrier rupture, or increased permeability to open the local release pathway and deliver the released functional materials to the target human contact area through the local release pathway.

[0028] According to certain embodiments of this application, the body fluid triggering information includes one or more of the following: pH value, leukocyte esterase status, protease activity, bacterial enzyme activity, fungal enzyme activity, inflammatory enzyme activity, microbial metabolite signal, glucose status, nitrite status, inflammatory marker status, redox status, temperature, humidity, exudate volume, wound infection-like status, microecological imbalance status, infection-like status, and positive results of paper-based fluid logic operation.

[0029] According to certain embodiments of this application, the release reservoir includes some or all of the following structures: micro reservoir, hydrogel reservoir, porous storage area, multi-layer sealed storage cavity, absorbent storage pad, polymer matrix, nanoparticle loading area, capsule interlayer, soluble storage bag, capillary locking cavity, and paper-based fluid storage tank.

[0030] According to certain embodiments of this application, the functional materials loaded in the release reservoir include: antibacterial materials, anti-inflammatory materials, anti-biofilm materials, barrier repair materials, pH regulating materials, prebiotics, adaptable probiotic materials, microecological regulation materials, hemostatic materials, wound healing promoting materials, antioxidant materials, soothing materials, nanoparticles, hydrogels, peptides, polysaccharides, polyphenols, plant extracts, chitosan-quercetin nanoparticles, or combinations thereof.

[0031] According to certain embodiments of this application, the types of the responsive gating structures include one or more of the following: pH-responsive barrier, enzyme-responsive barrier, leukocyte esterase-responsive barrier, inflammatory signal-responsive barrier, humidity-responsive barrier, redox-responsive barrier, metabolite-responsive barrier, glucose-responsive barrier, temperature-responsive barrier, soluble film, hydrogel valve, swollen polymer layer, biodegradable membrane, wetting switching barrier, capillary circuit breaker, and multilayer composite responsive membrane;

[0032] Materials used to prepare responsive gated structures include: polysaccharides, chitosan, sodium alginate, gelatin, cellulose derivatives, polyvinyl alcohol, polyethylene glycol, pH-sensitive polymers, enzyme-degradable polymers, hydrogel matrices, waxy hydrophobic barriers, soluble sugar-based films, protein-based films, peptide cross-linked hydrogels, nanocomposite coatings, or combinations of the above materials.

[0033] According to certain embodiments of this application, the responsive gating structure can be opened without an external power supply or electronic controller; the responsive gating structure is disposed between the body fluid contact layer and the release reservoir, between the trigger interface layer and the release reservoir, or between the release reservoir and the local release pathway.

[0034] According to certain embodiments of this application, the gating logic of the responsive gating structure includes:

[0035] AND gate logic requires two or more triggering conditions to open the partial release path;

[0036] OR gate logic, which opens the local release path only when any triggering condition is met;

[0037] Severity gating logic increases the release amount or release rate of functional material when additional severity support signals are present.

[0038] Threshold gating logic opens a local release path when the trigger signal reaches or exceeds a preset threshold.

[0039] Delayed gating logic: The local release pathway is only opened when the trigger condition of body fluid infiltration or circulation reaches a preset time.

[0040] Positive gating logic opens a local release path when the paper-based fluid logic operation outputs a positive result.

[0041] The effectiveness gating logic activates the local release pathway only when the effectiveness control conditions are met, confirming that the body fluid sample flow is sufficient or that the body fluid contact is adequate.

[0042] For example, pH-responsive gating allows for a significant increase in permeability when the pH of bodily fluids exceeds a preset threshold.

[0043] Enzyme-responsive gating; degradation occurs upon contact with leukocyte esterases, proteases, and bacterial / inflammatory enzymes.

[0044] Humidity-responsive gating: a capillary conduction bridge is formed after sufficient body fluid wets the area.

[0045] Redox response gating forms a capillary conduction bridge in response to redox reaction signals.

[0046] According to certain embodiments of this application, the structure of the local release pathway is: capillary microchannel, porous permeable membrane, hydrophilic liquid-conducting fiber, hydrogel channel, soluble channeling hole, microchannel, water-absorbing fiber, directional pore or anisotropic wetting structure.

[0047] According to certain embodiments of this application, the release reservoir and the local release pathway are physically separated from the sensing area, the paper-based logic operation area, the optical reading area, and the validity verification area; the physical separation methods include one or more of the following: reserved physical spacing, hydrophobic barrier layer, laminated film, vertical layering, independent fluid channel, directional drug release membrane, unidirectional flow layer, and partitioned sealed structure.

[0048] According to certain embodiments of this application, the system is integrated into sanitary napkins, panty liners, vaginal fluid collection pads, menstrual blood dressing devices, wound dressings, hydrogel wound patches, urine pads, sweat patches, skin patches, saliva detection kits, oral dressings, absorbent products, wound dressing interfaces, mucosal dressing interfaces, or disposable paper-based fluid boxes.

[0049] The above-mentioned scheme has at least the following beneficial effects: it maintains closure, low permeability, and trace release under normal body fluid conditions; when a specified body fluid trigger condition / logic positive state occurs, the gating structure opens, swells, dissolves, degrades, wets, and permeability increases, or capillary release is initiated. Drug release behavior is controlled by the body fluid trigger condition / logic positive state, and the drug release module can achieve localized targeted protection through physical layout, significantly reducing unnecessary exposure of functional materials in healthy states. This addresses the technical deficiencies of existing local release systems that lack body fluid-driven, logic-gated, and conditionally selective drug release. Attached Figure Description

[0050] The accompanying drawings are used to provide a further understanding of the technical solutions of this application and constitute a part of the specification. They are used together with the embodiments of this application to explain the technical solutions of this application and do not constitute a limitation on the technical solutions of this application.

[0051] Figure 1 This is an architecture diagram of a logic-gated responsive release system for local protection activated by body fluids;

[0052] Figure 2 This is a state diagram of a logic-gated responsive release system closing a partial release path;

[0053] Figure 3 This is a state diagram of a logic-gated responsive release system that enables a partial release path.

[0054] Figure 4 This is a schematic diagram of pH-responsive gating;

[0055] Figure 5 This is a schematic diagram of leukocyte esterase response gating;

[0056] Figure 6 This is a schematic diagram of protease response gating;

[0057] Figure 7 This is a schematic diagram of gating in response to inflammatory signals;

[0058] Figure 8 This is a schematic diagram of humidity-responsive gating;

[0059] Figure 9 This is a schematic diagram of redox response gating;

[0060] Figure 10 This is a schematic diagram of positive gating logic;

[0061] Figure 11 This is a schematic diagram of AND gate logic;

[0062] Figure 12 This is a schematic diagram of an OR gate logic;

[0063] Figure 13This is a schematic diagram of threshold gating logic;

[0064] Figure 14 This is a schematic diagram of the severity-based gating logic;

[0065] Figure 15 This is a schematic diagram of the delay gating logic;

[0066] Figure 16 This is a schematic diagram of the validity gating logic;

[0067] Figure 17 This is a schematic diagram of the release reservoir and the local release path arranged for front-side local release;

[0068] Figure 18 This is a schematic diagram of the activation process of local release pathways;

[0069] Figure 19 This is a schematic diagram illustrating the spatial separation between the release module and the sensing area;

[0070] Figure 20 This is a schematic diagram showing the separation between the release module and the sensing area through a hydrophobic wall space.

[0071] Figure 21 This is a schematic diagram showing the separation of the release module and the sensing area through a laminated film.

[0072] Figure 22 This is a schematic diagram showing the spatial separation between the release module and the sensing area via a directional membrane. Detailed Implementation

[0073] To make the objectives, technical solutions, and advantages of this application clearer, the following detailed description is provided in conjunction with the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative and not intended to limit the scope of this application.

[0074] It should be noted that although functional modules are divided in the device schematic diagram and a logical order is shown in the flowchart, in some cases, the steps shown or described may be performed in a different order than the module division in the device or the order in the flowchart. The terms "first," "second," etc., in the specification, claims, or the aforementioned drawings are used to distinguish similar objects and are not necessarily used to describe a specific order or sequence.

[0075] Most existing local protection and drug delivery systems (antibacterial pads, medicated dressings, hydrogel patches, functional absorbent products, and stimulus-responsive biomaterials) release drugs continuously and passively, or only respond to a single environmental stimulus; they cannot accurately distinguish between normal body fluid states and states such as infection-like, inflammation-like, microecological imbalance, wound infection, and risk-positive states.

[0076] The existing technology has the following problems:

[0077] Passive drug release: releasing active functional materials even under risk-free conditions;

[0078] Single stimulus limitation: Relying solely on single signals such as pH, humidity, or enzymes cannot distinguish between pathological changes and physiological fluctuations;

[0079] No logic-gated activation mechanism: It does not require multiple sets of body fluid trigger signals or logical positives to be met simultaneously for drug release;

[0080] The diagnostic system has low integration: the diagnostic output and drug release behavior are independent of each other and there is no functional linkage.

[0081] Insufficient spatial control: The drug release area is prone to interfering with sensing, optical readings, and diagnostic chemical reactions;

[0082] Uncontrolled local exposure: Continuous release of antibacterial / therapeutic functional materials can disrupt the local microecology, cause skin and mucous membrane irritation, shorten the lifespan of materials, and increase unnecessary contact with functional materials;

[0083] Limited applicability: Most release systems are only compatible with wound dressings / topical patches and cannot be widely used in sanitary napkins, vaginal collection pads, urine pads, saliva boxes, paper-based fluid devices, and other body fluid interfaces.

[0084] Aimed at addressing the technical deficiencies of existing local release systems, such as the lack of fluid-driven, logic-gated, and conditionally selective drug release, and especially the inability of existing devices to integrate multiple functions, embodiments of this application provide a logic-gated responsive release system for fluid-activated local protection.

[0085] Compared to passive antibacterial products, ordinary drug-loaded pads, and single-stimulus responsive materials, the drug release behavior of the logic-gated responsive release system provided in the embodiments of this application is controlled by body fluid triggering conditions / logic positive states. At the same time, the drug release module can achieve local targeted protection through physical layout, which greatly reduces unnecessary exposure of functional materials in a healthy state.

[0086] The embodiments of this application will be further described below with reference to the accompanying drawings.

[0087] Reference Figure 1 , Figure 2 and Figure 3 A logic-gated responsive release system for local protection against fluid activation, comprising:

[0088] Body fluid contact layer 1 is used to guide the fluid to the trigger interface layer 2;

[0089] Trigger interface layer 2 is used to detect, identify or respond to one or more bodily fluid trigger information, and generate trigger signals according to preset threshold rules, preset logic combination rules or upstream paper-based fluid logic operation results;

[0090] Release storage tank 4, which is filled with one or more protective, nursing or therapeutic functional materials;

[0091] Local release pathway 5 is a conduit connecting the release reservoir 4 and the human contact area 6;

[0092] The responsive gating structure 3 closes the local release pathway 5 under normal conditions to block, delay, or limit the release of functional materials. Upon receiving a biochemical trigger signal, it undergoes dissolution, swelling, degradation, softening, wetting, pore opening, capillary bridge formation, hydrogel expansion, barrier rupture, or increased permeability to open the local release pathway 5 and deliver the released functional materials to the target human contact area 6 through the local release pathway 5.

[0093] The following section provides a detailed description of each component of the system.

[0094] For fluid contact layer 1, fluid contact layer 1 receives and comes into contact with various human body fluids: menstrual blood, vaginal fluid, cervical secretions, wound exudate, urine, sweat, saliva, whole blood, plasma, serum, interstitial fluid, or a mixture of the above. Then the fluid is guided to trigger interface layer 2.

[0095] For trigger interface layer 2, trigger interface layer 2 captures markers in body fluids and generates a biochemical trigger signal when the marker information in the body fluids reaches the preset trigger conditions.

[0096] Fluid-triggered information includes one or more of the following: pH value, leukocyte esterase positivity, protease activity, bacterial enzyme activity, fungal enzyme activity, inflammatory enzyme activity, microbial metabolite signal, high glucose state, positive inflammatory marker, redox state, humidity, exudate volume, wound infection-like state, microecological imbalance state, infection-like state, and positive results from paper-based computational logic.

[0097] Thus, the interface layer 2 is triggered to respond to one or more bodily fluid trigger signals: pH change, leukocyte esterase positivity, protease activity, bacterial / fungal / inflammatory enzyme activity, microbial metabolites, inflammatory signals, redox, humidity, exudate volume, glucose status, nitrite status, and paper-based computational logic positive status.

[0098] For the release reservoir 4, the release reservoir 4 includes some or all of the following structures: micro reservoir, hydrogel reservoir, porous storage area, multi-layer sealed storage cavity, absorbent storage pad, polymer matrix, nanoparticle loading area, capsule interlayer, soluble storage bag, capillary locking cavity and paper-based fluid storage tank.

[0099] The arrangement of the release storage 4 includes: independent sealed cavity, printed patch, laminated sealed bag, inner layer, fiber coating area, porous membrane filling area, hydrogel plug, matrix filling channel, and independent storage island; it can be arranged above and below the sensing area 11, on the side, or completely physically separated.

[0100] Storage performance: Low base release under normal conditions, with a significant increase in drug release after activation; drug release dynamics include diffusion, capillary transport, hydrogel swelling and pushing, matrix dissolution, nanoparticle migration, capillary conduction, and body fluid replacement.

[0101] Release reservoir 4 stores one or more functional materials with protective, therapeutic, antibacterial, anti-inflammatory, anti-biofilm, barrier repair, pH regulation, prebiotic, compatible probiotic, microecological regulation, hemostatic, wound healing promotion, and soothing properties.

[0102] Functional materials are selected according to the application scenario and include: antibacterial materials, anti-inflammatory materials, anti-biofilm materials, barrier repair materials, pH regulating materials, prebiotics, compatible probiotic materials, microecological regulation materials, hemostatic materials, wound healing promoting materials, antioxidant materials, soothing materials, nanoparticles, hydrogels, peptides, polysaccharides, polyphenols, plant extracts, chitosan-quercetin nanoparticles or combinations thereof.

[0103] In a preferred embodiment, the storage container is loaded with: chitosan-quercetin nanoparticles, a hydrogel supporting the nanoparticles, a chitosan-based hydrogel, a quercetin-supported matrix, an antimicrobial peptide hydrogel, polysaccharide-polyphenol nanoparticles, or other biocompatible protective agents.

[0104] The preferred release material is chitosan-quercetin nanoparticles:

[0105] Chitosan's functions include: mucosal adhesion, film formation, broad-spectrum antibacterial activity, biocompatibility, and epithelial barrier repair.

[0106] Quercetin's effects include: antioxidant, anti-inflammatory, antibacterial, and inhibition of biofilm formation.

[0107] Nanoparticle preparation processes include: ionogel method, electrostatic self-assembly, nanoprecipitation, emulsion assembly, hydrogel blending, spray coating, freeze drying, and layer-by-layer self-assembly.

[0108] Nanoparticle loading methods: hydrogel reservoir, porous storage area, water-absorbing fiber, soluble film, paper-based matrix, non-woven fabric interlayer, micro reservoir.

[0109] Nanoparticle release triggering conditions: pH change, enzyme activity, humidity wetting, capillary conduction, barrier dissolution, hydrogel swelling, and paper-based logical positive state.

[0110] The Cs-Q formulation is only a preferred embodiment and does not limit the scope of protection of this application; the equivalent protective materials include: chitosan single-component nanoparticles, quercetin-loaded particles, polysaccharide and polyphenol nanoparticles, antimicrobial peptide hydrogels, anti-inflammatory hydrogels, adaptable probiotic materials, prebiotics, barrier repair agents, pH adjusters, hemostatic and wound healing promoting materials and compound formulations.

[0111] For example, chitosan-quercetin nanoparticles are encapsulated within a hydrogel matrix; under infection-like conditions, gated permeation conduction is activated, allowing body fluids to enter the reservoir and transport the nanoparticles along the pathway to the locally adhered surface.

[0112] Reference Figures 4 to 9 For the responsive gating structure 3, the types of responsive gating structure 3 include: pH responsive barrier, enzyme responsive barrier, leukocyte esterase responsive barrier, inflammatory signal responsive barrier, humidity responsive barrier, inflammatory signal responsive barrier, redox responsive barrier, metabolite responsive barrier, glucose responsive barrier, temperature responsive barrier, soluble film, hydrogel valve, swollen polymer layer, biodegradable membrane, wetting switching barrier, capillary circuit breaker and multilayer composite responsive membrane, one or more of these.

[0113] The materials for preparing the responsive gating structure 3 can be selected from: polysaccharides, chitosan, sodium alginate, gelatin, cellulose derivatives, polyvinyl alcohol, polyethylene glycol, pH-sensitive polymers, enzyme-degradable polymers, hydrogel matrices, waxy hydrophobic barriers, soluble sugar-based films, protein-based films, peptide cross-linked hydrogels, nanocomposite coatings, and combinations of the above materials.

[0114] The responsive gating structure 3 is disposed between the body fluid contact layer 1 and the release reservoir 4, between the trigger interface layer 2 and the release reservoir 4, or between the release reservoir 4 and the local release pathway 5.

[0115] In some embodiments, the responsive gating structure 3 can release drugs with only a single trigger signal or a combination thereof. The triggering conditions include: pH increase / decrease, leukocyte esterase positivity, protease activity, bacterial enzyme activity, fungal enzyme activity, inflammatory enzyme activity, microbial metabolite signal, high glucose state, positive inflammatory marker, redox state, humidity, exudate volume, wound infection-like state, microecological imbalance state, infection-like state, and positive output of paper-based arithmetic logic.

[0116] In other embodiments, drug release is initiated only when preset gating logic conditions are met; the gating logic conditions can be generated by chemical, paper-based fluid, mechanical, or optical methods, or output by paper-based computation.

[0117] Gating logic includes:

[0118] Reference Figure 11 AND gate logic, the local release path is opened only when two or more triggering conditions are met;

[0119] Reference Figure 12 OR gate logic, which can open the local release path when any trigger condition is met;

[0120] Reference Figure 14 Severity gating logic increases the release amount or release rate of functional materials when additional severity support signals are present.

[0121] Reference Figure 13 Threshold gating logic, which opens the local release path 5 when the trigger signal reaches or exceeds the preset threshold;

[0122] Reference Figure 15 The delayed gating logic activates the local release pathway only when the trigger condition of body fluid infiltration or circulation reaches a preset time.

[0123] Reference Figure 10 Positive gating logic, when the paper-based fluid logic operation outputs a positive result, opens the local release path 5;

[0124] Reference Figure 16 The effectiveness gating logic activates the local release pathway only when the effectiveness control conditions are met and the body fluid sample flow is sufficient or the body fluid contact is adequate.

[0125] For example, the preferred rule for gynecological vaginal / menstrual blood scenarios is: increased pH + positive leukocyte esterase, triggering drug release;

[0126] Superimposed severe signal amplification rule: elevated pH / positive leukocyte esterase+ (enzyme activity / high glucose / microbial metabolites), increase drug release intensity;

[0127] The matching paper-based logic circuit rule is: if the microbial logic is positive and the validity check is positive, drug release is initiated.

[0128] In the context of women's health, the system is triggered by infection-like conditions, with the core conditions being elevated pH and positive leukocyte esterase; elevated glucose, positive nitrite, protease activity, microbial metabolites, and inflammatory signals can serve as auxiliary triggering signals for severity.

[0129] In wound care scenarios, the system is triggered by wound infection conditions, including alkaline pH, protease activity, inflammatory enzyme activity, hyperexudate, microbial metabolite signals, or a combination of the above conditions.

[0130] The above rules are only preferred examples, and the trigger combinations can be replaced according to scenarios such as wound infection, urinary tract abnormalities, skin inflammation, oral infection, mucosal irritation, and flora imbalance.

[0131] The responsive gating structure is fluid-driven and can be opened without an external power source or electronic controller, allowing the functional materials in the release reservoir to be released locally through a local release pathway.

[0132] Reference Figure 17 For local release pathway 5, the structure of local release pathway 5 is: capillary microchannel, porous permeable membrane, hydrophilic liquid guiding fiber, hydrogel guiding groove, soluble guiding hole, microchannel, water-absorbing fiber, directional pore or anisotropic wetting structure.

[0133] Local release pathway 5 delivers the release functional material to designated contact areas: body fluid contact surface, mucosal bonding surface, wound bonding surface, skin bonding surface, absorption bonding interface, and local protective surface layer.

[0134] Reference Figure 18 The drug is released from the front side through a local release pathway 5 arranged for front-side local release. The process is as follows: the reservoir is closed, the activation is triggered, the gating is opened, and the material is released to the front side. The functional material only acts on the local biological interface and will not diffuse to the absorber core or diagnostic area. This improves the efficiency of local protection, reduces material consumption, and avoids interference with sensor readings.

[0135] In a preferred embodiment, the release module 12, which consists of the release reservoir 4, the responsive gating structure 3, and the local release pathway 5, is activated by a positive state of infection-like or microbial logic; however, it is not limited to microbial logic or gynecological applications, and can be adapted to various local risk scenarios such as wound infection, urinary tract infection, skin inflammation, and oral fluid infection.

[0136] Reference Figures 20 to 22 In some embodiments, the release reservoir 4 and the local release pathway 5 are physically separated from the sensing area 11, the paper-based logic operation area, the optical reading area 8, and the validity verification area. The physical separation methods include one or more of the following: reserved physical spacing, a hydrophobic barrier layer 13, a laminated film 14, vertical layering, independent fluid channels, directional drug release membranes, a unidirectional flow layer 15, and a partitioned sealed structure. Through physical separation, chemical interference, optical interference, reagent contamination, fluid backflow, signal crosstalk, and false positive readings are eliminated.

[0137] In a preferred embodiment, the diagnostic area outputs a risk signal, while the release area completes local protection through an independent pathway, and the two functions do not interfere with each other.

[0138] The logic-gated responsive release system can be integrated into various device forms: sanitary napkins, panty liners, vaginal fluid collection pads, wound dressings, skin patches, hydrogel patches, urine pads, saliva testing kits, absorbent products, disposable paper-based fluid boxes, wound dressing interfaces, mucosal dressing interfaces, and other local protective devices.

[0139] The logic-gated responsive release system can be equipped with mobile phones, optical colorimeters, fluorescence detectors, electrochemical detectors, and mechanical indicators to verify whether trigger conditions, logic positive states, and drug release events have occurred. The reading device functions to record trigger time, drug release location, functional material release intensity, color change, wetting state, and output window status; it also distinguishes between normal state, pending drug release state, drug release activated state, drug release completed state, unknown state, and invalid sample state. The reading device is an optional accessory and does not participate in drug release driving; the responsive release module 12 can operate independently without electronic components or external power supply.

[0140] The logic gated response release module 12 can be mass-produced using one or more of the following processes: hydrogel casting, thin film spraying / dipping, inkjet printing, screen printing, wax printing patterning, laser cutting, hot pressing lamination, adhesive bonding, micro-storage compression molding, freeze drying, electrospun fibers, nanoparticle loading, layer-by-layer self-assembly, microcapsule encapsulation, porous membrane filler, hydrogel patterning, and roll-to-roll continuous production.

[0141] The response gate and release reservoir 4 can be prefabricated separately and then assembled, or paper base, hydrogel, non-woven fabric, and multi-layer substrate can be directly used as the support layer 7 for in-situ molding; the manufacturing process can be adjusted according to the target equipment shape, compatible body fluid, triggering conditions, drug release materials, and local protection scenarios.

[0142] In one embodiment, a logic-gated response release system is integrated into sanitary napkins, panty liners, vaginal fluid collection pads, and menstrual blood bonding devices. Device structure: fluid contact surface, absorbent layer, optional paper-based fluid diagnostic circuit, response release reservoir 4, trigger response gating, and front-side directional release pathway. Triggering conditions: infection-like state, microecological imbalance (elevated pH, positive leukocyte esterase, enzyme activity, microbial metabolites, nitrite, high glucose, inflammatory signals, positive microbial logic). After triggering drug release, the reservoir releases chitosan-quercetin nanoparticles, a hydrogel loaded with these nanoparticles, a pH adjuster, prebiotics, compatible probiotics, anti-inflammatory agents, and microecological maintenance materials to the local bonding surface. Product advantages: No excess functional materials are released in a healthy state; local protection is activated only in risky states, avoiding disruption of the normal flora of the private area.

[0143] In another embodiment, a logic-gated response release system is integrated into a wound dressing or hydrogel wound patch. The dressing structure includes: a wound exudate contact layer, a trigger-response gating system, a release reservoir, and a wound-directed release pathway. Triggering conditions include: wound alkaline pH, protease activity, inflammatory enzyme activity, microbial metabolites, high exudate, redox changes, and wound infection-like conditions. Upon triggering, the reservoir releases antibacterial, anti-inflammatory, anti-biofilm, hemostatic, healing-promoting, antioxidant, barrier-repairing, and soothing nursing materials; the release pathway directionally delivers these functional materials to the wound adhesion surface, reducing diffusion loss to the outer layers.

[0144] In another embodiment, a logic-gated response release system is integrated into a urine pad, sweat patch, skin patch, saliva detection kit, oral patch, and disposable paper-based fluid cartridge. Triggering conditions for the urine device include: pH change, nitrite positivity, leukocyte esterase positivity, microbial metabolic signals, and urinary tract infection status. Triggering conditions for the sweat / skin patch include: pH change, inflammatory markers, sweat metabolites, bacterial enzyme activity, humidity, and skin irritation status. Triggering conditions for the saliva device include: pH change, microbial metabolic signals, enzyme activity, oral inflammation signals, and oral infection status. In these application scenarios, the reservoir is closed and has low activity under normal bodily fluid conditions; the protective material is released only under specified bodily fluid trigger / logic positive conditions.

[0145] Compared to traditional antibacterial pads, medicated dressings, and functional absorbent products, which involve continuous exposure and passive release of active materials, the logic-gated responsive release system in this embodiment sets up a trigger-response gating barrier to achieve conditionally selective drug release. It has the following differences: the drug release method is not simply passive; the drug release behavior is controlled by triggering conditions originating from body fluids; drug release can require multiple triggering conditions and a logic-positive state to be met simultaneously; it supports delayed, severity-graded, and effectiveness-gated drug release; the release pathway can directionally deliver functional materials to the anterior surface of the body; the drug release area can be physically separated from the diagnostic reading area; and the drug release behavior is linked to infection-like conditions, microecological imbalance, inflammation, wound infection, and risk-positive states.

[0146] The above is a detailed description of the preferred embodiments of this application, but this application is not limited to the embodiments. Those skilled in the art can make various equivalent modifications or substitutions without departing from the spirit of this application, and these equivalent modifications or substitutions are all included within the scope defined by the claims of this application.

Claims

1. A logic-gated responsive release system for local protection against body fluid activation, characterized in that, include: Body fluid contact layer, used to guide the fluid to the trigger interface layer; The trigger interface layer is used to detect, identify, or respond to one or more bodily fluid trigger information, and generate trigger signals according to preset threshold rules, preset logic combination rules, or upstream paper-based fluid logic operation results. Release the storage tank, which contains one or more protective, nursing, or therapeutic functional materials; A local release pathway is a conduit connecting the release reservoir to the area in contact with the human body. The responsive gating structure closes the local release pathway under normal conditions to block, delay, or limit the release of functional materials. Upon receiving the trigger signal, it undergoes dissolution, swelling, degradation, softening, wetting, pore opening, capillary bridge formation, hydrogel expansion, barrier rupture, or increased permeability to open the local release pathway and deliver the released functional materials to the target human contact area through the local release pathway.

2. The logic-gated responsive release system for local protection against body fluid activation according to claim 1, characterized in that, The body fluid triggering information includes one or more of the following: pH value, leukocyte esterase status, protease activity, bacterial enzyme activity, fungal enzyme activity, inflammatory enzyme activity, microbial metabolite signal, glucose status, nitrite status, inflammatory marker status, redox status, temperature, humidity, exudate volume, wound infection-like status, microecological imbalance status, infection-like status, and positive results of paper-based fluid logic operation.

3. The logic-gated responsive release system for local protection against body fluid activation according to claim 1, characterized in that, The release reservoir includes some or all of the following structures: micro reservoir, hydrogel reservoir, porous storage area, multi-layer sealed storage cavity, absorbent storage pad, polymer matrix, nanoparticle loading area, capsule interlayer, soluble storage bag, capillary locking cavity, and paper-based fluid storage tank.

4. The logic-gated responsive release system for local protection against body fluid activation according to claim 1, characterized in that, The functional materials loaded in the release reservoir include: antibacterial materials, anti-inflammatory materials, anti-biofilm materials, barrier repair materials, pH regulating materials, prebiotics, compatible probiotic materials, microecological regulating materials, hemostatic materials, wound healing promoting materials, antioxidant materials, soothing materials, nanoparticles, hydrogels, peptides, polysaccharides, polyphenols, plant extracts, chitosan-quercetin nanoparticles, or combinations thereof.

5. The logic-gated responsive release system for local protection against body fluid activation according to claim 1, characterized in that, The types of responsive gating structures include one or more of the following: pH-responsive barrier, enzyme-responsive barrier, leukocyte esterase-responsive barrier, inflammatory signal-responsive barrier, humidity-responsive barrier, redox-responsive barrier, metabolite-responsive barrier, glucose-responsive barrier, temperature-responsive barrier, soluble film, hydrogel valve, swollen polymer layer, biodegradable membrane, wetting switching barrier, capillary circuit breaker, and multilayer composite responsive membrane; Materials used to prepare responsive gated structures include: polysaccharides, chitosan, sodium alginate, gelatin, cellulose derivatives, polyvinyl alcohol, polyethylene glycol, pH-sensitive polymers, enzyme-degradable polymers, hydrogel matrices, waxy hydrophobic barriers, soluble sugar-based films, protein-based films, peptide cross-linked hydrogels, nanocomposite coatings, or combinations of the above materials.

6. The logic-gated responsive release system for local protection against body fluid activation according to claim 1, characterized in that, The responsive gating structure can be opened without an external power supply or electronic controller; the responsive gating structure is disposed between the body fluid contact layer and the release reservoir, between the trigger interface layer and the release reservoir, or between the release reservoir and the local release pathway.

7. The logic-gated responsive release system for local protection against body fluid activation according to claim 1, characterized in that, The gating logic of the responsive gating structure includes: AND gate logic requires two or more triggering conditions to open the partial release path; OR gate logic allows a partial release path to be opened when any triggering condition is met; Severity gating logic increases the release amount or release rate of functional material when additional severity support signals are present; Threshold gating logic opens a local release path when the trigger signal reaches or exceeds a preset threshold. Delayed gating logic: The local release pathway is only opened when the trigger condition of body fluid infiltration or circulation reaches a preset time. Positive gating logic opens a local release path when the paper-based fluid logic operation outputs a positive result. The effectiveness gating logic activates the local release pathway only when the effectiveness control conditions are met, confirming that the body fluid sample flow is sufficient or that the body fluid contact is adequate.

8. The logic-gated responsive release system for local protection against body fluid activation according to claim 1, characterized in that, The structure of the local release pathway is as follows: capillary microchannel, porous permeable membrane, hydrophilic liquid-conducting fiber, hydrogel channel, soluble channeling hole, microchannel, water-absorbing fiber, directional pore or anisotropic wetting structure.

9. The logic-gated responsive release system for local protection against body fluid activation according to claim 1, characterized in that, The release reservoir and the local release pathway are physically separated from the sensing area, paper-based logic operation area, optical reading area, and validity verification area; the physical separation methods include one or more of the following: reserved physical spacing, hydrophobic barrier layer, laminated film, vertical layering, independent fluid channel, directional drug release membrane, unidirectional flow layer, and partitioned sealed structure.

10. The logic-gated responsive release system for local protection against body fluid activation according to claim 1, characterized in that, The system is integrated into sanitary napkins, panty liners, vaginal fluid collection pads, menstrual blood dressing devices, wound dressings, hydrogel wound patches, urine pads, sweat patches, skin patches, saliva testing kits, oral dressings, absorbent products, wound dressing interfaces, mucosal dressing interfaces, or disposable paper-based fluid boxes.

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