A patch type ultrasonic biomarker integrated sensor and a detection method

By designing a patch-type integrated ultrasonic biomarker sensor, which combines an ultrasonic transducer array, a microneedle electrode array, and a flexible circuit, multi-parameter collaborative detection of muscle tissue is achieved. This solves the problems of single detection methods, high invasiveness, and insufficient early diagnosis in existing technologies, and is suitable for continuous monitoring of complex skin areas.

CN120918705BActive Publication Date: 2026-05-12SHENZHEN UNIV
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
SHENZHEN UNIV
Filing Date
2025-08-07
Publication Date
2026-05-12

AI Technical Summary

Technical Problem

Existing muscle injury detection technologies suffer from problems such as being single-modal, highly invasive, lacking early diagnostic capabilities, and lacking flexible and integrated design, making it difficult to achieve simultaneous assessment and real-time, continuous monitoring of muscle structure and biochemical state.

Method used

A patch-type integrated ultrasonic biomarker sensor is designed, which combines a patch-type ultrasonic transducer array, a microneedle electrode array, a flexible electronic circuit, and an acoustic coupling adhesive layer to achieve ultrasonic functional imaging, biomarker detection, and physiological electrical signal acquisition of muscle tissue. A multi-layer flexible circuit structure and a hydrogel adhesive layer are used to adapt to irregular skin areas, and the microneedle electrode array is used to painlessly penetrate the skin to obtain tissue fluid samples.

Benefits of technology

It achieves multifunctional integration of muscle tissue, enabling simultaneous detection of muscle anatomy, mechanical function, metabolic inflammation levels, and neural activity. It is suitable for continuous monitoring of complex curved areas, providing early diagnostic capabilities and avoiding the invasiveness and equipment limitations of traditional detection methods.

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Abstract

The application is suitable for the fields of high-end flexible sensing preparation and multi-modal sensing detection technology, and provides a patch type ultrasonic biomarker integrated sensor and a detection method.The sensor comprises a patch type ultrasonic transducer array, which is used for real-time monitoring of muscle and bone diseases, realizes multi-parameter multi-modal data information fusion detection and analysis of muscle and bone structure-function, a microneedle electrode array, which is used for in-situ detection of biomarkers and collection of physiological electrical signals, a flexible electronic circuit, which is used for bearing and connecting the patch type ultrasonic transducer array and the microneedle electrode array, and an acoustic coupling adhesive layer, which is used for skin fitting and acoustic coupling.The application can systematically evaluate the structure, mechanics, metabolic inflammation level and nerve function activity coordination of muscle and bone, provides a new means for early identification, quantitative evaluation and personalized intervention of muscle and bone diseases, and has important clinical and industrial values.
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Description

Technical Field

[0001] This invention relates to the field of flexible sensor fabrication and multimodal sensing and detection technology, specifically a patch-type integrated ultrasonic biomarker sensor and detection method. Background Technology

[0002] Sarcopenia and musculoskeletal disorders (such as muscle strain, tendon injury, and muscle fatigue-related musculoskeletal diseases) severely impact quality of life. Studies have found elevated levels of markers such as C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR) in patients with sarcopenia, particularly elderly patients with hip fractures. Furthermore, related studies indicate that pro-inflammatory factors, such as TNF-α and IL-6, show an elevated trend in sarcopenia patients. Meanwhile, modern industrial labor often involves work patterns characterized by low load, fast pace, high repetition, long duration, and forced postures. These forced postures easily induce local muscle fatigue, which can accumulate over time and lead to musculoskeletal damage. Currently, the clinical diagnosis of musculoskeletal injury and sarcopenia primarily relies on imaging techniques such as magnetic resonance imaging (MRI) and X-rays. However, these tools have low sensitivity in the early stages of disease and often lack a direct correlation with clinical symptoms. Especially in the early stages of musculoskeletal injury before significant structural changes have occurred, traditional imaging tools are ineffective. Against this backdrop, biomarker-based detection methods are gradually becoming an important supplementary approach. Inflammatory factors, oxidative stress products, and metabolic indicators can reflect early changes in the muscular microenvironment, representing potential means for early warning and continuous monitoring of muscle diseases. The National Institute for Occupational Safety and Health (NIOSH) in the United States also points out that detecting biomarkers in tissue fluid may allow for intervention before irreversible tissue damage occurs. Current biomarker detection methods largely rely on blood sampling or laboratory analysis, making wearable, localized, and real-time detection difficult. Furthermore, there is currently a lack of an integrated sensing system that can simultaneously monitor muscle anatomy, mechanical function, metabolic inflammation levels, and neural activity. Traditional assessment methods such as MRI, electromyography, or serological testing, while providing some information, have limitations such as expensive equipment, inability to monitor in real time, or only reflecting systemic conditions, failing to meet the clinical needs for localized, continuous, and multi-parameter monitoring of muscle tissue. Therefore, there is an urgent need for a multimodal sensing platform that combines minimally invasive puncture capabilities, electrochemical detection functions, and flexible mechanical imaging capabilities, enabling synergistic monitoring of muscle tissue structure, function, and inflammatory biomarkers for practical applications. In recent years, the rapid development of wearable flexible sensors and microneedle technology has provided new ideas for minimally invasive detection of superficial tissues. Microneedle electrodes can penetrate the stratum corneum of the skin without causing pain, effectively collecting interstitial fluid (ISF) or directly detecting local biochemical markers and physiological electrical signals in situ, such as inflammatory factors like IL-6 and TNF-α, as well as metabolites like lactic acid and pH, and electromyography. Meanwhile, ultrasound patches, due to their excellent skin adhesion and high-resolution imaging capabilities, are used for continuous monitoring of muscle structure and mechanical changes, and are particularly suitable for muscle function imaging, such as B-mode imaging, elastography, and Doppler imaging, enabling multi-parameter assessment of tissue stiffness, blood supply, and structure.

[0003] However, most existing technologies have the following drawbacks:

[0004] 1. Single modality and limited functionality: Existing muscle injury detection technologies are mostly single-modality, or can only analyze inflammatory indicators through body fluid sampling, or can only obtain tissue images (such as ultrasound, MRI), or can only obtain tissue physiological electrical signals (such as electromyography), and cannot achieve simultaneous assessment of muscle structure and biochemical state;

[0005] 2. Highly invasive and poorly wearable: Biomarker detection usually relies on invasive methods such as blood sampling and biopsy, which are not suitable for continuous dynamic monitoring and cannot collect data of the target area in real time during daily activities;

[0006] 3. Insufficient early diagnostic capabilities: For example, imaging techniques such as MRI and X-rays are not sensitive to minor injuries and early inflammatory responses, making it difficult to identify the early stages of muscle diseases before clinical symptoms appear;

[0007] 4. Lack of flexible and integrated design: Current ultrasound equipment is bulky, and microneedle sensors are mostly independent components. An integrated, flexible wearable system has not yet been formed, which limits its application in long-term monitoring and mobile scenarios.

[0008] Therefore, in view of the above situation, there is an urgent need to provide a patch-type integrated ultrasonic biomarker sensor and detection method to overcome the shortcomings in current practical applications. Summary of the Invention

[0009] The purpose of this invention is to provide an integrated patch-type ultrasonic biomarker sensor and detection method, which effectively solves the problems in the background art.

[0010] This invention is implemented as follows: a patch-type integrated ultrasonic biomarker sensor, comprising:

[0011] Patch-type ultrasonic transducer arrays are used to achieve ultrasonic functional imaging of muscle tissue and obtain structural anatomical information and stiffness distribution of muscles.

[0012] Microneedle electrode arrays are used for in-situ detection of biomarkers and acquisition of physiological electrical signals;

[0013] Flexible electronic circuitry is used to carry and connect the patch-type ultrasonic transducer array and the microneedle electrode array.

[0014] Acoustic coupling adhesive layer, used for skin adhesion and acoustic coupling.

[0015] As a further aspect of the present invention: the patch-type ultrasonic transducer array is composed of a one-dimensional or two-dimensional piezoelectric array, and the piezoelectric material of the patch-type ultrasonic transducer array includes PZT, PMN-PT, 1-3 composite material, piezoelectric polymer or micromechanical structure.

[0016] As a further aspect of the present invention: the ultrasound functional imaging includes A-mode, M-mode, two-dimensional B-mode imaging, multi-angle plane wave excitation and high-speed echo reception, Doppler blood flow imaging, and shear wave velocity estimation and elastic modulus imaging.

[0017] As a further aspect of the present invention: the microneedle electrode array is composed of ordered conductive sparse microneedles, each microneedle having a length of 500-800μm and a shape that is conical, cylindrical-conical composite, or hollow.

[0018] As a further aspect of the present invention: the surface of the microneedle electrode array is functionalized and immobilized with specific recognition molecules;

[0019] The specific recognition molecule is selected from antibodies, enzyme membranes, or electrode response membranes.

[0020] As a further aspect of the present invention: the biomarkers detected by the microneedle electrode array include inflammatory factors and metabolic indicators;

[0021] The inflammatory factors were selected from IL-6, TNF-α, and CRP;

[0022] The metabolic indicators were selected from lactate, creatine kinase, and pH value.

[0023] The physiological electrical signals include electromyographic signals.

[0024] As a further aspect of the present invention: the flexible electronic circuit is composed of a flexible substrate material and stretchable interconnecting conductors;

[0025] The flexible substrate material is selected from SEBS, PC, PI, TPU, PDMS or Eco-flex;

[0026] The stretchable interconnect conductor is a metal wire with a serpentine, horseshoe, or wavy structure.

[0027] As a further aspect of the present invention: the acoustic coupling adhesive layer is a hydrogel adhesive layer with a thickness of 200-300μm.

[0028] A method for detecting biomarkers, employing the aforementioned patch-type integrated ultrasonic biomarker sensor, includes the following steps:

[0029] The patch-type integrated ultrasound biomarker sensor is attached to the target muscle area to be monitored.

[0030] The hydrogel adhesive layer achieves adhesion to the skin and acoustic coupling, while the microneedle electrode array penetrates the stratum corneum and contacts the interstitial fluid.

[0031] The muscle injury area was located using flexible ultrasound functional imaging, and biomarkers of interstitial fluid were monitored using microneedle electrodes.

[0032] Electromyographic signals were collected using a microneedle electrode array to analyze the neurological function of muscle tissue and assess muscle fatigue.

[0033] A comprehensive assessment of muscle tissue health is conducted based on ultrasound functional imaging, microneedle biomarkers, and neurological function monitoring, generating a comprehensive analysis report.

[0034] As a further aspect of the present invention: the comprehensive analysis report includes structural images, elastograms, inflammation levels, and electromyography curves.

[0035] Compared with the prior art, the beneficial effects of the present invention are as follows:

[0036] 4. Beneficial effects compared to existing technologies:

[0037] 1. Multifunctional integration, comprehensive information dimensions

[0038] The integrated design of microneedle electrodes and ultrasound patches integrates ultrasound functional imaging, microneedle electrode biomarker detection, and physiological electrical signal (such as electromyography) acquisition, enabling in-situ synchronous detection of parameters such as muscle tissue anatomy, mechanical function, metabolic inflammation level, and neural activity synergy. Compared with traditional devices that only have single imaging or sampling functions, it achieves a more comprehensive and systematic health assessment capability.

[0039] 2. Flexible electronic circuitry, adaptable to irregular skin areas.

[0040] This invention employs a multi-layer flexible circuit structure design, including compliant materials such as SEBS, PI, PDMS, and TPU, as well as serpentine or wavy electrical interconnection methods, which significantly improves the overall fit and mechanical flexibility of the sensor. It is suitable for continuous application to complex curved areas such as the upper arm, leg, and shoulder, avoiding imaging distortion or signal interference caused by poor contact in traditional rigid probes.

[0041] 3. Minimally invasive, painless, and sustainable tissue fluid detection capabilities

[0042] The microneedle electrode layer is designed as a conductive microneedle array with a length of 500–800 μm, which can accurately penetrate the stratum corneum without touching nerve endings or capillaries, enabling in-situ continuous monitoring of metabolic and inflammatory indicators such as IL-6, TNF-α, lactic acid, and pH in interstitial fluid. This avoids the need for puncture, blood collection, and laboratory analysis required for traditional blood sampling, making it more suitable for continuous non-invasive physiological monitoring.

[0043] 4. Acoustic coupling adhesive layer

[0044] Employing an acoustic impedance-matched (1.4–1.6 MNayl) and medical-grade hydrogel layer, stable acoustic coupling and biocompatible adhesion between the skin and sensor are achieved. This can replace traditional coupling agents and also has good breathability and low allergenicity, avoiding the problems of traditional coupling agents such as easy drying, easy detachment, and easy skin discomfort. This ensures comfort and imaging quality in long-term application scenarios.

[0045] 5. Applicable to various clinical and health monitoring scenarios

[0046] It can be widely applied in areas such as sarcopenia, work-related musculoskeletal disorders, sports injury assessment, chronic fatigue monitoring, and postoperative rehabilitation follow-up. It is particularly suitable for patients who do not have significant imaging abnormalities in the early stages but whose functional or biochemical indicators are already abnormal, providing quantitative decision support for individualized intervention and precision rehabilitation. It can also be used in future smart healthcare platforms such as mobile healthcare, family health management, and AI-assisted rehabilitation assessment, and has good potential for industrialization and clinical translation. Attached Figure Description

[0047] To more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the specific embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of the present invention. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0048] Figure 1 This is a structural diagram of a patch-type integrated ultrasonic biomarker sensor provided by the present invention.

[0049] Figure 2 This is a schematic diagram of different combinations of patch-type ultrasonic transducer array and microneedle electrode array in this invention;

[0050] Figure 3 The flowchart illustrates a biomarker detection method provided by this invention.

[0051] In the attached diagram: 1-Patch ultrasonic transducer array, 2-Flexible electronic circuit, 3-Acoustic coupling adhesive layer, 4-Microneedle electrode array, 5-Microneedle electrode modification layer. Detailed Implementation

[0052] The technical solution of the present invention will now be clearly and completely described with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of the present invention. 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.

[0053] The present invention will be further explained below with reference to specific embodiments.

[0054] Please see Figures 1-3 The present invention provides a patch-type integrated ultrasonic biomarker sensor, comprising:

[0055] A patch-type ultrasonic transducer array 1 is used to realize ultrasonic functional imaging of muscle tissue and obtain structural anatomical information and stiffness distribution of muscle.

[0056] Microneedle electrode array 4 is used for in-situ detection of biomarkers and acquisition of physiological electrical signals; depending on different usage requirements and the characteristics of the target physiological region (e.g. Figure 2 As shown, the microneedle detection area is the region where the microneedle electrode array 4 is located, and the ultrasound imaging area is the region where the patch-type ultrasound transducer array 1 is located. The sensor structure can be flexibly combined to form various configurations. For example, a layered, surrounding structure can be used to achieve three-dimensional, enveloping detection of the target area; or a surrounding layout can be constructed on the same plane to achieve highly stable monitoring that adheres to the skin surface. The specific combination structure is not limited here.

[0057] Flexible electronic circuit 2 is used to carry and connect the patch ultrasonic transducer array 1 and the microneedle electrode array 4;

[0058] Acoustic coupling adhesive layer 3, used for skin adhesion and acoustic coupling;

[0059] It also includes a microneedle electrode modification layer 5.

[0060] The following is a further explanation of the patch-type ultrasonic transducer array 1, the flexible electronic circuit 2, the acoustic coupling adhesive layer 3, and the microneedle electrode array 4:

[0061] 1) Patch-type ultrasonic transducer array 1:

[0062] The patch-type ultrasonic transducer array 1 is composed of a one-dimensional or two-dimensional piezoelectric array. The piezoelectric material includes, but is not limited to, PZT, PMN-PT, 1-3 composite materials, piezoelectric polymers (such as PVDF-TrFE), or micromechanical structures (such as PMUT, CMUT). It is used to achieve ultrasonic functional imaging of muscle tissue, including but not limited to: achieving two-dimensional B-mode imaging to obtain muscle tissue structure maps; supporting multi-angle plane wave excitation and high-speed echo reception; Doppler blood flow imaging to obtain blood supply to muscle tissue; and combining shear wave tracking algorithms to achieve shear wave velocity estimation and elastic modulus imaging (SWE). It is used to obtain structural anatomical information and stiffness distribution of muscles, realizing non-invasive ultrasonic functional imaging.

[0063] 2) Microneedle electrode array 4:

[0064] This layer consists of an ordered array of conductive, sparsely spaced microneedles, each 500–800 μm long. The microneedles can be designed in a conical, column-conical composite, or hollow structure to reduce skin puncture resistance, allowing them to penetrate the stratum corneum and contact the interstitial fluid. The stratum corneum of human skin is typically 10–20 μm thick, and the epidermis is approximately 50–150 μm thick. Microneedles ≥500 μm in length ensure penetration to the superficial dermis or interstitial fluid layer beneath the epidermis, thus achieving contact with the interstitial fluid / local inflammatory factors. Their surface can be functionalized to immobilize specific recognition molecules (such as antibodies, enzyme membranes, and electrode response membranes), or designed with a hollow structure to utilize microfluidic aspiration of interstitial fluid for the detection of biological metabolites and inflammatory factors, including but not limited to:

[0065] Symptom factors: IL-6, TNF-α, CRP;

[0066] Metabolic indicators: lactate, creatine kinase, pH, etc.

[0067] Physiological signals: electromyographic signals, etc.

[0068] The detection methods include, but are not limited to, electrochemical voltammetry (CV), differential pulse voltammetry (DPV), or impedance spectroscopy (EIS), enabling in-situ, highly sensitive electrochemical detection of various biomarkers for monitoring early inflammatory states, metabolic disorders, etc.

[0069] 3) Flexible electronic circuit 2:

[0070] This is used to support and connect multimodal devices such as the patch-type ultrasonic transducer array 1, the microneedle electrode array 4, and the signal processing chip. The flexible electronic circuit 2 is composed of a flexible substrate material and stretchable interconnect conductors. The flexible substrate material is achieved using one or more combinations of polymers such as SEBS, PC, PI, and TPU, or silicone materials such as PDMS or Eco-flex, possessing good mechanical flexibility and skin compliance. Electrical interconnects utilize metal wires with special structures such as serpentine, horseshoe, and wavy shapes, or intrinsically stretchable conductive silver paste, liquid metal, or conductive polymers. It provides electrical interconnects and a flexible support structure to ensure the sensor's fit and comfort when attached to the skin surface.

[0071] 4) Acoustic coupling adhesive layer 3:

[0072] The outermost layer of the sensor features a hydrogel adhesive layer for efficient adhesion and acoustic coupling between the device and human skin. This layer is typically located between the microneedle electrode layer and the skin, or covers the contact surface of the ultrasound array area. The hydrogel adhesive layer is 200–300 μm thick, shorter than the microneedle length; an excessively thick adhesive layer would hinder the microneedles from reaching the interstitial fluid layer. The material can be a medical-grade hydrogel, such as polyacrylamide (PAAm), gelatin methacrylamide (GelMA), polyvinyl alcohol (PVA), or a composite hydrogel; it should be soft, transparent, and possess good stretchability and biocompatibility. The hydrogel's excellent wetting properties and polar groups allow for non-chemical adhesion to the skin, avoiding allergies or peeling irritation caused by traditional adhesives; ensuring long-term, stable, and low-irritation adhesion of the sensor to irregular skin surfaces such as the legs, upper arms, and shoulders. The hydrogel layer has an acoustic impedance that matches that of soft tissue (approximately 1.4–1.6 M ayl), achieving excellent ultrasound energy transmission capabilities. It can replace traditional ultrasound coupling agents, forming a low-reflection, high-transmittance acoustic interface between the patch-type ultrasound array and the skin. It ensures B-mode and shear wave imaging quality and reduces surface echo artifacts. The hydrogel is co-crosslinked or thermally bonded with a flexible encapsulation substrate; it is replaceable, facilitating multiple uses or site changes.

[0073] In this embodiment, the present invention proposes a patch-type integrated ultrasonic biomarker sensor, which is designed for in-situ detection and diagnostic assessment of muscle tissue health status through the fusion detection and analysis of multi-parameter and multi-modal data information on the structure and function of musculoskeletal tissue. The microneedle electrode sensor and the ultrasonic patch sensor work together, and the structure is integrated, the detection is complementary, and it is wearable.

[0074] The patch-type integrated ultrasound biomarker sensor provided by this invention aims to achieve in-situ simultaneous detection of anatomical configuration, mechanical function, metabolic inflammation level, and neural activity synergy within muscle tissue, solving the problems of single detection methods, insufficient early identification capability, and inability to achieve real-time dynamic monitoring in existing technologies. It provides a new means for the early identification, quantitative assessment, and personalized intervention of muscle tissue diseases, and has significant clinical and industrial value.

[0075] The patch-type integrated ultrasound biomarker sensor utilizes ultrasound functional imaging, in-situ biomarker detection, and physiological electrical signals to achieve in-situ synchronous acquisition and dynamic evaluation of key parameters related to the anatomical structure, mechanical function, metabolic inflammation level, and neurological functional activity of muscle tissue regions.

[0076] Please see Figures 1-3 This invention also provides a method for detecting biomarkers, using the aforementioned patch-type integrated ultrasonic biomarker sensor. The method includes the following steps:

[0077] The patch-type integrated ultrasound biomarker sensor is attached to the target muscle area to be monitored.

[0078] The hydrogel adhesive layer achieves adhesion to the skin and acoustic coupling, while the microneedle electrode array 4 penetrates the stratum corneum and contacts the interstitial fluid.

[0079] The muscle injury area was located using flexible ultrasound functional imaging, and biomarkers of interstitial fluid were monitored using microneedle electrodes.

[0080] Electromyographic signals were collected using a microneedle electrode array 4 to analyze the neurological function of muscle tissue and muscle fatigue status.

[0081] A comprehensive assessment of muscle tissue health is conducted based on ultrasound functional imaging, microneedle biomarkers, and neurofunctional monitoring, generating a comprehensive analysis report. This report includes structural images, elastograms, inflammation levels, and electromyography curves.

[0082] In this embodiment, a patch sensor is attached to the target muscle area to be monitored (such as the upper arm, neck, or inner thigh); the hydrogel layer achieves adhesion to the skin and acoustic coupling; the microneedle electrode array 4 non-invasively punctures the stratum corneum and contacts the interstitial fluid; firstly, the muscle injury area is subjected to B-mode structural imaging and elastography using an ultrasound array to identify the location of muscle injury, select the region of interest for shear wave excitation and high frame rate tracking, and reconstruct the elastic modulus map of the anterograde muscle area; simultaneously, the microneedles collect the concentration of inflammatory factors in the tissue fluid, and output real-time data using electrochemical methods such as differential pulse voltammetry (DPV) or electrochemical impedance spectroscopy (EIS); electromyography electrodes collect physiological signals, and the fatigue state is analyzed in combination with the upper computer algorithm; all data are wirelessly transmitted to the main control terminal to generate a comprehensive analysis report including structural images, elastograms, inflammation levels, and electromyography curves;

[0083] The system utilizes a flexible ultrasound array to achieve functional ultrasound imaging, including but not limited to: two-dimensional B-mode imaging to obtain muscle tissue structure diagrams; support for multi-angle plane wave excitation and high-speed echo reception; Doppler blood flow imaging to obtain blood supply to muscle tissue; and combining shear wave tracking algorithms to achieve shear wave velocity estimation and elastic modulus imaging (SWE). This enables the acquisition of muscle structural anatomy information and stiffness distribution, achieving non-invasive functional ultrasound imaging and accurately assessing muscle area damage, stiffness changes, and recovery.

[0084] Utilizing conductive microneedles with a length of 500-800μm to penetrate the stratum corneum and contact the interstitial fluid, and through electrode surface functional modification combined with methods such as differential pulse voltammetry (DPV) or electrochemical impedance spectroscopy (EIS), highly sensitive in-situ detection of various inflammatory factors and metabolites such as IL-6, TNF-α, lactate, and pH, as well as physiological electrical signals and electromyographic signals, is achieved, providing multi-dimensional comprehensive detection capabilities.

[0085] By integrating structural ultrasound B-mode images of muscles (including anatomical features such as muscle thickness, fiber length and angle, and echo intensity), shear wave elastography images (including shear wave velocity, muscle shear stiffness distribution, and viscoelastic parameters), in-situ biomarker detection results (such as inflammatory factors IL-6 and TNF-α, metabolites lactate, creatine kinase, and pH), and neurological function indicators (such as electromyography signals), a multimodal fusion detection and analysis of muscle tissue based on structure, mechanics, biochemistry, and neurology has been achieved. This multimodal integration strategy can systematically assess the anatomical configuration, mechanical function, metabolic inflammation level, and neural activity synergy of muscle status, and is particularly suitable for early screening, dynamic monitoring, and intervention assessment of various physiological or pathological conditions such as sarcopenia, sports injuries, occupational muscle fatigue, and postoperative rehabilitation.

[0086] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, and not to limit them; although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some or all of the technical features; and these modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. A patch-type integrated ultrasonic biomarker sensor, characterized in that, include: Patch-type ultrasonic transducer arrays are used to realize ultrasonic functional imaging of muscle tissue, enabling the fusion detection and analysis of structural-functional multi-parameter multimodal data information for musculoskeletal structures. Microneedle electrode arrays are used for in-situ detection of biomarkers and acquisition of physiological electrical signals; Flexible electronic circuitry is used to carry and connect the patch-type ultrasonic transducer array and the microneedle electrode array. Acoustic coupling adhesive layer, used for skin adhesion and acoustic coupling; The microneedle electrode array is composed of ordered conductive sparse microneedles, each with a length of 500-800 μm and a shape that is conical, cylindrical-conical composite, or hollow. The surface of the microneedle electrode array is functionalized to fix specific recognition molecules. The specific recognition molecule is selected from antibodies, enzyme membranes, or electrode response membranes; The microneedle electrode array is used to detect biomarkers including inflammatory factors and metabolic indicators; The inflammatory factors were selected from IL-6, TNF-α, and CRP; The metabolic indicators were selected from lactate, creatine kinase, and pH value. The physiological electrical signals include electromyographic signals; The flexible electronic circuit is composed of a flexible substrate material and stretchable interconnecting conductors; The flexible substrate material is selected from SEBS, PC, PI, TPU, PDMS or Eco-flex; The stretchable interconnect conductor is a metal wire with a serpentine, horseshoe, or wavy structure.

2. The patch-type integrated ultrasonic biomarker sensor according to claim 1, characterized in that, The patch-type ultrasonic transducer array is composed of a one-dimensional or two-dimensional piezoelectric array, and the piezoelectric material of the patch-type ultrasonic transducer array includes PZT, PMN-PT, 1-3 composite material or piezoelectric polymer.

3. The patch-type integrated ultrasonic biomarker sensor according to claim 1, characterized in that, The ultrasound functional imaging includes two-dimensional B-mode imaging, multi-angle plane wave excitation and high-speed echo reception, Doppler blood flow imaging, and shear wave velocity estimation and elastic modulus imaging.

4. The patch-type integrated ultrasonic biomarker sensor according to claim 1, characterized in that, The acoustic coupling adhesive layer is a hydrogel adhesive layer with a thickness of 200-300 μm.

5. A method for detecting biomarkers, employing the patch-type integrated ultrasonic biomarker sensor as described in any one of claims 1-4, characterized in that, The method includes the following steps: The patch-type integrated ultrasound biomarker sensor is attached to the target muscle area to be monitored. The hydrogel adhesive layer achieves adhesion to the skin and acoustic coupling, while the microneedle electrode array penetrates the stratum corneum and contacts the interstitial fluid. The muscle injury area was located using flexible ultrasound functional imaging, and biomarkers of interstitial fluid were monitored using microneedle electrodes. Electromyographic signals were collected using a microneedle electrode array to analyze the neurological function of muscle tissue and assess muscle fatigue. A comprehensive assessment of muscle tissue health is conducted based on ultrasound functional imaging, microneedle biomarkers, and neurological function monitoring, generating a comprehensive analysis report.

6. The detection method according to claim 5, characterized in that, The comprehensive analysis report includes structural images, elastograms, inflammation levels, and electromyography curves.