A flexible probe device for integrated compound muscle electrical stimulation and ultrasound imaging therapy

Abstract

This invention discloses an integrated flexible probe device combining combined muscle electrical stimulation and ultrasound imaging therapy. The ultrasound imaging and treatment module is connected to external ultrasound imaging and ultrasound therapy equipment to achieve ultrasound matching with the area to be imaged and treated, emitting ultrasound waves, receiving returned ultrasound waves, and transmitting them to the external ultrasound imaging and ultrasound therapy equipment. The electrical stimulation module is connected to an external electrical stimulation circuit to emit electrical stimulation pulses. This invention integrates a rigid ultrasound imaging probe, an array of piezoelectric ceramic sheets for ultrasound therapy, and an electrode layer. After connecting these components to the external ultrasound imaging, ultrasound therapy, and external electrical stimulation circuits, it overcomes the shortcomings of existing separate treatment schemes, achieving visualized ultrasound guidance, accurate positioning of damaged and atrophied muscles, real-time ultrasound monitoring, and dual therapeutic effects of ultrasound and electrical stimulation. This enables precise and targeted treatment of sarcopenia, improving treatment efficacy and efficiency.

Description

Technical Field

[0001] This invention belongs to the field of ultrasound and electrical pulse probes, specifically relating to an integrated flexible probe device for combined muscle electrical stimulation and ultrasound imaging therapy. Background Technology

[0002] Sarcopenia is a comprehensive degenerative disease characterized by a decrease in the volume and number of skeletal muscle fibers, decreased muscle strength, and increased connective tissue and fat. Its prevalence increases rapidly with age, and it is also very high among disabled and hospitalized patients. Therefore, sarcopenia is a major health problem facing the elderly and hospitalized patients in my country now and in the future. Exploring the best diagnostic and treatment methods for sarcopenia, and achieving early detection, accurate diagnosis, and active treatment, is key to improving patients' quality of life and survival rate.

[0003] Both neuromuscular electrical stimulation (EMS) and phased-array focused pulsed ultrasound (PIP) promote muscle tissue regeneration, improve muscle atrophy, and enhance muscle function, making them important treatment methods for sarcopenia rehabilitation. Combining these two techniques can enhance treatment efficacy and shorten treatment time and rehabilitation course. Furthermore, combining high-frequency continuous wave ultrasound diagnostic technology with visualized ultrasound guidance allows for accurate localization of damaged and atrophied muscles and real-time monitoring of treatment effects, thereby achieving precise and targeted treatment of sarcopenia and improving treatment effectiveness and efficiency. Therefore, simultaneous treatment with visualized ultrasound-guided EMS combined with PPI trimodal ultrasound has become a highly efficient, precise, and safe treatment method for sarcopenia.

[0004] Therefore, it is necessary to develop a flexible probe that integrates ultrasound imaging and treatment for composite muscle electrical stimulation therapy, so as to achieve an interface between precise ultrasound guidance, synergistic electro / acoustic trimodal composite therapy, and human body action. Summary of the Invention

[0005] To address the aforementioned problems, the present invention aims to provide an integrated flexible probe device for combined muscle electrical stimulation and ultrasound imaging therapy. Through an integrated structural design and the combination of a flexible matching layer and a rigid matching layer, a good acoustic matching design is achieved. This not only meets the integrated requirements of ultrasound imaging, ultrasound therapy, and electrical stimulation therapy, but also satisfies the acoustic matching between the probe and the human body and the good electrical stimulation output, allowing the probe to fit well with the skin.

[0006] The specific technical solution for achieving the objective of this invention is as follows:

[0007] An integrated flexible probe device combining combined muscle electrical stimulation and ultrasound imaging therapy, comprising an ultrasound imaging and treatment module and an electrical stimulation module;

[0008] The ultrasound imaging and treatment module is connected to external ultrasound imaging equipment and ultrasound treatment equipment to achieve ultrasound matching with the area to be imaged and treated, emit ultrasound waves, receive returned ultrasound waves, and transmit them to external ultrasound imaging equipment and ultrasound treatment equipment.

[0009] The electrical stimulation module is connected to an external electrical stimulation circuit and is used to generate electrical stimulation pulses.

[0010] Furthermore, the electrical stimulation module includes an electrode layer;

[0011] The electrode layer consists of two "U"-shaped electrodes with a central gap, one positive and one negative, each with a lead wire connected to an external electrical stimulation circuit. It receives and outputs electrical pulses generated by the external electrical stimulation circuit.

[0012] Furthermore, the ultrasound imaging and treatment module includes a flexible matching layer, a piezoelectric composite layer, and a double-layer flexible circuit layer;

[0013] The flexible matching layer, the piezoelectric composite layer, and the double-layer flexible circuit layer are connected in sequence.

[0014] The double-layer flexible circuit layer is used to connect the piezoelectric composite layer to external ultrasound imaging equipment and ultrasound therapy equipment.

[0015] The flexible matching layer and the piezoelectric composite layer work together to achieve acoustic impedance matching between the probe device and the part to be acted upon.

[0016] Furthermore, the piezoelectric composite layer includes an ultrasonic imaging probe and an ultrasonic therapy piezoelectric ceramic sheet;

[0017] The ultrasonic imaging probe and the ultrasonic therapy piezoelectric ceramic sheet are disposed on the piezoelectric composite layer substrate;

[0018] Multiple ultrasonic therapy piezoelectric ceramic plates are arranged in an array, with an ultrasonic imaging probe positioned at the center of the array.

[0019] A double-layer rigid acoustic matching layer is spin-coated onto the ultrasonic therapy piezoelectric ceramic sheet;

[0020] The double-layer rigid acoustic matching layer and flexible matching layer spin-coated on the ultrasonic therapy piezoelectric ceramic sheet work together to achieve acoustic impedance matching with the site to be treated.

[0021] Furthermore, the acoustic impedance of the double-layer rigid acoustic matching layer and the flexible matching layer is set as follows:

[0022] ;

[0023] ;

[0024] ;

[0025] in, The acoustic impedance of the piezoelectric ceramic sheet, The acoustic impedance of the part to be acted upon. The acoustic impedance of the first rigid acoustic matching layer spin-coated beneath the piezoelectric ceramic sheet used in ultrasonic therapy. The acoustic impedance of the second rigid acoustic matching layer spin-coated beneath the piezoelectric ceramic sheet used in ultrasonic therapy. The acoustic impedance of the flexible matching layer.

[0026] Furthermore, the dual-layer flexible circuit layer includes a positive electrode flexible island-bridge circuit layer and a negative electrode flexible island-bridge circuit layer;

[0027] The negative electrode flexible island-bridge circuit layer is used to connect the ultrasonic therapy piezoelectric ceramic sheet to the negative electrode of the external ultrasonic therapy device.

[0028] The positive electrode flexible island-bridge circuit layer includes an ultrasonic therapy positive electrode circuit, an ultrasonic imaging positive electrode circuit, and an ultrasonic imaging negative electrode circuit. The ultrasonic therapy positive electrode circuit connects the ultrasonic therapy piezoelectric ceramic sheet to the positive electrode of an external ultrasonic therapy device, and the ultrasonic imaging positive electrode circuit and the ultrasonic imaging negative electrode circuit connect the probe device to the positive and negative electrodes of an external ultrasonic imaging device.

[0029] Furthermore, the electrodes of the electrode layer are cast using graphene as a filler and PDMS as a base material.

[0030] The preparation process of the electrode layer electrode is as follows:

[0031] (1) Add anhydrous ethanol to the test tube and perform ultrasonic cleaning. Clean the tube after cleaning.

[0032] (2) Prepare glass tube solution. Take graphene into a glass tube to reach the required mass. Add diluent at a ratio of 1:10. After preparing the glass tube solution, put it into an ultrasonic instrument for ultrasonic mixing.

[0033] (4) Prepare test tube solutions. Two test tube solutions are required for the graphene glass tube solution, referred to as ab tubes below. Tube a is a 1:1 mixture of PDMS and cyclohexane, and tube b is a 1:1 mixture of curing agent and cyclohexane. The amount of each is 10% PDMS. After the test tube solutions are prepared, place them on a jog mixer for jog mixing.

[0034] (4) After the liquid in tubes a and b is mixed and the liquid in the glass tube is mixed by ultrasonication, first add the liquid in tube a to the glass tube and stir magnetically, then add the liquid in tube b to the glass tube and continue stirring magnetically.

[0035] (5) Drop the liquid from the glass tube into the mold and let it stand to complete the electrode preparation.

[0036] Furthermore, the flexible matching layer is spin-coated with alumina as filler and PDMS as base material. The acoustic impedance of the flexible matching layer is 2MRayl-3MRayl, and the thickness of the flexible matching layer (2) is... , The length of the ultrasonic wave.

[0037] Furthermore, the fabrication process of the flexible matching layer is as follows:

[0038] (1) Add anhydrous ethanol to the test tube and perform ultrasonic cleaning;

[0039] (2) Determine the mass of each component of PDMS, cyclohexane, and curing agent according to the proportion;

[0040] (3) Take aluminum oxide into the test tube to achieve the required mass;

[0041] (4) Take small amounts of PDMS into the test tube multiple times to achieve the required mass;

[0042] (5) Take small amounts of cyclohexane and curing agent into the test tube in sequence to achieve the required mass;

[0043] (6) Stir the test tube for 8 minutes to mix thoroughly;

[0044] (7) Drop the liquid from the test tube into the mold, place it for heating and curing, and let it stand to complete the preparation of the flexible matching layer (2).

[0045] Compared with the prior art, the beneficial effects of the present invention are as follows:

[0046] (1) The present invention integrates the rigid ultrasound imaging probe, the ultrasound therapy piezoelectric ceramic sheet array and the electrode layer into a single arrangement, and connects them with the external ultrasound imaging equipment, the ultrasound therapy equipment and the external electrical stimulation circuit. This overcomes the defects of the existing separate treatment schemes, realizes visualized ultrasound guidance, accurately locates damaged and atrophied muscles, provides real-time ultrasound monitoring and dual treatment effects of ultrasound and electrical stimulation, thereby achieving precise and targeted treatment of sarcopenia and improving treatment effect and efficiency.

[0047] (2) Most of the materials in the present invention are composed of flexible material polydimethylsiloxane (PDMS), and the acoustic impedance matching with the part to be acted is achieved together by the designed double-layer rigid acoustic matching layer and flexible matching layer. This realizes dynamic adaptation, long-term fit and efficient acoustic coupling of the curved surface of the part to be acted, replacing the traditional liquid coupling agent required by existing ultrasound equipment, and avoiding the problems caused by traditional liquid coupling agents, such as the need for frequent replacement after long-term use and easy infection of wounds.

[0048] The present invention will be further described below with reference to specific embodiments. Attached Figure Description

[0049] Figure 1 This is a schematic diagram of the integrated flexible probe device for combined muscle electrical stimulation and ultrasound imaging therapy according to the present invention.

[0050] Figure 2 This is a schematic diagram of the electrode layer of the present invention.

[0051] Figure 3 This is a schematic diagram of the piezoelectric composite layer of the present invention.

[0052] Figure 4 This is a schematic diagram of the piezoelectric ceramic and the double-layer rigid ultrasonic matching layer in the piezoelectric composite layer of the present invention.

[0053] Figure 5 This is a schematic diagram of the positive electrode flexible island-bridge circuit layer of the present invention.

[0054] Figure 6 This is a schematic diagram of the through-hole connection between the positive electrode flexible island-bridge circuit layer and the piezoelectric composite layer in an embodiment of the present invention.

[0055] Figure 7 This is a schematic diagram of the negative electrode flexible island-bridge circuit layer of the present invention.

[0056] Figure 8 This is a schematic diagram of the through-hole connection between the negative electrode flexible island-bridge circuit layer and the piezoelectric composite layer in an embodiment of the present invention.

[0057] Figure 9 This is a schematic diagram showing the connection between the probe device and the functional part in an embodiment of the present invention.

[0058] Figure 10 This is a schematic diagram showing the connection between the probe device, external electrical stimulation circuit, and ultrasound equipment in an embodiment of the present invention. Detailed Implementation

[0059] Example

[0060] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. 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.

[0061] As indicated in this application and claims, unless the context clearly indicates otherwise, the words "a," "an," "an," and / or "the" do not specifically refer to the singular and may also include the plural. Generally speaking, the terms "comprising" and "including" only indicate the inclusion of explicitly identified steps and elements, which do not constitute an exclusive list, and the method or apparatus may also include other steps or elements.

[0062] Unless otherwise specifically stated, the relative arrangement, numerical expressions, and values ​​of the components and steps described in these embodiments do not limit the scope of this application. It should also be understood that, for ease of description, the dimensions of the various parts shown in the drawings are not drawn to actual scale. Techniques, methods, and devices known to those skilled in the art may not be discussed in detail, but where appropriate, such techniques, methods, and devices should be considered part of the specification. In all examples shown and discussed herein, any specific values ​​should be interpreted as merely exemplary and not as limitations. Therefore, other examples of exemplary embodiments may have different values. It should be noted that similar reference numerals and letters in the following drawings denote similar items; therefore, once an item is defined in one drawing, it need not be further discussed in subsequent drawings.

[0063] Combination Figure 1 An integrated flexible probe device combining combined muscle electrical stimulation and ultrasound imaging therapy, comprising an ultrasound imaging and treatment module and an electrical stimulation module;

[0064] The ultrasound imaging and treatment module is connected to external ultrasound imaging and ultrasound treatment equipment to achieve ultrasound matching with the area to be imaged and treated, emit ultrasound waves, receive the returned ultrasound waves, and transmit them to the external ultrasound imaging and ultrasound treatment equipment; the ultrasound imaging and treatment module and the electrical stimulation module are bonded together from top to bottom, and the overall structure is encapsulated by PDMS.

[0065] The electrical stimulation module is connected to an external electrical stimulation circuit and is used to generate electrical stimulation pulses;

[0066] In this embodiment, the ultrasound imaging and treatment module and the external ultrasound imaging and ultrasound treatment devices are connected by wires, and the electrical stimulation module and the external electrical stimulation circuit are also connected by wires.

[0067] Combination Figure 2 The electrical stimulation module includes an electrode layer 1;

[0068] The electrode layer 1 consists of two "U"-shaped electrodes with a central gap, one positive and one negative. Copper wires are led out from each electrode and connected to an external electrical stimulation circuit. The electrode layer receives and outputs electrical pulses generated by the external electrical stimulation circuit.

[0069] The ultrasound imaging and treatment module includes a flexible matching layer 2, a piezoelectric composite layer 3, and a double-layer flexible circuit layer;

[0070] The flexible matching layer 2, the piezoelectric composite layer 3, and the double-layer flexible circuit layer are bonded together from bottom to top;

[0071] The double-layer flexible circuit layer is used to connect the piezoelectric composite layer 3 to external ultrasound imaging equipment and ultrasound therapy equipment.

[0072] The flexible matching layer 2 and the piezoelectric composite layer 3 work together to achieve acoustic impedance matching between the probe device and the part to be acted upon.

[0073] Specifically, combined Figure 3 The piezoelectric composite layer 3 includes an ultrasonic imaging probe 3.1 and an ultrasonic therapy piezoelectric ceramic sheet 3.2;

[0074] The ultrasonic imaging probe 3.1 and the ultrasonic therapy piezoelectric ceramic sheet 3.2 are disposed on the piezoelectric composite layer 3 substrate, i.e., on PDMS;

[0075] Multiple ultrasonic therapy piezoelectric ceramic sheets 3.2 are arranged in an array, and an ultrasonic imaging probe 3.1 is located at the center of the array. In this embodiment, there are a total of 64 ultrasonic therapy piezoelectric ceramic sheets 3.2, arranged in an 8x8 array, and the ultrasonic imaging probe 3.1 is located at the center of the array.

[0076] Combination Figure 4 The ultrasonic therapy piezoelectric ceramic sheet 3.2 is spin-coated with a double-layer rigid acoustic matching layer, and the hollow slots between the layers are filled with injected PDMS.

[0077] The double-layer rigid acoustic matching layer and flexible matching layer (2) spin-coated on the ultrasonic therapy piezoelectric ceramic sheet 3.2 together achieve acoustic impedance matching with the site to be treated.

[0078] According to the KLM model, the acoustic impedance of the double-layer rigid acoustic matching layer and the flexible matching layer is set as follows:

[0079]

[0080]

[0081]

[0082] in, The acoustic impedance of the piezoelectric ceramic sheet, The acoustic impedance of the part to be acted upon. The acoustic impedance of the first rigid acoustic matching layer spin-coated beneath the piezoelectric ceramic sheet used in ultrasonic therapy. The acoustic impedance of the second rigid acoustic matching layer spin-coated beneath the piezoelectric ceramic sheet used in ultrasonic therapy. Acoustic impedance of the flexible matching layer;

[0083] In this embodiment, Value , Value , Value Due to manufacturing errors in the experiment, Acoustic impedance can be in the range of 10 MRayl to 11 MRayl. Acoustic impedance can be in the range of 4 MRayl-5 MRayl. The acoustic impedance can be in the range of 2MRayl-3MRayl.

[0084] In addition, the piezoelectric composite layer 3 in this embodiment uses a type 1-3 PZT / epoxy resin piezoelectric composite material as the ultrasonic transducer unit material, and its two rigid matching layers are composite materials of epoxy resin and alumina.

[0085] Combination Figures 5 to 8 The double-layer flexible circuit layer includes a positive electrode flexible island-bridge circuit layer 4 and a negative electrode flexible island-bridge circuit layer 5; the double-layer flexible circuit layer including the positive electrode flexible island-bridge circuit layer 4 and the negative electrode flexible island-bridge circuit layer 5 are respectively connected to the piezoelectric composite layer 3 through the provided through holes, and the double-layer flexible circuit layer including the positive electrode flexible island-bridge circuit layer 4 and the negative electrode flexible island-bridge circuit layer 5 are also respectively connected to the ultrasonic imaging probe 3.1;

[0086] The negative electrode flexible island-bridge circuit layer 5 is used to connect the ultrasonic therapy piezoelectric ceramic sheet 3.2 to the negative electrode of the external ultrasonic therapy device.

[0087] The positive electrode flexible island-bridge circuit layer 4 includes an ultrasonic therapy positive electrode circuit 4.1, an ultrasonic imaging positive electrode circuit 4.3, and an ultrasonic imaging negative electrode circuit 4.4. The ultrasonic therapy positive electrode circuit 4.1 connects the ultrasonic therapy piezoelectric ceramic sheet 3.2 to the positive electrode of an external ultrasonic therapy device, and the ultrasonic imaging positive electrode circuit 4.3 and the ultrasonic imaging negative electrode circuit 4.4 connect the probe device to the positive and negative electrodes of an external ultrasonic imaging device.

[0088] The composite flexible probe of this solution integrates ultrasound imaging and treatment through composite muscle electrical stimulation therapy. It combines the ultrasound imaging probe, the ultrasound therapy piezoelectric ceramic plate array, and the electrical stimulation electrode into one unit, which are driven independently and cooperate with each other during use. This not only achieves wideband ultrasound imaging and good piezoelectric performance of ultrasound therapy, but also achieves good conductivity output of electrical stimulation therapy.

[0089] In addition, apart from the rigid ultrasound imaging probe and the piezoelectric ceramic plate array for ultrasound therapy, all other parts are made of flexible polydimethylsiloxane (PDMS) or composite materials based on PDMS (without changing the flexibility of PDMS), which makes the probe have good flexibility and can be adapted to the legs with different curvatures. In actual operation, pressure can be applied by the outer strap to better fit the skin, effectively and accurately completing the treatment of sarcopenia patients.

[0090] In addition, in this embodiment, the electrode of the electrode layer 1 is cast with 25% graphene as filler and PDMS as base material, with a resistance value of 0.2kΩ-1kΩ and a thickness of 0.1cm-0.2cm.

[0091] The preparation process of the electrode in electrode layer 1 is as follows:

[0092] (1) Add anhydrous ethanol to the test tube, perform ultrasonic cleaning for 15 minutes, and then clean with a lint-free cloth;

[0093] (2) Calculate the mass of each component according to the proportion. Put on gloves and turn on the electronic balance. After zeroing the balance, put the disposable glass tube on the electronic balance and prepare the glass tube solution. Take graphene until the glass tube reaches the required mass. Add diluent at a ratio of 1:10 (in actual experiments, diluent is usually added at a ratio of 1:15 or higher, with the diluent covering the graphene as the standard). After preparing the glass tube solution, put it into an ultrasonic instrument for ultrasonic mixing for 1 hour, changing the water every 10 minutes or so.

[0094] (4) Prepare test tube solutions. Two test tube solutions are required for the graphene glass tube solution (taking 2g PDMS as an example). They are referred to as tubes a and b below. Tube a is a mixture of PDMS and cyclohexane in a 1:1 ratio, and tube b is a mixture of curing agent and cyclohexane in a 1:1 ratio. The amount of each is 10% PDMS. After the test tube solutions are prepared, place them on a jog mixer for jog mixing for 8-10 minutes.

[0095] (4) After the liquid in tubes a and b is mixed and the liquid in the glass tube is ultrasonically mixed, first add the liquid in tube a to the glass tube and stir magnetically for 1 hour, then add the liquid in tube b to the glass tube and continue stirring magnetically for 0.5 hours. Stirring should be done at room temperature at 1500 rpm (the time can be extended).

[0096] (5) Drop the liquid from the glass tube into the mold and let it stand for 1-2 days to complete the electrode preparation.

[0097] The flexible matching layer 2 is spin-coated with 25% alumina as filler and PDMS as base material. The acoustic impedance of the flexible matching layer 2 is 2MRayl-3MRayl, and the thickness of the flexible matching layer 2 is [missing information]. , The length of the ultrasonic wave.

[0098] The fabrication process of the flexible matching layer 2 is as follows:

[0099] (1) Add anhydrous ethanol to the test tube and perform ultrasonic cleaning for 15 minutes. After cleaning, clean with a lint-free cloth.

[0100] (2) Determine the mass of each component of PDMS, cyclohexane and curing agent according to the ratio (PDMS:cyclohexane:curing agent is 1:1:0.2);

[0101] (3) Take aluminum oxide into the test tube to achieve the required mass;

[0102] (4) Take small amounts of PDMS into the test tube multiple times to achieve the required mass;

[0103] (5) Take small amounts of cyclohexane and curing agent into the test tube in sequence to achieve the required mass;

[0104] (6) Stir the test tube for 8 minutes to mix thoroughly;

[0105] (7) Drop the liquid from the test tube into the mold, place it on a heating platform to solidify at 100 degrees Celsius, and let it stand for 1-2 days to complete the preparation.

[0106] The dual-layer flexible circuit layer is first fabricated with PDMS films containing through-holes corresponding to the positive and negative electrodes of the ultrasonic therapy piezoelectric ceramic sheet and the ultrasonic imaging probe, respectively. Then, the target circuit pattern and through-hole filling are printed onto the PDMS film using composite silver ink using electrofluid inkjet printing technology. The film is then sintered at 85°C for 30 minutes, 160°C for 10 minutes, 280°C for 10 minutes, and 350°C for 10 minutes. After sintering, a second PDMS film with through-holes corresponding to the negative electrode of the ultrasonic therapy piezoelectric ceramic sheet is cast, and the second circuit layer is printed and the through-holes are filled. After printing, the film is then heated and cured.

[0107] The integrated flexible probe device for combined muscle electrical stimulation and ultrasound imaging therapy in this scheme is fabricated as follows: positive and negative electrode wires connected to the external electrical stimulation drive are placed in a mold. After the electrode layer 1 is cast and cured, the flexible matching layer 2 is cast. After the flexible matching layer 2 is cured, the ultrasound imaging probe 3.1 and the ultrasound therapy piezoelectric ceramic sheet 3.2 array with a double-layer rigid acoustic matching layer spin-coated on the bottom are arranged. Then, the hollow slots between the layers are filled with PDMS to expose the positive and negative electrodes of the ultrasound imaging probe 3.1 and the ultrasound therapy piezoelectric ceramic sheet 3.2 array with a double-layer rigid acoustic matching layer spin-coated on the bottom.

[0108] The through-hole molds are placed at the positive and negative terminals respectively, and PDMS is poured. After curing, the circuit pattern printed on the PDMS film with composite silver ink using electrohydraulic inkjet printing technology is sintered. After sintering, the wires are soldered to the circuit pattern. Then, the through-hole molds are fixed and another layer of PDMS is poured. The second layer of circuit is then printed. After printing, it is heated and cured. After curing, the copper wires that are connected to the external ultrasound treatment and imaging drive are soldered to the circuit pattern.

[0109] After testing the continuity of the circuit and confirming that it is working properly, encapsulate it with PDMS and lead out the copper wires of the ultrasound imaging and treatment module and the electrode layer.

[0110] like Figure 9and Figure 10 As shown, by attaching a probe device with complete electrical connections to a person's thigh, the functions of ultrasound imaging monitoring, ultrasound therapy, and electrical stimulation therapy can be realized.

[0111] The embodiments described above are merely illustrative of several implementation methods of this application, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the invention patent. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of this application, and these all fall within the protection scope of this application. Therefore, the protection scope of this patent application should be determined by the appended claims.

Claims

1. An integrated flexible probe device for combined muscle electrical stimulation and ultrasound imaging therapy, characterized by, It includes an ultrasonic imaging and treatment module and an electrical stimulation module; Among them, the ultrasonic imaging and treatment module is connected to an external ultrasonic imaging device and an ultrasonic treatment device, and is used to achieve ultrasonic matching with the imaging and treatment site to be imaged, emit ultrasonic waves, receive the returned ultrasonic waves and transmit them to the external ultrasonic imaging device and ultrasonic treatment device; The electrical stimulation module is connected to an external electrical stimulation circuit and is used to emit electrical stimulation pulses; The ultrasonic imaging and treatment module includes a flexible matching layer (2), a piezoelectric composite layer (3) and a double-layer flexible circuit layer; The flexible matching layer (2), the piezoelectric composite layer (3) and the double-layer flexible circuit layer are connected in sequence; Among them, the double-layer flexible circuit layer is used to connect the piezoelectric composite layer (3) with an external ultrasonic imaging device and an ultrasonic treatment device; The flexible matching layer (2) and the piezoelectric composite layer (3) cooperate to achieve acoustic impedance matching between the probe device and the site to be acted on; The piezoelectric composite layer (3) includes an ultrasonic imaging probe (3.1) and an ultrasonic treatment piezoelectric ceramic sheet (3.2); The ultrasonic imaging probe (3.1) and the ultrasonic treatment piezoelectric ceramic sheet (3.2) are arranged on the substrate of the piezoelectric composite layer (3); Multiple ultrasonic treatment piezoelectric ceramic sheets (3.2) are arranged in an array form, and the ultrasonic imaging probe (3.1) is arranged at the center of the array; A double-layer rigid acoustic matching layer is spin-coated on the ultrasonic treatment piezoelectric ceramic sheet (3.2); The double-layer rigid acoustic matching layer spin-coated on the ultrasonic treatment piezoelectric ceramic sheet (3.2) and the flexible matching layer (2) together achieve acoustic impedance matching with the site to be acted on; The acoustic impedance of the double-layer rigid acoustic matching layer and the flexible matching layer is set as: ； ； ； in, The acoustic impedance of the piezoelectric ceramic sheet, The acoustic impedance of the part to be acted upon. The acoustic impedance of the first rigid acoustic matching layer spin-coated beneath the piezoelectric ceramic sheet used in ultrasonic therapy. The acoustic impedance of the second rigid acoustic matching layer spin-coated beneath the piezoelectric ceramic sheet used in ultrasonic therapy. The acoustic impedance of the flexible matching layer.

2. The integrated flexible probe device for combined muscle electrical stimulation and ultrasound imaging therapy according to claim 1, characterized in that, The electrical stimulation module includes an electrode layer (1); The electrode layer (1) is two positive and negative "return" - shaped electrodes with a middle partition, and wires are respectively led out and connected to an external electrical stimulation circuit to receive and output the electrical pulses generated by the external electrical stimulation circuit.

3. The integrated flexible probe device for combined muscle electrical stimulation and ultrasonic imaging treatment according to claim 1, the double-layer flexible circuit layer includes a positive flexible island-bridge circuit layer (4) and a negative flexible island-bridge circuit layer (5); wherein The negative flexible island-bridge circuit layer (5) is used to connect the ultrasonic treatment piezoelectric ceramic sheet (3.2) to the negative pole of an external ultrasonic treatment device; The positive flexible island-bridge circuit layer (4) includes an ultrasonic treatment positive circuit (4.1), an ultrasonic imaging positive circuit (4.3) and an ultrasonic imaging negative circuit (4.4). The ultrasonic treatment positive circuit (4.1) connects the ultrasonic treatment piezoelectric ceramic sheet (3.2) to the positive pole of an external ultrasonic treatment device, and the ultrasonic imaging positive circuit (4.3) and the ultrasonic imaging negative circuit (4.4) connect the probe device to the positive and negative poles of an external ultrasonic imaging device.

4. The integrated flexible probe device for combined muscle electrical stimulation and ultrasound imaging therapy of claim 2, wherein, The electrode of the electrode layer (1) is made by pouring graphene as a filler and PDMS as a base material, and the The preparation process of the electrode of the electrode layer (1) is: (1) Add absolute ethanol into a test tube, perform ultrasonic cleaning, and clean it after cleaning; (2) Prepare glass tube solution. Take graphene into a glass tube to reach the required mass. Add diluent at a ratio of 1:

10. After preparing the glass tube solution, put it into an ultrasonic instrument for ultrasonic mixing. (4) Prepare test tube solutions. Two test tube solutions are required for the graphene glass tube solution, referred to as ab tubes below. Tube a is a 1:1 mixture of PDMS and cyclohexane, and tube b is a 1:1 mixture of curing agent and cyclohexane. The amount of each is 10% PDMS. After the test tube solutions are prepared, place them on a jog mixer for jog mixing. (4) After the liquid in tubes a and b is mixed and the liquid in the glass tube is mixed by ultrasonication, first add the liquid in tube a to the glass tube and stir magnetically, then add the liquid in tube b to the glass tube and continue stirring magnetically. (5) Drop the liquid from the glass tube into the mold and let it stand to complete the electrode preparation.

5. The integrated flexible probe device for combined muscle electrical stimulation and ultrasound imaging therapy of claim 1, wherein, The flexible matching layer (2) is formed by spin coating with alumina as filler and PDMS as base material. The acoustic impedance of the flexible matching layer (2) is 2MRayl-3MRayl, and the thickness of the flexible matching layer (2) is... , The length of the ultrasonic wave.

6. The integrated flexible probe device for combined muscle electrical stimulation and ultrasound imaging therapy according to claim 1, characterized in that, The fabrication process of the flexible matching layer (2) is as follows: (1) Add anhydrous ethanol to the test tube and perform ultrasonic cleaning; (2) Determine the mass of each component of PDMS, cyclohexane, and curing agent according to the proportion; (3) Take aluminum oxide into the test tube to achieve the required mass; (4) Take small amounts of PDMS into the test tube multiple times to achieve the required mass; (5) Take small amounts of cyclohexane and curing agent into the test tube in sequence to achieve the required mass; (6) Stir the test tube for 8 minutes to mix thoroughly; (7) Drop the liquid from the test tube into the mold, place it for heating and curing, and let it stand to complete the preparation of the flexible matching layer (2).

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