An intelligent implantable biochemical indicator monitoring sensor

Abstract

The present application discloses an intelligent implantable biochemical index monitoring sensor, which relates to the technical field of biosensors, and includes a blood glucose signal acquisition component, wherein the signal acquisition component includes a working electrode, a reference electrode, an electroactive domain and a blood glucose signal transmitting end, wherein one end of the working electrode and the reference electrode are in contact with the electroactive domain, an insulating layer is provided between the working electrode and the reference electrode, and the other ends of the working electrode and the reference electrode are electrically connected to the blood glucose signal transmitting end; the problem of the need to reserve an opening on the tissue surface, which causes the pain caused by the opening being pulled when used by the patient, and the greater risk of infection after the opening is pulled and torn, is avoided, thereby improving the comfort and safety of the patient in wearing the sensor, and facilitating the long-term implantation and use of the sensor.

Description

Technical Field

[0001] The present invention relates to the technical field of biosensors, and in particular to an intelligent implantable biochemical indicator monitoring sensor. Background Art

[0002] Implantable sensors can continuously and in real time monitor the patient's physical signs, such as blood sugar, blood lipids, and blood potassium concentrations, thereby providing more accurate and comprehensive health data. Implantable sensors and extracorporeal electronic components together constitute implantable medical devices for determining the presence and concentration of biological analytes. From the perspective of lightweight, implantable medical devices tend to be miniaturized, so the overall thickness of extracorporeal electronic components is required to be thinner and thinner. Sensors, as indispensable, are electrically connected to extracorporeal electronic components by providing multiple conductive contacts on the extracorporeal electronic components, which are directly connected to the working electrode and the reference electrode of the sensor, respectively. In order to avoid the potential short circuit risk between the working electrode and the reference electrode, the distance between the conductive contacts is usually increased, which correspondingly requires that the portion of the working electrode and the reference electrode used for electrical connection is longer, which is in contradiction with the thinner thickness of the extracorporeal electronic components required.

[0003] In order to solve the above problems, a Chinese patent with announcement number CN114767105B proposes an implantable electrochemical biosensor, which bends the sensor so that the part of the sensor electrically connected to the external electronic component is arranged in a manner nearly parallel to the surface of the external electronic component. That is, the sensor is bent between the sensing end and the electrical connection end, the sensing end is implanted in the body, and the electrical connection end not implanted in the body is electrically connected to the external electronic component, so that the external electronic component can be set to be thinner to meet the demand for lightweight.

[0004] Another disadvantage is that the sensor requires an opening to be reserved on the tissue surface for electrically connecting the sensor's electrodes to external electronic components. When the patient wears it, the opening on the tissue surface is easily pulled when the muscles move or the external electronic components are touched, increasing the patient's pain. In addition, when the opening is pulled and torn, there is a greater risk of infection, which is not conducive to the long-term implantation and use of the sensor. Summary of the invention

[0005] The present application provides an intelligent implantable biochemical indicator monitoring sensor to solve the problem in the comparative document that an opening needs to be reserved on the tissue surface, which causes pain when the opening is pulled when the patient uses it, and a greater risk of infection after the opening is pulled and torn. It improves the comfort and safety of the patient's wearing and facilitates the long-term implantation and use of the sensor.

[0006] The present application provides an intelligent implantable biochemical indicator monitoring sensor, including a blood glucose signal acquisition component, wherein the blood glucose signal acquisition component includes a working electrode, a reference electrode, an electroactive domain and a blood glucose signal transmitting end, wherein one end of the working electrode and the reference electrode are in contact with the electroactive domain, an insulating layer is provided between the working electrode and the reference electrode, the other ends of the working electrode and the reference electrode are electrically connected to the blood glucose signal transmitting end, and the blood glucose signal transmitting end sends the electrical signal to an external receiving end via wireless transmission.

[0007] Furthermore, the blood glucose signal acquisition component also includes a first biocompatible film, and the first biocompatible film covers the reference electrode and the electroactive domain.

[0008] Furthermore, it also includes a connecting belt, in which a battery is provided, the battery is electrically connected to the blood sugar signal collection component, and the blood sugar signal collection component is fixedly connected to the connecting belt.

[0009] Furthermore, the connecting belt is also fixedly connected with a blood lipid signal acquisition component, a body temperature signal acquisition component, and a blood potassium signal acquisition component, and the battery is electrically connected to the blood lipid signal acquisition component, the body temperature signal acquisition component, and the blood potassium signal acquisition component.

[0010] Furthermore, the structure of the blood lipid signal acquisition component is the same as that of the blood glucose signal acquisition component. The electroactive domain in the blood glucose signal acquisition component uses glucose oxidase, and the electroactive domain in the blood lipid signal acquisition component uses cholesterol oxidase. The body temperature signal acquisition component includes a body temperature detection circuit and a body temperature signal transmitting end.

[0011] Furthermore, the blood potassium signal acquisition component includes a sensitive membrane, an internal reference electrode, a solid electrolyte, an electrode tube, a blood potassium signal transmitting end and a second biocompatible membrane, the sensitive membrane is fixedly connected to the electrode tube, the inner side of the electrode tube is in contact with the solid electrolyte, the inner side of the solid electrolyte is in contact with the internal reference electrode, the solid electrolyte is in contact with the sensitive membrane, the internal reference electrode and the electrode tube are both electrically connected to the blood potassium signal transmitting end, and the sensitive membrane and the electrode tube are wrapped by the second biocompatible membrane.

[0012] Furthermore, the connecting belt is provided with a corrugated section, the corrugated section is provided between adjacent signal collection components, there are three corrugated sections in total, and the corrugated sections are made of flexible material.

[0013] Furthermore, the connecting belt is made of hydrogel.

[0014] Furthermore, a biomass power generation component is provided on the inner side of the connecting belt, and the biomass power generation component is used to provide electrical energy to the battery.

[0015] Furthermore, the bio-power generation components are arranged inside the corrugated section, and there are six groups of bio-power generation components in total, and the bio-power generation components adopt nano-piezoelectric generators.

[0016] One or more technical solutions provided in this application have at least the following technical effects or advantages: Firstly, by setting a signal transmitting end, the electrical signals of the working electrode and the reference electrode are sent to the external receiving end, thereby avoiding the electrical connection of the sensor with the external electronic components in the prior art, and further avoiding the thickness of the external electronic components required for the connection, thereby adapting to lightweight. In addition, it also solves the problem that the electrical connection between the sensor and the external electronic components requires an opening to be reserved on the tissue surface, which causes pain when the opening is pulled when used by the patient, and a greater risk of infection after the opening is pulled and torn, thereby improving the comfort and safety of the patient's wearing, and facilitating the long-term implantation and use of the sensor.

[0017] Secondly, by using a connecting belt to integrate the blood sugar acquisition component, the blood lipid signal acquisition component, the body temperature signal acquisition component and the blood potassium signal acquisition component, blood sugar, blood lipid, body temperature and blood potassium can be monitored simultaneously when the sensor is implanted, avoiding the problem of multiple sensors needing to be implanted multiple times to monitor multiple human biochemical indicators in the prior art, thereby achieving the integration and lightweight of the sensor.

[0018] Thirdly, by providing a corrugated section on the connecting belt, the corrugated section is made of flexible material, so that the connecting belt can bend and deform under force to adapt to the ups and downs of human muscle tissue, thereby improving the adaptability of the sensor to the human body and enhancing the comfort of the user.

[0019] Fourthly, by arranging a biopower generation component on the inner side of the corrugated section, the biopower generation component is electrically connected to the battery in the connecting belt. The biopower generation component adopts a nano-piezoelectric generator. When the connecting belt is continuously bent to adapt to the human muscle activity, the piezoelectric material of the nano-piezoelectric generator is repeatedly bent together with the corrugated section, and then the mechanical energy brought by the human muscle activity is converted into electrical energy to supply the battery. Therefore, when a small-sized and small-capacity battery is selected, the sensor can still be implanted for a long time, thereby realizing the miniaturization and lightweight of the sensor and improving the service life of the sensor. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] Figure 1 A cross-sectional view of a blood sugar signal acquisition component of an intelligent implantable biochemical indicator monitoring sensor proposed by the present invention Figure 2 A schematic diagram of the three-dimensional structure of an intelligent implantable biochemical indicator monitoring sensor proposed by the present invention Figure 3A cross-sectional view of a blood potassium signal acquisition component of an intelligent implantable biochemical indicator monitoring sensor proposed by the present invention Figure 4 A schematic diagram of the structure of a connecting belt of an intelligent implantable biochemical indicator monitoring sensor proposed by the present invention Figure 5 A cross-sectional view of a connecting belt of an intelligent implantable biochemical indicator monitoring sensor proposed by the present invention In the figure: 100. Blood glucose signal acquisition component; 200. Blood lipid signal acquisition component; 300. Body temperature signal acquisition component; 400. Blood potassium signal acquisition component; 1. Working electrode; 2. Reference electrode; 3. Electroactive domain; 4. Blood glucose signal transmitting end; 5. Insulating layer; 6. First biocompatible membrane; 7. Connecting belt; 8. Sensitive membrane; 9. Internal reference electrode; 10. Solid electrolyte; 11. Electrode tube; 12. Blood potassium signal transmitting end; 13. Second biocompatible membrane; 14. Corrugated section; 15. Bio-power generation component. DETAILED DESCRIPTION

[0021] To facilitate the understanding of the present invention, the present application will be described more comprehensively below with reference to the relevant drawings; the drawings show preferred embodiments of the present invention, but the present invention can be implemented in many different forms and is not limited to the embodiments described herein; on the contrary, the purpose of providing these embodiments is to enable a more thorough and comprehensive understanding of the disclosed content of the present invention.

[0022] It should be noted that the terms “vertical”, “horizontal”, “up”, “down”, “left”, “right” and similar expressions used in this document are only for illustrative purposes and do not represent the only implementation method.

[0023] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by technicians in the technical field to which the present invention belongs; the terms used in the specification of the present invention are only for the purpose of describing specific embodiments and are not intended to limit the present invention; the term "and / or" used herein includes any and all combinations of one or more related listed items.

[0024] Embodiment 1: Figure 1As shown, the present application provides an intelligent implantable biochemical indicator monitoring sensor including a blood glucose signal acquisition component 100, wherein the blood glucose signal acquisition component 100 includes a working electrode 1, a reference electrode 2, an electroactive domain 3 and a blood glucose signal transmitting terminal 4, wherein one end of the working electrode 1 and the reference electrode 2 are in contact with the electroactive domain 3, an insulating layer 5 is provided between the working electrode 1 and the reference electrode 2, and the other ends of the working electrode 1 and the reference electrode 2 are electrically connected to the blood glucose signal transmitting terminal 4, and the blood glucose signal transmitting terminal 4 sends the electrical signal to an external receiving terminal via wireless transmission.

[0025] Furthermore, the blood glucose signal acquisition component 100 further includes a first biocompatible membrane 6 , which covers the reference electrode 2 and the electroactive domain 3 .

[0026] Furthermore, the electroactive domain 3 in the blood sugar signal collection component 100 uses glucose oxidase.

[0027] Specific implementation: The user implants the sensor subcutaneously in the upper arm, and the working electrode 1 contacts the glucose molecules in the blood through the electroactive domain 3. The glucose molecules react with the glucose oxidase on the working electrode 1 to generate current, and the magnitude of the current is proportional to the concentration of glucose. The reference electrode 2 mainly provides a stable potential for correcting the current on the working electrode 1 to ensure the accuracy of the measurement. The insulating layer 5 is arranged between the working electrode 1 and the reference electrode 2 to prevent direct electrical contact between the two electrodes to ensure the accuracy of the current measurement. The electroactive domain 3 is the area where the working electrode 1 and the reference electrode 2 react with the glucose molecules in the blood sample. The other ends of the working electrode 1 and the reference electrode 2 are electrically connected to the blood glucose signal transmitting end 4, and the blood glucose signal transmitting end 4 sends the collected electrical signal to the external receiving end through wireless transmission. The first biocompatible film 6 covers the reference electrode 2 and the electroactive domain 3 to ensure the contact between the electrode and the blood sample while maintaining biocompatibility to prevent contamination and cell damage. The external receiving end receives and processes the electrical signal to complete the monitoring of the patient's blood glucose.

[0028] The technical solutions in the above embodiments of the present application have at least the following technical effects or advantages: By setting up a signal transmitting end, the electrical signals of the working electrode 1 and the reference electrode 2 are sent to an external receiving end, thereby avoiding the electrical connection of the sensor with the external electronic components in the prior art, and further avoiding the thickness of the external electronic components required for connection, thereby adapting to lightweight. In addition, it also solves the problem that the electrical connection between the sensor and the external electronic components requires an opening to be reserved on the tissue surface, which causes pain when the opening is pulled when used by the patient, and a greater risk of infection after the opening is pulled and torn, thereby improving the comfort and safety of the patient's wearing, and facilitating the long-term implantation and use of the sensor.

[0029] Embodiment 2: When users monitor human biochemical indicators, they need to monitor not only blood sugar, but also blood lipids, body temperature, and blood potassium. The embodiment of the present application is optimized based on the above embodiment.

[0030] like Figure 2-Figure 3 As shown, it also includes a connecting belt 7, in which a battery is provided. The battery is electrically connected to the blood sugar signal acquisition component 100, and the blood sugar signal acquisition component 100 is fixedly connected to the connecting belt 7.

[0031] Furthermore, the connecting belt 7 is also fixedly connected with a blood lipid signal acquisition component 200, a body temperature signal acquisition component 300, and a blood potassium signal acquisition component 400, and the battery is electrically connected to the blood lipid signal acquisition component 200, the body temperature signal acquisition component 300, and the blood potassium signal acquisition component 400.

[0032] Furthermore, the structure of the blood lipid signal acquisition component 200 is the same as that of the blood glucose signal acquisition component 100. The electroactive domain 3 in the blood glucose signal acquisition component 100 uses glucose oxidase, and the electroactive domain 3 in the blood lipid signal acquisition component 200 uses cholesterol oxidase. The body temperature signal acquisition component 300 includes a body temperature detection circuit and a body temperature signal transmitting end.

[0033] Furthermore, the blood potassium signal acquisition component 400 includes a sensitive membrane 8, an internal reference electrode 9, a solid electrolyte 10, an electrode tube 11, a blood potassium signal transmitting end 12 and a second biocompatible membrane 13, the sensitive membrane 8 is fixedly connected to the electrode tube 11, the inner side of the electrode tube 11 is in contact with the solid electrolyte 10, the inner side of the solid electrolyte 10 is in contact with the internal reference electrode 9, the solid electrolyte 10 is in contact with the sensitive membrane 8, the internal reference electrode 9 and the electrode tube 11 are both electrically connected to the blood potassium signal transmitting end 12, and the sensitive membrane 8 and the electrode tube 11 are wrapped by the second biocompatible membrane 13.

[0034] The technical solutions in the above embodiments of the present application have at least the following technical effects or advantages: The blood glucose signal acquisition component 100, the blood lipid signal acquisition component 200, the body temperature signal acquisition component 300 and the blood potassium signal acquisition component 400 are integrated by using a connecting belt 7, so that blood glucose, blood lipids, body temperature and blood potassium can be monitored simultaneously when the sensor is implanted, avoiding the problem of multiple sensors being implanted multiple times to monitor multiple human body signs in the prior art, thereby achieving integration and lightweight of the sensor.

[0035] Embodiment 3: When the sensor in the above embodiment is in use, due to its increased lateral size and the influence of muscle activity when implanted in the human body, the non-deformable sensor will increase the user's foreign body sensation; the embodiment of the present application is optimized based on the above embodiment.

[0036] like Figure 4 As shown, the connecting belt 7 is provided with a corrugated section 14, and the corrugated section 14 is provided between adjacent signal acquisition components. There are three corrugated sections 14 in total, and the corrugated sections 14 are made of flexible material.

[0037] Furthermore, the connecting belt 7 is made of hydrogel.

[0038] The technical solutions in the above embodiments of the present application have at least the following technical effects or advantages: By providing the corrugated section 14 on the connecting belt 7 and using a flexible material, the connecting belt 7 can bend and deform under force to adapt to the ups and downs of human muscle tissue, thereby improving the adaptability of the sensor to the human body and enhancing the comfort of the user.

[0039] Embodiment 4: The connecting belt 7 in the above embodiment will be repeatedly bent by muscle activity, and this part of mechanical energy is not utilized; the embodiment of the present application is optimized to a certain extent on the basis of the above embodiment.

[0040] like Figure 5 As shown, a biomass power generation component 15 is provided inside the connecting belt 7, and the biomass power generation component 15 is used to provide electrical energy to the battery.

[0041] Furthermore, the bio-power generation components 15 are arranged inside the corrugated section 14 , and there are six groups of the bio-power generation components 15 . The bio-power generation components 15 use nano-piezoelectric generators.

[0042] The technical solutions in the above embodiments of the present application have at least the following technical effects or advantages: By arranging a biopower generation component 15 on the inner side of the corrugated section 14, the biopower generation component 15 is electrically connected to the battery in the connecting belt 7. The biopower generation component 15 adopts a nano-piezoelectric generator. Therefore, when the connecting belt 7 is continuously bent to adapt to the muscle activity of the human body, the piezoelectric material of the nano-piezoelectric generator is repeatedly bent together with the corrugated section 14, and then the mechanical energy brought by the muscle activity of the human body is converted into electrical energy to supply the battery. Therefore, when a small-sized and small-capacity battery is selected, the sensor can still be implanted for a long time, thereby realizing the miniaturization and lightweight of the sensor and improving the service life of the sensor.

[0043] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. For those skilled in the art, the present invention may have various modifications and variations. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention shall be included in the protection scope of the present invention.

Claims

1. An intelligent implantable biochemical indicator monitoring sensor, characterized in that: The invention comprises a blood glucose signal acquisition component (100), wherein the blood glucose signal acquisition component (100) comprises a working electrode (1), a reference electrode (2), an electroactive domain (3) and a blood glucose signal transmitting end (4), wherein one end of the working electrode (1) and the reference electrode (2) are in contact with the electroactive domain (3), an insulating layer (5) is provided between the working electrode (1) and the reference electrode (2), the other ends of the working electrode (1) and the reference electrode (2) are electrically connected to the blood glucose signal transmitting end (4), and the blood glucose signal transmitting end (4) transmits the electrical signal to an external receiving end through wireless transmission.

2. The intelligent implantable biochemical indicator monitoring sensor according to claim 1, characterized in that: The blood sugar signal acquisition component (100) further comprises a first biocompatible film (6), wherein the first biocompatible film (6) covers the reference electrode (2) and the electroactive domain (3).

3. The intelligent implantable biochemical indicator monitoring sensor according to claim 1, characterized in that: It also comprises a connecting belt (7), wherein a battery is arranged in the connecting belt (7), the battery is electrically connected to the blood sugar signal collection component (100), and the blood sugar signal collection component (100) is fixedly connected to the connecting belt (7).

4. The intelligent implantable biochemical indicator monitoring sensor according to claim 3, characterized in that: The connecting belt (7) is also fixedly connected to a blood lipid signal acquisition component (200), a body temperature signal acquisition component (300), and a blood potassium signal acquisition component (400); and the battery is electrically connected to the blood lipid signal acquisition component (200), the body temperature signal acquisition component (300), and the blood potassium signal acquisition component (400).

5. The intelligent implantable biochemical indicator monitoring sensor according to claim 4, characterized in that: The structure of the blood lipid signal acquisition component (200) is the same as that of the blood glucose signal acquisition component (100); the electroactive domain (3) in the blood glucose signal acquisition component (100) uses glucose oxidase, while the electroactive domain (3) in the blood lipid signal acquisition component (200) uses cholesterol oxidase; the body temperature signal acquisition component (300) comprises a body temperature detection circuit and a body temperature signal transmitting end.

6. The intelligent implantable biochemical indicator monitoring sensor according to claim 4, characterized in that: The blood potassium signal acquisition component (400) comprises a sensitive membrane (8), an internal reference electrode (9), a solid electrolyte (10), an electrode tube (11), a blood potassium signal transmitting end (12) and a second biocompatible membrane (13); the sensitive membrane (8) is fixedly connected to the electrode tube (11); the inner side of the electrode tube (11) is in contact with the solid electrolyte (10); the inner side of the solid electrolyte (10) is in contact with the internal reference electrode (9); the solid electrolyte (10) is in contact with the sensitive membrane (8); the internal reference electrode (9) and the electrode tube (11) are both electrically connected to the blood potassium signal transmitting end (12); and the sensitive membrane (8) and the electrode tube (11) are wrapped by the second biocompatible membrane (13).

7. The intelligent implantable biochemical indicator monitoring sensor according to claim 3, characterized in that: The connecting belt (7) is provided with a corrugated section (14), the corrugated section (14) being provided between adjacent signal collection components, a total of three corrugated sections (14) being provided, and the corrugated sections (14) being made of a flexible material.

8. The intelligent implantable biochemical indicator monitoring sensor according to claim 5, characterized in that: The connecting belt (7) is made of hydrogel.

9. The intelligent implantable biochemical indicator monitoring sensor according to claim 7, characterized in that: A biomass power generation component (15) is provided on the inner side of the connecting belt (7), and the biomass power generation component (15) is used to provide electrical energy to the battery.

10. The intelligent implantable biochemical indicator monitoring sensor according to claim 9, characterized in that: The bio-power generation components (15) are arranged inside the corrugated section (14), and a total of six groups of the bio-power generation components (15) are provided. The bio-power generation components (15) use nano-piezoelectric generators.

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