Implantable biological electrode and component thereof

Abstract

The utility model relates to the technical field of biological information monitoring, and discloses an implantable biological electrode which comprises a signal output electrode, an annular body and a sensing section, and the signal output electrode is arranged on the annular body and used for being connected with an external circuit; the middle of the annular body is of an inner ring structure, the sensing section extends out of the inner side wall of the inner ring structure, and the sensing section can be bent downwards; before bending, the sensing section straightly extends into the inner ring structure, and after bending, the sensing section is exposed out of the bottom of the inner ring structure. According to the design, the overall thickness of the biological electrode is reduced, and the user experience is improved.

Description

Technical Field

[0001] The utility model relates to the technical field of biological information monitoring, in particular to an implantable biological electrode and a component thereof. Background Art

[0002] For people with diabetes, traditional fingertip blood glucose meters are invasive, provide limited information, and are unable to reflect blood glucose fluctuations and provide early warnings. These shortcomings no longer meet the needs of some people, especially those with type 1 diabetes who require real-time information on blood glucose fluctuations, and those with type 2 diabetes who require intensive insulin therapy. To meet the needs of continuous blood glucose monitoring, a biometric monitoring device with an introducer needle implanted in the subcutaneous tissue to measure blood glucose concentrations in interstitial fluid is a practical and practical continuous monitoring method. Its single-use lifespan is one to two weeks, significantly reducing the pain associated with continuous fingertip and venous blood sampling.

[0003] In the existing technology, implantable bioelectrodes are generally in an upright position, which is convenient for semi-insertion into the human subcutaneous tissue. However, the thickness of the biosensor will become thicker due to the height of the bioelectrode, which reduces the user's wearing experience. Most of the bioelectrodes on the market use additional accessories for assembly, such as using point gluing to connect multiple plastic parts and electrodes to achieve a sealed cavity, or using additional sealing rings to achieve sealing. The sealing structure of the bioelectrode is relatively complex.

[0004] Therefore, how to reduce the overall thickness of the bioelectrode and simplify the sealing structure of the bioelectrode to improve the user experience has become a technical problem that needs to be solved urgently. Utility Model Content

[0005] The main purpose of the present utility model is to provide an implantable electrode and an assembly, aiming to solve the technical problem of how to reduce the overall thickness of the bioelectrode and simplify the sealing structure of the bioelectrode.

[0006] To achieve the above objectives, in a first aspect, the present invention provides an implantable bioelectrode, comprising a signal output electrode, an annular body, and a sensing segment, wherein the signal output electrode is disposed on the annular body for connection to an external circuit; the annular body is connected to at least one sensing segment, and the annular body is a generally flat, continuous annular arrangement;

[0007] An inner ring structure is provided in the middle of the annular body, the sensing section extends from the inner side wall of the inner ring structure, and the sensing section can be bent downward;

[0008] Before bending, the sensing section extends straightly within the inner ring structure, and after bending, the sensing section leaks out of the bottom of the inner ring structure.

[0009] Preferably, the annular body further comprises an outer ring structure and a sealing ring body, wherein the sealing ring body is respectively connected to the outer ring structure and the inner ring structure;

[0010] The outer ring structure is provided with a pair of first assembly notches, and the two first assembly notches are symmetrically arranged relative to the central axis of the inner ring structure;

[0011] A line connecting the centerlines of the two first assembly gaps passes through the center point of the inner ring structure, and the line connecting the centerlines of the two first assembly gaps is perpendicular to the middle longitudinal section of the sensing section.

[0012] When the annular body on both sides of a pair of first assembly notches is squeezed, and when the two ends perpendicular to the pair of first assembly notches are squeezed, the sensing section bends from a straight extension state to a state leaking out from the bottom of the inner ring structure.

[0013] Preferably, the outer ring structure is provided with a pair of cutting edges on the outer peripheral side, and the two first assembly notches are respectively located at one cutting edge; the two cutting edges are symmetrically arranged relative to the central axis of the inner ring structure; and the two cutting edges are parallel to each other.

[0014] Preferably, the outer ring structure is provided with a pair of positioning holes, and the two positioning holes are respectively located between a first assembly notch and the inner ring structure; the two positioning holes are symmetrically arranged relative to the central axis of the inner ring structure; the two positioning holes are located at the connecting line of the two first assembly notches.

[0015] Preferably, the number of the sensing segments is one or more; the types of electrodes on all the sensing segments include three types of electrodes: a working electrode, a reference electrode and a counter electrode;

[0016] The sensing section is a single electrode structure, and is provided with one of a working electrode, a reference electrode and a counter electrode; or the sensing section is a composite electrode structure, and is provided with at least two of a working electrode, a reference electrode and a counter electrode.

[0017] Preferably, the sensing section is in the shape of an elongated strip, the width of the sensing section is 0.1 mm to 0.4 mm, the thickness of the sensing section is 0.05 mm to 0.3 mm, and the length of the sensing section is 2 mm to 7 mm;

[0018] After bending, the bending angle α between the sensing section and the annular body is 90° to 100°.

[0019] Preferably, the annular width of the outer ring structure is 0.5 mm to 2 mm, the diameter of the inner ring structure is 3 mm to 6 mm, and the outer ring diameter of the annular body is 9 mm to 40 mm.

[0020] The shape of the inner ring structure includes one or more shapes such as circle, ellipse, racetrack, etc.

[0021] The shape of the outer ring structure includes one or more shapes such as circle, ellipse, racetrack, etc.

[0022] Preferably, the signal output electrode includes a counter electrode contact, a working electrode contact and a reference electrode contact, and the electrodes on the sensing segment are electrically connected to external devices through the counter electrode contact, the working electrode contact and the reference electrode contact respectively.

[0023] Preferably, the sensing segments are arranged in an interdigitated arrangement, or in a daisy-shaped arrangement with the tips facing the center, or in a comb-shaped arrangement.

[0024] In a second aspect, the present application discloses an implantable bioelectrode, comprising the implantable bioelectrode of the first aspect above, wherein the number of the sensing segments is two; the two sensing segments are arranged opposite to each other; before bending, the two sensing segments respectively extend straight within the inner ring structure, and after bending, the two sensing segments respectively leak out of the bottom of the inner ring structure.

[0025] In a third aspect, the present application discloses an implantable bioelectrode, comprising the implantable bioelectrode of the first aspect above, wherein the annular body is provided with a fan-shaped notch, the fan-shaped notch connects the inner ring structure and the outer circumference of the annular body, and the center of the fan-shaped notch is the center of the inner ring structure.

[0026] In a fourth aspect, the present application discloses an implantable bioelectrode assembly, comprising the implantable bioelectrode according to the first, second or third aspect of claim 1 to the above;

[0027] The device further comprises a guide needle and a protective cover, wherein the guide needle and the protective cover are threadedly connected, the lower portion of the guide needle passes through the inner ring structure, the middle portion of the guide needle presses against the upper surface of the sealing ring body, and the protective cover presses against the lower surface of the sealing ring body, the sensing section is contained in the grooved needle of the lower half of the guide needle, and the sensing section is sealed in the enclosed space formed by the protective cover, the annular body, and the guide needle;

[0028] The number and positions of the guide needles are arranged corresponding to the sensing sections.

[0029] In the technical solution provided by the present invention, during the production and assembly process of the implantable bioelectrode, the sensing section extends from a straight line and is arranged in the inner ring structure. After bending, the sensing section leaks out of the bottom of the inner ring structure, and the overall thickness becomes lower; the setting of the inner ring structure and the sealing ring body of the annular body makes it possible to fix the sealing ring body and the inner ring structure so that the sensing section can be fixedly sealed at the lower part of the annular body, thereby improving the reliability of the bioelectrode; in the present technical solution, the bioelectrode contains a complete circular integrated design, and the main functional accessories are assembled with the electrode circular ring area to form a sealed cavity. The processing flow of the bending of the sensing section in the production and assembly is simplified, which meets the requirements of rapid production and reduces the use cost for consumers; at the same time, the sealing structure of the bioelectrode is simplified, the types of materials are reduced, and the process steps are reduced. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] One or more embodiments are exemplarily illustrated by corresponding drawings, which do not constitute limitations on the embodiments. Elements with the same reference numerals in the drawings are represented as similar elements, and unless otherwise stated, the figures in the drawings do not constitute proportional limitations.

[0031] Figure 1 This is a schematic structural diagram of an embodiment of the implantable bioelectrode of the present invention;

[0032] Figure 2 This is a schematic structural diagram of an embodiment of the implantable bioelectrode of the present invention, in which the sensing section leaks out of the bottom of the inner ring structure after being bent;

[0033] Figure 3 This is a schematic structural diagram of an embodiment of the implantable bioelectrode of the present invention from another angle;

[0034] Figure 4 This is a schematic structural diagram of an embodiment of the implantable bioelectrode of the present invention from another angle;

[0035] Figure 5 This is a schematic structural diagram of an embodiment of the implantable bioelectrode of the present invention from another angle;

[0036] Figure 6 This is a schematic structural diagram of an embodiment of the implantable bioelectrode of the present invention, in which the sensing section extends straightly within the inner ring structure;

[0037] Figure 7 This is a schematic structural diagram of another embodiment of the implantable bioelectrode of the present invention, in which two sensing segments extend straightly within the inner ring structure;

[0038] Figure 8 This is a schematic structural diagram of another embodiment of the implantable bioelectrode of the present invention, in which the sensing section extends straightly within the inner ring structure;

[0039] Figure 9 This is a cross-sectional schematic diagram of an embodiment of the implantable bioelectrode assembly of the utility model;

[0040] Figure 10 This is a schematic structural diagram of an embodiment of the implantable bio-electrode assembly of the present invention;

[0041] Figure 11 This is a schematic structural diagram of another embodiment of the implantable bioelectrode of the present invention;

[0042] Figure 12 This is a schematic structural diagram of another embodiment of the implantable bioelectrode of the present invention;

[0043] Figure 13 This is a schematic structural diagram of another embodiment of the implantable bioelectrode of the present invention;

[0044] Figure 14 This is a schematic structural diagram of another embodiment of the implantable bioelectrode of the present invention.

[0045] In the figure: 1-signal output electrode; 11-counter electrode; 12-working electrode; 13-reference electrode; 2-ring body; 21-inner ring structure; 22-first assembly notch; 23-cut edge; 24-positioning hole; 25-sector-shaped notch; 26-sealing ring body; 27-outer ring structure; 3-sensing segment; 4-guide needle; 5-protective cover. DETAILED DESCRIPTION

[0046] To facilitate understanding of the present invention, the present invention is described in more detail below with reference to the accompanying drawings and specific embodiments. It should be noted that when an element is described as being "fixed to" another element, it can be directly attached to the other element, or one or more elements can be interposed therebetween. When an element is described as being "connected to" another element, it can be directly connected to the other element, or one or more elements can be interposed therebetween. The terms "vertical," "horizontal," "left," "right," "inner," "outer," and similar expressions used in this specification are for illustrative purposes only. In the description of the present invention, the terms "first" and "second" are used solely for descriptive purposes and are not to be construed as indicating relative importance or implicitly specifying the number of technical features indicated. Therefore, unless otherwise specified, features specified as "first" or "second" may explicitly or implicitly include one or more of such features; "plurality" means two or more. The term "comprising" and any variations thereof are intended to be non-exclusive, and one or more other features, integers, steps, operations, units, components, and / or combinations thereof may be present or added.

[0047] In addition, unless otherwise expressly specified and limited, the terms "installed", "connected" and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection, an indirect connection through an intermediate medium, or internal communication between two components. All technical and scientific terms used in this specification have the same meaning as those commonly understood by technicians in the technical field of this utility model. The terms used in the specification of this utility model are only for the purpose of describing specific embodiments and are not used to limit the utility model. The term "and / or" used in this specification includes any and all combinations of one or more related listed items.

[0048] In addition, the technical features involved in different embodiments of the present invention described below can be combined with each other as long as they do not conflict with each other.

[0049] To achieve the above objectives, the present invention provides an implantable bioelectrode. Figure 1-14 , of which Figure 1 This is a schematic diagram of the structure of an implantable bioelectrode, specifically comprising a signal output electrode 1, an annular body 2, and a sensing segment 3. The signal output electrode 1 is disposed on the annular body 2 for connection to an external circuit; the annular body 2 is connected to at least one sensing segment 3, and the annular body 2 is a generally flat and continuous annular arrangement.

[0050] An inner ring structure 21 is provided in the middle of the annular body 2, and a sensing section 3 extends from the inner side wall of the inner ring structure 21. The sensing section 3 can be bent downward.

[0051] Before bending, the sensing section 3 extends straightly within the inner ring structure 21 . After bending, the sensing section 3 leaks out of the bottom of the inner ring structure 21 .

[0052] In the technical solution provided by the present invention, during the production and assembly process of the implantable bioelectrode, the sensing section 3 extends from a straight line and is arranged within the inner ring structure 21. After bending, the sensing section 3 leaks out of the bottom of the inner ring structure 21, and the overall thickness becomes lower; the contact area between the annular body 2 and the external components is large, making it easier for the bioelectrode itself to be fixed and externally connected, thereby enhancing the reliability of the bioelectrode assembly and electrical connection; the arrangement of the inner ring structure 21 and the sealing ring body 26 of the annular body 2 allows the sensing section 3 to be fixed and sealed to the lower part of the annular body 2 by fixing the sealing ring body 26 and the inner ring structure 21, thereby improving the reliability of the bioelectrode; the processing flow for bending the sensing section 3 during production and assembly is simplified, meeting the requirements of rapid production and reducing the cost of use for consumers. In the technical solution, the bioelectrode has a complete annular integrated design, and the main functional accessories are assembled with the electrode annular area to form a sealed cavity. The processing flow for bending the sensing section during production and assembly is simplified, meeting the requirements of rapid production and reducing the cost of use for consumers; at the same time, the sealing structure of the bioelectrode is simplified, the types of materials are reduced, and the process steps are reduced.

[0053] In this embodiment, the annular body 2 further includes an outer ring structure 27 and a sealing ring body 26 , and the sealing ring body 26 is connected to the outer ring structure 27 and the inner ring structure 21 respectively;

[0054] The outer ring structure 27 is provided with a pair of first assembly notches 22 , and the two first assembly notches 22 are symmetrically arranged relative to the central axis of the inner ring structure 21 ;

[0055] The center line connecting the two first assembly notches 22 passes through the center point of the inner ring structure 21 , and the center line connecting the two first assembly notches 22 is perpendicular to the middle longitudinal section of the sensing section 3 .

[0056] When the annular body 2 on both sides of the pair of first assembly notches 22 is squeezed, and when the two ends perpendicular to the pair of first assembly notches 22 are squeezed, the sensing section 3 bends from a straight extension state to a state leaking out from the bottom of the inner ring structure 21.

[0057] During assembly, it is only necessary to squeeze the outer ring structure 27 on both sides of the first assembly notch 22, and the sensing segment 3 in the inner ring structure 21 is bent from a straight extended state to leak out of the lower part of the bioelectrode. The assembly process is simple, and the processing flow of bending the sensing segment 3 in production assembly is simplified, further improving rapid production efficiency.

[0058] In this embodiment, the outer ring structure 27 is provided with a pair of cut edges 23 on its outer circumference, with the two first assembly notches 22 located at each cut edge 23. The two cut edges 23 are symmetrically arranged about the central axis of the inner ring structure 21 and are parallel to each other. During mass production, multiple bioelectrode units are located on the same substrate. The cut edges 23 serve to connect the bioelectrode units, facilitating subsequent cutting and forming of individual bioelectrodes, further improving rapid production efficiency.

[0059] In this embodiment, the outer ring structure 27 is provided with a pair of positioning holes 24, each located between a first assembly notch 22 and the inner ring structure 21. The two positioning holes 24 are symmetrically arranged about the central axis of the inner ring structure 21 and are located along the line connecting the two first assembly notches 22. The positioning holes 24 are used to position the bioelectrode during the bending process of the sensing segment 3, facilitating the subsequent extrusion of the annular body 2 to bend the sensing segment 3, further improving rapid production efficiency.

[0060] In this embodiment, the number of sensing segments 3 is one or more; the types of electrodes on all sensing segments 3 include three types of electrodes: working electrode, reference electrode and counter electrode;

[0061] The sensing section 3 is a single electrode structure, and one of the working electrode, reference electrode and counter electrode is provided on the sensing section 3; or, the sensing section 3 is a composite electrode structure, and at least two of the working electrode, reference electrode and counter electrode are provided on the sensing section 3.

[0062] Specifically, the sensing segment 3 can be a single electrode structure, that is, there is only one electrode, such as one of the working electrode, reference electrode and counter electrode; the sensing segment 3 can be a composite electrode, that is, there are two or more electrodes on one sensing segment 3, and the types of electrodes can be repeated or not, such as, there are a working electrode and a reference electrode on one sensing segment 3, or a working electrode and a counter electrode, or a reference electrode and a counter electrode, or a working electrode, a reference electrode and a counter electrode, or two / multiple working electrodes, or two / multiple reference electrodes, or two / multiple counter electrodes, or two / multiple working electrodes and reference electrodes and counter electrodes, etc.

[0063] Please refer to the attached Figure 11-14 Regarding the technical solution of multiple sensing segments 3, it is assumed that there are a first sensing segment, a second sensing segment, and a third sensing segment. Of course, the number of sensing segments 3 is ≥1. The example here is just one implementation example and does not mean that there can only be three sensing segments 3.

[0064] The electrode combinations on the first sensing segment, the second sensing segment, and the third sensing segment are as follows:

[0065] A. Single electrode combination mode, that is, each sensing segment has only one electrode, only undertakes the simplest function, and does not worry about cross contamination and short circuit between electrodes and other problems, so it can be made thinner and shorter than the sensing segment with composite electrode, such as 0.1-0.25mm wide and 1-4mm long; the length of the conventional composite electrode is usually more than 5mm, and the width is about 0.3mm. The smaller and shorter the sensing segment, the thinner and shorter the guide needle, which can reduce the pain and bleeding risk of implantation.

[0066] The first sensing segment is a working electrode (WE); the second sensing segment is a counter electrode (RE); and the reference electrode (CE);

[0067] B. Composite electrode combination mode

[0068] The first sensing segment is a working electrode (WE), a counter electrode (RE), and a reference electrode (CE); the second sensing segment is a working electrode (WE1) and a working electrode (WE2); and the third sensing segment is a working electrode (WE3) and a working electrode (WE4);

[0069] C. Composite electrode + single electrode combination mode

[0070] The first sensing segment is a counter electrode (RE) and a reference electrode (CE); the second sensing segment is a working electrode (WE); and the third sensing segment is a working electrode (WE1);

[0071] The improvement of the sensing segment 3 enables the device to measure more types of substances with minimal resources, improve the test function, and increase the manufacturing cost less.

[0072] One sensing segment 3 does multiple substance electrodes (WE1, WE2, RE, CE), which is equivalent to doing four electrodes on the sensing 13 of the thin needle, which is relatively complex; the modification is relatively complex, and different substances need to be modified on WE1 and WE2; the process requires high precision;

[0073] Different electrodes are set on different sensing segments, and different modified substances are set, which is relatively low in process complexity, not crowded, and the process difficulty is not increased, and more functions are realized. The process can be reused, and multiple substances can be measured at the same time.

[0074] The arrangement mode of the multiple sensing segments 3 on the bioelectrode 1 can be an interdigital arrangement, a center-penetrating daisy arrangement, a comb arrangement, or other arrangements. The arrangement mode of the multiple sensing segments needs to be matched with the corresponding implant guide needle to realize the implantation action.

[0075] In this embodiment, the sensing segment 3 is arranged in an elongated strip shape, the width of the sensing segment 3 is 0.1-0.4mm, the thickness of the sensing segment 3 is 0.05-0.3mm, and the length of the sensing segment 3 is 2-7mm.

[0076] After bending, the bending angle α between the sensing section 3 and the annular body 2 is 90° to 100°.

[0077] In this embodiment, the bending angle α between the sensing segment 3 and the annular body 2 is 90°~100°, which can be 90°, 100°, and preferably 93°±2°. If the bending angle is too small or too large, part of the sensing segment 3 will relatively protrude from the needle groove, and the sensing segment 3 cannot be completely contained in the needle groove of the guide needle 4, so that the sensing segment 3 cannot be inserted into the human skin with the guide needle 4, resulting in the failure of the implantation of the sensing segment 3 of the bioelectrode; another situation where the bending angle is too small or too large is that even after the sensing segment 3 enters the human skin with the guide needle 4, there is a certain probability that the user experience will be bad if the bending angle is too small or too large, and the user may feel "picking flesh" and cannot reach the non-sensing state.

[0078] In this embodiment, the annular width of the outer ring structure 27 is 0.5 mm to 2 mm, the diameter of the inner ring structure 21 is 3 mm to 6 mm, and the outer ring diameter of the annular body 2 is 9 mm to 40 mm;

[0079] The inner ring structure 21 of the annular body 2 may be in a circular, elliptical, rectangular, or racetrack shape. Specifically, the inner ring structure 21 may be in a circular, elliptical, racetrack, or rectangular shape. The specific shape may be adjusted based on actual manufacturing process requirements, such as the shape of the guide needle, the need to avoid internal components, and the need to reduce the overall product volume.

[0080] The outer ring structure 27 of the annular body 2 may be in a circular, elliptical, rectangular, or racetrack shape. Specifically, the outer ring structure 27 may be in a circular, elliptical, racetrack, or rectangular shape. The specific shape is adjusted to meet the requirements of the actual manufacturing process. The shape setting facilitates subsequent attachment of double-sided tape to the surface of human skin.

[0081] In this embodiment, the signal output electrode 1 includes a counter electrode 11 contact, a working electrode 12 contact and a reference electrode 13 contact, and the electrodes on the sensing segment 3 are electrically connected to external devices through the counter electrode 11 contact, the working electrode 12 contact and the reference electrode 13 contact respectively.

[0082] Specifically, the sensing segment 3 is implanted into the human skin along with the guide needle and comes into contact with the blood. A biometric recognition element corresponding to the target biological information, such as an antibody, enzyme, or DNA probe, is fixedly disposed on the surface of the sensing segment 3. For example, glucose oxidase can be used to detect the glucose concentration in the blood. The specific biochemical reaction and detection principle are known in the art and will not be elaborated on in this application.

[0083] The counter electrode 11, working electrode 12 and reference electrode 13 are electrically connected to the main control circuit board of the external device respectively. The main control circuit board is provided with a signal transmission module and a power supply. The biological information collected by the sensing segment 3 is sent to the external terminal through the main control circuit board. The terminal is responsible for processing and analyzing the collected biological signals to form biological signal data for user reference.

[0084] The shape, size, and spacing of the counter electrode contacts, working electrode contacts, and reference electrode contacts can be flexibly adjusted according to external components and equipment, thereby reducing the thickness of the bioelectrode 1. At the same time, corresponding models of bioinformation monitoring devices, such as continuous blood glucose monitors, can be quickly manufactured, meeting the requirements of rapid production and rapid replacement of biosensor components.

[0085] The counter electrode contact, working electrode contact, and reference electrode contact of the signal output electrode 1 are all flat contacts. The flat arrangement is more conducive to the reliability and ease of electrical connection. It is only necessary to apply conductive glue on the counter electrode, working electrode, and reference electrode to form an electrical connection with the external contacts, or the external contacts are also flat and can be directly pressed onto the counter electrode contact, working electrode contact, and reference electrode contact to form an electrical connection, which is also beneficial to reducing the thickness of the product.

[0086] The annular body 2 has a larger area relative to the sensing section 3 and is in the shape of a flat ring, making the annular body 2 easier to fix, so that the bioelectrode as a whole is easier to fix; at the same time, a double-sided adhesive sticker can be affixed to the surface of the annular body 2 for sticking to the surface of the human skin. The annular body 2 is in the shape of a flat ring as a whole, which allows for better contact and adhesion with the skin, so that the annular body 2 of the bioelectrode is more firmly attached to the surface of the human skin, and the sensing section 3 is more firmly in the state of being implanted / semi-implanted in the human skin.

[0087] In this embodiment, please refer to the attached Figure 11-14 The arrangement of the sensing segments 3 includes an interdigitated arrangement, a daisy-shaped arrangement with the tips facing the center, or a comb-shaped arrangement.

[0088] In another embodiment, please refer to the attached Figures 1-10 , of which Figure 7 The diagram is a schematic diagram of the structure of an implantable bioelectrode. Specifically, the present application discloses an implantable bioelectrode including the implantable bioelectrode of the first aspect described above, wherein the implantable bioelectrode has two sensing segments 3, the two sensing segments 2 being arranged opposite each other. Before bending, the two sensing segments 3 extend straight within the inner ring structure 21. After bending, the two sensing segments 3 extend out from the bottom of the inner ring structure 21. This implantable bioelectrode including two sensing segments 2 can simultaneously detect multiple biosignals, achieving more diverse detection and higher efficiency.

[0089] In another embodiment, please refer to the attached Figures 1-10 , wherein the Figure 8 As a kind of structural diagram of implantable bioelectrode, specifically, the application discloses an implantable bioelectrode, including the implantable bioelectrode of the first aspect described above, annular body 2 is provided with sector notch 25, sector notch 25 is communicated with the outer circumferential side of annular body 2 and inner ring structure 21, the center of sector notch 25 is the center of inner ring structure 21.The implantable bioelectrode containing sector notch 25, the length of sensing segment 3 is longer, can detect the biological signal of other larger or deeper part of human body, can also be used for animal biological signal detection.

[0090] The implantable bioelectrode of the first aspect, the second aspect and the third aspect described above can be integrally formed by punching process, and the flat bioelectrode is easier to be made by punching.

[0091] Another embodiment, please refer to the accompanying Figures 1-10 , wherein the Figure 9 As a kind of structural diagram of implantable bioelectrode assembly, specifically, the application discloses an implantable bioelectrode assembly, including the implantable bioelectrode of the first aspect described above;

[0092] Still including guide needle 4 and protective cover 5, guide needle 4 and protective cover 5 are threadedly connected, the lower part of guide needle 4 passes through inner ring structure 21, the middle part of guide needle 4 is pressed on the upper surface of sealing ring body 26, protective cover 5 is pressed on the lower surface of sealing ring body 23, sensing segment 3 is contained in the groove-shaped needle of the lower half of guide needle 4, and sensing segment 3 is sealed in the airtight space formed by protective cover 5, annular body 2 and guide needle 4;

[0093] The number and position of guide needle 4 are correspondingly arranged with sensing segment 3.

[0094] The above embodiments are only used to illustrate the technical scheme of the utility model, rather than limit it;Under the idea of the utility model, technical features in the above embodiments or different embodiments can also be combined, steps can be implemented in any order, and there are many other changes of different aspects of the utility model as described above, for the sake of simplicity, they are not provided in details;Although the utility model has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that: it can still modify the technical scheme recorded in the foregoing embodiments, or make equivalent replacement to part of technical features;And these modifications or replacements do not make the essence of corresponding technical scheme deviate from the scope of the technical scheme of the embodiments of the utility model.

Claims

1. An implantable bioelectrode, characterized in that: The device comprises a signal output electrode (1), an annular body (2) and a sensing segment (3); the signal output electrode (1) is arranged on the annular body (2) for connecting to an external circuit; the annular body (2) is connected to at least one sensing segment (3); the annular body (2) is arranged in a generally flat and continuous annular shape; An inner ring structure (21) is provided in the middle of the annular body (2), the sensing section (3) extends from the inner side wall of the inner ring structure (21), and the sensing section (3) can be bent downward; Before bending, the sensing section (3) extends straight inside the inner ring structure (21); after bending, the sensing section (3) leaks out of the bottom of the inner ring structure (21).

2. The implantable bioelectrode according to claim 1, wherein: The annular body (2) further comprises an outer ring structure (27) and a sealing ring body (26), wherein the sealing ring body (26) is respectively connected to the outer ring structure (27) and the inner ring structure (21); The outer ring structure (27) is provided with a pair of first assembly notches (22), and the two first assembly notches (22) are symmetrically arranged relative to the central axis of the inner ring structure (21); A line connecting the center lines of the two first assembly notches (22) passes through the center point of the inner ring structure (21), and a line connecting the center lines of the two first assembly notches (22) is perpendicular to a longitudinal section of the middle portion of the sensing section (3); When the annular body (2) on both sides of a pair of first assembly notches (22) is squeezed, and when the two ends perpendicular to the pair of first assembly notches (22) are squeezed, the sensing section (3) bends from a straight extended state to a state of leaking out from the bottom of the inner ring structure (21).

3. The implantable bioelectrode according to claim 2, wherein: The outer ring structure (27) is provided with a pair of cutting edges (23) on the outer peripheral side, and the two first assembly notches (22) are respectively located at one cutting edge (23); the two cutting edges (23) are symmetrically arranged relative to the central axis of the inner ring structure (21); and the two cutting edges (23) are parallel to each other.

4. The implantable bioelectrode according to claim 3, wherein: The outer ring structure (22) is provided with a pair of positioning holes (24), and the two positioning holes (24) are respectively located between a first assembly notch (22) and the inner ring structure (21); the two positioning holes (24) are symmetrically arranged relative to the central axis of the inner ring structure (21); and the two positioning holes (24) are located at the connecting line of the two first assembly notches (22).

5. The implantable bioelectrode according to claim 4, wherein: The number of the sensing segments (3) is one or more; the types of electrodes on all the sensing segments (3) include three types of electrodes: a working electrode, a reference electrode, and a counter electrode; The sensing section (3) is a single electrode structure, and one of a working electrode, a reference electrode, and a counter electrode is provided on the sensing section (3); or the sensing section (3) is a composite electrode structure, and at least two of the working electrode, the reference electrode, and the counter electrode are provided on the sensing section (3).

6. The implantable bioelectrode according to claim 5, wherein: The sensing section (3) is in the shape of an elongated strip, the width of the sensing section (3) is 0.1 mm to 0.4 mm, the thickness of the sensing section (3) is 0.05 mm to 0.3 mm, and the length of the sensing section (3) is 2 mm to 7 mm; After bending, the bending angle α between the sensing section (3) and the annular body (2) is 90° to 100°.

7. The implantable bioelectrode according to claim 6, wherein: The annular width of the outer ring structure (22) is 0.5 mm to 2 mm, the diameter of the inner ring structure (21) is 3 mm to 6 mm, and the outer ring diameter of the annular body (2) is 9 mm to 40 mm.

8. The implantable bioelectrode according to claim 1, wherein: The shape of the inner ring structure (21) includes a circular shape, an elliptical shape, a rectangular shape, a racetrack shape, etc.

9. The implantable bioelectrode according to claim 2, wherein: The shape of the outer ring structure (22) includes a circular shape, an elliptical shape, a rectangular shape, a racetrack shape, etc.

10. The implantable bioelectrode according to claim 7, wherein: The signal output electrode (1) comprises a counter electrode (11) contact, a working electrode (12) contact and a reference electrode (13) contact, and the electrodes on the sensing section (3) are electrically connected to an external device via the counter electrode (11) contact, the working electrode (12) contact and the reference electrode (13) contact, respectively.

11. The implantable bioelectrode according to any one of claims 1 to 10, characterized in that: The arrangement of the sensing segments (3) includes an interdigitated arrangement, a daisy-shaped arrangement with the tips facing the center, or a comb-shaped arrangement.

12. An implantable bioelectrode, characterized in that: An implantable bioelectrode comprising any one of claims 1 to 11, wherein the number of the sensing segments (2) is two; the two sensing segments (2) are arranged opposite to each other; before bending, the two sensing segments (3) respectively extend straight within the inner ring structure (21); after bending, the two sensing segments (3) respectively leak out of the bottom of the inner ring structure (21).

13. An implantable bioelectrode, characterized in that: The invention comprises an implantable bioelectrode according to any one of claims 1 to 3, wherein the annular body (2) is provided with a fan-shaped notch (25), the fan-shaped notch (25) connects the inner ring structure (21) and the outer peripheral side of the annular body (2), and the center of the fan-shaped notch (25) is the center of the inner ring structure (21).

14. An implantable bioelectrode assembly, characterized in that: Comprising any one of the implantable bioelectrodes according to claims 1 to 13; The invention also includes a guide needle (4) and a protective cover (5), wherein the guide needle (4) and the protective cover (5) are threadedly connected, the lower part of the guide needle (4) passes through the inner ring structure (21), the middle part of the guide needle (4) is pressed against the upper surface of the sealing ring body (26), and the protective cover (5) is pressed against the lower surface of the sealing ring body (26), the sensing section (3) is contained in the groove-shaped needle of the lower half of the guide needle (4), and the sensing section (3) is sealed in the closed space formed by the protective cover (5), the annular body (2) and the guide needle (4); The number and positions of the guide needles (4) are arranged correspondingly to the sensing section (3).

Images