A patch-type bioinformatics monitoring device

Abstract

This application relates to the field of bioinformatics monitoring, specifically a patch-type bioinformatics monitoring device that addresses the technical problem of low wearing comfort in bioinformatics monitoring devices. The device includes an upper adhesive layer; a lower adhesive layer having a first upper adhesive surface facing upwards, with the bottom surface of the lower adhesive layer used for skin adhesion; a soft adhesive layer; a bioelectrode; and a flexible circuit board. The implanted portion of the bioelectrode extends downwards from the soft adhesive layer, and the transfer portion of the bioelectrode is applied between the upper adhesive layer and the flexible circuit board and connected to the flexible circuit board. The upper adhesive layer and the first upper adhesive surface are bonded together to form a covering space, within which the soft adhesive layer, bioelectrode, and flexible circuit board are covered. This improves the user experience, and the overall device exhibits high skin-fitting properties.

Description

Technical Field

[0001] This invention relates to the field of bioinformatics monitoring technology, specifically to a patch-type bioinformatics monitoring device. Background Technology

[0002] Continuous glucose monitoring (CGM) systems provide real-time, continuous blood glucose level data for diabetic patients, which is of great significance for blood glucose management. A typical system includes a subcutaneously implanted sensor probe, a transmitter for collecting sensor signals and wirelessly transmitting data, and a terminal device for receiving and displaying the data. The transmitter is usually attached to the skin surface and transmits the biosignals collected by the sensor probe to the terminal device via wireless communication protocols such as Bluetooth.

[0003] However, while the mainstream CGM sensor transmitters on the market can achieve continuous monitoring, they generally suffer from high overall rigidity due to their structure and materials. This results in a strong foreign body sensation when attached to the skin, leading to poor skin fit. The transmitter cannot flexibly deform and fit the curved shape of the skin, making it easy to fall off during human activities and reducing wearing comfort.

[0004] Therefore, how to reduce the overall rigidity of bio-information monitoring devices, improve their flexibility and skin-fit, and reduce the wearer's foreign body sensation are technical problems that urgently need to be solved. Summary of the Invention

[0005] The present invention aims to at least solve the technical problems of existing bio-information monitoring devices, especially CGM sensor transmitters, which have high overall rigidity, obvious foreign body sensation, poor skin fit, low wearing comfort, and are easily scratched and dislodged by foreign objects, and to provide a patch-type bio-information monitoring device.

[0006] To solve the above-mentioned technical problems, the present invention adopts the following technical solution: A patch-type bioinformatics monitoring device, comprising: Top adhesive layer; The lower adhesive layer has a first upper adhesive surface facing upwards, and the bottom surface of the lower adhesive layer is used for bonding to the skin; Soft rubber layer; Bioelectrodes; Flexible circuit board; The implanted portion of the bioelectrode extends downward beyond the soft adhesive layer, and the adapter portion of the bioelectrode is attached between the upper adhesive layer and the flexible circuit board and connected to the flexible circuit board. The upper adhesive layer and the first upper adhesive surface are bonded together to form a covering space, and the soft adhesive layer, bioelectrode and flexible circuit board are covered within the covering space.

[0007] Among them, the patch type refers to the patch type bio-information monitoring device being attached to the surface of human skin in a patch-like manner. The patch type bio-information monitoring device is flexible and skin-friendly. It can be appropriately flexibly deformed and fitted to the curved shape of the human skin surface, similar to the application method of patch products such as bandages and plasters.

[0008] The encapsulation space refers to the closed or semi-closed internal space formed between the first upper adhesive surfaces of the upper and lower adhesive layers after they are bonded together. The soft adhesive layer, bioelectrode, and flexible circuit board are contained and protected within the encapsulation space.

[0009] Optionally, the upper adhesive layer has a first lower adhesive surface, with the first lower adhesive surface facing downwards; The first lower adhesive surface and the first upper adhesive surface are bonded together to form a covering space. The first lower adhesive surface and the first upper adhesive surface accommodate internal components such as a soft adhesive layer, bioelectrodes, and flexible circuit boards between the central region of the adhesive bio-information monitoring device.

[0010] Optionally, the lower adhesive layer has a second lower adhesive surface, which faces downwards and is adhered to the skin.

[0011] Optionally, it also has a skin-adhesive layer with a skin-adhesive surface facing downwards, the skin-adhesive surface being used to adhere to the skin, and the lower adhesive layer adhering to the skin-adhesive layer.

[0012] Optionally, the skin-adhesive layer has a second upper adhesive surface, which adheres to the lower adhesive layer.

[0013] Optionally, the thickness of the upper adhesive layer is 0.02~0.08mm, the thickness of the lower adhesive layer is 0.03mm~0.1mm, and the thickness of the soft adhesive layer is greater than the sum of the thicknesses of the upper adhesive layer, the flexible circuit board, and the lower adhesive layer. Both the upper and lower adhesive layers are extremely thin flexible layers, and the soft adhesive layer becomes the structural layer with the largest thickness proportion in the adhesive-type bio-information monitoring device. The flexible material properties of the soft adhesive layer make the overall mechanical properties of the device as flexible as the soft adhesive layer, thus reducing the overall rigidity.

[0014] Optionally, the Shore hardness of the soft rubber layer is 20A~40A, which is moderately soft and tough, skin-friendly, elastic, and shape-forming, and is suitable for the modulus of human skin feel. The Shore hardness of the flexible circuit board is greater than that of the soft adhesive layer, and the Shore hardness of the lower adhesive layer is less than that of the soft adhesive layer. The Shore hardness of the soft adhesive layer, flexible circuit board, and lower adhesive layer combined is 20A~40A, which is moderately soft and tough, skin-friendly, elastic, and shape-forming, and is suitable for the human skin modulus.

[0015] Optionally, the Shore hardness of the lower adhesive layer after bonding the flexible circuit board is 20A to 40A. The composite structure formed after the lower adhesive layer and the flexible circuit board are bonded still has good flexibility, and the rigidity of the bottom area of ​​the composite structure formed after the lower adhesive layer and the flexible circuit board are bonded will not be significantly increased due to the addition of the flexible circuit board.

[0016] The lower adhesive layer and flexible circuit board have good softness and elasticity. The lower adhesive layer is directly or indirectly adjacent to the skin-contact layer. The lower hardness allows the lower adhesive layer to better deform and conform to the slight undulations of the skin surface, improving the skin-contact comfort of the device.

[0017] Optionally, it also includes a rigid battery, wherein the soft adhesive layer is provided with a battery embedding area, and the rigid battery is embedded in the battery embedding area around its periphery; The bottom surface of the rigid battery presses against the flexible circuit board, and the top surface of the rigid battery presses against the bottom of the upper adhesive layer. The battery embedding area surrounds the periphery of the rigid battery with a soft adhesive layer, further buffering the rigidity of the rigid battery. The rigid battery is embedded inside the soft adhesive layer rather than stacked on top of the soft adhesive layer, so the thickness will not increase further.

[0018] Optionally, the flexible circuit board includes a component concentration area, the soft adhesive layer is provided with a component avoidance notch, the component concentration area is fitted with electronic components that protrude above the upper surface of the flexible circuit board, and the electronic components pass through the component avoidance notch and are accommodated between the upper adhesive layer and the flexible circuit board.

[0019] Optionally, it may also include a plastic layer, which is adhered to the bottom of the upper adhesive layer; The upper adhesive layer is a rigid film layer, and the plastic layer and the upper adhesive layer form a composite support layer; The composite support layer has a Shore hardness of 40A or higher.

[0020] Optionally, the plastic layer is flexible, and the Shore hardness of the plastic layer is 40A or higher; the periphery of the plastic layer is located within the upper adhesive layer.

[0021] Optionally, it may also include a first adhesive layer, which is bonded to the bottom of the plastic layer and the top of the soft rubber layer.

[0022] Optionally, a second adhesive layer is also included, which is bonded to the bottom of the soft adhesive layer and the top of the flexible circuit board.

[0023] Optionally, it may also include a side flexible circuit, which extends from the edge or upper surface of the flexible circuit board, and the other side of the side flexible circuit is connected to the transfer portion of the bioelectrode.

[0024] The beneficial effects of this invention are as follows: The upper and lower adhesive layers are bonded together to form a covering space, which allows the internal components of the patch-type bio-information monitoring device to be covered and fixed by the flexible upper and lower adhesive layers. Both the upper and lower adhesive layers are flexible thin-layer materials, which makes the patch-type bio-information monitoring device flexible as a whole, reduces the overall rigidity of the patch-type bio-information monitoring device, reduces the foreign body sensation of the wearer, and improves the skin fit and wearing comfort of the patch-type bio-information monitoring device.

[0025] By controlling the Shore hardness of each layer, the composite Shore hardness of the adhesive bio-information monitoring device after bonding and assembly is kept within the range of 20A to 40A. This gives the device the flexibility of a soft patch, allowing it to flexibly deform and conform to the curved shape of the human skin surface. This reduces the risk of the adhesive bio-information monitoring device falling off the skin. At the same time, it is moderately soft and flexible, skin-friendly, elastic, and shape-forming, and is compatible with the human skin modulus, resulting in high wearing comfort.

[0026] By setting a battery embedding area and a component avoidance gap in the soft adhesive layer, this invention allows the rigid battery and electronic components to be embedded inside the soft adhesive layer respectively. This invention achieves spatial reuse of the rigid battery and electronic components with the soft adhesive layer in the thickness direction, reducing the overall thickness of the device. At the same time, the soft adhesive layer can fill the gaps between the battery and components, further reducing the overall thickness and improving the overall flexibility. The wearer can better touch the device, thus improving the user's wearing experience. Attached Figure Description

[0027] Figure 1 This is a schematic diagram of the structure of a bioinformatics monitoring device in one or more embodiments of the present invention; Figure 2 This is a schematic diagram of the bioinformatics monitoring device from another angle in one or more embodiments of the present invention; Figure 3 This is a schematic diagram of the bioinformatics monitoring device from another angle in one or more embodiments of the present invention; Figure 4 This is an exploded view of a bio-information monitoring device in one or more embodiments of the present invention; Figure 5 This is a schematic diagram of the structure of the flexible adhesive layer in one or more embodiments of the present invention; Figure 6 This is a schematic diagram of the flexible adhesive layer from another angle in one or more embodiments of the present invention; Figure 7 This is a schematic diagram of the structure of a bioelectrode in one or more embodiments of the present invention; Figure 8This is a schematic diagram of the structure of the bioelectrode from another angle in one or more embodiments of the present invention; Figure 9 This is a schematic diagram of the structure of the second double-sided adhesive layer in one or more embodiments of the present invention; Figure 10 This is a schematic diagram of the assembly of the second double-sided adhesive layer and the bioelectrode in one or more embodiments of the present invention; Figure 11 This is a schematic diagram of the assembly of the second double-sided adhesive layer and the bioelectrode from another angle in one or more embodiments of the present invention; Figure 12 This is a schematic diagram of the assembly of the first double-sided adhesive layer, the second double-sided adhesive layer, and the bioelectrode in one or more embodiments of the present invention; Figure 13 This is a schematic diagram of the assembly of a first double-sided adhesive layer, a second double-sided adhesive layer, a bioelectrode, and a first adhesive layer in one or more embodiments of the present invention. Figure 14 This is a schematic diagram of the assembly of the first double-sided adhesive layer, the second double-sided adhesive layer, the bioelectrode, and the first adhesive layer from another angle in one or more embodiments of the present invention. Figure 15 This is a schematic diagram of the assembly of the first double-sided adhesive layer, the second double-sided adhesive layer, the bioelectrode, and the first adhesive layer from another angle in one or more embodiments of the present invention. Figure 16 This is a schematic diagram of the assembly of the first double-sided adhesive layer, the second double-sided adhesive layer, the bioelectrode, and the flexible adhesive layer in one or more embodiments of the present invention. Figure 17 This is a schematic diagram of the structure of a flexible circuit board in one or more embodiments of the present invention; Figure 18 This is a schematic diagram of the flexible circuit board from another angle in one or more embodiments of the present invention; Figure 19 This is a schematic diagram of the flexible circuit board from another angle in one or more embodiments of the present invention; Figure 20 This is a schematic diagram of the assembly of the flexible circuit board and the filler block in one or more embodiments of the present invention; Figure 21 This is a schematic diagram of the assembly of a flexible circuit board, a filler block, an ACF, and a bioelectrode in one or more embodiments of the present invention. Figure 22 This is a schematic diagram of the flexible circuit board, filler block, ACF and bioelectrode assembly from another angle in one or more embodiments of the present invention; Figure 23 for Figure 22 A magnified view of a portion of point D in the middle; Figure 24 This is a cross-sectional schematic diagram of a bioinformatics monitoring device in one or more embodiments of the present invention; Figure 25 for Figure 24 A magnified view of a portion of point A in the middle; Figure 26 for Figure 24 A magnified view of a portion of point B in the middle; Figure 27 This is a cross-sectional view of the bioinformatics monitoring device in one or more embodiments of the present invention from another angle; Figure 28 for Figure 27 A magnified view of a portion of point C in the middle; Figure 29 This is a schematic diagram of the structure of the soft adhesive layer in one or more embodiments of the present invention; Figure 30 This is yet another exploded view of the bioinformatics monitoring device in one or more embodiments of the present invention.

[0028] Explanation of reference numerals in the attached figures 1. Upper adhesive layer; 011. First lower adhesive surface; 2. Soft adhesive layer; 21. Battery embedding area; 22. Component clearance notch; 23. Third electrode clearance area; 24. First pad clearance area; 3. Bioelectrode; 31. Adapter section; 311a. First electrode contact; 311b. Second electrode contact; 311c. Third electrode contact; 32. Implantation section; 33. Connecting section; 4. Flexible circuit board; 401. Component concentration area; 402. Battery arrangement area; 403. First electrode clearance area; 410. Side branch Flexible circuit; 41. Circuit board pad connection; 411a. First circuit contact; 411b. Second circuit contact; 411c. Third circuit contact; 42. Circuit board connection; 43. Electronic component; 5. Lower adhesive layer; 51. First upper adhesive surface; 52. Second lower adhesive surface; 6. Rigid battery; 71. First battery spring; 72. Second battery spring; 8. Plastic layer; 9. First double-sided adhesive layer; 10. Second double-sided adhesive layer; 101. Electrode fixing groove; 102. Electrode clearance groove; 11. First adhesive layer; 12. Second adhesive layer; 13. ACF; 14. Filler block; 15. Skin layer; 151. Skin adhesive surface; 152. Second upper adhesive surface; 01. Bio-information monitoring device; 02. Flexible adhesive layer; 021. Conductive pad area; 022. Component clearance area; 023. Battery clearance area; 024. Second electrode clearance area; 03. Waterproof adhesive area. Detailed Implementation

[0029] To make the technical solution and beneficial effects of this application more apparent and understandable, a detailed description is provided below by listing specific embodiments. The accompanying drawings are not necessarily drawn to scale, and local features may be enlarged or reduced to more clearly show the details of the local features; unless otherwise defined, the technical and scientific terms used herein have the same meanings as those in the technical field to which this application pertains.

[0030] Example 1

[0031] like Figures 1-30 As shown, in order to solve the technical problems of existing bio-information monitoring devices, such as high overall rigidity, obvious foreign body sensation, poor skin fit, low wearing comfort, and easy to be scratched and fallen off by foreign objects, this embodiment proposes an adhesive bio-information monitoring device.

[0032] See Figure 1 and Figure 2 , Figure 1 This is a schematic diagram of the overall structure of the bioinformatics monitoring device in this embodiment. Figure 2 This is a structural schematic diagram of the bio-information monitoring device from another angle in this embodiment. Specifically, a bio-information monitoring device 01 can be used as a Bluetooth transmitter and a wireless transmitter in a continuous glucose monitoring system, but is not limited to this. It can also be used in continuous ketone body monitoring, continuous lactate monitoring, or other wearable bio-information monitoring scenarios that require wireless transmission of sensor signals.

[0033] See Figure 4 The bioinformation monitoring device 01 in this embodiment includes a bioelectrode 3 and a flexible circuit board 4.

[0034] See Figure 17 , Figure 17 This is a schematic diagram of the flexible circuit board in this embodiment. The flexible circuit board 4 is the core circuit carrier of the bio-information monitoring device 01. The flexible circuit board 4 is equipped with electronic components 43 required to realize functions such as signal acquisition, analog-to-digital conversion, data processing, and wireless communication. The electronic components 43 include, but are not limited to, microcontroller chips, Bluetooth communication chips, analog front-end chips, voltage regulator chips, crystal oscillators, and passive devices such as resistors, capacitors, and inductors.

[0035] In this embodiment, the flexible circuit board 4 uses a flexible substrate such as polyimide film as a carrier. The substrate thickness of the flexible circuit board can usually be as thin as tens of μm, which is lower than the thickness of the traditional rigid circuit board (the thickness of the rigid circuit board is usually above 0.4 mm).

[0036] In other embodiments, the flexible circuit board 4 can also be a rigid-flex board, with some areas of the rigid-flex board being rigid substrates and some areas being flexible substrates. The rigid-flex board combines the component load-bearing capacity of the rigid area with the bendability of the flexible area.

[0037] See Figure 7 , Figure 7 This is a schematic diagram of the structure of the bioelectrode in this embodiment. The bioelectrode 3 is a sensor for implantation under the skin. The part implanted under the skin has a sensor probe, and the part not implanted under the skin is a signal output part used to collect the biosignal from the sensor probe.

[0038] See Figure 8 , Figure 8 This is a schematic diagram of the bioelectrode from another angle in this embodiment. The bioelectrode 3 is a straight-bent configuration. Specifically, the bioelectrode 3 includes a main body, a connecting part 31, and an implantation part 32. The main body extends along or approximately along the thickness direction of the bioinformation monitoring device 01. See also... Figure 21 The adapter portion 31 extends horizontally, approximately parallel to the surface of the flexible circuit board 4, after being bent from the main body. The adapter portion 31 is attached between the upper adhesive layer 1 and the flexible circuit board 4, and connected to the flexible circuit board 4. The adapter portion 31 can be a plate-like or sheet-like structure, and it has multiple solder pads (connection contacts). See also... Figure 2 The implantable portion 32 extends from the end of the main body and protrudes from the bottom surface of the bio-information monitoring device 01 for implantation under the skin. It is equipped with a sensor probe for implantation under the skin. The implantable portion 32 can be a needle-shaped, sheet-shaped, or columnar structure. The adapter portion 31 and the implantable portion 32 are arranged at an angle of 90° to 95°.

[0039] See Figure 15 Specifically, the bioelectrode 3 has multiple connection points (i.e., pads) on its adapter portion 31. The number of connection points is typically three or more, such as... Figure 11 The first electrode contact 311a, the second electrode contact 311b, and the third electrode contact 311c are provided. The shape of the connecting contacts can be circular, square, or polygonal. The connecting contacts can be arranged in a horizontally spaced, vertically spaced, or other geometrically similar manner, such as a triangular or quadrilateral arrangement. The spacing between adjacent connecting contacts ranges from 0.3 mm to 2 mm.

[0040] The number of bioelectrodes 3 can be one, two, or more. When the bioinformation monitoring device 01 is equipped with multiple bioelectrodes 3, each bioelectrode 3 can perform different electrical functions, such as working electrode, reference electrode, and counter electrode.

[0041] The pads of the adapter portion 31 are aligned with the corresponding pads on the flexible circuit board 4. Electrical connection and mechanical fixation are achieved between the pads of the adapter portion 31 and the pads of the flexible circuit board 4 through bonding or soldering. Bonding methods include, but are not limited to, bonding using conductive adhesives such as ACF (anisotropic conductive film), ACP (anisotropic conductive paste), or silver paste. Soldering methods include, but are not limited to, solder paste reflow soldering, laser soldering, or ultrasonic soldering.

[0042] See Figure 22 and Figure 23 , Figure 22 This is a schematic diagram of the assembly structure of the flexible circuit board, filler block, ACF, and bioelectrode in this embodiment. Figure 23 yes Figure 22 The enlarged view at point D shows that the straight bending design of the bioelectrode 3 changes the connection structure between the bioelectrode 3 and the flexible circuit board 4 from a vertical connection in the thickness direction to a flat connection in the planar direction. This straight bending design significantly reduces the space occupied by the electrode connection structure in the thickness direction of the bio-information monitoring device 01 from the electrode height plus the clamping structure height in the traditional vertical connection method to an extremely thin adhesive or solder layer only between the bonding pad of the adapter 31 and the bonding pad of the flexible circuit board 4. The straight bending design of the bioelectrode 3 effectively reduces the size occupied by the bio-information monitoring device 01 in the thickness direction from the electrode connection level, further improving the overall thinness of the bio-information monitoring device 01.

[0043] Example 2

[0044] See Figure 5 , Figure 5 The diagram shows the structure of the flexible adhesive layer. Based on Embodiment 1, the bioinformatics monitoring device 01 in this embodiment also includes a flexible adhesive layer 02.

[0045] At least a portion of the transfer portion 31 of the bioelectrode 3 is bonded to the flexible circuit board 4 via a flexible adhesive layer 02. The flexible adhesive layer 02 is disposed between the area where the transfer portion 31 of the bioelectrode 3 is located and the flexible circuit board 4, or on the side of the flexible circuit board 4 opposite to the transfer portion 31 of the bioelectrode 3. The flexible adhesive layer 02 uses its own adhesiveness to press and fix the portion of the transfer portion 31 of the bioelectrode 3 onto the flexible circuit board 4, thus providing auxiliary fixation and enhancing the reliability of the connection between the bioelectrode 3 and the flexible circuit board 4.

[0046] The flexible adhesive layer 02 possesses overall flexibility and deformability, enabling it to undergo elastic deformation under external forces without breaking or permanent deformation. The flexible adhesive layer 02 gives the bio-information monitoring device 01 overall flexibility, allowing it to conform to the curved surface of human skin to a certain extent.

[0047] See Figure 6 , Figure 6 This is a structural schematic diagram of the flexible adhesive layer from another angle. In one embodiment, the entire transition portion 31 of the bioelectrode 3 is bonded to the flexible circuit board 4 through the flexible adhesive layer 02. The flexible adhesive layer 02 is provided with a pad conductive area 021 for pad connection. The pad conductive area 021 is also a pad avoidance area, which can be a conductive via, conductive notch, etc. The pads of the transition portion 31 are connected to the pads on the flexible circuit board 4.

[0048] See Figure 22 and Figure 23 In another embodiment, the contact area of ​​the transfer portion 31 of the bioelectrode 3 is electrically connected to the contact of the flexible circuit board 4 through the ACF13, and the non-contact area of ​​the transfer portion 31 of the bioelectrode 3 is mechanically fixed through the flexible adhesive layer 02. The ACF13 and the flexible adhesive layer 02 work together to ensure both the reliability of the electrical connection and the firmness of the mechanical fixation.

[0049] ACF13 is an ultra-thin anisotropic conductive film, ranging from 10μm to 50μm in thickness. After thermoforming, it conducts electricity only in the vertical direction (i.e., the thickness direction), ensuring that each contact of the bioelectrode 3 is connected to its corresponding contact on the flexible circuit board 4. The continuity resistance between each pad (contact) of the bioelectrode 3 and its corresponding contact on the flexible circuit board 4 is typically less than 10Ω, meeting the low impedance requirements for biosignal transmission. ACF13 is non-conductive in the horizontal direction (i.e., the planar direction), ensuring that adjacent pads at the connection point are mutually insulated. The insulation resistance between adjacent pads is greater than 10Ω. 9 The Ω insulation resistance ensures electrical isolation between the signal channels. The ACF13 also provides strong structural bonding strength, reliably fixing the adapter portion 31 of the bioelectrode 3 to the flexible circuit board 4.

[0050] To ensure reliable bonding of ACF13, the bonding area of ​​ACF13 around the pads of the adapter portion 31 of the bioelectrode 3 needs to be treated with ink opening. Ink opening refers to removing the covering insulating ink layer around the connection point, so that the conductive surface of the pad is exposed and raised above the surrounding reference plane; the height of the pad above the reference plane ranges from 0μm to 30μm.

[0051] The pads being raised above the reference plane ensures that sufficient local pressure can be applied to the conductive particles at the pads during the ACF13 hot pressing process, causing the conductive particles to be compressed and deformed at the pads to form a reliable electrical conduction path. At the same time, no concentrated pressure is applied to the non-contact interval areas, ensuring that the conductive particles between adjacent contacts remain dispersed and maintain insulation.

[0052] See Figure 17 , Figure 17 This is a schematic diagram of the flexible circuit board 4. The flexible circuit board 4 has a circuit board pad connection portion 41. The circuit board pad connection portion 41 has multiple pads, such as a first circuit contact 411a, a second circuit contact 411b, and a third circuit contact 411c, which can be connected to the first electrode contact 311a, the second electrode contact 311b, and the third electrode contact 311c of the bioelectrode 3, respectively. The shape and arrangement of the pads on the circuit board pad connection portion 41 are consistent with the pads of the bioelectrode 3 adapter portion 31 to ensure precise alignment during ACF13 hot pressing. The pads of the circuit board pad connection portion 41 are also surrounded by openings, and the pads of the circuit board pad connection portion 41 protrude 0μm to 30μm from the surface of the flexible circuit board 4 to meet the pressing requirements of the ACF13.

[0053] In actual products, the circuit board pad connection part 41 and the component concentration area 401 of the flexible circuit board 4 may not be on the same plane. The distance between the plane where the circuit board pad connection part 41 is located and the plane where the component concentration area 401 of the flexible circuit board 4 is located ranges from 0 mm to 1.5 mm.

[0054] See Figure 18 The flexible circuit board 4 also includes a side flexible circuit 410, which extends from the edge or upper surface of the flexible circuit board 4; the other side of the side flexible circuit 410 is connected to the transfer portion 31 of the bioelectrode 3; the side flexible circuit 410 includes a circuit board pad connection portion 41 and a circuit board connection portion 42.

[0055] See Figure 19 and Figure 20 The circuit board pad connection part 41 is structurally cut away from the component concentration area 401 of the flexible circuit board 4 as much as possible. Specifically, the three sides of the circuit board pad connection part 41 are separated from the component concentration area 401 by cuts or slits. Only one side of the circuit board pad connection part 41 retains electrical connection with the component concentration area 401 through the circuit board connection part 42. The three-sided cut structure of the circuit board pad connection part 41 gives the circuit board pad connection part 41 greater flexibility.

[0056] In the ACF13 hot-press bonding process, the circuit board pad connection part 41 can deform freely under the action of hot pressure to adapt to the slight unevenness on the surface of the bioelectrode 3 adapter part 31, effectively releasing the internal stress generated during the hot pressing process, and improving the process yield and connection reliability of ACF13 connection.

[0057] See Figure 18 , Figure 18 This is a schematic diagram of the flexible circuit board structure. The circuit board pad connection part 41, the circuit board connection part 42, and the flexible circuit board body 4 can form a Z-shape. The circuit board connection part 42 extends from the component concentration area 401 to the circuit board pad connection part 41 with at least two bends, forming a Z-shaped bending direction. The Z-shaped structure can effectively prevent cracking due to stress concentration at the connection edge between the circuit board pad connection part 41 and the transition part 31 of the bioelectrode 3. The Z-shaped bending structure acts as a buffer, dispersing the concentrated stress to each segment of the bend. It provides a flexible transition and buffer space between the circuit board pad connection part 41 and the component concentration area 401, allowing the circuit board pad connection part 41 to have a certain displacement relative to the component concentration area 401 in the thickness direction without causing electrical connection breakage. It increases the effective length of the connection path without increasing the plane area occupied, and also improves the flexibility and fatigue resistance of the connection part.

[0058] See Figure 5 , Figure 5 This is a schematic diagram of the flexible adhesive layer. The flexible adhesive layer 02 includes a first adhesive layer 11, a soft adhesive layer 2, and a second adhesive layer 12. The lower adhesive surface of the first adhesive layer 11 is bonded to the upper surface of the soft adhesive layer 2, and the upper adhesive surface of the second adhesive layer 12 is bonded to the lower surface of the soft adhesive layer 2.

[0059] The first adhesive layer 11 is a waterproof double-sided adhesive with a thickness ranging from 0.05 mm to 0.35 mm. The first adhesive layer 11 is preferably a waterproof foam adhesive, which has good bonding and sealing performance.

[0060] The adhesive upper surface (i.e., the upper adhesive surface) of the first adhesive layer 11 is bonded to a portion of the lower surface of the bioelectrode 3. Specifically, the upper adhesive surface of the first adhesive layer 11 is bonded to the non-contact area of ​​the lower surface of the transfer portion 31 of the bioelectrode 3, and the first adhesive layer 11 reliably presses and fixes the transfer portion 31 of the bioelectrode 3 onto the soft adhesive layer 2. The adhesive lower surface (i.e., the lower adhesive surface) of the first adhesive layer 11 is bonded to the upper surface of the soft adhesive layer 2, and the first adhesive layer 11 seals and bonds the upper surface of the soft adhesive layer 2, ensuring that external moisture does not seep into the interior of the bio-information monitoring device 01 through the upper surface of the soft adhesive layer 2.

[0061] The second adhesive layer 12 is also a layer of waterproof double-sided adhesive. The second adhesive layer 12 is preferably waterproof foam adhesive. The thickness of the second adhesive layer 12 ranges from 0.15 mm to 0.25 mm.

[0062] The adhesive upper surface (i.e., the upper adhesive surface) of the second adhesive layer 12 is bonded to the lower surface of the soft adhesive layer 2. The second adhesive layer 12 seals and bonds the lower surface of the soft adhesive layer 2, ensuring that external moisture will not seep into the interior of the bio-information monitoring device 01 through the lower surface of the soft adhesive layer 2. The adhesive lower surface (i.e., the lower adhesive surface) of the second adhesive layer 12 is bonded to the upper surface of the flexible circuit board 4.

[0063] The first adhesive layer 11 and the second adhesive layer 12 respectively achieve reliable bonding between the soft rubber layer 2 and the upper and lower adjacent structural layers. No additional mechanical fasteners are required during assembly. The soft rubber layer 2, as an intermediate support layer, provides flexibility and structural strength to the flexible adhesive layer 02 as a whole. Each layer is tightly bonded by adhesive, with no gaps between the layers. The sandwich-style stacked structure helps to control the total thickness of the flexible adhesive layer 02. Both the first adhesive layer 11 and the second adhesive layer 12 use waterproof double-sided adhesive. The first adhesive layer 11 and the second adhesive layer 12 achieve waterproof protection while achieving interlayer bonding and fixing. The first adhesive layer 11 and the second adhesive layer 12 achieve waterproof protection by fixing the interlayer structure. The first adhesive layer 11 and the second adhesive layer 12 do not require additional independent waterproof sealants.

[0064] In another embodiment, the flexible adhesive layer 02 may not employ the aforementioned three-layer structure; instead, it can be a single-layer flexible adhesive layer. For example, the flexible adhesive layer 02 can be a relatively thick flexible pressure-sensitive adhesive layer, such as a silicone-based or acrylic-based pressure-sensitive adhesive layer. This flexible pressure-sensitive adhesive layer simultaneously provides both adhesive and flexible support functions. Component clearance areas 022, battery clearance areas 023, and electrode clearance areas are also provided on the flexible pressure-sensitive adhesive layer.

[0065] In another embodiment, the flexible adhesive layer 02 may include more layers. For example, a reinforcing layer, such as a non-woven fabric reinforcing layer or a mesh fabric reinforcing layer, may be added between the flexible adhesive layer 2 and the first adhesive layer 11 or between the flexible adhesive layer 2 and the second adhesive layer 12. The reinforcing layer is used to improve the tensile strength and tear resistance of the flexible adhesive layer 02, and the reinforcing layer does not significantly increase the overall thickness of the flexible adhesive layer 02.

[0066] In another embodiment, the first adhesive layer 11 and the second adhesive layer 12 are not limited to waterproof foam adhesive. They can also be other types of waterproof double-sided adhesives, such as waterproof double-sided adhesives based on PET film or non-woven fabric coated with a waterproof adhesive, as long as they meet the dual requirements of interlayer bonding and waterproof sealing. In applications where waterproof performance requirements are not high, the first adhesive layer 11 and the second adhesive layer 12 can also be ordinary, non-waterproof double-sided adhesives.

[0067] The soft adhesive layer 2 is a flexible material layer without adhesive on both sides. The soft adhesive layer 2 itself is not adhesive; it is bonded to the adjacent structural layers above and below it via the first adhesive layer 11 and the second adhesive layer 12, respectively. The soft adhesive layer 2 is biocompatible.

[0068] The soft adhesive layer 2 includes at least one of a silicone layer, a TPU layer, and a TPE layer. The Shore A hardness of the soft adhesive layer 2 is preferably between 20A and 40A. The soft adhesive layer 2 with a Shore A hardness between 20A and 40A possesses sufficient softness to conform to the curvature of human skin and improve wearing comfort, while also having sufficient structural support to maintain the overall morphological integrity of the flexible adhesive layer 02. It exhibits moderate softness and toughness, skin-friendliness, elasticity, and shape retention, and is compatible with the modulus of human skin feel.

[0069] In one embodiment, the soft adhesive layer 2 is a silicone layer. Silicone has good temperature resistance, weather resistance, biocompatibility and flexibility. The silicone layer can be prepared into a sheet of the required shape and thickness by means of molding, injection molding or coating and curing. The Shore hardness can be selected between 20A and 40A.

[0070] In another embodiment, the soft adhesive layer 2 is a TPU layer. TPU has excellent wear resistance, elasticity and mechanical strength. The TPU film can be prepared by processes such as casting, blown film or extrusion. The thickness of the TPU film can be precisely controlled.

[0071] In another embodiment, the soft rubber layer 2 is a TPE layer. TPE includes various types such as styrene, polyolefin, and polyamide. TPE layers have good flexibility and processing performance, relatively low cost, and are suitable for large-scale mass production.

[0072] In another embodiment, the soft adhesive layer 2 is a composite layer structure of two or three of the aforementioned silicone layer, TPU layer, and TPE layer. For example, the composite structure of the silicone layer and TPU layer utilizes the softness of silicone and the abrasion resistance of TPU to complement each other.

[0073] In other alternative embodiments, the soft adhesive layer 2 can also be other flexible material layers with similar flexibility and biocompatibility, as long as the flexible material layer can meet the requirements of the bio-information monitoring device 01 for flexibility, thickness, structural support and biocompatibility.

[0074] See Figure 19 The flexible circuit board 4 has a component concentration area 401 on its surface. The component concentration area 401 is an area on the flexible circuit board 4 used for soldering or mounting electronic components 43. After the electronic components 43 are soldered onto the surface of the flexible circuit board 4, the electronic components 43 protrude from the surface of the flexible circuit board 4 in the thickness direction.

[0075] The flexible adhesive layer 02 has a component avoidance area 022 at a position corresponding to the component concentration area 401. See also Figure 6 , Figure 6 The short dashed line area in the diagram represents the component clearance area 022, which consists of through-holes, grooves, cutouts, or thinned areas on the flexible adhesive layer 02. The shape and size of the component clearance area 022 are adapted to the outer contour of the electronic components 43 in the component concentration area 401. When the flexible adhesive layer 02 is stacked and assembled with the flexible circuit board 4, the electronic components 43 protruding from the surface of the flexible circuit board 4 in the component concentration area 401 are embedded in the component clearance area 022.

[0076] When the maximum protrusion height of the electronic component 43 does not exceed the total thickness of the flexible adhesive layer 02, the electronic component 43 is completely embedded within the component clearance area 022 without exceeding the upper surface of the flexible adhesive layer 02, and the electronic component 43 does not increase the total thickness of the bio-information monitoring device 01 in that area. When the maximum protrusion height of the electronic component 43 slightly exceeds the total thickness of the flexible adhesive layer 02, the component clearance area 022 can also reduce the additional accumulation of the electronic component 43 in the thickness direction. Through the setting of the component clearance area 022, the protrusion height of the electronic component 43 is accommodated by the thickness of the flexible adhesive layer 02.

[0077] like Figure 19 As shown, the flexible circuit board 4 also has a battery placement area 402 on its surface, which is the area on the flexible circuit board 4 for placing the rigid battery 6. The rigid battery 6 is used to provide power to the electronic components 43 inside the bio-information monitoring device 01. The flexible adhesive layer 02 has a battery clearance area 023 at a position corresponding to the battery placement area 402. The battery clearance area 023 is a through hole, groove, hollowed-out area, or thinned area opened in the flexible adhesive layer 02. The shape and size of the battery clearance area 023 are adapted to the outer contour of the rigid battery 6.

[0078] When the flexible adhesive layer 02 and the flexible circuit board 4 are stacked and assembled, the rigid battery 6 in the battery arrangement area 402 is embedded in the battery clearance area 023. The thickness of the rigid battery 6 is accommodated by the battery clearance area 023 of the flexible adhesive layer 02, and the rigid battery 6 will not add extra thickness on top of the thickness of the flexible adhesive layer 02.

[0079] The rigid battery 6 can be a button cell, and the depth of the battery clearance area 023 should be adapted to the thickness of the button cell. When the rigid battery 6 and the battery clearance area 023 of the flexible adhesive layer 02 are combined, the thickness of the bio-information monitoring device 01 in the battery area can be effectively controlled.

[0080] In other embodiments, the rigid battery 6 can be a thin battery. Specifically, the rigid battery 6 can be a thin lithium polymer battery, a thin zinc-air battery, a thin lithium manganese battery, a thin solid-state battery, or a printed battery.

[0081] See Figure 19 The rigid battery 6 is electrically connected to the flexible circuit board 4 via battery springs. A first battery spring 71 and a second battery spring 72 are soldered onto the flexible circuit board 4. The first battery spring 71 and the second battery spring 72 are in elastic contact with the positive and negative terminals of the rigid battery 6, respectively, enabling the rigid battery 6 to supply power to the electronic components 43 on the flexible circuit board 4. The elastic deformation of the first battery spring 71 and the second battery spring 72 ensures reliable contact between the first battery spring 71 and the terminals of the rigid battery 6.

[0082] The component concentration area 401 and the battery arrangement area 402 do not overlap. In the planar projection direction of the flexible circuit board 4, the electronic components 43 and the rigid battery 6 are arranged in different areas, with no overlap between the component concentration area 401 and the battery arrangement area 402. This non-overlapping of the component concentration area 401 and the battery arrangement area 402 avoids the superposition of the electronic components 43 and the rigid battery 6 in the thickness direction. The non-overlapping of the component concentration area 401 and the battery arrangement area 402 ensures that the thickness of the bio-information monitoring device 01 in the component area is approximately equal to the circuit board thickness plus the height of the electronic components 43, and the thickness in the battery area is approximately equal to the flexible circuit board 4 thickness plus the thickness of the rigid battery 6. The bio-information monitoring device 01 will not experience an abnormally large thickness in any area due to superposition.

[0083] The flexible circuit board 4 is provided with a first electrode avoidance area 403, which is a through hole or notch opened in the flexible circuit board 4. The flexible adhesive layer 02 is correspondingly provided with a second electrode avoidance area 024, which is a through hole or notch opened in the flexible adhesive layer 02. The first electrode avoidance area 403 and the second electrode avoidance area 024 are aligned and connected to each other in the thickness direction of the bio-information monitoring device 01, and the first electrode avoidance area 403 and the second electrode avoidance area 024 form a channel penetrating the flexible circuit board 4 and the flexible adhesive layer 02 for the implantation portion 32 (implantation end) of the bioelectrode 3 to pass through.

[0084] See Figures 21-25 The implanted portion 32 of the bioelectrode 3 passes through the second electrode clearance area 024 and the first electrode clearance area 403, respectively, and extends out of the flexible circuit board 4. The implanted portion 32 of the bioelectrode 3 enters the second electrode clearance area 024 from the flexible adhesive layer 02 side, passes through the flexible adhesive layer 02 and then enters the first electrode clearance area 403, and finally passes through the flexible circuit board 4 before extending out from the bottom surface of the bio-information monitoring device 01. The first electrode clearance area 403 and the second electrode clearance area 024 allow the implanted portion of the bioelectrode 3 to pass from the inside to the outside of the bio-information monitoring device 01 without increasing its thickness.

[0085] The first electrode avoidance area 403 is located in the middle of the flexible circuit board 4, and the component concentration area 401 is located on one side of the middle of the flexible circuit board 4, for example, the right side; correspondingly, the battery arrangement area 402 is located on the other side of the middle of the flexible circuit board 4, for example, the left side. The second electrode avoidance area 024, the component avoidance area 022, and the battery avoidance area 023 on the flexible adhesive layer 02 are also arranged in a corresponding manner, with the central crossing area, the component avoidance area on one side, and the battery avoidance area on the other side. Each functional area does not interfere with the others, which reduces the thickness of the bio-information monitoring device 01 and facilitates the design and processing of each layer structure, thus improving manufacturing consistency.

[0086] Example 3

[0087] Based on the above embodiments, the patch-type bioinformatics monitoring device in this embodiment includes: Upper adhesive layer 1; The lower adhesive layer 5 has a first upper adhesive surface 51, with the first upper adhesive surface 51 facing upwards, and the bottom surface of the lower adhesive layer 5 is used to adhere to the skin. Soft rubber layer 2; Bioelectrode 3; Flexible circuit board 4; The implantation portion 32 of the bioelectrode 3 extends downward from the soft adhesive layer 2, and the transfer portion 31 of the bioelectrode 3 is attached between the upper adhesive layer 1 and the flexible circuit board 4 and connected to the flexible circuit board 4. The upper adhesive layer 1 and the first upper adhesive surface 51 are bonded together to form a covering space, and the soft adhesive layer 2, the bioelectrode 3 and the flexible circuit board 4 are covered in the covering space.

[0088] The lower adhesive layer 5 has a second lower adhesive surface 52, which faces downward and is directly adhered to the skin.

[0089] Example 4

[0090] Based on the above embodiments, see Figure 4 This embodiment describes the complete stacked structure of the bioinformatics monitoring device 01.

[0091] See Figures 24-28 From the top (side away from the skin) to the bottom (side close to the skin) of the bio-information monitoring device 01, the layer structure of the bio-information monitoring device 01 is as follows. It should be noted that the layered structure described here is only one implementation method, but is not limited to it. Provided that the technical solution is feasible, the order, structure and positional relationship between the layers can be appropriately adjusted, and the internal structure can also be added or reduced: Upper adhesive layer 1: The outermost (uppermost) layer of the upper adhesive layer 1 of the bio-information monitoring device 01 serves as the outer surface protective layer and appearance component of the bio-information monitoring device 01. It has a first lower adhesive surface 011, with the first lower adhesive surface 011 facing downward. The first lower adhesive surface 011 and the first upper adhesive surface 51 of the lower adhesive layer 5 are bonded together to form a covering space. The upper adhesive layer 1 is a very thin adhesive layer, a rigid film layer with a thickness of 0.02~0.08mm. Although the rigid film layer has relatively high hardness, it still has a certain degree of flexibility due to its extremely thin thickness. The material itself has waterproof properties, and the material can be PE, PU, ​​PI, PP, PVC, etc. In this embodiment, PU material is selected. The upper surface of the upper adhesive layer 1 is not adhesive, while the lower surface may or may not be adhesive.

[0092] Plastic layer 8: The plastic layer 8 is located below the upper adhesive layer 1 and is bonded to the lower surface of the upper adhesive layer 1. The plastic layer 8 can be made of thin engineering plastic sheets such as PET or PC, with a thickness between 0.08mm and 0.15mm. The plastic layer 8 provides some support and waterproofing. The plastic layer 8 is either adhesive-free on both sides or has adhesive on the upper surface. The waterproofing between the plastic layer 8 and the upper adhesive layer 1 mainly relies on the bonding between the lower surface of the upper adhesive layer 1 and the upper surface of the plastic layer 8 (at least one side of the lower surface of the upper adhesive layer 1 and the upper surface of the plastic layer 8 has adhesive).

[0093] The plastic layer 8 and the upper adhesive layer 1 form a composite support layer. The Shore hardness of the composite support layer is 40A or higher. The plastic layer 8 is flexible and has a Shore hardness of 40A or higher. The periphery of the plastic layer 8 is located within the upper adhesive layer 1.

[0094] First double-sided adhesive layer 9: The first double-sided adhesive layer 9 is located below the plastic layer 8 and above the bioelectrode 3. The upper adhesive surface of the first double-sided adhesive layer 9 is bonded to the lower surface of the plastic layer 8, and the lower adhesive surface of the first double-sided adhesive layer 9 is bonded to the upper surface of the transfer portion 31 of the bioelectrode 3. The first double-sided adhesive layer 9 is used to bond and fix the plastic layer 8 to the transfer portion 31 of the bioelectrode 3, ensuring that water does not enter the product through the lower surface of the plastic layer 8.

[0095] Second double-sided adhesive layer 10: The second double-sided adhesive layer 10 is located below the plastic layer 8. The adhesive-coated lower surface of the second double-sided adhesive layer 10 is bonded to the adhesive-coated upper surface of the first adhesive layer 11, and the non-adhesive lower surface of the plastic layer 8 is bonded to the adhesive-coated upper surface of the first adhesive layer 11. The second double-sided adhesive layer 10 is a waterproof double-sided adhesive, preferably a waterproof foam adhesive, and its thickness is close to the thickness of the bioelectrode 3, with a thickness deviation of -0.1 mm to 0.2 mm. The thickness of the second double-sided adhesive layer 10 is not less than the thickness of the bioelectrode 3.

[0096] See Figures 9-11 The second double-sided adhesive layer 10 is provided with an electrode fixing groove 101, which is used to fix the connecting section 33 of the bioelectrode 3 adapter 31 and the implantation section 32. The shape of the electrode fixing groove 101 is adapted to the connecting section 33, and its groove width is slightly smaller than the width of the connecting section 33. Its single-sided interference is 0mm to 0.3mm to ensure that water will not enter the product through the edge of the bioelectrode 3. In some embodiments, when the second double-sided adhesive layer 10 is thicker than the bioelectrode 3, the groove width of the electrode fixing groove 101 may also be slightly smaller than the outer width of the electrode adaptation area.

[0097] The second double-sided adhesive layer 10 is provided with an electrode clearance groove 102, which is used for the implantation part 32 of the bioelectrode 3 to pass through; the electrode clearance groove 102 is connected to the electrode fixing groove 101, or it may not be connected.

[0098] In some embodiments, the lower surface of the second double-sided adhesive layer 10 does not necessarily need to be adhesive.

[0099] The adapter portion 31 and ACF13 of bioelectrode 3: The adapter portion 31 of the bioelectrode 3 is located between the flexible adhesive layer 02 and the flexible circuit board 4. The contacts of the adapter portion 31 of the bioelectrode 3 are electrically connected and mechanically fixed to the contacts on the circuit board pad connection portion 41 of the flexible circuit board 4 through the ACF13.

[0100] ACF13 has a thin film structure and is located between the contact 31 of the bioelectrode 3 and the contact 4 of the flexible circuit board.

[0101] Flexible adhesive layer 02: See Figure 5 and Figure 6 The flexible adhesive layer 02 is located below the plastic layer 8. The flexible adhesive layer 02 is composed of three layers stacked together: a first adhesive layer 11, a soft adhesive layer 2, and a second adhesive layer 12. The flexible adhesive layer 02 is provided with a component avoidance area 022, a battery avoidance area 023, and a second electrode avoidance area 024.

[0102] First adhesive layer 11: The first adhesive layer 11 is located below the plastic layer 8. The first adhesive layer 11 has a third upper adhesive surface, which is bonded to the bottom of the plastic layer 8 and the lower surface of the second double-sided adhesive layer 10. The third upper adhesive surface is bonded to the lower surface of the partial transfer portion 31 of the bioelectrode 3. The first adhesive layer 11 has a third lower adhesive surface, which is bonded to the upper part of the soft adhesive layer 2.

[0103] Soft rubber layer 2: Please refer to Figure 29 , Figure 29 This is a schematic diagram of the structure of the soft adhesive layer 2. The soft adhesive layer 2 is a flexible material with biocompatibility that is not adhesive on both sides. It can be a flexible polymer elastomer material such as silicone, TPU, or TPE. The soft adhesive layer 2 can also be a composite layer structure of two or three of the above materials. The soft adhesive layer 2 is provided with a battery embedding area 21, and the hard battery 6 is embedded in the battery embedding area 21 around its periphery; The soft adhesive layer 2 is provided with a component clearance notch 22, and the electronic components 43 of the flexible circuit board 4 are embedded in the component clearance notch 22; The soft adhesive layer 2 is provided with a third electrode avoidance area 23, and the implantation part 32 of the bioelectrode 3 passes through the third electrode avoidance area 23; the third electrode avoidance area 23 is specifically an avoidance through hole; The soft adhesive layer 2 is provided with a first pad avoidance area 24. The connection pad of the bioelectrode 3 31 is exposed at least partially in the first pad avoidance area 24 to connect to the connection pad of the flexible circuit board 4.

[0104] The thickness of the soft adhesive layer 2 is greater than the sum of the thicknesses of the upper adhesive layer 1, the flexible circuit board 4, and the lower adhesive layer 5, and its Shore hardness is 20A~40A. The composite Shore hardness of the lower adhesive layer 5, the soft adhesive layer 2, and the flexible circuit board 4 after bonding and assembly is 20A~40A. It is moderately soft and tough, skin-friendly, elastic, and shape-forming, and is suitable for the modulus of human skin. The lower Shore hardness of the lower adhesive layer 5 plays a buffering and absorbing role in the rigidity of the flexible circuit board 4, and the composite structure still maintains good skin-friendly softness.

[0105] After assembly, the soft adhesive layer 2 can produce adaptive elastic deformation. When the upper adhesive layer 1 and the lower adhesive layer 5 are bonded together to form a covering space, the soft adhesive layer 2 is subjected to the covering pressure and undergoes local elastic deformation. The flexible material of the soft adhesive layer 2 actively adheres to and fills the gaps between the internal structural components of the adhesive bio-information monitoring device caused by irregular shape or dimensional tolerance. The gaps inside the device are mainly the gap between the periphery of the rigid battery 6 and the inner wall of the battery embedding area 21, the gap between the periphery of the electronic component 43 and the inner wall of the component clearance notch 22, the gap between the transfer part 31 of the bioelectrode 3 and the soft adhesive layer 2, the tiny gap between the upper surface of the flexible circuit board 4 and the lower surface of the soft adhesive layer 2 due to solder joint protrusion or trace protrusion, and other gaps between the layers due to the incomplete matching of the outer contour shape. The flexible elastomer material of the soft adhesive layer 2 expands and fills the surrounding gap space after being covered and compressed. After the external force is released, the elastic recovery force of the soft adhesive layer 2 causes it to continuously press against the surface of the structural components around the gap, forming a continuous elastic filling, eliminating the internal cavity, so that the patch-type bio-information monitoring device will not collapse locally due to the cavity when subjected to external pressure, improving structural integrity and pressure resistance. It forms a comprehensive flexible wrapping constraint for the internal hard battery 6, electronic components 43, bioelectrodes 3 and flexible circuit board 4, preventing the structural components from loosening or shifting due to vibration or impact during wear, ensuring the reliability of electrical connection; it isolates rigid components from the external environment, and the external impact force is first absorbed and buffered by the soft adhesive layer 2, reducing the risk of damage to rigid components; it makes the interior form a solid or near-solid structure, and the external force is evenly distributed and transmitted through the soft adhesive layer 2 rather than concentrated through the cavity wall, making the force on each part more balanced.

[0106] Second adhesive layer 12: The upper surface of the second adhesive layer 12 is sealed and bonded to the lower surface of the soft adhesive layer 2, and the lower surface of the second adhesive layer 12 is bonded to the upper surface of the flexible circuit board 4. The first adhesive layer 11 and the second adhesive layer 12 achieve waterproof protection through the fixed interlayer structure, ensuring that external moisture will not penetrate into the bio-information monitoring device 01 through the upper and lower surfaces of the soft adhesive layer 2.

[0107] The first adhesive layer 11 and the second adhesive layer 12 are provided with a second pad avoidance area and a third pad avoidance area at the position and shape of the first pad avoidance area 24 of the flexible adhesive layer 2. The first pad avoidance area 24, the second pad avoidance area, and the third pad avoidance area together form the pad conductive area 021 of the flexible adhesive layer 02. Figure 5 and Figure 6 The area enclosed by the midpoint line is the conductive area 021 of the solder pad; The first adhesive layer 11 and the second adhesive layer 12 are provided with a first component avoidance area and a second component avoidance area at the position and shape of the component avoidance notch 22 corresponding to the flexible adhesive layer 2. The first component avoidance area, the second component avoidance area, and the component avoidance notch 22 together form the component avoidance area 022 of the flexible adhesive layer 02. Figure 5 and Figure 6 The area enclosed by the short dashed lines is the component avoidance zone 022; The first adhesive layer 11 and the second adhesive layer 12 are provided with a first battery embedding area and a second battery embedding area corresponding to the position and shape of the battery embedding area 21 of the soft adhesive layer 2. The first battery embedding area, the second battery embedding area and the battery embedding area 21 together form the battery avoidance area 023 of the flexible adhesive layer 02. The first adhesive layer 11 and the second adhesive layer 12 are provided with a fourth electrode avoidance area and a fifth electrode avoidance area at the position of the third electrode avoidance area 23 of the soft adhesive layer 2. The third electrode avoidance area 23, the fourth electrode avoidance area and the fifth electrode avoidance area together form the second electrode avoidance area 024 of the flexible adhesive layer 02. The bottom surface of the rigid battery 6 presses against the flexible circuit board 4, and the top surface of the rigid battery 6 presses against the bottom of the upper adhesive layer 1.

[0108] Hard battery 6: The rigid battery 6 is located in the battery arrangement area 402 of the flexible circuit board 4, and the rigid battery 6 is embedded upward in the battery avoidance area 023 of the flexible adhesive layer 02.

[0109] Flexible circuit board 4: The flexible circuit board 4 is located below the flexible adhesive layer 02, and the upper surface of the flexible circuit board 4 is bonded to the lower surface of the second adhesive layer 12.

[0110] The flexible circuit board 4 has a component concentration area 401 on the side (upper surface) facing the flexible adhesive layer 02. Electronic components 43 that are higher than the upper surface of the flexible circuit board 4 are soldered / attached in the component concentration area 401. The electronic components 43 are embedded upward into the component avoidance area 022 of the flexible adhesive layer 02 and into the component avoidance notch 22 of the soft adhesive layer 2.

[0111] The flexible circuit board 4 is also soldered with a first battery spring 71 and a second battery spring 72, which are used to make elastic contact with the rigid battery 6. The flexible circuit board 4 is provided with a circuit board pad connection part 41, and the three sides of the circuit board pad connection part 41 are separated from the flexible circuit board body.

[0112] Fill block 14: See Figures 20-23 The filler block 14 is disposed in the lower gap of the circuit board pad connection part 41. The filler block 14 is used to fill the gap and provide support for the circuit board pad connection part 41, so that the pads of the circuit board pad connection part 41 and the pads of the bio-electrode 3 adapter part 31 are stably pressed together, thereby improving the connection stability.

[0113] Lower adhesive layer 5: See Figures 24-28 The lower adhesive layer 5 is a very thin waterproof double-sided or single-sided adhesive layer located below the flexible circuit board 4. Its upper surface needs to be covered with adhesive, and its lower surface can be covered with adhesive or not. Its thickness is 0.03mm to 0.1mm. The lower adhesive layer 5 has a first upper adhesive surface 51, which faces upward and is bonded to the first lower adhesive surface 011 of the upper adhesive layer 1. The lower adhesive layer 5 has a second lower adhesive surface 52, which faces downward. The second lower adhesive surface 52 is bonded to the skin layer 15, thereby fixing the upper adhesive layer 1 and the lower adhesive layer 5 and their covering space onto the skin layer 15.

[0114] The lower adhesive layer 5 is made of a material with waterproof properties. The upper adhesive layer 1 and the lower adhesive layer 5 together form the main waterproof barrier on the outer ring of the product after encapsulation. The lower surface edge of the upper adhesive layer 1 is bonded to the upper surface edge of the lower adhesive layer 5, forming a waterproof bonding area 03 (e.g., ...). Figure 26 (In the area marked with a dotted line), the waterproof bonding area 03 is specifically designed in a ring shape, with a bonding width of 0.5mm to 2mm, which can effectively prevent water penetration.

[0115] Skin-adhesive layer 15: Located at the bottom layer (closest to the skin) of the bio-information monitoring device 01, the skin-adhesive layer 15 is used to attach and fix the entire bio-information monitoring device 01 to the user's skin surface. The skin-adhesive layer 15 has a second upper adhesive surface 152 and a skin adhesive surface 151. The second upper adhesive surface 152 is used to adhere the lower adhesive layer 5, and the skin adhesive surface 151 is used to adhere the skin. The skin adhesive surface 151 can also adhere the release film.

[0116] The skin-adhesive layer 15 is preferably a medical-grade pressure-sensitive double-sided adhesive that meets skin biocompatibility requirements. The material of the skin-adhesive layer 15 can be an acrylic pressure-sensitive adhesive, a silicone pressure-sensitive adhesive, or a hydrocolloid adhesive. The skin-adhesive layer 15 has through-holes at positions corresponding to the implantation portion 32 of the bioelectrode 3, allowing the implantation portion 32 of the bioelectrode 3 to pass through.

[0117] The skin-adhesive surface 151 has suitable initial tack and holding power, which can maintain stable skin adhesion during the wearing period and will not cause damage to the skin when removed.

[0118] The various layers of the bioinformatics monitoring device 01 are mainly fixed and assembled using double-sided adhesive. The assembly process of the bioinformatics monitoring device 01 does not require the use of mechanical fasteners such as screws and clips. The assembly process of the bioinformatics monitoring device 01 is simple and fast, and the bioinformatics monitoring device 01 can be easily and efficiently assembled on automated production lines, resulting in low manufacturing costs.

[0119] The mechanical effects of the internal structure of the bioinformatics monitoring device 01 are as follows: External forces are sequentially dispersed in-plane by the upper adhesive layer 1, elastically absorbed and converted by the soft adhesive layer 2, homogenized in-plane by the flexible circuit board 4, absorbed by the residual force by the lower adhesive layer 5, and flexibly transmitted to the skin interface by the skin-adhesive layer 15. The hard layer disperses the force in-plane, the soft layer absorbs the force through elastic deformation, and the soft layer dissipates the residual force through deformation with extremely low stiffness. Finally, the force transmitted to the skin is reduced and homogenized, improving wearing comfort.

[0120] During bending deformation, the upper adhesive layer 1 withstands tensile or compressive stress without breaking, the soft rubber layer 2, as the main absorbent layer for bending deformation, reduces the stress requirements on the top and bottom layers, and the lower adhesive layer 5 and the skin-adhesive layer 15 undergo large-scale deformation with minimal stress to fully conform to the skin's curvature, further improving wearing comfort.

[0121] The Shore A hardness of the soft rubber layer 2 is 20A to 40A. This hardness range makes the soft rubber layer 2 moderately soft and tough. The softness allows the soft rubber layer 2 to follow the curvature of human skin to achieve good skin adhesion, while the toughness ensures that the soft rubber layer 2 will not tear or permanently deform during repeated bending and stretching. The elasticity of the soft rubber layer 2 allows it to actively conform to the surface of adjacent components under pressure to eliminate interface gaps and achieve sealing, and adaptively fills the gaps between layers inside the device to prevent moisture transmission. The shape retention of the soft rubber layer 2 allows the device to maintain its preset shape contour when there is no external force, and the shape and size of the internal functional structure are stable. The hardness of 20A to 40A is on the same order of magnitude as the elastic modulus of human skin. The soft rubber layer 2 deforms synchronously with the skin, and the interfacial shear stress is extremely small, reducing the risk of device detachment and skin irritation.

[0122] The Shore hardness of the flexible circuit board 4 is greater than that of the soft adhesive layer 2. The flexible circuit board 4 provides a rigid mounting platform for the electronic components 43, ensuring the reliability of the solder joints and the geometric stability of the wiring. The flexible circuit board 4 and the soft adhesive layer 2 form a rigid-flexible composite structure. When the device is bent as a whole, the deformation mainly occurs in the softer soft adhesive layer 2, and the flexible circuit board 4 only slightly follows the bending. The electronic components and electrical connections are protected by the preferential deformation of the soft adhesive layer 2.

[0123] The Shore hardness of the lower adhesive layer 5 is less than that of the soft adhesive layer 2. The lower adhesive layer 5 has a stronger adaptive deformation capability, which can fill the micro-undulations on the lower surface of the flexible circuit board 4 to form a gapless adhesive interface, while conforming to the micro-morphology of the skin surface to improve the adhesion stability. The lower adhesive layer 5 serves as a flexible buffer layer between the flexible circuit board 4 and the skin, transforming rigid contact into flexible contact.

[0124] The overall Shore A hardness of the three layers remains between 20A and 40A after combination. This is because the thickness of the soft adhesive layer 2 is dominant, and the overall mechanical response of the three-layer composite is determined by the soft adhesive layer 2. The high hardness of the flexible circuit board 4 and the low hardness of the lower adhesive layer 5 are contained by the dominant thickness of the soft adhesive layer 2. After combination, the overall structure still maintains moderate softness and toughness, skin-friendliness, elasticity, and shape retention, and still matches the modulus of human skin feel. The hardness of the three layers gradually softens from the inside to the outside: the internal rigidity protects the electronic components, the middle moderately flexible structure achieves shape retention and sealing, and the bottom is the softest and fits the skin best, maximizing wearing comfort while ensuring the reliability of electronic functions.

[0125] Based on the aforementioned three layers of soft adhesive layer 2, flexible circuit board 4, and lower adhesive layer 5 with varying hardness, the addition of upper adhesive layer 1 (rigid film layer, PU or other film material, thickness 0.02mm to 0.08mm) and plastic layer 8 (PET, PC or other engineering plastics, thickness 0.08mm to 0.15mm) results in an overall Shore hardness of 20A to 40A for the five-layer composite.

[0126] Although the upper adhesive layer 1 and the plastic layer 8 are harder than the soft rubber layer 2, their combined thickness is only 0.10 mm to 0.23 mm, much less than the thickness of the soft rubber layer 2. The thickness of the soft rubber layer 2 is dominant in the total thickness of the five layers, and the overall mechanical response of the five-layer composite under external force is still determined by the soft rubber layer 2. The high hardness of the upper adhesive layer 1 and the plastic layer 8 is contained and diluted by the dominant thickness of the soft rubber layer 2. After the five layers are combined, the overall structure still maintains a moderate level of flexibility and toughness.

[0127] The device comprises five layers forming a composite structure from top to bottom: a hard surface, a soft middle layer, a hard inner core, and the softest bottom layer. The upper adhesive layer 1 and the plastic layer 8 provide wear-resistant and waterproof protection and sealing support for the surface. The soft adhesive layer 2, with its dominant thickness, determines the overall softness of the device, ranging from 20A to 40A. The flexible circuit board 4 carries electronic components within the flexible body, and the lower adhesive layer 5 provides the softest skin contact interface at the bottom. While each of the three high-hardness functional layers fulfills its function, their extremely thin thickness does not alter the overall soft feel of the device. When worn, the device still exhibits a flexible adhesive body with a Shore hardness of 20A to 40A, combining moderate softness and toughness, skin-friendliness, elasticity, and shape retention, and is compatible with the modulus of human skin.

[0128] In this application, the terms "center," "longitudinal," "lateral," "length," "width," "thickness," "height," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," "clockwise," and "counterclockwise" indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the purpose of simplifying the description of this application and do not indicate that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. In other words, they should not be construed as limitations on this application.

[0129] In this application, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating the relative importance of the indicated features or the number of indicated technical features. Therefore, a feature specified as "first" or "second" may explicitly include at least one of those features. In this application, "multiple" means at least two, such as two, three, etc.; "several" means at least one, such as one, two, three, etc., unless otherwise explicitly specified.

[0130] In this application, unless otherwise expressly defined, the terms "installation," "connection," "linking," "fixing," "setting," etc., should be interpreted broadly. For example, "connection" can be a fixed connection, a detachable connection, or an integral part; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium; it can also refer to the internal communication of two components or the interaction between two components. Those skilled in the art can understand the specific meaning of the above terms in this application according to the specific circumstances.

[0131] In this application, unless otherwise expressly defined, the terms "above," "on top of," "over," "above," "below," "below," "below," or "below" for "first feature over second feature" can refer to the first and second features being in direct contact, or to the first and second features being in indirect contact through an intermediate medium. Furthermore, "above," "over," and "below" for "first feature over second feature" can mean the first feature is directly above or diagonally above the second feature, or simply indicates that the horizontal height of the first feature is higher than the horizontal height of the second feature. Similarly, "below," "below," and "below" for "first feature over second feature" can mean the first feature is directly below or diagonally below the second feature, or simply indicates that the horizontal height of the first feature is lower than the horizontal height of the second feature.

[0132] It should be understood that the above embodiments are exemplary and are not intended to include all possible embodiments covered by the claims. Various modifications and changes can be made to the above embodiments without departing from the scope of this disclosure. Similarly, the various technical features of the above embodiments can be arbitrarily combined to form other embodiments of this application that may not be explicitly described. Therefore, the above embodiments only illustrate several embodiments of this application and do not limit the scope of protection of this patent application.

Claims

1. A patch-type bioinformatics monitoring device, characterized in that, include: Upper adhesive layer (1); The lower adhesive layer (5) has a first upper adhesive surface (51) facing upwards, and the bottom surface of the lower adhesive layer (5) is used to adhere to the skin. Soft rubber layer (2); Bioelectrode (3); Flexible circuit board (4); Hard battery (6); The implantation portion (32) of the bioelectrode (3) extends downward from the soft adhesive layer (2), and the adapter portion (31) of the bioelectrode (3) is attached between the upper adhesive layer (1) and the flexible circuit board (4) and connected to the flexible circuit board (4). The soft adhesive layer (2) is provided with a battery embedding area (21), and the rigid battery (6) is embedded in the battery embedding area (21) on its periphery; the bottom surface of the rigid battery (6) presses against the flexible circuit board (4), and the top surface of the rigid battery (6) presses against the bottom of the upper adhesive layer (1); The upper adhesive layer (1) and the first upper adhesive surface (51) are bonded together to form a covering space, and the soft adhesive layer (2), bioelectrode (3) and flexible circuit board (4) are covered in the covering space; It also includes a plastic layer (8), which is bonded to the bottom of the upper adhesive layer (1); The upper adhesive layer (1) is a rigid film layer, and the plastic layer (8) and the upper adhesive layer (1) form a composite support layer; The thickness of the soft adhesive layer (2) is greater than the sum of the thicknesses of the upper adhesive layer (1), the flexible circuit board (4), and the lower adhesive layer (5). The Shore hardness of the soft adhesive layer (2), the flexible circuit board (4), and the lower adhesive layer (5) is 20A~40A. It is moderately soft and tough, skin-friendly, elastic, and shape-forming, and is suitable for the human skin modulus.

2. The patch-type bioinformatics monitoring device as described in claim 1, characterized in that, The upper adhesive layer (1) has a first lower adhesive surface (011) facing downwards; The first lower adhesive surface (011) and the first upper adhesive surface (51) are bonded together to form a covering space.

3. The patch-type bioinformatics monitoring device as described in claim 1, characterized in that, The lower adhesive layer (5) has a second lower adhesive surface (52), the second lower adhesive surface (52) faces downward, and the second lower adhesive surface (52) is bonded to the skin; or, It also has a skin-adhesive layer (15) with a skin-adhesive surface (151) facing downwards, the skin-adhesive surface (151) being used to adhere to the skin, and the lower adhesive layer (5) adhering to the skin-adhesive layer (15).

4. The patch-type bioinformatics monitoring device as described in claim 3, characterized in that, The skin-adhesive layer (15) has a second upper adhesive surface (152) which adheres to the lower adhesive layer (5).

5. The patch-type bioinformatics monitoring device as described in claim 1, characterized in that, The thickness of the upper adhesive layer (1) is 0.02mm~0.08mm, and the thickness of the lower adhesive layer (5) is 0.03mm~0.1mm.

6. The patch-type bioinformatics monitoring device as described in claim 1, characterized in that, The soft rubber layer (2) has a Shore hardness of 20A~40A, and is moderately soft and tough, with good skin-fitting, elastic and shape-forming properties, and is suitable for the human skin modulus. The Shore hardness of the flexible circuit board (4) is greater than that of the soft adhesive layer (2), and the Shore hardness of the lower adhesive layer (5) is less than that of the soft adhesive layer (2).

7. The patch-type bioinformatics monitoring device as described in claim 6, characterized in that, The Shore hardness of the lower adhesive layer (5) after bonding the flexible circuit board (4) is 20A~40A.

8. The patch-type bioinformatics monitoring device as described in claim 1, characterized in that, The flexible circuit board (4) includes a component concentration area (401), the soft adhesive layer (2) is provided with a component clearance notch (22), the component concentration area (401) is attached with electronic components (43) that protrude above the upper surface of the flexible circuit board (4), and the electronic components (43) pass through the component clearance notch (22) and are accommodated between the upper adhesive layer (1) and the flexible circuit board (4).

9. The patch-type bioinformatics monitoring device as described in claim 1, characterized in that, The composite support layer has a Shore hardness of 40A or higher.

10. The patch-type bioinformatics monitoring device as described in claim 9, characterized in that, The plastic layer (8) is flexible and has a Shore hardness of 40A or higher; the periphery of the plastic layer (8) is located within the upper adhesive layer (1).

11. The patch-type bioinformatics monitoring device as described in claim 10, characterized in that, It also includes a first adhesive layer (11), which is bonded to the bottom of the plastic layer (8) and the top of the soft rubber layer (2).

12. The patch-type bioinformatics monitoring device as described in claim 11, characterized in that, It also includes a second adhesive layer (12), which is bonded to the bottom of the soft adhesive layer (2) and the top of the flexible circuit board (4).

13. The patch-type bioinformatics monitoring device as described in claim 1, characterized in that, It also includes a side flexible circuit (410) that branches off from the edge or upper surface of the flexible circuit board (4) and is connected on the other side to the transfer portion (31) of the bioelectrode (3).

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