Implantable devices for biosensors

Abstract

An implantation device for a biosensor includes a housing unit, an implantation module, a base, a sensor assembly, and a removal element. The housing unit includes a housing component and a bottom cover, the housing component defining an accommodating space. The implantation module is disposed within the accommodating space and is operable for automatic needle insertion and removal. The base is detachably positioned within the implantation module and includes a main housing, an adhesive pad, and an outer release layer. The sensor assembly is detachably positioned within the base, and after needle insertion, the sensor assembly can be attached to the main housing. The removal element is connected to the bottom cover and the outer release layer; when the bottom cover is removed from the housing component, the outer release layer can be peeled off from the adhesive pad. The overall configuration facilitates ease of use.

Description

[Technical Field]

[0001] This invention relates to a system and method for applying a biological detection system to an organism, and more particularly to an implantation device for installing a biological detection device on the skin surface of an organism and implanting a biological sensor under the skin of an organism. [Previous Technology]

[0002] The traditional method of self-testing blood glucose involves drawing blood from a capillary with a needle, placing a drop onto a blood glucose test strip, and then having a machine read the blood glucose value. When performed correctly, the measured blood glucose value can be very accurate. If the measured blood glucose value is too high or too low, treatment can be initiated as soon as possible. Some people may need to measure their blood glucose frequently, especially those with poorly controlled blood glucose, those undergoing insulin therapy, or those experiencing significant blood glucose fluctuations.

[0003] Another type of instrument that allows for self-monitoring of blood glucose is CGM (Continuous Glucose Monitoring). This involves placing a sensor needle under the patient's skin to continuously measure the concentration of glucose in the interstitial fluid, as glucose in the blood diffuses into the tissue fluid and then enters the cells. The sensor can estimate blood glucose levels through calculations and can provide real-time blood glucose level values. Blood glucose is recorded at regular intervals, and a trend curve of blood glucose changes is displayed to issue warnings when blood glucose is too high or too low.

[0004] Current research shows that for patients with type 1 and type 2 diabetes who require insulin injections, the use of CGM can reduce glycated hemoglobin by approximately 0.6% compared to measurements taken via finger-prick blood glucose testing. It can also reduce the total daily duration of hypoglycemia.

[0005] CGMs must be worn by users for extended periods, therefore miniaturization is an inevitable trend. The architecture of a CGM includes: (a) a sensor for measuring physiological signals corresponding to the concentration of glucose in the human body; (b) a transceiver for receiving and transmitting physiological signals; and (c) an implantable device for attaching the sensor to the transceiver and attaching the transceiver to the user's skin, as well as implanting the sensor under the user's skin.

[0006] To achieve safe and accurate implantation of sensors under the user's skin, enabling the transmission of physiological signals detected by the sensors to the corresponding receiving device of the transceiver, allowing the user to obtain their blood glucose status at any time, the applicant has filed US Publication Nos. US20210030960A1 and US20210030344A1. However, the applicant believes that the aforementioned implantation device can further enhance functionality and provide more convenient and faster sensor placement under the user's skin. Furthermore, the applicant expects the improved sensor to facilitate easier assembly during manufacturing and production, significantly improving production yield and speed. [Summary of the Invention]

[0007] Therefore, the object of the present invention is to provide an implantable device for a biosensor that can improve the technical problems of existing implantable devices.

[0008] Therefore, the biosensor implantation device of the present invention includes a housing unit, an implantation module, a base, a sensor assembly, and a tear-off element. The housing unit includes a housing member and a bottom cover detachably coupled to the housing member, the housing member defining an accommodating space. The implantation module is disposed in the accommodating space and can be operated to perform automatic needle insertion and automatic needle withdrawal. The base is detachably confined within the implantation module, the base including a main housing, an adhesive pad fixed to the main housing, and a detachable outer release layer attached to the adhesive pad. The sensor assembly is detachably confined within the base, and after needle insertion by the implantation module, the sensor assembly can be engaged with the main housing. The tear-off element is connected to the bottom cover and the outer release layer, and when the bottom cover is removed from the housing member, the outer release layer can be torn off from the adhesive pad.

[0009] The advantages of the present invention are: the tear-off element is connected to the bottom cover and the outer release layer, and when the bottom cover is removed from the outer shell, the outer release layer can be torn off from the adhesive pad at the same time, and the implantation device can be quickly positioned on the user's skin, so as to achieve the purpose of convenient and fast operation.

Implementation Method

[0011] Before the present invention is described in detail, it should be noted that similar elements are represented by the same numbers in the following description.

[0012] Referring to Figures 1 to 5, an embodiment of the implantation device of the biosensor of the present invention includes a housing unit 1, an implantation module 2, two fixing members 3, a base 4, a sensor assembly 5, a tear-off element 6, and a desiccant 7.

[0013] The outer casing unit 1 includes an outer casing 10, a top cover 20 fixed inside the outer casing 10, an inner liner 30 located inside the outer casing 10 and on one side of the top cover 20, and a bottom cover 40 that can be airtightly connected to the outer casing 10. The outer casing 10 defines a receiving space 11, and a chamber 21 separated from the receiving space 11 is formed between the top cover 20 and the outer casing 10. The top cover 20 may include an opening 22 for placing the desiccant 7 (in package, tablet, or granular form) into the chamber 21. During product assembly, the desiccant 7 is placed into the chamber 21 and then the opening 22 is sealed, but there are still pores for moisture prevention inside the can. In another embodiment, if a packaged desiccant with a size larger than the opening 22 is used, the opening 22 does not need to be sealed.

[0014] Referring to Figure 6, the inner liner 30 is a hollow ring frame and has an inner peripheral surface 31, an outer peripheral surface 32 opposite to the inner peripheral surface 31, a plurality of actuating portions 33 disposed on the inner peripheral surface 31, a pair of spring-shaped and downwardly extending insert portions 34, a pair of claws 35 extending downwardly from the bottom edge, and a fourth alignment mark 36 disposed on the outer peripheral surface 32. The fourth alignment mark 36 is a triangular mark.

[0015] The bottom cover 40 is used to be detachably coupled to the opening of the receiving space 11 of the outer casing 10 and includes a chassis portion 41.

[0016] The implantation module 2 is disposed in the accommodating space 11 of the outer shell unit 1. The implantation module 2 includes a main body unit 50, a guide group 60, an implantation seat 70, a first elastic member 81, a needle extraction seat 90, a second elastic member 82 and a needle implantation member 100.

[0017] The main body unit 50 is engaged with the outer shell unit 1 and is slidably fitted relative to the inner liner 30. The main body unit 50 has a main body 51 and a detachable main body cover 52 engaged with the main body 51. The main body 51 and the main body cover 52 together form a displacement space 53. Referring to FIG7, the main body 51 has a bottom wall 511, an annular wall 512 intersecting and connected to the bottom wall 511, a plurality of snap-fit ​​portions 513 disposed on the annular wall 512, a plurality of fastening portions 514 disposed on the annular wall 512, a pair of sliding grooves 515 disposed on the annular wall 512 and communicating with the bottom wall 511, a pair of locking portions 516 protruding from the annular wall 512 and respectively corresponding to the snap-fit ​​portions 34, and a first alignment mark 517 disposed on the annular wall 512. The bottom wall 511 has four lower positioning holes 518, and the included angles θ1, θ2, θ3, and θ4 are formed between two adjacent lower positioning holes 518. These included angles θ1, θ2, θ3, and θ4 are asymmetrical. The first alignment mark 517 corresponds to the fourth alignment mark 36, and the first alignment mark 517 is a triangular mark. Referring to Figure 5, the main cover 52 has a plurality of connecting portions 521 that interlock with the snap-fit ​​portions 513, two plate-shaped limiting members 522 (see Figure 2), a second alignment mark 523 corresponding to the first alignment mark 517, and four upper positioning holes 524. The second alignment mark 523 is a triangular mark, and the included angles formed between two adjacent upper positioning holes 524 are the same as the included angles θ1, θ2, θ3, and θ4, respectively. These included angles are asymmetrical.

[0018] Referring to Figure 8, the guide assembly 60 is located in the displacement space 53 and has four guide posts 61 connecting the main body 51 and the main body cover 52. As shown in Figure 3, one end of each guide post 61 is inserted into the corresponding lower positioning hole 518, and the other end is inserted into the corresponding upper positioning hole 524. The included angles formed between two adjacent guide posts 61 are the same as included angles θ1, θ2, θ3, and θ4, respectively, and these included angles are asymmetrical. As shown in Figure 7, in this embodiment, the included angle formed between two guide posts 61 is not equal to the included angle formed between the other two opposing guide posts 61. Besides being cylindrical, the cross-sectional shape of the guide posts 61 can vary depending on different application requirements.

[0019] The implant 70 is detachable and located on the main body unit 50, and is guided by the guide group 60 to move in the displacement space 53. The implant 70 has a flat plate 71, an outer cylindrical member 72 intersecting with the flat plate 71, an inner cylindrical member 73 intersecting with the flat plate 71 and located inside the outer cylindrical member 72, a plurality of catheters 74 connected to the inner cylindrical member 73, a limiting component 75 connected to the inner cylindrical member 73 and limiting the needle extraction seat 90 relative to the implant 70, a plurality of latching parts 76 being pulled by the latching part 33 and detachably embedded in the latching part 514 of the main body 51, four first guide holes 77 through which the guide posts 61 can slide, a positioning member 78 protruding from the flat plate 71, and a fifth alignment mark 79 disposed on the outer cylindrical member 72 and corresponding to the first alignment mark 517. The first guide holes 77 are respectively disposed inside the conduits 74, and the included angles formed between two adjacent first guide holes 77 are the same as included angles θ1, θ2, θ3, and θ4, respectively. These included angles are asymmetrical (as shown in Figure 8, and also indicated in Figure 7). Referring to Figure 9, each conduit 74 has a bottom section 741 connected to the flat plate 71, a top section 742 opposite to the bottom section 741 along the axial direction of the corresponding guide post 61, and a hollow portion 743 between the bottom section 741 and the top section 742 and communicating with the corresponding first guide hole 77. The limiting assembly 75 has a pair of hook-shaped buckles 751, and a limiting groove 752 is formed between the buckles 751 and the inner cylinder 73 for the limiting member 522 to be inserted. The limiting component 75 limits the needle extraction seat 90, so that the implantation seat 70, the main body cover 52, and the needle extraction seat 90 constitute a needle extraction limiting structure B. The latching portions 76 are connected to the outer cylindrical member 72, and the latching portions 76 cooperate with the locking portions 514 to form a firing limiting structure A between the implantation seat 70 and the main body member 51. The positioning member 78 has two convex column-shaped connecting portions 781 (see Figure 3).

[0020] One end of the first elastic member 81 is positioned relative to the main body unit 50 and abuts against the main body cover 52, while the other end springs against the implant seat 70. The first elastic member 81 may be a pre-compressed spring.

[0021] The needle extraction seat 90 is detachably located at the implantation seat 70 and is guided by the guide assembly 60. The needle extraction seat 90 has four second guide holes 91 through which the guide posts 61 can slide, and a third alignment mark 92 corresponding to the first alignment mark 517. An included angle θ1, θ2, θ3, θ4 is formed between two adjacent second guide holes 91, and the included angles θ1, θ2, θ3, θ4 are asymmetrical (see Figure 10).

[0022] The second elastic element 82 abuts against the implantation seat 70 and the needle extraction seat 90. The second elastic element 82 may be a pre-compressed spring.

[0023] The implantation needle 100 has a body 110 and an implantation needle 120 connected to the body 110 for carrying the sensor 502.

[0024] The fasteners 3 are slidably inserted into the grooves 515 of the main body 51, and each has a pushing part 301, a support part 302 opposite to the pushing part 301, a first hook 303 between the pushing part 301 and the support part 302, and a connecting part 304 between the pushing part 301 and the support part 302. The connecting part 304 has a guide slope 305 that can be actuated by the corresponding pawl 35. When the bottom cover 40 is closed relative to the outer shell 10, the pushing parts 301 are resisted by the bottom cover 40, so that the fasteners 3 are positioned relative to the main body 51.

[0025] The base 4 is detachably positioned within the main body unit 50. The base 4 has a main housing 401, a bonding layer 420, an adhesive pad 402, and an outer release layer 403. The main housing 401 has a snap-fit ​​groove 400, a periphery 404, and two recessed slots 405 formed at the bottom of the periphery 404. The periphery 404 has a pair of first sides 406 and a pair of second sides 407 connected to the first sides 406, the length of the first sides 406 being equal to or less than the length of the second sides 407. In one embodiment, the adhesive pad 402 is attached to the detachable outer release layer 403. The main housing 401 is made of a rigid material relative to the adhesive pad 402. The first hooks 303 of the fasteners 3 can be respectively engaged in the slots 405. Referring to Figures 11 and 12, the adhesive pad 402 has a first notch 407' corresponding to one of the first side edges 406. The outer release layer 403 has a second notch 408 corresponding to the first notch 407'. The main housing 401 can be made of materials including PC (Polycarbonate), ABS (Acrylonitrile Butadiene Styrene), PC / ABS blend (Polycarbonate / Acrylonitrile Butadiene Styrene), and PP (Polypropylene). The Shore D hardness of these materials is typically between 50 and 90, preferably between 70 and 80, and can be measured according to ASTM D2240 or ISO 868 standards.

[0026] The sensor assembly 5 is detachably confined to the base 4. The sensor assembly 5 includes a sensing base 501 and a sensor 502 connected to the sensing base 501 and passing through the implant needle 120. The sensing base 501 has two concave fitting portions 503 that can be fitted into the connecting portions 781 (only one fitting portion 503 and one connecting portion 781 are shown in Figure 3 due to overlapping lines of sight). The sensing base 501 is positioned relative to the main body 51 by the common support of the supporting portions 302. In one embodiment, the fitting portions 503 are convex (not shown) and fit together with the concave (not shown) connecting portions 781 to prevent the sensing base 501 from rotating before the sensor is implanted.

[0027] The tear-off element 6 is connected to the base 4 and the bottom cover 40. As shown in Figures 11 to 13, the tear-off element 6 is connected to the chassis portion 41 and located inside the corresponding first side 406, and inside and adjacent to the second recess 408. One type of tear-off element 6 can be foam or other materials with a certain thickness, elasticity and bidirectional adhesive force. Biocompatible materials are preferred. Corresponding to this type of foam tear-off element 6, the outer release layer 403 has a plurality of fine pores 412. When the bottom cover 40 is removed from the opening of the receiving space 11, the outer release layer 403 can be peeled off from the adhesive pad 402 through the tear-off element 6 connected to the chassis portion 41.

[0028] As shown in Figure 12, in practice, upon receiving the material, the bonding layer is attached to an inner release layer 403', and the adhesive pad 402 is also attached to the outer release layer 403. Referring to Figure 11, the assembly steps of the main housing 401 of the base 4 with the bonding layer 420, the inner release layer 403', the adhesive pad 402, and the outer release layer 403 are as follows:

[0029] (a) The base 4 performs an attachment step of the bonding layer 420: the bonding layer 420, to which the inner release layer 403' is attached, is attached to the bottom surface of the main housing 401. The bonding layer 420 is made of a polymer material, such as thermoplastic polyurethane (TPU) or ethylene-vinyl acetate copolymer (EVA), and it is preferable to choose a biocompatible material.

[0030] (ii) A preheating and pressing step for the bonding layer 420: preheating and pressing is performed from the outside of the inner release layer 403' opposite to the bonding layer 420, and the bonding layer 420 is hot-pressed towards the main housing 401 so that the bonding layer 420 is bonded to a bottom surface of the main housing 401. As shown in FIG12, the bonding layer 420 shows at least one preheating and pressing position 420'. In this preheating and pressing step, the bonding layer 420 is hot-pressed at a temperature of 75°C to 85°C and a pressure of 3.5 kg / cm2 to 4.5 kg / cm2 for 3 to 10 seconds. After the preheating and pressing step of the bonding layer 420 is completed, the inner release layer 403' is peeled off from the bonding layer 420.

[0031] (iii) The attachment step of the adhesive pad 402: The adhesive pad 402 with the outer release layer 403 attached is attached to the bonding layer 420, wherein the adhesive pad 402 has an adhesive surface 402' attached to the outer release layer 403, and the adhesive pad 402 shows at least one hot-press position 402.

[0032] (iv) A hot-pressing step for the adhesive layer 402: hot pressing is performed from the outside of the outer release layer 403 opposite to the adhesive pad 402, and the adhesive pad 402 and the bonding layer 420 are hot-pressed towards the main housing 401, so that the adhesive pad 402 is bonded to the main housing 401 through the bonding layer 420. In this hot-pressing step, the temperature is 115°C to 125°C and the pressure is 3.5 kg / cm² to 4.5 kg / cm² for 10 to 20 seconds.

[0033] (V) The attachment step of the tear-off element 6 is to align the setting position of the tear-off element 6 with at least the hot pressing position 402” of the adhesive pad 402, the preheat pressing position 420' of the bonding layer 420 and the bottom cover 40.

[0034] In order to further understand the effects produced by the combination of the various components of the present invention, the technical means used, and the expected effects, the following explanation will be provided, which will hopefully lead to a deeper and more specific understanding of the present invention.

[0035] As shown in Figures 1, 2, 3, 13, and 14, when the implantation device of the present invention is assembled, the bottom cover 40 is airtightly fitted onto the outer shell 10. At this time, the main body 51 and the main body cover 52 are connected as one unit by the snap-fit ​​parts 513 and the connecting parts 521. Before firing, a gap is maintained between the top cover 20 of the outer shell unit 1 and the top of the main body cover 52, and the snap-fit ​​part 76 of the implant seat 70 snaps onto the snap-fit ​​part 514 of the main body 51, so that the implant seat 70 is in an upper position. The firing limiting structure A formed between the implant seat 70 and the main body 51 generates a safety lock, so that the implant seat 70 is positioned relative to the main body 51. The first elastic member 81 is pre-compressed between the implant seat 70 and the main body cover 52 and contains a release elastic force. The limiting members 522 are inserted into the limiting groove 752 and restrict the buckle plates 751 from radial deviation. The needle extraction limiting structure B creates a safety lock on the needle extraction seat 90 and positions the needle extraction seat 90 relative to the implant seat 70. The second elastic member 82 is pre-compressed between the needle extraction seat 90 and the implant seat 70 and contains a release elastic force. The needle extraction seat 90 is in an unexpelled position. The fitting portions 503 of the sensor assembly 5 are fitted with the connecting portion 781, so that the sensing base 501 is connected to the implant seat 70. The implant needle 120 of the needle implant 100 is hidden inside the main body 51 and shielded by the base 4, and the base 4 is positioned relative to the main body 51. At the same time, the pushing portions 301 of the fixing members 3 are resisted by the bottom cover 40, so that the fixing members 3 are positioned relative to the main body 51. The sensing base 501 of the sensor assembly 5 is supported by the support portions 302 and is positioned relative to the main body 51, and the first hooks 303 are engaged in the slots 405.

[0036] When it is to implant the sensor 502 under the skin of a human body, the operation procedure is as follows:

[0037] As shown in Figure 15, the operator first removes the bottom cover 40 from the outer casing 10. The bottom cover 40 has a force-applying part 42, which is configured to withstand a force, and a support part 43 is formed at the corresponding side end of the force-applying part 42. The distance between the support part 43 and the force-applying part 42 forms a force-applying torque with the force. The force-applying torque allows the user to rely on the force-applying part 42 to form a lateral partial opening between the bottom cover 40 and the outer casing 10. When the bottom cover 40 is removed from the opening of the receiving space 11, the outer release layer 403 can be peeled off from the adhesive pad 402 by the action of the peeling element 6 connected to the base part 41 of the bottom cover 40 and the outer release layer 403. After peeling off the outer release layer 403, the operator can attach the adhesive pad 402 of the base 4 to the part of the human body to be implanted.

[0038] As shown in Figures 16 and 17, when the operator applies force to press the outer shell 10 of the outer shell unit 1, the outer shell 10 drives the top cover 20 and the inner liner 30 to move toward the human body part, and the inner liner 30 reaches the critical position of the first strike, ready to release the firing limit structure A, while the main cover 52 has not yet moved.

[0039] As shown in Figures 18 and 19, when the operator applies force and continuously presses the outer casing 10 of the outer casing unit 1, the pawl 35 of the inner liner 30 exerts a guiding force on the linkage 304 of the fixing members 3, causing the fixing members 3 to move along the slide grooves 515 and move outward. This is an unlocking action on the fixing members 3 before firing, thereby releasing the restriction between the sensor assembly 5 and the base 4.

[0040] As shown in Figures 20 and 21, when the operator applies force and continuously presses the outer shell 10 of the outer shell unit 1, the gap between the inner liner 30 and the main body cover 52 decreases or disappears. Simultaneously, the actuating part 33 of the inner liner 30 actuates the latching part 76 of the implant 70, disengaging it from the locking part 514 of the main body 51. At the same time, the locking parts 34 engage with the corresponding locking parts 516, and the inner liner 30 is positioned relative to the main body 51. Furthermore, the firing limiting structure A is destroyed, and after the latching part 76 of the implant 70 disengages from the locking part 514 of the main body 51, the constraint of the main body 51 on the implant 70 is released. Furthermore, when the outer casing unit 1 is pressed, the claw 35 of the inner liner 30 will pull the linkage part 304 of the fixing members 3, and the fixing members 3 will move outward of the main body 51 at the same time, causing the support parts 302 to disengage from the support of the sensing base 501, and causing the first hooks 303 to disengage from the slots 405 respectively. Moreover, the setting of the guide ramps 305 makes the action of the claw 35 pulling the fixing members 3 quite smooth.

[0041] As shown in Figures 22 and 23, when the latching part 76 of the implant 70 is disengaged from the latching part 514 of the main body 51, the constraint of the main body 51 on the implant 70 is released, the pre-compressed elastic force of the first elastic member 81 is released, and the elastic force of the first elastic member 81 provides the implant 70 to move away from the implant needle direction of the main body cover 52, and the implant 70 is positioned in a lower position, and the sensor assembly 5 is driven by the implant 70 and the implant needle 100 to be positioned in a ejection position, and the sensor 502 is also implanted under the skin of the human body along with the implant needle 120, and the sensing base 501 of the sensor assembly 5 is snapped into the latching groove 400 of the base 4.

[0042] Next, as shown in Figures 24 and 25, the limiting groove 752 of the implantation seat 70 separates from the limiting member 522 of the main body cover 52, thereby releasing the locking of the limiting component 75 to the needle extraction seat 90. The pre-compressed elastic force of the second elastic member 82 is also released, causing the needle extraction seat 90 to drive the implant needle 100 to move in a needle extraction direction R opposite to the needle extraction direction. The implant needle 120 retracts into the implantation seat 70. The positioning member 78 at the bottom of the implantation seat 70 still presses the sensor assembly 5 onto the base 4, which can prevent the kinetic energy of the needle extraction from affecting the rebound of the sensor assembly 5.

[0043] As shown in Figure 26, the operator pulls the outer shell unit 1, the implanted module 4 and the base 4 off the human body surface and the base 4, leaving the base 4 and the sensor assembly 5 on the human body surface (the base 4 and the sensor assembly 5 left on the human body surface are not shown in Figure 26).

[0044] The operator puts the bottom cover 40 that was originally removed back on the bottom of the outer casing 10 and seals the bottom cover 40 to the bottom of the outer casing 10.

[0045] The effects that the present invention can produce are summarized below:

[0046] 1. As shown in Figures 11 and 12, the tearing element 6 is disposed on the inner periphery of the main housing 401. Its material is harder than the adhesive tape, providing a support surface for tearing the release paper. This facilitates the concentration of tearing torque and greatly improves the success rate of tearing the release paper when opening the can, reaching 99%. If the tearing element is disposed on the adhesive tape and its material is softer than the base, the success rate of tearing the release paper when opening the can will decrease.

[0047] Second, the adhesive pad 402 near the tearing element 6 is provided with the first notch 407', and the outer release layer 403 is provided with the second notch 408. The first notch 407' and the second notch 408 can be used to allow gas to escape, reduce tearing resistance, and make tearing easier. A gap or notch is designed at the edge or a specific position of the outer release layer 403, which can provide a tearing starting point and make tearing easier.

[0048] Third, introducing microstructures, such as tiny pores 412 or fine textured surfaces, into the surface of the outer release layer 403 helps reduce adhesion. Additionally, considering the tearing direction, designing the tearing direction along the weaker parts of the structure or shape makes tearing easier.

[0049] Fourth, the tear-off element 6 is attached to the adhesive pad 402 after hot pressing. Since the adhesive pad 402 has less adhesion at the hot pressing position 402” after hot pressing than the adhesion at other parts, it is more conducive to the simultaneous tear-off of the tear-off element 6 when the cover is opened.

[0050] In summary, when the bottom cover 40 is removed from the outer shell 10, the outer release layer 403 can be peeled off from the adhesive pad 402 at the same time, and the implantation device can be quickly positioned on the user's skin, achieving the purpose of convenient and fast operation, and indeed achieving the purpose of the present invention.

[0051] However, the above description is only an embodiment of the present invention and should not be construed as limiting the scope of the present invention. Any simple equivalent changes and modifications made in accordance with the scope of the patent application and the contents of the patent specification shall still fall within the scope of the patent of the present invention. [Simplified Explanation of the Diagram]

[0010] Other features and effects of the present invention will be clearly presented with reference to embodiments in the accompanying drawings, wherein: FIG1 is a perspective combined sectional view of an embodiment of the implantation device of the biosensor of the present invention; FIG2 is a sectional view along line II-II in FIG1; FIG3 is a sectional view along line III-III in FIG1, illustrating the configuration of the plurality of guide posts; FIG4 is a perspective exploded view of this embodiment; FIG5 is a partial perspective exploded view of this embodiment; FIG6 is a perspective view of an inner liner of this embodiment; FIG7 is a perspective view of a main body of this embodiment; FIG8 is a perspective schematic diagram of an implantation seat and a plurality of guide posts of this embodiment; FIG9 is a partial sectional view of the implantation seat of this embodiment; FIG10 is a top view of a needle extraction seat of this embodiment; FIG11 is a plan view of a tear-off element of this embodiment; FIG12 is a perspective exploded schematic diagram of a tear-off element of this embodiment; FIG13 is a plan combined view of this embodiment with the bottom cover closed and in a ready-to-fire state; FIG14 is a sectional view along line XIV-XIV in FIG13. Figure 15 is an operational schematic diagram of this embodiment with the bottom cover open and in a state ready for needle implantation; Figure 16 is an operational schematic diagram of this embodiment, illustrating the state of pressing a housing component after opening the cover and initiating firing; Figure 17 is a cross-sectional view along line XVII-XVII in Figure 16; Figure 18 is a schematic diagram of a safety unlocking operation before firing in this embodiment; Figure 19 is a cross-sectional view along line XIX-XIX in Figure 18; Figure 20 is a schematic diagram of a firing pin operation in this embodiment; Figure 21 is a cross-sectional view along line XXI-XXI in Figure 20; Figure 22 is a schematic diagram of needle implantation completion in this embodiment; Figure 23 is a cross-sectional view along line XXIII-XXIII in Figure 22; Figure 24 is a schematic diagram of a needle removal operation in this embodiment, illustrating the state of needle removal completion; Figure 25 is a schematic diagram along line XXV- A cross-sectional view of XXV; and Figure 26 is a schematic diagram of a base and a sensor assembly detached from the bottom of a main body in this embodiment.

Claims

1. An implantation device for a biosensor, comprising: a housing unit including a housing component and a bottom cover detachably coupled to the housing component, the housing component defining an accommodating space; an implantation module disposed in the accommodating space, operable to perform automatic needle insertion and automatic needle withdrawal; a base detachably positioned within the implantation module, the base including a main housing having a periphery, an adhesive pad fixed to the main housing, and a detachable outer release layer attached to the adhesive pad, the main housing being made of a rigid material relative to the adhesive pad, the periphery having a pair of first sides and a pair of second sides connected to the first sides, the adhesive pad having a first recess corresponding to one of the first sides, and the outer release layer having a second recess corresponding to the first recess; A sensor assembly, detachably located on the base, and which can be attached to the main housing after the implantation module needle is inserted; and a tear-off element connected to the bottom cover and the outer release layer, and disposed on the inner periphery of the main housing, the tear-off element being located inside and adjacent to the second recess, and which can tear the outer release layer from the adhesive pad when the bottom cover is removed from the housing.

2. The implantable device for the biosensor as described in claim 1, wherein, The base also includes a bonding layer disposed between the main housing and the adhesive pad. The bonding layer is preheated and pressed to the main housing, and the adhesive pad is then heat-pressed to the main housing through the bonding layer.

3. An implantable device for a biosensor as described in claim 2, wherein, The base also includes an inner release layer for the bonding layer to attach to, and is preheated and pressed from an outer side of the inner release layer opposite to the bonding layer, so that the bonding layer is preheated and pressed to the main housing.

4. An implantable device for a biosensor as described in claim 3, wherein, The assembly process of the base's main housing with the bonding layer, inner release layer, adhesive pad, and outer release layer involves the following steps: First, attaching the bonding layer, with the inner release layer attached, to the main housing. Next, a preheating and pressing step is performed on the bonding layer, where preheating and pressing is performed from the outside of the inner release layer opposite to the bonding layer, and the bonding layer is pressed towards the main housing to adhere to the main housing. After the preheating and pressing step is completed, the inner release layer is peeled off from the bonding layer. Then, attaching the adhesive pad, with the outer release layer attached, to the bonding layer. Finally, a heat-pressing step is performed on the adhesive pad, where heat-pressing is performed from the outside of the outer release layer opposite to the adhesive pad, and the adhesive pad and bonding layer are pressed towards the main housing to adhere the adhesive pad through the bonding layer to the main housing.

5. An implantable device for a biosensor as described in claim 4, wherein, The bonding layer of the base is made of polymer material, and the bonding layer has at least one preheating and pressing position, and the adhesive pad has at least one heat pressing position.

6. An implantable device for a biosensor as described in claim 5, wherein, In the preheating and pressing step, the base is hot-pressed at a temperature of 75℃~85℃ and a pressure of 3.5kg / cm2~4.5kg / cm2 for 3 to 10 seconds.

7. An implantable device for a biosensor as described in claim 6, wherein, In this hot pressing step, the base is hot-pressed at a temperature of 115℃~125℃ and a pressure of 3.5kg / cm2~4.5kg / cm2 for 10 to 20 seconds.

8. An implantable device for a biosensor as described in claim 5, wherein, The position of the tear-off element corresponds at least to the hot-pressing position of the adhesive pad, the preheating and pressing position of the bonding layer, and the bottom cover.

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