Biosensor implantation device and implantation method thereof

Abstract

A biosensor implantation device and implantation method thereof generally include an upper cover, an implantation module, and a base. The implantation module is arranged in the upper cover, and when the upper cover is pressed down, the implantation seat is displaced downward by the elastic force of the first elastic member to release the limiting relationship with the upper cover, and the automatic needle implantation is performed. When the automatic needle implantation is completed, the upper cover is still in a pressed down state, the limiting relationship between the implantation seat and the upper cover is released, and the limiting relationship between the implantation seat and the needle extraction seat is released, so that the needle extraction seat completes the automatic needle extraction by the elastic force of the second elastic member, and the time for the automatic needle implantation and automatic needle extraction of the present invention is no more than 100 milliseconds. In addition, after the upper cover and the bottom cover are combined, not only can the airtight space inside the implantation device be prevented from getting damp by the chemical reagents on the sensor test piece, but also the bottom cover and the upper cover can form an anti-mis-implantation structure to prevent the implantation device from accidentally falling and causing mis-implantation.

Description

Technical Field

[0001] The present invention relates to a biosensor implantation device and an implantation method thereof, and in particular to a biosensor for implanting an energy glucose value sensing test piece under the skin of a living being and continuously acquiring physiological signals. Background Art

[0002] There is currently an implantation device that can implant a test strip under the skin of a living being (US10,413,183 patent case). The implantation device 5000 includes a locking ring seat 5004, a plunger 5002 that can slide through the locking ring seat 5004, a striker seat 5136 installed inside the plunger 5002, a non-prestressed striker spring 5138 installed between the plunger 5002 and the striker seat 5136, a needle seat 5146 sleeved inside the striker seat 5136, a needle seat spring 5144 that bounces between the striker seat 5136 and the needle seat 5146, and a sensor 5108.

[0003] When the implant device of the previous case is to be used for needle implantation, the user must depress the plunger 5002 to compress the non-pre-compressed firing pin spring 5138, and use the plunger rib 5152 to deflect the corresponding snap arm 5142, thereby releasing the limiting relationship between the plunger rib 515 and the snap arm 5142, and use the elastic force of the non-pre-compressed firing pin spring 5138 to restore and drive the firing pin seat 5136 and the needle seat 5146 downward for needle implantation.

[0004] When the needle implantation is completed and the striker seat 5136 is still in the needle implantation position, the user must release the downward pressure on the plunger 5002 to move the plunger 5002 upward, release the limiting relationship of the needle seat 5146, and then use the elastic force of the pre-compressed needle seat spring 5144 to release the needle seat 5146 to drive the piercing member 5110 to retract toward the inside of the plunger 5002, and the sensor 5108 is left on the surface of the human skin.

[0005] In other words, although the implantation device of the previous case can complete the needle implantation and needle withdrawal, the implantation requires the downward pressure of the user's hand to pierce the piercing member 5110 into the human skin surface, and when withdrawing the needle, the user must release the plunger 5002, and the needle seat 5146 will drive the piercing member 5110 to retract into the plunger 5002. Accordingly, the implantation and needle withdrawal method of the previous case is a two-stage operation and does not belong to the elastic implantation method. What's more, the smoothness of the implantation and needle withdrawal will be affected by the user's proficiency. For operators with less operating experience, if the force on the plunger is not released after pressing down the plunger 5002, the piercing member 5110 will continue to stay under the user's skin, which may increase the user's discomfort.

[0006] In other words, the implanted device in the previous case may cause operational uncertainty and discomfort to the user due to the user's proficiency in operation. Summary of the invention

[0007] One object of the present invention is to provide a biosensor implantation device and implantation method that operates smoothly and reduces the user's discomfort during automatic needle implantation and automatic needle withdrawal by means of elastic needle implantation, and the time required to complete automatic needle implantation and automatic needle withdrawal is no more than 100 milliseconds.

[0008] Another object of the present invention is to provide an implantation device having a structure for preventing mis-implantation of a needle by forming a bottom cover and an upper cover, thereby preventing the implantation device from accidentally falling during transportation and causing mis-implantation of a needle.

[0009] Yet another object of the present invention is to provide an airtight space inside an implant device by combining a bottom cover with an upper cover, and to set a desiccant at an appropriate location inside the airtight space according to actual needs to prevent the chemical reagents on the sensor test piece on the sensor assembly from getting wet.

[0010] The biosensor implantation device of the present invention comprises a cover body and an implantation module;

[0011] The cover body has a containing space;

[0012] The implantation module is arranged in the accommodation space of the cover body;

[0013] The implant module comprises:

[0014] The main body is connected to the cover body, and the main body and the cover body together form

[0015] Displacement space;

[0016] The implant seat can be removed and limited to the cover body, and is located between the main body and the

[0017] Displacement of the cover: spatial displacement;

[0018] A first elastic member is elastically disposed between the implant seat and the cover body;

[0019] A needle extraction seat, which can be removed and is limited to the implantation seat;

[0020] A second elastic member is elastically pressed between the implantation seat and the needle withdrawal seat;

[0021] A base, which can be removed and is limited to the main body;

[0022] A sensor assembly, which can be removed and is confined to the base;

[0023] Among them, the cover body is pressed down, so that the implant seat is moved downward by the elastic force of the first elastic member to release the limiting relationship with the cover body, and automatic needle implantation is performed. When the needle implantation is completed, the cover body is still in a pressed down state, the limiting relationship between the implant seat and the cover body is released, and the limiting relationship between the implant seat and the needle withdrawal seat is released, so that the needle withdrawal seat completes automatic needle withdrawal by releasing the elastic force of the second elastic member.

[0024] In the biosensor implantation device of the present invention, the needle withdrawal seat of the implantation module is connected to the needle implantation component.

[0025] In the biosensor implantation device of the present invention, the implantation seat and the cover body of the implantation module respectively have limiting grooves and limiting members for limiting each other, and the implantation seat also has a limiting component for keeping the needle withdrawal seat limited relative to the implantation seat. By mutually arranging the above structures, the implantation seat, the cover body and the needle withdrawal seat constitute a needle withdrawal limiting structure.

[0026] In the biosensor implantation device of the present invention, the inner circumferential surface of the cover body has at least one detent portion, the main body has a buckling portion, and the implantation seat has at least one buckling portion that is detent by the detent portion and can be detached from and embedded in the buckling portion of the main body. By mutually arranging the above structures, a firing limit structure is formed between the implantation seat and the main body.

[0027] In the biosensor implantation device of the present invention, the first elastic member and the second elastic member of the implantation module are pre-compressed springs.

[0028] The biosensor implant device of the present invention further comprises a bottom cover which can be airtightly combined with the cover body, so that an airtight space is generated inside the implant device, and a desiccant is arranged at an appropriate position in the airtight space.

[0029] In the biosensor implantation device of the present invention, the cover body further comprises an embedded locking portion, and the main body of the implantation module comprises a locking portion that is locked with the embedded locking portion.

[0030] In the biosensor implantation device of the present invention, the base has a sensor component positioning portion for the sensor component to be combined and positioned.

[0031] In the biosensor implantation device of the present invention, the sensor component positioning portion can include a groove to be tightly matched with the sensor component.

[0032] In the biosensor implantation device of the present invention, the sensor component positioning portion includes a fitting portion provided in the groove and bonded to the sensor component.

[0033] In the biosensor implantation device of the present invention, the sensor component positioning portion further comprises an elastic fastener elastically fastened with the sensor component.

[0034] The biosensor implantation device of the present invention, the implantation module also includes a needle implantation auxiliary seat that can be removed and installed on the needle implantation member, and the sensor component can be removed and kept in a limited position relative to the needle implantation auxiliary seat.

[0035] In the biosensor implantation device of the present invention, the time for the implantation module to complete automatic needle implantation and automatic needle withdrawal is no more than 100 milliseconds.

[0036] In the biosensor implantation device of the present invention, the time taken by the implantation module to complete automatic needle implantation and automatic needle withdrawal is no more than 8 milliseconds.

[0037] In the biosensor implantation device of the present invention, the time taken by the implantation module to complete automatic needle implantation and automatic needle withdrawal is no more than 4 milliseconds.

[0038] In the biosensor implantation device of the present invention, the time taken by the implantation module to complete automatic needle implantation and automatic needle withdrawal is no more than 2 milliseconds.

[0039] The biosensor implantation device of the present invention comprises a cover body and an implantation module;

[0040] The cover body has a containing space;

[0041] The implantation module is arranged in the accommodation space of the cover body;

[0042] The implant module comprises:

[0043] A main body and a main body cover connected to the main body, wherein the main body and the

[0044] A displacement space is formed between the main body covers;

[0045] The implant seat can be removed and limited to the main body cover, and is located between the main body and the

[0046] The displacement space displacement of the main body cover;

[0047] A first elastic member is elastically pressed between the implant seat and the main body cover;

[0048] A needle extraction seat, which can be removed and is limited to the implantation seat;

[0049] A second elastic member is elastically pressed between the implantation seat and the needle withdrawal seat;

[0050] A base, which can be removed and is limited to the main body;

[0051] A sensor assembly, which can be removed and is confined to the base;

[0052] The cover is pressed down, so that the implant seat is displaced downward by the elastic force of the first elastic member to release the limiting relationship with the main body cover, and the needle is automatically implanted. When the needle is implanted, the cover is still in the state of being pressed down, the limiting relationship between the implant seat and the main body cover is released, and the limiting relationship between the implant seat and the needle withdrawal seat is released, so that the needle withdrawal seat can automatically withdraw the needle by releasing the elastic force of the second elastic member.

[0053] Furthermore, the first elastic member is compressed and stored by the main body cover, so that the reaction force of the first elastic member will not be felt when the cover body is pressed, thereby improving the smoothness of automatic needle insertion and automatic needle withdrawal.

[0054] In the biosensor implantation device of the present invention, the needle withdrawal seat of the implantation module is connected to the needle implantation component.

[0055] In the biosensor implantation device of the present invention, the implantation seat of the implantation module and the main body cover respectively have limiting grooves and limiting members for limiting each other, and the implantation seat also has a limiting component for keeping the needle withdrawal seat limited relative to the implantation seat. By mutually arranging the above structures, the implantation seat, the cover body and the needle withdrawal seat constitute a needle withdrawal limiting structure.

[0056] In the biosensor implantation device of the present invention, the inner circumferential surface of the cover body has at least one detent portion, the main body has a buckling portion, and the implantation seat has at least one buckling portion that is detent by the detent portion and can be detached from and embedded in the buckling portion of the main body. By mutually arranging the above structures, a firing limit structure is formed between the implantation seat and the main body.

[0057] In the biosensor implantation device of the present invention, the first elastic member and the second elastic member of the implantation module are pre-compressed springs.

[0058] The biosensor implant device of the present invention further comprises a bottom cover which can be airtightly combined with the cover body, so that an airtight space is generated inside the implant device, and a desiccant is arranged at an appropriate position in the airtight space.

[0059] In the biosensor implantation device of the present invention, the cover body further comprises an embedded locking portion, and the main body of the implantation module comprises a locking portion capable of interlocking with the embedded locking portion.

[0060] In the biosensor implantation device of the present invention, the base has a sensor component positioning portion for the sensor component to be combined and positioned.

[0061] In the biosensor implantation device of the present invention, the sensor component positioning portion can include a groove to be tightly matched with the sensor component.

[0062] In the biosensor implantation device of the present invention, the sensor component positioning portion includes a fitting portion provided in the groove and bonded to the sensor component.

[0063] In the biosensor implantation device of the present invention, the sensor component positioning portion further comprises an elastic fastener elastically fastened with the sensor component.

[0064] The biosensor implantation device of the present invention, the implantation module also includes a needle implantation auxiliary seat that can be removed and installed on the needle implantation member, and the sensor component can be removed and kept in a limited position relative to the needle implantation auxiliary seat.

[0065] In the biosensor implantation device of the present invention, the time for the implantation module to complete automatic needle implantation and automatic needle withdrawal is no more than 100 milliseconds.

[0066] In the biosensor implantation device of the present invention, the time taken by the implantation module to complete automatic needle implantation and automatic needle withdrawal is no more than 8 milliseconds.

[0067] In the biosensor implantation device of the present invention, the time taken by the implantation module to complete automatic needle implantation and automatic needle withdrawal is no more than 4 milliseconds.

[0068] In the biosensor implantation device of the present invention, the time taken by the implantation module to complete automatic needle implantation and automatic needle withdrawal is no more than 2 milliseconds.

[0069] The method for implanting a biosensor of the present invention comprises:

[0070] The implant device includes a displacement space formed by a cover body and a main body;

[0071] An implantation module is arranged in the displacement space. The implantation module can move up and down in the displacement space by means of the pre-compressed first elastic member and the pre-compressed second elastic member inside, and can automatically implant and withdraw the needle;

[0072] A firing limit structure provided between the implantation module and the main body, for releasing the implantation module and keeping it in the position before the needle is implanted;

[0073] A needle withdrawal limiting structure provided between the implantation module and the cover body, when the needle withdrawal limiting structure is released, the implantation module can be moved upward from the post-implantation position to the pre-implantation position;

[0074] Among them, when the implant device is pressed down and not released, the firing limit structure is released, and the implant module is displaced downward by releasing the elastic force of the pre-compressed first elastic member to complete automatic needle implantation, and the needle withdrawal limit structure is automatically released after the implant module completes automatic needle implantation, and the implant module is displaced upward by releasing the elastic force of the pre-compressed second elastic member to complete automatic needle withdrawal, and the implant module positions the sensor component on the implant module on the base during the downward displacement for automatic needle implantation, and the time to complete automatic needle implantation and automatic needle withdrawal is no more than 100 milliseconds.

[0075] In the biosensor implantation method of the present invention, the optimal time for the implantation module to complete automatic needle implantation and automatic needle withdrawal is no more than 8 milliseconds.

[0076] In the biosensor implantation method of the present invention, the optimal time for the implantation module to complete automatic needle implantation and automatic needle withdrawal is no more than 4 milliseconds.

[0077] In the biosensor implantation method of the present invention, the optimal time for the implantation module to complete automatic needle implantation and automatic needle withdrawal is no more than 2 milliseconds.

[0078] The implantation method of the biosensor of the present invention comprises an implantation module having an implantation seat and a needle withdrawal seat, wherein the implantation seat and the main body form a limit to produce a firing limit structure, and the needle withdrawal seat and the implantation seat form a limit to produce a needle withdrawal limit structure, and the needle withdrawal seat and the implantation seat respectively have a needle implantation member and a push portion.

[0079] In the biosensor implantation method of the present invention, the base has a sensor component positioning portion for the sensor component to be combined and positioned.

[0080] In the biosensor implantation method of the present invention, the sensor component positioning portion can include a groove that is tightly matched with the sensor component.

[0081] In the biosensor implantation method of the present invention, the sensor component positioning portion includes a fitting portion provided in the groove and bonded to the sensor component.

[0082] In the biosensor implantation method of the present invention, the sensor component positioning portion further comprises an elastic fastener elastically fastened to the sensor component.

[0083] The biosensor implantation method of the present invention is as follows: after the implantation module performs automatic needle implantation, the needle implantation member penetrates the base to implant the sensing test piece under the skin of the organism, and the push portion tightly abuts against the sensor component to prevent the sensor component from being separated from the sensor component positioning portion of the base at the moment of needle implantation.

[0084] In the biosensor implantation method of the present invention, the pre-compressed first elastic member is elastically pressed between the implantation seat and the main body cover, and the pre-compressed first elastic member is a pre-compressed spring.

[0085] In the biosensor implantation method of the present invention, the pre-compressed second elastic member is elastically pressed between the implantation seat and the needle seat, and the pre-compressed second elastic member is a pre-compressed spring.

[0086] In the biosensor implantation method of the present invention, the implantation device further comprises a bottom cover which can be airtightly combined with the cover body, so that an airtight space is generated inside the implantation device, and a desiccant is arranged at an appropriate position in the generated airtight space.

[0087] The method for implanting a biosensor of the present invention comprises:

[0088] An implant device, comprising a displacement space formed by a main body cover and a main body;

[0089] An implantation module is arranged in the displacement space, and the implantation module can move up and down in the displacement space by means of the pre-compressed first elastic member and the pre-compressed second elastic member inside, so as to automatically implant and withdraw the needle;

[0090] A firing limit structure provided between the implantation module and the main body, for releasing the implantation module and keeping it in the position before the needle is implanted;

[0091] A needle withdrawal limiting structure provided between the implantation module and the main body cover, when the needle withdrawal limiting structure is released, enables the implantation module to move upward from a post-implantation position to a pre-implantation position;

[0092] Among them, when the implant device is pressed down and not released, the firing limit structure is released, and the implant module is displaced downward by releasing the elastic force of the pre-compressed first elastic member to complete automatic needle implantation, and the needle withdrawal limit structure is automatically released after the implant module completes automatic needle implantation, and the implant module is displaced upward by releasing the elastic force of the pre-compressed second elastic member to complete automatic needle withdrawal, and the implant module positions the sensor component on the implant module on the base during the downward displacement for automatic needle implantation, and the time to complete automatic needle implantation and automatic needle withdrawal is no more than 100 milliseconds.

[0093] In the biosensor implantation method of the present invention, the optimal time for the implantation module to complete automatic needle implantation and automatic needle withdrawal is no more than 8 milliseconds.

[0094] In the biosensor implantation method of the present invention, the optimal time for the implantation module to complete automatic needle implantation and automatic needle withdrawal is no more than 4 milliseconds.

[0095] In the biosensor implantation method of the present invention, the optimal time for the implantation module to complete automatic needle implantation and automatic needle withdrawal is no more than 2 milliseconds.

[0096] The implantation method of the biosensor of the present invention comprises an implantation module having an implantation seat and a needle withdrawal seat, wherein the implantation seat and the main body form a limit to produce the firing limit structure, and the needle withdrawal seat and the implantation seat form a limit to produce the needle withdrawal limit structure, and the needle withdrawal seat and the implantation seat respectively have a needle implantation member and a push portion.

[0097] In the biosensor implantation method of the present invention, a sensor component positioning portion is provided on the base corresponding to the position of the sensor component.

[0098] In the biosensor implantation method of the present invention, the sensor component positioning portion includes a groove that is tightly matched with the sensor component.

[0099] In the biosensor implantation method of the present invention, the sensor component positioning portion includes a fitting portion provided in the groove and bonded to the sensor component.

[0100] In the biosensor implantation method of the present invention, the sensor component positioning portion further comprises an elastic fastener elastically fastened to the sensor component.

[0101] According to the biosensor implantation method of the present invention, after the implantation device module is implanted, the implantation needle penetrates the base to implant the sensing test piece under the skin of the organism, and the push portion tightly abuts against the sensor component to prevent the sensor component from being separated from the sensor component positioning portion of the base at the moment of implantation.

[0102] In the biosensor implantation method of the present invention, the pre-compressed first elastic member is elastically pressed between the implantation seat and the main body cover, and the first pre-compressed elastic member is a pre-compressed spring.

[0103] In the biosensor implantation method of the present invention, the pre-compressed second elastic member is elastically pressed between the implantation seat and the needle withdrawal seat, and the pre-compressed second elastic member is a pre-compressed spring.

[0104] In the biosensor implantation method of the present invention, the implantation device further comprises a bottom cover which can be airtightly combined with the cover body, so that an airtight space is generated inside the implantation device, and a desiccant is arranged at an appropriate position in the airtight space.

[0105] The beneficial effect of the present invention is that the implantation device of the biosensor of the present invention also has a structure to prevent the needle from being implanted by mistake. When the implantation device is assembled as a whole and has not yet been used, the bottom cover and the upper cover form a limit so that the upper cover cannot be pressed down, thereby preventing the implantation device from accidentally falling during transportation and causing the needle to be implanted by mistake. BRIEF DESCRIPTION OF THE DRAWINGS

[0106] Figure 1 is a perspective exploded view of a first embodiment of an implantation device of a biosensor of the present invention;

[0107] Figure 2 is an incomplete exploded perspective view of some components of the first embodiment;

[0108] Figure 3 is a cross-sectional schematic diagram of the first embodiment, illustrating a state in which a needle is to be implanted;

[0109] Figure 4 is along Figure 3 The cross-sectional view taken along the straight line IV-IV in FIG.

[0110] Figure 5 is a schematic diagram of the first embodiment in use, illustrating a state where a bottom cover is removed and the needle is ready for implantation;

[0111] Figure 6 is along Figure 5 A cross-sectional view taken along the straight line VI-VI in FIG.

[0112] Figure 7 is an operation schematic diagram of the first embodiment, illustrating a needle implantation instant state;

[0113] Figure 8 is along Figure 7 A sectional view taken along the line VIII-VIII in FIG.

[0114] Fig. 9 is another operation schematic diagram of the first embodiment, illustrating a state immediately after implantation;

[0115] Fig.10 is along Fig. 9 A sectional view taken along the line X-X in FIG.

[0116] Fig.11 is another operation schematic diagram of the first embodiment, illustrating a needle implantation instant state;

[0117] Fig.12 is along Fig.11 A sectional view taken along the straight line ⅩⅡ-ⅩⅡ in FIG.

[0118] Fig.13 is another operational schematic diagram of the first embodiment, illustrating a post-separation state;

[0119] Fig.14 is along Fig.13 A sectional view taken along the straight line ⅩⅣ-ⅩⅣ in FIG.

[0120] Fig.15is another operation diagram of the first embodiment, illustrating how to return the bottom cover to its original state after use;

[0121] Fig.16 is along Fig.15 A sectional view taken along the straight line XVI-XVI in FIG.

[0122] Fig.17 It is an incomplete three-dimensional composite diagram of the first embodiment with an additional protective ring;

[0123] Fig.18 yes Fig.17 A cross-sectional schematic diagram of a state in which a needle is ready for implantation;

[0124] Fig.19 is along Fig.18 A sectional view taken along the line XIX-XIX in FIG.

[0125] Fig. 20 is similar to Fig.19 An operation diagram, illustrating the state at the moment of needle implantation; Fig.21 is along Fig. 20 A sectional view taken along the straight line XXⅠ-XXⅠ in FIG.

[0126] Fig. 22 is a schematic diagram of the first embodiment after assembly;

[0127] Fig.23 is a schematic diagram of the first embodiment with the bottom cover removed;

[0128] Fig.24 is a schematic diagram of the needle implantation operation of the first embodiment;

[0129] Fig.25 is a schematic diagram of the first embodiment before the bottom cover is removed;

[0130] Fig.26 is a schematic diagram of using a tear-off assembly to remove a release layer when removing the bottom cover of the first embodiment;

[0131] Fig. 27 is a block diagram of the operation flow of the first embodiment;

[0132] Fig.28 It is a schematic diagram of a top cover sealingly covering the base when the needle implantation is completed and the test piece is implanted under the skin of a living being in the first embodiment;

[0133] Fig.29 yes Figure 3 An incomplete partial enlarged schematic diagram showing that the sensor assembly is clamped inside the implant device by the implant needle auxiliary seat;

[0134] Fig.30 is similar Figure 1 a perspective exploded view of

[0135] Fig.31 is a combined cross-sectional view of a second embodiment of the implant device of the biosensor of the present invention;

[0136] Fig.32 is along Fig.31 A sectional view taken along the straight line XXⅩⅡ-XXⅩⅡ in FIG.

[0137] Fig.33 It is a combined cross-sectional view of a third embodiment of the implant device of the present invention. DETAILED DESCRIPTION

[0138] The present invention is described in detail below with reference to the accompanying drawings and embodiments.

[0139] Please read Figures 1 to 4 , which is the implantation device and implantation method of the biosensor of the first embodiment of the present invention, the implantation device of the present invention can also be in a can-shaped form (for example: a dry can), but is not limited thereto, and the implantation device includes:

[0140] An upper cover 10 has an accommodating space 14 and a pair of locking portions 124 .

[0141] An implantation module 30 is disposed in the accommodating space 14 , and includes a main body component 300 , an implantation seat 33 , a first elastic member 34 , a needle withdrawal seat 35 , a second elastic member 37 , a base 50 , and a sensor component 70 .

[0142] The main body component 300 has a top 302 , a bottom 303 , and a displacement space 301 between the top 302 and the bottom 303 , and the bottom 303 of the main body component 300 has a pair of locking portions 315 that can be locked with the embedded locking portions 124 .

[0143] The implant seat 33 can be removed and limited to the top 302 of the main component 300, and can move up and down in the displacement space 301 between the top 302 and the bottom 303.

[0144] The inner circumference of the upper cover 10 has a pair of detent parts 123, and the implant seat 33 has a pair of snap parts 335 which are respectively detent by the detent parts 123 and can be detached from and embedded in a pair of buckling parts 317 of the bottom 303 of the main body component 300. The snap parts 335 of the implant seat 33 resist the buckling parts 317 of the bottom 303 of the main body component 300, so that a needle limiting structure A is generated between the implant seat 33 and the main body component 300.

[0145] The implant seat 33 and the top 302 of the main body component 300 respectively have a limiting groove 330 and a limiting member 323 for limiting each other, and the implant seat 33 also has a limiting component 334.

[0146] The first elastic member 34 is elastically pressed between the implant seat 33 and the top 302 of the main body assembly 300 . In this embodiment, the first elastic member 34 is a pre-compressed spring.

[0147] A needle withdrawal seat 35 connected to a needle implanting member 36 can be removed and limited on the implanting seat 33, and the limiting component 334 of the implanting seat 33 limits the needle withdrawal seat 35, so that a needle withdrawal limiting structure B is formed between the needle withdrawal seat 35 and the implanting seat 33.

[0148] The second elastic member 37 is elastically pressed between the implantation seat 33 and the needle withdrawal seat 35 . In this embodiment, the second elastic member 37 is a pre-compressed spring.

[0149] The base 50 can be removed and is limited to the bottom 303 of the main assembly 300 , and the base 50 has a base 51 , an adhesive sheet 52 fixed to the base 51 , and a release layer 55 that can be torn off and adhered to the adhesive sheet 52 .

[0150] In the present embodiment, the sensor assembly 70 can be detached from the base 50, and the sensor assembly 70 has a sensing base 71, and the sensing base 71 has a fitting portion 711, and a sensing test piece 72 connected to the sensing base 71 and inserted into the implant needle 36, and the base 50 has a sensor assembly positioning portion 500 for the sensor assembly 70 to be combined and positioned. In the present embodiment, the sensor assembly positioning portion 500 can include a groove 501 to form a tight fit with the sensor assembly 70, or the sensor assembly positioning portion 500 can include a fitting portion 502 (which can be made of double-sided adhesive) in the groove 501 to form an adhesive setting with the sensor assembly 70 (matching reference 501). Fig.31 ), or the sensor assembly positioning portion 500 can include an elastic fastener 503 that is engaged with the sensor assembly 70 (with reference to Fig.32 ).

[0151] The implantation module 30 also includes a needle-implantation auxiliary seat 38 that can be removed and installed on the needle-implantation component 36, and the sensor assembly 70 can be removed and kept limited relative to the needle-implantation auxiliary seat 38, and the needle-implantation auxiliary seat 38 has a base 381, three wings 382 extending outward from the base 381, and several convex tenon-shaped connecting parts 383 protruding from the bottom of the base 381, and each of the wings 382 has several notches 384, allowing the wings 382 to be compressed in a radial direction perpendicular to the axis L and have the ability to rebound outward after being compressed; by generating a limiting relationship between the needle-implantation auxiliary seat 38 and the main body 31 before needle implantation, the needle-implantation component 36 can be prevented from swinging left and right and pulling when implanted under the human body, thereby improving the stability of the needle-implantation stroke and reducing the patient's pain.

[0152] Furthermore, if Figure 3 and Figure 4 When the first embodiment of the implant device of the present invention is assembled as a whole, the top 302 and the bottom 303 of the main body component 300 are connected to each other and connected as a whole, and a distance D is maintained between the top of the upper cover 10 and the top of the top 302 of the main body component 300; and the buckle portion 335 of the implant seat 33 resists the buckle stop portion 317 of the bottom 303 of the main body component 300, so that the implant seat 33 is located in a pre-needle implantation position, and the first elastic member 34 is pre-compressed between the implant seat 33 and the top 302 of the main body component 300 to generate compression storage force, and The second elastic member 37 is pre-compressed between the needle withdrawal seat 35 and the implantation seat 33 and contains a return elastic force. The needle withdrawal seat 35 is located at a position before needle implantation. The fitting portion 711 of the sensor assembly 70 is tightly matched with the connecting portion 383, so that the sensing base 71 is connected to the needle implantation auxiliary seat 38, and the needle implantation auxiliary seat 38 is tightly connected to the main body 361 of the needle implantation member 36. Therefore, the needle implantation member 36 can be hidden inside the bottom 303 of the main assembly 300 and be shielded by the base 50, and the base 50 is positioned relative to the bottom 303 of the main assembly 300.

[0153] When the implantation device of the first embodiment of the present invention is to automatically implant the test strip 72 under the skin of a living being, the operation is as follows:

[0154] With reference Figure 5 and Figure 6 The user first peels off the release layer 55, and then adheres the adhesive sheet 52 of the base 50 to the biological part to be implanted. Figure 7 and Figure 8When the user has not yet pressed the upper cover 10, the needle implantation limiting structure A between the implant seat 33 and the bottom 303 of the main body component 300 has not been released and remains in a pre-needle implantation position. When the upper cover 10 is pressed with force, the detent portion 123 detents the buckle portion 335 of the implant seat 33 to bend and deform inward and disengage from the buckle portion 317 of the main body component 300, releasing the bottom 303 of the main body component 300 and the needle implantation limiting structure A of the implant seat 33. At the same time, the clamping portion 315 engages with the corresponding embedding portion 124, and the upper cover 10 is embedded and positioned relative to the bottom 303 of the main body component 300.

[0155] With reference Fig. 9 and Fig.10 When the bottom 303 of the main component 300 and the implantation needle limiting structure A of the implantation seat 33 are released, the elastic force of the pre-compressed first elastic member 34 is released, so that the implantation seat 33 moves downward to the implantation needle position, and the sensor component 70 is driven by the implantation seat 33 to be located at a post-implantation needle position, and the sensing test piece 72 is also implanted under the biological skin along with the implantation needle member 36, and the sensing base 71 of the sensor component 70 is positioned at the sensor component positioning portion 500 on the base 50 and is left on the biological surface. When the implantation needle is completed, the sensor component 70 is moved downward to the implantation needle position, and ... During automatic needle implantation, the limiting groove 330 of the implantation seat 33 is separated from the limiting member 323 of the top 302 of the main body component 300, so that the needle withdrawal limit structure B of the needle withdrawal seat 35 and the implantation seat 33 is released, and the elastic force of the pre-compressed second elastic member 37 is released, so that the needle withdrawal seat 35 moves toward the front direction of the needle implantation, driving the needle implantation member 36 to shrink and move between the implantation seat 33 and the needle implantation auxiliary seat 38, so that the needle implantation member 36 will not be exposed, achieving the effect of the hidden design of the needle implantation member 362, and completing the automatic needle withdrawal (see FIG. Fig.11 and Fig.12 ), and utilize the effect of the tight fit between the fitting portion 711 and the connecting portion 383 to connect the needle implant auxiliary seat 38 to the sensing base 71 of the sensor assembly 70.

[0156] Afterwards, the user pulls up the upper cover 10 and the implantation module 30 as a whole relative to the base 50 on the biological surface, thereby completing the automatic needle implantation and automatic needle withdrawal of the biosensor implantation device of the first embodiment of the present invention.

[0157] Accordingly, the implantation device of the first embodiment of the present invention belongs to a one-stage pressing elastic needle implantation structure. When the user presses down the upper cover 10, the implantation seat 33 is released by the elastic force of the pre-compressed first elastic member 34 and moves downward to release the limiting relationship with the top 302 of the main body component 300, so as to perform automatic needle implantation; when the automatic needle implantation is completed, the upper cover 10 is still in a pressed down state, the limiting relationship between the implantation seat 33 and the top 302 of the main body component 300 is released, and the limiting relationship between the implantation seat 33 and the needle withdrawal seat 35 is released, so that the needle withdrawal seat 35 completes the automatic needle withdrawal by releasing the elastic force of the pre-compressed second elastic member 37, and the time to complete the automatic needle implantation and automatic needle withdrawal is no more than 100 milliseconds, or no more than 50 milliseconds, or no more than 8 milliseconds, 6 milliseconds, 4 milliseconds, or 2 milliseconds.

[0158] Ginseng Figures 3 to 12 , is a method for implanting a biosensor according to the first embodiment of the present invention, comprising:

[0159] An implant device includes a displacement space 301 formed by a top 302 and a bottom 303 of a main body component 300.

[0160] An implantation module 30 is disposed in the displacement space 301. The implantation module 30 can move up and down in the displacement space 301 by means of two pre-compressed first elastic members 34 and second elastic members 37 inside to perform automatic needle implantation and automatic needle withdrawal. In this embodiment, the first elastic member 34 and the second elastic member 37 are pre-compressed springs.

[0161] A needle implantation limiting structure A disposed between the implantation module 30 and the bottom of the main body component 300 is used to release the implantation module 30 and maintain it in a pre-needle implantation position.

[0162] A needle withdrawal limiting structure B is provided between the implantation module 30 and the top 302 of the main body component 300. When the needle withdrawal limiting structure B is released, the implantation module 30 can be moved upward from a post-implantation position to a pre-implantation position.

[0163] Among them, when the implantation device is pressed down but not released, the needle implantation limiting structure A is released, and the implantation module 30 moves downward by releasing the elastic force of the pre-compressed first elastic member 34 to complete the automatic needle implantation, and the needle withdrawal limiting structure B is automatically released after the implantation module 30 completes the automatic needle implantation, and the implantation module 30 moves upward by releasing the elastic force of the pre-compressed second elastic member 37 to complete the automatic needle withdrawal; and the implantation module 30 positions a sensor component 70 on a base 50 during the downward displacement for the automatic needle implantation process, and the time to complete the automatic needle implantation and automatic needle withdrawal is no more than 100 milliseconds, or no more than 50 milliseconds, or no more than 8 milliseconds, 6 milliseconds, 4 milliseconds, or 2 milliseconds.

[0164] In the above implantation method, the implantation module 30 also has an implantation seat 33 and a needle extraction seat 35. The implantation seat 33 and the main body 31 form a limit to generate a needle implantation limit structure A, and the needle extraction seat 35 and the implantation seat 33 form a limit to generate a needle extraction limit structure B. And,

[0165] The needle withdrawal seat 35 and the implantation seat 33 respectively have a needle implanting member 36 and a push portion 337. After the implantation module is implanted, the needle implanting member 36 penetrates the base 50 to implant a sensing test piece 72 under the skin of a living being. The push portion 337 tightly abuts against the sensor component 70 to prevent the sensor component 70 from being separated from the sensor component positioning portion 500 of the base 50 at the moment of needle implantation.

[0166] Also, please refer to Figure 1 and Figure 4 , is a second embodiment of the present invention, an implantation device of a biosensor with an anti-mis-implantation needle structure and an implantation method thereof, the implantation device of the present invention is also in a can-like form (for example: a dry can), but is not limited thereto, and the implantation device includes:

[0167] An upper cover 10 , a bottom cover 20 , an implantation module 30 , a base 50 and a desiccant 60 .

[0168] The upper cover 10 includes a shell 11 , a cover body 12 positioned inside the shell 11 , and a locking portion 124 is provided near the bottom of the cover body 12 . The upper cover 11 also has a convex ring portion 115 and a mating portion 116 .

[0169] The bottom cover 20 can be removed and airtightly combined with the upper cover 10 to produce an airtight space 200, in which a desiccant is arranged. In this embodiment, the bottom cover 20 and the upper cover 10 can be preferably combined in a hard interference manner, but it is not limited thereto. The bottom cover 20 has a top edge 223, and the top edge 223 is provided with a mating piece 227 corresponding to the mating portion 116 of the upper cover 11, and the inner circumferential surface of the bottom cover 20 also has a supporting portion 228 that is abutted against the outer side of the embedding portion 124, and the bottom cover 20 is concavely provided with a ring groove 224 on the inner side surface corresponding to the position of the convex ring portion 115 of the upper cover 10 and capable of embedding the convex ring portion 115, so that the upper cover 10 and the bottom cover 20 are combined.

[0170] In this embodiment, the user can install an airtight ring 13 made of elastic material between the protruding ring portion 115 and the annular groove 224 according to actual needs. The airtight ring 13 can further enhance the airtightness of the combination of the upper cover 10 and the bottom cover 20 .

[0171] The implantation module 30 is arranged in the upper cover 10 and linked with the upper cover 10, and the implantation module 30 has a main body component 300, the main body component 300 has a main body part 31, a main body cover 32 connected to the main body part 31 and defining a displacement space 301 together with the main body part 31, and the main body component 300 has a clamping portion 315 supported on the inner side of the embedding portion 124 of the upper cover 10, and the clamping portion 315 can produce a mutual snap-fit ​​relationship with the embedding portion 124 of the upper cover 10 when the upper cover 10 is pressed downward.

[0172] In this embodiment, it is further defined that the locking portion 315 of the main component 300 is disposed on the main body 31 of the main component 300, and the locking portion 315 is supported against the inner side of the embedding portion 124 of the cover body 12 of the upper cover 10. When the bottom cover 20 has not been removed, the supporting portion 228 of the bottom cover 20 and the embedding portion 124 of the cover body 12 of the upper cover 10 can form a limit, so that the upper cover 10 cannot move downward, so as to avoid the implant device accidentally falling off during transportation and causing the needle to be implanted by mistake.

[0173] In addition, the implantation module 30 also includes an implantation seat 33 arranged in the displacement space 301, a first elastic member 34 which is elastically supported between the implantation seat 33 and the main body cover 32 and provides the implantation seat 33 with movement in the needle implantation direction F, a needle withdrawal seat 35 arranged inside the implantation seat 33, a needle implantation member 36 connected to the needle withdrawal seat 35, a second elastic member 37 which is elastically supported between the implantation seat 33 and the needle withdrawal seat 35 and provides the needle withdrawal seat 35 with movement in a needle withdrawal direction R opposite to the needle implantation direction F, a needle implantation auxiliary seat 38 which can be detached and installed on the needle implantation auxiliary seat 36, and a sensor assembly 70 which can be detached and installed on the needle implantation auxiliary seat 38, and the sensor assembly 70 has a sensing base 71, and a sensing test piece 72 which is connected to the sensing base 71 and penetrates the needle implantation member 36.

[0174] In this embodiment, the first elastic member 34 and the second elastic member 37 are pre-compressed springs.

[0175] Furthermore, the inner circumference of the cover body 12 of the upper cover 10 has a pair of detents 123, and the implant seat 33 has a pair of buckle portions 335 which are respectively detent by the detent portions 123 and can be separated and embedded in a buckle portion 317 of the main body 31. By means of the structural relationship between the detent portions 123, the buckle portion 317 and the buckle portion 335, a needle implantation limiting structure A is formed between the implant seat 33 and the main body 31, and

[0176] The implant seat 33 and the main body cover 32 respectively have a limiting groove 330 and a limiting member 323 for limiting each other, and the limiting component 334 of the implant seat 33 limits the needle withdrawal seat 35. Through the structural relationship of the limiting groove 330, the limiting member 323 and the limiting component 334, the implant seat 33, the main body cover 32 and the needle withdrawal seat 35 form a needle withdrawal limiting structure B.

[0177] The base 50 can be detached and positioned relative to the main body 31, and the base 50 can be snapped and positioned after the sensor assembly 70 is detached from the needle-implanting auxiliary seat 38. The base 50 has a base 51, an adhesive sheet 52 fixed to the base 51, a second hook 54 that can be detached and embedded by the first hook 43, and a release layer 55 that can be torn off and adhered to the adhesive sheet 52, and the base 50 has a sensor assembly positioning portion 500 that can be combined and positioned by the sensor assembly 70. In this embodiment, the sensor assembly positioning portion 500 includes a groove 501 that is tightly matched with the sensor assembly 70, or the sensor assembly positioning portion 500 includes a fitting portion 502 (which can be made of double-sided adhesive material) provided in the groove 501 to be glued to the sensor assembly 70 (with reference to FIG. 2 ). Fig.31 ), or the sensor assembly positioning portion 500 includes an elastic fastener 503 that is engaged with the sensor assembly 70 (matching reference Fig.32 ).

[0178] It is worth mentioning that in the first embodiment and the second embodiment of the present invention, the implant device further includes a pair of fixing members 40, which are disposed in a slide groove 310 of the main member 31 of the main assembly 300, and each has a push portion 41 corresponding to a stop portion 226 of the base 20, a support portion 42 opposite to the push portion 41, a first hook 43 between the push portion 41 and the support portion 42, and a linkage portion 44 between the push portion 41 and the support portion 42, the linkage portion 44 having a guide inclined surface 441, and

[0179] The pushing portions 41 of the fixing member 40 are respectively resisted by the blocking portions 226 of the bottom cover 20 , so that the fixing member 40 is positioned relative to the main body 31 , and the sensing base 71 of the sensor assembly 70 is supported by the supporting portion 42 and remains positioned relative to the main body 31 , and the first hook 43 of the fixing member 40 is embedded in the second hook 54 .

[0180] Furthermore, further cooperation Figure 3 to Figure 4 For explanation, when the bottom cover 20 has not been removed, the fixing member 40 interferes with the cover body 12 of the upper cover 10 and the bottom cover 20 respectively. The fixing member 40 ensures that the upper cover 10 cannot move downward, which can further enhance the certainty of preventing the needle from being mis-implanted.

[0181] Furthermore, by pressing the sensor component 70 against the lower edge by the fixing part 40 and combining the fixing part 40 with the base 50, the base 50 is restricted in the implantation device. When the bottom cover 20 is removed, the user can press down the upper cover 10 to drive the cover body 12 of the upper cover 10 to move downward, drive the fixing part 40 to move laterally, and release the limiting relationship between the fixing part 40 and the sensor component 70 and the base 50. By releasing the elastic force of the pre-compressed first elastic part 34 in the implantation module 30, the implantation needle part 36 and the sensing test piece 72 on the sensor component 70 are implanted subcutaneously. At the same time, the sensor component 70 is combined with the base 50, and the sensing test piece 72 remains subcutaneously. Then, by releasing the elastic force of the pre-compressed second elastic part 37 of the implantation module 30, the implantation needle part 36 is withdrawn, thereby completing automatic implantation and withdrawal.

[0182] Furthermore, please see Figure 3 , Figure 4 and Fig. 22 (For ease of explanation, Figure 22 to Figure 26 Only a simplified diagram is shown), the outer shell 11 and the bottom cover 20, or the upper cover 10 and the bottom cover 20 of the present invention are an airtight combination structure, so that the interior of the implant device is airtight, and the desiccant 60 can be set at any appropriate position inside the implant device. In addition, in the above-mentioned preferred embodiment, any related component in the implant device can be a component that is integrally injection-molded with the desiccant 60, or a desiccant layer can be generated on the inner circumferential surface of the outer shell 11 (not shown in the figure), so that the interior of the implant device is dry and the sensor component 70 is prevented from getting wet.

[0183] In addition, if Figure 3 and Figure 4 The base 50 also has a tear-off assembly 23 fixed to the bottom plate portion 21 of the bottom cover 20. The tear-off assembly 23 is connected to the release layer 55 on the adhesive sheet 52. When the bottom cover 20 is removed, the release layer 55 can be torn off through the tear-off assembly 23 at the same time, so that the user can tear off the release layer 55 and expose the adhesive sheet 52 when implanting, which helps to improve the skin adhesion. In this embodiment, the bottom cover 20 is generally designed as a cap body. In other embodiments, it can also be a sheet-type aluminum foil cover (not shown).

[0184] In addition, it is worth mentioning that the implant device of the present invention and the sensor assembly 70 are assembled as follows: Figure 3 , Figure 4, when the components in the needle implant unit 30 are assembled, the outer shell 11 is then mounted on the implant module 30. At this time, the sensor component 70 has been pre-clamped on the implant module 30 by the needle implant auxiliary seat 38, and finally the bottom cover 20 is combined with the outer shell 11; in other words, the implant device of the present invention does not need to grasp the sensor component 70 on the base 20. Basically, the implant device assembly method described in the present invention is assembled at the factory end, but it is not limited to the medical staff or messenger self-assembly by disassembling the components in the implanter. When the user wants to install and use it, the user only needs to simply operate the implant device, for example: press the implant device, position the sensor component 70 on the base 50 through the needle implant process, and at the same time, use the adhesive sheet 52 of the base 50 to stick the base 50 to the biological skin surface.

[0185] Another example Fig.15 and Fig.16 , the user puts the originally removed bottom cover 20 back on the bottom of the upper cover 10, and uses the combination of the convex ring portion 115 and the annular groove 224 to seal the bottom cover 20 to the bottom of the outer shell 11. When the bottom cover 20 is put back on the bottom of the outer shell 11, the matching portion 116 and the matching piece 227 can be used to lock each other, so as to achieve the purpose of accurate alignment and foolproofing; in addition, the implant device can be used as a waste storage space. When the user has finished using the base 50, it can be disassembled and stored in the original implant device, allowing the user to discard it according to the medical waste disposal regulations.

[0186] See also Figure 31 to Figure 32 , which is a third embodiment of the implantation device of the biosensor and the implantation method thereof of the present invention. The implantation device of the present invention can be in a can-like form (e.g., a dry can), but is not limited thereto. First, the implantation device of the third embodiment of the present invention is described. The implantation device includes:

[0187] A cover body 12 has a containing space 14 , and the cover body 12 has a pair of locking portions 124 .

[0188] An implantation module 30 is disposed in the accommodating space 14, and the implantation module 30 includes:

[0189] A main body 31 is engaged with the cover body 12 , and the main body 31 and the cover body 12 together form a displacement space 301 , and the main body 31 has a pair of locking portions 315 that can be locked with the embedded locking portions 124 .

[0190] An implant seat 33 can be removed and limited to the cover body 12, and can move in the displacement space 301 between the main body 31 and the cover body 12; wherein,

[0191] The inner circumference of the cover body 12 has a pair of detent parts 123, and the implant seat 33 has a pair of snap parts 335 which are respectively detent by the detent parts 123 and can be detached from and embedded in a pair of buckling parts 317 of the main body 31. The snap parts 335 of the implant seat 33 resist the buckling parts 317 of the main body 31, so that a needle implantation limiting structure A is generated between the implant seat 33 and the main body 31.

[0192] The implant seat 33 and the cover body 12 respectively have a limiting groove 330 and a limiting member 100 for limiting each other, and the implant seat 33 also has a limiting component 334.

[0193] A first elastic member 34 is elastically disposed between the implant seat 33 and the cover body 12 . In this embodiment, the first elastic member 34 is a pre-compressed spring.

[0194] A needle withdrawal seat 35 connected to a needle implanting member 36 can be removed and limited to the implanting seat 33, and the limiting component 334 of the implanting seat 33 limits the needle withdrawal seat 35, so that a needle withdrawal limiting structure B is formed between the needle withdrawal seat 35 and the implanting seat 33.

[0195] A second elastic member 37 is elastically supported between the implantation seat 33 and the needle withdrawal seat 35 . In this embodiment, the second elastic member 37 is a pre-compressed spring.

[0196] A base 50 can be removed and limited to the main body 31, and the base 50 has a base 51, an adhesive sheet 52 fixed to the base 51, and a release layer 55 that can be torn off and adhered to the adhesive sheet 52.

[0197] A sensor assembly 70 is detachably limited to a base 50, and the sensor assembly 70 has a sensing base 71, and a sensing test piece 72 connected to the sensing base 71 and inserted into the implant needle 36, and the base 50 has a sensor assembly positioning portion 500 for the sensor assembly 70 to be combined and positioned. In this embodiment, the sensor assembly positioning portion 500 includes a groove 501 that is tightly matched with the sensor assembly 70, or the sensor assembly positioning portion 500 includes a fitting portion 502 (which can be made of double-sided adhesive material) in the groove 501 to be adhered to the sensor assembly 70 (such as Fig.31 ), or the sensor assembly positioning portion 500 includes an elastic fastener 503 that is engaged with the sensor assembly 70 (see Fig.32 ).

[0198] It is worth mentioning that the implantation module 30 also includes a needle-implantation auxiliary seat 38 that can be detached and mounted on the needle-implantation member 36, and the sensor assembly 70 can be detached and kept in a limited position relative to the needle-implantation auxiliary seat 38, and the needle-implantation auxiliary seat 38 has a base 381, three fins 382 extending outward from the base 381, and a plurality of tenon-shaped connecting portions 383 protruding from the bottom of the base 381 (see FIG. Fig.32 ), each wing 382 has a plurality of notches 384, which allow the wing 382 to be compressed in a radial direction perpendicular to the axis L and have the ability to rebound outward after being compressed; by creating a limiting relationship between the needle implantation auxiliary seat 38 and the main body 31 before the needle implantation, it can avoid the needle implantation component from swinging left and right and being pulled when implanted under the skin of the human body, thereby improving the stability of the needle implantation stroke and reducing the patient's pain.

[0199] like Fig.33 As shown, the implant device of the fourth embodiment of the present invention is described below, wherein the implant device comprises:

[0200] A cover body 12 has a containing space 14 , and the cover body 12 has a pair of locking portions 124 .

[0201] An implantation module 30 is disposed in the accommodating space 14, and the implantation module 30 includes:

[0202] A main body 31 and a main body cover 32 connected to the main body 31, a displacement space 301 is formed between the main body 31 and the main body cover 32, and the main body 31 has a pair of clamping parts 315 that can be respectively locked with the embedded parts 124, and a distance D is maintained between the top of the cover body 12 and the top of the main body cover 32.

[0203] An implant seat 33 can be removed and limited to the main body cover 32, and can move in the displacement space 301 between the main body 31 and the main body cover 32; wherein,

[0204] The inner circumference of the cover body 12 has a pair of detent portions 123, and the implant seat 33 has a pair of snap portions 335 that are respectively detent by the detent portions 123 and can be separated from and embedded in the pair of buckling portions 317 of the main body 31. The buckling portions 335 of the implant seat 33 resist the buckling portions 317 of the main body 31, so that a needle implantation limiting structure A is generated between the implant seat 33 and the main body 31; and

[0205] The implant seat 33 and the main body cover 32 respectively have a limiting groove 330 and a limiting member 320 for limiting each other, and the implant seat 33 also has a limiting component 334.

[0206] A first elastic member 34 is elastically supported between the implant seat 33 and the main body cover 32 . In this embodiment, the first elastic member 34 is a pre-compressed spring.

[0207] A needle withdrawal seat 35 connected to a needle implanting member 36 can be removed and limited to the implanting seat 33, and the limiting component 334 of the implanting seat 33 limits the needle withdrawal seat 35, so that a needle withdrawal limiting structure B is formed between the needle withdrawal seat 35 and the implanting seat 33.

[0208] A second elastic member 37 is elastically supported between the implantation seat 33 and the needle withdrawal seat 35 . In this embodiment, the second elastic member 37 is a pre-compressed spring.

[0209] A base 50 can be removed and limited to the main body 31, and the base 50 has a base 51, an adhesive sheet 52 fixed to the base 51, and a release layer 55 that can be torn off and adhered to the adhesive sheet 52.

[0210] A sensor assembly 70 is detachably limited to a base 50, and the sensor assembly 70 has a sensing base 71, and a sensing test piece 72 connected to the sensing base 71 and inserted into the implant needle 36, and the base 50 has a sensor assembly positioning portion 500 for the sensor assembly 70 to be combined and positioned. In this embodiment, the sensor assembly positioning portion 500 includes a groove 501 that is tightly matched with the sensor assembly 70, or the sensor assembly positioning portion 500 includes a fitting portion 502 (which can be made of double-sided adhesive material) in the groove 501 to be adhered to the sensor assembly 70 (such as Fig.31 ), or the sensor assembly positioning portion 500 includes an elastic fastener 503 that is engaged with the sensor assembly 70 (eg Fig.32 ).

[0211] It is worth mentioning that the implantation module 30 also includes a needle-implantation auxiliary seat 38 that can be removed and mounted on the needle-implantation member 36, and the sensor assembly 70 can be removed and kept in a limited position relative to the needle-implantation auxiliary seat 38, and the needle-implantation auxiliary seat 38 has a base 381, three fins 382 extending outward from the base 381, and a plurality of tenon-shaped connecting portions 383 convexly arranged at the bottom of the base 381 (see the first embodiment for details). Figure 3 and Figure 4 ), each wing 382 has a plurality of notches 384, which allow the wing 382 to be compressed in a radial direction perpendicular to the axis L and have the ability to rebound outward after being compressed; by creating a limiting relationship between the needle implantation auxiliary seat 38 and the main body 31 before the needle implantation, it can avoid the needle implantation component from swinging left and right and being pulled when implanted under the human body, thereby improving the stability of the needle implantation stroke and reducing the patient's pain.

[0212] Regardless of the first embodiment or the second to fourth embodiments of the present invention, the implant device is characterized in that when the user presses the upper cover or the cover body to release the implant needle limiting structure A, the elastic force of the pre-compressed first elastic member 34 is released to drive the implant seat 33 to move downward for automatic implantation; in other words, the implant device of the present invention uses elastic force to implant the needle, rather than relying on hand pressure. Therefore, the implant device of the present invention can effectively solve the problem in the prior art that the smoothness of implantation and withdrawal of the needle is affected by the user's operating proficiency.

[0213] In addition, when the implantation device of the third embodiment and the fourth embodiment of the present invention is to be implanted, the sensing test piece 72 is implanted under the skin of a living being, and the operation is described as follows:

[0214] Cooperate Fig.31 , Fig.32 and Fig.33 The user first tears off the release layer 55 and then adheres the adhesive sheet 52 of the base 50 to the biological part to be implanted. When the user has not yet pressed the upper cover 10, the needle-implanting limiting structure A between the implant seat 33 and the main body 31 has not yet been released, and is maintained at a pre-needle-implanting position. When the cover body 12 is pressed with force, the detent portion 123 detents the buckle portion 335 of the implant seat 33 to disengage from the buckle portion 317 of the main body 31, and the needle-implanting limiting structure A between the implant seat 33 and the main body 31 is released. At the same time, the clamping portion 315 engages with the corresponding embedding portion 124, and the cover body 12 is embedded and positioned relative to the main body 31.

[0215] When the needle-implanting limiting structure A of the main body 31 and the implanting seat 33 is released, the elastic force of the pre-compressed first elastic member 34 is released to allow the implanting seat 33 to move downward to the needle-implanting position, and the sensor assembly 70 is driven by the implanting seat 33 to be located at a post-implanting position, and the sensing test piece 72 is also implanted under the biological skin along with the needle-implanting member 36. The sensing base 71 of the sensor assembly 70 is positioned at the sensor assembly positioning portion 500 on the base 50 and is left on the biological surface. When the automatic needle-implanting is completed, because the limiting groove 330 of the implanting seat 33 and the limiting member 100 of the upper cover 10, or the implanting seat 33 After the limiting groove 330 is separated from the limiting member 320 of the main body cover 32, the needle withdrawal limiting structure B of the needle withdrawal seat 35 and the implantation seat 33 is released, and then the elastic force of the pre-compressed second elastic member 37 is released to provide the needle withdrawal seat 35 to move toward the front direction of the needle implantation, driving the needle implantation member 36 to shrink and move between the implantation seat 33 and the needle implantation auxiliary seat 38, so that the needle implantation member 36 will not be exposed, achieving the effect of the hidden design of the needle implantation member 362, completing automatic needle withdrawal, and utilizing the tight fit between the fitting portion 711 and the connecting portion 383 to connect the needle implantation auxiliary seat 38 to the sensing base 71 of the sensor assembly 70.

[0216] Afterwards, the user pulls up the cover body 12 and the implantation module 30 as a whole relative to the base 50 on the biological surface, thereby completing the implantation and removal of the biosensor implantation device of the third embodiment and the fourth embodiment of the present invention.

[0217] Accordingly, the implantation device of the third embodiment and the fourth embodiment of the present invention belongs to a one-stage pressing elastic needle implantation structure. When the user presses down the cover body 12, the implantation seat 33 is displaced downward by releasing the elastic force of the pre-compressed first elastic member 34 to release the limiting relationship with the cover body 12 or the main body cover 32, and automatic needle implantation is performed; when the automatic needle implantation is completed, the cover body 12 is still in a pressed state, the limiting relationship between the implantation seat 33 and the cover body 12 or the main body cover 32 is released, and the limiting relationship between the implantation seat 33 and the needle withdrawal seat 35 is released, so that the needle withdrawal seat 35 completes the automatic needle withdrawal by releasing the elastic force of the pre-compressed second elastic member 37; and the implantation device of the present invention also includes a bottom cover (not shown) that can be airtightly combined with the cover body, so that an airtight space is generated inside the implantation device, and a desiccant is provided at an appropriate position in the airtight space, and the desiccant is used to prevent the chemical reagent on the test piece 72 from getting damp.

[0218] Next, when the implantation device of the third embodiment and the fourth embodiment of the present invention is to be implanted and the sensing test piece 72 is implanted under the skin of a living being, the operation is as follows:

[0219] An implant device includes a displacement space 301 formed by a main body cover 32 and a main body 31.

[0220] An implantation module 30 is disposed in the displacement space 301. The implantation module 30 can move up and down in the displacement space 301 by means of two pre-compressed first elastic members 34 and second elastic members 37 inside to perform needle implantation and needle extraction.

[0221] A needle implantation limiting structure provided between the implantation module 30 and the main body 31 is used to release the implantation module 30 and maintain it in a pre-needle implantation position.

[0222] A needle withdrawal limiting structure is provided between the implantation module 30 and the main body cover 32. When the needle withdrawal limiting structure B is released, the implantation module 30 can move upward from a post-implantation position to a pre-needle implantation position.

[0223] Among them, when the implantation device is pressed down but not released, the needle implantation limiting structure A is released, and the implantation module 30 moves downward by releasing the elastic force of the pre-compressed first elastic member 34 to complete automatic needle implantation, and the needle withdrawal limiting structure B is automatically released after the implantation module 30 completes automatic needle implantation, and the implantation module 30 moves upward by releasing the elastic force of the pre-compressed second elastic member 37 to complete automatic needle withdrawal; and the implantation module 30 positions a sensor component 70 on the implantation module 30 on a base 50 during the downward displacement for automatic needle implantation.

[0224] Regardless of the third embodiment or the fourth embodiment, the time for completing automatic needle implantation and automatic needle withdrawal of the present invention is no more than 100 milliseconds, or no more than 50 milliseconds, or no more than 8 milliseconds, 6 milliseconds, 4 milliseconds, or 2 milliseconds.

[0225] Furthermore, in the fourth embodiment, the present invention can utilize the design of the main body cover 32 to compress the first elastic member 34 to store force, so that the user will not feel the reaction force of the first elastic member 34 when pressing the cover body 12, thereby improving the user's smoothness in operation. Among them, it is worth mentioning that in the above two implantation methods, the implantation module 30 has an implantation seat 33 and a needle withdrawal seat 35, and the implantation seat 33 and the main body 31 form a limit to generate a needle implantation limit structure A, and the needle withdrawal seat 35 and the implantation seat 33 form a limit to generate a needle withdrawal limit structure B.

[0226] The needle withdrawal seat 35 and the implantation seat 33 respectively have a needle implanting member 36 and a push portion 337. After the implantation module 30 is implanted, the needle implanting member 36 penetrates the base 50 to implant a sensing test piece 72 under the skin of a living being. The push portion 337 tightly abuts against the sensor component 70 to prevent the sensor component 70 from being separated from the sensor component positioning portion 500 of the base 50 at the moment of needle implantation.

[0227] The effects that the present invention can produce are summarized as follows:

[0228] 1. The implantation device of the present invention utilizes two pre-compressed first elastic members 34 and second elastic members 37 to enable the implantation module to generate an elastic force to automatically implant and automatically withdraw the needle, rather than relying on the force of the user's hand to implant the needle, and has the function of completing continuous automatic implantation and automatic withdrawal of the needle by pressing the upper cover 10 or the cover body 12 in one step. In other words, the present invention can greatly improve the certainty of operation, and can effectively solve the problem that the smoothness of implantation and withdrawal of the needle is affected by the user's operational proficiency in the conventional patent.

[0229] Second, in the implant device of the present invention, the bottom cover 20 is airtightly combined with the upper cover 10 or the cover body 12, so that an airtight space is formed inside the upper cover 10 or the cover body 12 and the bottom cover 20, and the desiccant 60 is provided to prevent the chemical reagent on the sensing test piece 72 from getting wet, so as to ensure the detection accuracy of the sensor assembly 70. In addition, a dryness indicating unit 61 (see FIG. 1 ) can be added outside or inside the housing 11 of the upper cover 10. Figure 4Preferably, the dryness indicating unit can be a dryness indicating material), and the housing 11 has a transparent or translucent portion, so that the user can identify whether the implant device has been damp through the dryness indicating unit 61. The arrangement and position of the desiccant 60 are not limited by the type disclosed in the embodiment, and the combination of the bottom cover 20 and the housing 11 is not limited by the hard interference type disclosed in the embodiment.

[0230] 3. When the implant device of the present invention is assembled as a whole but has not yet been used, the stopper portion 228 of the bottom cover 20 and the locking portion 124 of the upper cover 10 or the cover body 12 form a limit, which can prevent the implant device from accidentally falling during transportation and causing the needle to be implanted incorrectly.

[0231] Fourth, after the needle is withdrawn, the needle implanting member 36 is retracted and moved between the implanting seat 33 and the needle implanting auxiliary seat 38, and the needle implanting member 36 will not be exposed, thus achieving the effect of the hidden design of the needle implanting member 362.

[0232] 5. The first elastic member 34 is compressed and stored by the main body cover 32 so that the first elastic member 34 does not directly contact the upper cover 10 or the cover body 12. Therefore, when pressing down the upper cover 10 or the cover body 12 to implant the needle, the operator does not need to resist the elastic force of the spring, which saves effort when performing the automatic needle implantation operation.

[0233] 6. By using the limiting structure formed by the needle implantation auxiliary seat 38 and the main body 31 before the needle implantation, the needle implantation component can be prevented from swinging left and right and being pulled when implanted under the human body, thereby improving the stability of the needle implantation stroke and reducing the patient's pain.

[0234] 7. The base 50 has a sensor component positioning portion 500 for combining and positioning the sensor component 70. The sensor component positioning portion 500 includes a groove 501 that is tightly fitted with the sensor component 70, or the sensor component positioning portion 500 includes a fitting portion 502 (which can be made of double-sided tape) in the groove 501 that is adhered to the sensor component 70, or the sensor component positioning portion 500 includes an elastic fastener 503 that is snap-fitted with the sensor component 70.

[0235] 8. After the upper cover 10 or the cover body 12 is pressed, the time for completing automatic needle implantation and automatic needle withdrawal is no more than 100 milliseconds, or no more than 50 milliseconds, or no more than 8 milliseconds, 6 milliseconds, 4 milliseconds, or 2 milliseconds.

[0236] 9. In terms of the assembly sequence of the components of the present invention, the first elastic member 34, the needle withdrawal seat 35, the second elastic member 37 and the implantation seat 33 are first installed between the main cover 32 and the main body 31, and the implantation needle member 36 is finally inserted into the needle implantation auxiliary seat 38 and the sensor component 70, and the implantation needle member 36 is combined with the needle withdrawal seat 35. Thus, the sensor component 70 and the implantation module 30 have a clutch design, which can not only greatly improve the assembly yield, but also effectively reduce the use cost of the sensor component 70.

[0237] 10. The sensor assembly 70 of the present invention has been pre-clamped inside the implant module 30 by the needle-implanting auxiliary seat 38. Therefore, the implant device of the present invention does not need to grasp the sensor assembly 70 on the base 20, which is more convenient and time-saving to operate.

[0238] XI. The implant device of the present invention is provided with a protective ring 80 (such as Fig.17 As shown in the figure, before the needle is implanted, the base 50 is located inside the bottom edge of the protective ring 80. When the bottom edge of the protective ring 80 is against the biological surface, the base 50 will not contact the biological surface. The operator can move the implantation device to the desired implantation position, and then press down the upper cover 10 to automatically implant the needle. The protective ring 80 can be retracted relative to the upper cover 10 under the force, and the base 50 will also be attached to the biological surface. Therefore, by using the protective ring 80, it can be adjusted to the desired position before the needle is implanted, which is very convenient to use.

[0239] 12. When the bottom cover 20 is put back on the bottom of the outer shell 11, the engaging portion 116 and the engaging piece 227 are interlocked with each other to achieve the purpose of accurate alignment and foolproofing.

Claims

1. A biosensor implantation device, comprising a cover and an implantation module, characterized in that: The cover body has a containing space; The implantation module is arranged in the accommodation space of the cover body; The implant module comprises: The main body is engaged with the cover body, and the main body and the cover body together form a displacement space; The implant seat can be removed and limited to the cover body, and can be displaced in the displacement space between the main body and the cover body; A first elastic member is elastically disposed between the implant seat and the cover body; A needle extraction seat, which can be removed and is limited to the implantation seat; A second elastic member is elastically pressed between the implantation seat and the needle withdrawal seat; A base, which can be removed and is limited to the main body; A sensor assembly, which can be removed and is confined to the base; The cover body is pressed down, so that the implant seat is displaced downward by the elastic force of the first elastic member to release the limiting relationship with the cover body, and the needle is automatically implanted. When the needle is implanted, the cover body is still in a pressed down state, the limiting relationship between the implant seat and the cover body is released, and the limiting relationship between the implant seat and the needle withdrawal seat is released, so that the needle withdrawal seat can automatically withdraw the needle by releasing the elastic force of the second elastic member. The needle withdrawal seat of the implantation module is connected to the needle implantation part; the implantation module also includes a needle implantation auxiliary seat that can be removed and installed on the needle implantation part, and the sensor component can be removed and kept limited relative to the needle implantation auxiliary seat, the needle implantation auxiliary seat has a base, and wings extending outward from the base, each of the wings has a number of notches, allowing the wings to be compressed in a radial direction perpendicular to the axis and have the ability to rebound outward after being compressed, so that a limiting relationship is generated between the needle implantation auxiliary seat and the main body before needle implantation; the first elastic member and the second elastic member of the implantation module are pre-compressed springs.

2. The biosensor implant device according to claim 1, characterized in that: The implant seat and the cover body of the implant module respectively have a limiting groove and a limiting member for limiting each other, and the implant seat also has a limiting component for keeping the needle withdrawal seat limited relative to the implant seat. By means of the mutual arrangement of the limiting groove, the limiting member and the limiting component, the implant seat, the cover body and the needle withdrawal seat constitute a needle withdrawal limiting structure.

3. The biosensor implant device according to claim 1, characterized in that: The inner circumferential surface of the cover body has at least one detent part, the main body has a buckling part, and the implant seat has at least one buckling part that is detent by the detent part and can be detached from and embedded in the buckling part of the main body. By the mutual arrangement of the detent part, the buckling part and the buckling part, a firing limit structure is formed between the implant seat and the main body.

4. The biosensor implant device according to claim 1, characterized in that: It also comprises a bottom cover which can be airtightly combined with the cover body, so that an airtight space is generated inside the implant device, and a desiccant is arranged at an appropriate position in the airtight space.

5. The biosensor implant device according to claim 1, characterized in that: The cover body also has an embedded clamping portion, and the main body of the implant module has a clamping portion that is locked with the embedded clamping portion.

6. The biosensor implant device according to claim 1, characterized in that: The base has a sensor component positioning portion for the sensor component to be combined and positioned.

7. The biosensor implant device according to claim 6, characterized in that: The sensor assembly positioning portion can include a groove to produce a tight fit with the sensor assembly.

8. The biosensor implant device according to claim 7, characterized in that: The sensor component positioning portion includes a fitting portion provided in the groove to be bonded to the sensor component.

9. The biosensor implant device according to claim 6, characterized in that: The sensor assembly positioning portion also includes an elastic fastener elastically fastened to the sensor assembly.

10. The biosensor implant device according to claim 1, characterized in that: The time taken by the implantation module to complete automatic needle implantation and automatic needle withdrawal is no more than 100 milliseconds.

11. The biosensor implant device according to claim 10, characterized in that: The time taken by the implantation module to complete automatic needle implantation and automatic needle withdrawal is no more than 8 milliseconds.

12. The biosensor implant device according to claim 10, characterized in that: The time taken by the implantation module to complete automatic needle implantation and automatic needle withdrawal is no more than 4 milliseconds.

13. The biosensor implant device according to claim 10, characterized in that: The time taken by the implantation module to complete automatic needle implantation and automatic needle withdrawal is no more than 2 milliseconds.

14. A biosensor implantation device, comprising a cover and an implantation module, characterized in that: The cover body has a containing space; The implantation module is arranged in the accommodation space of the cover body; The implant module comprises: A main body and a main body cover connected to the main body, wherein a displacement space is formed between the main body and the main body cover; An implant seat, which can be removed and limited to the main body cover, and can be displaced in the displacement space between the main body and the main body cover; A first elastic member is elastically pressed between the implant seat and the main body cover; A needle extraction seat, which can be removed and is limited to the implantation seat; A second elastic member is elastically pressed between the implantation seat and the needle withdrawal seat; A base, which can be removed and is limited to the main body; A sensor assembly, which can be removed and is confined to the base; The cover is pressed down, so that the implant seat is displaced downward by the elastic force of the first elastic member to release the limiting relationship with the main body cover, and the needle is automatically implanted. When the needle is implanted, the cover is still in the state of being pressed down, the limiting relationship between the implant seat and the main body cover is released, and the limiting relationship between the implant seat and the needle withdrawal seat is released, so that the needle withdrawal seat can automatically withdraw the needle by releasing the elastic force of the second elastic member. Furthermore, the first elastic member is compressed and stored by the main body cover, so that the reaction force of the first elastic member will not be felt when the cover body is pressed, thereby improving the smoothness of automatic needle insertion and automatic needle withdrawal; The needle withdrawal seat of the implantation module is connected to the needle implantation part; the implantation module also includes a needle implantation auxiliary seat that can be removed and installed on the needle implantation part, and the sensor component can be removed and kept limited relative to the needle implantation auxiliary seat, the needle implantation auxiliary seat has a base, and wings extending outward from the base, each of the wings has a number of notches, allowing the wings to be compressed in a radial direction perpendicular to the axis and have the ability to rebound outward after being compressed, so that a limiting relationship is generated between the needle implantation auxiliary seat and the main body before needle implantation; the first elastic member and the second elastic member of the implantation module are pre-compressed springs.

15. The biosensor implant device according to claim 14, characterized in that: The implantation seat and the main body cover of the implantation module respectively have a limiting groove and a limiting member for limiting each other, and the implantation seat also has a limiting component for keeping the needle withdrawal seat limited relative to the implantation seat. By means of the mutual arrangement of the limiting groove, the limiting member and the limiting component, the implantation seat, the cover body and the needle withdrawal seat constitute a needle withdrawal limiting structure.

16. The biosensor implant device according to claim 14, characterized in that: The inner circumferential surface of the cover body has at least one detent part, the main body has a buckling part, and the implant seat has at least one buckling part that is detent by the detent part and can be detached from and embedded in the buckling part of the main body. By the mutual arrangement of the detent part, the buckling part and the buckling part, a firing limit structure is formed between the implant seat and the main body.

17. The biosensor implant device according to claim 14, characterized in that: It also comprises a bottom cover which can be airtightly combined with the cover body, so that an airtight space is generated inside the implant device, and a desiccant is arranged at an appropriate position in the airtight space.

18. The biosensor implant device according to claim 14, characterized in that: The cover body also has an embedded clamping portion, and the main body of the implant module has a clamping portion that can be locked with the embedded clamping portion.

19. The biosensor implant device according to claim 14, characterized in that: The base has a sensor component positioning portion for the sensor component to be combined and positioned.

20. The biosensor implant device according to claim 19, characterized in that: The sensor assembly positioning portion can include a groove to produce a tight fit with the sensor assembly.

21. The biosensor implant device according to claim 20, characterized in that: The sensor component positioning portion includes a fitting portion provided in the groove to be bonded to the sensor component.

22. The biosensor implant device according to claim 19, characterized in that: The sensor assembly positioning portion also includes an elastic fastener elastically fastened to the sensor assembly.

23. The biosensor implant device according to claim 14, characterized in that: The time taken by the implantation module to complete automatic needle implantation and automatic needle withdrawal is no more than 100 milliseconds.

24. The biosensor implant device according to claim 23, characterized in that: The time taken by the implantation module to complete automatic needle implantation and automatic needle withdrawal is no more than 8 milliseconds.

25. The biosensor implant device according to claim 23, characterized in that: The time taken by the implantation module to complete automatic needle implantation and automatic needle withdrawal is no more than 4 milliseconds.

26. The biosensor implant device according to claim 23, characterized in that: The time taken by the implantation module to complete automatic needle implantation and automatic needle withdrawal is no more than 2 milliseconds.

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