Implantation device

Abstract

To enhance the convenience of a user while reducing the manufacturing processes of a sensor and an implantation device, and to implant the sensor by a sanitary and painless method.SOLUTION: Provided is a method of assembling a physiological signal monitoring device on a body surface of a living body, in which the physiological signal monitoring device is used for measuring a physiological signal and includes a sensor module and a transmitter. The method includes the following steps of: (a) removing the bottom cover 20 from the housing 11 to expose the adhesive pad from the bottom opening; (b) attaching the adhesive pad to the body surface while holding the housing; (c) applying a pressing force to the housing to remove the sensor module 70 from the implant module 30 and implant the signal sensing end under the body surface; (d) removing the implant device while leaving the sensor module on the body surface; and (e) placing the transmitter on the base such that the signal output end is electrically connected to the port.SELECTED DRAWING: Figure 1

Description

Cross - Reference to Related Applications

[0001] This application claims the benefit of the filing dates of U.S. Provisional Patent Application No. 62 / 882,140, filed on August 2, 2019, and Taiwan Patent Application No. 109100992, filed on January 10, 2020, the disclosures of which are hereby incorporated by reference in their entireties herein.

Technical Field

[0002] The present invention relates to an operating method, and particularly to a method for assembling a physiological signal monitoring device on the body surface of a living body.

Background Art

[0003] Chronic diseases such as diabetes and chronic cardiovascular diseases are becoming more common worldwide due to the lifestyle of people living in urban areas. Therefore, it is necessary to regularly monitor specific physiological parameters of patients with chronic diseases to effectively control their conditions, avoid deterioration, and provide prompt treatment.

[0004] However, much of the physiological data needs to be obtained in vivo. Also, in order to perform monitoring efficiently, it is necessary to obtain multiple measurement data every day. To avoid the discomfort of patients caused by multiple blood samplings or extractions of body fluids, some persons skilled in the art use small sensing elements embedded in subcutaneous tissue for a relatively long time so as to be fixed to the skin surface in accordance with the signal processing components. This can be used for several days without the need to remove it, and can collect and analyze data such as blood glucose levels, blood lipids, cholesterol concentrations, or other measured values that provide physiological parameters at any time, providing real - time physiological data monitoring. The same concept can also be applied when embedding an electronic device such as a chip into the skin of an animal.

[0005] This type of physiological parameter measuring device has traditionally been made by separately assembling the sensor and the embedding device because the manufacturing process is difficult. The sensor contains reagents such as enzymes and needs to be placed inside the body. The reagents need to be moisture-proof and sterilized during manufacturing, while the embedding device does not require these procedures.

[0006] According to conventional methods, such as the devices and methods disclosed in U.S. Patent No. 9,693,713, the sensor is sealed in a container with a desiccant to isolate the source of contamination and maintain a dry and hygienic state. If the container cannot achieve the required sterilization conditions, the container may be further stored in a blister shell. Before performing a physiological test, the user peels off the blister shell, opens the airtight container, assembles the sensor at the bottom of the embedding device, and finally uses the embedding device to place the sensor on the skin. The manufacturing process of such a device is relatively simple, but the manufacturing cost has increased due to the individual manufacturing processes of the two devices. For the user, the embedding device and the sensor need to be assembled together before use, which is inconvenient and troublesome. Also, in the descriptions of the specifications of U.S. Patent Publication US20170188912 and U.S. Patent US8764657B2, the embedding device is opened in a cyclic manner and usually takes at least one time, typically two to three times, to fully open, so there is a problem of taking a long time.

[0007] Furthermore, during the process of embedding the sensor, it can basically be divided into two steps: needle embedding and needle extraction. If either of these procedures cannot be completed immediately or there is no consistency in the procedures, it may cause pain and discomfort to the user. Summary of the Invention Problems to be Solved by the Invention

[0008] Therefore, several technical problems need to be solved, such as enhancing user convenience while reducing the manufacturing processes of the sensor and the embedding device, effectively maintaining the dry state of the physiological parameter sensor before embedding, and enabling embedding in a hygienic and painless manner.

Means for Solving the Problems

[0009] According to one aspect of the present invention, there is provided a method of assembling a physiological signal monitoring device on the body surface of a living body. The physiological signal monitoring device is used for measuring physiological signals and includes a sensor module and a transmitter. The sensor module is configured to be disposed on the body surface by an embedding device. The sensor module includes a sensor that measures the physiological signal and has a signal sensing end and a signal output end, a base that houses the sensor, and an adhesive pad disposed under the base and configured to attach the base to the body surface. The transmitter has a port for receiving the physiological signal. The embedding device includes a housing having a bottom opening, an embedding module disposed in the housing and supporting the sensor module, and a bottom cover removably coupled to the bottom opening. The method includes: (a) removing the bottom cover from the housing to expose the sticker from the bottom opening; (b) attaching the adhesive pad to the body surface while holding the housing; (c) applying a pressing force to the housing to remove the sensor module from the embedding module and embed the signal sensing end under the body surface; (d) removing the embedding device while leaving the sensor module on the body surface; and (e) disposing the transmitter on the base such that the signal output end is electrically connected to the port.

[0010] According to another aspect of the present invention, there is provided a method of assembling a physiological signal monitoring device on the body surface of a living body. The physiological signal monitoring device is used for measuring physiological signals and includes a sensor module and a transmitter. The sensor module is configured to be disposed on the body surface by an embedded device. The sensor module includes a sensor that measures the physiological signal and has a signal sensing end and a signal output end, a base that houses the sensor, and an adhesive pad that is connected to the base and is configured to attach the base to the body surface. The transmitter has a port for receiving the physiological signal. The embedded device includes a housing having a bottom opening, an embedded module disposed within the housing for supporting the sensor module, and an airtight container that houses the embedded module and forms an airtight space. The method includes: (a) removing the airtight container from the embedded device to expose the adhesive pad from the bottom of the embedded device; (b) attaching the adhesive pad to the body surface while holding the housing; (c) applying a pressing force to the housing to remove the sensor module from the embedded module and embed the signal sensing end under the body surface; (d) removing the embedded device while leaving the sensor module on the body surface; and (e) disposing the transmitter on the base such that the signal output end is electrically connected to the port of the transmitter.

[0011] According to yet another aspect of the present invention, there is provided a method of assembling a physiological signal monitoring device on the body surface of a living body, the physiological signal monitoring device being used for measuring physiological signals and including a sensor module and a transmitter. The sensor module is configured to be disposed on the body surface by an embedding device. The sensor module includes a sensor that measures the physiological signal and has a signal sensing end and a signal output end, a base that houses the sensor, and an adhesive pad that is connected to the base and is configured to attach the base to the body surface. The transmitter has a port for receiving the physiological signal. The embedding device includes a housing having an accommodation space, an embedding module disposed in the housing and supporting the sensor module, and a sealing element that airtightly seals the accommodation space. The method includes: (a) removing the sealing element from the embedding module to expose the sticker from the bottom of the embedding module; (b) attaching the adhesive pad to the body surface while holding the housing; (c) applying a pressing force to the housing to remove the sensor module from the embedding module and embed the signal sensing end under the body surface; (d) removing the embedding device while leaving the sensor module on the body surface; and (e) disposing the transmitter on the base such that the signal output end is electrically connected to the port of the transmitter.

[0012] The novel design of the present invention can fully meet the requirement of reducing manufacturing costs. Therefore, the present invention has industrial applicability.

Brief Description of the Drawings

[0013] The objects and advantages of the present invention will become more readily apparent to those skilled in the art after considering the following detailed description and the accompanying drawings.

[0014]

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Mode for Carrying Out the Invention

[0015] Next, the present invention will be described more specifically with reference to the following embodiments. Note that the following description of the preferred embodiments of the present invention is presented herein for purposes of illustration and explanation only. They are not intended to be exhaustive or limited to the exact form disclosed.

[0016] The hermetic drying container of the present invention incorporates an embedded device into a sensing device and maintains a dry environment for the device. Refer to FIGS. 1 to 10. According to FIG. 1, the drying container 100 has a hermetic joint maintained by the housing 11 and the bottom cover 20, and a sealed space is formed inside. The casing assembly 10 includes the housing 11, a lining piece 12 disposed inside the housing 11, and a leak-proof ring 13 selectively added and disposed around the housing 11. The hermetic space formed together by the housing 11 and the bottom cover 20 is for accommodating other elements such as the embedded module 30, the lower mount base 50, the sensor assembly 70, and the drying element 60. The lower mount base 50 and the sensor assembly 70 are separated from the drying container 100 after the completion of the embedding process and form the shape of a module to be disposed on the skin surface of a living body where the sensor needs to be embedded. Therefore, the combination of the lower mount base 50 and the sensor assembly 70 may also be a detachable module. From FIGS. 3 and 4, it can be seen that the lower mount base 50 and the sensor assembly 70 are separately disposed in different locations in the storage state and are to be embedded.

[0017] As shown in FIGS. 1 to 4, the housing 11 is cup-shaped, and the upper wall 111 is disposed at a portion like the bottom of the cup. There is a bottom opening on the lower surface 112 opposite to the upper wall 111 along the axis L. According to the present embodiment, a first coupling portion coupled to the bottom cover 20 is formed at the bottom opening of the housing 11. The first coupling portion is coupled to the bottom cover 20 through sleeve engagement (hard interference), but is not limited thereto. The housing 11 further includes a mating portion 116 having a concave shape. In one embodiment, in order for a person to observe the drying state of the drying element 60, a drying indicator 61 such as a cobalt-containing humidity indicator or a cobalt-free humidity indicator can be disposed at a position of the housing 11 or the bottom cover 20 made of a transparent or translucent material. Another example of the drying indicator 61 is a printed layer of a zeolite-containing resin, which can be determined by absorbing moisture and making the resin layer transparent. The drying indicator 61 can be used for a user to observe the drying in the container in order to avoid the use of abnormal products.

[0018] The lining piece 12 has a shape of a hollow cylindrical cup and is sleeved in the housing 11. The lining piece 12 is in close contact with the inner surface 117 of the housing 11 and has an inner peripheral surface 121 that can define an accommodation space 14 for accommodating the embedded module 30, an outer peripheral surface 122 opposite to the inner peripheral surface 121, a pair of operating portions 123 protruding from the inner peripheral surface 121, a pair of locking portions 124 disposed along the axis L from the side of the operating portions 123, and a plurality of slot seats 126 protruding from the outer peripheral surface 122 and each defining an accommodation groove 125 with the outer peripheral surface 122. The locking portion 124 has a through hole communicating the outer peripheral surface 122 and the inner peripheral surface 121. The accommodation groove 125 can be used for disposing the desiccant 60.

[0019] Since the lining piece 12 and the housing 11 are in close contact via a plurality of fitting portions 127, it is not necessary to change their relative positions. Due to the presence of the plurality of fitting portions 127 on the upper surface of the lining piece 12, a desiccant 60 is provided in the gap formed between the lining piece 12 and the housing 11. In this embodiment, the lining piece 12 can define at least one of a desiccant accommodation space in the upper part of the lining piece 12 and a plurality of accommodation grooves 125 extending from the side wall of the lining piece 12. In another embodiment, the inner peripheral surface 121 of the lining piece 12 may include a desiccant accommodation space (not shown). According to another embodiment of the present invention, as shown in FIGS. 32 and 33, the lining piece 12 can be regarded as a part of the housing 11, and vice versa. That is, without departing from the scope of the present invention, it means that the lining piece 12 and the housing 11 can be independent components, or the two components can be integrally formed.

[0020] The bottom cover 20 is detachably attached to the housing 11 and has a chassis portion 21 substantially orthogonal to the axis L and a peripheral wall 22 extending from around the chassis portion 21. The peripheral wall 22 has an inner surface 221, an outer surface 222 on the side opposite to the inner surface 221, a brim 223 connected between the inner surface 221 and the outer surface 222, a ring groove 224 in which the convex ring 115 can be embedded and is recessed in the inner surface 221, a pair of closing portions 226 protruding from the inner surface 221, and a somewhat semi-circular plate-shaped positioning piece 227 protruding from the brim 223. The bottom opening of the housing 11 conforms to the configuration of the bottom cover 20. The positioning piece 227 can be nested in the mating portion 116. The mating between the positioning piece 227 and the mating portion 116 provides the user with foolproof and alignment functions when operating to open and close the container. Further, when there are requirements for the directionality of the internal components of the drying container, the combination of the mating portion 116 and the positioning piece 227 can be used as a set of reliable alignments, which is beneficial for improving production efficiency. Also, the mating portion 116 is utilized as a positioning member of the housing 11 serving as a reference point for estimating the amount of deformation of the opening of the housing 11, making the opening of the housing 11 have a round appearance during injection molding, which is useful for the airtight process.

[0021] The outer surface 222 of the bottom cover 20 has a force-applying portion 228 protruding from the outer surface 222 adjacent to the brim 223. The force-applying portion 228 enables the user to easily open and close the bottom cover 20. Further, since the force-applying portion 228 is provided to control the opening force to 2 kilogram-force (kgf) or less, the container can be easily opened, is resistant to negative pressure, and the user can quickly disassemble it with little force.

[0022] According to this embodiment, the inner surface 221 of the bottom cover 20 defines a second joint portion that engages with the first joint portion of the housing 11, but is not limited to other methods. In another embodiment, the leak-proof ring 13 formed of an elastic washer having an elastic material can also be sleeved on the outer ring surface 114 of the bottom ring 113. The leak-proof ring 13 is disposed on one side of the ring groove 224 and can be hermetically sleeved on the ring portion 225 disposed outside the leak-proof ring 13. As shown in FIG. 3, when the housing 11 and the bottom cover 20 are assembled, the leak-proof ring 13 can combine them in an airtight state. According to another embodiment, the ring groove 224 of the bottom cover 20 and the convex ring portion 115 of the housing 11 can also form a joint portion in an airtight state. According to another embodiment, in order to provide an airtight storage environment for the drying container 100, the bottom cover 20 may be implemented in the form of an aluminum foil (not shown), which can also provide a sealing effect.

[0023] The results of the negative pressure test of the drying container stored in various temperature and humidity environments are taken out at different times to confirm the airtight function, and the average daily moisture absorption of the drying container is confirmed by a weighing test. According to the experimental results, the moisture absorption rate of the dry airtight container of the present invention is 200 mg or less per day, 50 mg or less per day, 1 mg or less per day, 0.5 mg or less per day, 0.3 mg or less per day, or 0.25 mg or less per day. In another embodiment, the dry airtight container can reach storage conditions of relative humidity 0 to 100% and temperature 0 to 45°C, relative humidity 0 to 100% and temperature 0°C to 40°C, or relative humidity 10 to 90% and temperature 4 to 30°C, and maintain a storage period of at least 2 years or at least 1 year, both of which have a good airtight effect. The present invention is not limited by the embodiments of the hard interference pattern disclosed by the examples.

[0024] It is worth mentioning that generally, a hinge connection (not shown) is arranged between the bottom cover 20 of the drying container 100 and the housing 11. By using the can opening design of the present invention with a convex ring and a ring groove, while operating the drying container 100 to embed the sensor, the housing 11 can be more easily pressed against and embedded into the surface of the living body's skin. The convex ring and ring groove sleeve design of the present invention can simplify the manufacturing process, reduce the probability of wear of the manufacturing mold, and is beneficial to improving the process yield compared with the screw-rotary can opening design.

[0025] As shown in FIGS. 3, 4 and 31, the sensor assembly 70 includes a sensor 72. The sensor 72 is embedded in the skin surface P which is the subcutaneous part of the living body and measures the physiological signals of the living body. The sensor assembly 70 includes a sensor base 71 and a sensor 72 connected to the sensor base 71 and held partially within the implant needle 362. The sensor base 71 has a plurality of concave engaging portions 711 configured to engage with the connecting portion 383 of the auxiliary implant sheet 38. The sensor assembly 70 can also be regarded as a single module. For example, the sensor 72 may include a substrate 722, and at least one working electrode 724 and a reference electrode 725 are arranged on the substrate 722. At least the working electrode 724 has a chemical reagent 720 including at least one analyte-responsive enzyme 726 and a polymer film layer 728. The chemical reagent 720 is configured to obtain data regarding specific physiological parameters in the living body, such as glucose concentration or other parameters in the interstitial fluid.

[0026] The sensor 72 is not limited to other types of electrode arrangement structures. Since the sensor 72 needs to be kept in an airtight and dry state during storage and before implantation, the storage space 14 of the airtight and dry container 100 for carrying the sensor assembly 70 is provided with a desiccant 60 for maintaining a long-term stable period (such as more than one year) of the reagent. The gap between each element in the dry container 100 of the present invention can be used as a vent hole for the desiccant 60 and communicates with the sensor 72 so that the desiccant 60 maintains a good function for moisture absorption. In particular, in another embodiment, the airtight container 100 of the present invention does not even need to dispose the desiccant 60. In a state of excellent airtightness, the humidity inside the container becomes very low as in the initial stage of manufacturing, so it is not affected by humidity and the long-term effectiveness of the chemical reagent can be maintained. Therefore, the sensor 72 can have consistent and good accurate performance during the storage period for one year, two years or longer.

[0027] The desiccant 60 can be disposed at any appropriate position within the dry container 100. As in the embodiment shown in FIGS. 1 and 2A, the desiccant 60 is disposed in the receiving groove 125 of the lining piece 12. The embedding module 30 for carrying the sensor assembly 70 is disposed in the receiving space 14 inside the lining piece 12. Viewed in another way, the lining piece 12 is disposed between the housing 11 and the embedding module 30. The desiccant 60 can also be disposed between a plurality of fitting portions 127 on the outer peripheral surface 122 of the lining piece 12. According to another embodiment, as shown in FIGS. 2A and 3-4, the desiccant 60 may be sandwiched between the outer peripheral surface 122 of the lining piece 12 and the housing 11, or may be disposed on the inner peripheral surface 121. The desiccant 60 can be disposed at an appropriate position of the embedding module 30 or the bottom cover 20, or the desiccant 60 can be disposed near the sensor assembly 70, or the desiccant 60 can be integrally formed with the sensor base 71. The desiccant 60 can be arranged in combination at different positions according to environmental requirements. The desiccant 60 can be a desiccant-embedded polymer, a water-absorbing material, a hygroscopic material, a molecular sieve drying sheet, a desiccant-embedded plastic sheet, or a drying sheet formed by injection molding using an internal component of the container 100.

[0028] The embedding module 30 is installed in the accommodation space 14 and includes a main body 31 having a hollow cylindrical shape, a main cover 32 connected to the main body 31 and limiting a displacement space 301 together with the main body 31, a needle embedding sheet 33 movably arranged in the displacement space 301 along the axis L, a first elastic element 34 arranged between the needle embedding sheet 33 and the main cover 32 in a pre-compression manner, a needle extraction sheet 35 slidably installed inside the needle embedding sheet 33 along the axis L, a needle embedding piece 36 connected to the needle extraction sheet 35, and a second elastic element 37 arranged between the needle embedding sheet 33 and the needle extraction sheet 35 in another pre-compression manner. The first elastic element 34 is configured to provide an elastic force to the needle embedding sheet 33 to move away from the main cover 32 along the embedding direction F. The second elastic element 37 is configured to provide an elastic force to the needle extraction sheet 35 to move along the needle extraction direction R. The components within the embedding module 30 form a driving group for driving the needle embedding piece 36, releasing force to the embedding module 30, and embedding the sensor 72 under the skin of a living body.

[0029] The main body 31 has a bottom wall 311, a cylindrical wall 312 intersecting and connected to the bottom wall 311, a hollow tubular conduit 313 protruding from the bottom wall 311, two elastic pieces 314 connected to the cylindrical wall 312 and facing each other, and a pair of latch portions 315 that can be respectively engaged with the locking portion 124. The cylindrical wall 312 has a pair of slide grooves 310 extending along the axis L, a pair of recesses 316, a pair of stop portions 317 adjacent to the recesses 316, and a pair of buckle ears 318. The conduit 313 has a pressing hole 319 that narrows inward and widens outward. The slide grooves 310 are connected to the pressing hole 319, and the elastic pieces 314 have an elasticity that may cause a bias with respect to the axis L. The latch portions 315 are respectively arranged at the movable ends of the elastic pieces 314.

[0030] The main cover 32 has a central hole 321 corresponding to the axis L, a pair of buckle holes 322 that can be respectively fastened to the buckle ears 318, and a pair of restraint elements 323 arranged on opposite sides along the axis L.

[0031] The needle embedding sheet 33 has a flat plate portion 331, an inner cylinder member 332 that intersects and connects with the flat plate portion 331, an outer cylinder member 333 that intersects and connects with the flat plate portion 331 and surrounds the inner cylinder member 332, a limiting element 334 arranged on the inner tube member 332 to maintain the needle extraction sheet 35 at a certain position relative to the needle embedding sheet 33, a pair of buckle portions 335 respectively arranged on the outer cylinder member 333 and removably seated on the stop portion 317, and a pair of limiting grooves 336 that extend parallel to the parallel axis L and are adjacent to the limiting element 334. The buckle portion 335 is in the shape of a spring and has elasticity that may cause a bias with respect to the axis L.

[0032] According to an embodiment of the present invention, the first and second elastic elements 34, 37 are compression springs.

[0033] According to an embodiment of the present invention, the needle embedding piece 36 has a main body portion 361 and a hollow embedding needle 362 connected to the main body portion 361.

[0034] In particular, the embedding module 30 further includes an auxiliary embedding sheet 38 removably disposed on the needle embedding piece 36, and the sensor assembly 70 removably maintains its position relative to the auxiliary embedding sheet 38. The auxiliary embedding sheet 38 has a base mount 381, three fins 382 extending outward from the base mount 381, and a plurality of connecting portions 383 protruding from the bottom of the base mount 381 and having a dovetail shape. Each of the fins 382 has a plurality of recesses 384, can be compressed in the radial direction perpendicular to the axis L, and has the ability to bounce upward outward after being compressed. By the constrained position of the auxiliary embedding sheet 38 and the main body 31 before embedding the needle, the left and right deflections and tensions when embedding the needle subcutaneously in the living body can be avoided. The stability of the needle is enhanced and the pain of the living body and the patient is reduced. The sensor assembly 70 can be removably carried on the auxiliary embedding sheet 38. In other embodiments, the auxiliary embedding sheet 38 may be integrated with other components of the embedding module 30 or the sensor assembly 70 (not shown).

[0035] The fixing members 40 are respectively installed in the slide grooves 310 of the main body 31 and are slidable along the slide grooves 310. Each of the fixing members 40 has a pressing portion 41 corresponding to the closing portion 226, a supporting portion 42 opposite to the pressing, a first hook 43 disposed between the pressing portion 41 and the supporting portion 42, and a guiding portion 44 having a guiding inclined surface 441 disposed between the pressing portion 41 and the supporting portion 42.

[0036] The lower mount base 50 is detachably arranged with respect to the main body 31. The sensor assembly positioning portion on the lower mount base 50 includes a groove 78 configured such that the sensor assembly 70 can be buckled and positioned after being removed from the auxiliary embedding sheet 38. The lower mount base 50 has a base mount 51, an adhesive pad 52 fixed to the base mount 51, a buckle set 53 arranged on the base mount 51, a second hook 54 configured to detachably hook with the first hook 43, and a release layer 55 that is releasably attached to the adhesive pad 52 and can be removed before the manufacturing process.

[0037] The base mount 51 has a sensor assembly positioning portion 511 for positioning the sensor assembly 70. The sensor assembly positioning portion 511 may be an elastic sheet material having a closed upper surface 512 to prevent contamination of the sensor assembly 70. The buckle set 53 protrudes from the upper surface 512, has an inverted V-shaped cross section, and is elastic in at least one direction.

[0038] In another embodiment (see FIGS. 38 - 39), the buckle set 53 can be replaced with a double-sided sticker 56. The bottom of the sensor base 71 is adhered to the double-sided sticker 56, and the side wall of the sensor base 71 is sandwiched by the sensor assembly positioning portion 511. In another embodiment (see FIGS. 40 - 41), the elastic ring 514 of the sensor assembly positioning portion 511 and the sensor base 71 can be press-fitted to position the sensor assembly 70 on the lower mount base 50, and the buckle set 53 is no longer necessary. In another embodiment, the lower mount base 50 and the sensor assembly 70 can be pre-assembled (not shown).

[0039] To further explain the cooperative effects of the elements of the present invention, the use of technical means, and the expected effects, the following description is provided. It is considered that those skilled in the art can understand the present invention more deeply and specifically.

[0040] In the embodiment shown in FIGS. 3 and 4, when the first embodiment of the airtight drying container 100 of the present invention is assembled, the bottom cover 20 is hermetically closed with respect to the housing 11. In the unused state, the bottom cover 20 and the housing 11 can be hermetically combined by using the ring groove 224 embedded in the convex ring 115, and an airtight space is formed inside the casing assembly 10 (or the housing 11) and the bottom cover 20. In combination with the desiccant 60, the purpose of moisture resistance can be achieved, and the detection accuracy of the sensor 72 can be ensured. In another embodiment, the convex ring 115 may be disposed on the bottom cover 20, and the ring groove 224 may be provided on the housing 11.

[0041] In the stored state, the position of the needle-inserting sheet 33 in the displacement space 301 is adjacent to the main cover 32, and the locking portion 317 of the main body 31 and the buckle portion 335 of the needle-inserting sheet 33 form a constrained state. The needle-inserting sheet 33 is in the upper position. The first elastic element 34 is pre-compressed between the needle-inserting sheet 33 and the main cover 32 and includes a releasable elastic force. The restraint elements 323 are respectively inserted into the restraint grooves 336 and are configured to limit the restraint element 334 from radial deflection. The restraint element 334 is used to generate a latch on the needle-removing sheet 35 positioned with respect to the needle-inserting sheet 33, and as a result, the displacement of the needle-inserting sheet 33 in the insertion direction F is limited. There is a distance D between the main cover 32 and the lining piece 12.

[0042] In a state where the drying container 100 is completely assembled but not in use, the fixing member 40 abuts against the bottom cover 20. Specifically, the pressing portions 41 of the fixing member 40 are respectively restrained by the closing portions 226 of the bottom cover 20. Due to the installation method of the fixing member 40, the movement of the lining piece 12 is restricted, preventing the drying container 100 from accidentally falling and causing internal components to scatter or malfunction, thus preventing malfunction and enabling effective utilization. On the other hand, the support portion 42 of the fixing member 40 is also used to produce a supporting effect on the sensor base 71 of the sensor assembly 70. When the first hook 43 engages with the second hook 54, the lower mount base 50 is positioned relative to the main body 31.

[0043] As shown in FIGS. 5 - 6, when the bottom cover 20 is removed or opened and the drying container 100 is placed on the skin surface of a living body (indicated by a dashed line in the horizontal direction), as shown in FIGS. 7 - 8, the housing 11 can be operated to move the lining piece 12 downward, that is, in the direction toward the skin surface. During the process, the operating portion 123 of the lining piece 12 pushes the buckle portion 335 along its inclined surface, finally releasing the restraint state between the stop portion 317 and the buckle portion 335, and automatically releasing the force that presses the needle embedding sheet 33 in the embedding direction F by the first elastic element 34 in the embedding module, enabling the sensor 72 to be embedded under the skin of the living body. When the housing 11 is pushed downward by an external force, the lower end of the lining piece 12 drives the guide portion 44 of the fixing member 40. At the same time, the fixing member 40 moves away from the axis L, and by separating the support portion 42 from the support of the sensor base 71, the first hook 43 is also separated from the second hook 54 respectively. The use of the guide inclined surface 441 can make the movement of the lining piece 12 that drives the fixing member 40 very smooth.

[0044] During the embedding process, when the housing 11 is operated to drive the lining piece 12 downward, the distance D between the main cover 32 and the lining piece 12 disappears, and only the operating portion 123 on the inner peripheral surface 121 of the lining piece 12 slides along the inclined surface of the buckling portion 335. Since the external force applied to the housing 11 is not transmitted below the main body 31, the embedded living body does not feel the external force. The restoring force of the first elastic element 34 is configured not to act on the cover main body 12 during the pressing down of the cover main body 12. After the user presses the lining piece 12, since the operating portion 123 is caught by the lower part of the main body 31, the user cannot raise the lining piece 12 without feeling vibration or noise. As shown in FIGS. 7 to 8, at this point, the restraint element 323 of the main cover 32 and the limiting groove 336 of the needle embedding sheet 33 are still in a restrained state, and the needle extraction restraint structure is not released. As shown in FIGS. 8 to 10, after the bottom cover 20 is removed or opened, during the embedding process, when the lower mounting base 50 is separated from the sensor assembly 70 and is embedded by the force that the detachable module is released by the embedding module 30, the sensor assembly 70 is assembled to the lower mounting base 50, and the sensor 72 is embedded under the skin of the living body.

[0045] In the embodiments shown in FIGS. 3 to 10, the main cover 32 of the embedding module 30 is an individual component. Those skilled in the art can combine the devices according to the drawings. For example, according to different embodiments, as shown in FIGS. 36 to 37, the operation processes of automatic needle embedding and automatic needle extraction are similar to those of the previous embodiments. The lining piece 12 may be designed to have the function of the main cover 32. Therefore, the main cover 32 does not need to be held as an individual component, and the main body 31 and the lining piece 12 are connected to each other. The embedding module 30 includes a main body 31 connected to the lining piece 12, and the main body 31 and the lining piece 12 constitute a displacement space 301.

[0046] The main body 31 has a pair of latch portions 315 that can be respectively engaged with each locking portion 124, a needle embedding seat 33 that removably forms a restraint with respect to the lining piece 12 and is movable within a displacement space 301 between the main body 31 and the lining piece 12, a first elastic element 34 which is a pre-compressed spring and is disposed between the needle embedding seat 33 and the lining piece 12, a needle extraction seat 35 that can maintain the restraint on the needle embedding seat 33, and a second elastic element 37 that is pre-compressed between the needle embedding seat 33 and the needle extraction seat 35. There is at least one operating portion 123 on the inner peripheral surface of the lining piece 12. The needle embedding seat 33 can be driven by the operating portion 123 and has a buckle portion 335 that is detachably disposed within the main body 31. The buckle portion 335 of the needle embedding seat 33 that resists against the stop portion 317 of the main body 31 forms an operating restraint structure between the needle extraction seat 35 and the main body 31.

[0047] In another embodiment, as shown in FIGS. 34 to 35, since the housing 11 has technical features including the lining piece 12 and the main cover 32, there may be cases where even a separate lining piece 12 and main cover 32 are not required. The embedding module is coupled to the housing 11 and includes a main body 31 that forms a displacement space 301 together with the housing 11, a needle embedding seat 33 that removably forms a restraint with respect to the housing 11 and is movable within the displacement space 301 between the main body 31 and the housing 11, a first elastic element 34 which is a pre-compressed spring and is disposed between the needle embedding seat 33 and the housing 11, a needle extraction seat 35 that can maintain the restraint on the needle embedding seat 33, and a second elastic element 37 that is pre-compressed between the needle embedding seat 33 and the needle extraction seat 35.

[0048] In another embodiment, as shown in FIGS. 32-33, the housing 11 and the lining piece 12 are integrally formed to constitute the casing assembly 10. The embedding module is coupled to the casing assembly 10 and includes a main body 31 that forms a displacement space 301 together with the casing assembly 10, a needle embedding sheet 33 that removably forms a restraint with respect to the casing assembly 10 and is movable within the displacement space 301 between the main body 31 and the casing assembly 10, a first elastic element 34 that is a pre-compressed spring disposed between the needle embedding sheet 33 and the casing assembly 10, a needle extraction sheet 35 that can maintain the restraint with respect to the needle embedding sheet 33, and a second elastic element 37 that is pre-compressed between the needle embedding sheet 33 and the needle extraction sheet 35.

[0049] As shown in FIGS. 9-10, when the first elastic element 34 of the embedding module 30 releases force, the needle embedding sheet 33 is pushed out away from the main cover 32, automatically releasing the restraint between the restraint element 323 of the main cover 32 and the limiting groove 336 of the needle embedding sheet 33. At this time, while the housing 11 is being pushed down, the limiting element 334 keeps the needle extraction sheet 35 in position relative to the needle embedding sheet 33.

[0050] As shown in FIGS. 11-12, due to the separation of the restraint element 323, the limiting element 334 that initially held the needle extraction sheet 35 in position relative to the needle embedding sheet 33 can no longer hold itself in the initial position and deviates in the direction of the limiting groove 336. As a result, the needle extraction sheet 35 is released from the restraint of the needle embedding sheet 33, and the restraint on the movement of the needle extraction sheet 35 in the needle extraction direction R is released. Therefore, at this time, the second elastic element 37, which has a spring load applied between the needle embedding sheet 33 and the needle extraction sheet 35, can release its elastic force and move the needle extraction sheet 35 in the needle extraction direction R. Thus, the needle 362 that has just completed the embedding procedure can be immediately withdrawn, completing the continuous embedding and extraction operations.

[0051] The first and second elastic elements 34, 37 can be made of, for example, a coil spring or a pneumatic / pneumatic element. Due to the instantaneous elastic release of the two pre-compressed elastic elements 34, 37, the needle insertion and extraction are completed. Therefore, by using an automatic mechanism, the present invention can implant a sensor subcutaneously from an implanting device stored in a container, complete the needle insertion and extraction operations in a very short time, without causing discomfort to the person being implanted, and the living body does not feel pain even after the implantation operation is completed. Since the user does not feel the reaction force of the first elastic element 34 when pressing the housing 11, the smoothness of the automatic needle insertion / extraction process is improved, and the time to complete the automatic needle insertion / extraction operation is 100 milliseconds (ms) or less, 50 ms or less, 8 ms, 6 ms, 4 ms, or 2 ms or less.

[0052] Also, according to the present invention, after an external force is applied to the upper wall 111 of the housing 11, operations such as unlocking, needle insertion, and needle extraction can be continuously completed. During the operation, the user can complete the implantation without releasing the hand from the housing 11, and the implanting device functions by implanting an elastic needle rather than being pressed down by the user's hand. Therefore, the implanting device of the present invention can effectively solve the problem that in the conventional method, the proficiency of the user's operation is low, which affects the smoothness of implantation and needle extraction. Figures 13 to 14 show that the needle 362 is completely retracted into the accommodation space 14 of the lining piece 12 after the needle extraction process, more specifically, inside the auxiliary implanting sheet 38, preventing the sharp needle 362 from being exposed outside the housing opening and causing an accident.

[0053] Figures 15 - 16 show how the bottom cover 20 is recombined after use. After the embedding is completed, the user can easily combine the bottom cover 20 and the housing 11 using the positioning pieces 227 on the bottom cover 20 and the mating part 116 at the bottom opening of the housing 11 to achieve accurate alignment and foolproof purposes. Also, the dry airtight storage device 100 can be used as a waste storage means. The used lower base mount 50 can be removed and stored in the original dry airtight storage device 100, so that the user can discard it in accordance with medical waste disposal requirements.

[0054] As shown in Figures 17 - 19, another embodiment of the dry airtight container according to the present invention is different from the first embodiment in that a protective ring 80 is added and the protective ring 80 is sleeved on the bottom of the housing 11. Since the lower mount base 50 is disposed inside the lower end of the protective ring 80 before embedding, when the lower end of the protective ring 80 abuts against the skin surface of the living body, the lower mount base 50 is not in contact with the skin surface. The user can move the embedding device to the position to be implanted, and then a trigger operation of pushing down the casing assembly 10 (or the housing 11) is executed (as shown in Figures 20 and 21), and the housing 11 is pushed down. After embedding, by applying force, the protective ring 80 can be retracted relative to the casing assembly 10 (or the housing 11), and then the lower base mount 50 is adhered to the skin surface. Therefore, using the protective ring 80 of this embodiment, the skin position required before the needle embedding operation can be adjusted, which is very convenient in use.

[0055] As shown in FIGS. 22 to 26 (for convenience of explanation, FIGS. 22 to 26 are only shown as simplified diagrams), the drying container 100 of the present invention integrated with the embedding device and the sensor has a housing 11 and a bottom cover 20, and forms an airtight coupling structure in an airtight state inside. The desiccant 60 can be arranged at any appropriate position inside the drying container. Also, in one embodiment, the desiccant is arranged on the inner peripheral surface of the housing 11 or the outer peripheral surface of the lining piece 12. At least one component related to the peripheral surface or the embedding module 30 is integrally formed with the desiccant 60, or is composed of an accommodation space for arranging the desiccant 60 (as shown in FIGS. 22 and 23), or the sensor assembly 70 has the desiccant 60 (not shown), or, as shown in FIG. 25, a desiccant layer 62 is formed on the inner peripheral surface of the housing 11 or the bottom cover 20, or an accommodation space for arranging the desiccant 60 is arranged (not shown). This keeps the inside of the drying container in a dry state, prevents the sensor assembly 70 from getting wet, especially prevents the chemical reagent 720 of the sensor 72 from deliquescing (as shown in FIG. 31), and ensures the detection accuracy of the sensor 72. The chemical reagent 720 includes, for example, at least one analyte-responsive enzyme 726 and a polymer film layer 728.

[0056] In another embodiment, as shown in FIGS. 25 and 26, the lower base mount 50 further has a tearing element 23 attached to the chassis portion 21. The tearing element 23 is connected to a release layer 55 on the adhesive pad 52. When the container is opened (i.e., when the bottom cover 20 is removed), the release layer 55 is torn together with the tearing element 23, and as a result, the user can peel off the release layer 55 and expose the adhesive pad 52 during the embedding. This helps to improve the adhesion of the adhesive pad 52 to the skin.

[0057] In another embodiment, the sensor 72 may be designed to have a specific rigidity, and thus, it is not necessary to provide the needle embedding piece 36, and the embedding module 30 does not need to include a needle extraction device.

[0058] Furthermore, referring to FIG. 27, the operation method of the embedding device according to the present invention can be described as follows.

[0059] As shown in FIGS. 3 and 4, the housing 11 is combined with the bottom cover 20 to form an accommodation space 14 inside. The embedding module 30 is disposed within the accommodation space 14. The needle embedding sheet 33 and the main body 31 are in a trigger restraint state. The bottom cover 20 restrains the fixing member 40 under unexpected situations such as accidental dropping or dropping to the ground, preventing the change from the first operation state (storage state instead of embedding) to the second operation state (embedding state).

[0060] As shown in FIGS. 5 and 6, the user can remove the bottom cover 20 from the bottom of the housing 11 to release the restraint on the fixing member 40 and place the lower base mount 50 on the skin surface of the living body. In some embodiments, the bottom cover 20 is opened without being removed from the housing 11 during the embedding process.

[0061] As shown in FIGS. 7 to 12, the user can press the housing 11 to release the trigger restraint and cause the embedding module 30 to shift from the first operation state to the second operation state. When the embedding module 30 shifts to the second operation state, the sensor assembly 70 is disposed on the lower base mount 50, the needle (or sharp needle) 362 is embedded in the subcutaneous portion, and the needle embedding process is completed. As shown in FIGS. 13 and 14, during the needle extraction process, the embedding module 30 moves toward the position of the first operation state, and thus the needle 362 is retracted into the housing 11 without being exposed to the outside.

[0062] As shown in FIGS. 15 and 16, the bottom cover 20 is re-coupled to be coupled to the housing 11.

[0063] In particular, in the assembly order of the components of the present invention, the first elastic element 34, the needle extraction sheet 35, the second elastic element 37, and the needle embedding sheet 33 are pre-attached between the main cover 32 and the main body 31. The needle embedding piece 36 is finally placed between the auxiliary embedding sheet 38 and the sensor assembly 70. The needle embedding piece 36 is used to couple with the needle extraction sheet 35, whereby the sensor assembly 70 and the embedding module 30 form a clutch design, not only greatly improving the assembly yield, but also effectively reducing the cost of the sensor assembly 70.

[0064] As shown in FIGS. 1, 28A, 28B, and 29, the method for assembling the drying container 100 of the present invention is such that after the components of the embedding module 30 are assembled, the housing 11 is installed on the embedding module 30. At this time, the sensor assembly 70 is pre-fastened inside the embedding module 30 via the auxiliary embedding sheet 38, and finally, the bottom cover 20 is combined with the housing 11. In other words, the present invention does not require an operation of gripping the sensor assembly 70 on the lower base mount 50 by the embedding module 30. The above method for assembling the drying container 100 is basically assembled in a factory, but is not limited to being assembled by medical personnel or users by dividing and embedding the embedding module 30. When the user wants to use the device, the user only needs to simply operate the embedding device, such as pressing the drying container. The sensor assembly 70 on the lower mount base 50 is installed through the embedding process, and the adhesive pad 52 of the lower mount base 50 attaches the lower mount base 50 to the skin surface.

[0065] Figures 28A and 28B show that after the sensor 72 is embedded under the skin surface P of the living body, the sensor assembly 70 and the lower mount base 50, which are simultaneously arranged on the skin surface P of the living body, need to be equipped with the transmitter 90 to operate. The transmitter 90 is used to process the physiological signals measured by the sensor 72 and enable the signals to be transmitted externally. Figure 28A shows that the transmitter 90 is not attached to the lower mount base 50, and the upper dotted-line contour in Figure 28B shows the transmitter 90 attached to the lower mount base 50 in the form of an upper cover. In order to reduce the number of components embedded during the embedding process and reduce the load on the drying container, the detachable module of the present invention does not include a transmitter. The separately arranged transmitter 90 and sensor assembly 70 can improve the production yield of the device to ensure that the electronic components are not damaged by the sterilization process.

[0066] Referring to FIGS. 42 and 43, both are regarded as schematic cross-sectional views along one of the y-y lines of the embodiment shown in FIG. 2B, but the housing 11 and the bottom cover 20 in FIG. 42 are separated. The convex ring 115 beside the bottom opening 111' under the housing 11 is used to combine with the ring groove 224 of the bottom cover 20, and the bottom cover 20 and the housing 11 can be firmly engaged by hard interference. In FIG. 42, the bottom cover convex ring 224' is formed near the bottom cover opening 20' and abuts against the convex ring 115, and the housing ring groove 115' is formed in the housing 11 to accommodate the bottom cover convex ring 224'. In FIG. 43, the bottom cover convex ring 224' is arranged on the convex ring 115, and the convex ring 115 is also arranged in the ring groove 224, thereby achieving the effect of hard interference and preventing the bottom cover 20 from being separated from the bottom opening 111'. The convex ring 115 and the housing ring groove 115' shown in FIGS. 42 and 43 face outward. That is, they face the opposite side of the bottom opening 111'. On the other hand, the ring groove 224 and the bottom cover convex ring 224' face inward. That is, they face the bottom cover opening 20'. Therefore, when removing the bottom cover 20 from the bottom opening 111', the bottom cover convex ring 224' needs to pass through the convex ring 115. That is, it is necessary to break through the obstacle of the convex ring 115. Furthermore, the leak-proof ring 13 (see FIG. 4) can be additionally provided in the housing ring groove 115'. This is not only firmly sealed by the housing ring groove 115' but also firmly sealed by the convex ring 224' to achieve the effects of airtightness and moisture-proofness. In another embodiment, the convex ring 115 is arranged on the bottom cover 20, and the ring groove 224 is on the bottom opening 111'.

[0067] As can be seen from FIGS. 44 and 45, the side surface of the housing 11 has a recess 118 and a flange 118'. The bottom cover 20 has an operating portion (force applying portion) 228, and the opposite end naturally serves as a force supporting portion 228'. The force supporting portion 228' provides support in the process when the bottom cover 20 is opened. The principle of force application is that the distance D' from the force supporting portion 228' to the operating portion 228 and the applied force F' form a moment of force. That is, the "moment of force" is equal to the value obtained by multiplying the "distance D'" by the "applied force F'". Therefore, by controlling the distance D' and the applied force F', the size of the housing 11 and the magnitude of the force required to open the housing 11 can be adjusted.

[0068] For example, in order to enhance the airtightness of the embedding device, in principle, the better the fit between the bottom cover 20 and the housing 11, the better, but the force required to open the bottom cover 20 becomes excessive. It is very inconvenient to use. If the user applies excessive force to open the bottom cover 20, the embedding device is often thrown out of the hand, damaging the internal objects. Taking the embedding device of the present invention as an example, the inventor considered the cover opening moment design of the embedding device in consideration of both easy opening and airtightness of the device. Considering that the container can accommodate different forms or different sizes of needle embedding mechanisms and / or needle extraction mechanisms, the distance D' from the operating portion 228 to the force supporting portion 228' being 15 to 100 mm is a very appropriate distance, and the preferred range is 30 to 80 mm. Regarding the applied force F', a larger range is 0.2 to 10 kgf, and a general range is 0.5 to 6 kgf. If you want to open the bottom cover 20 with a smaller force, the range is within 1 to 3 kgf, or the opening force can be 2 kgf or less.

[0069] Therefore, depending on the range of the applied force F' and the arrangement and combination of the range of the distance D' from the support portion to the force application portion, the force moment is approximately 3 to 1000 kgf-mm, a more appropriate range is 6 to 800 kgf-mm. An even better range is 15 to 480 kgf-mm, and a much better range is 30 to 240 kgf-mm. When it is necessary to open the container with a small force, the moment is about 200 kgf-mm or less. If the size of the bottom opening remains unchanged, the applied moment can be adjusted by adjusting the size of the operation portion 228. Since the operation portion 228 is a convex portion, the length L' of the convex portion is 1 millimeter or more.

[0070] As shown in FIGS. 46A to 46D, FIGS. 46A to 46D are schematic views of the operation of continuously opening the bottom cover 20 according to an embodiment of the present invention. When the operation portion 228 is operated, the side opening op between the housing 11 and the bottom cover 20 is formed such that the bottom cover 20 moves away from the bottom opening 111' of the housing 11 due to the applied moment, and the housing 11 becomes operable. The embedded module 30 can embed a part of the sensor 72 subcutaneously and measure physiological signals. Further, the bottom cover 20 is provided with a positioning piece 227 for mating with the mating portion 116 (see FIGS. 1 and 2B) of the housing 11. The bottom cover 20 has a center point 20C. The first virtual line L1 extends from the center point 20C to the mating portion 116 (positioning piece 227), and the center point 20C extends the second virtual line L2 toward the operation portion 228. The first and second virtual lines L1 and L2 form an angle 20A of 5 to 180 degrees.

[0071] Referring to FIGS. 46A to 46D, FIGS. 46A to 46D are schematic views of a continuous operation of opening the bottom cover 20 of another embodiment of the present invention. A series of continuous operation diagrams are based on a side view of the housing 11 of the present invention combined with the upward bottom cover 20. First, referring to FIG. 46A, FIG. 46A shows that the bottom cover 20 has an operation portion 228, and an end portion opposite to the operation portion 228 forms a force support portion 228'. When the user attempts to open the bottom cover 20, a force F' can be applied in a direction away from the housing 11 at the operation portion 228. In one embodiment of the present invention, the bottom cover 20 is formed of a relatively elastic material. Since the desiccant 60 is present in the housing 11, when moisture is absorbed, the air pressure in the housing 11 slightly decreases so as to be lower than the atmospheric pressure, and the atmospheric pressure provides an additional pressure to closely fit the bottom cover 20 to the housing 11.

[0072] In FIG. 46A, when the operation portion 228 is pushed by the applied force F' and a lateral opening (or partial lateral opening) op is not yet formed between the bottom cover 20 and the housing 11, the first abutment R-A is disposed near the root portion 228r, and the outwardly projecting operation portion 228 can provide an additional force arm with respect to the applied force F' to increase the moment for opening the bottom cover 20. When a slight separation occurs between the bottom cover 20 and the housing 11, the balance between the internal air pressure and the external air pressure of the housing 11 can be achieved by the inflow of outside air, making it easier for the bottom cover 20 to be detached from the housing 11.

[0073] Referring to FIGS. 46A through 46D, when the force F' applied to the operation unit 228 is continuously applied, the side opening op gradually expands, and the resistance force generated by the combination of the bottom cover 20 and the housing 11 moves from the first abutment R-A to the second abutment R-B, or, in other words, moves from near the root portion 228r of the operation unit 228 to the force support portion 228'. As shown in FIG. 46B, since the second abutment R-B is away from the operation unit 228, the force arm is long, the moment is large, and the opening operation becomes easy. Similarly, in FIG. 46C, since the distance between the third abutment R-C and the operation unit 228 is farther than the distance between the second abutment R-B and the operation unit 228, the force arm is longer and the opening application is much easier. Finally, in the situation of FIG. 46D, the bottom cover 20 is about to be fully opened. At this time, the fourth abutment R-D substantially coincides with the force support portion 228', and the overall length of the force arm is close to the diameter of the bottom cover 20 and the length of the operation unit 228. It should be noted that the deformation of the bottom cover 20 in FIGS. 46A to 46D is slightly exaggerated. Actually, when the bottom cover 20 is made of a harder material, the deformation when the bottom cover 20 is opened is very small. Nevertheless, the change in the force support portion 228' is still similar to that shown in FIGS. 46A to 46D.

[0074] Referring to FIG. 47, with the user holding the housing 11 in one hand and applying a pulling force F' to the operation part 228 with the other hand, the bottom cover 20 is opened, and a side opening op is formed between the bottom cover 20 and the housing 11. The holding method of the housing 11 can be selected according to the convenience of the user. Since the direction of the force received by the force application part 228 is away from the bottom opening 111', during the opening process of the bottom cover 20, due to the clamping between the convex ring 115 and the ring groove 22, the applied force F' tends to move in the direction of the force F' applied to the housing 11. However, the user needs to hold the housing 11 to resist this tendency so that the housing 11 does not accidentally pop out. The recess 118 (see FIG. 29) of the housing 11 of the present invention is configured so that the user's hand can hold it firmly, and since the flange 118' stops the hand, the housing 11 is not easily detached from the hand along the axial direction of the housing 11.

[0075] Referring to FIGS. 48 and 49, it can be seen that the sensor 90 is disposed on the lower mounting base 50, and the second positioning portion 90' of the sensor 90 fits with the first positioning portion 51' of the lower mounting base 50. This also has an absolutely reliable effect, that is, when the mounting direction of the sensor 90 is opposite to the mounting direction in FIG. 48, the sensor 90 cannot be disposed on the lower mounting base 50. The sensor assembly 70 is disposed on the sensor assembly positioning portion 511 during the embedding process. Referring to FIG. 28B, the signal sensing end 721 of the sensor 72 is embedded subcutaneously, and the other end of the sensor 72 is the signal output end 723 exposed on the upper portion of the sensor base 71. When the transmitter 90 is covered by the lower mounting base 50, the signal output end 723 is electrically connected to the electrical connection port 921 of the input portion 92 of the transmitter 90. Next, the transmitter 90 wirelessly transmits the physiological signal measured by the sensor 72. The transmitter 90 is fixed to the lower mounting base 50 by the coupling of its sensor fixing groove 91 and the sensor fixing buckle 57 of the lower mounting base 50. The adhesive pad 52 (see FIG. 48) is provided at the bottom of the lower mounting base 50, and the sensor module (or the detachable module including the lower mounting base 50 and the sensor assembly 70) is fixed to the skin surface P of the living body via the adhesive pad 52.

[0076] FIGS. 50 and 51 show that the second operation portion 228a is a recessed structure extending along the outer side wall of the bottom cover 20, and the recessed structure provides greater friction by the finger to facilitate the user to remove the bottom cover 20 from the bottom opening 111' in a similar manner. The connection relationships among elements such as the convex ring 115, the housing ring groove 115', and the ring groove 224 are the same as those in the figure of FIG. 42, and there is no need to repeatedly show them here.

[0077] Referring to FIGS. 52 and 53, FIGS. 52 and 53 show that the third operation portion 228b has a concave structure, providing a relatively large frictional force to the finger and facilitating the user to remove the bottom cover 20 from the bottom opening 111' as well. Different from the embodiments of FIGS. 51 and 42, the convex ring 115 of the housing 11 and the housing ring groove 115' face inward, that is, they point to the center of the bottom opening 111'. The ring groove 224 and the convex ring 224' of the bottom cover 20 face outward, that is, they face the convex ring 115 and the housing ring groove 115'. In the embodiment of FIG. 53, it can be understood that the ring groove 224 and the bottom cover convex ring 224' are surrounded by the convex ring 115 and the housing ring groove 115'. Therefore, when the user grips the third operation portion 228b, the bottom cover 20 is slightly recessed inward, so that the ring groove 224 and the convex ring 115 are separated from the contact state, creating a gap for air to flow in. As a result, the housing 11 can no longer maintain negative pressure. That is, since the air pressure inside and outside the housing 11 is balanced, the user can easily remove the bottom cover 20.

[0078] Referring to FIGS. 54 and 55, FIGS. 54 and 55 disclose that the outer wall 228c of the bottom cover 20 of the bottom cover serves as a direct operation portion. That is, the user may apply a force to the bottom cover 20 in a direction away from the housing 11 while directly applying a force to the outer wall 228c of the bottom cover to open the bottom cover 20. Since the entire circumference of the outer wall 228c of the bottom cover can be used as an operation portion, when the user selects a position on the outer wall 228c of the bottom cover to apply a force, the opposite side of this position can be regarded as the force support portion 228'.

[0079] Referring to FIG. 56, FIG. 56 is a schematic perspective view after the bottom cover according to one embodiment of the present invention is removed from the housing. As an example, only the protruding operation part 228 is taken up, but the present invention is not limited thereto. The embodiments of FIGS. 50 to 53 are substantially the same when the bottom cover 20 is opened. When the bottom cover 20 is separated from the bottom opening 111', it can be seen that the adhesive pad 52 has an adhesive surface and there is a lower mounting base 50 thereunder. The convex ring 115 can be seen near the bottom opening 111'. The ring groove 224 can be seen from the bottom cover opening 20' of the bottom cover 20, and the positioning piece 227 is also removed from the fitting part 116. Next, the user can press the adhesive pad 52 against the skin surface P of the living body where the sensor 72 (see FIG. 49) is placed and operate the housing 11 to achieve the effect of arranging the sensor.

[0080] Combine the schematic diagrams of FIGS. 56 to 57 and FIGS. 58 to 61 of the operation flow for assembling the physiological signal monitoring device on the surface of the living body. FIG. 58 shows a schematic diagram in which the user holds the housing 11 and attaches the adhesive pad 52 toward the surface P of the living body. In FIG. 58, the bottom of the embedded module 30 faces the skin. The starting mechanism of the embedded module 30 of the present invention has been described before and need not be repeated. When the user applies a pressing force to the housing 11, the pressing force moves the housing downward, removes the sensor module 70 from the embedded module 30, and embeds the signal sensing end 721 of the sensor 72 under the skin P of the living body. For the embedding process, also refer to FIGS. 7 to 10.

[0081] FIG. 59 shows the step of removing the embedding device while leaving the sensor module 70 on the surface P of the living body. In the above-mentioned embedding process, since the sensor module 70 is pre-attached to the base 50, the two can be regarded as one item.

[0082] Figure 60 shows that after the aforementioned steps are completed, the user places the transmitter 90 on the base 50, and the signal output end of the sensor 72 (sensor base 71) is electrically connected to the electrical connection port 921 of the transmitter 90. The outer edge 95 of the transmitter 90 and the inner edge 59 of the base 50 can be combined by a configuration match such as a concave-convex fit. The user can know the relative relationship between the transmitter 90 and the base 50 by using the positioning portion 90' of the sensor 90 and the positioning portion 50' of the base 50. According to a preferred embodiment, the transmitter 90 is inserted vertically into the base 50 from above the base 50.

[0083] Referring to FIG. 61, after the above physiological signal monitoring device 400 is placed on the body surface P, wireless communication can be established between the sensor 90 and the user device 200 loaded with application software such as transmitting messages to each other via a Bluetooth (registered trademark) system. The physiological signal (such as a physical or chemical signal related to the glucose concentration in the living body) sensed by the sensor 72 from the subcutaneous part of the living body through the signal sensing end 721 can be converted into a voltage or current signal, interpreted and processed by the transmitter 90, and transmitted to the user device 200 via wireless communication. Commonly used user devices 200 include smartphones, physiological signal transceivers, or blood glucose meters, etc. In order to display and analyze data, an appropriate application program can be loaded, the collected data can be saved, and a medical unit or a home care unit for further applications can be provided.

[0084] Figures 62 and 63 show two other exemplary embodiments of the drying and airtight storage container of the present invention. The embodiment shown in Figure 62 incorporates the features of the housing 11 and the main cover 32 into the lining piece 12. In the embodiment shown in Figure 63, the features of the housing 11 are incorporated into the lining piece 12 to provide the accommodation space 14 for accommodating the embedded module 30. When the sealing element 300 in the figure is arranged at the bottom opening of the lining piece 12, an airtight space is formed by the lining piece 12 and the sealing element 300, and the devices contained in the airtight space can be stored for a long time.

[0085] Therefore, according to an embodiment of the present invention for assembling a physiological signal monitoring device on the surface of a living body, referring to the embodiment shown in Figure 62 and then referring to the process steps similar to those shown in Figures 56 to 62, it can be understood as (a) removing the sealing element 300 from the housing (lining piece 12) to expose the adhesive pad 52 from the bottom of the housing, (b) attaching the adhesive pad 52 to the body surface P while holding the housing, and (c) applying a pressing force to the housing to remove the sensor module 70 from the embedded module 30 and embed the signal sensing end 721 under the body surface P. Since the subsequent assembly and operation procedures have been described in detail before, there is no need to repeat them.

[0086] FIG. 64 shows another exemplary embodiment of the drying and airtight storage container of the present invention. The sealing body 400 and the sealing element 300 are used to form an airtight container that provides an accommodation space for accommodating an embedding device (not shown). After referring to the embodiment shown in FIG. 64, referring to the same process steps as those shown in FIGS. 56 to 61, (a) removing the airtight container from the embedding device to expose the adhesive pad 52 from the bottom of the embedding device, (b) while holding the housing 11, attaching the adhesive pad 52 to the body surface P, and (c) applying a pressing force to the housing 11 to remove the sensor module 70 from the embedding module 30 and embed the signal sensing end 721 under the surface P of the living body. Since the subsequent assembly and operation procedures have been described in detail before, there is no need to repeat them. The sealing body 400 can be one of a blister, an aluminum foil package, and a drying container.

[0087] The operation process of the embedding device (sensor carrier container) of the present invention and the assembly method of the transmitter further provide a relatively quick and simple installation method for users, facilitating the user to quickly complete the assembly of the physiological signal monitoring device on the body surface.

[0088] The main effects of the present invention are summarized as follows.

[0089] (1) In the drying airtight container of the present invention, the bottom cover and the housing are hermetically combined, the bottom cover and the housing form an airtight space, and by combining with a desiccant, the deliquescence of the chemical reagent on the sensor in the sealed space can be avoided, ensuring the detection accuracy of the sensor. Furthermore, a drying display unit can be added outside or inside the housing (the drying display unit may be a drying display material). Since there is a transparent or translucent part on the opposite side of the housing, the user can confirm whether the sensor is wet by the drying display unit. The installation method and position of the desiccant are not limited by the form disclosed in the embodiment.

[0090] (2) The airtight coupling method of the airtight container according to the present invention is based on the coupling method of the convex ring and the ring groove. When the container is closed, the moisture absorption rate inside the container is 200 mg or less per day, 50 mg or less per day, 1 mg or less per day, 0.5 mg or less per day, 0.3 mg or less per day, or 0.25 mg or less per day, and the storage conditions of the container are at a relative humidity of 0 to 100% and a temperature of 0 to 45°C, or at a relative humidity of 0 to 100% and a temperature of 0 to 40°C, or at a relative humidity of 10 to 90% and a temperature of 4 to 30°C. The effect can be maintained for at least two years or at least one year during storage, and it has a good airtightness effect, is easy to open, and is resistant to negative pressure. The present invention can achieve the effect of airtight coupling by the method of hard interference.

[0091] (3) The detachable module of the present invention does not include a transmitter. The transmitter and the sensor assembly are arranged separately so that the electronic components of the transmitter are not damaged due to the high temperature or chemical environment required for the sterilization process. Therefore, the production yield of the transmitter can be improved.

[0092] (4) The embedded module of the present invention mainly uses the elastic force provided by two pre-compressed elastic members to make the embedded module an automatic mechanism to sequentially use the first and second elastic members. Since the elastic force for inserting and removing the needle is provided by the embedded module, it is not necessary to rely on the force from the user's hand to push the needle. There is also an effect of completing the automatic needle insertion and needle removal operations by pressing the housing assembly in one step. In other words, the present invention can greatly improve the certainty of operation and effectively solve the problem of the prior art that the smoothness of needle insertion and needle removal is affected by the proficiency of the user during use.

[0093] (5) When the overall assembly of the dry airtight container according to the present invention is completed and has not been used yet, the restraint portion formed by the contact portion of the bottom cover and the engagement portion of the housing can avoid accidental needle insertion due to accidental dropping of the container during transportation.

[0094] (6) The needle embedding piece is pulled out and exposed at a position between the needle embedding sheet and the auxiliary embedding sheet so as not to be exposed, and the effect of hiding the needle embedding piece after use can be obtained.

[0095] (7) The main cover compresses and stacks the first elastic element so that the first elastic element does not directly contact the casing assembly. Therefore, the operator does not need to resist the elastic force from the first elastic element when the casing assembly is pushed down for the needle embedding operation, and the embedding operation becomes easier.

[0096] (8) Due to the restraint relationship between the auxiliary embedding sheet and the main body before the needle is embedded, left - right displacement and pulling when the needle is embedded under the skin of the living body can be avoided. The stability of the needle stroke is improved, and the pain of the living body and the patient is reduced.

[0097] (9) After the user manually presses the casing assembly, the embedding module is triggered, and the elastic force provided by the first and second elastic elements is automatically used. Thus, the time for sequentially embedding and extracting the needle is 100 milliseconds or less, 50 milliseconds or less, 8 milliseconds or less, 6 milliseconds or less, 4 milliseconds or less, or 2 milliseconds or less.

[0098] (10) In the assembly order of the components of the present invention, the first elastic element, the needle extraction sheet, the second elastic element, and the needle embedding sheet are pre - attached between the main cover and the main body, and the needle embedding piece is finally attached between the auxiliary embedding sheet and the sensor assembly. The needle embedding piece is used to couple with the needle extraction sheet. Thereby, the sensor assembly and the embedding module form a clutch design, which not only greatly improves the assembly yield but also effectively reduces the cost of the sensor assembly.

[0099] (11) The sensor assembly of the present invention is pre-assembled with the embedding module via an auxiliary embedding sheet, and finally, the bottom cover is combined with the housing. In other words, the present invention does not require an operation of gripping the sensor assembly on the lower mounting base by the embedding module.

[0100] (12) According to an embodiment of the present invention, a protective ring can be sleeved on the bottom of the housing. Since the lower base mount is disposed inside the lower end of the protective ring before the embedding operation, when the lower end of the protective ring hits the skin surface of the living body, the lower base mount does not contact the skin surface. The user can move the embedding device to the embedding position, and then a trigger operation of pushing down the casing assembly or the housing is executed. Therefore, with the protective ring of this embodiment, it can be adjusted to the required position, the needle embedding operation can be carried out, and it is very convenient to use.

[0101] (13) The outer surface of the bottom cover has a force-applying portion that protrudes from the outer surface adjacent to the brim. The presence of the force-applying portion makes it easier for the user to open and close the bottom cover. In addition, since a force-applying portion that controls the opening force to 2 kg (kgf) or less is provided, it is easy to open, strong against negative pressure, and can be quickly disassembled without much effort on the part of the user. The fitting between the positioning piece and the fitting portion provides a foolproof and alignment function to the user when operating to open and close the container.

[0102] (14) The bottom cover is provided with a tearing element that can help peel off the end of the release layer of the self-adhesive pad so as to realize the effect of peeling off the release layer simultaneously when the bottom cover is opened, and the user does not need to peel off the release layer with bare hands. Therefore, the risk of inaccurate detection data due to contamination of the sensor is reduced, and the problem that the contaminated adhesive pad causes a decrease in adhesive force is avoided.

[0103] (XV) The operation process of the embedding device (sensor carrier) of the present invention and the assembly method using the transmitter further provide a relatively quick and easy installation method for the user to facilitate the user to quickly complete the assembly of the physiological signal monitoring device on the body surface.

[0104] Through the above-described embodiments, the storage device and method capable of maintaining a dry state provided by the present invention should be a major innovation in the technical field. Obviously, the device and method of the present invention can achieve many effects that are difficult to expect in the prior art.

[0105] Although the present invention has been described with respect to what is presently considered to be the most practical and preferred embodiments, it is to be understood that the present invention need not be limited to the disclosed embodiments. On the contrary, various modifications and similar arrangements included within the spirit and scope of the appended claims are intended to be covered, and the broadest interpretation should be given so as to encompass all such modifications and similar structures.

Claims

1. 1. A method for assembling a physiological signal monitoring device to a body surface of a living subject, comprising: the physiological signal monitor is used to measure a physiological signal, and includes a sensor module and a transmitter, the sensor module being configured to be placed on the body surface by an implanted device; The physiological signal monitoring device comprises: the sensor module including a sensor for measuring the physiological signal and having a signal sensing end and a signal output end, a base for housing the sensor, and an adhesive pad disposed under the base and configured to attach the base to the body surface; a transmitter having a port for receiving the physiological signal; Equipped with The implanted device comprises: a housing having a bottom opening; an embedment module disposed within the housing and supporting the sensor module; a bottom cover removably coupled to the bottom opening; Including, The method comprises: (a) removing the bottom cover from the housing to expose the sticker through the bottom opening; (b) attaching the adhesive pad to the body surface while holding the housing; (c) applying a compressive force to the housing to detach the sensor module from the implantation module and implant the signal sensing end beneath the body surface; (d) removing the implanted device while leaving the sensor module on the body surface; (e) placing the transmitter on the base such that the signal output is electrically connected to the port.

2. 2. The method of claim 1, wherein step (c) comprises applying the pressing force to actuate the embedding module and releasing the actuation force to remove the sensor module from the embedding module and place the sensor on the base.

3. The method of claim 1 , wherein the compressive force is applied to a surface of the housing opposite the bottom opening.

4. the bottom opening has a convex ring disposed along an edge of the bottom opening; the bottom cover having an annular groove disposed along an edge of the bottom cover; The convex ring is mounted in the annular groove; The bottom cover has a side wall adjacent to the bottom opening and an operating portion configured on the side wall to support a force; A support portion is formed at an end portion opposite the operation portion, The method of claim 1 , wherein the distance between the operating portion and the support portion and the force form an operating moment, whereby a lateral peel is formed between the bottom cover and the housing, and the bottom cover peels off from the housing.

5. The method according to claim 4 , wherein the operating portion is a convex portion protruding from an outer wall surface of the bottom cover.

6. The method according to claim 4 , wherein the operating portion is a recessed portion recessed from an outer wall surface of the bottom cover.

7. The method of claim 4 , wherein the handling portion is an outer wall of the bottom cover.

8. The step (a) comprises: (a1) using a stress concentration state to induce partial lateral peeling between the bottom cover and the housing; The method of claim 4 , further comprising: (a2) continuously applying the force to the operating portion in a direction away from the housing to expand the partial side peeling.

9. the bottom opening has a first bevel structure disposed on a sidewall of the bottom opening; and the bottom cover has a second bevel structure mating with the first bevel structure.

2. The method of claim 1, wherein said step (a) comprises applying a torque to one of said housing and said bottom cover to remove said bottom cover from said housing.

10. The base has an inner edge; The method of claim 1 , wherein the transmitter has an outer edge configured to match the inner edge of the base such that the transmitter is configured to be placed on top of the base.

11. The method of claim 10 , wherein in step (e), the transmitters are disposed on the base along a vertical direction.

12. The method of claim 10 , wherein the inner edge of the base and the outer edge of the transmitter are matched in configuration.

13. 1. A method for assembling a physiological signal monitoring device to a body surface of a living subject, comprising: the physiological signal monitor is used to measure a physiological signal, and includes a sensor module and a transmitter, the sensor module being configured to be placed on the body surface by an implanted device; The physiological signal monitoring device comprises: the sensor module including a sensor for measuring the physiological signal and having a signal sensing end and a signal output end, a base for accommodating the sensor, and an adhesive pad connected to the base and configured to attach the base to the body surface; a transmitter having a port for receiving the physiological signal; Equipped with The implanted device comprises: a housing having a bottom opening; an embedment module disposed within the housing and supporting the sensor module; an airtight container that houses the embedded module and forms an airtight space; Including, The method comprises: (a) removing the airtight container from the embedding device to expose the adhesive pad from a bottom of the embedding device; (b) attaching the adhesive pad to the body surface while holding the housing; (c) applying a compressive force to the housing to detach the sensor module from the implantation module and implant the signal sensing end beneath the body surface; (d) removing the implanted device while leaving the sensor module on the body surface; (e) placing the transmitter on the base such that the signal output is electrically connected to the port of the transmitter.

14. 14. The method of claim 13, wherein the airtight container is at least one of a blister, an aluminum foil package, and a desiccant vial.

15. 1. A method for assembling a physiological signal monitoring device to a body surface of a living subject, comprising: the physiological signal monitor is used to measure a physiological signal, and includes a sensor module and a transmitter, the sensor module being configured to be placed on the body surface by an implanted device; The physiological signal monitoring device comprises: the sensor module including a sensor for measuring the physiological signal and having a signal sensing end and a signal output end, a base for housing the sensor, and an adhesive pad connected to the base and configured to attach the base to the body surface; a transmitter having a port for receiving the physiological signal; Equipped with The implanted device comprises: a housing having an accommodation space; an embedment module disposed within the housing and supporting the sensor module; A sealing element for sealing the storage space; Including, The method comprises: (a) removing the sealing element from the embedment module to expose the sticker from a bottom of the embedment module; (b) attaching the adhesive pad to the body surface while holding the housing; (c) applying a compressive force to the housing to detach the sensor module from the implantation module and implant the signal sensing end beneath the body surface; (d) removing the implanted device while leaving the sensor module on the body surface; (e) placing the transmitter on the base such that the signal output is electrically connected to the port of the transmitter.

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