Embedding Device

Abstract

To provide an embedding device which is sanitary and causes no pain capable of improving convenience for a user, and effectively maintaining a dry state of a physiological parameter sensor before transplantation while reducing manufacturing processes of the sensor and the embedding device.SOLUTION: An embedding device includes a housing 11, an embedding module 30, a removable module, and bottom part cover 20. The housing 11 includes a bottom opening. The embedding module 30 includes an embedding device and a staple extraction device. The removable module includes a sensor 70 that removably engages with the embedding module 30, and a base 50 on which the sensor 70 is attached. The bottom part cover 20 is removably coupled to the bottom opening so that the housing 11 and the bottom part cover 20 form a storage space together. The embedding module 30 and the removable module are stored in the storage space. The bottom part cover 20 includes an operation part for supporting force and a support part formed at an end part on the opposite side of the operation part.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 August 2, 2019, and Taiwanese Patent Application No. 109100992, filed January 10, 2020, the disclosures of which are incorporated by reference in their entireties herein. [Technical field]

[0002] The present invention relates to a container, and more particularly to a container for mounting a sensor and a method of operating the same. [Background technology]

[0003] Chronic diseases such as diabetes and chronic cardiovascular diseases are more common than ever in the world due to the lifestyle of people living in urban areas. Therefore, certain physiological parameters of patients with chronic diseases need to be monitored regularly to effectively control their condition, avoid deterioration and provide prompt treatment.

[0004] However, most physiological data needs to be obtained by in vivo methods. Also, multiple measurements need to be taken daily to monitor effectively. To avoid the discomfort of patients caused by multiple blood draws or extractions of bodily fluids, some practitioners use small sensing elements embedded in subcutaneous tissue for a relatively long time, so as to be fixed to the skin surface in correspondence with signal processing components. It can be used for days, does not need to be removed, and can collect and analyze data at any time, such as blood glucose levels, blood fats, cholesterol concentrations, or other measurements that provide physiological parameters, to provide instantaneous physiological data monitoring. A similar concept can be applied to embedding electronic devices such as chips into the skin of animals.

[0005] This type of physiological parameter measuring device is traditionally made by assembling the sensor and the implanted device separately due to the difficult manufacturing process. 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, whereas the implanted device does not require these steps.

[0006] According to conventional methods, such as the device and method 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 sanitary condition. 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 tears off the blister shell, opens the airtight container, assembles the sensor to the bottom of the implantation device, and finally places the sensor on the skin using the implantation device. Although the manufacturing process of such a device is relatively simple, the separate manufacturing process of the two devices increases the manufacturing cost. For the user, the implantation device and the sensor need to be assembled together before use, which is inconvenient and troublesome. In addition, in the description of the specifications of U.S. Patent Publication US20170188912 and U.S. Patent US8764657B2, the implantation device is opened by a cyclical method, and it usually takes at least one time, typically two to three times, to open completely, which is a problem of time.

[0007] Furthermore, the sensor implantation process can be essentially divided into two steps: needle implantation and needle extraction. If either of these steps are not completed quickly or inconsistently, it may cause pain or discomfort to the user. Summary of the Invention [Problem to be solved by the invention]

[0008] Therefore, several technical issues remain to be resolved, such as how to increase user convenience while reducing the manufacturing steps of the sensors and implanted devices, effectively maintain the dry state of physiological parameter sensors prior to implantation, and enable implantation in a hygienic and painless manner. [Means for solving the problem]

[0009] According to one aspect of the present invention, an implantation device for rapidly implanting a sensor subcutaneously for measuring a physiological signal of an analyte in a biological fluid of a living body is disclosed. The implantation device includes a housing, an implantation module, a detachable module, and a bottom cover. The housing has a bottom opening. The implantation module includes an implantation device and a needle removal device. The detachable module includes the sensor removably engaged with the implantation module and a base configured to mount the sensor. The bottom cover is removably coupled to the bottom opening such that the housing and the bottom cover together form a receiving space. The implantation module and the detachable module are received in the receiving space. The bottom cover has an operating portion configured to bear a force and a support portion formed at an end opposite to the operating portion. The distance between the operating portion and the support portion and the force form an operating moment, and a user causes a lateral separation between the bottom cover and the housing. After the bottom cover is separated from the bottom opening, the housing is manipulated to cause the implantation module to release the force, detach the detachable module from the implantation module, and implant a portion of the sensor subcutaneously to measure a physiological signal.

[0010] According to another aspect of the present invention, a physiological signal monitoring system for quickly assembling and measuring a physiological signal of an analyte in a living body is disclosed. The physiological signal monitoring system includes an implantation device and a transmitter. The implantation device includes a housing having a bottom opening, an implantation module including an implantation device and a needle removal device, and a detachable module including a sensor, a base, and a bottom cover. The sensor is removably partially embedded in the living body. The base is for the sensor to be placed on the base after the sensor is partially embedded in the living body. The bottom cover is removably coupled to the bottom opening such that the housing and the bottom cover together form a receiving space. The transmitter is coupled to the base after the sensor is partially embedded in the living body to transmit the physiological signal measured by the sensor. The bottom cover has an operating portion configured to support a force and a support portion formed at an opposite end of the operating portion, and the distance and force between the operating portion and the support portion form an operating moment, and after lateral separation between the bottom cover and the housing is initiated by the operating moment, the bottom cover moves away from the bottom opening, and the housing is placed under operating conditions to operate the embedded module, remove the detachable module from the embedded module, subcutaneously implant a portion of the sensor, and measure the physiological signal.

[0011] According to another aspect of the present invention, a physiological signal monitoring system for quickly assembling and measuring a physiological signal of a living body having a skin surface is disclosed, the physiological signal monitoring system includes a housing having a bottom opening, a mechanism module disposed in the housing, a sensor module removably disposed in the mechanism module to be attached to the skin surface, and the bottom cover removably coupled to the bottom opening such that the housing and the bottom cover together form a storage space, the mechanism module and the sensor module are accommodated in the storage space, the bottom cover has an operating part configured to bear a force and a support part formed at an end opposite to the operating part, a distance between the operating part and the support part and the force form an operating moment, and after a lateral separation between the bottom cover and the housing is initiated by the operating moment, the bottom cover is moved away from the bottom opening, and the housing is placed in an operating state such that the sensor module is attached to the skin surface to measure the physiological signal.

[0012] The novel design of the present invention can fully meet the requirement of reducing the manufacturing cost, so 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 of ordinary skill in the art after considering the following detailed description and the accompanying drawings.

[0014] [Figure 1] FIG. 2 is an assembly diagram of an airtight dry container for carrying a sensor and implanting the sensor subcutaneously in a living subject, according to an embodiment of the present invention. [Figure 2A] FIG. 2 is an assembly drawing showing more detail of some elements of the embodiment of FIG. 1. [Figure 2B] FIG. 1 is a schematic perspective view of an implantation device according to some embodiments of the present invention. [Diagram 3]FIG. 2C is a schematic cross-sectional view along the xx direction of one embodiment shown in FIG. 2B, showing the container embedded in the storage state. [Figure 4] 4 is a schematic cross-sectional view taken along line IV-IV of the embodiment shown in FIG. 3 or along the yy direction of one embodiment shown in FIG. 2B. [Diagram 5] FIG. 2 is a schematic diagram of the embodiment shown in FIG. 1 with the bottom cover removed and ready for embedding. [Figure 6] FIG. 6 is a cross-sectional view of the embodiment shown in FIG. 5 taken along line VI-VI. [Figure 7] FIG. 2 is a schematic diagram of the embodiment shown in FIG. 1, showing that the bottom cover has been removed and implantation can be performed instantaneously while the needle is not implanted in the subcutaneous portion. [Figure 8] FIG. 8 is a cross-sectional view of the embodiment shown in FIG. 7 taken along line VIII-VIII. [Figure 9] FIG. 2 is a schematic diagram of the embodiment shown in FIG. 1, showing the container in a stage immediately after implantation. [Figure 10] 10 is a cross-sectional view taken along line XX of the embodiment shown in FIG. 9. [Figure 11] FIG. 2 is a schematic diagram of the embodiment shown in FIG. 1, illustrating the stage of needle removal after implantation. [Figure 12] FIG. 12 is a cross-sectional view of the embodiment shown in FIG. 11 taken along line XII-XII. [Figure 13] FIG. 2 is a schematic diagram of the embodiment shown in FIG. 1, shown at a stage where implantation has been completed. [Figure 14] FIG. 14 is a cross-sectional view of the embodiment shown in FIG. 11 taken along line XIV-XIV. [Figure 15] FIG. 2 is a schematic diagram of the embodiment shown in FIG. 1, showing the bottom cover restored; [Figure 16] FIG. 16 is a cross-sectional view of the embodiment shown in FIG. 15 taken along line XVI-XVI. [Figure 17] FIG. 2 is a partially assembled perspective view of another embodiment of the airtight dry container of the present invention. [Figure 18]FIG. 18 is a schematic diagram of the embodiment shown in FIG. 17, shown ready for implantation. [Figure 19] FIG. 19 is a cross-sectional view of the embodiment shown in FIG. 18 taken along line XIX-XIX. [Figure 20] FIG. 18 is a schematic diagram of the embodiment shown in FIG. 17, shown during implantation. [Figure 21] FIG. 21 is a cross-sectional view of the embodiment shown in FIG. 20 taken along line XXI-XXI. [Figure 22] FIG. 2 is a schematic diagram showing an airtight drying container according to another embodiment of the present invention. [Figure 23] FIG. 18 is a schematic diagram of the embodiment shown in FIG. 17 with the bottom cover removed and ready for embedding. [Figure 24] FIG. 18 is a schematic diagram of the embodiment shown in FIG. 17, illustrating the embedding operation. [Diagram 25] FIG. 18 is a schematic diagram of the embodiment shown in FIG. 17, shown prior to removal of the bottom cover. [Figure 26] 18 is a schematic diagram of a peel element removing a release layer when the bottom cover of the embodiment shown in FIG. 17 is removed. [Figure 27] FIG. 2 is a schematic operation flow diagram of the airtight drying container according to the present invention. [Figure 28A] 1 is a schematic diagram showing an upper cover not covering a base assembly when the needle embedding procedure is completed and the sensor is embedded in a subcutaneous portion in the first embodiment. FIG. [Figure 28B] FIG. 11 is a schematic diagram showing a top cover covering the base assembly after the needle embedding procedure is completed and the sensor is embedded in the subcutaneous portion in the first embodiment. [Figure 29] FIG. 4 is a schematic diagram showing an enlarged portion of FIG. 3, illustrating that the sensor assembly is fixed inside the airtight dry container by a needle-embedded support. [Diagram 30] FIG. 2 is an assembly drawing similar to FIG. 1; [Diagram 31] 1 is a schematic cross-sectional view of a detachable module placed on the surface of a living body according to the present invention. [Diagram 32] FIG. 2C is a schematic cross-sectional view taken along the xx direction of one embodiment shown in FIG. 2B. [Diagram 33] FIG. 2C is a schematic cross-sectional view along the yy direction of one embodiment shown in FIG. 2B. [Diagram 34] FIG. 2C is a schematic cross-sectional view taken along the xx direction of one embodiment shown in FIG. 2B. [Diagram 35] FIG. 2C is a schematic cross-sectional view along the yy direction of one embodiment shown in FIG. 2B. [Diagram 36] FIG. 2C is a schematic cross-sectional view taken along the xx direction of one embodiment shown in FIG. 2B. [Figure 37] FIG. 2C is a schematic cross-sectional view along the yy direction of one embodiment shown in FIG. 2B. [Figure 38] FIG. 2C is a schematic cross-sectional view taken along the xx direction of one embodiment shown in FIG. 2B. [Figure 39] FIG. 2C is a schematic cross-sectional view along the yy direction of one embodiment shown in FIG. 2B. [Diagram 40] FIG. 2C is a schematic cross-sectional view taken along the xx direction of one embodiment shown in FIG. 2B. [Diagram 41] FIG. 2C is a schematic cross-sectional view along the yy direction of one embodiment shown in FIG. 2B. [Diagram 42] FIG. 2C is a schematic cross-sectional view of one of the embodiments shown in FIG. 2B along line yy, where the housing is separated from the bottom cover. [Diagram 43] FIG. 2C is a schematic cross-sectional view of one of the embodiments shown in FIG. 2B taken along line yy. [Diagram 44] 1 is a schematic perspective view of a bottom cover and housing combination of the present invention; [Diagram 45] FIG. 45 is a top view of the bottom cover and housing combination according to FIG. 44. [Figure 46A] 1A-1D are schematic diagrams of the sequential operation of opening the bottom cover according to an embodiment of the present invention. [Figure 46B] 1A-1D are schematic diagrams of the sequential operation of opening the bottom cover according to an embodiment of the present invention. [Figure 46C] 1A-1D are schematic diagrams of the sequential operation of opening the bottom cover according to an embodiment of the present invention. [Figure 46D] 1A-1D are schematic diagrams of the sequential operation of opening the bottom cover according to an embodiment of the present invention. [Figure 47] 1 is a schematic perspective view showing a user manually removing a bottom cover from a housing according to one embodiment of the present invention; FIG. [Figure 48] FIG. 1 is a schematic diagram of a combination of a transmitter disposed on a base attached to the surface of a living body via a mounting pad according to one embodiment of the present invention. [Figure 49] 1 is an exploded schematic diagram of a transmitter, base and sensor assembly of the present invention; [Figure 50] 1 is a schematic diagram of a housing and bottom cover of an implantation device according to another embodiment of the present invention. [Figure 51] FIG. 51 is a schematic cross-sectional view of the embodiment of FIG. 50 taken along line yy. [Figure 52] 13 is a schematic diagram of a housing and bottom cover of an implantation device according to yet another embodiment of the present invention. [Figure 53] FIG. 53 is a schematic cross-sectional view of the embodiment of FIG. 52 taken along line xx. [Figure 54] 13 is a schematic diagram of a bottom cover of an embedding device according to another embodiment of the present invention. [Figure 55] FIG. 55 is a schematic cross-sectional view of the embodiment of FIG. 54 taken along line yy. [Figure 56] FIG. 2 is a schematic perspective view of the embedding device after the bottom cover has been opened. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0015] Next, the present invention will be described more specifically with reference to the following embodiments. It should be noted that the following descriptions of preferred embodiments of the present invention are presented herein for purposes of illustration and description only. They are not intended to be exhaustive or limited to the precise forms disclosed.

[0016] The airtight dry container of the present invention incorporates an embedding device into a sensing device and maintains a dry environment for the device. Please refer to Figs. 1-10. According to Fig. 1, the dry container 100 has an airtight space formed inside by an airtight joint maintained by a housing 11 and a bottom cover 20. The casing assembly 10 includes a housing 11, a lining piece 12 disposed inside the housing 11, and a leak-proof ring 13 selectively additionally disposed around the housing 11. The airtight space formed by the housing 11 and the bottom cover 20 together is for accommodating other elements such as an embedding module 30, a lower mount base 50, a sensor assembly 70, and a desiccant element 60. The lower mount base 50 and the sensor assembly 70 constitute a form of a module that is separated from the dry container 100 after completion of the embedding process and placed 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 be a detachable module. 3 and 4, it can be seen that the lower mounting base 50 and the sensor assembly 70 are separately positioned and embedded in different locations during storage.

[0017] As shown in Figs. 1-4, the housing 11 has a cup-like shape, and the upper wall 111 is disposed in a portion like the bottom of the cup. A bottom opening is provided on the lower surface 112 opposite to the upper wall 111 along the axis L. According to this embodiment, a first coupling portion is formed in the bottom opening of the housing 11 to be coupled to the bottom cover 20. The first coupling portion is coupled to the bottom cover 20 via sleeve engagement (hard interference), but is not limited thereto. The housing 11 further includes a compounding portion 116 having a concave shape. In one embodiment, a dryness indicator 61, such as a cobalt-containing humidity indicator or a cobalt-free humidity indicator, can be disposed at the housing 11 or the bottom cover 20, which are made of a transparent or translucent material, so that a person can observe the dryness state of the desiccant element 60. Another example of the dryness indicator 61 is a printed layer of a zeolite-containing resin, which can be judged by absorbing moisture and making the resin layer transparent. The dryness indicator 61 can be used by a user to observe the dryness in the container to avoid the use of an abnormal product.

[0018] The lining piece 12 has a hollow cylindrical cup shape and is sleeved in the housing 11. The lining piece 12 has an inner peripheral surface 121 that is in close contact with the inner surface 117 of the housing 11 and can define the receiving space 14 for receiving the embedding module 30, an outer peripheral surface 122 opposite to the inner peripheral surface 121, a pair of actuating parts 123 protruding from the inner peripheral surface 121, a pair of locking parts 124 arranged along the axis L from the actuating part 123 side, and a plurality of slot seats 126 protruding from the outer peripheral surface 122 and defining receiving grooves 125 with the outer peripheral surface 122. The locking parts 124 have through holes communicating with the outer peripheral surface 122 and the inner peripheral surface 121. The receiving grooves 125 can be used to place the desiccant 60.

[0019] Since the lining piece 12 and the housing 11 are in close contact with each other via the multiple fittings 127, the relative positions of the two do not need to be changed. The desiccant 60 is provided in a gap formed between the lining piece 12 and the housing 11 by the presence of the multiple fittings 127 on the upper surface of the lining piece 12. In this embodiment, the lining piece 12 can define at least one of a desiccant accommodating space and a multiple accommodating groove 125 extending from the side wall of the lining piece 12 at the upper portion of the lining piece 12. In another embodiment, the inner peripheral surface 121 of the lining piece 12 can include a desiccant accommodating space (not shown). According to another embodiment of the present invention, the lining piece 12 can be considered as a part of the housing 11 and vice versa, as shown in Figures 32 and 33. This means that the lining piece 12 and the housing 11 can be independent components or the two components can be integrally formed without departing from the scope of the present invention.

[0020] The bottom cover 20 is detachably attached to the housing 11, and has a chassis portion 21 that is substantially perpendicular to the axis L, and a peripheral wall 22 that extends from the periphery of the chassis portion 21. The peripheral wall 22 has an inner surface 221, an outer surface 222 opposite to the inner surface 221, a brim 223 connected between the inner surface 221 and the outer surface 222, a ring groove 224 that can embed the convex ring 115 and is recessed in the inner surface 221, a pair of blocking portions 226 that protrude from the inner surface 221, and a slightly semicircular plate-like positioning piece 227 that protrudes from the brim 223. The bottom opening of the housing 11 coincides with the configuration of the bottom cover 20. The positioning piece 227 can be nested in the blending portion 116. The blending between the positioning piece 227 and the blending portion 116 provides the user with the functions of foolproofing and alignment when operating to open and close the container. In addition, when the internal components of the drying container have directional requirements, the combination of the blending part 116 and the positioning piece 227 can be used as a set of reliable alignment, which is beneficial to improve production efficiency. Also, the blending part 116 can be used as a positioning member of the housing 11, which is a reference point for estimating the deformation amount of the opening of the housing 11, so as to make the opening of the housing 11 have a round appearance during injection molding, which is helpful to the airtight process.

[0021] The exterior surface 222 of the bottom cover 20 has a force application portion 228 protruding from the exterior surface 222 adjacent the brim 223. The force application portion 228 allows a user to easily open and close the bottom cover 20. Furthermore, the force application portion 228 is provided to control the opening force to 2 kilograms force (kgf) or less, so that the container is easy to open, resistant to negative pressure, and can be quickly disassembled by a user with little force.

[0022] According to this embodiment, the inner surface 221 of the bottom cover 20 defines a second joint that is engaged with the first joint of the housing 11, but is not limited to other methods. In another embodiment, the leakproof 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 leakproof ring 13 can be disposed on one side of the ring groove 224 and hermetically sleeved on the ring portion 225 disposed on the outside of the leakproof ring 13. As shown in FIG. 3, when the housing 11 and the bottom cover 20 are assembled, the leakproof ring 13 can combine the two 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 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 can 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 dry container stored in different temperature and humidity environments are taken out at different times to check the airtight function, and the average daily moisture absorption of the dry container is checked 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 a storage condition of 0-100% relative humidity and 0-45°C temperature, a storage condition of 0-100% relative humidity and 0°C to 40°C temperature, or a storage condition of 10-90% relative humidity and 4-30°C temperature, and maintain a storage period of at least 2 years or at least 1 year, both of which have good airtight effect. The present invention is not limited by the embodiments of the hard interference patterns disclosed by the examples.

[0024] It is worth mentioning that a hinge connection (not shown) is usually arranged between the bottom cover 20 of the dry container 100 and the housing 11. By utilizing the can opening design of the present invention with a convex ring and a ring groove, the housing 11 can be more easily pressed and embedded into the surface of the skin of the living body while manipulating the dry container 100 to embed the sensor. Compared with the screw-turn type can opening design, the convex ring and ring groove sleeve design of the present invention can make the manufacturing process simpler and reduce the probability of the manufacturing mold being worn out, which is beneficial to improving the process yield.

[0025] The sensor assembly 70 includes a sensor 72, as shown in FIG. 3, FIG. 4, and FIG. 31. The sensor 72 is embedded in a skin surface P, which is a subcutaneous portion of a living body, and measures a physiological signal of the living body. The sensor assembly 70 includes a sensor base 71 and a sensor 72 connected to the sensor base 71 and partially held within the embedding needle 362. The sensor base 71 has a plurality of concave engagement portions 711 configured to engage with the connection portions 383 of the auxiliary embedding sheet 38. The sensor assembly 70 can also be considered as a single module. For example, the sensor 72 may include a substrate 722, on which at least one working electrode 724 and a reference electrode 725 are disposed. At least the working electrode 724 has a chemical reagent 720 including at least one analyte-responsive enzyme 726 and a polymer membrane layer 728. The chemical reagent 720 is configured to obtain data regarding a particular physiological parameter in the living body, such as a glucose concentration or other parameter 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 embedding, the storage space 14 of the airtight dry container 100 for carrying the sensor assembly 70 is provided with a desiccant 60 to maintain the long-term stability of the reagent (such as one year or more). The gaps between each element in the dry container 100 of the present invention can be used as vents for the desiccant 60, and communicate 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 be provided with a desiccant 60. In an airtight state, the humidity inside the container is very low, just like at the beginning of manufacture, so that the long-term effectiveness of the chemical reagent is not affected by humidity. Therefore, the sensor 72 can have consistently good and accurate performance for one year, two years, or longer during the storage period.

[0027] The desiccant 60 may be disposed at any suitable position in the drying 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 carrying the sensor assembly 70 is disposed in the receiving space 14 inside the lining piece 12. From another perspective, the lining piece 12 is disposed between the housing 11 and the embedding module 30. The desiccant 60 may also be disposed between a plurality of fittings 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 may be disposed at a suitable position of the embedding module 30 or the bottom cover 20, or the desiccant 60 may be disposed near the sensor assembly 70, or the desiccant 60 may be integrally formed with the sensor base 71. The desiccant 60 can be arranged in different positions and combinations according to environmental requirements. The desiccant 60 can be a desiccant embedded polymer, a water absorbing material, a hygroscopic material, a molecular sieve desiccant sheet, a desiccant embedded plastic sheet, or a desiccant sheet formed by injection molding with the internal components of the container 100.

[0028] The embedding module 30 is installed in the receiving space 14 and includes a body 31 having a hollow cylindrical shape, a main cover 32 connected to the body 31 and defining a displacement space 301 together with the body 31, a needle embedding sheet 33 movably arranged in the displacement space 301 along an axis L, a first elastic element 34 arranged between the needle embedding sheet 33 and the main cover 32 in a pre-compressed manner, a needle removal sheet 35 slidably installed inside the needle embedding sheet 33 along the axis L, a needle embedding piece 36 connected to the needle removal sheet 35, and a second elastic element 37 arranged between the needle embedding sheet 33 and the needle removal sheet 35 in another pre-compressed 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 removal sheet 35 to move along the needle removal direction R. Components within the implantation module 30 form a drive group that drives the needle implantation piece 36, causing the implantation module 30 to release force to implant the sensor 72 subcutaneously within the living body.

[0029] The main body 31 has a bottom wall 311, a cylindrical wall 312 connected to the bottom wall 311 in a crosswise manner, 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 parts 315 that can be engaged with the locking parts 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 parts 317 adjacent to the recesses 316, and a pair of buckle ears 318. The conduit 313 has a push hole 319 that narrows toward the inside and widens toward the outside. The slide groove 310 is connected to the push hole 319, and the elastic piece 314 has elasticity that may cause a deviation with respect to the axis L. The latch parts 315 are respectively disposed 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 fastened to the buckle ears 318 respectively, and a pair of restraining elements 323 arranged opposite each other along the axis L.

[0031] The needle embedding sheet 33 has a flat plate portion 331, an inner tube member 332 crosswise connected to the flat plate portion 331, an outer tube member 333 crosswise connected to the flat plate portion 331 and surrounding the inner tube member 332, a limiting element 334 arranged on the inner tube member 332 so as to maintain the needle removal sheet 35 at a fixed position relative to the needle embedding sheet 33, a pair of buckle portions 335 respectively arranged on the outer tube member 333 and removably seated on the stop portion 317, and a pair of limiting grooves 336 extending parallel to the parallel axis L and adjacent to the limiting element 334. The buckle portion 335 is in the shape of a spring and has elasticity that can 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 one 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 tenon shape. The fins 382 each have a plurality of recesses 384, and can be compressed in a radial direction perpendicular to the axis L, and have the ability to spring outward after being compressed. The restrained position of the auxiliary embedding sheet 38 and the main body 31 before the needle is embedded can avoid side-to-side bending and pulling when the needle is embedded subcutaneously in the living body. This increases the stability of the needle and reduces pain to the living body or the patient. The sensor assembly 70 can be removably transported 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 blocking portion 226, a supporting portion 42 opposite to the pressing portion, a first hook 43 disposed between the pressing portion 41 and the supporting portion 42, and a guide portion 44 having a guide inclined surface 441 disposed between the pressing portion 41 and the supporting portion 42.

[0036] The lower mount base 50 is detachably disposed relative to the main body 31. The sensor assembly positioning portion on the lower mount base 50 includes a groove 78 configured to allow the sensor assembly 70 to buckle and be positioned after being removed from the auxiliary embedding sheet 38. The lower mount base 50 includes a base mount 51, an adhesive pad 52 fixed to the base mount 51, a buckle set 53 disposed on the base mount 51, a second hook 54 configured to detachably hook with the first hook 43, and a release layer 55 releasably attached to the adhesive pad 52 and removable 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 an upper surface 512 that is closed to prevent contamination to 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 glued to the double-sided sticker 56, and the sidewall 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] In order to further explain the cooperation effect of the elements of the present invention, the use of technical means, and the expected effects, the following description is provided, which is believed to enable those skilled in the art to have a deeper and more specific understanding of the present invention.

[0040] 3 and 4, when the first embodiment of the dry airtight container 100 of the present invention is assembled, the bottom cover 20 is hermetically closed to the housing 11. In an unused state, the bottom cover 20 and the housing 11 can be hermetically combined by utilizing 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, which, in combination with the desiccant 60, can achieve the purpose of moisture resistance and ensure the detection accuracy of the sensor 72. In another embodiment, the convex ring 115 can be disposed on the bottom cover 20, and the ring groove 224 is provided on the housing 11.

[0041] In the storage state, the position of the needle embedding 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 embedding sheet 33 form a restraining state. The needle embedding sheet 33 is in the upper position. The first elastic element 34 is pre-compressed between the needle embedding sheet 33 and the main cover 32 and contains a releasable elastic force. The restraining elements 323 are inserted into the limiting grooves 336 respectively and configured to limit the limiting element 334 from radial bending. The limiting element 334 is used to generate a latch on the needle removal sheet 35 positioned relative to the needle embedding sheet 33, so that the displacement of the needle embedding sheet 33 in the embedding direction F is limited. There is a distance D between the main cover 32 and the lining piece 12.

[0042] When the drying container 100 is completely assembled and not in use, the fixing member 40 abuts against the bottom cover 20. Specifically, the pressing parts 41 of the fixing member 40 are respectively restrained by the closing parts 226 of the bottom cover 20. The installation method of the fixing member 40 limits the movement of the lining piece 12, and prevents the drying container 100 from accidentally dropping and causing internal parts to fly off or break down, resulting in malfunction, and can be effectively utilized. Meanwhile, the support part 42 of the fixing member 40 is also used to generate a support effect for the sensor base 71 of the sensor assembly 70, and the lower mount base 50 is positioned relative to the main body 31 by the first hook 43 engaging with the second hook 54.

[0043] As shown in Figures 5-6, when the bottom cover 20 is removed or opened and the drying container 100 is placed on the skin surface of the living body (indicated by a dashed line in the horizontal direction), the housing 11 can be operated to move the lining piece 12 downward, i.e., in the direction toward the skin surface, as shown in Figures 7-8. During the process, the actuating part 123 of the lining piece 12 pushes the buckle part 335 along its inclined surface, and finally releases the restrained state between the stop part 317 and the buckle part 335, causing the first elastic element 34 in the embedding module to automatically release the force pushing the needle embedding sheet 33 in the embedding direction F, so that the sensor 72 can be embedded subcutaneously in 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 part 44 of the fixing member 40, and at the same time, the fixing member 40 moves away from the axis L, and the support part 42 moves away from the support of the sensor base 71, so that 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 driving 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 part 123 on the inner peripheral surface 121 of the lining piece 12 slides along the slope of the buckle part 335, and the external force applied to the housing 11 is not transmitted downward to the main body 31, so that 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 body 12 while the cover body 12 is being pressed down. After the user presses the lining piece 12, the operating part 123 is caught on the lower part of the main body 31, so that the user cannot lift the lining piece 12 without feeling vibration or noise. As shown in Figures 7 to 8, at this time, the restraining 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 removal restraining structure has not been released. As shown in Figures 8 to 10, during the embedding process, after the bottom cover 20 is removed or opened, the lower mount base 50 is separated from the sensor assembly 70, and the detachable module is embedded due to the force released by the embedding module 30, and the sensor assembly 70 is assembled to the lower mount base 50, and the sensor 72 is embedded under the skin of the living body.

[0045] In the embodiment shown in Figures 3-10, the main cover 32 of the embedding module 30 is a separate component. Those skilled in the art can assemble the device according to the drawings. For example, according to a different embodiment, as shown in Figures 36-37, the operation process of automatic needle embedding and automatic needle removal is similar to that of the previous embodiment, 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 a separate component, and the body 31 and the lining piece 12 are connected to each other. The embedding module 30 includes a body 31 connected to the lining piece 12, and the 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 engaged with each of the locking portions 124, a needle-embedded sheet 33 that forms a releasable restraint with respect to the lining piece 12 and is movable within the displacement space 301 between the main body 31 and the lining piece 12, a first elastic element 34 that is a pre-compressed spring and is disposed between the needle-embedded sheet 33 and the lining piece 12, a needle-removal sheet 35 that can maintain restraint with respect to the needle-embedded sheet 33, and a second elastic element 37 that is pre-compressed between the needle-embedded sheet 33 and the needle-removal sheet 35. The inner peripheral surface of the lining piece 12 has at least one actuating portion 123, and the needle-embedded sheet 33 has a buckle portion 335 that can be driven by the actuating portion 123 and is releasably disposed within the main body 31. The buckle portion 335 of the needle-embedded sheet 33 resists the stop portion 317 of the main body 31, and an actuating restraint structure is formed between the needle-removal sheet 35 and the main body 31.

[0047] In another embodiment, as shown in Figures 34-35, the housing 11 has the technical feature of including the lining piece 12 and the main cover 32, so that even a separate lining piece 12 and a main cover 32 may not be required. The embedding module includes a main body 31 coupled to the housing 11 and forming a displacement space 301 together with the housing 11, a needle embedding sheet 33 removably forming a restraint with respect to the housing 11 and movable within the displacement space 301 between the main body 31 and the housing 11, a first elastic element 34 disposed between the needle embedding sheet 33 and the housing 11 and being a pre-compressed spring, a needle removal sheet 35 capable of maintaining a restraint with respect to the needle embedding sheet 33, and a second elastic element 37 pre-compressed between the needle embedding sheet 33 and the needle removal sheet 35.

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

[0049] 9-10 , when the first elastic element 34 of the embedding module 30 releases the force, the needle embedding sheet 33 is pushed away from the main cover 32, and the restriction between the restraining element 323 of the main cover 32 and the limiting groove 336 of the needle embedding sheet 33 is automatically released. At this time, while the housing 11 is being pressed down, the needle removal sheet 35 is maintained in position relative to the needle embedding sheet 33 by the limiting element 334.

[0050] As shown in Figures 11-12, due to the separation of the restraining element 323, the limiting element 334 that initially held the needle removal sheet 35 in a 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. This releases the needle removal sheet 35 from the restraint of the needle embedding sheet 33, and the restraint on the movement of the needle removal sheet 35 in the needle removal direction R is released. Therefore, at this time, the second elastic element 37, which is spring-loaded between the needle embedding sheet 33 and the needle removal sheet 35, can release its elastic force and move the needle removal sheet 35 in the needle removal direction R. Therefore, the needle 362 that has just completed the embedding procedure can be instantly extracted to complete the successive embedding and extraction operations.

[0051] The first and second elastic elements 34, 37 can be made of, for example, helical springs or pneumatic / pneumatic elements. The instantaneous elastic release of the two pre-compressed elastic elements 34, 37 completes the needle implantation and needle removal, so that the present invention can use an automatic mechanism to implant a sensor subcutaneously from an implantation device stored in a container and complete the needle implantation and needle removal operations in a very short time, without causing discomfort to the implanter, and without causing pain to the living body after the implantation operation is completed. The user does not feel the reaction force of the first elastic element 34 when pressing the housing 11, so the smoothness of the automatic needle implantation and removal process is improved, and the time to complete the automatic needle implantation and removal operation is less than 100 milliseconds (ms), less than 50 ms, 8 ms, 6 ms, 4 ms, or 2 ms.

[0052] In addition, according to the present invention, after an external force is applied to the upper wall 111 of the housing 11, the operation of unlocking, needle embedding, needle removal and the like can be continued and completed. During the operation, the user can complete the embedding without releasing the housing 11, and the embedding device works by embedding the elastic needle, instead of pushing it down with the user's hand. Therefore, the embedding device of the present invention can effectively solve the problem that the user's operation proficiency is low in the conventional method, which affects the smoothness of embedding and needle removal. Figures 13-14 show that the needle 362 is completely pulled back into the accommodation space 14 of the lining piece 12 after the needle removal process, and more specifically, is inside the auxiliary embedding sheet 38, which prevents the sharp needle 362 from being exposed outside the housing opening and causing an accident.

[0053] 15-16 show how the bottom cover 20 is reassembled after use. After the embedding is completed, the user can easily assemble the bottom cover 20 and the housing 11 by using the positioning piece 227 on the bottom cover 20 and the combination part 116 at the bottom opening of the housing 11 to achieve the purpose of accurate alignment and foolproofing. In addition, the dry sealed storage device 100 can be utilized as a waste storage means. The used lower base mount 50 can be removed and stored in the original dry sealed storage device 100, so that the user can dispose of it according to the medical waste disposal requirements.

[0054] As shown in Figs. 17-19, another embodiment of the dry airtight container according to the present invention differs from the first embodiment in that a protective ring 80 is added, and the protective ring 80 is sleeved to the bottom of the housing 11. The lower mount base 50 is placed inside the lower end of the protective ring 80 before implantation, so that 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 implantation device to the position to be implanted, and then a trigger action is performed to push down the casing assembly 10 (or the housing 11) (as shown in Figs. 20 and 21), and the housing 11 is pushed down. After implantation, the protective ring 80 can be retracted relative to the casing assembly 10 (or the housing 11) by applying force, and then the lower base mount 50 is adhered to the skin surface. Therefore, the protective ring 80 of this embodiment can be utilized to adjust to the required skin position before the needle implantation operation is performed, which is very convenient in use.

[0055] As shown in Figures 22-26 (for convenience of explanation, Figures 22-26 are shown only in simplified views), 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, forming an airtight joint structure in an airtight state inside. The desiccant 60 can be disposed at any suitable position in the drying container. In one embodiment, the desiccant is disposed 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 configured with a receiving space for disposing the desiccant 60 (as shown in Figures 22 and 23), or the sensor assembly 70 has the desiccant 60 (not shown), or a desiccant layer 62 is formed on the inner peripheral surface of the housing 11 or the bottom cover 20, or a receiving space for disposing the desiccant 60 is disposed (not shown) as shown in Figure 25. This keeps the interior of the drying container dry and prevents the sensor assembly 70 from getting wet, particularly the chemical reagent 720 of the sensor 72 from deliquescing (as shown in FIG. 31 ), ensuring 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 Figures 25 and 26, the lower base mount 50 further includes a tear element 23 attached to the chassis portion 21. The tear 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 along with the tear element 23, so that the user can peel away the release layer 55 and expose the adhesive pad 52 at the point of implantation. This helps to improve adhesion of the adhesive pad 52 to the skin.

[0057] In another embodiment, the sensor 72 may be designed to have a particular stiffness, and therefore need not include a needle implantation piece 36, and the implantation module 30 need not include a needle removal device.

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

[0059] As shown in Figures 3 and 4, the housing 11 is combined with the bottom cover 20 to form an accommodating space 14 therein. The embedding module 30 is disposed in the accommodating 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 to prevent it from changing from the first operating state (not embedded but stored state) to the second operating state (embedded state) under unexpected circumstances such as accidental dropping or dropping to the ground.

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

[0061] As shown in Figures 7-12, a user can press the housing 11 to release the trigger constraint and cause the implantation module 30 to transition from the first operating state to the second operating state. When the implantation module 30 transitions to the second operating state, the sensor assembly 70 is positioned on the lower base mount 50, and the needle (or sharp needle) 362 is implanted in the subcutaneous portion, completing the needle implantation process. As shown in Figures 13 and 14, during the needle removal process, the implantation module 30 moves toward the position of the first operating state, so that the needle 362 is retracted back into the housing 11 without being exposed to the outside.

[0062] The bottom cover 20 is then reattached to connect to the housing 11 as shown in FIGS.

[0063] In particular, in the assembly sequence of the components of the present invention, the first elastic element 34, the needle removal sheet 35, the second elastic element 37 and the needle embedding sheet 33 are pre-installed between the main cover 32 and the 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 removal sheet 35, so that the sensor assembly 70 and the embedding module 30 form a clutch design, which not only greatly improves the assembly yield but also effectively reduces the cost of the sensor assembly 70.

[0064] As shown in Figs. 1, 28A, 28B and 29, the assembly method of the dry container 100 of the present invention is as follows: 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 the operation of gripping the sensor assembly 70 on the lower base mount 50 by the embedding module 30. The assembly method of the dry container 100 described above 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, he or she only needs to operate the embedding device simply, such as by pressing the dry 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 sticks the lower mount base 50 to the skin surface.

[0065] 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 mounting base 50, which are simultaneously disposed on the skin surface P of the living body, need to be equipped with a transmitter 90 to operate. The transmitter 90 is used to process the physiological signal measured by the sensor 72 and enable the signal to be transmitted to the outside. FIG. 28A shows that the transmitter 90 is not attached to the lower mounting base 50, and the upper dotted outline of FIG. 28B shows the transmitter 90 attached to the lower mounting 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 of the drying container, the detachable module of the present invention does not include a transmitter. The separately disposed transmitter 90 and the sensor assembly 70 can improve the production yield of the device because it ensures that the electronic components are not damaged by the sterilization process.

[0066] 42 and 43, both of which are considered as schematic cross-sectional views along line yy of one of the embodiments 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, so that the bottom cover 20 and the housing 11 can be tightly engaged by hard interference. In FIG. 42, the bottom cover convex ring 224' is formed near the bottom cover opening 20' to abut 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 disposed on the convex ring 115, and the convex ring 115 is also disposed 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 Fig. 42 and Fig. 43 face outward, i.e., face the opposite side of the bottom opening 111'. Meanwhile, the ring groove 224 and the bottom cover convex ring 224' face inward, i.e., face the bottom cover opening 20'. Therefore, when the bottom cover 20 is removed from the bottom opening 111', the bottom cover convex ring 224' needs to pass through the convex ring 115, i.e., break through the obstacle of the convex ring 115. Furthermore, the leakproof ring 13 (see Fig. 4) can be additionally provided in the housing ring groove 115', which is not only tightly sealed in the housing ring groove 115' but also tightly sealed in the convex ring 224' to achieve the effect of airtightness and moisture-proofness. In another embodiment, the convex ring 115 is disposed on the bottom cover 20, and the ring groove 224 is on the bottom opening 111'.

[0067] As can be seen from Figures 44 and 45, the side of the housing 11 has a recess 118 and a flange 118', the bottom cover 20 has an operating part (force application part) 228, and the opposite end is naturally a force support part 228', which provides support in the process of opening the bottom cover 20. The principle of force application is that the distance D' from the force support part 228' to the operating part 228 and the applied force F' form a force moment, i.e., the "force moment" is equal to the value of "distance D'" multiplied 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 increase the airtightness of the embedding device, in principle, the tighter the bottom cover 20 and the housing 11 are, the better, but the force required to open the bottom cover 20 will be excessive. It is very inconvenient to use. If the user applies excessive force to open the bottom cover 20, the embedding device will often be thrown out of the hand, causing damage to the internal object. Taking the embedding device of the present invention as an example, the inventor has considered the cover opening moment design of the embedding device after considering both the easy opening and airtightness of the device. Considering that the container can accommodate needle embedding mechanisms and / or needle removal mechanisms of different shapes or different sizes, the distance D' from the operating part 228 to the force support part 228' is 15 to 100 mm, which is a very appropriate distance, and the preferred range is 30 to 80 mm. For the applied force F', the larger range is 0.2 to 10 kgf, and the general range is 0.5 to 6 kgf. If it is desired 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 arrangement and combination of the range of the applied force F' and the range of the distance D' from the support part to the force application part, the force moment is about 3 to 1000 kgf-mm, and a more suitable 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. If a small force is required to open the container, the moment will be about 200 kgf-mm or less. If the size of the bottom opening does not change, the applied moment can be adjusted by adjusting the size of the operating part 228. Since the operating part 228 is a convex part, the length L' of the convex part is 1 millimeter or more.

[0070] As shown in Figures 46A-46D, Figures 46A-46D are schematic diagrams of the operation of successively opening the bottom cover 20 according to an embodiment of the present invention. When the operating part 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, the housing 11 becomes operable, and the embedding module 30 can embed a part of the sensor 72 subcutaneously and measure physiological signals. In addition, the bottom cover 20 is provided with a positioning piece 227 for blending with the blending part 116 of the housing 11 (see Figures 1 and 2B). The bottom cover 20 has a center point 20C. The first virtual line L1 extends from the center point 20C to the blending part 116 (the positioning piece 227), and the center point 20C extends along the second virtual line L2 toward the operating part 228. The first and second imaginary lines L1, L2 form an angle 20A of 5 to 180 degrees.

[0071] 46A to 46D, which are schematic diagrams of a sequence of operations for opening the bottom cover 20 of another embodiment of the present invention. The sequence of sequential operation diagrams is based on a side view of the housing 11 of the present invention combined with the bottom cover 20 facing upward. First, refer to FIG. 46A, which shows that the bottom cover 20 has an operating portion 228, and the opposite end of the operating portion 228 forms a force support portion 228'. When a user tries to open the bottom cover 20, a force F' can be applied at the operating portion 228 in a direction away from the housing 11. In one embodiment of the present invention, the bottom cover 20 is formed of a relatively elastic material. Due to the presence of the desiccant 60 in the housing 11, when it absorbs moisture, the air pressure in the housing 11 drops slightly to be lower than the atmospheric pressure, and the atmospheric pressure provides additional pressure to make the bottom cover 20 fit the housing 11 more closely.

[0072] In Fig. 46A, when the operating portion 228 is pressed by the applied force F' and a side opening (or partial side opening) op is not yet formed between the bottom cover 20 and the housing 11, the first abutment RA is disposed near the root portion 228r, and the outwardly protruding operating portion 228 can provide an additional force arm for 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 inflow of outside air can balance the internal air pressure of the housing 11 and the external air pressure, making it easier to separate the bottom cover 20 from the housing 11.

[0073] 46A to 46D, when the force F' applied to the operating part 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 RA to the second abutment RB, or from the vicinity of the root part 228r of the operating part 228 to the force support part 228'. As shown in FIG. 46B, the second abutment RB is farther away from the operating part 228, so the force arm is longer, the moment is larger, and the opening operation is easier. Similarly, in FIG. 46C, the distance between the third abutment RC and the operating part 228 is farther than the distance between the second abutment RB and the operating part 228, so 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 RD is almost coincident with the force support part 228', and the length of the whole force arm is close to the diameter of the bottom cover 20 and the length of the operating part 228. It should be noted that the deformation of the bottom cover 20 in Figs. 46A-46D is a little exaggerated, and in fact, if 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 part 228' is still similar to that shown in Figs. 46A-46D.

[0074] Referring to FIG. 47, a user holds the housing 11 with one hand, and applies a force F' to pull the operating part 228 with the other hand to open the bottom cover 20, so that 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 applied by the force application part 228 is away from the bottom opening 111', the applied force F' gives the housing 11 a tendency to move in the direction of the applied force F' due to the clamping between the convex ring 115 and the ring groove 22 during the opening process of the bottom cover 20. 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 for the user's hand to hold it firmly, and the flange 118' stops the hand, so that the housing 11 is not easily removed from the hand along the axial direction of the housing 11.

[0075] 48 and 49, it can be seen that the sensor 90 is placed on the lower mount base 50, and the second positioning portion 90' of the sensor 90 is fitted with the first positioning portion 51' of the lower mount base 50. This also has a foolproof effect, that is, if the mounting direction of the sensor 90 is opposite to that of FIG. 48, the sensor 90 cannot be placed on the lower mount base 50. The sensor assembly 70 is placed 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 a signal output end 723 exposed on the top of the sensor base 71. When the transmitter 90 is covered by the lower mount 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, and then the transmitter 90 wirelessly transmits the measured physiological signal to the sensor 72. The transmitter 90 is fixed to the lower mount base 50 by engaging its sensor fixing groove 91 with the sensor fixing buckle 57 of the lower mount base 50. An adhesive pad 52 (see FIG. 48 ) is provided on the bottom of the lower mount base 50, and the sensor module (or a detachable module including the lower mount base 50 and the sensor assembly 70) is fixed to the skin surface P of the living body via the adhesive pad 52.

[0076] 50 and 51 show that the second operating portion 228a is a recessed structure extending along the outer side wall of the bottom cover 20, and the recessed structure provides greater friction for the fingers to facilitate the user to remove the bottom cover 20 from the bottom opening 111' in a similar manner. The connection relationships between elements such as the convex ring 115, the housing ring groove 115', and the ring groove 224 are the same as those in FIG. 42, and do not need to be repeatedly shown here.

[0077] 52 and 53, which show that the third operating portion 228b is a concave structure, which provides a relatively large frictional force to the finger, facilitating the user to remove the bottom cover 20 from the bottom opening 111' as well. Different from the embodiment of FIG. 51 and FIG. 42, the convex ring 115 and the housing ring groove 115' of the housing 11 face inward, i.e., point toward the center of the bottom opening 111', and the ring groove 224 and the convex ring 224' of the bottom cover 20 face outward, i.e., face the convex ring 115 and the housing ring groove 115'. It can be seen that in the embodiment of FIG. 53, 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 operating portion 228b, the bottom cover 20 is slightly recessed inward, causing the ring groove 224 and the convex ring 115 to separate from each other, creating a gap through which air can flow in. As a result, the housing 11 can no longer maintain negative pressure. That is, the air pressure inside and outside the housing 11 is balanced, allowing the user to easily remove the bottom cover 20.

[0078] 54 and 55, which disclose that the bottom cover outer wall 228c of the bottom cover 20 is directly an operating part. That is, to open the bottom cover 20, a user may apply a force to the bottom cover 20 along a direction away from the housing 11 while directly applying a force to the bottom cover outer wall 228c. Since the entire circumference of the bottom cover outer wall 228c can be used as an operating part, when a user selects a position on the bottom cover outer wall 228c and applies a force, the opposite side of this position can be regarded as a force support part 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, and only the protruding operation part 228 is taken as an example, but the present invention is not limited thereto. The embodiment of FIGS. 50-53 is substantially the same after 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 the lower mounting base 50 is located below it. 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 has also been removed from the blending part 116. Next, the user can press the adhesive pad 52 against the skin surface P of the living body on which the sensor 72 (see FIG. 49) is placed, and operate the housing 11 to achieve the effect of placing the sensor.

[0080] The main advantages of the present invention are summarized as follows:

[0081] (1) The dry airtight container of the present invention is an airtight combination of a bottom cover and a housing, which form an airtight space, and can avoid the drying and deliquescence of the chemical reagent on the sensor in the sealed space, ensuring the detection accuracy of the sensor. In addition, a dryness indication unit can be added to the outside or inside of the housing (the dryness indication unit can be a dryness indication material), and the opposite part of the housing has a transparent or translucent part, so that the dryness indication unit allows the user to check whether the sensor is wet. The installation method and position of the desiccant are not limited to the form disclosed in the embodiment.

[0082] (II) The airtight container airtight coupling method of the present invention is a convex ring and ring groove coupling method. When the container is closed, the moisture absorption rate in 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 container is stored under the conditions of 0-100% relative humidity and 0-45°C, 0-100% relative humidity and 0-40°C, or 10-90% relative humidity and 4-30°C, and the effect can be maintained for at least two years or at least one year during storage, with good airtight effect, easy to open, and resistant to negative pressure. The present invention can achieve the effect of airtight coupling by the method of hard interference.

[0083] (3) The detachable module of the present invention does not include a transmitter. The transmitter and sensor assembly are located separately, ensuring that the electronic components of the transmitter are not damaged by the high temperatures or chemical environments required for the sterilization process. This improves the production yield of the transmitter.

[0084] (4) The embedding module of the present invention mainly uses the elastic force provided by the two pre-compressed elastic members, making the embedding module an automatic mechanism to sequentially use the first and second elastic members. Since the elastic force for embedding and withdrawing the needle is provided by the embedding module, there is no need to rely on the force from the user's hand to push the needle. It also has the effect of completing the automatic needle embedding and needle withdrawal operations by pushing the casing assembly in one step. In other words, the present invention can greatly improve the reliability of the operation, and also effectively solve the problem of the prior art that the smoothness of needle embedding and needle withdrawal is affected by the user's skill during use.

[0085] (5) When the overall assembly of the dry airtight container of the present invention is completed and has not yet been used, the restraint portion formed by the abutment portion of the bottom cover and the engagement portion of the housing can prevent the needle from being accidentally embedded due to the container being accidentally dropped during transportation.

[0086] (6) The needle embedding piece can be pulled out to a position between the needle embedding sheet and the auxiliary embedding sheet so as not to be exposed, thereby achieving the effect of hiding the needle embedding piece after use.

[0087] (7) The main cover compresses and stores 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 pressed down for the needle embedding operation, making the embedding operation easier.

[0088] (8) The restraining relationship between the auxiliary embedding sheet and the main body before the needle is embedded can prevent left / right shifting and pulling when embedding the needle under the skin of the living body, improving the stability of the needle stroke and reducing pain for the living body and the patient.

[0089] (9) After a user manually presses the casing assembly, the embedding module is triggered to automatically use the elastic forces provided by the first and second elastic elements to sequentially embed and withdraw the needle in a time of less than 100 milliseconds, less than 50 milliseconds, less than 8 milliseconds, less than 6 milliseconds, less than 4 milliseconds, or less than 2 milliseconds.

[0090] (10) In the assembly sequence of the components of the present invention, the first elastic element, the needle removal sheet, the second elastic element and the needle embedding sheet are pre-installed between the main cover and the body, and the needle embedding piece is finally installed between the auxiliary embedding sheet and the sensor assembly. The needle embedding piece is used to connect with the needle removal sheet, thereby forming an embedded module clutch design with the sensor assembly, which not only greatly improves the assembly yield, but also effectively reduces the cost of the sensor assembly.

[0091] (11) The sensor assembly of the present invention is pre-assembled with the embedding module through the auxiliary embedding sheet, and finally the bottom cover is combined with the housing. In other words, the present invention does not require the operation of holding the sensor assembly on the lower mounting base by the embedding module.

[0092] (12) According to one embodiment of the present invention, the protective ring can be sleeved at the bottom of the housing. The lower base mount is disposed inside the lower end of the protective ring before the implantation operation, so that 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 implantation device to the implantation position, and then perform a trigger action to press down the casing assembly or the housing. Therefore, the protective ring of this embodiment can be used to adjust to the required position, forcing the needle implantation operation to be performed, which is very convenient to use.

[0093] (13) The outer surface of the bottom cover has a force application portion protruding from the outer surface adjacent to the brim. The presence of the force application portion makes it easier for the user to open and close the bottom cover. In addition, since a force application portion is provided that controls the opening force to 2 kg (kgf) or less, it is easy to open, resistant to negative pressure, and can be quickly disassembled without user effort. The blending between the positioning piece and the blending portion provides the user with foolproof and alignment functions when operating to open and close the container.

[0094] (14) The bottom cover is provided with a tearing element, which can help the user to tear off the edge of the release layer of the adhesive pad, so that the effect of peeling off the release layer at the same time as opening the bottom cover is realized, and the user does not need to peel off the release layer with bare hands, thus reducing the risk of inaccurate detection data caused by contamination of the sensor, and avoiding the problem that the contaminated adhesive pad causes a decrease in adhesive strength.

[0095] Through the above-mentioned 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.

[0096] While the present invention has been described in terms of what are presently considered to be the most practical and preferred embodiments, it is to be understood that the invention is not necessarily limited to the disclosed embodiments, but rather is intended to cover various modifications and similar arrangements included within the spirit and scope of the appended claims, and should be accorded the broadest interpretation so as to encompass all such modifications and similar structures. The invention as originally claimed in the present application is set forth below. [1] 1. An implantation device for rapid subcutaneous implantation of a sensor for measuring a physiological signal of an analyte in a biological fluid of a living organism, comprising: a housing having a bottom opening; an implantation module including an implantation device and a needle removal apparatus; a removable module including the sensor removably engaging with an embedded module and a base configured to mount the sensor; a bottom cover removably coupled to the bottom opening such that the housing and the bottom cover together form an accommodation space; The embedded module and the detachable module are accommodated in the accommodation space, The bottom cover has an operating portion configured to support a force and a support portion formed at an end opposite to the operating portion; the distance between the operating part and the support part and the force form an operating moment, and the user causes a lateral separation between the bottom cover and the housing; After the bottom cover is separated from the bottom opening, the housing is operated to cause the implantation module to release the force, detach the detachable module from the implantation module, and implant a portion of the sensor subcutaneously to measure a physiological signal. [2] The embedding device according to [1], wherein the operating portion is a convex portion protruding from an outer wall surface of the bottom cover. [3] The embedding device according to [1], wherein the operating portion is a recess recessed from an outer wall surface of the bottom cover. [4] The embedding device according to [1], wherein the operating portion is a side wall of the bottom cover. [5] the bottom opening and the bottom cover each have a first joint and a second joint; the first joint is a convex ring disposed along an edge of the bottom opening; the second joint is an annular groove disposed along an edge of the bottom cover; 2. The embedding device according to claim 1, wherein the convex ring is fitted into the annular groove. [6] The embedding device according to [1], wherein the operating moment is within a range of 3 to 1000 kgf-mm. [7] The embedding device according to [1], wherein the operating moment is within a range of 0.2 to 10 kgf-mm. [8] The embedding device according to [1], wherein the distance between the operating part and the support part is within a range of 15 to 100 millimeters. [9] The embedding device according to [1], wherein the storage space is an airtight space.

[10] the bottom cover of the housing has a first compounding portion; The housing has a second blending portion, The embedding device of [1], wherein the first and second blending portions are configured to abut each other.

[11] the bottom cover defines a reference point; The embedding device described in

[10] , wherein an angle formed by a first virtual line extending from the reference point to the first blending portion and a second virtual line extending from the reference point to the operating portion is in the range of 5 to 180 degrees.

[12] 1. A physiological signal monitoring system for rapidly assembling and measuring a physiological signal of a analyte in vivo, comprising: an implantation apparatus including a housing having a bottom opening and an implantation module including an implantation device and a needle removal apparatus; a detachable module including a sensor that is removably partially embedded in the living body, a base on which the sensor is disposed after the sensor is partially embedded in the living body, and a bottom cover that is removably coupled to the bottom opening such that the housing and the bottom cover together form a storage space; a transmitter coupled to the base after the sensor is partially implanted in the living body to transmit the physiological signal measured by the sensor; The bottom cover has an operating portion configured to support a force and a support portion formed at an end opposite to the operating portion; The distance between the operating portion and the support portion and the force form an operating moment; after a lateral separation between the bottom cover and the housing is initiated by the operating moment, the bottom cover moves away from the bottom opening; The housing is placed under operating conditions to operate the implanted module, detach the detachable module from the implanted module, implant a portion of the sensor subcutaneously, and measure the physiological signal.

[13] The physiological signal monitoring system described in

[12] , wherein the operating portion is a convex portion protruding from an outer wall surface of the bottom cover, and the length of the convex portion is 1 millimeter or more.

[14] The physiological signal monitoring system according to

[12] , wherein the operating portion is a recess recessed from the outer wall surface of the bottom cover.

[15] The physiological signal monitoring system described in

[12] , wherein the operating unit is a side wall of the bottom cover.

[16] the bottom opening and the bottom cover each have a first joint and a second joint; the first joint is a convex ring disposed along an edge of the bottom opening; the second joint is an annular groove disposed along an edge of the bottom cover; The physiological signal monitoring system of

[12] , wherein the convex ring is fitted into the annular groove.

[17] A physiological signal monitoring system for quickly assembling and measuring a physiological signal of a living body having a skin surface, comprising: a housing having a bottom opening; a mechanism module disposed in the housing; a sensor module removably disposed on the mechanism module so as to be attached to the skin surface; a bottom cover removably coupled to the bottom opening such that the housing and the bottom cover together form a storage space; The mechanism module and the sensor module are accommodated in an accommodation space, The bottom cover has an operating portion configured to support a force and a support portion formed at an end opposite to the operating portion; The distance between the operating portion and the support portion and the force form an operating moment; A physiological signal monitoring system, wherein after lateral separation between the bottom cover and the housing is initiated by the operating moment, the bottom cover moves away from the bottom opening and the housing is placed in an operational state such that the sensor module is attached to the skin surface to measure the physiological signal.

[18] The physiological signal monitoring system described in

[17] , wherein the operating portion is a convex portion protruding from an outer wall surface of the bottom cover.

[19] the bottom opening and the bottom cover each have a first joint and a second joint; the first joint is a convex ring disposed along an edge of the bottom opening; the second joint is an annular groove disposed along an edge of the bottom cover; The physiological signal monitoring system of

[17] , wherein the convex ring is fitted into the annular groove.

[20] The physiological signal monitoring system according to

[17] , wherein the accommodation space is an airtight space.

Claims

1. 1. An implantation device for rapid subcutaneous implantation of a sensor for measuring a physiological signal of an analyte in a biological fluid of a living organism, comprising: a housing having a bottom opening; an implantation module including an implantation device and a needle removal apparatus; a removable module including the sensor removably engaging with an embedded module and a base configured to mount the sensor; a bottom cover removably coupled to the bottom opening such that the housing and the bottom cover together form an accommodation space; The embedded module and the detachable module are accommodated in the accommodation space, The bottom cover has an operating portion configured to support a force and a force support portion formed at an end portion opposite the operating portion, the operation portion is a convex portion protruding from an outer wall surface of the bottom cover in a horizontal direction perpendicular to an opening direction of the bottom opening, the bottom cover has a bottom surface, and a distance line segment passing through the operation unit and the force support unit is parallel to the bottom surface; the operating portion has an upper surface and a lower surface, the force being applied from the lower surface in an upward direction perpendicular to the lower surface to move the bottom cover away from the housing and open the bottom cover, and the force being applied from the upper surface in a downward direction perpendicular to the upper surface to move the bottom cover closer to the housing and close the bottom cover; the distance segment and the force form an operating moment, allowing a user to cause a lateral separation between the bottom cover and the housing; After the bottom cover is separated from the bottom opening, the housing is operated to cause the implantation module to release a force to detach the detachable module from the implantation module, and to subcutaneously implant a portion of the sensor and measure a physiological signal; the base includes an adhesive pad to which a release layer is attached; the bottom cover includes a chassis portion attached to a tear element; the tear element is connected to the release layer; The tear element is configured to peel the release layer from the adhesive pad when the bottom cover is removed from the bottom opening.

2. the bottom opening and the bottom cover each have a first joint and a second joint; the first joint is a convex ring disposed along an edge of the bottom opening; the second joint is an annular groove disposed along an edge of the bottom cover; The implantation device of claim 1 , wherein the convex ring is fitted into the annular groove.

3. The operating moment is within a range of 3 to 1000 kgf-mm (0.0294 to 9.8 [N-m]), The force acting on the operating portion and away from the bottom opening is within a range of 0.2 to 10 kgf (1.96 to 98 [N]), The implantation device according to claim 1 , wherein the distance between the operating portion and the force support portion is in the range of 15 to 100 millimeters.

4. The implantation device of claim 1 , wherein the containment space is an airtight space.

5. the bottom cover of the housing has a first compounding portion; The housing has a second blending portion, The first blending section and the second blending section are configured to be in contact with each other, the bottom cover defines a reference point; The embedding device of claim 1, wherein an angle formed by a first virtual line extending from the reference point to the first blending portion and a second virtual line extending from the reference point to the operating portion is in the range of 5 to 180 degrees.

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