Applicator device for applying an on-body unit
By integrating the first trigger mechanism with the housing design, the assembly gap and cumulative tolerance issues of existing application devices are resolved, improving the reliability of sensor implantation and user experience, and simplifying structural design.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- SHENZHEN SISENSING TECH CO LTD
- Filing Date
- 2025-12-23
- Publication Date
- 2026-06-26
AI Technical Summary
The existing application device's split trigger mechanism has assembly gaps and cumulative tolerances, resulting in indirect force transmission, loose feel, and even possible jamming or trigger failure, affecting the implantation success rate. In addition, it has a complex structure, a large number of parts, and high manufacturing complexity.
The design incorporates a first triggering mechanism and a housing, which are integrally molded. The pressing part actuates the first holding part to release the moving body, driving the sensor to be implanted under the skin. This eliminates assembly gaps and accumulated tolerances, improves structural rigidity and stability, and reduces the risk of false triggering through the reasonable arrangement of the pressing part and the housing.
It improves the reliability of the application device and the user experience, ensures the success rate and stability of sensor implantation, simplifies the structural design, and reduces manufacturing complexity and the number of parts.
Smart Images

Figure CN122272011A_ABST
Abstract
Description
Technical Field
[0001] This disclosure relates to the biomedical engineering industry, and more specifically to an application device for applying an on-body unit. Background Technology
[0002] For clinical diagnosis or personal health monitoring, continuous monitoring of physiological parameters in a user's body is frequently required. For example, for diabetic patients, it is essential to monitor their blood glucose levels in real-time and continuously so that they can regulate these levels through methods such as dietary adjustments or medication, thereby reducing the occurrence of complications caused by abnormal glucose concentrations. Currently, Continuous Glucose Monitoring (CGM) systems are an important glucose monitoring tool that obtains glucose concentration information by implanting sensors under the patient's skin, thus enabling real-time monitoring of blood glucose levels.
[0003] Generally, an application device typically includes a housing, an auxiliary mechanism releasably held within the housing, a sensor disposed within the auxiliary mechanism, and a triggering mechanism configured to release the auxiliary mechanism. When the auxiliary mechanism is released, it is actuated and moves the sensor toward the user to apply the sensor to the user. In the prior art, the triggering mechanism is typically designed as a separate component from the housing. Specifically, the triggering mechanism is a component independent of the housing, assembled at one end of the housing. The triggering mechanism releases the auxiliary mechanism by cooperating with structural components inside the housing (e.g., a retaining part within the housing for holding the auxiliary structure).
[0004] However, the aforementioned split structure presents potential reliability risks. Microscopic gaps or tolerance accumulation may exist during the assembly of the two independent components, leading to indirect force transmission, a loose feel, and even, in extreme cases, jamming or trigger failure, affecting the implantation success rate. Furthermore, this design often requires complex snap-fit or connecting structures on the housing to assemble the trigger mechanism, resulting in a complex structure that hinders the compactness of the overall device design. Additionally, it increases the number of components, manufacturing complexity, and assembly costs. Summary of the Invention
[0005] This disclosure is made in view of the above-mentioned state of the prior art, and its purpose is to provide a highly reliable application device that is easy for users to use.
[0006] Therefore, this disclosure provides an application device for applying an oncounit, the oncounit including a sensor at least partially implantable under the skin of a host and a transmitter operatively connected to the sensor. The application device includes: a housing including a proximal end near the surface of the host skin and a distal end away from the surface of the host skin; a motion body disposed within the housing and configured to be detachably coupled to the oncounit; a puncture member operatively coupled to the motion body and configured to implant the sensor at least partially under the skin; and a drive mechanism configured to push the motion body proximally. The application device includes a first trigger mechanism, the first trigger mechanism including a first holding portion configured to hold the motion body and a pressing portion actuating the first holding portion, the first holding portion responding to a force applied to the pressing portion to release the motion body, the released motion body being driven by the drive mechanism towards the proximal end to place the sensor at least partially under the skin of the host via the puncture member; the first trigger mechanism is integrally formed with the housing.
[0007] The application device disclosed herein provides an application device in which a first triggering mechanism is integrally formed with a housing. Specifically, by integrally forming the first triggering mechanism with the housing, during application, a force is applied to the first holding part by a pressing part, thereby actuating the first holding part and releasing the moving body coupled to the first holding part. Finally, the moving body, driven by a drive mechanism, drives the puncture member and sensor to be implanted subcutaneously into the host. In this case, the integral forming of the first triggering mechanism with the housing eliminates the assembly gap and accumulated tolerances between the first triggering mechanism and the housing, thereby improving the structural rigidity and stability of the triggering structure.
[0008] Additionally, in the application device disclosed herein, optionally, the surface of the distal end of the housing has a through structure, and the pressing portion at least partially coincides with the projection of the through structure along the central axis of the application device, wherein the pressing portion at least partially coincides with the projection of the housing in a direction perpendicular to the central axis of the application device. In this case, the pressing portion is substantially arranged within or below the contour range of the distal surface of the housing, that is, the top surface of the pressing portion is not higher than (e.g., flush with or recessed into) the peripheral surface of the distal end of the housing, thereby reducing accidental triggering and improving the reliability of the application device.
[0009] Additionally, in the application device disclosed herein, optionally, the first triggering mechanism further includes: a first actuating part configured to link the pressing part and the first holding part. The first holding part is formed at the distal end of the housing in a manner extending towards the proximal end. The first actuating part is configured to extend in a direction having a predetermined angle with the central axis of the application device, and the first linkage point between the first actuating part and the first holding part is close to the proximal end of the first holding part. In this case, the first holding part is constructed as a cantilever structure with its distal end as the deformation root. By setting the first linkage point near the proximal end (i.e., the free end) of the first holding part, the lever arm distance between the point of force application and the deformation root is substantially extended. The longer lever arm allows the user to generate the required bending moment with only a smaller driving force, thereby reducing the force required to trigger the application device.
[0010] Additionally, in the application device disclosed herein, optionally, the end of the first actuating part near the first holding part has a curved structure, and the first actuating part and the first holding part form a U-shaped groove. In this case, the U-shaped groove constitutes a stress dispersion feature. By smoothing the geometric abrupt change at the connection between the first actuating part and the first holding part, the local peak stress generated during actuation can be effectively released, and the tendency for the connection between the first actuating part and the first holding part to break can be suppressed, thereby ensuring the structural integrity of the triggering mechanism during the deformation process under stress.
[0011] Additionally, in the application device disclosed herein, optionally, the end of the first actuating part near the pressing part has a hardness not less than that of the end near the first holding part. In this case, by ensuring the rigidity of the transmission medium to suppress the self-compression or buckling deformation of the first actuating part when pressed, it is possible to suppress the absorption of the longitudinal displacement of the pressing part by the material deformation of the first actuating part, so that the input displacement of the pressing part can be directly and instantly converted into an effective output displacement that drives the first holding part to deflect. This can suppress the trigger stroke lag or ineffective idle stroke caused by insufficient rigidity of the first actuating part, thereby improving the response speed and actuation reliability of the application device.
[0012] Additionally, in the application device disclosed herein, optionally, the projection of the first actuating part along the central axis of the application device coincides with the long axis direction of the body unit. In this case, based on the requirement for long axis matching between the body unit and the outer contour of the upper arm, using the first actuating part as a reference for the user's force application operation, it is possible to guide the user to naturally align the long axis of the body unit with the extension direction of the upper arm when triggering application. This ensures that the adhesive patch of the body unit can form a maximum effective contact area with the skin surface, thereby improving the fit and long-term stability of the wear.
[0013] Additionally, in the application device disclosed herein, optionally, the distal end of the moving body has a first recessed structure, and when the moving body is at its distal end, the first actuating part at least partially passes through the first recessed structure. In this case, the first recessed structure accommodates at least a portion of the first actuating part, such that the first actuating part and the moving body partially overlap in the axial dimension rather than being simply stacked in series. This effectively reduces the axial cumulative height of the internal components, thereby reducing the longitudinal dimension and overall volume of the application device while ensuring functional integrity.
[0014] Additionally, in the application device disclosed herein, optionally, the distal end of the puncture member has a second recessed structure, and when the puncture member is at the distal end, the first actuating portion at least partially passes through the second recessed structure. In this case, the second recessed structure allows the puncture member to overlap with the first actuating portion in axial space as it moves distally, thereby reaching a more extreme position closer to the distal end of the housing. By eliminating mechanical interference between components, the puncture member can be completely detached from human tissue, and it can also be completely retracted into the housing, thereby reducing the risk of needle retention and the potential for needle puncture injury.
[0015] Additionally, in the application device disclosed herein, optionally, the first triggering mechanism further includes an additional holding portion and a second actuating portion. The additional holding portion is connected to the pressing portion via the second actuating portion, and the projections of the additional holding portion and the second actuating portion onto the central axis of the application device are aligned with the projections of the first holding portion and the first actuating portion onto the central axis of the application device. In this case, by introducing the additional holding portion and the second actuating portion and setting them opposite to the original first holding portion and the first actuating portion, a pair of radially aligned clamping or supporting forces can be formed on the moving body, thereby eliminating the overturning moment caused by unilateral force, ensuring that the moving body maintains a stable and non-skewed locking posture in the state to be activated, and improving the reliability of the overall triggering mechanism and the consistency of the operating feel.
[0016] Additionally, in the application device disclosed herein, the housing may optionally include at least one limiting portion disposed on the opposite or same side as the first holding portion, and the limiting portion abutting against the moving body. In this case, the limiting portion (or the first limiting portion) disposed on the same side as the first holding portion can balance the frictional force exerted by the first holding portion on the moving body during the triggering process, while the limiting portion (or the second limiting portion) disposed on the opposite side of the first holding portion can provide a reverse supporting force to counteract the biasing force exerted by the first holding portion and the drive mechanism on the moving body in the holding state, thereby suppressing the moving body from tilting to one side. Thus, by limiting the radial degree of freedom of the moving body by the first holding portion, it can be made to always stably displace along a preset axial path, thereby reducing jamming or operational failure caused by swaying.
[0017] According to this disclosure, an application device for an application body unit that is easy for users to use and has high reliability can be provided. Attached Figure Description
[0018] This disclosure will now be explained in further detail by way of example only with reference to the accompanying drawings.
[0019] Figure 1 This is an application overview diagram illustrating the analyte monitoring system involved in this embodiment example.
[0020] Figure 2 This is a schematic diagram showing a first-view view of the medical device involved in the examples of this disclosure.
[0021] Figure 3 This is a schematic diagram showing a second perspective of the medical device involved in the examples of this disclosure.
[0022] Figure 4 This is a block diagram illustrating an electronic device of a medical device according to an example of this disclosure.
[0023] Figure 5A This is a first-view schematic diagram showing the overall appearance of the analyte monitoring system involved in the example of this disclosure.
[0024] Figure 5B This is a first-view cross-sectional schematic diagram illustrating the analyte monitoring system involved in the example of this disclosure.
[0025] Figure 6 This is a schematic diagram showing the overall appearance of the analyte monitoring system involved in the example of this disclosure from a second perspective.
[0026] Figure 7A This is a schematic diagram illustrating the first state of decoupling between the cap and the housing as described in this disclosure example.
[0027] Figure 7BThis is a schematic diagram illustrating a second state of decoupling between the cap and the housing as described in the examples of this disclosure.
[0028] Figure 8A This is a schematic diagram showing a first-view perspective of the housing involved in the example of this disclosure.
[0029] Figure 8B This is a schematic diagram showing a second view of the housing involved in the example of this disclosure.
[0030] Figure 9A This is a schematic diagram illustrating another embodiment of the housing involved in the examples of this disclosure.
[0031] Figure 9B This is a schematic diagram illustrating another embodiment of the housing involved in the examples of this disclosure.
[0032] Figure 10A It shows the relationship with Figure 9A A schematic diagram of the cap fitting the shell.
[0033] Figure 10B It shows the relationship with Figure 9B A schematic diagram of the cap fitting the shell.
[0034] Figure 11 This is an exploded schematic diagram illustrating the analyte monitoring system described in this disclosure example.
[0035] Figure 12A This is a perspective view illustrating the first housing involved in the example of this disclosure.
[0036] Figure 12B This is a perspective view showing the first housing involved in the example of this disclosure from a second perspective.
[0037] Figure 12C This is a schematic cross-sectional view of the first housing involved in the example of this disclosure.
[0038] Figure 13 This is an exploded schematic diagram showing the first housing, auxiliary mechanism, and first drive mechanism involved in the example of this disclosure.
[0039] Figure 14A This is a schematic cross-sectional view showing the moving body involved in the example of this disclosure being held.
[0040] Figure 14B This is a schematic cross-sectional view showing the motion subject involved in the example of this disclosure when it is released.
[0041] Figure 14C This is a schematic cross-sectional view showing the moving body involved in the example of this disclosure being held.
[0042] Figure 15A This is an exploded schematic diagram from a first perspective showing the second housing and auxiliary mechanisms involved in the examples of this disclosure.
[0043] Figure 15B This is an exploded schematic diagram from a second perspective illustrating the second housing and auxiliary mechanisms involved in the examples of this disclosure.
[0044] Figure 15C This is an exploded schematic diagram from a third perspective illustrating the second housing and auxiliary mechanisms involved in the examples of this disclosure.
[0045] Figure 16A This is an exploded schematic diagram from a first perspective showing the moving body, the second drive mechanism, and the puncture member involved in the example of this disclosure.
[0046] Figure 16B This is an exploded schematic diagram from a second perspective showing the moving body, the second drive mechanism, and the puncture member involved in the example of this disclosure.
[0047] Figure 17A This is a schematic cross-sectional view showing the puncture member being held as described in the example of this disclosure.
[0048] Figure 17B This is a schematic cross-sectional view showing the puncture member involved in the example of this disclosure being released.
[0049] Figure 18A This is a first-view cross-sectional view showing the instrument kit involved in this disclosure before the application of medical devices.
[0050] Figure 18B This is a second-view cross-sectional view showing the instrument kit involved in the example of this disclosure before the application of medical instruments.
[0051] Figure 18C This is a cross-sectional view showing a first-view application of a medical device to a kit of instruments involved in this disclosure.
[0052] Figure 18D This is a cross-sectional view showing a second perspective of the instrument kit applied in the medical device according to the example of this disclosure.
[0053] Figure 18E This is a cross-sectional view showing the medical device being applied to a host by the instrument kit involved in this disclosure example.
[0054] Figure 18F This is a cross-sectional view showing the puncture component of the instrument kit involved in this disclosure in a second state after the medical device has been applied.
[0055] Figure 18GThis is a cross-sectional view showing the puncture component of the instrument kit involved in this disclosure in a third state after the medical device has been applied.
[0056] Figure 19 This is a cross-sectional view showing the moving body of the device kit 1 according to the example of this disclosure when the medical device is applied and then locked back into the first retaining part.
[0057] Figure 20A This is an exploded schematic diagram of the puncture component involved in the example of this disclosure.
[0058] Figure 20B This is a schematic diagram showing a first-view view of the assembled piercing member involved in the example of this disclosure.
[0059] Figure 20C This is a cross-sectional view showing the puncture member involved in the example of this disclosure.
[0060] Figure 20D This is a schematic diagram showing a second view of the assembled piercing member involved in the example of this disclosure.
[0061] Figure 20E This is a cross-sectional view showing another structure of the puncture member involved in the examples of this disclosure.
[0062] Figure 20F This is an external view showing another structure of the puncture member involved in the example of this disclosure.
[0063] Figure 20G This is a cross-sectional view showing another structure of the puncture member involved in the examples of this disclosure.
[0064] Figure 20H This is a cross-sectional view showing another structure of the puncture member involved in the examples of this disclosure.
[0065] Figure 20I This is a cross-sectional view showing another structure of the puncture member involved in the examples of this disclosure.
[0066] Figure 20J This is a cross-sectional view showing another structure of the puncture member involved in the examples of this disclosure.
[0067] Figure 21A This is an exploded view from a first perspective showing the sterilization components involved in the examples of this disclosure.
[0068] Figure 21B This is an exploded view showing a second perspective of the sterilization component involved in the example of this disclosure.
[0069] Figure 22A This is a structural schematic diagram showing a first-view view of the base involved in the example of this disclosure.
[0070] Figure 22B This is a structural schematic diagram showing a second view of the base involved in the example of this disclosure.
[0071] Figure 23 This is a schematic diagram illustrating the structure of the sensor involved in the example of this disclosure.
[0072] Figure 24 This is a schematic diagram showing the sensor disposed on the base as described in the example of this disclosure.
[0073] Figure 25A This is a schematic diagram showing the sealing cap of the present disclosure being disposed on the support portion.
[0074] Figure 25B It shows Figure 25A A cross-sectional view along the XX section line.
[0075] Figure 25C This is a structural schematic diagram showing a first-view view of the sealing cap involved in the example of this disclosure.
[0076] Figure 25D This is a structural schematic diagram showing a second perspective of the sealing cap involved in the example of this disclosure.
[0077] Figure 26 This is a schematic diagram illustrating the structure of the sharp object involved in the example of this disclosure.
[0078] Figure 27 This is a schematic diagram illustrating the structure of the first sealing element involved in the example of this disclosure.
[0079] Figure 28A This is a schematic diagram showing a first-view view of a sharp object assembled on a base, as described in this disclosure example.
[0080] Figure 28B This is a schematic diagram showing a second perspective of a sharp object mounted on a base, as described in the example of this disclosure.
[0081] Figure 28C This is a schematic diagram showing the limited depth portion abutting against the sealing cap as described in the example of this disclosure.
[0082] Figure 29A This is a schematic diagram illustrating the structure of the cap involved in the example of this disclosure.
[0083] Figure 29B This illustrates a cross-sectional view of the cap as described in the example of this disclosure.
[0084] Figure 30A This is a schematic diagram showing a first-view view of the cap being assembled onto the base, as described in the example of this disclosure.
[0085] Figure 30B This is a schematic diagram showing a second-view view of the cap being assembled onto the base, as described in the example of this disclosure.
[0086] Figure 30C This is a cross-sectional view showing the sterilization component involved in the example of this disclosure.
[0087] Figure 31A This is a schematic diagram showing the cap before coupling with a sharp object, as illustrated in the examples of this disclosure.
[0088] Figure 31B This is a schematic diagram illustrating the coupling of a cap with a sharp object as described in the examples of this disclosure.
[0089] Figure 32A This is a schematic diagram showing the cap and base before coupling, as illustrated in the example of this disclosure.
[0090] Figure 32B This is a schematic diagram showing the cap and base coupled together as described in the example of this disclosure.
[0091] Figure 33A This is a schematic diagram showing the electronic device and base involved in the example of this disclosure before assembly.
[0092] Figure 33B This is a schematic diagram showing the electronic device and its base as described in the present disclosure.
[0093] Figure 33C This is a schematic diagram showing the spring and connector before assembly, as described in the example of this disclosure.
[0094] Figure 33D This is a schematic diagram showing the spring and connector assembly involved in the example of this disclosure.
[0095] Figure 33E This is a schematic diagram illustrating the structure of the connector involved in the example of this disclosure.
[0096] Figure 34A This is a schematic diagram illustrating the assembly of the top cover and base as described in this disclosure example.
[0097] Figure 34B This is a schematic diagram illustrating the assembly of the top cover and base as described in this disclosure example.
[0098] Figure 34C It shows Figure 34B The diagram shows an enlarged view of region A.
[0099] Figure 35 This is a schematic diagram showing the assembly of the housing with the sterilization assembly containing the electronic device and the top cover, as described in the example of this disclosure. Detailed Implementation
[0100] Hereinafter, preferred embodiments of the present disclosure will be described in detail with reference to the accompanying drawings. In the following description, the same reference numerals are used for the same components, and repeated descriptions are omitted. Furthermore, the drawings are merely schematic diagrams, and the proportions of the components or the shapes of the components may differ from actual figures.
[0101] It should be noted that the terms "comprising" and "having" and any variations thereof in this disclosure, such as a process, method, system, product, or device that includes or has a series of steps or units, are not necessarily limited to those steps or units that are explicitly listed, but may include or have other steps or units that are not explicitly listed or that are inherent to such processes, methods, products, or devices.
[0102] It should be noted that in this article, relative position and direction terms such as "above", "facing upward", "below", "facing downward", "up and down direction", "left side", "facing left side", "left side", "facing left side", "right side", "facing right side", "right side", "facing right side", "left and right direction", "front", "facing forward", "back", "facing backward", and "front and back direction" are used with reference to the usual operating posture and should not be considered as restrictive.
[0103] First, let me introduce the relevant terminology used in this disclosure.
[0104] "Decoupling" can refer to removing coupling.
[0105] "Tightness" can refer to the degree of tightness between components.
[0106] In some examples, the analyte monitoring system disclosed herein may also be referred to as an analyte monitoring device, analyte monitor, analyte concentration information acquisition device, or biomonitoring device, etc. Additionally, the sensors involved in the examples of this disclosure may also be referred to as monitoring probes, sensing probes, or electrode probes, etc.
[0107] In some examples, for an analyte of glucose, the sensor can be a glucose sensor, and the analyte level can be glucose concentration. However, it is not limited to glucose concentration. For example, by changing the sensing layer of the sensor, other body fluid components besides glucose concentration can also be obtained. These body fluid components can be, for example, one or more of the following: glucose, acetylcholine, amylase, bilirubin, cholesterol, human chorionic gonadotropin, creatine kinase, creatine, creatine anhydride, DNA, fructosamine, glutamine, growth hormone, hormones, blood ketones, lactate, oxygen, peroxides, prostate-specific antigen, prothrombin, RNA, thyroid-stimulating hormone, or troponin.
[0108] For ease of description, some examples below use glucose as the analyte, and correspondingly, the analyte level is the glucose concentration. It should be noted that this does not constitute a limitation of this disclosure, and unless there is a contradiction, the relevant descriptions also apply to other analyte levels.
[0109] The analytical substance monitoring system described in this disclosure is illustrated below with reference to the accompanying drawings.
[0110] Figure 1 This diagram illustrates an application overview of the analyte monitoring system 1 according to an example of this embodiment. In some examples, the analyte monitoring system 1 may include a medical device 800 and an application device 1000, the medical device 800 being applied to a host via the application device 1000, and the host obtaining physiological information through the medical device 800 applied to themselves. In some examples, the medical device 800 may be applied to a desired location. In this disclosure, the medical device 800 may also be referred to as an on-body unit 800.
[0111] In some examples, the analyte monitoring system 1 may include a reading device 900 that is communicatively connected to the medical device 800 (see [reference]). Figure 1 The medical device 800 applied to the host can transmit the acquired physiological information, for example wirelessly, to the reading device 900, thereby enabling the host to read and monitor its own physiological information.
[0112] In addition, this disclosure also provides an instrument kit 90, which may include the application device 1000 disclosed herein for applying the medical device 800 to a host.
[0113] In some examples, medical device 800 can be configured to acquire the host's analyte levels. In some examples, medical device 800 can be a sensing device. In some examples, medical device 800 can be an analyte sensor device that can generate information about a specific analyte in the body fluid based on the body fluid, such as reacting with the analyte in the body fluid and generating analyte information. In this case, the sensor 820 reacts with the analyte in the body fluid, thereby facilitating the acquisition of analyte information in the body fluid. For example, medical device 800 can be applied to the host's body surface and at least partially located under the host's skin to acquire the host's subcutaneous glucose concentration.
[0114] In this disclosure, the analyte sensor device can target one or more of the following: glucose, acetylcholine, amylase, bilirubin, cholesterol, human chorionic gonadotropin, creatine kinase, creatine, creatine anhydride, DNA, fructosamine, glutamine, growth hormone, hormones, ketone bodies, lactate, oxygen, peroxides, prostate-specific antigen, prothrombin, RNA, thyroid-stimulating hormone, or troponin.
[0115] The following description uses glucose as an example to illustrate the medical device 800 involved in this disclosure. It should be noted that, for other analytes, those skilled in the art can perform analysis on other analytes by making minor modifications to the medical device 800 used for glucose.
[0116] Figure 2 This is a schematic diagram showing a first-view view of the medical device 800 to which this disclosure is based. Figure 3 This is a schematic diagram showing a second view of the medical device 800 to which the present disclosure example relates.
[0117] In some examples, medical device 800 may include sensor 820 and dressing 860 (see Figure 2 or Figure 3 In some examples, the sensor 820 may be supported on the applicator 860. In this disclosure, the applicator 860 may also be referred to as the transmitter 860.
[0118] In some examples, sensor 820 can be placed partially or entirely under the skin of the host. In other words, sensor 820 can be placed at least partially under the skin. This allows for the monitoring of physiological information in the subcutaneous tissue fluid.
[0119] In some examples, after being placed subcutaneously, sensor 820 can react with glucose in the subcutaneous tissue fluid to generate glucose information for the host. The patch 860 can be applied to the host's body surface. In some examples, patch 860 can also receive the glucose information generated by sensor 820. In some examples, patch 860 can also provide the sensor 820 with the electrical energy required to acquire physiological information. This facilitates continuous monitoring by sensor 820 under the host's skin.
[0120] In some examples, the implanted portion of sensor 820 can be elongated. In some examples, the implanted portion can be rigid. This facilitates placement under the host's skin. In other examples, the implanted portion can be flexible, in which case the host's foreign body sensation can be reduced. In some examples, after being implanted into the host, the implanted portion reaches the dermis and is located in the interstitial space of the skin, allowing sensor 820 to collect glucose information from the interstitial fluid.
[0121] In some examples, the applicator 860 may also include a hole 862 extending from the upper surface to the lower surface (see...). Figure 2 or Figure 3 And when the sensor 820 is assembled into the application part 860, the axis of the sensor 820 can pass through the hole 862 (see Figure 2 or Figure 3In this case, the sharp object 270 (described later) is inserted subcutaneously through the hole, which helps to place the sensor 820 subcutaneously.
[0122] In some examples, the implantation site may include a working electrode and a counter electrode. In this disclosure, a sensing layer including a glucosidase may be disposed on the working electrode. The sensor 820, placed subcutaneously, can generate a current signal by reacting with glucose in tissue fluid or blood via the glucosidase on the working electrode, forming a circuit with the counter electrode. This current signal is then analyzed to obtain glucose concentration information. In some examples, the current signal generated by the sensor 820 can be transmitted to the dressing 860.
[0123] In some examples, the implanted portion may also include a reference electrode. In some examples, the reference electrode may form a known and fixed potential difference with the tissue fluid or blood. In this case, the potential difference between the working electrode and the tissue fluid or blood can be measured by the potential difference formed between the reference electrode and the working electrode. This allows for a more accurate determination of the voltage generated by the working electrode. Consequently, the electronic device 880 of the dressing portion 860 (described later) can automatically adjust and maintain a stable voltage at the working electrode according to a preset voltage value, so that the measured current signal can more accurately reflect the glucose concentration information in the tissue fluid or blood. In some examples, the number of reference electrodes may be one or more, for example, two.
[0124] In some examples, the patch 860 is configured to adhere to the surface of a host. In some examples, the patch 860 may also include an adhesive sheet 870 with adhesive properties (see [link to original text]). Figure 2 or Figure 3 The application portion 860 can be applied to and fixed to the surface of the host's body by the adhesive sheet 870.
[0125] In some examples, the body element 800 has a racetrack-shaped profile in its projection along the central axis CA of the application device 1000. In some examples, the body element 800 has a major axis LA in a direction intersecting the central axis CA of the application device 1000.
[0126] Figure 4 This is a block diagram illustrating the electronic device 880 of the medical device 800 to which this disclosure relates.
[0127] See in some examples Figure 4The dressing unit 860 may also include an electronic device 880. The electronic device 880 can receive glucose information generated by the sensor 820. In some examples, the electronic device 880 can further process the glucose information. In other examples, the electronic device 880 can also transmit the received glucose information to an external device, such as the reading device 900 described below. Additionally, the electronic device 880 can also power the sensor 820.
[0128] In some examples, electronic device 880 may include power module 882, switching module 884, and processing module 886 (see [link to documentation]). Figure 4 The power supply module 882 can supply power to the sensor 820 and / or the processing module 886, the switch module 884 can control the connection and disconnection between the power supply module 882 and the sensor 820 and / or the processing module 886, and the processing module 886 can process the signal (e.g., glucose information) generated by the sensor 820.
[0129] In some examples, the applicator 860 has an initial mode configured as an open circuit and an operating mode configured as a closed circuit. In this case, the applicator 860 is configured as an open circuit when in the initial mode, thereby saving power consumption before the applicator 860 enters the operating state. In some examples, the switch module 884 can be in an open state when the applicator 860 is configured as the initial mode, and the switch module 884 can be in a closed state when the applicator 860 is configured as the operating mode. That is, the switch module 884 can switch the applicator 860 from the initial mode to the operating mode. In this case, controlling the switching of the applicator 860 from the initial mode to the operating mode by the switch module 884 can effectively reduce power consumption before operation.
[0130] Additionally, in some examples, the electronic device 880 may also include a storage module 888 (see [link to documentation]). Figure 4 The storage module 888 can store the signals generated by the sensor 820. Additionally, in some examples, the electronic device 880 may also include a communication module 890 (see...). Figure 4 The communication module 890 can communicate with external devices (e.g., smart terminal devices). In some examples, the communication module 890 can be a Bluetooth module, an NFC module, a Wi-Fi module, etc. In some examples, the smart terminal device can be a smartphone, a smartwatch, a tablet, a computer, etc.
[0131] In some examples, the applicator 860 can be configured to be activated from an initial mode to an operating mode by magnetic or optical action. In this case, activating the applicator 860 from the initial mode to the operating mode by a non-contact component such as magnetic or optical action can help to miniaturize the applicator 860.
[0132] In other examples, the switch module 884 may also be configured as a magnetically controlled switch. For example, in the initial mode, the switch module 884 may be in an open state, and when the magnetic force acting on the switch module 884 changes, the switch module 884 may switch from the open state to the closed state, thereby activating the applicator 860 from the initial mode to the working mode.
[0133] In some examples, the application device 1000 may include a magnet. When the medical device 800 is not yet applied to the host, the switching module 884 of the electronic device 880 may be in an open state because the electronic device 880 of the medical device 800 is currently near the magnet. When the medical device 800 is applied to the host, the switching module 884 of the electronic device 880 may be activated to a closed state because the electronic device 880 of the medical device 800 is currently away from the magnet.
[0134] Additionally, in some examples, the power module 882 of the electronic device 880 can also be configured to provide power to the sensor 820. In some examples, when the electronic device 880 is in an initial mode, the power module 882 can be disconnected from the sensor 820, and when the electronic device 880 is activated to an operating mode (i.e., when the switch module 884 is closed), the power module 882 can be connected to the sensor 820 to provide power to the sensor 820.
[0135] In some examples, as described above, the applicator 860 can be configured to communicate with an external device via wireless or wired communication. In this case, by configuring the applicator 860 to communicate with an external device, the analyte information acquired by the sensor 820 can be read in real time or periodically. In some examples, the external device can be a reading device 900.
[0136] In some examples, as described above, the medical device 800 can communicate with the reading device 900. In some examples, the reading device 900 can be a display with communication capabilities. In some examples, the communication function of the reading device 900 can be implemented through wireless or wired communication. Wireless communication methods can include Bluetooth, NFC, Wi-Fi, etc. Wired communication methods can include USB, fiber optic, etc.
[0137] In other examples, the reading device 900 may also be a smart terminal with an application installed that is compatible with the medical device 800. The smart terminal can be a laptop, tablet, smartphone, etc.
[0138] As described above, the medical device 800 of this disclosure can be applied to a host via the application device 1000. Hereinafter, the analyte monitoring system 1 of this disclosure will be described in detail with reference to the accompanying drawings.
[0139] Figure 5A This is a schematic diagram showing the overall appearance of the analyte monitoring system 1 according to the example of this disclosure from a first perspective; Figure 5B This is a first-view cross-sectional schematic diagram showing the analyte monitoring system 1 involved in the example of this disclosure. Figure 6 This is a second-view schematic diagram showing the overall appearance of the analyte monitoring system 1 according to the example of this disclosure. Figure 5A A schematic diagram showing the central axis CA of the application device 1000 and the coupling of the cap 700 and the housing 10 is shown. Figure 5B Sensor 820 is not shown.
[0140] See in some examples Figure 5A and Figure 5B The analyte monitoring system 1 disclosed herein is an integrated structure, with the medical device 800 pre-assembled into the application device 1000 at the factory stage. The analyte monitoring system 1 can be provided to the user in an integrated package, allowing the user to directly apply the medical device 800 to the host via the application device 1000 without any assembly steps during use.
[0141] See in some examples Figure 5B The analyte monitoring system 1 may include an application device 1000 and a medical device 800. In some examples, the medical device 800 may be releasably held in the application device 1000.
[0142] In some examples, the analyte monitoring system 1 may include a cap 700 coupled to the application device 1000. In some examples, the cap 700 may have a sealed space that accommodates at least a portion of the sensor 820. This allows at least a portion of the sensor 820 to be isolated from external contaminants.
[0143] See in some examples Figure 5B The application device 1000 may include a housing 10. In some examples, a cap 700 may be coupled to the housing 700. Thus, a medical device 800 can be covered within the application device 1000.
[0144] In some examples, the cap 700 may be removably coupled to the housing 10. In some examples, removing the cap 700 may expose the medical device 800 held in the application device 1000. In some examples, when the cap 700 is removed, a user may use the application device 1000 to apply the medical device 800 to the host.
[0145] As described above, the medical device 800 may include a sensor 820 and an applicator 860. The sensor 820 may extend from the bottom of the applicator 860. In some examples, the cap 700 is configured to provide a sealed space for the tail 821 of the sensor 820. This allows for the isolation of external contaminants before the sensor 820 is implanted into the host.
[0146] See in some examples Figure 5B The instrument kit 90 may include a sharp object 270. In some examples, the sharp object 270 may be configured to carry a tail 821 and penetrate the subcutaneous tissue of the host.
[0147] In some examples, the cap 700 may be coupled to at least one of the medical device 800 or the sharp object 270 to form a sealed space accommodating at least a portion of the sensor 820. For example, the cap 700 may be coupled to the medical device 800, or to the sharp object 270, or simultaneously to both the medical device 800 and the sharp object 270 to form the aforementioned sealed space.
[0148] In some examples, the cap 700 may also be configured to provide a sealed space for the tail of the sharp object 270. In some examples, the sharp object 270 may pass through the applicator 860 and extend from the bottom of the applicator 860, and the portion of the sharp object 270 extending out of the applicator 860 may be accommodated in the sealed space.
[0149] In some examples, the sharp object 270 may have a space for carrying and accommodating the sensor 820, which may be at least partially accommodated within the sharp object 270. In some examples, the sharp object 270 and the sensor 820 may be at least partially located within the aforementioned sealed space.
[0150] In some examples, the sharp object 270 may not have space to support and accommodate the sensor 820. In this case, the angle between the sensor 820 and the sharp object 270 can be properly set so that the tail 821 of the sensor 820 fits against the sharp object 270.
[0151] See in some examples Figure 5B The cap 700 may include a mating portion 720. In some examples, the mating portion 720 may be coupled to at least one of the medical device 800 and the sharp object 270. This allows for the formation of a sealed space that accommodates at least a portion of the sensor 820.
[0152] In some examples, the mating part 720 has a chamber 710 configured to receive at least a portion of the sensor 820. In some examples, the tail of the sharp object 270 and the tail 821 of the sensor 820 can be jointly received in the chamber 710. Thus, a sealed space can be provided for the tail of the subcutaneously penetrable sharp object 270 and the tail 821 of the subcutaneously implanted sensor 820.
[0153] In some examples, the sharp object 720 may have a needle-like portion 272 and a cap portion 276. The mating portion 720 may be coupled to the end of the cap portion 276 near the applicator portion 860 to form the aforementioned sealed space. In some examples, the mating portion 720 may be formed by relative screwing to the end of the cap portion 276 near the applicator portion 860 (i.e., the connecting portion 2741). In some examples, the sealed space may also be formed by snap-fit, male-female mating, or other similar methods.
[0154] In some examples, the cap 700 may include a bottom cover 770 that engages with the mating portion 720. In some examples, the bottom cover 770 may be coupled to the housing 10 of the application device 1000.
[0155] In some examples, the bottom cover 770 can be removably coupled to the housing 10.
[0156] Figure 7A This is a schematic diagram showing a first state in which the cap 700 is decoupled from the housing 10, as illustrated in this disclosure example. Figure 7B This is a schematic diagram showing a second state in which the cap 700 is decoupled from the housing 10, as illustrated in this disclosure example.
[0157] In some examples, housing 10 may have engagement feature 191, and bottom cover 770 may have engagement feature 791. For ease of description, engagement feature 191 of housing 10 will be referred to as first engagement feature 191, and engagement feature of bottom cover 770 will be referred to as second engagement feature 791.
[0158] In some examples, the bottom cover 770 can be coupled to the housing 10 by the engagement of the first engagement feature 191 and the second engagement feature 791.
[0159] In some examples, the end of the application device 1000 that is away from the host when in use can be referred to as the distal end, and the end of the application device 1000 that is facing the host when in use can be referred to as the proximal end.
[0160] In some examples, the first engagement feature 191 may have a first engagement surface facing the distal end. In some examples, the second engagement feature 791 may have a second engagement surface facing the proximal end. When the first engagement surface abuts against the second engagement surface, the cap 700 may be coupled to the housing 10.
[0161] See in some examples Figure 7A and Figure 7B The housing 10 may include a proximal end portion having a first engagement feature 191. In some examples, the first engagement feature 191 may extend circumferentially along the housing 10. In some examples, the first engagement feature 191 may be an annular opening formed at the proximal end portion. In some examples, the first engagement feature 191 may be formed as a guide groove at the proximal end portion, such as an annular groove formed as the inner wall of the proximal end portion.
[0162] As described above, the bottom cover 770 may have a second engagement feature 791. In some examples, the second engagement feature 791 may be a protrusion formed on the periphery of the bottom cover 770.
[0163] In some examples, the bottom cover 770 can move along the first engagement feature 191 to separate from the application device 1000. In some examples, the movement of the bottom cover 770 along the first engagement feature 191 can disengage the engagement of the first engagement feature 191 and the second engagement feature 791 to decouple the bottom cover 770 and the application device 1000.
[0164] See in some examples Figure 6 and Figure 7A During the decoupling process between the cap 700 and the housing 10, the second engagement feature 791 and the first engagement feature 191 can move relative to each other. In some examples, the second engagement feature 791 can move along the extension path of the first engagement feature 191. In some examples, the movement path of the second engagement feature 791 relative to the first engagement feature 191 can be an arc.
[0165] In some examples, the engagement of the first engagement feature 191 and the second engagement feature 791 can be disengaged by relative screwing of the housing 10 and the cap 700. In some examples, the medical device 800 held in the application device 1000 can be exposed by relative screwing of the housing 10 and the cap 700. In some examples, the cap 700 can be decoupled from the housing 10 by rotating it relative to the housing 10 by a preset angle. In some examples, the cap 700 can be decoupled from the sharp object 270 in response to decoupling from the housing 10.
[0166] The angle of the arc corresponding to the movement path of the second engagement feature 791 relative to the first engagement feature 191 is set as a preset angle. In some examples, the preset angle may be the same as the angle at which the cap 700 is coupled to the sharp object 270. In some examples, the relative turning direction when decoupling the cap 700 and the housing 10 may be opposite to the relative turning direction when coupling the cap 700 and the sharp object 270. Thus, the cap 700 can be decoupled from the sharp object 270 while simultaneously decoupling from the housing 10.
[0167] In some examples, the angle corresponding to the path defined by the first engagement feature 191 can be equal to a preset angle. Thus, when the second engagement feature 791 is moved from the starting position to the ending position along the first engagement feature 191, the cap 700 can be decoupled from the housing 10.
[0168] In some examples, the angle corresponding to the path defined by the first engagement feature 191 can be greater than a preset angle. The user can rotate the second engagement feature 791 along the extension path of the first engagement feature 191 by a preset angle through observation or other means to decouple the cap 700 from the housing 10.
[0169] See in some examples Figure 5A The housing 10 may have a first indicator 192, and the cap 700 may have a second indicator 792. In some examples, the cap 700 is coupled to the housing 10 when the first indicator 192 and the second indicator 792 are aligned. When the analyte monitoring system 1 is removed from the packaging, it can be determined whether the analyte monitoring system 1 has undergone any undesirable morphological changes before use based on whether the first indicator 192 and the second indicator 792 are aligned.
[0170] In some examples, during the decoupling of the cap 700 from the housing 10, the first indicator 192 and the second indicator 792 can move relative to each other. In some examples, the movement path of the second indicator 792 relative to the first indicator 192 can be an arc, and the angle corresponding to the arc can be equal to a preset angle.
[0171] In some examples, after the cap 700 is screwed relative to the housing 10 at a preset angle, the cap 700 can then move away from the housing 10 to decouple it from the housing 10 (see [reference]). Figure 5A , Figure 7A and Figure 7B ).
[0172] Figure 8A This is a schematic diagram showing a first view of the housing 10 involved in the example of this disclosure; Figure 8B This is a schematic diagram showing a second view of the housing 10 involved in the example of this disclosure.
[0173] See in some examples Figure 8A and Figure 8B The housing 10 may have a decoupling groove 193. In some examples, the decoupling groove 193 may communicate with the first engagement feature 191. In some examples, the decoupling groove 193 may be configured to provide a path for decoupling the cap 700 from the housing 10. In some examples, the decoupling groove 193 may be located at one end of the first engagement feature 191, for example, at the end position of the first engagement feature 191.
[0174] In some examples, the second engagement feature 791 can move from the end of the first engagement feature 191 away from the decoupling groove 193 to the end near the decoupling groove 193. In some examples, when the second engagement feature 791 moves to the end of the first engagement feature 191 near the decoupling groove 193, the second engagement feature 791 can enter the decoupling groove 193. In some examples, the second engagement feature 791 can move away from the housing 10 along the extending direction of the decoupling groove 193.
[0175] In some examples, the housing 10 may have at least one first engagement feature 191, for example, one, two, three, or four first engagement features 191. In some examples, when the housing 10 has multiple first engagement features 191, the multiple first engagement features 191 may be symmetrically arranged near the proximal end of the housing 10. This allows for stable coupling of the cap 700 to the application device 1000. In some examples, the number of second engagement features 791 may be the same as the number of first engagement features 191.
[0176] Figure 9A This is a schematic diagram illustrating another embodiment of the housing 10 involved in the examples of this disclosure. Figure 9B This is a schematic diagram illustrating another embodiment of the housing 10 involved in the examples of this disclosure. Figure 10A It shows the relationship with Figure 9A A schematic diagram of the cap 700 that fits the housing 10. Figure 10B It shows the relationship with Figure 9B A schematic diagram of the cap 700 that fits the housing 10.
[0177] In some examples, housing 10 may be coupled to cap 700 in such a way that it is at least partially received in cap 700.
[0178] In some examples, as described above, the first engagement feature 191 may have a first engagement surface facing the distal end. In some examples, as described above, the second engagement feature 791 may have a second engagement surface facing the proximal end. When the first engagement surface 12 abuts against the second engagement surface 712, the cap 700 may be coupled to the housing 10.
[0179] See in some examples Figure 9A and Figure 9B The first joining feature 191 may be a circumferential rib formed near the proximal end. See some examples. Figure 10A and Figure 10B The second joining feature 791 can be a circumferential rib formed on the cap 700.
[0180] In some examples, a decoupling structure may be present between two adjacent first engagement features 191. In some examples, the second engagement feature 791 can be disengaged from the first engagement feature by relative rotation of the cap 700 and the housing 10. This allows the cap 700 to be decoupled from the housing 10. In some examples, the decoupling structure may refer to a portion near the end where no other structure is formed, for example, a portion where the first engagement feature 191 is not formed; in this case, there is no need to additionally provide the decoupling groove 193 mentioned above. Thus, when the second engagement feature 791 is operated in accordance with the decoupling structure, it can be released in a direction away from the housing 10, thereby decoupling the cap 700 and the housing 10.
[0181] In some examples, at least a portion of the structure of the second joining feature 791 may be a tearable feature.
[0182] See in some examples Figure 10B The tearable feature may have a breakable portion 713. In some examples, the breakable portion can be removed in a direction away from the central axis CA. This allows for at least partial disengagement of the engagement between the first engagement feature 191 and the second engagement feature 791.
[0183] See in some examples Figure 10B The breakable portion may have discontinuous circumferential ribs, and when the discontinuous circumferential ribs abut against the first engagement feature 191, the cap 700 may be connected to the housing 10. In some examples, the breakable portion may have continuous circumferential ribs.
[0184] See in some examples Figure 10B The tearable feature may have a protrusion 7131. In some examples, the protrusion may be attached to the breakable portion. This facilitates user removal of the breakable portion. In some examples, the protrusion 7131 may serve as a second indicator 792 of the cap, engaging with the first indicator 192 of the housing 10.
[0185] In some examples, the second engagement feature 791 includes a circumferential rib disposed opposite to the tearable feature. When the tearable portion is removed, the second engagement feature 791 can be disengaged from the circumferential rib disposed opposite the tearable feature by relative rotation of the cap 700 and the housing 10. This allows the cap 700 to engage with the housing 10.
[0186] Embodiments of this disclosure include: A. A method of using an analyte monitoring system, the analyte monitoring system comprising an application device having a housing, a cap removably coupled to the housing, a medical device held in the application device, and a sharp object fitted to the medical device, the method of use comprising: relative screwing the housing and the cap to expose the medical device held in the application device, wherein the cap decouples from the sharp object in response to decoupling from the housing.
[0187] In some examples, Embodiment A may be combined with any one or more of the following additional elements: Element 1: The cap is rotated by a predetermined angle relative to the housing to decouple from the housing. Element 2: The housing includes a proximal end having a first engagement feature. Element 3: The first engagement feature extends circumferentially along the housing. Element 4: The first engagement feature is a guide groove, an annular opening, or a circumferential rib formed at the proximal end. Element 5: The cap has a second engagement feature. Element 6: The second engagement feature is a protrusion or circumferential rib formed on the cap. Element 7: The second engagement feature moves along the extension path of the first engagement feature. Element 8: The movement path of the second engagement feature relative to the first engagement feature is an arc, the angle corresponding to the arc being equal to the predetermined angle. Element 9: The housing has a first indicator portion, and the cap has a second indicator portion, wherein the first indicator portion and the second indicator portion move relative to each other during the decoupling of the cap from the housing. Element 10: The movement path of the second indicator relative to the first indicator is an arc, the angle corresponding to the arc being equal to the preset angle. Element 11: After the cap and the housing are rotated relative to each other at the preset angle, the second engagement feature moves from one end of the first engagement feature to the other end, and the cap moves away from the housing to decouple from the housing. Element 12: In response to an action applied to the cap along the central axis of the application device, the second engagement feature is released along the decoupling groove. Element 13: The housing of the application device also has an engagement feature along which the bottom cover moves to separate from the application device. Element 14: The projection of the body unit along the central axis of the application device has a racetrack-shaped profile. Element 15: The body unit has a major axis in a direction intersecting the central axis of the application device.
[0188] Figure 11 This is an exploded schematic diagram of the analyte monitoring system 1 as described in this disclosure example.
[0189] In this disclosure, the device kit 90 may include an application device 1000 for applying the medical device 800 to a host. See also: [link to example]. Figure 11The application device 1000 may include a housing 10 providing a space for movement, and an auxiliary mechanism 20 (described later) configured to move within the space of movement of the housing 10. The housing 10 may have a proximal end that is close to the host during operation and a distal end that is distant from the host. The auxiliary mechanism 20 may be releasably held in the housing 10 and may house the medical device 800. The auxiliary mechanism 20 may be configured to move relative to the housing 10 and be driven toward the host when released to apply the medical device 800 to the host. It is understood that, herein, "proximal end" may be understood as the end that is close to the host during operation, and "distal end" may be understood as the end that is distant from the host during operation.
[0190] In some examples, the housing 10 may have a movable space, and the auxiliary mechanism 20 may be releasably retained within the housing 10. In some examples, the auxiliary mechanism 20 may be movable within the movable space of the housing 10 when it is released. Additionally, in some examples, the housing 10 may also define the application site of the medical device 800 on the host's body surface.
[0191] See in some examples Figure 11 The housing 10 may include a first housing 100 and a second housing 140. In some examples, the second housing 140 may be fitted onto the first housing 100. The first housing 100 and the second housing 140, when fitted together, may form a space for movement. The first housing 100 may releasably hold the auxiliary mechanism 20. In some examples, the first housing 100 may define the application site of the medical device 800 on the body surface of the host. In some examples, the second housing 140 may define the application site of the medical device 800 on the body surface of the host.
[0192] In some examples, the second housing 140 may be fixedly assembled to the first housing 100. In some examples, the first housing 100 and the second housing 140 may be integrally formed.
[0193] In some examples, the second housing 140 may define a path of movement for the auxiliary mechanism 20. After being released by the first housing 100, the auxiliary mechanism 20 may move relative to the second housing 140 along the path defined by the second housing 140 and apply the medical device 800 to the application site. In this disclosure, the axes of the first housing 100 and the second housing 140 may be substantially parallel to the central axis CA of the application device 1000.
[0194] See in some examples Figure 11The auxiliary mechanism 20 may include a moving body 200 and a receiving portion 250. In some examples, the moving body 200 may be releasably held in the first housing 100. In some examples, the moving body 200 may be configured to move along a movement path defined by the second housing 140 when released. In some examples, the receiving portion 250 may be disposed in the moving body 200 and may be configured to releasably hold the medical device 800. In some examples, after the moving body 200 is released, it may move toward the proximal end of the housing 10, and the receiving portion 250 may also move toward the proximal end of the housing 10 to apply the medical device 800, housed within the receiving portion 250, to the host. In this disclosure, the distal end of the moving body 200 is the end of the application device 1000 that is away from the host during use, and the proximal end of the moving body 200 is the end of the application device 1000 that is towards the host during use.
[0195] See in some examples Figure 11 The instrument kit 90 may include a sharp object 270 and a support 280 for supporting the sharp object 270 and assembled to the moving body 200. Hereinafter, for ease of description, the sharp object 270 and the support 280 may be referred to as a whole as the puncture member 260.
[0196] In some examples, the puncture member 260 may be disposed within the moving body 200. When the moving body 200 is released, it can be driven proximally and, through the puncture member 260, place the medical device at least partially under the skin of the host. Specifically, the puncture member 260 may be disposed within the moving body 200 through the receiving portion 250. After the moving body 200 is released, it can move proximally towards the housing 10, and the receiving portion 250 and the puncture member 260 also move proximally towards the housing 10 to apply the medical device 800, received within the receiving portion 250, to the host. In some examples, the puncture member 260 may penetrate subcutaneously into the host, thereby placing the medical device 800 at least partially under the host's skin.
[0197] In some examples, the implantable subcutaneous component (e.g., a sensor) in the medical device 800 can have a certain degree of rigidity. Therefore, the sensor can be implanted subcutaneously without the need for the puncture member 260. In other words, the device kit 90 may also exclude the puncture member 260, allowing the sensor to be implanted subcutaneously based on its own rigidity.
[0198] See in some examples Figure 11The application device 1000 may further include a first drive mechanism 30. In some examples, the first drive mechanism 30 may be configured to apply an action to the auxiliary mechanism 20 in a proximal manner. In some examples, when the auxiliary mechanism 20 is released, the first drive mechanism 30 may drive the auxiliary mechanism 20 toward the host. Thus, the medical device 800, releasably held in the auxiliary mechanism 20, can be automatically applied to the host.
[0199] In some examples, the first actuation mechanism 30 may be configured to apply an action to the motion body 200 in a proximal manner. When the motion body 200 is released, it may be driven proximally by the first actuation mechanism 30 to push the medical device 800, housed within the receiving portion 250, toward the host, for example, toward the application site defined by the receiving housing 10. Alternatively, the medical device 800 may be at least partially placed subcutaneously in the host via the puncture member 260.
[0200] In other examples, the application device 1000 may not include the first drive mechanism 30. In this case, the motion body 200 may also be manually driven to move towards the proximal end when it is released.
[0201] Figure 12A This is a perspective view showing the first housing 100 involved in the example of this disclosure; Figure 12B This is a perspective view showing the first housing 100 involved in the example of this disclosure from a second perspective. Figure 12C This is a schematic cross-sectional view of the first housing 100 as described in this disclosure.
[0202] In some examples, as described above, housing 10 may include a first outer shell 100. In some examples, the first outer shell 100 may be formed as a hollow cylindrical shell extending vertically along the central axis CA of the application device 1000. In some examples, the first outer shell 100 may be formed as a cylindrical shell with an opening only at its proximal end.
[0203] See in some examples Figure 12A The first housing 100 may include a peripheral portion 110 and a distal portion 120. In some examples, the distal portion 120 may be formed on the peripheral portion 110 in a manner close to the distal end of the housing 10. In some examples, the central axis CA may pass through the geometric center of the distal portion 120.
[0204] See in some examples Figure 12AThe first housing 100 may include a first holding portion 130. In some examples, the first holding portion 130 may be configured to releasably hold the moving body 200. In some examples, the first holding portion 130 may be located at the distal end 120. In some examples, the first holding portion 130 may extend from the distal end 120 along the central axis CA toward the proximal end of the application device 1000. In this case, when the moving body 200 is held at the distal end 120, the moving body 200 may be located within the hollow portion of the peripheral portion 110, and when the moving body 200 is released, the moving body 200 may move substantially along the axial direction of the peripheral portion 110. That is, when the moving body 200 is released, the moving body 200 may move substantially along the central axis CA. In this disclosure, the distal end of the first holding portion 130 is the end of the application device 1000 that is away from the host during use, and the proximal end of the first holding portion 130 is the end of the application device 1000 that is toward the host during use.
[0205] In some examples, the first retaining part 130 can be releasably interlocked with the retained part (e.g., the first locking part 236 of the moving body 200, which will be described later below) by at least one of the following structures: a latch, a hook, a bolt, or a pin. In this case, the first retaining part 130 and the first locking part 236 are releasably interlocked by at least one of the following structures: a latch, a hook, a bolt, or a pin, thereby providing an interlocking method that is easy to release.
[0206] In some examples, the number of first retaining portions 130 can be one or more, such as 1, 2, 3, or 4. In some examples, if there are multiple first retaining portions 130, the multiple first retaining portions 130 can be symmetrically arranged at the end 120. Figure 12A In the embodiment shown, the number of first holding parts 130 can be 1.
[0207] In some examples, the first holding portion 130 may have a distal surface, and the first locking portion 236 may have a proximal surface. When the moving body 200 is held, the distal surface of the first holding portion 130 and the proximal surface of the first locking portion 236 may engage with each other. In some examples, when the moving body 200 is released, the distal surface of the first holding portion 130 and the proximal surface of the first locking portion 236 may separate from each other.
[0208] In some examples, at least a portion of the first retaining part 130 may be L-shaped or hook-shaped. This facilitates the formation of a structure such as a snap fastener to interlock with the first locking part 236.
[0209] See in some examples Figure 12CThe first retaining portion 130 may include an arm 132 extending generally along the central axis CA, and a protrusion 134 linked to the arm 132 and projecting toward the central axis CA in a direction generally orthogonal to the central axis CA. In some examples, the arm 132 of the first retaining portion 130 may extend from the distal end 120. In this case, when the protrusion 134 of the first retaining portion 130 engages with the first locking portion 236, the first retaining portion 130 can be easily released from the first locking portion 236 by actuating the arm 132 to actuate the protrusion 134.
[0210] In some examples, the arm 132 of the first retaining portion 130 may be elastic. In some examples, the arm 132 of the first retaining portion 130 may be elastic in a direction substantially orthogonal to the central axis CA.
[0211] In some examples, the arm 132 of the first retaining part 130 may tend to contract toward the central axis CA in the direction from the distal end to the proximal end. That is, in the natural state (i.e., without external force), the end of the arm 132 near the proximal end is closer to the central axis CA than the end of the arm 132 near the distal end. In other examples, the arm 132 may also be approximately parallel to the central axis CA.
[0212] In some examples, arm 132 can pivot when acted upon in a direction generally orthogonal to the central axis CA. For instance, when acted upon in a manner away from the central axis CA and in a direction generally orthogonal to the central axis CA, arm 132 can pivot so that the proximal end of arm 132 moves away from the central axis CA. This allows for easy release of the held component.
[0213] In some examples, the first retaining portion 130 can swing when the arm 132 is acted upon in a direction generally orthogonal to the central axis CA. For example, when the arm 132 is acted upon in a manner away from the central axis CA and in a direction generally orthogonal to the central axis CA, the arm 132 can swing so that the proximal end of the arm 132 moves away from the central axis CA.
[0214] In some examples, the first retaining portion 130 can pivot or swing with the connection point between the first retaining portion 130 and the distal end portion 120 as the fulcrum.
[0215] In some examples, the arm 132 of the first retaining portion 130 can be brought closer to the central axis CA in a direction from the distal end to the proximal end, and the protrusion 134 of the first retaining portion 130 can protrude toward the central axis CA. In this case, the first locking portion 236 can be held on the inner side (near the central axis CA) by bringing the first retaining portion 130 inward as a whole, and the first locking portion 236 can be released by actuating the first retaining portion 130 on the outer side (away from the central axis CA), thereby facilitating the holding and releasing of the first locking portion 236.
[0216] In other examples, the arm 132 of the first retaining portion 130 may be moved away from the central axis CA in a direction from the distal end to the proximal end, and the protrusion 134 of the first retaining portion 130 may protrude away from the central axis CA. In this case, by dispersing the first retaining portion 130 as a whole outward, the first locking portion 236 can be retained on the outer side (away from the central axis CA), and by actuating the first retaining portion 130 toward the inner side (closer to the central axis CA), the first locking portion 236 can be released, thereby facilitating the retention and release of the first locking portion 236.
[0217] However, the examples disclosed herein are not limited thereto. The concept of the present invention is that the first retaining part 130 forms a structure such as a buckle, hook, latch, or pin to retain the retained part, and releases the retained part by removing the buckle, hook, latch, or pin from its original position. Based on this concept, the arm 132 of the first retaining part 130 and the protrusion 134 of the first retaining part 130 can also move closer or protrude in other directions when a buckle can be formed.
[0218] In some examples, the protrusion 134 of the first retaining portion 130 may have a distally facing surface. In some examples, the distally facing surface of the protrusion 134 may be approximately orthogonal to the central axis CA. The retained component (e.g., the first locking portion 236 of the moving body 200 described below) can be held in place and prevented from moving towards the proximal end by overlapping / abutting against the distally facing surface of the protrusion 134. When the arm 132 of the first retaining portion 130 is actuated to disengage the distally facing surface of the protrusion 134 from its original position, i.e., no longer abutting against the retained component, the retained component will be released.
[0219] In other words, the first retaining part 130 can be a structure such as a latch, hook, latch, or pin formed on the first housing 100 (e.g., the distal end 120 of the first housing 100). For example, the first retaining part 130 can be formed as a structure that can be decomposed into at least two parts, such as a finger-shaped, straight, L-shaped, J-shaped, or Z-shaped structure, at least one part (e.g., an arm connected to the first housing 100) can pivot, and the other part (e.g., a protrusion protruding outward from the arm and abutting against the retained member) can move away from the initial position as it pivots, thereby releasing the hook, latch, top, support, etc., from the retained member.
[0220] See in some examples Figure 12A and Figure 12B The first housing 100 may include a first limiting portion 180. In some examples, the first limiting portion 180 may be configured to maintain the balance of the moving body 200 in a plane orthogonal to the central axis CA of the application device 1000. This reduces the likelihood of the moving body 200 wobbling, which could lead to the failure of the application device 1000.
[0221] In some examples, the first limiting portion 180 may extend generally along the central axis CA of the application device 1000. In some examples, the first limiting portion 180 may extend along the central axis CA in a direction from the distal end to the proximal end. In some examples, the first limiting portion 180 may be provided at the distal end 120. In some examples, the first retaining portion 130, the first limiting portion 180, and the first housing 100 may be integrally formed.
[0222] In some examples, the number of first limiting parts can be one or more. For example, the number of first limiting parts can be 1, 2, 3 or 4, etc.
[0223] In some examples, the number of first limiting parts 180 can be two. For example, see Figure 12A and Figure 12BThe first limiting part may include a first limiting part 180a and a first limiting part 180b. The first limiting part 180a and the first limiting part 180b may be provided on opposite sides of the central axis CA. Preferably, the first limiting part 180a and the first limiting part 180b may be provided on opposite sides of the central axis CA approximately along the direction in which the first holding part 130 can be actuated. In this case, since the first holding part 130 is in contact with the first locking part 236, when the first holding part 130 is actuated, the first locking part 236 will be subjected to the action applied by the first holding part 130 in the actuation direction of the first holding part 130 and / or in the opposite direction to the actuation direction, which will cause the moving body 200 to tend to wobble. The action of the first limiting part 180 can suppress the wobble of the moving body 200, thereby maintaining the assembly accuracy of the moving body 200 with other structural components (e.g., the second housing 140, the piercing member 260, etc.).
[0224] In some examples, the first limiting part 180a may be an arm respectively disposed on both sides of the first holding part 130. In some examples, the second limiting part 180b may be disposed opposite to the first holding part 130.
[0225] In some examples, the housing 10 may include a limiting portion 180, which is disposed on the opposite side or the same side as the first retaining portion 130 and abuts against the moving body 200. In this case, the limiting portion 180 (or the first limiting portion 180a) disposed on the same side as the first retaining portion 130 can balance the frictional force exerted by the first retaining portion 130 on the moving body 200 during the triggering process, and the limiting portion 180 (or the second limiting portion 180b) disposed on the opposite side of the first retaining portion 130 can provide a reverse supporting force to counteract the biasing force of the first retaining portion 130 and the first drive mechanism 30 on the moving body 200 in the holding state, thereby suppressing the moving body 200 from tilting to one side. Thus, by limiting the radial degree of freedom of the moving body 200 by the first retaining portion 130, it can be made to always move stably along a preset axial path, thereby reducing jamming or operational failure caused by sway.
[0226] Figure 13 This is an exploded view showing the first housing 100, auxiliary mechanism 20, and first drive mechanism 30 involved in the example of this disclosure; Figure 14A This is a schematic cross-sectional view showing the moving body 200 involved in the example of this disclosure being held; Figure 14B This is a schematic cross-sectional view showing the motion body 200 involved in the example of this disclosure when it is released; Figure 14C This is a schematic cross-sectional view showing the moving body 200 involved in the example of this disclosure being held. It should be noted that... Figure 14A and Figure 14BThe diagram mainly illustrates the holding and releasing of the moving body 200 by the first holding part 130, but does not show the first drive mechanism 30 or other components.
[0227] In some examples, as described above, the auxiliary mechanism 20 may include a motion body 200 and a receiving portion 250 disposed on the motion body 200. The motion body 200 may be releasably held on the first housing 100. In some examples, the motion body 200 may be releasably held by a first holding portion 130. After being released, the motion body 200 may be driven proximally to push the medical device 800, housed within the receiving portion 250, toward the host.
[0228] See in some examples Figure 13 A first driving part 30 may be provided between the moving body 200 and the first housing 100. The first driving part 30 can apply force to the moving body 200 in a proximal manner. After the moving body 200 is released, it can be driven proximally by the first driving part 30 to push the medical device 800 housed in the receiving part 250 toward the host.
[0229] In other examples, as described above, the application device 1000 may also exclude the first drive unit 30. In this case, when the motion body 200 is released, the motion body 200 may also be pushed toward the host by human force, thereby pushing the medical device 800 housed in the receiving part 250 toward the host.
[0230] In some examples, the moving body 200 may include a first bottom 210, a second bottom 220, and a sidewall 230 connecting the first bottom 210 and the second bottom 220 (see [link]). Figure 13 The first bottom 210 may be located near the distal end, the second bottom 220 may be located near the proximal end, and the receiving portion 250 may be disposed on the second bottom 220.
[0231] In some examples, a hollow portion may be formed between the first bottom 210, the second bottom 220, and the sidewall 230. In some examples, the puncture member 260 may be disposed within the hollow portion of the moving body 200.
[0232] In some examples, the first drive mechanism 30 may be disposed between the auxiliary mechanism 20 and the first housing 100. In some examples, the two ends of the first drive mechanism 30 may abut against the first housing 100 and the auxiliary mechanism 20, respectively.
[0233] In some examples, the auxiliary mechanism 20 may include a positioning part 212 for positioning the first drive mechanism 30. In some examples, the positioning part 212 may be disposed on the second bottom 220. In some examples, the positioning part 212 may be disposed on the second bottom 220 in a manner surrounding the hollow portion. Thus, the first drive mechanism 30 can apply a stable driving force to the moving body 200 through the positioning part 212.
[0234] In some examples, the positioning portion 212 may be a protrusion extending distally from the second bottom 220 along the central axis CA. In some examples, the positioning portion 212 may be a columnar protrusion. In some examples, the positioning portion 212 may be cylindrical. In some examples, the distal end of the positioning portion 212 may have a groove for receiving the first drive mechanism 30. Thus, the first drive mechanism 30 can stably abut against the auxiliary mechanism 20.
[0235] In some examples, the positioning portion 212 may include a plurality of support frames 214 formed on the first bottom 210 and arranged around the hollow portion 200 (see Figure 13 In some examples, multiple support frames 214 may be formed on the sidewall 230 and symmetrically arranged around the hollow portion. In some examples, the support frame 214 may have a groove 213 for supporting the first drive mechanism on the side near the distal end. Thus, the first drive mechanism 30 can stably abut against the multiple support frames in a manner that fits the moving body to apply a stable driving force to the auxiliary mechanism.
[0236] In some examples, multiple support frames 214 may be formed on the sidewall 230 of the moving body 200. In some examples, the moving body 200 and the positioning part 212 may be integrally formed.
[0237] In some examples, the distal end of the moving body 200 has a first recessed structure 231 (see...). Figure 13 When the moving body 200 is at the distal end, the first actuating part 504 passes through the first recessed structure 231 at least partially. In this case, the first recessed structure 231 accommodates at least part of the first actuating part 504, such that the first actuating part 504 and the moving body 200 partially overlap in the axial dimension rather than being simply stacked in series. This effectively reduces the axial cumulative height of the internal components, thereby reducing the longitudinal dimension and overall volume of the application device 1000 while ensuring functional integrity.
[0238] Figure 15A This is an exploded schematic diagram from a first perspective showing the second housing 140 and auxiliary mechanism 10 involved in the example of this disclosure. Figure 15B This is an exploded schematic diagram from a second perspective showing the second housing 140 and auxiliary mechanism 10 involved in the example of this disclosure. Figure 15C This is an exploded schematic diagram from a third perspective showing the second housing 140 and auxiliary mechanism 10 involved in the example of this disclosure.
[0239] In some examples, the second housing 140 may have an opening slot 141 through which the positioning portion 212 extends (see [reference]). Figure 15A Therefore, during the assembly of the auxiliary mechanism 20 into the second housing 140, the positioning part 212 can extend through the second housing 140 to abut against the first drive structure 30.
[0240] In some examples, the positioning part 212 may be provided at the first bottom 210. In this case, the positioning part 212 can also more stably define the position at which the first drive mechanism 30 applies force to the moving body 200.
[0241] In some examples, the first drive mechanism 30 may have an energy storage state and an energy release state. When the first drive mechanism 30 switches from the energy storage state to the energy release state, it can release energy and act on the moving body 200 in a proximal manner. When the moving body 200 is held, the first drive mechanism 30 may exist in the energy storage state between the moving body 200 and the first housing 100. When the moving body 200 is released, the first drive mechanism 30 may switch from the energy storage state to the energy release state and act on the moving body 200 in a proximal manner.
[0242] In some examples, the first drive mechanism 30 can have a compressed state and an extended state, and can release energy when switching from the compressed state to the extended state. In some examples, the first drive mechanism 30 can be a compressible elastic component. In some examples, the first drive mechanism 30 can be a spring. Thus, an actuation mechanism for the moving body 200 can be provided through a simplified structural design.
[0243] See in some examples Figure 12A or Figure 12B The distal end 120 may have a positioning portion 122. In some examples, the positioning portion 122 may be cylindrical. In this case, the other end of the first drive mechanism 30 may be sleeved on the positioning portion 122. In some examples, the positioning portion 122 may be hollow cylindrical. In this case, the other end of the first drive mechanism 30 may be sleeved on or embedded in the positioning portion 122. In some examples, the positioning portion 122 may consist of at least two arc-shaped columns.
[0244] Furthermore, the application device 1000 disclosed herein is not limited thereto. In some examples, the application device 1000 may not include the first drive mechanism 30. In this case, when the moving body 200 is released, the moving body 200 can also be moved toward the proximal end by manually applying an action to the moving body 200.
[0245] See in some examples Figure 13 The moving body 200 may include a first locking part 236 configured to releasably interlock with the first holding part 130. Thus, the moving body 200 can be releasably held in the first holding part 130 by the cooperation of the first locking part 236 with the first holding part 130.
[0246] In some examples, the first locking part 236 may be provided on the side wall 230 of the moving body 200. That is, the first locking part 236 may be provided on the side wall 230 of the moving body 200. The first locking part 236 may cooperate with the first retaining part 130 to retain the moving body 200 in the first housing 100.
[0247] In some examples, the number of first locking portions 236 can be one or more, such as 1, 2, 3, or 4. In some examples, the number of first locking portions 236 can be the same as the number of first retaining portions 130. Figure 13 In the embodiment shown, the number of first locking parts 236 is 1.
[0248] In some examples, if there are multiple first holding parts 130, there are also multiple first locking parts 236. On the projection along the central axis CA, the positions of the multiple first locking parts 236 may be the same as the positions of the multiple first holding parts 130.
[0249] In some examples, the first locking portion 236 can be formed as a snap fastener. Specifically, the first locking portion 236 can have a proximal surface, to which the first retaining portion 130 can retain the moving body 200 by overlapping, abutting, or engaging, and to which the first retaining portion 130 can release the moving body 200 by disengaging from the surface (see [reference]). Figure 14A and Figure 14BIn other words, the first holding part 130 and the first locking part 236 can be formed as an interlocking structure. In the direction along the central axis CA, the projections of the first holding part 130 and the first locking part 236 have an overlapping portion. The first holding part 130 holds the first locking part 236 through this overlapping portion, and the first holding part 130 and / or the first locking part 236 can be moved away from each other to eliminate this overlapping portion, thereby releasing the first locking part 236 from the first holding part 130. In some examples, the first holding part 130 and / or the first locking part 236 can be actuated in a way that they are facing away from each other, thereby releasing the first locking part 236 from the first holding part 130.
[0250] In some examples, the first locking portion 236 may be approximately parallel to or away from the central axis CA in the direction from the proximal end to the distal end. In this case, the first locking portion 236 may be closer to the central axis CA than the first retaining portion 130, thereby facilitating interlocking with the inwardly retracting first retaining portion 130.
[0251] In other examples, the first locking portion 236 may be approximately parallel to or toward the central axis CA in the direction from the proximal end to the distal end. In this case, the first locking portion 236 may be further away from the central axis CA than the first retaining portion 130, thereby facilitating interlocking with the outwardly distributed first retaining portion 130.
[0252] In some examples, the first locking portion 236 may be formed in such a way that it is recessed from the outer surface of the sidewall 230 toward the central axis CA. In some examples, the first locking portion 236 may be formed as a hollow structure, for example, a through hole extending through the sidewall 230 in a direction approximately orthogonal to the central axis CA. In some examples, a second recessed structure 290 communicating with the first locking portion 236 may be formed in the moving body 200, and the first actuating portion 504 may be arranged at the distal end through the second recessed structure 290.
[0253] In some examples, the first locking portion 236 may also be formed such that the periphery of the first bottom 210 protrudes from the sidewall 230 along a direction orthogonal to the central axis CA, in which case the first bottom 210 and the sidewall 230 may be fixedly connected. In other examples, the first locking portion 236 may also be in the form of an inverted hook or an L-shape.
[0254] The examples disclosed herein are not limited thereto. As described above, the concept of the present invention is to form a fastener, hook, latch, or pin structure between the first retaining portion 130 and the first locking portion 236 for interlocking. In this case, the first locking portion 236 may have a surface facing the proximal end of the applying device 1000, and the first retaining portion 130 retains the first locking portion 236 by engaging the proximal end surface of the first retaining portion 130 with the distal end surface of the first retaining portion 130, and the first retaining portion 130 releases the first locking portion 236 by separating the proximal end surface of the first locking portion 236 from the distal end surface of the first retaining portion 130.
[0255] See in some examples Figure 14A and Figure 14B The first holding part 130 can be formed in an L-shape, and the first locking part 236 is formed as a hollow structure provided on the side wall 230. When the moving body 200 is held, that is, as Figure 14A As shown, the protrusion 134 of the first retaining part 130 is located within the hollow structure of the first locking part 236, thereby supporting the moving body 200 to retain it. When the moving body 200 is released, i.e., as shown... Figure 14B As shown, the arm 132 of the first holding part 130 pivots in a direction away from the central axis CA and moves the protrusion 134 away from the central axis CA. The protrusion 134 leaves the hollow structure of the first locking part 236, thereby releasing the moving body 200. Under the action of the first driving mechanism 30, the moving body 200 moves towards the proximal end.
[0256] Additionally, in some examples, the application device 1000 may also include a first trigger mechanism 50 configured to disengage the first retaining portion 130 from the first locking portion 236 to release the moving body 200 (see also...). Figure 12A , Figure 12C , Figure 14A or Figure 14B Therefore, the moving body 200 can be conveniently released via the first triggering mechanism 50.
[0257] In some examples, the application device 1000 may further include a first triggering mechanism 50. The first triggering mechanism 50 is configured to trigger the first holding portion 130 to release the moving body 200. In some examples, the first triggering mechanism 50 may be configured to actuate the first holding portion 130 and / or the first locking portion 236 in a manner that moves them away from each other to release the moving body 200. For example, the first triggering mechanism 50 may be configured to actuate the first holding portion 130 to move away from the central axis CA to release the holding of the first locking portion 236, thereby releasing the moving body 200. That is, the first triggering mechanism 50 may be configured to actuate the first holding portion 130 and / or the first locking portion 236 to move them away from each other, thereby releasing the first locking portion 236.
[0258] In some examples, the number of first triggering mechanisms 50 can be one or more. For example, the number of first triggering mechanisms 50 can be 1, 2, 3, or 4, etc. In some examples, the number of first holding parts 130 can be one or more. For example, the number of first holding parts 130 can be 1, 2, 3, or 4, etc. In some examples, the number of first holding parts 130 can be the same as the number of first triggering mechanisms 50.
[0259] In some examples, the number of first locking parts 236 can be one or more. For example, the number of first locking parts 236 can be 1, 2, 3 or 4, etc. In some examples, the number of first locking parts 236 can be the same as the number of first holding parts 130.
[0260] The following description assumes that there are two first triggering mechanisms 50.
[0261] In some examples, the two first trigger mechanisms 50 can be arranged symmetrically. In some examples, the number of second recessed structures 290 can be two. In some examples, the two second recessed structures 290 can be arranged symmetrically. In some examples, the moving body 200 may not have the first marking portion 239, and the support 280 may not have the second marking portion 281.
[0262] In some examples, the first trigger mechanism 50 may include a pressing part 502 and a first actuating part 504 (see Figure 14A and Figure 14B In some examples, the first triggering mechanism 50 may include a pressable part 502 that can be pressed during operation, and a first actuation part 504 configured to be linked with the pressable part 502 and actuate the first holding part 130.
[0263] In some examples, the projection of the first actuation unit 504 along the central axis CA of the application device coincides with the long axis LA of the body unit 800. In this case, based on the requirement for the body unit 800 to match the long axis of the outer contour of the upper arm, the first actuation unit 504 is used as a reference for the user's force application operation. This guides the user to naturally align the long axis LA of the body unit 800 with the extension direction of the upper arm when the application is triggered. As a result, it is ensured that the adhesive patch 870 of the body unit 800 can form a maximum effective contact area with the skin surface, thereby improving the fit and long-term stability of the wear.
[0264] In some examples, the first triggering mechanism 50 may be mounted on the distal end 120. In some examples, the first triggering mechanism 50 may be formed on the distal end 120. In some examples, by applying an action to the pressing part 502, the first actuating part 504 may actuate the first holding part 130, thereby releasing the first holding part 130 from holding the moving body 200 so that the moving body 200 is released.
[0265] In some examples, the first actuation unit 504 may be configured to apply an action to the first holding unit in a direction substantially orthogonal to the central axis CA of the application device to actuate the first holding unit 130. In this case, when the first actuation unit 504 is driven, the first holding unit 130 can be actuated away from or closer to the central axis CA, thereby enabling the first holding unit 130 to unlock from the locked component (e.g., the first locking unit 236) in a manner away from or closer to the central axis CA.
[0266] In some examples, the first actuating part 504 may extend along a direction having a preset angle with the central axis CA. In some examples, the preset angle may not be zero. In this case, when the first actuating part 504 is applied at an appropriate angle, the first actuating part 504 can apply an action to the first holding part 130 in a direction orthogonal to the central axis CA of the applying device to actuate the first holding part 130.
[0267] In some examples, the first actuating part 504 can be acted upon along its extending direction to actuate the first holding part 130. For example, when the preset angle is 90 degrees, the first actuating part 504 can be acted upon in a direction orthogonal to the central axis CA to actuate the first holding part 130. Thus, the first actuating part 504 can actuate the first holding part 130 to release the first locking part 236 by moving it closer to or further away from the central axis CA.
[0268] In some examples, when the preset included angle is between 0 and 90 degrees or between 90 and 180 degrees, such as preset included angles of 20, 30, 40, 45, 60, 70, 80, 100, 120, 130, 135, 150, 160, or 170 degrees, the action applied to the first actuating part 504 along its extension direction can be decomposed into an action parallel to the central axis CA and an action orthogonal to the central axis CA. Thus, by acting orthogonally to the central axis CA, the first holding part 130 can be actuated to release the first locking part 236 by moving closer to or further away from the central axis CA.
[0269] In some examples, the first actuating part 504 may extend along a direction having a predetermined angle with the central axis CA and toward the distal end. Thus, the first actuating part 504 can be easily actuated at the distal end.
[0270] In some examples, the first actuating part 504 can be acted upon along the direction of the central axis of the applying device 1000 to actuate the first holding part 130. In some examples, when the first actuating part 504 is acted upon along the direction of the central axis CA, the first actuating part 504 can act upon the first holding part 130 in a direction orthogonal to the central axis CA.
[0271] In some examples, the first actuating part 504 may be coupled to the first retaining part 130. In some examples, in response to the application of an action to the first actuating part 504, the first retaining part 130 may be driven to swing away from or towards the central axis CA of the application device 1000 with the connection position of the first retaining part 130 and the distal end 120 as the fulcrum.
[0272] In some examples, the first actuation part 504 can be acted upon along the direction of the central axis CA of the application device 1000. In this case, the first holding part 130 and the first actuation part 504 can form a lever system as a whole, with the connection position of the first holding part 130 and the distal end 120 as the fulcrum. When the first actuation part 504 is driven by an action along the direction of the central axis CA, a torque can be generated to actuate the first holding part 130 to swing along the direction close to or away from the central axis CA with the connection position as the fulcrum. As a result, the first holding part 130 can release the first locking part 236 in a manner that is close to or away from the central axis CA.
[0273] In some examples, the first actuating part 504 may be connected to the proximal side of the first holding part 130. In some examples, the first actuating part 504 may be connected to the arm 134 of the first holding part 130. In some examples, the first actuating part 504 may be connected to the proximal side of the arm of the first holding part 130. This facilitates actuation of the first holding part 130.
[0274] In some examples, the first linkage point 136 of the first actuating part 504 and the first retaining part 130 is close to the proximal end of the first retaining part 130. In this case, the first retaining part 130 is configured as a cantilever structure with its distal end as the deformation root. By placing the first linkage point 136 close to the proximal end (i.e., the free end) of the first retaining part 130, the lever arm distance between the point of force application and the deformation root is substantially extended. The longer lever arm allows the user to generate the required bending moment with only a smaller driving force, thereby reducing the force required to actuate the first retaining part 130.
[0275] In some examples, the distal end 120 may have a through structure. In some examples, the first actuating part 504 may be connected to the first retaining part 130 and extend to the through structure in a predetermined direction. The predetermined direction may refer to a direction having a predetermined angle with the central axis CA. Thus, the first actuating part 504 can be actuated through the through structure, improving operational convenience. In some examples, the through structure may be an opening formed in the distal end 120.
[0276] In some examples, the first actuating part 504 and the first retaining part 130 can be integrally formed. In this case, the overall rigidity and stability of the first actuating part 504 and the first retaining part 130 can be improved, which is suitable for transmitting the torque that can drive the first retaining part 130 to swing.
[0277] In some examples, the end of the first actuating part 504 near the first holding part 130 may have a curved structure. In this case, the lever arm length of the first holding part 130 and the first actuating part 504 as a whole can be increased, thereby generating a torque sufficient to actuate the first holding part 130 to swing with a small force. In other words, a small force can be applied to the first actuating part 504 to actuate the first holding part 130. In addition, the curved structure can serve as a support point to improve the overall stability of the first holding part 130 and the first actuating part 504; furthermore, the curved structure can change the direction of the force applied to the first actuating part 504, so that the force applied to the first actuating part 504 can be effectively transmitted to the first holding part 130 and actuate the first holding part 130 to swing in a direction close to or away from the central axis CA.
[0278] In some examples, the first actuating part 504 and the first retaining part 130 form a U-shaped groove. In this case, the U-shaped groove constitutes a stress dispersion feature. By smoothing the geometric abrupt change at the connection between the first actuating part 504 and the first retaining part 130, the local peak stress generated during actuation can be effectively released, suppressing the tendency for fracture at the connection between the first actuating part 504 and the first retaining part 130, thereby ensuring the structural integrity of the first triggering mechanism 50 during the deformation process under stress.
[0279] In some examples, when the effect applied to the first trigger mechanism 50 disappears, the first trigger mechanism 50 and the first holding part 130 can return to their initial positions.
[0280] As described above, applying an action to the pressing part 502 can actuate the first holding part 130 by the first actuating part 504. In some examples, the pressing part 502 may be connected to the first actuating part 504.
[0281] In some examples, the pressing part 502 and the first actuating part 504 can be integrally formed. This simplifies the structural design of the first triggering mechanism 50 and improves its stability.
[0282] In some examples, the end of the first actuating part 504 near the pressing part 502 has a hardness not less than that of the end near the first holding part 130. In this case, by ensuring the rigidity of the transmission medium to suppress the self-compression or buckling deformation of the first actuating part 504 when it is pressed, it is possible to suppress the absorption of the longitudinal displacement of the pressing part 502 by the material deformation of the first actuating part 504, so that the input displacement of the pressing part 502 can be directly and instantly converted into an effective output displacement that drives the first holding part 130 to deflect. This can suppress trigger stroke lag or invalid idle stroke caused by insufficient rigidity of the first actuating part 504.
[0283] In some examples, the pressing part 502 may be located at the distal end 120. In some examples, the pressing part may be located in a through structure at the distal end 120. Thus, the first holding part 130 can release the first locking part 236 by a simple operation.
[0284] In some examples, the application device 1000 may also include a gasket 60 fitted to and covering the through structure (see [reference]). Figure 11 In some examples, the first trigger structure 50 can be driven by applying an action at the position of the pad 60.
[0285] In some examples, the pressing portion 502 may be generally disc-shaped. In some examples, the pressing portion 502 may be generally frustum-shaped. In some examples, the pressing portion 502 may be generally flush with the distal end portion 120. In some examples, the pressing portion 502 may extend through the distal end portion 120, and the pressing portion 502 at least partially coincides with the projection of the through structure in the direction along the central axis CA of the application device, and the pressing portion 502 at least partially coincides with the projection of the housing 10 in the direction perpendicular to the central axis CA of the application device.
[0286] As described above, in this case, the pressing part 502 is substantially arranged within or below the contour range of the surface of the distal end 120 of the housing 10, that is, the top surface of the pressing part 502 is not higher than (e.g. flush with or recessed in) the peripheral surface of the distal end 120 of the housing 10, thereby reducing accidental triggering.
[0287] In some examples, the pressing part 502 may be located on the periphery of the housing 10.
[0288] In some examples, the first triggering mechanism 50, the first holding part 130, and the housing 10 can be integrally formed. This simplifies the overall structural design of the application device.
[0289] In some examples, the first trigger mechanism 50 and the housing 10 can be integrally formed.
[0290] As described above, by integrally molding the first trigger mechanism 50 with the housing, force can be applied to the first holding part 130 via the pressing part 502 during application, thereby actuating the first holding part 130 and releasing the moving body 200 coupled to the first holding part 130. Finally, the moving body 200 can drive the puncture member 260 and the sensor 820 to be implanted subcutaneously into the host under the drive of the first drive mechanism 130. In this case, the integral molding of the first trigger mechanism 50 with the housing 10 can eliminate the assembly gap and accumulated tolerance between the first trigger mechanism 50 and the housing 10, thereby improving the structural rigidity and stability of the first trigger mechanism 50.
[0291] In some examples, as described above, the first actuation part 504 of the first triggering mechanism 50 can actuate the first holding part 130 to release the first holding part 130 from holding the moving body 200, thereby releasing the moving body 200.
[0292] In some examples, the first actuating portion 504 may be formed as a structure extending from the pressing portion 502 toward the first retaining portion 130 (see [reference]). Figure 14AIn some examples, the number of first actuating parts 504 can be one or more, such as 1, 2, 3, or 4. In some examples, the number of first actuating parts 504 can be the same as the number of first holding parts 130.
[0293] As described above, the first holding portion 130 can be parallel to the central axis CA in the direction toward the proximal end. The first actuating portion 504 is configured to actuate the first holding portion 130 so that the end of the first holding portion 130 near the proximal end moves away from the central axis CA, thereby releasing the holding of the moving body 200.
[0294] Before the first actuating part 504 actuates the first holding part 130, the first holding part 130 interlocks with the first locking part 236 to hold the moving body 200 (see...). Figure 14A When the first actuating part 504 actuates the first holding part 130 (for example, by pressing the pressing part 502 in a proximal direction), under the actuation of the first actuating part 504, the first holding part swings in a direction away from the central axis CA, so that the protrusion 134 of the first holding part 130 disengages from the first locking part 236, thereby releasing the interlock between the first holding part 130 and the first locking part 236, thereby releasing the moving body 200 (see...). Figure 14B ).
[0295] In some examples, the first triggering mechanism 50 also includes an additional holding part 131 and a second actuating part 505 (see Figure 14C The additional holding part 131 is connected to the pressing part 502 via the second actuating part 505. The projections of the additional holding part 131 and the second actuating part 505 in the direction of the central axis CA of the application device are on the same straight line as the projections of the first holding part 130 and the first actuating part 504 in the direction of the central axis CA of the application device.
[0296] In this configuration, the introduction of the additional retaining part 131 and the second actuating part 505, positioned opposite to the original retaining part 130 and the first actuating part 504, creates a pair of radially aligned clamping or supporting forces on the moving body 200. This eliminates the overturning moment caused by unilateral force, ensuring the moving body 200 maintains a stable, non-skewed locked posture when ready to be activated. This improves the overall reliability of the triggering mechanism and the consistency of the operating feel. Specifically, the overturning moment is the tendency of the moving body 200 to deflect around the axis due to the force point deviating from the central axis CA. If this tendency is not eliminated, it will cause the component to tilt and jam. The additional retaining part 131 effectively avoids this risk by providing a reverse balancing torque.
[0297] In some examples, the second housing 140 may include a first defining mechanism 150 and a second defining mechanism 170 (see [reference]). Figure 15A In some examples, the first limiting mechanism 150 and the second limiting mechanism 170 may be interconnected. In some examples, the first limiting mechanism 150 and the second limiting mechanism 170 may be hollow columnar structures. In some examples, the first limiting mechanism 150 may releasably hold the moving body 200 and may define the movement path of the moving body 200. In some examples, the second limiting mechanism 170 may define the receiving position of the medical device 800.
[0298] See in some examples Figure 12B The first housing 100 may have a third retaining portion 124. See some examples. Figure 15B The second housing 140 may have a third locking portion 142. In some examples, a third retaining portion 124 may be coupled to the third locking portion 142. In some examples, the third retaining portion 124 may be releasably interlocked with the third locking portion 142 by at least one of a latch, hook, latch, or pin.
[0299] In some examples, during the assembly of the first housing 100 and the second housing 140, the third retaining part 124 may be aligned with the third locking part 142.
[0300] In some examples, the number of third retaining parts 124 can be one or more, such as 1, 2, 3, or 4. In some examples, if there are multiple third retaining parts 124, the multiple third retaining parts 124 can be symmetrically arranged on the inner wall of the first housing 100.
[0301] In some examples, the number of third locking parts 142 can be one or more, such as 1, 2, 3, or 4. In some examples, if there are multiple third locking parts 142, the multiple third locking parts 142 can be symmetrically arranged on the periphery of the second housing 140.
[0302] See in some examples Figure 12B The first housing 100 may have a third identification portion 125. See also: [examples omitted] Figure 15B The second housing 140 may have a fourth marking portion 143. In some examples, during the assembly of the first housing 100 and the second housing 140, the third marking portion 125 may be aligned with the fourth marking portion 143.
[0303] In some examples, the third marking portion 125 may be coupled to the fourth marking portion 143. In some examples, the coupling between the third marking portion 125 and the fourth marking portion 143 may be a male-female mating mechanism. For example, the shape of the third marking portion 125 may be a groove, and the shape of the fourth marking portion 143 may be a protrusion.
[0304] In some examples, the third marking portion 125 may abut against the fourth marking portion 143 in the circumferential direction of the housing 10. This can suppress undesirable relative rotation between the first housing 100 and the second housing 140.
[0305] In some examples, the number of third identifier parts 125 can be one or more. For example, the number of third identifier parts 125 can be one, two, three, or four. In some examples, the number of fourth identifier parts 143 can be one or more. For example, the number of fourth identifier parts 143 can be one, two, three, or four. In some examples, the number of third identifier parts 125 and the number of fourth identifier parts 143 can be the same.
[0306] In some examples, during the assembly of the first housing 100 and the second housing 140, the third retaining portion 124 and the third locking portion 142 can be aligned by aligning the third marking portion 125 with the fourth marking portion 143. This facilitates the alignment of the third retaining portion 124 and the third locking portion 142 during assembly.
[0307] In some examples, in the application device 1000 according to this disclosure, the housing 10 may include a first outer shell 100 having a first holding portion 130 and a second outer shell 140 fitable to the first outer shell 100. The second outer shell 140 may have a first limiting mechanism 150 and a second limiting mechanism 170 communicating with each other. The second limiting mechanism 170 may be configured to define the receiving position of the medical device 800. The auxiliary mechanism 20 may be fitted to the first limiting mechanism 150 and movable along the first limiting mechanism 150 when the moving body 200 is released by the first holding portion 130. In this case, the movement of the moving body 200 is defined by the first limiting mechanism 150 of the second outer shell 140, and the receiving position of the medical device 800 is defined by the second limiting mechanism 170 of the second outer shell 140, thereby facilitating more accurate application of the medical device 800 to the host.
[0308] In some examples, the first limiting mechanism 150 may have a limiting part 151 (see Figure 15BThe limiting portion 151 can restrict the moving body 200, thereby preventing undesirable rotation of the moving body 200. In some examples, the limiting portion 151 can be a groove and / or a ridge. In some examples, the limiting portion 151 can include a ridge 154 disposed on the inner wall of the first limiting mechanism 150 and extending generally along the central axis CA. In some examples, the limiting portion 151 can also include a groove 152 disposed on the inner wall of the first limiting mechanism 150 and extending generally along the central axis CA. In some examples, the length of the ridge 154 and the groove 152 can be less than the height of the first limiting mechanism 150, and the ridge 154 and the groove 152 can be generally collinear in the direction of the central axis CA.
[0309] In some examples, the number of limiting portions 151 can be one or more, such as 1, 2, 3, or 4. In some examples, multiple limiting portions 151 can be evenly distributed on the sidewall of the first limiting mechanism 150.
[0310] In some examples, the ridge 154 of the limiting portion 151 can engage with the limiting portion 232 of the moving body 200, which includes a groove structure, thereby preventing undesirable rotation of the moving body 200. In some examples, the moving body 200 can be assembled to the first limiting mechanism 150 along the groove 152. Thus, the groove 152 can provide a guiding effect during assembly.
[0311] In some examples, the limiting part 151 may also include a slot 156 provided on the first limiting mechanism 150 (see Figure 15B In some examples, the notch 156 can be used to provide engagement space for the protrusion 234 of the moving body 200.
[0312] In some examples, the slot 156 can also be configured to expose the first locking portion 236 when the moving body 200 is held in the first holding portion 130. In this case, the first holding portion 130 can hold the first locking portion 236 through the slot 156; in addition, by forming the slot 156 for exposing the first locking portion 236 in the first limiting mechanism 150, sufficient movement stroke can be provided for the moving body 200 with a smaller spatial structure, which is beneficial to improving the integration of the application device.
[0313] In some examples, the first limiting mechanism 150 may also include reinforcing ribs 158 disposed on the inner wall (see...). Figure 15BIn some examples, the reinforcing ribs 158 may extend generally along the direction of the central axis CA. In some examples, the number of reinforcing ribs 158 may be multiple, such as 2, 3, 4, 6, etc. In some examples, the reinforcing ribs 158 may be evenly distributed on the inner wall of the first defining mechanism 150. In some examples, the reinforcing ribs 158 may provide line contact when the moving body moves relative to the first housing.
[0314] In some examples, the first limiting mechanism 150 can restrict the travel of the moving body 200 in the direction along the central axis CA. In this case, by limiting the travel of the moving body 200 in the direction along the central axis CA by the first limiting mechanism 150, the medical device 800 housed in the receiving portion 250 can be pushed a predetermined distance more accurately, thereby enabling the medical device 800 to be applied to the host more accurately.
[0315] Additionally, in some examples, when projected along the central axis CA, the receiving portion 250 may at least partially overlap with the wall of the first limiting mechanism 150, and the distal end of the moving body 200 may at least partially overlap with the wall of the first limiting mechanism 150 (see [reference]). Figure 14A In this case, by making the receiving part 250 and the moving body 200 at least partially overlap with the wall of the first limiting mechanism 150, it is possible to effectively limit the travel of the moving body 200 along the first limiting mechanism 150 while simplifying the structure.
[0316] Additionally, in some examples, a protrusion is provided on the distal end of the moving body 200, protruding in a direction generally orthogonal to the central axis CA and away from the central axis CA. In this case, the protrusion forms a latch with the wall of the first limiting mechanism 150, thereby effectively limiting the excessive travel of the moving body 200 toward the proximal end.
[0317] As described above, the auxiliary mechanism may include a positioning part 212 for positioning the first drive mechanism 30. In some examples, the positioning part 212 may be disposed on the side of the receiving part 250 facing the distal end.
[0318] In some examples, the second limiting mechanism 170 may have an opening slot 141 through which the positioning part 212 extends. In some examples, the opening slot 141 may extend from the second limiting mechanism 170 to the first limiting mechanism 150. In this case, the movement stroke of the moving body 200 along the central axis CA can be further limited by the cooperation of the positioning part 212 and the moving body 200.
[0319] In some examples, the number of openings 141 can be the same as the number of support frames for the positioning part 212. Thus, the positioning part 212 can extend through the second housing 140 to abut against the first drive mechanism 30.
[0320] Additionally, in some examples, the first limiting mechanism 150 can suppress the rotation of the moving body 200. In this case, by suppressing the rotation of the moving body 200, it is possible to prevent undesirable rotation of the puncture member 260 during application.
[0321] Additionally, in some examples, the first defining mechanism 150 may include grooves and / or ridges that are continuously or discontinuously disposed on the inner wall, generally along the direction of the central axis CA. In this case, by engaging the moving body 200 with the grooves and / or ridges of the first defining mechanism 150, undesirable rotation of the moving body 200 within the first defining mechanism 150 can be effectively suppressed.
[0322] Additionally, in some examples, the moving body 200 may include a groove and / or ridge disposed on the outer wall of the side wall 230 generally along the direction of the central axis CA. In this case, by engaging the groove and / or ridge of the moving body 200 with the groove and / or ridge of the first defining mechanism 150, undesirable rotation of the moving body 200 within the first defining mechanism 150 can be effectively suppressed.
[0323] Additionally, in some examples, the first limiting mechanism 150 and the second limiting mechanism 170 may be hollow cylindrical, and the inner diameter of the first limiting mechanism 150 may not be greater than the inner diameter of the second limiting mechanism 170. In this case, by setting the first limiting mechanism 150 and the second limiting mechanism 170 to hollow cylindrical shapes, it is convenient for the auxiliary mechanism 20 to move along the first limiting mechanism 150 and the second limiting mechanism 170.
[0324] Additionally, in some examples, when the moving body 200 is released, the moving body 200 can move along the first limiting mechanism 150 and the receiving portion 250 can move along the second limiting mechanism 170. In this case, by moving the moving body 200 along the first limiting mechanism 150 and the receiving portion 250 along the second limiting mechanism 170, the medical device 800 housed in the receiving portion 250 can be applied more accurately to the desired location on the host's body surface.
[0325] In some examples, a confined portion 232 may be provided on the side wall 230 of the moving body 200 (see...). Figure 15B The restricted part 232 can cooperate with the restricting part 151 of the first restricting mechanism 150 to suppress undesirable rotation of the moving body 200.
[0326] In some examples, the restricted portion 232 may include a groove 235 formed on the outer wall of the sidewall 230. In some examples, the groove 235 may be formed between two side-by-side ridges. In some examples, the restricted portion 232 may also include an arm 233 formed by the sidewall 230 extending distally along the direction of the groove 235. In some examples, the restricted portion 232 may also include a protrusion 234 projecting from the arm 233 along a direction generally orthogonal to the central axis CA and away from the central axis CA. In some examples, the number of restricted portions 232 may be one or more, such as 1, 2, 3, or 4. In some examples, the number of restricted portions 232 may be the same as the number of restrictive portions 151. In some examples, the multiple restricted portions 232 may be evenly distributed on the sidewall 230. In some examples, the arm 233 may be elastic.
[0327] In some examples, when projected along a direction approximately orthogonal to the central axis CA, the projection surface of the protrusion 234 of the restricted portion 232 can be further away from the central axis CA than the projection of the slot 156 of the restricting portion 151. Furthermore, the projection of the ridge 154 can substantially align with the projection of the slot 235. Additionally, the projection of the protrusion 234 can substantially align with the projection of the slot 152. In some examples, the length and / or width of the receiving portion 250 can be greater than the diameter of the first limiting mechanism 150.
[0328] In some examples, the sidewall 230 of the moving body 200 may have a moving body limiting portion 238 (described later). The moving body limiting portion 238 may restrict the puncture member 260 disposed within the moving body 200, thereby preventing undesirable rotation of the puncture member 260. In some examples, the moving body limiting portion 238 may be formed as a groove and / or a ridge. In some examples, the moving body limiting portion 238 may be two ridges arranged side by side and a groove located between the two ridges.
[0329] See in some examples Figure 15C The second housing 140 may include a magnet receiving portion 252. As described above, the application device 1000 may include a magnet. In some examples, the magnet receiving portion 252 may be configured to receive a magnet.
[0330] In some examples, the auxiliary mechanism 20 may have a passage 254 through which the magnet receiving portion 252 extends. In some examples, the magnet receiving portion 252 may pass through the passage 254 during the assembly of the auxiliary mechanism 20 into the second housing 140.
[0331] In some examples, the passage 254 may be provided on the side of the auxiliary mechanism 20 that has the receiving portion 250. In this case, by bringing the passage 254 closer to the receiving portion 250, when the medical device 800 has not yet been applied to the host (i.e., when the auxiliary mechanism 20 is assembled to the second housing 140), the magnet housed in the passage 254 can be brought closer to the medical device 800 housed in the receiving portion 250, thereby helping to keep the switching module 884 of the electronic device 880 in the off state.
[0332] Embodiments of this disclosure include: B. An instrument kit for applying a medical device, the instrument kit comprising an application device for applying the medical device to a host, the application device including a housing and an auxiliary mechanism, the housing including a proximal end that is close to the host during operation and a distal end that is distant from the host, the auxiliary mechanism releasably holding the medical device and movable relative to the housing when released, the auxiliary mechanism being configured to be driven in a direction toward the proximal end when released to place the medical device at least partially under the skin of the host.
[0333] In some examples, Embodiment B may be combined with any one or more of the following additional elements. Element 1: The auxiliary mechanism includes a motion body releasably held in the housing and configured to be movable relative to the housing when released, and a receiving portion disposed in the motion body and configured to receive and accommodate the medical device. Element 2: The housing includes a first retaining portion configured to releasably hold the motion body, and the motion body includes a first locking portion configured to releasably interlock with the first retaining portion. Element 3: The application device further includes a first triggering mechanism configured to disengage the first retaining portion from the first locking portion to release the motion body. Element 4: It also includes a sharp object and a support configured to support the sharp object and fitted to the motion body, wherein when the motion body is released, the motion body is driven toward the proximal end and, through the sharp object, places the medical device at least partially under the skin of the host.
[0334] Element 5: The application device further includes a first drive mechanism configured to apply an action to the auxiliary device in a manner toward the proximal end and to drive the motion body toward the host when the auxiliary device is released. Element 6: The housing includes a first outer shell having the first retaining portion and a second outer shell fitable to the first outer shell, the second outer shell having a first limiting mechanism and a second limiting mechanism in communication with each other, the auxiliary mechanism being fitted to the first limiting mechanism and movable along the first limiting mechanism when the motion body is released by the first retaining portion. Element 7: The first retaining portion has a surface facing the distal end, and the first locking portion has a surface facing the proximal end; when the motion body is held, the surface of the first retaining portion facing the distal end engages with the surface of the first locking portion facing the proximal end; when the motion body is released, the surface of the first retaining portion facing the distal end separates from the surface of the first locking portion facing the proximal end. Element 8: The first retaining portion has an arm extending generally along the central axis of the application device, and a protrusion linked to the arm and projecting generally along a direction orthogonal to the central axis of the application device. Element 9: The arm of the first retaining portion is elastic in a direction substantially orthogonal to the central axis of the application device. Element 10: The arm of the first retaining portion is pivotable or swingable toward or away from the central axis of the application device. Element 11: The arm of the first retaining portion approaches the central axis of the application device in a direction from the distal end to the proximal end, and the protrusion of the first retaining portion protrudes toward the central axis of the application device. Element 12: The arm of the first retaining portion moves away from the central axis of the application device in a direction from the distal end to the proximal end, and the protrusion of the first retaining portion protrudes away from the central axis of the application device. Element 13: The first locking portion moves away from or substantially parallel to the central axis of the application device in a direction from the proximal end to the distal end. Element 14: The first locking portion approaches or substantially parallel to the central axis of the application device in a direction from the proximal end to the distal end. Element 15: The first housing includes a hollow cylindrical periphery and a distal end disposed near one end of the periphery, wherein the first retaining portion is disposed at the distal end.
[0335] Element 16: The first housing further includes a first limiting portion extending generally along the central axis of the application device, the first limiting portion being configured to maintain the balance of the moving body in a plane orthogonal to the central axis of the application device. Element 17: The first limiting portion is disposed at the distal end, and the first retaining portion, the first limiting portion, and the first housing are integrally formed. Element 18: The first triggering mechanism includes a pressable portion for operation and a first actuating portion configured to be linked with the pressable portion and actuate the first retaining portion. Element 19: The first actuating portion extends along a direction having a predetermined angle with the central axis of the application device. Element 20: The first actuating portion extends along a direction having a predetermined angle with the central axis of the application device and toward the distal end.
[0336] Element 21: The first actuating part is actuated in response to an action applied to the first actuating part along its extension direction. Element 22: The first actuating part is actuated in response to an action applied to the first actuating part along the central axis of the application device. Element 23: The first actuating part is connected to the first retaining part. Element 24: The first actuating part, the first retaining part, and the pressing part are integrally formed. Element 25: In response to an action applied to the first actuating part, the first retaining part is driven to swing away from or towards the central axis of the application device with the connection point of the first retaining part and the distal end as a fulcrum. Element 26: The distal end has a through structure, and the first actuating part is connected to the first retaining part and extends to the through structure in a predetermined direction. Element 27: The end of the first actuating part near the first retaining part has a curved structure. Element 28: The pressing part is located in the through structure. Element 29: The first triggering mechanism, the first retaining part, and the first housing are integrally formed. Element 30: The first triggering part is configured to be actuated along the central axis of the application device. Element 31: When the moving body is released, the moving body is movable along the first limiting mechanism and the receiving portion is movable along the second limiting mechanism. Element 32: The first limiting mechanism restricts the travel of the moving body in the direction along the central axis of the application device. Element 33: Projected along the central axis of the application device, the receiving portion at least partially coincides with the wall of the first limiting mechanism, and the end of the moving body near the distal end at least partially coincides with the wall of the first limiting mechanism. Element 34: The first triggering mechanism and the first holding mechanism are integrally formed in the housing.
[0337] Element 35: The first triggering mechanism is integrally formed with the housing. Element 36: The projection of the pressing portion and the through structure along the central axis of the application device at least partially coincides. Element 37: The projection of the pressing portion and the housing along a direction perpendicular to the central axis of the application device at least partially coincides. Element 38: The first actuating portion can be connected to the arm of the first retaining portion near the proximal end. Element 39: The first actuating portion and the first retaining portion form a U-shaped groove. Element 40: The end of the first actuating portion near the pressing portion has a hardness not less than that of the end near the first retaining portion. Element 41: The projection of the first actuating portion along the central axis of the application device coincides with the long axis direction of the body unit. Element 42: The distal end of the moving body has a first recessed structure, and when the moving body is at the distal end, the first actuating portion at least partially passes through the first recessed structure. Element 43: The first triggering mechanism further includes an additional holding portion and a second actuating portion. The additional holding portion is connected to the pressing portion via the second actuating portion. The projections of the additional holding portion and the second actuating portion onto the central axis of the application device are collinear with the projections of the first holding portion and the first actuating portion onto the central axis of the application device. Element 44: The housing includes at least one limiting portion disposed on the opposite side or the same side as the first holding portion. The limiting portion abuts against the moving body.
[0338] Figure 16A This is an exploded schematic diagram from a first perspective showing the moving body 200, the second drive mechanism 40, and the puncture member 260 involved in the example of this disclosure; Figure 16B This is an exploded schematic diagram from a second perspective showing the moving body 200, the second drive mechanism 40, and the puncture member 260 involved in the example of this disclosure; Figure 17A This is a schematic cross-sectional view showing the puncture member 260 being held according to an example of this disclosure; Figure 17B This is a schematic cross-sectional view showing the puncture member 260 as described in this disclosure example being released.
[0339] In some examples, the moving body 200 and the puncture member 260 may be integrally fixedly connected. In other examples, the moving body 200 and the puncture member 260 may be detachably assembled and coupled. In some examples, the puncture member 260 may be releasably held by the moving body 200.
[0340] In some examples, as described above, the moving body 200 may have a first bottom 210 near its distal end, a second bottom 220 near its proximal end, and a sidewall 230 connecting the first bottom 210 and the second bottom 220. In some examples, a hollow portion may be formed between the first bottom 210, the second bottom 220, and the sidewall 230. In some examples, see [link to relevant documentation]. Figure 16A The receiving portion 250 may be disposed in the second bottom 220 and face proximally. In some examples, the piercing member 260 may be disposed within the hollow portion. In some examples, the second bottom 220 may have a through hole 226. Additionally, in some examples, the piercing member 260 may pass through the through hole 226.
[0341] In some examples, the puncture member 260 may be releasably disposed on the moving body 200, and the puncture member 260 may be configured to be movable relative to the receiving portion 250 when released. For example, when the puncture member 260 is released, it may move relative to the receiving portion 250 in a direction away from the host.
[0342] In some examples, the application device 1000 may also include a second drive mechanism 40 (see Figure 16A The second drive mechanism 40 can be configured to apply force to the puncture member 260 in a distal manner. When the puncture member 260 is released, the puncture member 260 can be driven distally by the second drive mechanism 40 to remove the puncture member 260 from the host.
[0343] In other examples, the application device 1000 may not include the second drive mechanism 40. In this case, the puncture member 260 can be manually driven away from the host. For example, in some examples, the puncture member 260 may also be integrally connected to the motion body 200, and the puncture member 260 may be moved away from the host by manually moving the motion body 200 in a direction away from the host.
[0344] In some examples, the puncture member 260 may be releasably disposed within the hollow portion of the moving body 200. In some examples, the puncture member 260 may move along the hollow portion of the moving body 200 when released. In this case, the hollow portion is formed by the first bottom 210, the second bottom 220, and the sidewall 230, and the receiving portion 250 is disposed in the second bottom 220, and the puncture member 260 is disposed in the hollow portion, thereby facilitating the movement of the puncture member 260 relative to the receiving portion 250 when released. Thus, when the medical device 800 is applied to the host, the puncture member 260 is released and moves relative to the receiving portion 250, thereby enabling the puncture member 260 to leave the host.
[0345] In other examples, the puncture component 260 may also be fixedly mounted on the moving body 200. In this case, when the medical device 800 is applied to the host, the moving body 200 can be manually removed from the host as a whole, thereby allowing the puncture component 260 to also leave the host.
[0346] Additionally, in some examples, the first limiting mechanism 150 may also include a protrusion 160 disposed on the inner wall (see Figure 15B (More details to follow).
[0347] In some examples, a second drive mechanism 40 may be provided between the second bottom 220 of the moving body 200 and the puncture member 260. The second drive mechanism 40 is configured to apply an action to the puncture member 260 distally. When the puncture member 260 is released, the second drive mechanism 40 can apply an action to the puncture member 260 distally to disengage it from the host. In some examples, the second drive mechanism 40 may be located between the support 280 of the puncture member 260 and the second bottom 220 of the moving body 200. This facilitates the second drive mechanism 40 in applying an action to the puncture member 260 away from the receiving portion 250.
[0348] In some examples, as described above, the moving body 200 may include a sidewall 230. In some examples, the moving body 200 may include a limiting portion 238 disposed on the sidewall 230 (see...). Figure 16B The puncture member 260 may have a confined portion 285 (see...). Figure 16B When the puncture member 260 is assembled with the moving body 200, the moving body 200 can limit the movement of the puncture member 260 by limiting the restricting portion 285 through the limiting portion 238. In some examples, the number of limiting portions 238 can be one or more, such as 1, 2, 3, or 4. In some examples, multiple limiting portions 238 can be evenly distributed on the inner wall of the sidewall 230.
[0349] In some examples, the moving body 200 may also include a second retaining part 242 (see Figure 16A and Figure 16B The piercing member 260 may have a second locking portion 286 (see...). Figure 16A and Figure 16BWhen the puncture member 260 is assembled with the moving body 200, the moving body 200 can interlock with the puncture member 260 via the second retaining part 242 to retain the puncture member 260. In some examples, the retention of the puncture member 260 by the second retaining part 242 can be a releasable retention. In some examples, the number of second retaining parts 242 can be one or more, such as 1, 2, 3, or 4. In one example, multiple second retaining parts 242 can be evenly distributed on the sidewall 230.
[0350] Additionally, in some examples, the motion body 200 can be configured to suppress rotation of the puncture member 260. In this case, by suppressing unwanted rotation of the puncture member 260 during application, the user experience during the application of the medical device 800 can be improved. In some examples, the motion body 200 can suppress unwanted rotation of the puncture member 260 during application via the application limiting portion 238.
[0351] Additionally, in some examples, the moving body 200 may include grooves and / or ridges disposed on the inner wall of the sidewall 230 generally along the central axis CA. In this case, by having the grooves and / or ridges disposed on the inner wall of the sidewall of the moving body 200 engage with the grooves and / or ridges of the puncture member 260, undesirable rotation of the puncture member 260 during application can be effectively suppressed. That is, in some examples, the limiting portion 238 of the moving body 200 may be grooves and / or ridges disposed on the inner wall of the sidewall 230 generally along the central axis CA.
[0352] In some examples, the limiting portion 238 of the moving body 200 may be formed as a groove structure. In some examples, the limiting portion 238 may include two ridges arranged side by side on the inner wall of the side wall 230 generally along the direction of the central axis CA, and a groove formed between the two ridges.
[0353] Additionally, in some examples, the moving body 200 may have a cutout 242 generally along the central axis CA (see Figure 16A and Figure 16B In this case, by providing a cut 242 along the direction of the central axis CA on the moving body 200, it is convenient to apply force to the piercing member 260 provided in the hollow part of the moving body 200.
[0354] Additionally, in some examples, a protrusion 160 may be provided on the inner wall of the first limiting mechanism 150, which can protrude toward the central axis CA via a cut 242. In this case, when the moving body 200 moves along the first limiting mechanism 150, the protrusion 160 on the inner wall of the first limiting mechanism 150 can act on the piercing member 260 via the cut 242 of the moving body 200, thereby providing a triggering mechanism for the piercing member 260 with a simplified structure.
[0355] In some examples, the second retaining portion 242 of the moving body 200 can be a cutout formed on the sidewall 230 (see...). Figure 16A and Figure 16B In some examples, the second retaining portion 242 may extend generally along the central axis CA and communicate with each other through a first cut 244, a second cut 246, and a third cut 248. The first cut 244 may be proximal, and the third cut 248 may be distal. In some examples, the width of the second cut 246 may differ from the width of the first cut 244 and the width of the third cut 248. In some examples, the width of the second cut 246 may be greater than the widths of the first cut 244 and the third cut 248.
[0356] In some examples, the puncture member 260 may include a sharp object 270 and a support 280 for supporting the sharp object 270 (see [reference]). Figure 16A and Figure 16B In some examples, the support 280 of the puncture member 260 may be disposed within the hollow portion of the moving body 200, the receiving portion 250 may be disposed in the second bottom 220, the second bottom 220 may have a through hole 226, and the sharp object 270 may pass through the through hole 226 of the second bottom 220. In this case, by providing the sharp object 270 through the through hole 226 of the second bottom 220, the sharp object 270 can engage with the medical device 800 disposed within the receiving portion 250, thereby facilitating the placement of the medical device 800 at least partially under the skin of the host via the puncture member 260.
[0357] Additionally, in some examples, the moving body 200 may also include a positioning structure 224 disposed on the second bottom 220 for positioning the second drive mechanism 40 (see Figure 14A In some examples, the positioning structure 224 may be cylindrical. In some examples, the positioning structure 224 may be a hollow cylinder. In this case, the second drive mechanism 40 can be positioned by fitting it onto the positioning structure 224, thereby defining the drive position of the second drive mechanism 40.
[0358] Additionally, in some examples, when the puncture member 260 is held, the distance between the support 280 and the first bottom 210 may be no less than the length of the sharp object 270 protruding from the receiving portion 250. In this case, by setting the distance between the support 280 and the first bottom 210 to be no less than the length of the sharp object 270 protruding from the receiving portion 250, space can be provided for the puncture member 260 to move away from the host, thereby reducing undesirable harm to the host caused by the puncture member 260.
[0359] In other examples, the sharp object 270 and the support 280 can be configured to be detachably assembled. This facilitates the separate sterilization of the sharp object 270.
[0360] In some examples, the confined portion 285 of the puncture member 260 can be formed as a ridge structure (see...). Figure 16B In some examples, the restricted portion 285 may include two grooves arranged side-by-side on the sidewall of the support 280 generally along the central axis CA, and a ridge formed between the two grooves. In some examples, the number of restricted portions 285 may be one or more, such as 1, 2, 3, or 4. In some examples, the number of restricted portions 285 may be equal to the number of restrictive portions 238.
[0361] Additionally, in some examples, the support 280 may include grooves and / or ridges disposed on the outer wall generally along the central axis CA. In this case, the grooves and / or ridges of the support 280 engage with grooves and / or ridges on the inner side wall of the moving body 200, thereby effectively suppressing undesirable rotation of the puncture member 260. That is, the limiting portion 285 of the puncture member 260 may be formed as grooves and / or ridges disposed on the outer wall generally along the central axis CA. The limiting portion 285 of the puncture member 260 may engage with the limiting portion 238 of the moving body 200 to suppress undesirable rotation of the puncture member 260.
[0362] Additionally, in some examples, the puncture member 260 may include a second locking portion 286 configured to releasably interlock with the second retaining portion 242 (see also...). Figure 17A Thus, the piercing member 260 can be releasably held in the second holding portion 242 by the cooperation of the second locking portion 286 and the second holding portion 242. In some examples, the second locking portion 286 may be provided on the support 280 of the piercing member 260.
[0363] In some examples, the second locking portion 286 may include an arm 287 extending generally along the central axis CA, and a protrusion 288 linked to the arm 287 and projecting generally in a direction orthogonal to the central axis CA away from the central axis CA (see [link to relevant documentation]). Figure 16Aand 16B In this case, when the puncture member 260 is placed inside the hollow portion of the moving body 200, it overlaps with the cut 242 of the moving body 200 via the second locking portion 286 (see...). Figure 17A This allows the piercing member 260 to be held while maintaining a simplified structure. In some examples, the arm 287 of the second locking part 286 may be elastic in a direction generally orthogonal to the central axis CA of the applying device 1000.
[0364] As described above, the moving body 200 may have a cut 242 generally along the central axis CA. In some examples, when the piercing member 260 is held, the protrusion 288 of the second locking portion 286 may pass through the cut 242. In this case, by engaging the protrusion 288 of the second locking portion 286 with the cut 242 of the moving body 200, the second locking portion 286 can be held with a simplified structure.
[0365] Additionally, in some examples, when the puncture member 260 is released, the arm 288 of the second locking part 286 can be pressed toward the central axis CA. This allows for easy release of the second locking part 286.
[0366] Additionally, in some examples, the second retaining part 242 and the second locking part 286 can be releasably interlocked by at least one of the following structures: a latch, a hook, a bolt, or a pin. In this case, the second retaining part 242 and the second locking part 286 are releasably interlocked by at least one of the following structures, thereby providing an interlocking method that is easy to release.
[0367] In some examples, the second locking portion 286 of the puncture member 260 may be formed as a shoulder structure. In some examples, the second locking portion 286 may include an arm 287 extending distally in a direction generally along the central axis CA, and a protrusion 288 projecting from the end of the arm 287 in a direction generally orthogonal to and away from the central axis CA. In some examples, the arm 287 may be elastic. In some examples, the arm 287 may gradually move away from the central axis CA in a distal direction. In some examples, when projected along the central axis CA, the projection plane of the protrusion 288 may wholly or partially coincide with the projection plane of the first incision 244. In some examples, the number of second locking portions 286 may be one or more, such as one, two, three, or four. In some examples, the number of second locking portions 286 may be equal to the number of second retaining portions 242.
[0368] Additionally, in some examples, the width of the distal surface of the protrusion 288 may be less than the width of the second cut 246 and may be greater than the width of the first cut 224 and the second cut 246.
[0369] In some examples, when assembling the first limiting mechanism 150 and the moving body 200, the protrusion 160 provided on the inner wall of the first limiting mechanism 150 can pass sequentially through the third cut 248, the second cut 246, and the first cut 244. In this case, by providing the first cut 244, the protrusion 160 can protrude out of the moving body 200; by providing the second cut 246, a holding mechanism for the piercing member 260 can be provided; and by providing the third cut 248, a structure that facilitates assembly can be provided. The protrusion 160 enters the first cut 244 through the third cut 248 and the second cut 246, and the protrusion 288 of the second locking portion 286 protrudes through the second cut 246, thereby providing a retention mechanism for the piercing member 260. Additionally, the protrusion 160 can abut against the protrusion 288 of the second locking portion 286 through the first cut 244, thus providing a triggering mechanism for releasing the second locking portion 286. In some examples, the widths of the second cut 246 and the first cut 244 may be the same.
[0370] In some examples, the protrusion 160 can act on the second locking portion 286 in a direction orthogonal to the central axis CA. In this case, the second locking portion 286 is biased inward and disengaged from the host (see [link]). Figure 17B ).
[0371] In some examples, after the puncture member 260 is released by the moving body 200, the second drive mechanism 40 drives the puncture member 260 toward the distal end to remove the puncture member 260 from the host.
[0372] In some examples, the second drive mechanism 40 may have the same or similar configuration as the first drive mechanism 30; for details regarding the characteristics of the second drive mechanism 40, please refer to the description of the characteristics of the first drive mechanism 30. In some examples, the second drive mechanism 40 may be a spring. Thus, an actuation mechanism for the puncture member 260 can be provided through a simplified structural design.
[0373] In some examples, the second drive mechanism 40 may be disposed between the support 280 and the second bottom 220, and when the puncture member 260 is held, the distance between the support 280 and the first bottom 210 is not less than the depth to which the sensor 820 is implanted subcutaneously. In this case, by providing sufficient space for movement for the puncture member 260, it is possible to facilitate the removal of the puncture member 260 from the host.
[0374] In some examples, the moving body 200 also includes a first marking portion 239 disposed on the side wall 230 (see Figure 16B In some examples, the first marking portion 239 may be used to limit the assembly direction of the support 280 to the moving body 200.
[0375] In some examples, the support 280 may include a second identification portion 281 that can be coupled to the first identification portion 239 (see [reference]). Figure 16B In this case, the moving body 200 and the support 280 can have a unique assembly orientation.
[0376] In some examples, the first marking portion 239 may be a rib or groove formed on the sidewall 230 and extending along the central axis CA, and the second marking portion 281 may be a groove or rib formed on the support 280.
[0377] In some examples, when the puncture member 260 is triggered to unlock, the puncture member 260 can be driven to a position close to the distal end 120. In some examples, the puncture member 260 can be driven to a position abutting the distal end 120. Thus, the puncture member 260 can retract with its maximum stroke, reducing the risk of exposure of the puncture member 260.
[0378] In some examples, when the puncture member 260 is released, it can transition along a first path defined by the moving body 200 to a second path defined by the first housing 100.
[0379] In some examples, the process of the puncture member 260 being released and moving relative to the moving body 200 may include a first state in which the movement path is defined by the moving body 200, a second state in which the movement path is defined by the moving body 200 and the first housing 100, and a third state in which the movement path is defined by the first housing 100. This allows the puncture member 260 to leave the host along a predetermined path.
[0380] See in some examples Figure 12B The first housing 100 may include a limiting portion 123 extending from the distal end 120. The limiting portion 123 may be used to receive the puncture member 260 and define the movement path of the puncture member 260.
[0381] In some examples, the support 280 may also include a second recessed structure 290 (see Figure 16BWhen the support 280 is assembled with the application device 1000, the second recessed structure 290 can be disposed on the same side as the first retaining portion 130. In this case, when the piercing member 260 transitions from the first path defined by the moving body 200 to the second path defined by the first housing 100, the first retaining portion 130 and / or the first actuating portion 504 can pass through the second recessed structure 290, thereby ensuring that the piercing member 260 is not obstructed when entering the second path.
[0382] In some examples, the distal end of the puncture member 260 has a second recessed structure 290 (see...). Figure 16B When the puncture member 260 is at the distal end, the first actuating part 504 at least partially passes through the second recessed structure 290. In this case, the second recessed structure 290 allows the puncture member 260 to overlap with the first actuating part 504 in axial space as it moves distally, thereby reaching a limit position closer to the distal end of the housing 10. By eliminating mechanical interference between components, the puncture member 260 can be completely detached from the host tissue and can also be completely housed inside the housing 10, thereby reducing the risk of needle retention and needlestick injury.
[0383] In some examples, the puncture member 260 may have a positioning portion 289 disposed on the support 280 (see Figure 16A In some examples, the positioning part 289 can be a columnar structure. One end of the second drive mechanism 40 can be sleeved on the positioning part 289 of the piercing member 260, and the other end of the second drive mechanism 40 can be sleeved on the positioning part 224 of the moving body 200 (see...). Figure 14A In this way, the second drive mechanism 40 is positioned between the moving body 200 and the puncture member 260.
[0384] In some examples, the application device 1000 also provides a triggering mechanism to disengage the second retaining portion 242 from the second locking portion 286, thereby releasing the piercing member 260 from the moving body 200. That is, in some examples, the application device 1000 further includes a second triggering mechanism configured to separate the second retaining portion 242 from the second locking portion 286 to release the piercing member 260. Thus, the piercing member 260 can be conveniently released via the second triggering mechanism.
[0385] As described above, the second locking portion 286 is formed as a shoulder structure capable of abutting against the second retaining portion 242, thereby being held by the second retaining portion 242 in the form of a clasp. In some examples, a triggering mechanism is provided that can actuate the second retaining portion 242 or the second locking portion 286 to separate the second retaining portion 242 from the second locking portion 286.
[0386] In some examples, the triggering mechanism acting on the second retaining portion 242 and the second locking portion 286 can be provided on the travel path of the second locking portion 286. This triggering mechanism can be invoked when the moving body 200 moves towards the proximal end. In some examples, the triggering mechanism can be a protrusion provided on the travel path of the second locking portion 286. In this case, when the second locking portion 286 passes the protrusion, the arm 287 of the second locking portion 286 can be compressed towards the central axis CA and undergo elastic deformation, so that the protrusion 288 of the second locking portion 286 separates from the second cut 246 and the third cut 248.
[0387] In some examples, as previously described, a protrusion 160 is provided on the inner wall of the first limiting mechanism 150 (see [reference]). Figure 15B When the moving body 200 moves along the first limiting mechanism 150, the first cut 244, the second cut 246, and the third cut 248 of the moving body 200 can pass through the protrusion. Additionally, when the piercing member 260 is held within the hollow portion of the moving body 200, the second locking portion 286 of the piercing member 260 is deformed by the pressure of the protrusion 160 and moves away from the junction of the second cut 246 and the third cut 248, thereby releasing the piercing member 260.
[0388] Furthermore, when assembling the moving body 200 and the first limiting mechanism 150, the protrusion 160 can sequentially pass through the third cut 248, the second cut 246, and the first cut 244 until the moving body 200 is assembled with the first limiting mechanism 150. By using the protrusion 160 provided on the inner wall of the first limiting mechanism 150, and the first cut 244, the second cut 246, and the third cut 248 provided on the side wall 230 of the moving body 200, a triggering mechanism for movement can be provided without adversely affecting the assembly of the moving body 200 and the first limiting mechanism 150.
[0389] In some examples, after the application of the instrument kit 1 is completed, the motion body 200 can be acted on in the proximal-to-distal direction to lock the motion body 200 back into the first holding part 130.
[0390] Figure 18A This is a first-view cross-sectional view showing the device kit 1 according to the example of this disclosure before the application of the medical device 800; Figure 18B This is a cross-sectional view from a second perspective showing the device kit 1 involved in the example of this disclosure before the application of the medical device 800. Figure 18C This is a cross-sectional view showing the medical device 800 applied in the device kit 1 according to the example of this disclosure from a first perspective; Figure 18DThis is a cross-sectional view showing the second perspective of the medical device 800 applied by the device kit 1 involved in the example of this disclosure; Figure 18E This is a cross-sectional view showing the medical device 800 being applied to a host by the device kit 1 according to the example of this disclosure; Figure 18F This is a cross-sectional view showing the puncture component 260 of the instrument kit 1 according to the example of this disclosure in a second state after the medical device 800 has been applied; Figure 18G This is a cross-sectional view showing the puncture component 260 of the instrument kit 1 according to the example of this disclosure in a third state after the medical device 800 has been applied; Figure 19 This is a cross-sectional view showing the motion body 200 of the device kit 1 according to the example of this disclosure, when the medical device 800 is applied and then locked again in the first retaining part 130; wherein, attached Figure 18A To be continued Figure 19 The first drive mechanism 30 and the second drive mechanism 40 are not shown.
[0391] The application process of the application device 1000 will now be described again: applying the medical device 800 to the host via the application device 1000 may include an application phase and a withdrawal phase. In the application phase, the medical device 800 may be applied to the host; in the withdrawal phase, the puncture member 260 may be removed from the host.
[0392] See in some examples Figure 18A and Figure 18B Before the medical device 800 is applied, the moving body 200 is locked in the first holding part 130.
[0393] During the application phase, pressing the pressing part 502 of the first triggering mechanism 50 causes the first actuating part 504 of the first triggering mechanism 50 to actuate the first holding mechanism 130 in a direction away from the central axis CA, thereby separating the first holding part 130 from the first locking part 236 and releasing the moving body 200; then, the first driving mechanism 30 applies an action to the moving body 200 in a proximal manner, causing the moving body 200 to move proximally; then, under the action of the puncture member 260, the medical device 800 contained in the receiving part 250 is at least partially placed under the host's skin.
[0394] In some examples, the application device 1000 may not include the first drive mechanism 30. In this case, when the motion body 200 is released, the motion body 200 may also be driven toward the host by human power, thereby applying the medical device 800 contained in the receiving portion 250 to the host through the puncture member 260.
[0395] During the retraction phase, as the moving body 200 moves proximally along the first limiting mechanism 150, the protrusion 160 on the inner wall of the first limiting mechanism 150 passes through the second incision 246 on the moving body 200 and approaches the second locking portion 286 of the piercing member 260. The protrusion 160 compresses the second locking portion 286, causing the second locking portion 286 to pivot in a direction close to the central axis CA, thereby separating the second locking portion 286 from the second retaining portion 242 (see...). Figure 18C and Figure 18D Next, the second drive mechanism 40 applies force to the puncture member 260 in a distal manner, so that the puncture member 260 moves distally and leaves the host.
[0396] See in some examples Figure 18A and Figure 18B The puncture member 260 may include a junction 2741 protruding from the bottom of the medical device 800. In some examples, the medical device 800 has not yet been applied to the host (binding) when the second locking portion 286 is disengaged from the second retaining portion 242. Figure 18C and 18D At this point, the moving body 200 and the receiving portion 250 can continue to be driven proximally, while the puncture member 260 can be driven distally. In this case, since the puncture member 260 is prematurely triggered to unlock, when the medical device 800 is applied to the host, the puncture member 260 has already moved a distance distally relative to the moving body 200. Therefore, the connecting portion 2741 can assist in applying the medical device 800 to the host in a posture that does not protrude from the bottom of the medical device 800, thereby improving user comfort. For example, see... Figure 18D and Figure 18E When the medical device 800 is applied to the host, the bottom of the junction 2741 is flush with the bottom of the medical device 800. In some examples, the bottom of the junction 2741 may not protrude from the bottom of the medical device 800 when the medical device 800 is applied to the host.
[0397] In some examples, when the timing of the puncture mechanism 260 being triggered for unlocking is appropriately set, the bottom of the engagement 2741 may not protrude from the proximal end of the housing 10 throughout the application process. That is, the puncture mechanism 260 can be triggered to unlock either when the bottom of the engagement 2741 has moved to the proximal end of the housing 10 or before it has moved to the proximal end of the housing 10. In this case, the bottom of the engagement 2741 does not act on the host, improving user comfort.
[0398] See in some examples Figure 18EWhen the medical device 800 is applied to the host, the protrusion 234 of the moving body 200 can abut against the slot 156. Specifically, the lower surface of the protrusion 234 of the moving body 200 can abut against the upper surface of the slot 156. This restricts the moving body 200 from moving further proximally, thereby facilitating the movement of the subsequent puncture component 260 away from the host.
[0399] In some examples, the puncture member 260 may also be fixedly connected to the moving body 200. Additionally, in some examples, the application device 1000 may not include the second drive mechanism 40. In this case, after the medical device 800 is applied to the host, the moving body 200 can be driven manually in a direction away from the host, thereby allowing the puncture member 260, fixedly connected to the moving body 200, to follow the moving body 200 away from the host.
[0400] Furthermore, it should be noted that during the retraction phase, the first drive mechanism 30 (or with human intervention) can still exert an action on the moving body 200 towards the host. In other words, for the first drive mechanism 30, which is configured as an elastic component (e.g., a spring), when the moving body 200 is driven towards the host and the medical device 800 housed in the receiving portion 250 is applied to the host's body surface, the first drive mechanism 30 can still be in an energy-storing state. In this case, during the retraction phase, the medical device 800 is tightly attached to the host's body surface under the action of the first drive mechanism 30, thereby effectively reducing the possibility of the medical device 800 detaching from the host during the retraction phase.
[0401] See in some examples Figure 18F and Figure 18G The piercing member 260 can be driven to a position abutting against the first housing 100. In some examples, the limiting portion 123 can receive the protrusion 288 of the second locking portion 286. In some examples, the size of the protrusion 288 of the second locking portion 286 can be equal to or slightly smaller than the size of the limiting portion 123. Figure 18F This illustrates a second state in which the puncture member 260 is in a position where its movement path is restricted by the path-limiting portion 123 of the moving body 200 and the first housing 100. Figure 18G The image shows the piercing member 260 in a third state where its movement path is restricted by the limiting portion 123 of the first housing 100.
[0402] See in some examples Figure 19The moving body 200 can be locked again to the first retaining part 130. In some examples, the moving body 200 can be acted on in a direction toward the distal end so that the moving body 200 can be locked again to the first retaining part 130. In some examples, when the moving body 200 can be locked again to the first retaining part 130, the cap 700 can be coupled to the housing 10. This facilitates the storage and organization of the instrument set 1.
[0403] Embodiments of this disclosure include: C. An instrument kit comprising a puncture member and an application device cooperating with the puncture member to apply the medical device to a host, the application device comprising a housing and an auxiliary mechanism, the housing comprising a proximal end proximal to the host during operation and a distal end distal to the host, the auxiliary mechanism releasably holding the medical device and movable relative to the housing upon release, the auxiliary mechanism being configured to be driven in a proximal direction upon release to place the medical device at least partially under the skin of the host via the puncture member, and to drive the puncture member away from the host in response to an action on the application device in a distal direction.
[0404] In some examples, Embodiment C may be combined with any one or more of the following additional elements: Element 1: The auxiliary mechanism includes a motion body releasably held in the housing and configured to be movable relative to the housing when released, and a receiving portion disposed in the motion body and configured to receive and accommodate the medical device. Element 2: The puncture mechanism is releasably held in the motion body and configured to be movable relative to the receiving portion when released. Element 3: It further includes a second drive mechanism configured to apply force to the puncture member toward the distal end. Element 4: When the puncture mechanism is released, the puncture member is driven away from the host in response to the action applied to the puncture member by the second drive mechanism. Element 5: The puncture member includes a grooved sharp object and a support for supporting the sharp object, the medical device being wholly or partially placed in the groove of the sharp object, and the second drive mechanism being configured to apply force to the support.
[0405] Element 6: The moving body includes a second retaining portion for holding the puncture member, the puncture member including a second locking portion configured to releasably interlock with the second retaining portion. Element 7: The moving body has a first bottom near the distal end, a second bottom near the proximal end, a sidewall connecting the first bottom and the second bottom, and a hollow portion formed between the first bottom, the second bottom, and the sidewall, the receiving portion being disposed at the second bottom and movable along the hollow portion when the puncture member is released. Element 8: The second locking portion includes an arm extending generally along the central axis of the application device, and a protrusion disposed on the arm and projecting generally away from the central axis of the application device in a direction orthogonal to the central axis of the application device. Element 8: The moving body has a cutout generally along the central axis of the application device, and when the puncture member is held, the protrusion of the second locking portion passes through the cutout.
[0406] Element 9: The puncture member includes a second locking portion configured to releasably interlock with the second retaining portion and disposed on the support. The second locking portion includes an arm extending generally along the central axis of the application device, and a protrusion linked to the arm and projecting generally away from the central axis of the application device in a direction orthogonal to the central axis of the application device. Element 10: A protrusion is provided on the inner wall of the first defining mechanism, which can project toward the central axis of the application device via the incision. Element 11: The arm of the second locking portion is elastic in a direction generally orthogonal to the central axis of the application device.
[0407] Element 12: The moving body has a cut approximately along the central axis of the application device, and when the piercing member is held, the protrusion of the second locking portion passes through the cut. Element 13: When the piercing member is released, the arm of the second locking portion is pressed toward the central axis of the application device.
[0408] Element 14: When the puncture member is released, it can transition along a first path defined by the moving body to a second path defined by the first housing. Element 15: The first housing includes a limiting portion disposed at the distal end for defining the second path. Element 16: Projected along the central axis of the application device, the limiting portion defining the second path at least partially coincides with the moving body. Element 17: The process of the puncture member being released and moving relative to the moving body includes a first state in which a movement path is defined by the moving body, a second state in which a movement path is defined by the moving body and the housing, and a third state in which a movement path is defined by the housing. Element 18: The support has a second recessed structure in a direction generally along the central axis of the application device, through which the first retaining portion and / or the first actuating portion passes when the puncture member transitions to the second path. Element 19: The moving body can be actuated in a direction toward the distal end to lock the first locking portion into the first retaining portion. Element 20: The support is configured to be mounted on the moving body in a predetermined direction. Element 21: The distal end of the puncture member has a second recessed structure, and when the puncture member is at the distal end, the first actuating part at least partially passes through the second recessed structure.
[0409] In some examples, embodiment B, and embodiments combining embodiment B with any one or more of the corresponding elements 1 to 17, can be combined with embodiment A or a combination of embodiment A and its corresponding elements.
[0410] Figure 20A This is an exploded schematic diagram of the puncture member 260 involved in the example of this disclosure; Figure 20B This is a schematic diagram showing the first view of the assembled piercing member 260 according to the example of this disclosure; Figure 20C This is a cross-sectional view showing the puncture member 260 as described in this disclosure example; Figure 20D This is a schematic diagram showing a second view of the assembled piercing member 260 involved in the example of this disclosure. Figure 20E This is a cross-sectional view showing another structure of the puncture member 260 involved in the example of this disclosure. Figure 20F This is an external view showing another structure of the puncture member 260 involved in the example of this disclosure.
[0411] As mentioned above, see Figure 20A and Figure 20BThe puncture member 260 may include a sharp object 270 and a support 280 supporting the sharp object 270. In some examples, the sharp object 270 and the support 280 may be integrally formed. In other examples, the sharp object 270 may be detachably assembled with the support 280. In some examples, the sharp object 270 may have a groove, and the medical device 800 may be placed wholly or partially in the groove. In some examples, a second drive mechanism 40 may act on the support 280. In this case, by placing the medical device 800 wholly or partially in the groove of the sharp object 270, it is possible to facilitate the placement of the medical device 800 at least partially under the skin of the host via the puncture member 260. In some examples, the implantation portion of the sensor 820 may be placed within the groove 274 of the sharp object 270.
[0412] In some examples, the sharp object 270 may include a needle-like portion 272 (see [reference]). Figure 20A In some examples, a groove extending along the length of the needle portion 272 may be provided on the needle portion 272. The medical device 800 may be at least partially disposed within the groove of the sharp object 270. In this case, the sensor 820 may be received within the groove to facilitate the sensor 820 being placed subcutaneously in the host along with the sharp object 270.
[0413] In some examples, the sharp object 270 may include a cap 276 connected to the needle-like portion 272 (see [reference]). Figure 20A In some examples, the needle portion 272 can be fitted to the support 280 via the cap portion 276.
[0414] See in some examples Figure 20A The support 280 may include a hole 2821 configured to receive a cap 276, the cap 276 extending through the hole 2821 and fitted into the support 280. In some examples, the support 280 may include a sharps retainer 282 having the hole 2821. In some examples, the cap 276 may be secured to the sharps retainer 282.
[0415] In some examples, the cap 276 may include a second part 278 and a third part 279 connected in sequence (see [reference]). Figure 20C In some examples, the sharp object 270 can be secured to the support 280 via the third part 239.
[0416] In some examples, the third portion 279 has a plurality of fingers configured to snap onto the support 280. In some examples, the cap 276 has a tip remote from the sensor control device and an end opposite to the tip, with the plurality of fingers formed at the tip and extending away from the central axis of the tip 270 in a direction from tip to end. Thus, the tip 270 can be secured to the support 280 in a one-way locking manner.
[0417] In some examples, the number of fingers can be 2, 3, 4, 5, or 6, etc.
[0418] In some examples, the third part 279 may be elastic. In some examples, the sharp object fixing part 282 may be elastic.
[0419] In some examples, during assembly, multiple fingers can be compressed in a direction toward the central axis CA, and can return to an expanded posture after the multiple fingers have extended through the hole 2821. This allows them to snap into the support 280.
[0420] In some examples, the sharp object fixing portion 282 may also include a limiting portion 289 configured to inhibit rotation of the sharp object 270 (see [reference]). Figure 20C and Figure 20D In some examples, the limiting portion 289 may be formed as a groove that restricts the circumferential movement of the finger. In some examples, the limiting portion 289 may be formed by two adjacent protrusions to restrict the circumferential movement of the finger.
[0421] In some examples, when the sharp object 270 is fitted onto the support 280, the finger can engage with the groove. This prevents the sharp object 270 from rotating.
[0422] See in some examples Figure 20E and Figure 20F The third part 279 may have retaining teeth configured to engage with the support 280. In some examples, the retaining teeth may have abutting surfaces that are inclined away from the central axis of the tip 270 along the direction from tip to end. Thus, the tip 270 can be secured to the support 280 in a one-way locking manner.
[0423] In some examples, the sharp object fixing part 282 may have a sharp object fixing arm 2822. In some examples, the sharp object fixing arm 2822 may be resilient.
[0424] In some examples, during assembly, the retaining teeth can press the sharp object retaining arm 2822 in a direction away from the central axis CA, and can return to an expanded posture after the retaining teeth have extended through the end of the sharp object retaining arm 2822 away from the hole 2821. This allows it to snap into the support 280.
[0425] See in some examples Figure 20F There can be multiple limiting portions 289. In some examples, multiple limiting portions 289 can abut against three planes of the third portion 279 that do not have fixed teeth. Thus, it is possible to suppress the rotation of the sharp object 270.
[0426] In some examples, the second portion 248 can be a structure with a central geometry larger than the diameter of the hole 2821, for example, it can be a cylinder with a diameter larger than the hole 2821. Thus, the second portion 248 can limit the axial travel of the sharp object 270. Furthermore, the engagement of the second portion 248 and the third portion 279 can axially fix the sharp object 270 to the support 280.
[0427] In some examples, the cap 276 may include a first portion 277, a second portion 278, and a third portion 279 connected in sequence. The first portion 277 may be used to mate with the medical device 800.
[0428] Figure 20G This is a cross-sectional view showing another structure of the puncture member 260 involved in the example of this disclosure. Figure 20H This is a cross-sectional view showing another structure of the puncture member 260 involved in the example of this disclosure. Figure 20I This is a cross-sectional view showing another structure of the puncture member 260 involved in the example of this disclosure. Figure 20J This is a cross-sectional view illustrating another structure of the piercing member 260 involved in the examples of this disclosure. It should be noted that some identical or similar structures are described above and will not be repeated here.
[0429] See in some examples Figure 20G and Figure 20H The limiting portion 289 can be a semi-enclosed structure. In some examples, the limiting portion 289 can be at least partially disposed above the third portion 279. This helps to prevent the third portion 279 from excessively extending into the support 280.
[0430] In some examples, the number of first joining structures 27411 can be one or more (see [reference]). Figure 20G and Figure 20H For example, the number of first joining structures 27411 can be 1, 2, 3, or 4. In some examples, the number of second joining structures 721 can also be 1 or more. For example, the number of second joining structures 721 can be 1, 2, 3, or 4. In some examples, the number of first joining structures 27411 and the number of second joining structures 721 can be equal.
[0431] See in some examples Figure 20I The limiting portion 289 may have a limiting hole 2891. In some examples, the sharp object 270 may extend at least partially into the limiting hole 2891. In some examples, the needle-like object 272 may extend at least partially into the limiting hole 2891. This reduces the wobbling of the sharp object 270 in the support 280.
[0432] In some examples, the limiting hole 2891 can be aligned with the hole 2821.
[0433] See in some examples Figure 20J The third part 279 may have a preset taper. In some examples, along the central axis CA and towards the proximal end, the sidewalls of the third part 279 may gradually move away from the central axis CA. This facilitates the fitting of the sharp object 270 to the support 280.
[0434] In some examples, the stiffness of the third portion 279 can be greater than the stiffness of the sharp object fixing portion 282. In some examples, the third portion 279 can have a deformable portion. In some examples, the deformable portion can be formed by the third portion 279 being recessed towards the central axis CA. In this case, during the process of assembling the sharp object 270 onto the support 280, since the third portion 279 is compressed against the sharp object fixing portion 282, the formation of the deformable portion provides space for the sharp object fixing portion 282 to deform under pressure, thereby facilitating the assembly of the sharp object 270 onto the support 280. In some examples, the deformable portion can be a cut formed in the third portion 279.
[0435] In other examples, the stiffness of the third part 279 may also be less than or equal to the stiffness of the sharp object fixing part 282.
[0436] In some examples, the sidewall of the third portion 279 may partially abut against the inner wall of the sharp object fixing portion 282. In some examples, the size of the sidewall of the third portion 279 may be smaller than the size of the inner wall of the sharp object fixing portion 282.
[0437] See in some examples Figure 20J The third portion 279 may have a limiting flange 2791. In some examples, the limiting flange 2791 may be configured to limit the length of the third portion 279 extending into the support 280.
[0438] Figure 21A This is an exploded view from a first perspective showing the sterilization components involved in the examples of this disclosure. Figure 21B This is an exploded view showing a second perspective of the sterilization component involved in the example of this disclosure.
[0439] As described above, during the user's use of the analyte monitoring system 1, the sharp object 270 and the sensor 820 can at least partially penetrate the host's subcutaneous tissue. In some examples, the sharp object 270 and the sensor 820 can be sterilized. In some examples, the sensor 820 can be sterilized using radiation sterilization. Radiation sterilization methods can include, for example, electron beam radiation, gamma ray radiation, X-ray radiation, or a combination thereof. This contributes to the health and safety of the host.
[0440] In some examples, after the sharp object 270 and sensor 820 are sterilized, they can be stored in a sealed space. In this case, the sharp object 270 and sensor 820 can remain in a sterile space until the user uses the analyte monitoring system 1.
[0441] See in some examples Figure 21A and Figure 21B The analyte monitoring system 1 may include a sharp object 270, a sealing assembly 500, a sealing cap 600, a sensor 820, a base 830, and a cap 700. In some examples, the sharp object 270, sealing assembly 500, sealing cap 600, sensor 820, base 830, and cap 700 may constitute a sterilization assembly. In some examples, the entire sterilization assembly may be sterilized. In some examples, when sterilizing the entire sterilization assembly, components such as the cap 700 may be made of at least a material that allows radiation to pass through. In some examples, suitable materials for making the cap 700 may be non-magnetic metals, thermoplastics, ceramics, rubber, composite materials, or combinations thereof.
[0442] In some examples, the sterilization assembly may have a sealed space. In some examples, the sharp object 270 and the sensor 820 may be at least partially located within the sealed space of the sterilization assembly.
[0443] In some examples, the sharp object 270, sealing assembly 500, sealing cap 600, sensor 820, base 830, and cap 700 can be assembled together to form the aforementioned sealed space.
[0444] Figure 22A This is a structural schematic diagram showing the base 830 involved in the example of this disclosure from a first perspective. Figure 22B This is a structural schematic diagram showing the base 830 involved in the example of this disclosure from a second perspective.
[0445] See in some examples Figure 22A and Figure 22B The application portion 860 may include a base 830. In some examples, the outline of the base 830 may be approximately racetrack-shaped.
[0446] In some examples, the base 830 may include an opening 831. In some examples, the sensor 820 may be supported on the base 830. In some examples, the central axis of the tail 821 of the sensor 820 may extend through the opening 831.
[0447] In some examples, the outline of the opening 831 may be the same as the outline of the first portion 277 of the sharp object 270. This reduces the movement of the sharp object 270 within the opening 831.
[0448] In some examples, the outline of the opening 831 can be approximately racetrack-shaped. In this case, since the outline of the opening 831 is the same as the outline of the first portion 277 of the sharp object 270, it is possible to suppress undesirable rotation of the sharp object 270 in the opening 831.
[0449] In some examples, the outline of the opening 831 may also be a non-circular shape such as a polygon, a square, or a fan.
[0450] In some examples, the opening 831 can be a through hole. This allows the sharp object 270 and the sensor 820 to pass through the opening 831 and extend out of the bottom surface of the base 830, thereby facilitating the implantation of the sharp object 270 and the sensor 820 under the skin of the host.
[0451] See in some examples Figure 22A The base 830 may include a support portion 832. In some examples, the support portion 832 may be a boss. In some examples, the support portion 832 may be configured to support at least a portion of the sensor 820.
[0452] See in some examples Figure 22A and Figure 22B The base 830 may include a substrate 833. In some examples, a support portion 832 may be disposed on the substrate 833. In some examples, an opening 831 may extend through the support portion 832 and the substrate 833.
[0453] See in some examples Figure 22A The base 830 may include a mounting portion 834. In some examples, the mounting portion 834 may be disposed on the support portion 832.
[0454] In some examples, the assembly part 834 may also be disposed on the substrate 833.
[0455] See in some examples Figure 22AThe base 830 may include a fixing portion 838. In some examples, the fixing portion 838 may be configured to fix the sensor 820. In some examples, the fixing portion 838 may be disposed on the substrate 833. In some examples, the fixing portion 838 may be a protrusion formed on the substrate 833.
[0456] See in some examples Figure 22A There can be two fixing parts 838. In some examples, the two fixing parts 838 can be set opposite to each other.
[0457] In other examples, the number of fixing parts 838 may be one. For example, the fixing part 838 may be a fork structure with a groove structure.
[0458] In other examples, the number of fixing parts 838 can be greater than two. For example, the number of fixing parts 838 can be four, five, six, or seven, etc. This allows for more stable fixing of the contact part 823.
[0459] See in some examples Figure 22A The fixing part 838 may have an inclined surface 8381. In some examples, the inclined surface 8381 may be inclined along the direction from the top end to the bottom end of the fixing part 838 and in a direction away from the fixing part 838. This facilitates the alignment of the slot accommodating the sensor 820 on the electronic device 880 with the sensor 820. (Detailed description later) Figure 23 This is a schematic diagram illustrating the structure of the sensor 820 involved in the example of this disclosure.
[0460] See in some examples Figure 23 The medical device 800 may include a sensor 820. In some examples, the sensor 820 may be configured to generate analyte level information for the host. In some examples, the sensor 820 may be partially or completely implanted subcutaneously in the host. In some examples, after being implanted subcutaneously, the sensor 820 may react with analytes in the subcutaneous tissue fluid to generate analyte level information for the host.
[0461] See in some examples Figure 23 The sensor 820 may include a tail 821. In some examples, the tail 821 may be used for implantation into a host.
[0462] In some examples, sensor 820 may include a contact 823 for electrical connection (see Figure 23 In some examples, contact 823 may be configured to connect to electronic device 880. In some examples, contact 823 may have electrical contacts.
[0463] See in some examples Figure 23The contact portion 823 and the tail portion 821 of the sensor 820 can form an angle of 0° to 90°. This facilitates the placement of the tail portion 821 into the opening portion 831 or the electrical connection of the contact portion 823 to the electronic device 880 when implanted into the host.
[0464] See in some examples Figure 23 The sensor 820 may include a coupling portion 822. In some examples, the coupling portion 822 may connect the tail portion 821 and the contact portion 823. That is, the tail portion 821, the coupling portion 822, and the contact portion 823 may be connected in sequence. Thus, the analyte level signal generated by the tail portion 821 can be transmitted to the contact portion 823 through the coupling portion 822.
[0465] Figure 24 This is a schematic diagram showing the sensor 820 disposed on the base 830 according to an example of this disclosure.
[0466] See in some examples Figure 24 The sensor 820 can be mounted on the base 830. This makes it easy to keep the sensor 820 under the skin of the host.
[0467] See in some examples Figure 24 The sensor 820 may be at least partially located in the opening 831. In some examples, the tail 821 may be at least partially located in the opening 831. In some examples, the tail 821 may extend through the opening 831 and out of the bottom surface of the base 830. This facilitates the implantation of the sensor 820 at least partially under the skin of the host. Furthermore, since the sharp object 270 extends through the opening 831, it facilitates the sharp object 270 to accommodate the tail 821 of the sensor 820 and to carry the tail 821 for implantation into the host.
[0468] In some examples, the tail 821 can be aligned with the opening 831. This further facilitates the reception of the tail 821 by the sharp object 270.
[0469] See in some examples Figure 24 The sensor 820 may be located at least partially outside the opening 831. In some examples, the connecting part 822 and the contact part 823 may also be located outside the opening 831.
[0470] See in some examples Figure 24 The application portion 860 may include a channel 400. In some examples, the channel 400 may extend toward the opening 831. In some examples, see... Figure 24 The sensor 820 can pass through the channel 400 and be located at the opening 831. In some examples, the connector 822 can extend through the channel 400.
[0471] See in some examples Figure 24 In some examples, channel 400 may be provided on support portion 832. In some examples, sensor 820 may enter opening portion 831 via channel 400 provided on support portion 832.
[0472] In some examples, the channel 400 may have a fixed size that adapts to the connector 822, which may be equal to or similar in size to the connector 822. This minimizes the gap between the connector 822 and the channel 400, thereby facilitating the formation of a seal in the channel 400.
[0473] In some examples, the sealing component 500 may form a seal in the channel 400 or in the direction of extension of the channel 400. In some examples, the sealing component 500 may be disposed in the channel 400. In some examples, the sealing component 500 may be at least partially disposed in the channel 400.
[0474] As described above, the fixing portions 838 can be arranged opposite each other. In some examples, the fixing portions 838 can be symmetrically distributed on both sides of the sensor 820. In some examples, the fixing portions 838 can clamp the contact portion 823. This reduces the shaking of the sensor 820 during assembly.
[0475] Figure 25A This is a schematic diagram showing the sealing cap 600 of the present disclosure being disposed on the support portion 832. Figure 25B It shows Figure 25A A cross-sectional view along the XX section line. Figure 25C This is a structural schematic diagram showing a first-view view of the sealing cap 600 involved in the example of this disclosure. Figure 25D This is a structural schematic diagram from a second perspective showing the sealing cap 600 involved in the example of this disclosure.
[0476] See in some examples Figure 25A The application portion 860 may include a sealing cap 600. In some examples, the sealing cap 600 may cover the base 830 and the sensor 820. In some examples, the sealing cap 600 may cover the support portion 832.
[0477] In some examples, the sealing cap 600 can completely cover the support portion 832. In other words, in some examples, the projection of the sealing cap 600 onto the support portion 832 along the axial direction of the support portion 832 can completely coincide. This improves the structural compactness and facilitates subsequent sealing of the upper interface.
[0478] In some examples, the sealing cap 600 may at least partially cover the channel 400. This helps to form a sealing interface at the channel 400. Additionally, it helps to retain the sensor 820 within the channel 400.
[0479] In some examples, the sealing cap 600 and the support portion 832 can be fixedly connected by one or more methods such as adhesives or ultrasonic welding. This enhances the sealing performance of the sealing cap 600.
[0480] See in some examples Figure 25A and Figure 25B The sealing cap 600 may have a central hole 610 aligned with the opening 831. In some examples, the central hole 610 may be configured to allow a sharp object 270 to extend through it.
[0481] See in some examples Figure 25B and Figure 25C The outline of the central hole 610 can be the same as the outline of the opening 831. That is, the outline of the central hole 610 can be the same as the outline of the first portion 277 of the sharp object 270. As a result, unwanted rotation of the sharp object 270 in the central hole 610 can be suppressed.
[0482] In other examples, the profile of the central hole 610 may also be different from the profile of the opening 831.
[0483] See in some examples Figure 25D The sealing cap 600 may have a first notch 620. In some examples, the first notch 620 may be aligned with the channel 400. In some examples, the first notch 620 may at least partially coincide with the channel 400. This allows the connecting portion 822 to pass through the channel 400.
[0484] Additionally, in some examples, channel 400 may also be provided on the sealing cover 600. In some examples, channel 400 may extend toward the central hole 610. In some examples, channel 400 may be provided on the side of the sealing cover 600 near the support portion 832.
[0485] As described above, the base 830 may include an assembly portion 834. See also: [examples omitted] Figure 22A Assembly section 834 may have a first bag 8341. See some examples. Figure 22A The first bag 8341 may surround the opening 831. In some examples, the first bag 8341 may be an annular groove.
[0486] See in some examples Figure 25BThe assembly part 834 can mate with the sealing cap 600. In some examples, the sealing cap 600 can be received at least partially in the first bag 8341.
[0487] In some examples, adhesive may be injected into the first bag 8341 before the sealing cap 600 is assembled onto the assembly portion 834. This helps to seal the interface between the assembly portion 834 and the sealing cap 600.
[0488] See in some examples Figure 25B A gap may exist between the portion of the sealing cap 600 that receives the first bag 8341 and the bottom of the first bag 8341. In this case, by leaving a certain flow space for the adhesive between the sealing cap 600 and the first bag 8341, it is possible to facilitate the flow of the adhesive to fill the gap between the parts, thereby helping to seal the interface between the assembly 834 and the sealing cap 600.
[0489] See in some examples Figure 22A The first bag of 8341 can be connected to channel 400. Thus, the adhesive can seal channel 400. In some examples, adhesive can be injected into channel 400 to seal it.
[0490] See in some examples Figure 25A The base 830 may have a first limiting portion 835. In some examples, the sealing cap 600 may have a second limiting portion 650. In some examples, during the assembly of the sealing cap 600 to the assembly portion 834, the first limiting portion 835 may be aligned with the second limiting portion 650. This allows for more accurate assembly of the sealing cap 600 to the assembly portion 834.
[0491] See in some examples Figure 25A The first limiting portion 835 may be disposed on the assembly portion 834, and the second limiting portion 650 may be disposed on the sealing cover 600. In some examples, the shape of the first limiting portion 835 may be complementary to the shape of the second limiting portion 650. For example, the first limiting portion 835 may be a groove, and the second limiting portion 650 may be a protrusion.
[0492] In addition, in some examples, the first limiting part 835 may also be provided on the substrate 833, and the second limiting part 650 may also be provided on the sealing cover 600.
[0493] In some examples, when the first limiting portion 835 is aligned with the second limiting portion 650, the first notch 620 can be aligned with the connecting portion 822. In this case, by aligning the first limiting portion 835 and the second limiting portion 650, the first notch 620 can be aligned with the connecting portion 822, thereby facilitating the assembly of the sealing cap 600.
[0494] See in some examples Figure 25A The first limiting portion 835 can abut against the second limiting portion 650. In some examples, the first limiting portion 835 can abut against the second limiting portion 650 in the circumferential direction of the assembly portion 834. This prevents the sealing cover 600 from rotating relative to the assembly portion 834, thereby reducing the risk of damage to the sensor 820 due to rotation of the sealing cover 600.
[0495] Figure 26 This is a schematic diagram illustrating the structure of the sharp object 270 involved in the example of this disclosure.
[0496] As mentioned above, see Figure 26 The analyte monitoring system 1 may include a sharp object 270. In some examples, the sharp object 270 may be configured to implant the sensor 820 at least partially under the skin of the host.
[0497] See in some examples Figure 26 The sharp object 270 may include a needle-like portion 272. This facilitates the insertion of the sharp object 270 into the tissue.
[0498] See in some examples Figure 26 The sharp object 270 may include a groove 274. In some examples, the groove 274 may be configured to receive a tail portion 821. In some examples, the groove 274 may be provided on the needle portion 272. In some examples, the groove 274 may extend along the length of the needle portion 272.
[0499] In some examples, the opening of the slot 274 can face the tail 821. This facilitates the entry of the tail 821 into the slot 274.
[0500] See in some examples Figure 26 The sharp object 270 may include a cap 276. In some examples, the cap 276 may be located at least partially in the opening 831.
[0501] See in some examples Figure 26 The cap portion 276 may include a first portion 277. In some examples, the outer contour of the first portion 277 is substantially the same as the inner contour of the opening 831. As described above, the contour of the opening 831 may be substantially racetrack-shaped. In some examples, the contour of the first portion 277 may also be substantially racetrack-shaped. This prevents undesirable rotation of the first portion 277 within the opening 831.
[0502] In some examples, the outline of the first part 277 can also be a non-circular shape such as a polygon, a square, or a fan.
[0503] See in some examples Figure 26The cap 276 may include a second portion 278. In some examples, the second portion 278 may be configured to secure the first sealing element 510.
[0504] See in some examples Figure 26 The cap 276 may include a third portion 279. In some examples, the third portion 279 may be configured to secure the sharp object 270 to the support 280.
[0505] See in some examples Figure 26 The needle-like portion 272 can be connected to the cap portion 276. In some examples, the needle-like portion 272 can be fixed to the cap portion 276. In some examples, the cap portion 276 can hold the needle-like portion 272. Thus, the needle-like portion 272 can more stably carry the sensor 820 into the tissue.
[0506] In some examples, the needle-like portion 272 may penetrate the cap portion 276. In some examples, the needle-like portion 272 may be fixed to the first portion 277 of the cap portion 276.
[0507] In some examples, the sharp object 270 may have a slotted portion 275 (see [reference]). Figure 26 In some examples, the slotted portion 275 may be located on the side of the first portion 277 near the tail portion 821. This facilitates the entry of the tail portion 821 into the slotted portion 275.
[0508] In some examples, the opening of the slot 274 may face the slotted portion 275. In some examples, the slot 274 may communicate with the slotted portion 275. This allows the tail portion 821 to easily enter the slot 274 through the slotted portion 275.
[0509] Figure 27 This is a schematic diagram showing the structure of the first sealing element 510 involved in the example of this disclosure.
[0510] See in some examples Figure 27 The sealing assembly 500 may include a first sealing element 510. In some examples, the first sealing element 510 may be configured to seal the opening 831. In some examples, the first sealing element 510 may be configured to seal the upper interface of the opening 831.
[0511] See in some examples Figure 21A or Figure 21BThe first sealing element 510 can be disposed between the sharp object 270 and the sealing cap 600. In some examples, the first sealing element 510 can seal the interface between the sharp object 270 and the sealing cap 600. In some examples, the first sealing element 510 can seal the central hole 610. In some examples, the first sealing element 510 can seal the opening 831 by sealing the central hole 610. It should be noted that since there is already a sealing interface between the sealing cap 600 and the base 830, the upper interface of the central hole 610 can also be regarded as the upper interface of the opening 831, and sealing the opening 831 is also equivalent to sealing the central hole 610.
[0512] In some examples, the first sealing element 510 may be made of an elastic material. In some examples, the first sealing element 510 may be made of materials such as silicone resin, thermoplastic elastomer (TPE), polytetrafluoroethylene, or rubber. This improves the sealing performance of the first sealing element 510.
[0513] Figure 28A This is a schematic diagram showing a first-view view of a sharp object 270 assembled on a base 830, as described in this disclosure example. Figure 28B This is a schematic diagram showing a second view of the sharp object 270 being mounted on the base 830, as described in this disclosure example. Figure 28C This is a schematic diagram showing the depth limit 2742 abutting against the sealing cap 600 as described in the example of this disclosure.
[0514] See in some examples Figure 28A and Figure 28B The sharp object 270 can be fitted onto the base 830. In some examples, the sharp object 270 can extend through the opening 831. In some examples, the sharp object 270 can be at least partially located in the opening 831.
[0515] See in some examples Figure 28A and Figure 28B The first part 277 may extend at least partially into an opening 831. This facilitates coupling of the sharp object 270 with the cap 700.
[0516] See in some examples Figure 28A and Figure 28B The needle-like portion 272 can extend at least partially into the opening 831. This facilitates the insertion of the needle-like portion 272 into the subcutaneous tissue of the host.
[0517] See in some examples Figure 28BThe sharp object 270 can be configured to accommodate at least a portion of the sensor 820. In some examples, the sharp object 270 can accommodate the tail 821 of the sensor 820. In some examples, the sharp object 270 can also be configured to penetrate tissue carrying at least a portion of the sensor 820. In some examples, the sharp object 270 can penetrate tissue carrying the tail 821. This facilitates the implantation of the sensor 820 into the host.
[0518] As described above, the groove 274 can be configured to receive the tail 821. In some examples, the needle-like portion 272 with the groove 274 can also be configured to carry the tail 821 into the tissue. In this case, receiving the tail 821 through the groove 274 facilitates the needle-like portion 272 carrying the tail 821 into the tissue.
[0519] See in some examples Figure 28A The first sealing element 510 can be fitted onto the cap 276. In some examples, both ends of the first sealing element 510 can be embedded in the cap 276. In this case, the risk of the first sealing element 510 falling off the cap 276 when the sharp object 270 moves can be reduced.
[0520] As described above, the cap 276 may include a second portion 278. In some examples, a first sealing element 510 may be fitted onto the second portion 278. In some examples, the first sealing element 510 may have a first hole 511 (see...). Figure 26 In some examples, a sharp object 270 may pass through the first hole 511 to allow the first sealing element 510 to be fitted onto the second portion 278.
[0521] In some examples, the first sealing element 510 may be fitted over the second portion 278 in a covering manner. In some examples, the outer contour of the second portion 278 may be the same as the inner contour of the first sealing element 510. In some examples, the second portion 278 may be an annular protrusion on the cap 276, and the first sealing element 510 may be a collar with a vertical cross-section in the shape of a C (see...). Figure 26 and Figure 27 ).
[0522] In some examples, the size of the first sealing element 510 may be slightly smaller than the size of the second portion 278. This allows the first sealing element 510 to fit more tightly onto the second portion 278.
[0523] See in some examples Figure 28A One side of the first sealing element 510 can engage with the sharp object 270, and the other side of the first sealing element 510 can engage with the sealing cap 600.
[0524] See in some examples Figure 28AThe first sealing element 510 may surround the central hole 610. This facilitates the sealing of the central hole 610 by the first sealing element 510. In some examples, the first sealing element 510 may be annular.
[0525] In some examples, the first sealing element 510 may be a sealing gasket or an O-ring.
[0526] See in some examples Figure 28A A sharp object 270 can enter the opening 831 through the first hole 511. In some examples, the first hole 511 can be aligned with the opening 831. This allows the sharp object 270 to pass through the first hole 511 and enter the opening 831.
[0527] In some examples, the sharp object 270 can apply pressure to the first sealing element 510. In some examples, the sharp object 270 can press the first sealing element 510 against the sealing cap 600 to deform the first sealing element 510. In some examples, the first sealing element 510 can deform under pressure to seal the interface between the sharp object 270 and the sealing cap 600. In some examples, the first sealing element 510 surrounding the opening 831 can deform under pressure to seal the upper interface of the opening 831. This improves the sealing performance of the first sealing element 510.
[0528] See in some examples Figure 26 and Figure 28C The cap portion 276 may include a depth-limiting portion 2742. In some examples, the depth-limiting portion 2742 may be configured to limit the depth of the insertion opening 831 of the first portion 277. In some examples, the depth-limiting portion 2742 may be disposed within the first portion 277. In some examples, the depth-limiting portion 2742 may protrude beyond the first portion 277. In other examples, the depth limit 2742 may also be located on the bottom surface of the second portion 278 and protrude outward from the second portion 278.
[0529] See in some examples Figure 28C When the first part 277 passes through the opening 831 and out of the base 830, the depth limiting part 2742 can abut against the sealing cover 600. This helps to make the sharp object 270 more stably fitted to the base 830.
[0530] In other examples, the depth limit 2742 may also abut against the support 832.
[0531] It should be noted that when the sharp object 270 is assembled on the base 830, since the sharp object 270 and the sealing cover 600 are connected through the first sealing element 510, that is, the connection between the sharp object 270 and the sealing cover 600 is an elastic connection, and the sharp object 270 will apply pressure to the first sealing element 510, if the pressure applied to the first sealing element 510 is uneven, different positions of the first sealing element 510 will have different degrees of deformation, which will not be able to provide stable support for the sharp object 270, and may cause the sharp object 270 to shake. Therefore, by the depth limiting part 2742 abutting against the sealing cover 600, the sharp object 270 can be provided with rigid support, reducing the shaking of the sharp object 270.
[0532] In some examples, the thickness of the first sealing element 510 before compression can be greater than the thickness of the depth limiting portion 2742. This helps to ensure that the first sealing element 510 is sufficiently compressed to perform its sealing function.
[0533] In some examples, the depth limiting portion 2742 may be integrally formed with the first portion 277 or the second portion 278. Additionally, in some examples, the depth limiting portion 2742 may be detachably connected to the first portion 277 or the second portion 278.
[0534] Figure 29A This is a schematic diagram illustrating the structure of the cap 700 involved in the example of this disclosure. Figure 29B This illustrates a cross-sectional view of the cap 700 as described in this disclosure example.
[0535] As mentioned above, see Figure 29A The analyte monitoring system 1 may include a cap 700. In some examples, the cap 700 may be configured to receive a tail portion 821. In some examples, the cap 700 may also be configured to seal an opening 831. In some examples, the cap 700 may be mounted on a base 830.
[0536] See in some examples Figure 29A The cap 700 may include a mating platform 740. In some examples, the mating platform 740 may be part of the bottom cap 770. In some examples, the cap 700 may be coupled to the housing 10 via the mating platform 740. In some examples, the mating platform 740 may be embedded in the proximal end of the housing 10.
[0537] In some examples, when the cap 70 is coupled to the housing 10, the first engagement feature 191 may surround the engagement platform 740.
[0538] In some examples, the mating base 740 may be elastic. In some examples, the mating base 740 may include an elastic wall 741. In some examples, the mating portion 720 may be disposed on the wall 741. In some examples, the elasticity of the wall 741 can be changed by varying its thickness. For example, the elasticity of the wall 741 can be increased by decreasing its thickness. In this case, since the first engagement feature 191 is a flat thread and the engagement portion 2741 is a helical thread, when the cap 700 is screwed on, the travel distance of the mating portion 720 in the direction of the central axis CA is different from the travel distance of the mating base 740. This causes deformation at the connection between the mating portion 720 and the mating base 740. By adjusting the elasticity of the wall 741 by changing its thickness, the connection between the mating portion 720 and the mating base 740 can be made more easily deformable, thereby facilitating the decoupling of the mating portion 720 and the engagement portion 2741.
[0539] See in some examples Figure 29A The cap 700 may include a second rib 750. In some examples, the second rib 750 may be located on the side of the mating platform 740. In this case, the second rib 750 reduces the force required to relatively screw the housing 10 and the cap 700 by making the contact between the housing 10 and the mating platform 740 a line contact, thereby facilitating the decoupling of the housing 10 and the cap 700. In some examples, the second rib 750 may surround the mating platform 740. In some examples, there may be multiple second ribs 750.
[0540] See in some examples Figure 29B The cap 700 may have a chamber 710. In some examples, the chamber 710 may be configured to receive a tail 821. In some examples, the tail 821, the cap 276, and the needle 272 may be at least partially located in the chamber 710.
[0541] See in some examples Figure 29B The cap 700 may include a container for a desiccant 760. In some examples, the desiccant 760 may be located in the chamber 710. This facilitates keeping the chamber 710 dry.
[0542] In some examples, the desiccant 760 may be contained in the chamber 790 of the bottom cover 770 (see [reference]). Figure 29B Specifically, the cap 700 may further include a base plate 772 that engages with the engagement platform 740. The engagement platform 740 and the base plate 772 may mate to form a chamber 790 (see [link to documentation]). Figure 29B In some examples, chambers 710 and 790 may be connected.
[0543] In some examples, the base plate 772 can be connected to the mating platform 740. In some examples, the base plate 772 and the mating platform 740 can be fixedly connected by one or more methods such as adhesives, ultrasonic welding, etc. This helps to seal the chamber 710.
[0544] In some examples, the base plate 772 may be made of a transparent material. In this case, after the cap 700 is fitted onto the base 830, the base plate 772 makes it easy to confirm whether the sensor 820 is accommodated in the slot 274.
[0545] Figure 30A This is a schematic diagram from a first-view perspective showing the cap 700 assembled on the base 830 according to an example of this disclosure. Figure 30B This is a schematic diagram from a second perspective showing the cap 700 assembled on the base 830 according to an example of this disclosure. Figure 30C This is a cross-sectional view showing the sterilization component involved in the example of this disclosure.
[0546] In some examples, the cap 700 can be fitted onto the base 830. In some examples, when the cap 700 is fitted onto the base 830, the cap 700 can be coupled to the sharp object 270. In some examples, the cap 700 can apply a tensile force to the sharp object 270. In some examples, the cap 700 can apply a tensile force to the sharp object 270 by coupling with it. In other words, the sharp object 270 can also apply a tensile force to the cap 700 by coupling with it. In this case, by applying a tensile force to the cap 700 through the sharp object 270, the cap 700 can fit more tightly against the bottom surface of the base 830, thereby helping to seal the interface between the cap 700 and the base 830. In addition, the interaction force between the cap 700 and the sharp object 270 helps to maintain the assembly relationship between the cap 700 and the base 830.
[0547] In some examples, the coupling between the cap 700 and the sharp object 270 can be threaded coupling. This makes the coupling between the cap 700 and the sharp object 270 more stable.
[0548] As mentioned above, see Figure 30B The sharp object 270 can extend through the opening 831. See some examples. Figure 30C The sharp object 270 protruding from one side of the opening 831 can be coupled to the cap 700. In some examples, the cap 276 can protrude from the opening 831 and be coupled to the cap 700.
[0549] As described above, the cap 700 can be removably coupled to the housing 10. See also: [link to example]. Figure 30CThe cap 700 can accommodate the sharp object 270 and the tail 821. In some examples, the size of the bottom cover 770 can be larger than the size of the mating portion 720. For example, the diameter of the bottom cover 770 can be larger than the diameter of the mating portion 720. In some examples, the size of the mating platform 740 can be slightly smaller than the size of the proximal end of the housing 10, and the size of the bottom cover 770 can be equal to the size of the proximal end of the housing 10. In this case, by providing a sealing space for the sharp object 270 and the tail 821 by covering the bottom of the housing 10 with the cap 700, a larger receiving space can be formed, thereby accommodating more desiccant 760 and helping to keep the sealed space dry.
[0550] See in some examples Figure 30A and Figure 30B The sealing assembly 500 may include a second sealing element 520. In some examples, the second sealing element 520 may be configured to seal the opening 831. In some examples, the second sealing element 520 may be configured to seal the lower interface of the opening 831. In some examples, the interface between the cap 700 and the base 830 and the lower interface of the opening 831 may be the same interface.
[0551] See in some examples Figure 30A and Figure 30B The second sealing element 520 can be disposed between the cap 700 and the base 830. This helps to seal the interface between the cap 700 and the base 830.
[0552] In some examples, the second sealing element 520 may surround the opening 831. This facilitates sealing of the opening 831 by the second sealing element 520. In some examples, the second sealing element 520 may be annular.
[0553] See in some examples Figure 30A and Figure 30B The second sealing element 520 can be a sealing gasket or an O-ring.
[0554] In some examples, the second sealing element 520 may be made of an elastic material. In other examples, the second sealing element 520 may be made of materials such as silicone resin, thermoplastic elastomer (TPE), polytetrafluoroethylene, or rubber. This improves the sealing performance of the second sealing element 520.
[0555] In some examples, the second sealing element 520 may be fitted onto the cap 700. In some examples, the second sealing element 520 may be fitted onto the end of the cap 700 near the base 830.
[0556] See in some examples Figure 30CThe cap 700 may have a first sealing groove 780 on the side near the base 830. In some examples, the second sealing element 520 may be at least partially embedded in the first sealing groove 780.
[0557] See in some examples Figure 30B The side of the base 830 near the cap 700 may have a second sealing groove 839. In some examples, the second sealing element 520 may be at least partially embedded in the second sealing groove 839.
[0558] In some examples, the second sealing element 520 may be assembled into the first sealing groove 780 of the cap 700 first, and then the cap 700 may be assembled into the base 830. In other examples, the second sealing element 520 may be assembled into the second sealing groove 839 of the base 830 first, and then the cap 700 may be assembled into the base 830.
[0559] In some examples, the depth of the first sealing groove 780 may be greater than the depth of the second sealing groove 839. In this case, when the cap 700 is assembled onto the base 830 from below, it helps to prevent the second sealing element 520 from falling off during assembly.
[0560] In some examples, the shape of the second sealing element 520 may be the same as or similar to the contour of the first sealing groove 780 and the second sealing groove 839. In this case, by making the first sealing groove 780 and the second sealing groove 839 have a shape that is closer to the second sealing element 520, the fit between the second sealing element 520 and the first sealing groove 780 and the second sealing groove 839 can be improved, thereby improving the sealing performance of the second sealing element 520.
[0561] In some examples, the dimensions of the first sealing groove 780 and the second sealing groove 839 may be slightly smaller than the dimensions of the second sealing element 520. This allows for more thorough compression of the second sealing element 520, thereby improving its sealing performance.
[0562] See in some examples Figure 30A and Figure 30B The second sealing element 520 may have a second hole 521. In some examples, the needle portion 272 and the tail portion 821 may at least partially extend out of the opening 831 and enter the second hole 521.
[0563] In some examples, the second hole 521 can be aligned with the opening 831. This allows the needle-like portion 272 and the tail portion 821 to pass through the second hole 521.
[0564] In some examples, see Figure 30, one side of the second sealing element 520 can engage with the cap 700, and the other side of the second sealing element 520 can engage with the base 830.
[0565] In some examples, the cap 700 can apply pressure to the second sealing element 520. In some examples, the cap 700 can press the second sealing element 520 against the base 830 to deform the second sealing element 520. In some examples, the second sealing element 520 can deform under pressure to seal the interface between the cap 700 and the base 830. In some examples, the second sealing element 520 surrounding the opening 831 can deform under pressure to seal the lower interface of the opening 831. This improves the sealing performance of the second sealing element 520.
[0566] As described above, the sharp object 270 can apply a pulling force to the cap 700 by coupling with it. In some examples, the pressure exerted by the cap 700 on the second sealing element 520 can be the pulling force exerted by the sharp object 270 on the cap 700.
[0567] As described above, the cap 276 can be coupled to the cap 700. See also some examples. Figure 26 and Figure 30C The cap portion 276 may have a connecting portion 2741. In some examples, the connecting portion 2741 may be located at the end of the cap portion 276 near the cap 700. In some examples, the connecting portion 2741 may be located at the portion of the cap portion 276 that protrudes from the bottom surface of the base 830. This facilitates coupling of the connecting portion 2741 with the cap 700.
[0568] See in some examples Figure 29A and Figure 30C The cap 700 may have a mating portion 720. In some examples, the mating portion 720 may be located at one end of the cap 700 near the base 830. In some examples, the mating portion 720 may be disposed on the engagement platform 740. In some examples, the mating portion 720 and the engagement platform 740 may be integrally formed.
[0569] In some examples, the joint 2741 may be coupled to the mating part 720. In some examples, the joint 2741 and the mating part 720 may be coupled by relative screwing.
[0570] Figure 31A This is a schematic diagram showing the cap 700 before coupling with the sharp object 270 as described in this disclosure example. Figure 31B This is a schematic diagram showing the cap 700 coupled to the sharp object 270 as described in this disclosure example.
[0571] See in some examples Figure 26 and Figure 31A The joint 2741 may have a first engagement structure 27411. In some examples, the mating part 720 may have a second engagement structure 721. In some examples, the first engagement structure 27411 may be a groove structure. In some examples, the second engagement structure 721 may be an arc-shaped protrusion structure. In some examples, during the relative twisting of the joint 2741 and the mating part 720, the first engagement structure 27411 may rotate relative to the second engagement structure 721 under the constraint of the second engagement structure 721, and the second engagement structure 721 may also rotate relative to the first engagement structure 27411 under the constraint of the first engagement structure 27411.
[0572] See in some examples Figure 31A and Figure 31B The coupling between the engagement portion 2741 and the mating portion 720 can be threaded coupling. In some examples, the first engagement structure 27411 can be a first thread. In some examples, the second engagement structure 721 can be a second thread. In some examples, the second thread can have a preset angle. In some examples, the preset angle can be 90 degrees. In some examples, through the coupling of the first thread and the second thread, the guide engagement portion 2741 can be rotated 90 degrees relative to the mating portion 720 to couple with the mating portion 720.
[0573] See in some examples Figure 30C The width of the first thread can be equal to or similar to the width of the second thread. This improves the tightness of the coupling between the first engagement structure 27411 and the second engagement structure 721.
[0574] In some examples, the number of turns of the first and second threads can be adapted by taking into account the tightness of the connection between the sharp object 270 and the cap 700 and the thickness of the base 830.
[0575] In some examples, the first and second threads can be herringbone threads. This improves the tightness of the coupling between the joint 2741 and the mating part 720.
[0576] In other examples, the first and second threads can also be flat threads.
[0577] As described above, the wall 741 can be elastic. For example, when the first thread and the second thread are helical threads, the elasticity of the moving wall 741 can be greater; when the first thread and the second thread are flat threads, the elasticity of the wall 741 can be smaller.
[0578] See in some examples Figure 26The first engagement structure 27411 may include a first engagement end 27412, a second engagement end 27414, and an engagement groove 27413. In some examples, the first engagement end 27412 and the second engagement end 27414 may be located on both sides of the engagement groove 27413.
[0579] See in some examples Figure 30C The dimensions of the engagement groove 27413 can match the dimensions of the second engagement structure 721. In some examples, the width of the engagement groove 27413 in the vertical direction can be equal to or similar to the width of the second engagement structure 721. In some examples, the width of the engagement groove 27413 can be the distance between the first engagement end 27412 and the second engagement end 27414.
[0580] In some examples, when the first engagement structure 27411 is a first thread, the distance between the first engagement end 27412 and the second engagement end 27414 can be the width of the first thread.
[0581] See in some examples Figure 31A The mating portion 720 may have a guide groove 723. In some examples, the guide groove 723 may be configured to guide the engagement portion 2741 into the mating portion 720 along the axial direction of the mating portion 720. In some examples, the first engagement end 27412, the engagement groove 27413, and the second engagement end 27414 of the engagement portion 2741 may sequentially enter the guide groove 723.
[0582] In some examples, the guide groove 723 may extend along the axial direction of the mating portion 720. In some examples, the axial direction of the mating portion 720 may be vertical. This facilitates coupling between the joining portion 2741 and the mating portion 720.
[0583] See in some examples Figure 26 The first engagement end 27412 may have an engagement notch 27415. In some examples, the contour of the engagement notch 27415 may be the same as the contour of the end of the second engagement structure 721 near the guide groove 723. In some examples, as the first engagement end 27412 enters the guide groove 723, the end of the second engagement structure 721 near the guide groove 723 may pass through the engagement notch 27415, enter the engagement groove 27413, and abut against the second engagement end 27414.
[0584] See in some examples Figure 31A and Figure 31B When the second engagement structure 721 abuts against the second engagement end 27414, it is permissible to rotate the engagement portion 2741 and the mating portion 720 relative to each other.
[0585] In some examples, when the second engagement structure 721 abuts against the second engagement end 27414, the engagement groove 27413 can be aligned with the second engagement structure 721. This facilitates the relative screwing of the engagement portion 2741 and the mating portion 720.
[0586] See in some examples Figure 31B After the joint portion 2741 and the mating portion 720 are screwed together, the first joint structure 27411 can be coupled with the second joint structure 721.
[0587] See in some examples Figure 31B The mating portion 720 may have a first rib 722. In some examples, the first rib 722 may be located at the end of the second engagement structure 721 (i.e., the end of the second engagement structure 721 away from the guide groove 723). In some examples, the first rib 722 may be configured to prevent the engagement portion 2741 and the mating portion 720 from continuing to rotate relative to each other after the engagement portion 2741 and the mating portion 720 have been rotated relative to each other by a preset angle. In some examples, after the engagement portion 2741 and the mating portion 720 have been rotated relative to each other by a preset angle, the first rib 722 may abut against the first engagement end 27412 and the second engagement end 27414 to prevent the engagement portion 2741 and the mating portion 720 from continuing to rotate relative to each other. In some examples, the first rib 722 may extend along the axial direction of the mating portion 720.
[0588] In some examples, the included angle between the first rib 722 and the guide groove 723 in the circumferential direction of the mating part 720 can be equal to a preset angle.
[0589] Figure 32A This is a schematic diagram showing the cap 700 before coupling with the base 830 as described in this disclosure example. Figure 32B This is a schematic diagram showing the cap 700 coupled to the base 830 as described in this disclosure example.
[0590] See in some examples Figure 22B and Figure 32A The base 830 may include a guide 836. See some examples. Figure 32A and Figure 32B The cap 700 may include a guided portion 730. In some examples, the guide portion 836 may be a guide rail. In some examples, when the cap 700 rotates, the guided portion 730 may move along the guide portion 836. Thus, the cap 700 can be rotated along a desired motion path.
[0591] See in some examples Figure 29A The guided portion 730 may be disposed on the mating platform 740. In some examples, the guided portion 730 may be connected to the mating portion 720.
[0592] See in some examples Figure 32A and Figure 32B The guided part 730 can cooperate with the guide part 836. In some examples, the guide part 836 can guide the guided part 730. In some examples, the guided part 730 can move along the guide part 836 during screwing.
[0593] See in some examples Figure 22B The guide portion 836 may be formed by recessing the bottom surface of the base 830. In some examples, the guide portion 836 may be a guide groove formed by recessing the bottom surface of the base 830.
[0594] See in some examples Figure 22B The guide portion 836 can be arc-shaped. In some examples, the guide portion 836 can have a predetermined curvature. In some examples, the angle corresponding to the predetermined curvature can match a preset angle. For example, the angle corresponding to the predetermined curvature can be equal to the preset angle. It should be noted that since the guided portion 730 has a certain thickness in the guiding direction, the angle corresponding to the predetermined curvature can also be slightly larger than the preset angle.
[0595] In some examples, the guide portion 836 may have a predetermined radius. In some examples, the predetermined radius may match the radius corresponding to the first engagement feature 191. Thus, the coupling between the cap 700 and the cap portion 276 can be simultaneously decoupled when the cap 700 is subsequently decoupled from the application device 1000.
[0596] See in some examples Figure 32A and Figure 32B The base 830 may have a third limiting portion 837. In some examples, the third limiting portion 837 may be provided on the guide portion 836 or on an extension of the guide portion 836.
[0597] In some examples, the third limiting part 837 can cooperate with the guided part 730. This limits the rotational stroke of the cap 700. In some examples, the third limiting part 837 can be fixedly engaged with the guided part 730. This limits the position of the endpoint of the guided part 730's movement.
[0598] In some examples, the third limiting portion 837 may be a protrusion. In some examples, the guided portion may have a groove. In some examples, the groove of the guided portion 730 may couple with the protruding third limiting portion 837.
[0599] See in some examples Figure 32AThe guide portion 836 may have a starting position and a ending position. In some examples, during the coupling of the engagement portion 2741 and the mating portion 720, the starting position of the guided portion 730 may be the starting position of the guide portion 836, and the ending position of the guided portion 730 may be the ending position of the guide portion 836.
[0600] In some examples, the third limiting part 837 may be provided at one end of the guide part 836 near the termination position. This allows the guided part 730 to be restricted at the termination position.
[0601] See in some examples Figure 32A In the guiding direction of the guide portion 836, both ends of the third limiting portion 837 may have engagement slopes. This facilitates coupling of the third limiting portion 837 with the groove of the guided portion 730.
[0602] In some examples, the joint 2741 and the mating part 720 can be rotated relative to each other to make the joint 2741 and the mating part 720... Figure 32A The relative position change in the middle is Figure 32B The relative position within.
[0603] In some examples, the channel 400 can be sealed by assembling the sensor 820 to the assembly portion 834, injecting adhesive into the assembly portion 834, and then covering the assembly portion with a sealing cap 600. In some examples, the upper interface of the opening 831 can be sealed by assembling the first sealing element 510 to the sharp object 270 and then assembling the sharp object 270 to the sealing cap 600. In some examples, the lower interface of the opening 831 can be sealed by assembling the second sealing element 520 to the cap 700 and then assembling the cap 700 to the base 830. Thus, a sealed space for sealing the sharp object 270 and the sensor 820 can be formed.
[0604] Figure 33A This is a schematic diagram showing the electronic device 880 and the base 830 before assembly, as described in the example of this disclosure. Figure 33B This is a schematic diagram showing the electronic device 880 and the base 830 as described in this disclosure. Figure 33C This is a schematic diagram showing the spring 881 and connector 883 before assembly, as described in the example of this disclosure. Figure 33D This is a schematic diagram showing the assembled spring 881 and connector 883 involved in the example of this disclosure. Figure 33E This is a schematic diagram illustrating the structure of connector 883 as described in this disclosure example.
[0605] In some examples, the electronic device 880 can be mounted on the base 830. In some examples, the electronic device 880 can be connected to the sensor 820 after being mounted on the base 830.
[0606] See in some examples Figure 33A and Figure 33B The electronic device 880 may have space for a sharp object 270 to pass through. This facilitates the mounting of the electronic device 880 onto the base 830.
[0607] See in some examples Figure 33A and Figure 33B The sensor 820 can be connected to the electronic device 880. As described above, the contact portion 823 of the sensor 820 can be connected to the electronic device 880.
[0608] See in some examples Figure 33C and Figure 33D The electronic device 880 may include a spring contact 881. In some examples, the spring contact 881 may be configured to connect the contact 823 to the circuit board of the electronic device 880. In some examples, the spring contact 881 may contact the contact 823. In some examples, the spring contact 881 may be made of a conductive material. In some examples, there may be multiple spring contact 881s, for example, the number of spring contact 881s may be 2, 3, 4, 5, and 6.
[0609] In some examples, the spring 881 can be fixedly connected to the circuit board of the electronic device 880. For example, the spring 881 can be soldered to the circuit board of the electronic device 880. This facilitates the electrical connection between the sensor 820 and the electronic device 880.
[0610] In other examples, the spring 881 can also be fixedly connected to the base 830.
[0611] See in some examples Figure 33D and Figure 33E The electronic device 880 may include a connector 883. In some examples, the connector 883 may be configured to hold a spring 881.
[0612] See in some examples Figure 33C and Figure 33D Spring 881 can be fitted to connector 883. See some examples. Figure 33E The connector 883 may have a recess 885. In some examples, the recess 885 may have a similar profile and size to the spring 881. Thus, when the connector 883 covers the spring 881, it can limit the relative position between the multiple springs 881.
[0613] See in some examples Figure 33A and Figure 33BConnector 883 may cover contact portion 823 and fixing portion 838. In some examples, connector 883 may be aligned with contact portion 823 and fixing portion 838.
[0614] See in some examples Figure 33E The connector 883 may have a cross-shaped recess 887. In some examples, the cross-shaped recess 887 may have a similar profile and size to the contact portion 823 and the retaining portion 838. In some examples, the size of the cross-shaped recess 887 may be slightly smaller than that of the contact portion 823 and the retaining portion 838. This allows the connector 883 to fit more tightly over the contact portion 823 and the retaining portion 838.
[0615] In other examples, connector 883 can also be fixedly connected to base 830 by adhesive or ultrasonic welding.
[0616] Figure 34A This is a schematic diagram showing the assembly of the top cover 840 and the base 830 as described in this disclosure example. Figure 34B This is a schematic diagram showing the assembly of the top cover 840 and the base 830 as described in this disclosure example. Figure 34C It shows Figure 34B The diagram shows an enlarged view of region A.
[0617] See in some examples Figure 34A The application portion 860 may include a top cover 840. In some examples, the top cover 840 may be fitted onto the base 830. In some examples, the top cover 840 may cover the base 830. In some examples, the outline of the top cover 840 may be the same as the outline of the base 830. In some examples, the outermost periphery of the top cover 840 may be the same as the outermost periphery of the base 830.
[0618] See in some examples Figure 34B The cover 840 can mate with the base 830 to form a first space. In some examples, an electronic device 880 can be housed in the first space. This helps to seal the electronic device 880.
[0619] In some examples, the top cover 840 can be fixed to the base 830. For example, the top cover 840 can be fixed to the base 830 by adhesive. This helps to seal the first space.
[0620] In some examples, the top cover 840 can be detachably attached to the base 830. For example, the top cover 840 can be detachably attached to the base 830 by means of snap-fit, screw-fit, or other similar methods.
[0621] See in some examples Figure 34A and Figure 34BSharp object 270 can pass through the top cover 840 and be fitted onto the sealing cover 600.
[0622] See in some examples Figure 34C The cover 840 may have a third hole 841. In some examples, the third hole 841 may be configured to allow a sharp object 270 to pass through. In some examples, the third hole 841 may be aligned with the opening 831. In some examples, the third hole 841 may be aligned with the central hole 610. This facilitates the fitting of the sharp object 270 onto the sealing cover 600.
[0623] In some examples, a sealed interface may be formed around the opening 831 between the top cover 840 and the base 830. In some examples, the sensor 820 may extend through the sealed interface.
[0624] See in some examples Figure 25C The sealing cap 600 may have a central boss 640. In some examples, the central boss 640 may be located on the side of the sealing cap 600 near the upper cover 840. In some examples, the central boss 640 may be at least partially embedded in the upper cover 840. This helps to limit the relative position between the sealing cap 600 and the upper cover 840.
[0625] See in some examples Figure 34C The central boss 640 can be inserted into the third hole 841. In some examples, the central boss 640 can be aligned with the third hole 841. This facilitates the insertion of the central boss 640 into the third hole 841. In some examples, the outer edge of the central boss 640 can fit against the inner edge of the third hole 841.
[0626] See in some examples Figure 34C The upper cover 840 has an annular ridge 842. In some examples, the annular ridge 842 may be located on the side of the upper cover 840 near the sealing cap 600. In some examples, the annular ridge 842 may surround the third hole 841. In some examples, the annular ridge 842 may fit against the outer edge of the central boss 640. In this case, by increasing the contact area between the upper cover 840 and the sealing cap 600, it is possible to help seal the interface between the upper cover 840 and the sealing cap 600.
[0627] See in some examples Figure 25C and Figure 34C The sealing cap 600 may have an annular flange 630. In some examples, the annular flange 630 may be located at the outermost periphery of the sealing cap 600. In some examples, the annular flange 630 may surround the central boss 640. In some examples, the annular flange 630 may extend toward and abut against the upper cover 840.
[0628] See in some examples Figure 34C The annular flange 630 can form a second pocket 660 with the central boss 640. In some examples, the annular ridge 842 can be received at least partially in the second pocket 660.
[0629] In some examples, the top cover 840 can seal the cap 660 to form a sealing joint. In some examples, adhesive can be injected into the second bag 660. In some examples, the interface between the top cover 840 and the sealing cap 600 can be sealed by injecting adhesive into the second bag 660.
[0630] See in some examples Figure 34C The central hole 610 can pass through the central boss 640. This allows a sharp object 270 to pass through the sealing cover 600.
[0631] In some examples, the upper surface of the cover 840 can be substantially coplanar with the upper surface of the sealing cover 600. In other words, the upper surface of the cover 840 can be substantially flush with the upper surface of the sealing cover 660. In this case, the overall flatness of the upper surface of the application portion 860 can be improved, thereby enabling a simpler sealing of the upper interface (see the sealing of the upper interface method described herein).
[0632] In some examples, to facilitate the assembly of the sterilization components, the assembly process may generally include a first step (i.e., assembling the sharp object 270 and the first sealing element 510), a second step (i.e., assembling the sensor 820, the base 830 and the sealing cap 600), a third step (i.e., assembling the cap 700 and the second sealing element 520), and a fourth step.
[0633] In some examples, in the first step, a sharp object 270 may be passed through the first hole 511 of the first sealing element 510 so that the first sealing element 510 is fitted onto the second portion 278 of the sharp object 270. In some examples, in the second step, the tail portion 821 of the sensor 820 may be aligned with the opening 831 of the base 830, the connecting portion 822 with the channel 400, and the contact portion 823 with the fixing portion 838, so that the sensor 820 is assembled onto the base 830. In some examples, in the second step, adhesive may be injected into the first pouch 8341 of the assembly portion 834, and after aligning the second limiting portion 650 of the sealing cap 600 with the first limiting portion 835 of the base 830 and the first notch 620 with the channel 400 and the connecting portion 822, the sealing cap 600 may be assembled onto the assembly portion 834, so that the sealing cap 600 is at least partially housed in the first pouch 8341. In some examples, in the second step, the adhesive sheet 870 can also be assembled onto the bottom surface of the base 830 (i.e., the side near the cap 700), thereby enabling the assembly of the sharp object 270, the first sealing element 510, the sealing cap 600, the sensor 820, and the base 830.
[0634] In some examples, in the third step, the second sealing element 520 can be fitted into the first sealing groove 780 of the cap 700. This completes the assembly of the second sealing element 520 and the cap 700.
[0635] In some examples, in the fourth step, the sharp object 270, which is equipped with the first sealing element 510, can be first assembled onto the base 830, which is equipped with the sensor 820 and the sealing cover 600, and then the sharp object 270 and the base 830 can be assembled onto the cap 700, which is equipped with the second sealing element 520. In this way, the assembly of the sealing assembly can be completed.
[0636] In other examples, in the fourth step, the base 830, which is equipped with the sensor 820 and the sealing cap 600, can be assembled first onto the cap 700, which is equipped with the second sealing element 520, and then the base 830 and the cap 700 can be assembled onto the sharp object 270, which is equipped with the first sealing element 510.
[0637] In some examples, in the fourth step, the assembled sharp object 270 and base 830 can be aligned with the cap 700. In some examples, during the alignment of the sharp object 270 and base 830 with the cap 700, the second sealing groove 839 can be aligned with the second hole 521 and the first sealing groove 780 of the second sealing element 520, and the first engagement structure 27411 of the engagement portion 2741 can be aligned with the guide groove 723 of the mating portion 720.
[0638] In some examples, during the assembly of the sharp object 270 and the base 830 onto the cap 700, the engagement portion 2741 of the sharp object 270 extending from the bottom surface of the base 830 can be aligned with the mating portion 720 of the cap 700, and the guided portion 730 can be aligned with the starting position 8361 of the guide portion 836. In some examples, after aligning the engagement portion 2741 with the mating portion 720 and the guided portion 730 with the starting position 8361, the cap 700 can be rotated relative to the base 830 by a preset angle along the extension direction of the guide portion 836, so that the guided portion 730 moves to the ending position 8362 of the guide portion 836.
[0639] In some examples, a sealing space is formed when the guided part 730 is in the termination position 8326.
[0640] In some examples, after the guided portion 730 is moved to the termination position 8362, the guided portion 730 can be coupled to the third limiting portion 837 at the termination position 8362 to limit further movement of the guided portion 730 and hold it in the termination position 8362. In this case, limiting the position of the guided portion 730 by the third limiting portion 837 allows for a fixed relative position between the sharp object 270, the base 830, and the cap 700, thereby facilitating the assembly of the sterilization component into the application device 1000. Furthermore, since the tension between the sharp object 270 and the cap 700 increases with the relative twisting angle, limiting the position of the guided portion 730 by the third limiting portion 837 limits the magnitude of the tension between the sharp object 270 and the cap 700, thereby reducing the risk of component deformation or damage due to excessive tension between the sharp object 270 and the cap 700.
[0641] In some examples, after the entire sterilization assembly is sterilized, the electronic device 880 can be assembled onto the sterilized base 830. In some examples, before assembling the electronic device 880 onto the sterilized base 830, the spring contact 881 can be fixedly connected to the circuit board of the electronic device 880, and then the connector 883 can be placed over the spring contact 881.
[0642] In some examples, after assembling the electronic device 880, the top cover 840 can be assembled onto the base 830.
[0643] Figure 35 This is a schematic diagram showing the assembly of the housing 10 involved in the example of this disclosure with a sterilization assembly in which electronic device 880 and top cover 840 are assembled.
[0644] In some examples, the sterilization assembly of the present disclosure, which includes electronic device 880 and cover 840, may be referred to as a pre-assembled module.
[0645] In some examples, the cap 276 in the pre-assembled module can be removably and sealingly engaged with the applicator 860 above the opening 831. In some examples, the cap 700 in the pre-assembled module can be removably and sealingly engaged with the applicator 860 below the opening 831.
[0646] In some examples, the mating part 720 and the bottom cover 770 can be integrally formed. Thus, the cap 700 can be coupled to the application device 1000 on the one hand, forming a sealed space that constitutes at least a portion of the receiving sensor 820 on the other hand.
[0647] See in some examples Figure 35 The sterilization assembly, which is equipped with electronic device 880 and top cover 840, can be moved along the assembly direction D to assemble it onto the application device 1000, so that the cap 700 is fitted onto the proximal end of the application device 1000.
[0648] Due to at least one of the following reasons, such as the non-circular nature of the applicator 860 and the non-circular nature of the receiving portion 250, the non-centered nature of the holes in the applicator 860 and the receiving portion 250, and the engagement of the sharp object 270 with the support 280, it is necessary to assemble the applicator 860 into the application device 1000 in a certain orientation.
[0649] See in some examples Figure 8A or Figure 8B The housing 10 may have an assembly groove 194.
[0650] In some examples, the guide portion 730 is moved to the termination position 8362 of the guide portion 836, which allows multiple components of the pre-assembly module to be aligned with multiple components of the application device 1000 during the assembly of the pre-assembly module with the application device 1000. This enables efficient assembly. In some examples, at the termination position 8326, the applicator portion 860 is aligned with the receiving portion 250. In some examples, at the termination position 8326, the engagement feature (second engagement feature 791) of the cap 700 is aligned with the assembly groove 194.
[0651] In some examples, housing 10 may have a linear mounting groove 194. This allows cap 700 to be linearly coupled to application device 1000.
[0652] In some examples, the assembly groove 194 may be located at the end of the first engagement feature 191 away from the decoupling groove 193. In some examples, the second engagement feature 791 may be aligned with the assembly groove 194 during the integral assembly of the sterilization assembly comprising the electronic device 880 and the top cover 840 onto the application device 1000.
[0653] See in some examples Figure 8A or Figure 8BThe mounting groove 194 may have an engaging portion 1941. In some examples, the second engaging feature 791 may enter the housing 10 along the extending direction of the mounting groove 194 and abut against the engaging portion 1941. In some examples, when the second engaging feature 791 abuts against the engaging portion 1941, force may be applied to the cap 700 and the housing 10 to cause the second engaging feature 791 to press against the engaging portion 1941 and enter the first engaging feature 191. This helps to stably couple the cap 700 to the housing 10.
[0654] See in some examples Figure 35 The housing 10 may have a limiting protrusion 195. In some examples, after the second engagement feature 791 presses against the engaging portion 1941 and enters the first engagement feature 191, the second engagement feature 791 may abut against the limiting protrusion 195. In some examples, the limiting protrusion 195 may be configured to restrict the second engagement feature 791 to one end of the first engagement feature 191 near the mounting groove 194. This helps to prevent the cap 700 from decoupling from the housing 10 before user use.
[0655] In some examples, the extension direction of the first engagement feature 191 may intersect with the extension direction of the mounting groove 194. This allows the cap 700 and the housing 10 to be decoupled in a manner different from coupling the cap 700 to the housing 10.
[0656] In some examples, the extension direction of the first engagement feature 191 may be orthogonal to the extension direction of the mounting groove 194. This facilitates coupling and decoupling of the cap 700 and the housing 10. However, this disclosure is not limited to this; the extension direction of the first engagement feature 191 may have a predetermined angle with the extension direction of the mounting groove 194, such as 60 degrees, 70 degrees, or 80 degrees.
[0657] In some examples, the assembly groove 194 may extend along the central axis CA of the application device 1000. However, this disclosure is not limited thereto, and the assembly groove 194 may extend along a direction having a predetermined angle with the central axis CA of the application device 1000, for example, along a direction having a 10-degree, 20-degree, or 30-degree angle with the central axis CA.
[0658] As described above, the sharp object 270 can be detachably assembled with the support 280. See also: [examples omitted] Figure 5B and Figure 35 During the process of assembling the sterilization assembly, which includes the electronic device 880 and the top cover 840, into the application device 1000, the cap 276 of the sharp object 270 can extend through the hole 2821 and be fitted onto the support 280.
[0659] In some examples, after the housing 10 is assembled with the sterilization assembly containing the electronic device 880 and the cover 840, the application device 1000 may have a fixed relative position with the medical device, the sharp object 270, and the cap 700. The relative positions between the components are described in detail below.
[0660] In some examples, the medical device 800 may be non-circular in shape.
[0661] In some examples, the sharp object 270 may not be fitted at the geometric center of the medical device 800. This facilitates the mounting of the battery 8821.
[0662] In some examples, the auxiliary mechanism 20 may include a housing 10, a moving body 200, and a receiving portion 250. In some examples, the housing 10, the moving body 200, and the receiving portion 250 may have a fixed relative position. In some examples, the receiving portion 250 may be configured to releasably hold the medical device 800. In some examples, the receiving portion 250 may accommodate the medical device 800.
[0663] In some examples, the medical device 800 and the cap 700 may have a fixed relative position. In some examples, the base 830 and the cap 700 may have a fixed relative position.
[0664] In some examples, the cap 700 can be assembled into the housing 10 in a preset orientation by aligning the first and second indicators. This allows the medical device 800 to be aligned and housed in the receiving portion 250.
[0665] As described above, the base 830 may have a third limiting portion 837, which may be coupled to the guided portion 730. In some examples, the third limiting portion 837 can be coupled to the guided portion 730 to keep the relative position of the base 830 and the cap 700 fixed. In some examples, when the third limiting portion 837 is coupled to the guided portion 730, the base 830 and the cap 700 may have a fixed relative position. In some examples, the third limiting portion 837 may be provided on the guide portion 836 or an extension of the guide portion 836.
[0666] In some examples, during the assembly of the base 830 and cap 700 of the medical device 800, the guided part 730 can be aligned with the starting position 8361 of the guided part 836.
[0667] In some examples, when the guided portion 730 is aligned and abuts against the starting position 8361, the base 830 and the cap 700 can be rotated relative to each other to cause the engaging portion 2741 and the mating portion 720 to rotate relative to each other. In some examples, during the relative rotation of the base 830 and the cap 700, the guided portion 730 can move from the starting position 8361 along the extending direction of the guide portion 836 to the ending position 8362. In some examples, when the guided portion 730 moves to the ending position 8362, the guided portion 730 can couple with the third limiting portion 837 located at the ending position 8362. In this case, the guide part 836 guides the guided part 730, so that the base 830 and the cap 700 can be screwed to a preset relative position. The third limiting part 837 limits the guided part 730, so that the base 830 and the cap 700 can maintain a preset relative position. Thus, when assembling the cap 700 and the housing 10, the medical device 800 is aligned with the receiving part 250.
[0668] In some examples, during the assembly of the base 830 and cap 700 of the medical device 800, the first engagement structure 27411 can be aligned with the inlet groove 723.
[0669] In some examples, when the first engaging structure 27411 is aligned and enters the guide groove 723, the engaging portion 2741 and the mating portion 720 can rotate relative to each other when the base 830 and the cap 700 are screwed relative to each other. In some examples, when the engaging portion 2741 and the mating portion 720 rotate relative to each other, the first engaging structure 27411 can rotate relative to the second engaging structure 721. In some examples, the first engaging structure 27411 can be aligned with the guide groove 723 so that the engaging portion 2741 aligns with the mating portion 720. In some examples, the first rib 722 can be provided at the end of the second engaging structure 721 away from the guide groove 723. In some examples, the first engaging structure 27411 can move from the guide groove 723 along the extending direction of the second engaging structure 721 to the first rib 722. In some examples, when the first engaging structure 27411 moves to the first rib 722, the first engaging structure 27411 can abut against the first rib 722. In some examples, the angle at which the first joining structure 27411 rotates relative to the second joining structure 721 can be equal to a preset angle.
[0670] In some examples, when the guided portion 730 is aligned with the starting position 8361, the first engaging structure 27411 can be aligned with the guide groove 723. In some examples, when the guided portion 730 is coupled with the third limiting portion 837, the first engaging structure 27411 can be aligned with the first rib 722. In this case, after rotating the cap 700 relative to the medical device 800 and the sharp object 270 at a preset angle, the cap 700 can be coupled to both the medical device 800 and the sharp object 270 simultaneously.
[0671] In some examples, the user can decouple the housing 10 and the cap 700 by rotating them relative to each other.
[0672] The following describes in detail the process of decoupling the cap 700 from the sharp object 270.
[0673] In some examples, during the decoupling of the cap 700 from the sharp object 270, the mating portion 720 and the engaging portion 2741 can move relative to each other. In some examples, the mating portion 720 can rotate relative to the engaging portion 2741. In some examples, the angle of rotation of the mating portion 720 relative to the engaging portion 2741 can be a preset angle.
[0674] In some examples, during the decoupling of the cap 700 from the sharp object 270, the first engaging structure 27411 may move relative to the second engaging structure 721 away from the first rib 722. In some examples, the first engaging structure 27411 may move relative to the second engaging structure 721 until it reaches the guide groove 723. In some examples, when the first engaging structure 27411 moves to the guide groove 723, it may move along the guide groove 723 in a direction away from the second engaging structure 721 until the engaging portion 2741 is decoupled from the mating portion 720.
[0675] In some examples, the movement path of the second engagement structure 721 relative to the first engagement structure 27411 can be an arc, and the angle corresponding to the arc can be equal to a preset angle. Thus, after the cap 700 and the sharp object 270 are rotated at a preset angle relative to each other, the cap 700 and the sharp object 270 can be decoupled.
[0676] In some examples, the angle at which the mating part 720 rotates relative to the joint 2741 may be less than a preset angle. In this case, since the second engagement feature 791 abuts against one end of the first engagement feature 191 after the user has turned the cap 700 relative to the housing 10 at a preset angle, preventing the user from continuing to turn, by making the angle at which the mating part 720 rotates relative to the joint 2741 less than the preset angle, the cap 700 can be decoupled from the sharp object 270 in advance, thereby reducing the possibility that the cap 700 is decoupled from the housing 10 but has not yet been decoupled from the sharp object 270, making it easier for the user to use the analyte monitoring system 1 normally. In addition, compared to the case where the relative rotation angle between the mating part 720 and the joint part 2741 is greater than the preset angle, the relative rotation between the cap 700 and the housing 10 can provide guidance for the relative rotation between the mating part 720 and the joint part 2741. This helps to avoid the situation where the cap 700 and the housing 10 are decoupled but the mating part 720 and the joint part 2741 are not decoupled, thereby reducing the possibility that the cap 700 may damage the sharp object 270 and the sensor 820.
[0677] In some examples, after the cap 700 is decoupled from the sharp object 270, the cap 700 and the sharp object 270 no longer exert tension on each other, and the first sealing element 510 and the second sealing element 520 are no longer compressed, thereby releasing the seal on the upper and lower interfaces of the opening 831 and exposing the sharp object 270 and the medical device 800.
[0678] The following is a detailed description of the decoupling process between the cap 700 and the medical device 800.
[0679] In some examples, decoupling of the cap 700 from the medical device 800 may refer to the decoupling of the cap 700 from the base 830 of the medical device 800. See also [link to relevant documentation] for some examples. Figure 10A The base 830 may have a guide portion 836 and a third limiting portion 837. In some examples, the cap 700 may include a guided portion 730. In some examples, the base 830 may be coupled to the cap 700 via the third limiting portion 837, which is coupled to the guided portion 730.
[0680] In some examples, during the decoupling of the cap 700 from the base 830, the guided portion 730 can move relative to the guide portion 836 and the third limiting portion 837. In some examples, the guided portion 730 can move along the extension path of the guide portion 836 after decoupling from the third limiting portion 837. In some examples, the movement path of the guided portion 730 relative to the guide portion 836 and the third limiting portion 837 can be an arc, and the angle corresponding to the arc can be equal to a preset angle. Thus, after the cap 700 and the base 830 are rotated relative to each other by a preset angle, the cap 700 and the base 830 can be decoupled.
[0681] As described above, the guide portion 836 can be arc-shaped, and the angle corresponding to the arc can be equal to a preset angle. This helps to make the movement path of the guided portion 730 arc-shaped, and to limit the angle corresponding to the arc of the movement path of the guided portion 730 within a preset angle.
[0682] In some examples, the third limiting part 837 may be located at the ending position 8362. In some examples, during the decoupling of the cap 700 from the base 830, the guided part 730 may move from the ending position 8362 to the starting position 8361.
[0683] The following describes the decoupling of the cap 700 from the housing 10, the decoupling of the cap 700 from the sharp object 270, and the decoupling of the cap 700 from the medical device 800.
[0684] In some examples, the decoupling of the cap 700 from the housing 10, the decoupling of the cap 700 from the sharp object 270, and the decoupling of the cap 700 from the medical device 800 can be synchronized; that is, the cap 700 can begin decoupling from the housing 10, the sharp object 270, and the medical device 800 simultaneously and complete decoupling simultaneously. In some examples, the decoupling processes of the cap 700 from the housing 10, the decoupling processes of the cap 700 from the sharp object 270, and the decoupling processes of the cap 700 from the medical device 800 can be performed simultaneously. In some examples, during the decoupling process of the cap 700 from the above three components, the rotation angle of the second engagement feature 791 relative to the first engagement feature 191, the rotation angle of the mating part 720 relative to the engagement part 2741, and the rotation angle of the guided part 730 relative to the guiding part 836 and the third limiting part 837 can be equal in real time. In some examples, during the decoupling process, when the second engagement feature 791 moves from one end of the first engagement feature 191 to the other end, the first engagement structure 27411 can move from the first rib 722 into the groove 723, and the guided part 730 can move from the end position 8362 to the start position 8361.
[0685] The embodiments disclosed herein include: D. An analyte monitoring system, characterized in that it includes a base, the base including an opening; a sensor disposed on the base, the sensor including a tail portion located in the opening, a connecting portion located outside the opening, and a contact portion, the connecting portion connecting the tail portion and the contact portion; and a sealing assembly configured to seal the opening, the sealing assembly including a first sealing element.
[0686] In some examples, Embodiment D may be combined with any one or more of the following additional elements: Element 1: The first sealing element has a first hole aligned with the opening. Element 2: It further includes a sharp object extending through the opening, the sharp object including a cap portion engaging with the first sealing element. Element 3: The first sealing element is fitted onto the cap portion, with both ends of the first sealing element embedded in the cap portion. Element 4: The tail portion is aligned with the opening. Element 5: The sharp object further includes a needle-like portion configured to receive the tail portion and carry the tail portion into tissue. Element 6: It further includes a cap having a chamber configured to receive the tail portion, the sharp object being coupled to the cap to press the sharp object against the first sealing element. Element 7: The cap portion has an engagement portion at one end near the base, and the cap has a mating portion at one end near the base that is coupled to the engagement portion. Element 8: The engagement portion and the mating portion are coupled to each other by relative screwing. Element 9: The engagement portion has a first engagement structure, and the mating portion has a second engagement structure. Element 10: The first engagement structure includes a first engagement end, a second engagement end, and an engagement groove, the dimensions of which match the dimensions of the second engagement structure. Element 11: The first engagement end has an engagement notch. Element 12: The first engagement structure is a first thread, and the second engagement structure is a second thread, the second thread having a preset angle. Element 13: The mating portion has a first rib located at the end point of the second engagement structure. Element 14: The mating portion has a guide groove. Element 15: The base includes a support portion having a channel extending toward the opening, the connecting portion extending through the channel. Element 16: It also includes a sealing cap, the sealing cap at least partially covering the channel. Element 17: The sealing cap has a first notch, at least a portion of which coincides with the channel, the connecting portion passing through the first notch. Element 18: The sealing cap engages with the first sealing element. Element 19: The base has a guide portion, the cap having a guided portion that moves along the guide portion when screwed. Element 20: The guide portion is a guide groove formed by an indentation in the bottom surface of the base. Element 21: The guide portion is an arc shape with a predetermined curvature. Element 22: The base has a third limiting portion disposed on the guide portion or an extension line of the guide portion and engaging with the guided portion. Element 23: During the coupling of the engaging portion and the mating portion, the starting position of the guided portion is the starting position of the guide portion, and the ending position of the guided portion is the ending position of the guide portion. Element 24: The third limiting portion is a protrusion, and the guided portion has a groove engaging with the third limiting portion. Element 25: The base further includes a fixing portion for fixing the contact portion. Element 26: It also includes a top cover having a third hole aligned with the central hole.Element 27: Also includes a sealing cap having a central boss that is embedded in the third hole, the outer edge of the central boss abutting against the inner edge of the third hole. Element 28: The top cover has an annular ridge surrounding the third hole, and the sealing cap has an annular flange that surrounds the central boss and forms a second pocket with the central boss, the annular ridge being at least partially received in the second pocket. Element 29: The cap includes a first portion whose outer contour matches the inner contour of the opening and is racetrack-shaped. Element 30: The sharp object includes a depth-limiting portion protruding from the first portion.
[0687] E. An analyte monitoring system, characterized in that it comprises a base, the base including an opening; a sensor disposed on the base, the sensor including a tail portion located in the opening, a connecting portion located outside the opening, and a contact portion, the connecting portion connecting the tail portion and the contact portion; a sealing assembly sealing the opening; and a channel extending toward the opening, the sealing assembly forming a seal in the channel or in the direction of extension of the channel.
[0688] In some examples, Embodiment E may be combined with any one or more of the following additional elements: Element 1: The sealing assembly is at least partially disposed in the channel. Element 2: The base includes a support portion, the support portion being a boss. Element 3: The channel is disposed on the support portion. Element 4: It also includes a sealing cap, the sealing cap at least partially covering the channel. Element 5: It also includes a sealing cap, the channel being disposed on the sealing cap. Element 6: The sealing cap has a central hole aligned with the opening. Element 7: The sealing cap has a first notch, at least a portion of the first notch coinciding with the channel. Element 8: The base includes a mounting portion that mates with the sealing cap. Element 9: The base has a first limiting portion, the sealing cap has a second limiting portion, the first limiting portion aligning with the second limiting portion to guide the sealing cap to be mounted on the mounting portion. Element 10: The first limiting portion abuts against the second limiting portion in the circumferential direction of the mounting portion. Element 11: The assembly has a bag surrounding the opening and communicating with the channel, and the sealing cap is at least partially received in the bag. Element 12: A gap exists between the portion of the sealing cap received in the bag and the bottom of the bag. Element 13: The base has a guide portion, and the cap has a guided portion that moves along the guide portion when screwed. Element 14: The guide portion is a guide groove formed by a recess in the bottom surface of the base. Element 15: The guide portion is an arc shape with a predetermined curvature. Element 16: The base has a third limiting portion disposed on the guide portion or an extension line of the guide portion and engaging with the guided portion. Element 17: It also includes a sharp object with a cap portion, the cap portion having a connecting portion at one end near the base, and the cap having a mating portion coupling with the connecting portion at one end near the base, wherein during the coupling of the connecting portion and the mating portion, the starting position of the guided portion is the starting position of the guide portion, and the ending position of the guided portion is the ending position of the guide portion. Element 18: The third limiting portion is a protrusion, and the guided portion has a groove that mates with the third limiting portion. Element 19: The base further includes a fixing portion for fixing the contact portion. Element 20: It also includes a top cover having a third hole aligned with the central hole. Element 21: It also includes a sealing cap having a central boss that is inserted into the third hole, with the outer edge of the central boss abutting against the inner edge of the third hole. Element 22: The top cover has an annular ridge surrounding the third hole, and the sealing cap has an annular flange that surrounds the central boss and forms a second pocket with the central boss, the annular ridge being at least partially received in the second pocket. Element 23: The sharp object includes a needle-like portion configured to carry the tail portion to pierce tissue.Element 24: The cap portion includes a first part, the outer contour of which matches the inner contour of the opening and both are racetrack-shaped. Element 25: The sharp object includes a depth-limiting portion protruding from the first part.
[0689] F. An analyte monitoring system, characterized in that it includes a base, the base including an opening; a sensor disposed on the base, the sensor including a tail portion located in the opening, a connecting portion located outside the opening, and a contact portion, the connecting portion connecting the tail portion and the contact portion; and a sealing assembly configured to seal the opening, the sealing assembly including a second sealing element.
[0690] In some examples, embodiment F may be combined with any one or more of the following additional elements: Element 1: The second sealing element has a second hole aligned with the opening. Element 2: It further includes a cap configured to receive the tail and engage with the second sealing element. Element 3: The cap presses the second sealing element against the base. Element 4: The cap has a first sealing groove on the side near the base, and the base has a second sealing groove on the side near the cap. Element 5: It further includes a sharp object configured to receive the tail and carry the tail into tissue, the cap being coupled to the sharp object to apply pressure to the second sealing element. Element 6: The cap and the sharp object are coupled to each other by relative screwing. Element 7: The base has a guide portion, and the cap has a guided portion that moves along the guide portion when screwed. Element 8: The guide portion is a guide groove formed by a recess in the bottom surface of the base. Element 9: The guide portion is an arc shape with a predetermined curvature. Element 10: The base has a third limiting portion disposed on the guide portion or an extension line of the guide portion and engaging with the guided portion. Element 11: The sharp object further includes a cap portion, the end of the cap portion near the base having a joining portion, and the end of the cap portion near the base having a mating portion coupling with the joining portion. During the coupling of the joining portion and the mating portion, the starting position of the guided portion is the starting position of the guide portion, and the ending position of the guided portion is the ending position of the guide portion. Element 12: The third limiting portion is a protrusion, and the guided portion has a groove engaging with the third limiting portion. Element 13: The base further includes a fixing portion for fixing the contact portion. Element 14: It also includes a top cover, the top cover having a third hole aligned with the central hole. Element 15: It also includes a sealing cap, the sealing cap having a central boss, the central boss being inserted into the third hole, and the outer edge of the central boss abutting against the inner edge of the third hole. Element 16: The top cover has an annular ridge surrounding the third hole, and the sealing cap has an annular flange surrounding the central boss and forming a second pocket with the central boss, the annular ridge being at least partially received in the second pocket. Element 17: The sharp object includes a needle-like portion configured to carry the tail portion to pierce tissue. Element 18: The cap includes a first portion whose outer contour matches the inner contour of the opening and is both racetrack-shaped. Element 19: The sharp object includes a depth-limiting portion protruding from the first portion.
[0691] G. An analyte monitoring system, characterized in that it includes a base, the base including an opening; a sensor disposed on the base, the sensor including a tail portion located in the opening, a connecting portion located outside the opening, and a contact portion, the connecting portion connecting the tail portion and the contact portion; a sealing assembly configured to seal the opening, the sealing assembly including a first sealing element and a second sealing element; and a channel extending toward the opening, the sealing assembly forming a seal in the channel or in the direction of extension of the channel.
[0692] In some examples, embodiment G can be combined with any one or more of embodiments D, E and F.
[0693] H. A method for assembling a sterilization assembly, the sterilization assembly comprising a base having a guide portion, a sensor, a sealing cap, a sharp object, a sealing assembly, and a cap having a guided portion, the guide portion having a starting position and an ending position, the sealing assembly comprising a first sealing element and a second sealing element, characterized in that: the sensor is assembled on the base; the sealing cap is disposed on the base and the sensor; the sharp object passes through the first sealing element and is assembled on the base; the second sealing element is sleeved on the cap; when the guided portion is aligned and abuts against the starting position, the cap and the base are rotated relative to each other so that the cap is simultaneously coupled to the base and the sharp object.
[0694] In some examples, embodiment H can be combined with any one or more of the following additional elements: Element 1: The base includes an opening through which the sharp object and the sensor extend from the bottom surface of the base. Element 2: Includes a channel extending toward the opening through which the sensor passes and is located at the opening. Element 3: The sealing cap at least partially covers the channel. Element 4: The sealing cap has a first notch aligned with the channel. Element 5: The sharp object includes a cap on which the first sealing element is fitted. Element 6: The sensor includes a tail, and the cap has a chamber configured to receive the tail. Element 7: The sharp object has an engagement portion. Element 8: The cap has a mating portion. Element 9: After relative screwing of the cap to the base, the engagement portion couples with the mating portion. Element 10: Relative screwing of the cap to the base at a predetermined angle causes the cap to couple simultaneously with both the base and the sharp object. Element 11: The guide portion is arc-shaped. Element 12: The guide portion has a predetermined curvature. Element 13: The angle corresponding to the predetermined curvature matches the preset angle. Element 14: The base has a third limiting portion. Element 15: After the cap and the base are screwed relative to each other, the third limiting portion couples with the guided portion.
[0695] I. A method for assembling an analyte monitoring system, the method comprising assembling a sensor assembly with an application device, the sensor assembly including a sensor, a sensor control device, a sharp object, and a cap, the sensor being configured to extend from the bottom of the sensor control device, the sharp object being configured to pass through the sensor control device and extend from the bottom of the sensor control device, the cap having a chamber for receiving the tail of the sensor and the tail of the sharp object, wherein the cap is coupleable with at least one of the sensor control device and the sharp object to form a sealed space for sealing the tail of the sensor and the tail of the sharp object, the cap being removably coupled to the application device.
[0696] In some examples, Embodiment I may be combined with any one or more of the following additional elements: Element 1: The sharp object includes a needle-like portion and a cap configured to receive the needle-like portion, the cap including an abutment portion configured to abut against the top of the sensor control device, and a joint portion formed in the cap and extending from the bottom of the sensor control device. Element 2: The cap and the joint portion are coupled in a relative screwing manner. Element 3: The bottom of the sensor control device has a guide portion configured to guide the cap relative to the joint portion when the cap and the joint portion are screwed relative to each other. Element 4: The guide portion is a guide groove formed by a recess in the bottom of the sensor control device. Element 5: The guide portion is arc-shaped with a predetermined curvature. Element 6: The cap has a guided portion configured to move along the guide portion. Element 7: During coupling of the joint portion and the cap, the guide portion defines the starting and ending positions of the movement of the guided portion.
[0697] Element 8: During coupling of the joint and the cap, the starting position of the guided portion is the starting position of the guide portion, and the ending position of the guided portion is the ending position of the guide portion. Element 9: In response to the guide portion guiding the guided portion from the starting position to the ending position, the sharp object and / or the applicator portion has a first preset orientation relative to the cap. Element 10: The cap of the sharp object has a plurality of fingers configured to snap onto the support. Element 11: The cap has a top end remote from the sensor control device and an end opposite to the top end, the plurality of fingers being formed at the top end and extending away from the central axis of the sharp portion in a direction from the top end to the end end. Element 12: The cap has a top end remote from the sensor control device and an end opposite to the top end, the plurality of fingers being generally tapering in a direction from the end end to the top end. Element 13: Assembling the sensor assembly with the application device includes fastening the sensor assembly to the application device. Element 14: The application device includes a housing and an auxiliary mechanism assembled within the housing. The aux...
Claims
1. An application device for applying an on-body unit, characterized in that, The on-body unit comprises a sensor implantable at least partially under the host's skin, and a transmitter operatively connected to the sensor; The application device comprises: a housing comprising a proximal end proximate to a host's skin surface, and a distal end distal to the host's skin surface; a moving body disposed inside the housing and configured to be detachably coupled with the on-body unit; a piercing member operatively coupled to the moving body and configured to implant the sensor at least partially under the skin; a driving mechanism configured to push the moving body towards the proximal end; and a first trigger mechanism comprising a first holding portion configured to hold the moving body, and a pressing portion configured to actuate the first holding portion; the first holding portion is released in response to a force applied on the pressing portion; the released moving body is driven by the driving mechanism towards the proximal end to implant the sensor at least partially under the host's skin through the piercing member; the first trigger mechanism is integrally formed with the housing.
2. The application device of claim 1, wherein: a surface of the distal end of the housing has a through structure; a projection of the pressing portion and the through structure in a direction along a central axis of the application device at least partially coincides; wherein: a projection of the pressing portion and the housing in a direction perpendicular to the central axis of the application device at least partially coincides.
3. The application device of claim 1, wherein: the first trigger mechanism further comprises a first actuating portion configured to link the pressing portion and the first holding portion; the first holding portion is formed on the distal end of the housing in a manner extending towards the proximal end, wherein: the first actuating portion is configured to extend in a direction having a preset included angle with the central axis of the application device, and a first linkage site of the first actuating portion and the first holding portion is proximate to the proximal end of the first holding portion.
4. The application device of claim 3, wherein: an end of the first actuating portion proximate to the first holding portion has a curved structure, the first actuating portion and the first holding portion form a U-shaped notch.
5. The application device of claim 3, wherein: a hardness of an end of the first actuating portion proximate to the pressing portion is not less than a hardness of an end of the first actuating portion proximate to the first holding portion.
6. The application device of claim 3, wherein: a projection of the first actuating portion in a direction along the central axis of the application device coincides with a long axis direction of the on-body unit.
7. The application device of claim 3, wherein: a distal end of the moving body has a first recess structure, and when the moving body is in the distal end, the first actuating portion at least partially passes through the first recess structure.
8. The application device of claim 3, wherein: a distal end of the piercing member has a second recess structure, and when the piercing member is in the distal end, the first actuating portion at least partially passes through the second recess structure.
9. The application device of any one of claims 3-5, wherein: The first trigger mechanism further comprises an additional retaining portion and a second actuating portion, The additional retaining portion is connected with the pressing portion via the second actuating portion, and a projection of the additional retaining portion and the second actuating portion in the direction of the central axis of the application device is located on the same straight line as a projection of the first retaining portion and the first actuating portion in the direction of the central axis of the application device.
10. The application device according to claim 1, characterized in that, The housing further comprises at least one limiting portion, which is arranged on the opposite side or the same side of the first retaining portion, and which abuts against the moving body.