Monitoring apparatus and electron beam irradiation sterilization apparatus
By designing a monitoring device including a main housing, sensor and sealing cover, the problems of probe biological enzyme damage and electronic components damage in the sensor sterilization method of existing blood monitoring device are solved, and effective probe sterilization and simplification of user operation are achieved.
Patent Information
- Application Number
- PCT/CN2023/119062
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Filing Date
- 2023-09-15
- Publication Date
- 2025-03-20
AI Technical Summary
The sterilization method of existing blood monitoring device sensors has the problem of damage to the bioenzymes on the surface of the probe (ethylene oxide gas sterilization) and the problem of irreversible damage to electronic components (electron beam irradiation sterilization). At the same time, the user's operation is complicated and there is a risk of inadequate assembly.
A monitoring device is designed, which includes a main housing, a sensor and a sealing cover. The sensor can be moved relative to the main housing, and the sealing cover forms a sealing cavity through the cover body and grooves to shield the sensor body and expose the probe to the electron beam irradiation, ensuring effective sterilization of the probe without damaging the electronic components.
It realizes effective sterilization of blood monitoring device sensors without increasing user operation complexity and assembly risks, ensuring the biosafety of the probe and the integrity of electronic components.
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Figure CN2023119062_20032025_PF_FP_ABST
Abstract
Description
Monitoring device and electron beam irradiation sterilization device Technical Field
[0001] The present application relates to the field of electronic medical technology, and in particular to a monitoring device and an electron beam irradiation sterilization device. Background Art
[0002] A blood monitoring device is a wearable device that can continuously monitor the blood composition of the interstitial fluid under the skin. The sensor of the blood monitoring device includes internal electronic components and an exposed probe. The sensor is applied to the surface of the human skin and the probe on the sensor is implanted into the subcutaneous tissue. The user wears the sensor of the blood monitoring device on the surface of the skin, and the probe implanted in the subcutaneous tissue continuously analyzes the blood status. The implanted probe must meet biosafety requirements and must undergo a sterilization process to ensure sterility and safety, preventing local infection caused by bacteria, viruses, and other hazards, which could pose a threat to the user's health.
[0003] Currently, the main sterilization methods for sensors used in blood monitoring devices are ethylene oxide gas sterilization and electron beam irradiation. While ethylene oxide gas sterilization is very effective for electronic components, it can damage the biological enzymes attached to the probe surface, causing sensor failure. Electron beam irradiation can effectively sterilize probes without destroying the enzymes, but it can cause irreversible damage to electronic components.
[0004] In related technologies, the sensors of blood monitoring devices are separated into passive and active components. The passive probes are sterilized using electron beam irradiation, while the active electronic components are sterilized using ethylene oxide gas. This method can resolve the incompatibility between sterilization methods and the passive and active components, but it also requires additional sterile packaging and requires additional steps for users to assemble the passive and active components. This increases the complexity of the user operation and also poses the risk of improper assembly.
[0005] Summary of the Invention
[0006] According to various embodiments of the present application, a monitoring device and an electron beam irradiation sterilization device are provided.
[0007] In a first aspect, the present application provides a monitoring device, comprising:
[0008] A main housing, wherein the main housing has a first accommodating cavity;
[0009] A sensor element is disposed in the first accommodating cavity and includes a sensor body and a probe connected to the sensor body, wherein the sensor element is movable relative to the main housing;
[0010] The sealing cover includes a cover body and a groove provided on the cover body and opening in a direction close to the sensor element. The cover body is connected to the main shell and abuts against the sensor body. The groove is provided around the sensor element to form a sealed cavity for accommodating the probe. The sealing cover is used to form a radiation shield for the sensor body and expose the probe to electron irradiation.
[0011] In some embodiments, the cover is made of a shielding material, and the groove is made of a non-shielding material.
[0012] In some embodiments, a second accommodating cavity is provided on the sealing cover. When the shielding member is moved into the second accommodating cavity, the shielding member can be detachably connected to the outer wall of the sealing cavity and shield the sensor body.
[0013] In some embodiments, the sealed cavity is cylindrical.
[0014] In some embodiments, the sealed cavity is arranged concentrically or eccentrically relative to the axis of the main housing.
[0015] In some embodiments, the sealing cover further includes: a sealing cover plate and a first side plate; the first side plate is connected to the sealing cover plate, and the sealing cover plate, the outer wall of the sealing cavity and the first side plate are arranged to form the second accommodating cavity.
[0016] In some embodiments, the sealing cover further includes a second side plate, which is spaced apart from and connected to the first side plate.
[0017] In some embodiments, the outer wall of the first side panel and / or the inner wall of the second side panel are provided with a connecting piece, the side wall of the main shell is provided with a matching piece, and the connecting piece is connected with the matching piece.
[0018] In some embodiments, the connecting member is a guide member, and at least two of the guide members are arranged at intervals along the outer wall of the first side panel and / or the inner wall of the second side panel; the matching member is a stop member, and at least two of the stop members are arranged at intervals along the side wall of the main shell (1); the guide member is connected in a matching manner with the stop member.
[0019] In some embodiments, the monitoring device further comprises: a fastening ring, against which one end of the sealing cover away from the sensing element abuts, and the fastening ring is connected to the main housing to limit the sealing cover.
[0020] In some embodiments, a driving member is further provided in the main shell, the driving member is fixed to the first accommodating cavity, the sensing member is connected to the driving member, and the driving member can push the sensing member to the outside of the main shell through the first accommodating cavity.
[0021] In some embodiments, the sensor body includes: a housing and an electronic component built into the housing; the probe extends out of the housing; and a first sealing member is provided at a connection between the housing and the probe.
[0022] In some embodiments, the sensor further comprises a steel needle assembly, wherein the steel needle assembly comprises: a handle and a steel needle connected to the handle;
[0023] The handle is arranged at one end of the sensor body; the steel needle is sleeved on the probe, and the end of the steel needle away from the handle passes through the sensor body and extends to the other end of the sensor body.
[0024] In some embodiments, a second seal is provided between the handle and the sensor body; and / or a third seal is provided between the groove and the sensor body.
[0025] In a second aspect, the present application also provides an electron beam irradiation sterilization device, comprising: a shielding member and a monitoring device as described above, wherein the shielding member is adapted to the shape of the second accommodating cavity, and the shielding member can be moved into the second accommodating cavity during electron beam irradiation sterilization to shield the sensor body and expose the probe to the electron beam.
[0026] The details of one or more embodiments of the present application are set forth in the following drawings and description. Other features, objects, and advantages of the present application will become apparent from the description, drawings, and claims. BRIEF DESCRIPTION OF THE DRAWINGS
[0027] In order to more clearly illustrate the embodiments of the present application or the technical solutions in the conventional technology, the following briefly introduces the drawings required for use in the embodiments or the conventional technology descriptions. Obviously, the drawings described below are merely embodiments of the present application. For ordinary technicians in this field, other drawings can be obtained based on the disclosed drawings without any creative work.
[0028] FIG1 is a schematic diagram of an application scenario of a monitoring device according to some embodiments.
[0029] FIG2 is a schematic structural diagram of a monitoring device according to some embodiments.
[0030] FIG3 is a schematic diagram of a partial structure of a monitoring device according to some embodiments.
[0031] FIG4 is a schematic diagram of an explosion structure of a monitoring device according to some embodiments.
[0032] FIG5 is a schematic cross-sectional view of a monitoring device according to some embodiments.
[0033] FIG6 is an enlarged structural diagram of point A in FIG5 .
[0034] FIG. 7 is a schematic structural diagram of a sensing element according to some embodiments.
[0035] FIG8 is a schematic structural diagram of a shielding member according to some embodiments.
[0036] FIG. 9 is a schematic structural diagram of a sealing cover at a first viewing angle according to some embodiments.
[0037] FIG. 10 is a schematic structural diagram of a sealing cover at a second viewing angle according to some embodiments.
[0038] FIG. 11 is a schematic structural diagram of a fastening ring according to some embodiments.
[0039] FIG12 is a schematic structural diagram of an electron beam irradiation sterilization device according to some embodiments.
[0040] FIG. 13 is a schematic diagram of an electron beam irradiation sterilization process according to some embodiments.
[0041] In the accompanying drawings: 100, monitoring device; 1, main shell; 11, first accommodating chamber; 110, cavity opening; 12, fitting part; 13, driving part; 14, external thread; 2, sensing part; 21, sensor body; 211, housing; 212, electronic component; 213, first sealing part; 22, probe; 3, sealing cover; 30, cover body; 31, groove; 32, sealing chamber; 33, second accommodating chamber; 34, sealing cover plate; 35, first side plate; 36, second side plate; 37, connecting part; 4, fastening ring; 41, internal thread; 42, limiting part; 23, steel needle assembly; 231, handle; 232, steel needle; 5, second sealing part; 6, third sealing part; 200, shielding part; 201, passage; 300, object to be measured; 400, processing terminal; 500, electron beam irradiation sterilization device; 600, electron beam. DETAILED DESCRIPTION
[0042] The following will be combined with the drawings in the embodiments of this application to clearly and completely describe the technical solutions in the embodiments of this application. Obviously, the embodiments described are only part of the embodiments of this application, not all of the embodiments. Based on the embodiments of this application, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of this application.
[0043] It should be noted that when a component is referred to as being "mounted on" another component, it may be mounted directly on the other component or there may be a central component. When a component is considered to be "set on" another component, it may be directly set on the other component or there may be a central component. When a component is considered to be "fixed to" another component, it may be directly fixed to the other component or there may be a central component.
[0044] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the art to which this application pertains. The terms used herein in the specification of this application are for the purpose of describing specific embodiments only and are not intended to limit this application. The term "or / and" as used herein includes any and all combinations of one or more of the associated listed items.
[0045] It should be noted that, in this article, “proximal end” and “proximal side” are used to refer to the end or side closer to the operator, and are the opposite position or direction to the terms “distal end” and “distal side”; “distal end” and “distal side” refer to the end or side farther from the operator, and are the opposite position or direction to the terms “proximal end” and “proximal side”.
[0046] In recent years, minimally invasive, non-invasive, and continuous blood glucose monitoring devices have emerged, evolving towards miniaturization, diversification, intelligence, and precision. These devices have revolutionized the way blood glucose monitoring is performed. These devices provide insights into a subject's physical condition, enabling real-time and accurate responses.
[0047] Continuous monitoring devices apply a sensor to the surface of human skin and implant a probe into the subcutaneous tissue. The probe continuously analyzes blood status information, such as glucose, neutral lipids, and blood oxygen parameters. The probe implanted into the subcutaneous tissue must meet biosafety standards and undergo a sterilization process to ensure sterility and prevent local infection caused by bacteria, viruses, and other hazards, which could pose a threat to the user's health.
[0048] The following is a detailed description with reference to the accompanying drawings. Figure 1 is a schematic diagram of the application scenario of the monitoring device 100 provided in this embodiment. As shown in Figure 1, the monitoring device 100 pushes the sensor to the skin surface of the object to be tested 300, uses the probe on the sensor to obtain the blood data of the object to be tested 300, and sends it to the processing terminal 400 through the network; the processing terminal 400 can receive the blood data of the object to be tested 300, and give relevant guidance information or suggestions after analysis to facilitate the control of the blood status. The processing terminal 400 can be a mobile phone, tablet or computer, etc., and the corresponding monitoring software is installed on the processing terminal 400.
[0049] 2 and 4 , the present application provides a monitoring device 100 that can be used in the field of electronic medical technology to monitor the blood status of a subject 300. The monitoring device 100 includes a main housing 1, a sensor 2, and a sealing cover 3.
[0050] The main housing 1 has a first accommodating chamber 11 having a cavity opening 110 . The sensor 2 is accommodated in the first accommodating chamber 11 .
[0051] In this embodiment, the main shell 1 can be cylindrical with a circular cross-section, or can be in the shape of a circular plate or other irregular shapes. The main shell 1 can be made of PE (polyethylene), PP (polypropylene), PS (Polystyrene), PVC (Polyvinylchloride) or PET (polyethyleneglycol terephthalate). In some embodiments, the main shell 1 is integrally formed. In other embodiments, the main shell 1 is divided into sections, and the sections are fixed by welding. In other embodiments, the sections can also be fixed by other fixing methods such as screw connection, hinge connection or clamping.
[0052] Referring to Figures 4, 5, and 7, the sensor element 2 includes a sensor body 21 and a probe 22 connected to the sensor body 21. The sensor element 2 is movable relative to the main housing 1. Specifically, in the initial state, the sensor body 21 and probe 22 are housed within the main housing 1. In use, the sensor body 21 and probe 22 are displaced from their initial positions by an external force and move relative to the main housing 1. The probe 22 then moves outside the main housing 1 and is implanted on the body surface to detect relevant blood data.
[0053] In some embodiments, the sensor body 21 includes a housing 211 and an electronic component 212 embedded within the housing 211. The probe 22 is connected to the electronic component 212 and extends from the housing 211. In some embodiments, the electronic component 212 may include a microprocessor, a power management module, an acquisition and amplification module, an A / D conversion module, a wireless communication module, and a battery. The wireless communication module enables contactless communication between the processing terminal 400 and the sensor body 21.
[0054] A first seal 213 is provided at the connection between the housing 211 and the probe 22. This fills the gap between the probe 22 and the housing 211, creating a sealed space within the sensor body 21. The first seal 213 can be an O-ring, silicone, UV-curable adhesive, or other materials. The first seal 213 at the connection between the housing 211 and the probe 22 provides physical isolation from the external environment, effectively preventing gases and liquids from entering the sensor element 2, thereby improving the accuracy and stability of the sensor element 2.
[0055] As shown in FIG5-6 , in some embodiments, to ensure that the probe 22 of the sensor 2 is smoothly implanted into the body surface and is not damaged during the implantation process, the sensor 2 further includes a steel needle assembly 23. The steel needle assembly 23 includes a handle 231 and a steel needle 232 connected to the handle 231.
[0056] The handle 231 is provided at one end of the sensor body 21 , so that the steel needle 232 is connected and fixed to the sensor body 21 through the handle 231 .
[0057] The steel needle 232 is sheathed within the probe 22. The end of the steel needle 232, away from the handle 231, penetrates the sensor body 21 and extends to the other end of the sensor body 21. In use, when the sensor body 21 moves relative to the main housing 1, the steel needle assembly 23 and the probe 22 move synchronously relative to the main housing 1. This protects the exposed portion of the probe 22 on the sensor 2 and assists in implanting the probe 22 into the body surface. Once the steel needle 232 and probe 22 are implanted simultaneously, the steel needle 232 can be withdrawn manually or automatically, leaving the probe 22 in the subcutaneous tissue on the body surface.
[0058] The implanted probe 22 must meet biosafety requirements. Before being implanted, the probe 22 must undergo a sterilization process to ensure sterility and safety, thereby preventing local infection caused by bacteria, viruses, and other hazards that could threaten the user's health.
[0059] In related technologies, the sensors of monitoring devices are separated into passive and active components. The passive probes are sterilized using electron beam irradiation, while the active electronic components are sterilized using ethylene oxide gas. This method can resolve the incompatibility between sterilization methods and the passive and active components, but it also requires additional sterile packaging and requires additional steps to assemble the passive and active components during use, which increases the complexity of the user operation and also poses the risk of improper assembly.
[0060] In order to ensure that the electron beam irradiation sterilization of the probe 22 is completed while the product structure is intact and to avoid additional product assembly process, the monitoring device 100 is further provided with a sealing cover 3. The following is a detailed description with reference to the accompanying drawings.
[0061] 3-5 and 9 , the monitoring device 100 is further provided with a sealing cover 3 that seals the cavity 110 of the main housing 1. Specifically, the sealing cover 3 includes a cover body 30 and a groove 31 provided on the cover body 30 and opening in a direction close to the sensing element 2. The cover body 30 is connected to the main housing 1 and abuts against the sensor body 21. The groove 31 surrounds the sensing element 2 to form a sealed cavity 32 for accommodating the probe 22.
[0062] In some embodiments, the upper surface of the groove 31 of the sealing cover 3 abuts against the lower surface of the sensor 2, the probe 22 extends out of the housing 211 of the sensor 2 and is accommodated in the groove 31, and the groove 31 is surrounded by the housing 211 to form a sealed cavity 32 for accommodating the probe 22. The sealed cavity 32 can serve as a physical isolation area for the probe 22.
[0063] In other embodiments, as shown in FIG5 , the sensor 2 further includes a steel needle assembly 23, which includes a handle 231 and a steel needle 232 connected to the handle 231. The handle 231 is disposed at one end of the sensor body 21; the steel needle 232 is sleeved on the probe 22, and the end of the steel needle 232 away from the handle 231 passes through the sensor body 21 and extends to the other end of the sensor body 21. At this time, the upper surface of the groove 31 of the sealing cover 3 abuts against the lower surface of the sensor 2, the handle 231 is disposed at one end of the sensor body 21, the steel needle 232 connected to the handle 231 and the probe 22 extend out of the housing 211 of the sensor 2 and are accommodated in the groove 31. The groove 31 is surrounded by the housing 211 and the handle to form a sealed cavity 32 for accommodating the probe 22.
[0064] The sealing cover 3 is used to form a radiation shield for the sensor body 21 and to expose the probe 22 to electron irradiation.
[0065] In some embodiments, the cover 30 is made of a shielding material and the groove 31 is made of a non-shielding material. It is understood that when the monitoring device 100 needs to be sterilized by electron beam 600 irradiation, since the cover 30 abuts against the sensor body 21, the cover 30 is arranged relative to the sensor body 21 along at least one irradiation direction of the electron beam, so that the cover 30 can shield the electron irradiation and avoid irreversible damage to the electronic components in the sensor body 21. In addition, the groove 31 is made of a non-shielding material, so that the probe 22 can be exposed to electron irradiation for irradiation sterilization, so that a sterile environment is formed in the sealed cavity 32. Optionally, the shielding material is any material that can block (or substantially block) radiation transmission. For example, it can be a metal such as lead, aluminum, alloy, stainless steel material or high-density polymer, which is not limited in this application.
[0066] In some embodiments, as shown in FIG10 , the sealing cover 3 is provided with a second accommodating cavity 33, which allows the shielding member 200 to be moved in and out. When the shielding member 200 is moved into the second accommodating cavity 33, it can be detachably connected to the outer wall of the sealing cavity 32 and shield the sensor body 21. Optionally, the detachable connection includes a sleeve connection, a snap connection, a threaded connection, etc., which is not limited in this application.
[0067] As shown in Figure 8, in this embodiment, the shielding member 200 can be made of any material that can block (or substantially block) radiation transmission. The shielding member 200 can be made of metal such as lead, aluminum, alloy, stainless steel material or high-density polymer, which is not limited in this application. The shape of the shielding member 200 is adapted to the second accommodating cavity 33. Optionally, the shielding member 200 is provided with a passage 201 to allow the electron beam 600 to pass through. The shape of the passage 201 can be cylindrical, conical, variable cross-section, etc., and the shape of the passage 201 is adapted to the shape of the second accommodating cavity 33. When the shielding member 200 is sleeved on the outer wall of the sealed cavity 32, the sealed cavity 32 passes through the passage 201. In this arrangement, when the shielding member 200 moves into the second accommodating cavity 33 of the sealing cover 3, the shielding member 200 can block the sensor body 21 and expose the probe 22 to the electron beam 600.
[0068] As shown in FIG13 , when the monitoring device 100 needs to be sterilized by electron beam 600 irradiation, the shielding member 200 can be moved into the second accommodating chamber 33 of the sealing cover 3. When the shielding member 200 is moved into the second accommodating chamber 33 of the sealing cover 3, the shielding member 200 is sleeved onto the outer wall of the sealed chamber 32, and the sealed chamber 32 passes through the passage 201. Thus, the shielding member 200 can shield the sensor body 21 to form a shielded area, preventing the electronic components 212 in the sensor body 21 from being damaged by the electron beam 600. At the same time, the probe 22 is exposed to the electron beam 600, forming an unshielded area. The electron beam 600 passes through the passage 201 of the shielding member 200 and the sealed chamber 32, sterilizing the probe 22 and the steel needle 232 by electron beam 600 irradiation, thereby creating a sterile environment within the sealed chamber 32.
[0069] After the electron beam 600 irradiation sterilization is completed, the shielding member 200 can be removed, thereby completing the integrated electron beam 600 irradiation sterilization of the monitoring device 100 .
[0070] In some embodiments, the sealing cavity 32 is cylindrical and is concentric or eccentric relative to the axis of the main housing 1. When the sealing cavity 32 is eccentric relative to the axis of the main housing 1, when the shielding member 200 moves into or out of the second accommodating cavity 33, the sealing cavity 32 passes through the passage 201 on the shielding member 200, so that the shielding member 200 can only move axially relative to the monitoring device 100 in the direction of the shielding member 200 moving in or out, and cannot rotate radially relative to the sealing cover 3. This limits the position of the shielding member 200 within the second accommodating cavity 33, eliminating the need for an additional limiting mechanism, reducing processing costs, and ensuring a more stable fit between the shielding member 200 and the sealing cover 3 during sterilization. Of course, in other embodiments, the sealing cavity 32 can be square or other special shapes, as long as it can adapt to the shape of the shielding member 200 and pass through the shielding member 200. This is not limited in this application.
[0071] As shown in FIG9-10 , the sealing cover 3 is a part of the product structure of the monitoring device. On the one hand, it protects the probe 22 to form a physically isolated sterile space around the probe 22 . On the other hand, it serves as a holder for accommodating the shielding member 200 , thus serving two purposes.
[0072] In some embodiments, the sealing cover 3 further includes a sealing cover plate 34 and a first side plate 35 .
[0073] A groove 31 is provided on the sealing cover 34. Specifically, the sealing cover 34 includes a first surface relatively close to the sensor 2 and a second surface relatively away from the sensor 2. The first surface is provided with a groove 31 that opens in a direction close to the sensor 2, and the groove 31 is sealed and connected to the sensor body 21. Optionally, a third sealing member 6 is provided between the groove 31 and the sensor body 21. By providing the third sealing member 6, the sealing effect of the sealing cavity 32 can be improved, and the sealing performance of the sealing cavity 32 can be ensured. The third sealing member 6 can be integrally formed in the sealing cavity 32 or the sensor body 21, that is, the third sealing member 6 can be configured as a part of the sealing cavity 32, or as a part of the housing 211 of the sensor body 21. The third sealing member 6 can also be an O-ring, silicone, UV light curing glue, etc.
[0074] Furthermore, the sealing cover 3 is provided with a second accommodating cavity 33, which allows the shielding member 200 to be moved in and out. In some embodiments, the first side plate 35 is connected to the sealing cover plate 34. The sealing cover plate 34, the outer wall of the sealing cavity 32, and the first side plate 35 enclose the second accommodating cavity 33. Specifically, the second surface of the sealing cover plate 34, the outer wall of the sealing cavity 32, and the inner wall of the first side plate 35 enclose the second accommodating cavity 33. The shape of the second accommodating cavity 33 can be roughly cylindrical, cylindrical, or other shapes, as long as it is compatible with the shape of the shielding member 200, and this application is not limited thereto.
[0075] The monitoring device 100 also includes a limiting structure. In some embodiments, the sealing cover 3 also includes a second side plate 36, which is spaced apart around the first side plate 35 and connected to the first side plate 35. The outer wall of the first side plate 35 and / or the inner wall of the second side plate 36 are provided with a connector 37, and the side wall of the main housing 1 is provided with a mating piece 12, and the connector 37 is matingly connected to the mating piece 12. By providing the connector 37 on the outer wall of the first side plate 35 and / or the inner wall of the second side plate 36, providing the side wall of the main housing 1 with a mating piece 12, and matingly connecting the connector 37 with the mating piece 12, relative rotational movement of the sealing cover 3 relative to the main housing 1 when connected to the main housing 1 is avoided, making the connection between the sealing cover 3 and the main housing 1 more stable.
[0076] In some embodiments, the connecting member 37 is configured as a guide member recessed into the outer wall of the first side panel 35 and / or the inner wall of the second side panel 36, and the mating member 12 is configured as a stopper recessed into the side wall of the main housing 1. Alternatively, in some embodiments, the guide member may be a guide groove, and the corresponding stopper may be a guide rib. The engagement between the guide member and the stopper serves as a guide to guide the installation of the sealing cover 3 onto the main housing 1, thereby precisely positioning the sealing cover 3.
[0077] In some embodiments, at least two guide members are arranged at intervals along the circumference of the outer wall of the first side plate 35 and / or the inner wall of the second side plate 36, and correspondingly, at least two stop members are arranged at intervals along the side wall of the main housing 1. Optionally, the number of guide members and stop members can be 2, 4, 6, or other numbers respectively.
[0078] Correspondingly, in some embodiments, at least two guide posts 12 are provided at intervals on the side wall of the main shell 1, and the at least two guide posts 12 are respectively correspondingly engaged with at least two guide grooves 37. With such an arrangement, when the sealing cover 3 is mated with the main shell 1, the at least two guide grooves 37 provided on the outer wall of the first side plate 35 and / or the inner wall of the second side plate 36 can be correspondingly engaged and fixed with the at least two guide posts 12 on the side wall of the main shell 1. In some embodiments, each guide groove extends along the axial direction of the sealing cover 3. With such an arrangement, the relative rotational movement between the sealing cover 3 and the main shell 1 can be limited, so that the sealing cover 3 can only be translated up and down along the axial direction of the main shell 1, ensuring that the steel needle 232 and the probe 22 are always in the axial direction of the sealing cavity 32.
[0079] As shown in FIG11 and FIG4 , in some embodiments, the monitoring device 100 further includes a fastening ring 4 , and one end of the sealing cover 3 away from the sensor 2 abuts against the fastening ring 4 , and the fastening ring 4 is connected to the main housing 1 to limit the sealing cover 3 .
[0080] In some embodiments, the fastening ring 4 is provided with internal threads 41, and the sidewall of the main housing 1 is also provided with external threads 14. The fastening ring 4 and the main housing 1 are threadedly connected, thereby restricting axial movement of the fastening ring 4 relative to the main housing. Specifically, the end of the sealing cover 3 away from the sensor 2 abuts against the fastening ring 4, and the fastening ring 4 is threadedly connected to the external threads 14 on the sidewall of the main housing via the internal threads 41. The provision of the fastening ring 4 presses and secures the sealing cover 3, further restricting axial movement of the sealing cover 3 relative to the main housing 1.
[0081] In order to avoid interference with at least two fittings 12 on the side wall of the main housing 1 and ensure that the fastening ring 4 is pressed and fixed to the sealing cover 3, the fittings 12 on the side wall of the main housing 1 and the external threads 14 are arranged at intervals along the axial direction of the main housing 1.
[0082] Of course, in other embodiments, in addition to the threaded fit between the fastening ring 4 and the main shell 1, the fastening ring 4 and the main shell 1 can also be connected by snap fit, interference fit, etc., and the fitting movement between the two can be circumferential rotation or axial fastening, which is not limited in this application.
[0083] In some embodiments, the fastening ring 4 is further provided with a limiting portion 42, which is used to cooperate with the sealing cover 3. Since the limiting portion 42 is cooperated with the sealing cover 3, the limiting portion 42 can further limit the axial movement of the sealing cover 3 relative to the fastening ring 4 along the main shell 1.
[0084] In some embodiments, a driving member 13 is further provided in the main shell 1, and the driving member 13 is fixed to the first accommodating cavity 11. The sensor 2 is connected to the driving member 13, and the driving member 13 can push the sensor 2 to the outside of the main shell 1 through the cavity opening 110 of the first accommodating cavity 11.
[0085] In some embodiments, the driving member 13 is a ejection mechanism and may include an elastic member. In an initial state, the elastic member is energized. In a use state, the elastic member undergoes elastic deformation and drives the sensor 2 to move. In other embodiments, the driving member 13 is not limited to this, as long as it can drive the sensor 2 to move relative to the main housing 1. This application does not elaborate on this.
[0086] Optionally, the monitoring device 100 further includes a trigger member disposed on the main housing 1, the trigger member being connected to the driver 13 and configured to trigger the driver 13. When the trigger member is triggered by an external force, the driver 13 drives the sensor 2 to move from the proximal end to the distal end relative to the main housing 1 until the sensor 2 is attached to the skin surface, and the probe 22 is then implanted into the subcutaneous tissue of the body surface.
[0087] As shown in FIG6 , in some embodiments, a second seal 5 is provided between the handle 231 and the sensor body 21; in some embodiments, a third seal 6 is provided between the groove 31 and the sensor body 21. The second seal 5 and the third seal 6 may be O-rings, silicone, UV curable adhesive, or the like.
[0088] Referring to FIG12 , the present application further provides an electron beam irradiation sterilization device 500 , comprising: a shielding member 200 and the aforementioned monitoring device 100 . In particular:
[0089] The shielding member 200 is adapted to the shape of the second accommodating cavity 33 . The shielding member 200 can be moved into the second accommodating cavity 33 during the electron beam 600 irradiation sterilization to shield the sensor body 21 and expose the probe 22 to the electron beam 600 .
[0090] In this embodiment, shielding member 200 is not part of monitoring device 100. Shielding member 200 can be moved into second accommodating cavity 33 of sealing cover 3 and fitted onto the outer wall of sealed cavity 32. Shielding member 200 shields sensor body 21, forming a shielded area to protect it from damage from electron beam 600. Simultaneously, probe 22 is exposed to electron beam 600, forming an unshielded area. Electron beam 600 passes vertically through passage 201 of shielding member 200 and sealed cavity 32, sterilizing probe 22. After electron beam 600 sterilization is complete, shielding member 200 is removed, labeled, and packaged for sale.
[0091] The various technical features of the above-described embodiments can be combined arbitrarily. To make the description concise, not all possible combinations of the various technical features in the above-described embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.
[0092] Those skilled in the art should recognize that the above embodiments are merely intended to illustrate the present application and are not intended to limit the present application. As long as they are within the spirit of the present application, appropriate changes and modifications to the above embodiments are within the scope of protection claimed in the present application.
Claims
1. A monitoring device, characterized in that: include: A main housing (1), the main housing (1) having a first accommodating cavity (11); A sensor (2) is disposed in the first accommodating cavity (11), comprising a sensor body (21) and a probe (22) connected to the sensor body (21); the sensor (2) is movable relative to the main housing (1); A sealing cover (3) comprises a cover body (30) and a groove (31) provided on the cover body (30) and opening in a direction close to the sensor element (2); the cover body (30) is connected to the main shell (1) and abuts against the sensor body (21); the groove (31) surrounds the sensor element (2) to form a sealed cavity (32) for accommodating the probe (22); the sealing cover (3) is used to form a radiation shield for the sensor body (21) and expose the probe (22) to electron irradiation.
2. The monitoring device according to claim 1, characterized in that: The cover (30) is made of shielding material, and the groove (31) is made of non-shielding material.
3. The monitoring device according to claim 1, characterized in that: The sealing cover (3) is provided with a second accommodating cavity (33), and when the shielding element (200) moves into the second accommodating cavity (33), it can be detachably connected to the outer wall of the sealing cavity (32) and shield the sensor body (21).
4. The monitoring device according to claims 1-3, characterized in that: The sealing cavity (32) is cylindrical.
5. The monitoring device according to claims 1-4, characterized in that: The sealing chamber (32) is arranged concentrically or eccentrically relative to the axis of the main housing (1).
6. The monitoring device according to any one of claims 1 to 5, characterized in that: The sealing cover (3) further comprises: a sealing cover plate (34) and a first side plate (35); The first side plate (35) is connected to the sealing cover plate (34), and the sealing cover plate (34), the outer wall of the sealing cavity (32) and the first side plate (35) are arranged to form the second accommodating cavity (33).
7. The monitoring device according to claim 6, characterized in that: The sealing cover (3) further comprises a second side plate (36), The second side plate (36) is arranged at intervals around the first side plate (35) and is connected to the first side plate (35).
8. The monitoring device according to claim 7, characterized in that: The outer wall of the first side plate (35) and / or the inner wall of the second side plate (36) are provided with a connecting piece (37), the side wall of the main shell (1) is provided with a matching piece (12), and the connecting piece (37) is matched and connected with the matching piece (12).
9. The monitoring device according to claim 8, characterized in that: The connecting member (37) is a guide member, and at least two of the guide members are arranged at intervals along the outer wall of the first side plate (35) and / or the inner wall of the second side plate (36); The matching piece (12) is a stopper, and at least two of the stoppers are arranged at intervals along the side wall of the main housing (1); The guide member is cooperatively connected with the stop member.
10. The monitoring device according to any one of claims 1 to 9, characterized in that: The monitoring device further comprises a fastening ring (4), against which one end of the sealing cover (3) away from the sensor (2) abuts, and the fastening ring (4) is connected to the main housing (1) to limit the position of the sealing cover (3).
11. The monitoring device according to any one of claims 1 to 10, characterized in that: A driving member (13) is also provided in the main housing (1), the driving member (13) is fixed to the first accommodating cavity (11), the sensing member (2) is connected to the driving member (13), and the driving member (13) is capable of pushing the sensing member (2) to the outside of the main housing (1) via the first accommodating cavity (11).
12. The monitoring device according to any one of claims 1 to 11, characterized in that: The sensor body (21) comprises: a housing (211) and an electronic component (212) built into the housing (211); the probe (22) is connected to the electronic component (212) and extends out of the housing (211); and a first sealing member (213) is provided at the connection between the housing (211) and the probe (22).
13. The monitoring device according to any one of claims 1 to 12, characterized in that: The sensor (2) further comprises a steel needle assembly (23), wherein the steel needle assembly (23) comprises: a handle (231) and a steel needle (232) connected to the handle (231); The handle (231) is arranged at one end of the sensor body (21); The steel needle (232) is sleeved on the probe (22), and one end of the steel needle (232) away from the handle (231) penetrates the sensor body (21) and extends to the other end of the sensor body (21).
14. The monitoring device according to claim 13, characterized in that: A second sealing member (5) is provided between the handle (231) and the sensor body (21); and / or A third sealing member (6) is provided between the groove (31) and the sensor body (21).
15. An electron beam irradiation sterilization device, characterized in that: include: A shielding element (200) and a monitoring device (100) according to any one of claims 1 to 14, wherein: The shielding member (200) is adapted to the shape of the second accommodating cavity (33), and the shielding member (200) can be moved into the second accommodating cavity (33) during electron beam irradiation sterilization to shield the sensor body (21) and expose the probe (22) to the electron beam.
Citation Information
Patent Citations
Focused sterilization and sterilized sub-assemblies for analyte monitoring systems
CN112423664A
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CN114305405A
In-vivo blood glucose monitoring device and continuous blood glucose monitor assembly
CN115844396A
Glucose monitoring device and method for sterilizing glucose monitoring device
CN116602666A
Analyte sensor applicator
WO2023163957A1