Method of sterilizing a medical device kit
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- SHENZHEN SISENSING TECH CO LTD
- Filing Date
- 2022-07-05
- Publication Date
- 2026-05-29
AI Technical Summary
In the existing technology, the sterilization methods of medical device kits are complicated and inconvenient for users. Electron beam sterilization can damage the function of electronic devices, while ethylene oxide sterilization can affect the activity of chemical substances in sensors. Existing shielding structures are complicated and require additional assembly.
The method involves sealing the sensing part of the analyte sensor within a containment chamber, sterilizing it using electron beam irradiation, sterilizing the electronic device in a chemical gas atmosphere, and assembling it through a sealed casing. This avoids interference from the electron beam with the electronic device and simplifies the sterilization process.
It enables a simple sterilization process, ensuring that the functions of sensors and electronic devices are not damaged. Users do not need to assemble it separately, which improves the safety and convenience of use.
Smart Images
Figure CN117379573B_ABST
Abstract
Description
Technical Field
[0001] This disclosure generally relates to the biomedical engineering industry, and more specifically to a method for sterilizing a medical device kit. Background Technology
[0002] For clinical diagnosis or personal health monitoring, it is often necessary to use analyte sensors to monitor various analytes in the human body. For example, for diabetic patients, it is essential to monitor the glucose concentration of tissue fluid in real time and continuously so as to regulate the glucose concentration in a timely manner through methods such as adjusting diet or administering medication, thereby reducing the possibility of complications caused by abnormal glucose concentrations.
[0003] Currently, users typically monitor glucose concentration in tissue fluid using glucose sensors that can be inserted under the skin and react with glucose in tissue fluid, and electronic devices that are applied to the skin and connected to the glucose sensors. To insert the glucose sensor under the skin and apply the electronic device to the skin, an insertion device is usually required. Specifically, the insertion device includes a needle that can pierce the skin to insert the glucose sensor under the skin, and then the needle is separated from the glucose sensor and removed from the skin.
[0004] For user health and safety reasons, glucose sensors and needles implanted in the human body or positioned under the skin must be sterile during insertion. Therefore, sterilization is typically required to effectively eliminate or kill transmissible agents (such as bacteria, fungi, and viruses). Common sterilization methods, such as electron beam sterilization, can be used for final sterilization of sensors; however, electron beam sterilization can damage electronic devices, affecting their normal function. Another common sterilization method is ethylene oxide sterilization, which sterilizes electronic components via gaseous chemical sterilization; however, ethylene oxide can affect the activity of chemicals in the sensor. In the prior art, Chinese patent publication CN112423664A, entitled "Focused Sterilization and Sterilized Sub-components for an Analytical Monitoring System," discloses a sterilization method. This patent employs a mutual shielding method to protect the two components and achieve sterilization. When sterilizing the electronic components, a liquid-sealed method is used to protect the sensor from chemical gases. For the sensor, a shielding material is used on the outer casing of the electronic device to prevent the electron beam from affecting it. However, this sterilization method requires an additional shielding structure, making it relatively complex. Existing technologies typically sterilize the sensor and electronic device separately and then package them individually. However, this method requires additional assembly for user use, causing inconvenience. Summary of the Invention
[0005] This disclosure was made in view of the above-mentioned state of the prior art, and its purpose is to provide a sterilization method for a medical device kit. According to the sterilization method of this disclosure, the sterilization operation is simple and convenient for subsequent use by the user.
[0006] Therefore, this disclosure provides a sterilization method for a medical device kit, the medical device kit including an analyte sensor, an electronic device, a lower housing having a receiving chamber, and an upper housing sealed to the lower housing. The analyte sensor has a sensing portion capable of reacting with an analyte to generate a sensing signal, and a connection portion electrically connected to the sensing portion. The electronic device is configured to be coupled to the connection portion and receive the sensing signal generated by the sensing portion. The sterilization method includes placing the sensing portion of the analyte sensor in the receiving chamber of the lower housing, sealing the receiving chamber in such a way that the sensing portion is sealed, irradiating the lower housing with an electron beam, coupling the electronic device to the connection portion, and sealing the upper housing and the lower housing.
[0007] In this disclosure, the sensing part of the analyte sensor is placed in a sealed containment chamber. The sensing part within the containment chamber is sterilized using electron beam irradiation before the electronic device and sensor are assembled. Finally, the upper and lower housings are assembled. In this configuration, the sensing part of the sensor can be sterilized using an electron beam, while the electronic device remains unaffected by the electron beam. Furthermore, the upper housing, electronic device, analyte sensor, and lower housing are assembled, eliminating the need for additional assembly by the user and facilitating subsequent use.
[0008] Furthermore, in the sterilization method disclosed herein, optionally, the electron beam irradiation dose is greater than or equal to 15 kGy and less than or equal to 50 kGy. Thus, using an appropriate electron beam irradiation dose to sterilize the target device can effectively kill bacteria and other microorganisms in the target device without causing adverse effects on the materials of the medical device kit.
[0009] Additionally, in the sterilization method disclosed herein, optionally, the medical device kit further includes a puncture member comprising a main body and a sharp object disposed on the main body and having a receiving groove for accommodating the sensing portion, the sharp object being sealed within the receiving chamber. In this case, the sharp object of the puncture member can be encapsulated together with the sensing portion of the sensor within the receiving chamber, thereby enabling simultaneous sterilization of the sharp object and the sensing portion using an electron beam, and ensuring that the sterilization process is unaffected by microorganisms in the external environment of the receiving chamber.
[0010] Alternatively, in the sterilization method disclosed herein, the puncture member may be covered by the upper housing, projected radially along the instrument kit. In this case, the puncture member is not exposed, thereby minimizing the risk of accidental injury to the user from the puncture member.
[0011] Additionally, in the sterilization method disclosed herein, optionally, after coupling the electronic device to the connection portion, the method further includes placing the electronic device in a chemical gas atmosphere. This allows the electronic device to be sterilized using chemical gases.
[0012] Furthermore, in the sterilization method disclosed herein, the chemical gas may optionally be ethylene oxide. Therefore, ethylene oxide can be used to sterilize electronic devices.
[0013] Additionally, in the sterilization method disclosed herein, molten wax may optionally be used to seal the receiving chamber. This allows the receiving chamber to be sealed using a wax seal, and when the analyte sensor is needed, the wax seal can be broken by mechanical force (pulling out the analyte sensor), minimizing damage to the analyte sensor.
[0014] Furthermore, in the sterilization method disclosed herein, optionally, the electronic device is not within the irradiation range of the electron beam. This prevents the electron beam from affecting the electronic device.
[0015] Additionally, in the sterilization method disclosed herein, the lower housing may optionally include a desiccant disposed within the receiving chamber. This allows the environment within the receiving chamber to be kept dry by the desiccant, thereby protecting the sensing components and / or sharp objects sealed within the receiving chamber from moisture in the environment.
[0016] Furthermore, in the sterilization method disclosed herein, optionally, the outer contour of the upper box body matches the inner contour of the lower box body, and the outer edge of the upper box body includes a rubber ring. This allows the upper and lower box bodies to be assembled, and the rubber ring increases the sealing performance after assembly.
[0017] According to this disclosure, a sterilization method for a medical device kit can be provided. The sterilization method of this disclosure is simple to operate and facilitates subsequent use by the user. Attached Figure Description
[0018] Figure 1 This is an illustration showing the application of the medical device kit involved in this disclosure.
[0019] Figure 2A This is a schematic diagram illustrating the analyte sensor and electronic device involved in this disclosure.
[0020] Figure 2B This is a schematic diagram showing the assembled structure of the analyte sensor, electronic device and puncture component involved in this disclosure.
[0021] Figure 2C This is an exploded view showing the analyte sensor, electronic device, and puncture component involved in this disclosure.
[0022] Figure 2D This is a bottom view of the platform involved in this disclosure.
[0023] Figure 2E This is a schematic diagram showing the structure of the analyte sensor involved in this disclosure.
[0024] Figure 2F This is a schematic diagram showing the structure of the sharp object involved in this disclosure.
[0025] Figure 3 This is an overall flowchart illustrating the sterilization method for the medical device kits involved in this disclosure.
[0026] Figure 4 This is a schematic diagram showing the upper and lower boxes before and after assembly, as described in this disclosure.
[0027] Figure 5A This is a rear view of the lower housing as described in this disclosure.
[0028] Figure 5B This illustrates the scope of this disclosure. Figure 5A A cross-sectional view of the lower box along the BB' direction.
[0029] Figure 5C This illustrates the scope of this disclosure. Figure 5B A magnified view of a portion of the image.
[0030] Figure 6A This is a schematic diagram showing the picked-up upper box as described in this disclosure.
[0031] Figure 6B This is a cross-sectional view showing the picked-up upper box body as described in this disclosure.
[0032] Figure 7 This is a flowchart illustrating a sterilization method for the medical device kit involved in this disclosure.
[0033] Explanation of reference numerals in the attached figures:
[0034] Medical device kits…1000.
[0035] Upper box body…100, storage section…110, moving body…120, clamping section…121, first drive mechanism…131, second drive mechanism…132, pressing section…140,
[0036] Lower box body…200, receiving chamber…210, sealing element…220, platform…230, hollow part…231,
[0037] Electronic device…300, receiver…310, through hole…320,
[0038] Analyte sensor…400, sensing part…410, connection part…420,
[0039] Working electrode…411, reference electrode…412, counter electrode…413,
[0040] First contact…421, second contact…422, third contact…423
[0041] Piercing component…500, main body…510, sharp object…520 Detailed Implementation
[0042] The present disclosure will now be described in further detail with reference to the accompanying drawings and specific embodiments. In the drawings, the same components or components having the same function are denoted by the same symbols, and repeated descriptions of them are omitted.
[0043] This disclosure relates to a sterilization method for a medical device kit. The sterilization method for the medical device kit according to specific embodiments of this disclosure will be described in detail below with reference to the accompanying drawings.
[0044] Figure 1 This is an illustration showing the application of the medical device kit 1000 involved in this disclosure.
[0045] like Figure 1 As shown, in some examples, the medical device kit 1000 may include an analytical sensor 400 that can acquire physiological information of the host, an upper housing 100 that can apply the analytical sensor 400 to the host, an electronic device 300 that can receive the physiological information acquired by the analytical sensor 400, and a lower housing 200 that can house the analytical sensor 400.
[0046] In some examples, the analyte sensor 400 can generate information about specific analytes in the body fluid based on the body fluid itself, such as by reacting with analytes in the body fluid and generating analyte information. In this case, by having the sensor react with the analytes in the body fluid, it is convenient to obtain information about the analytes in the body fluid.
[0047] In some examples, the analyte sensor 400 and the electronic device 300 can be applied to the host together. Thus, the analyte sensor 400 can acquire physiological information from the host and transmit that information to the electronic device 300.
[0048] although Figure 1 The wearing positions of the analyte sensor 400 and electronic device 300 are shown, but this embodiment is not limited to this. For example, the analyte sensor 400 and electronic device 300 can also be worn on the abdomen, waist, legs, etc.
[0049] In addition, this disclosure also provides a monitoring system, which may include an analyte sensor 400 capable of acquiring physiological information of the host, an electronic device 300 capable of receiving the physiological information acquired by the analyte sensor 400, and a reading device 900 communicatively connected to the electronic device 300 (see [link to relevant documentation]). Figure 1 The analyte sensor 400 applied to the host can transmit the acquired physiological information to the reading device 900 via, for example, wirelessly through the electronic device 300, thereby enabling the host to read and monitor its own physiological information.
[0050] In this embodiment, the analyte targeted by the analyte sensor 400 device may be one or more of the following: glucose, uric acid, myocardial enzyme, lactic acid, dopamine, acetylcholine, amylase, bilirubin, cholesterol, human chorionic gonadotropin, creatine kinase, creatine, creatine anhydride, DNA, fructosamine, glutamine, growth hormone, hormone, ketone bodies, lactate, oxygen, peroxide, prostate-specific antigen, prothrombin, RNA, thyroid-stimulating hormone, or troponin.
[0051] The following description of the medical device kit 1000 in this embodiment example will primarily use glucose as the analyte. It should be noted that, for other analytes, those skilled in the art can perform analysis by making slight modifications to the analyte sensor 400 used for glucose.
[0052] (Electronic device 300 and analyte sensor 400)
[0053] Figure 2A This is a schematic diagram showing the analyte sensor 400 and electronic device 300 involved in this disclosure. Figure 2B This is a schematic diagram showing the assembled structure of the analyte sensor 400, electronic device 300 and puncture component 500 involved in this disclosure. Figure 2C This is an exploded view showing the analyte sensor 400, electronic device 300 and puncture member 500 involved in this disclosure. Figure 2D This is a bottom view showing the stage 230 involved in this disclosure. Figure 2E This is a schematic diagram showing the structure of the analyte sensor 400 involved in this disclosure. Figure 2F This is a schematic diagram showing the structure of the sharp object 520 involved in this disclosure.
[0054] As described above, in this embodiment, the medical device kit 1000 may include an electronic device 300 and an analyte sensor 400 (see above). Figure 2A ).
[0055] In some examples, reference Figure 1 and Figure 2A The electronic device 300 and the analyte sensor 400 can ultimately be applied together to the host. The analyte sensor 400 can be partially implanted into the host, and the electronic device 300 can be connected to the analyte sensor 400 and applied to the surface of the host's body.
[0056] In some examples, the analyte sensor 400 can acquire physiological information of the host. The electronic device 300 can receive the physiological information of the analyte generated by the analyte sensor 400. In some examples, the electronic device 300 can further process the physiological information of the analyte. In some examples, the electronic device 300 can transmit the physiological information of the analyte, or the processed physiological information of the analyte, to other devices.
[0057] In some examples, the surface of the electronic device 300 adjacent to and connected to the analyte sensor 400 can be an adhesive surface. This allows the electronic device 300 to adhere to the skin surface via adhesion.
[0058] Typically, for the health and safety of the host, the implanted portion of the analyte sensor 400 needs to be sterilized. Common sterilization methods include electron beam sterilization and ethylene oxide sterilization. However, the analyte sensor 400 usually contains chemical substances (such as enzymes), and ethylene oxide can affect the activity of these chemicals; while electron beam sterilization can impair the function of the electronic device 300. Therefore, the analyte sensor 400 and the electronic device 300 cannot be sterilized simultaneously.
[0059] (Analyte Sensor 400)
[0060] In some examples, reference Figure 2E The analyte sensor 400 may include a sensing portion 410 and a connection portion 420. In some examples, the sensing portion 410 of the analyte sensor 400 may be implanted on, for example, the surface of a human body and come into contact with tissue fluid within the body. In some examples, the connection portion 420 may be connected to an electronic device 300 located on the body surface. When the analyte sensor 400 is in operation, the sensing portion 410 may react with the tissue fluid within the body to generate a sensing signal (e.g., an electrical signal), and transmit the sensing signal to the electronic device 300 on the body surface via the connection portion 420. The electronic device 300 processes the sensing signal to obtain the concentration of the analyte.
[0061] In this embodiment, although the analyte sensor 400 directly detects the analytes in the tissue fluid, the concentration of the analytes in the tissue fluid and the concentration of the analytes in the blood are often strongly correlated. The concentration of the analytes in the blood can also be determined by detecting the analytes in the tissue fluid.
[0062] In some examples, the length of the sensing portion 410 can be determined based on the depth of subcutaneous implantation, which in turn can be determined based on the desired insertion location. In some examples, the width of the sensing portion 410 can be limited to approximately 0.5 mm or less. Generally, the narrower the sensing portion 410, the less pain the host will experience during implantation and use.
[0063] In some examples, the sensing portion 410 may include a working electrode 411, a reference electrode 412, and a counter electrode 413, and the connection portion 420 may include a first contact 421 connected to the working electrode 411 via a lead, a second contact 422 connected to the reference electrode 412 via a lead, and a third contact 423 connected to the counter electrode 413 via a lead.
[0064] In some examples, the working electrode 411 may have sensing reagents, which may include enzymes and redox mediators. Taking glucose as an analyte, the enzyme may be glucose oxidase or glucose dehydrogenase. Redox mediators (ROMs) can accelerate the transfer of electrons between electron donors and acceptors through their own cyclic conversion between oxidized and reduced states. Thus, glucose in human body fluids can undergo redox reactions under the catalysis of enzymes, resulting in electron transfer and converting the glucose concentration signal in tissues into an electrical signal.
[0065] In some examples, the reference electrode 412 can form a known and fixed potential difference with the tissue fluid or blood. In this case, the potential difference between the working electrode 411 and the tissue fluid or blood can be measured by the potential difference formed between the reference electrode 412 and the working electrode 411, thereby accurately determining the voltage generated by the working electrode 411. As a result, the electronic device 300 can automatically adjust and maintain the voltage at the working electrode 411 according to a preset voltage value, so that the measured current signal can more accurately reflect the glucose concentration value.
[0066] In some examples, the counter electrode 413 can form a circuit with the working electrode 411 to generate a current signal.
[0067] In addition, in this embodiment, the working electrode 411, reference electrode 412 and counter electrode 413 of the sensing part 410 are arranged in a dispersed manner, but the embodiments of this disclosure are not limited to this, and may also include a side-by-side (parallel) arrangement.
[0068] In some examples, the current signal generated by the sensing portion 410 can be transmitted via wires to contacts (e.g., first contact 421, second contact 422, and third contact 423) of the connection portion 420. In some examples, the contacts (e.g., first contact 421, second contact 422, and third contact 423) can be connected to the electronic device 300, thereby allowing the physiological signal obtained by the sensing portion 410 to be transmitted via the connection portion 420 to the electronic device 300 for analysis. The electronic device 300 then analyzes and determines the concentration of the analyte.
[0069] It should be noted that, Figure 2E The shape of the analyte sensor 400 is only schematically shown. This embodiment is not limited to this, and the analyte sensor 400 may also be other shapes.
[0070] (Piercing component 500)
[0071] In this embodiment, in some examples, the medical device kit 1000 may include a puncture member 500 (see...). Figure 2F ).
[0072] In some examples, the puncture member 500 may be configured to implant a portion of the analyte sensor 400 into the host. In some examples, the puncture member 500 may implant the sensing portion 410 of the analyte sensor 400 into the host. In some examples, the puncture member 500 implants the sensing portion 410 into the host while simultaneously puncturing the user. In some examples, for the health and safety of the host, the portion of the puncture member 500 that will be inserted into the user is also sterilized.
[0073] In some examples, the puncture member 500 may include a body portion 510 and a sharp object 520. In some examples, the sharp object 520 may be disposed on the body portion 510. In some examples, the sharp object 520 may be sterilized.
[0074] See in some examples Figure 2F The sharp object 520 may have a receiving groove. In some examples, the receiving groove of the sharp object 520 may accommodate the sensing portion 410.
[0075] In some examples, the sharp object 520 may be made of stainless steel. This reduces the risk of using the sharp object 520, and the stainless steel material provides sufficient hardness for skin penetration, making it suitable for use on the object being tested. Alternatively, in some examples, the sharp object 520 may also be made of plastic, glass, or metal. This allows for control over the manufacturing cost of the sharp object 520.
[0076] (Assembly of electronic device 300, analyte sensor 400, and puncture component 500)
[0077] like Figure 2B , Figure 2C and Figure 2D As shown, the medical device kit 1000 may include a stage 230.
[0078] In some examples, stage 230 can be used to mount the analyte sensor 400. In some examples, stage 230 can be used to mount the connecting portion 420. In some examples, the top view profile of stage 230 and the top view profile of connecting portion 420 may be substantially the same, thereby facilitating the mounting of connecting portion 420.
[0079] In some examples, the stage 230 may have a hollow portion 231, and in some examples, the sensing portion 410 may pass through the hollow portion 231. In some examples, when the connecting portion 420 is placed on the stage 230, the sensing portion 410 passes through the hollow portion 231, and the connecting portion 420 and the sensing portion 410 are perpendicular to each other.
[0080] In some examples, the sharp part 520 of the piercing member 500 can penetrate into the hollow part 231, and the sensing part 410 is accommodated in the receiving groove of the sharp part 520.
[0081] In some examples, the electronic device 300 may include a receiving portion 310. In some examples, the receiving portion 310 may be formed to match the shape of the mounting stage 230, and the mounting stage 230 may be embedded in the receiving portion 310. In some examples, when the mounting stage 230, on which the connecting portion 420 is mounted, is embedded in the receiving portion 310, the electronic device 300 and the connecting portion 420 may be coupled.
[0082] In some examples, the electronic device 300 may include a through-hole 320. In some examples, the connecting portion 420 may be placed on the stage 230 and the sensing portion 410 may extend through the hollow portion 231, allowing the sharp part 520 of the piercing member 500 to penetrate the hollow portion 231. When the receiving portion 310 of the electronic device 300 and the stage 230 are fitted (assembled), the main body portion 510 of the piercing member 500 may pass through the through-hole 320 of the electronic device 300. Thus, the sequential assembly of the analyte sensor 400, the piercing member 500, and the electronic device 300 can be realized.
[0083] In some examples, after the sensing portion 410 and the sharp object 520 protrude from the hollow portion 231, the sensing portion 410 and the sharp object 520 are located within the receiving chamber 210 (described in detail later).
[0084] Figure 3 This is an overall flowchart illustrating the sterilization method of the medical device kit 1000 involved in this disclosure.
[0085] In some examples, the sterilization method of the medical device kit 1000 may include: electron beam sterilization of the analyte sensor 400 (step S10), chemical sterilization of the electronic device 300 (step S20), and assembly of the analyte sensor 400 and the electronic device 300 (step S30). In this case, by using different sterilization methods to sterilize the analyte sensor 400 and the electronic device 300 separately, the safety of host use can be improved, and the electron beam sterilization does not affect the function of the electronic device 300, nor does the chemical sterilization affect the function of the analyte sensor 400. The assembled sterilized analyte sensor 400 and electronic device 300 can be easily applied to the host.
[0086] In some examples, the sterilization method of the medical device kit 1000 may also include electron beam sterilization or chemical sterilization of the puncture component 500.
[0087] In some examples, the analyte sensor 400, the puncture component 500, and the electronic device 300 may also be assembled in step S30.
[0088] (Assembly of upper box 100 and lower box 200)
[0089] Figure 4 This is a schematic diagram showing the upper box 100 and lower box 200 as disclosed herein before and after assembly. Figure 5A This is a rear view of the lower housing 200 as described in this disclosure.
[0090] Figure 5B This illustrates the scope of this disclosure. Figure 5A A cross-sectional view of the lower box body 200 along the BB' direction.
[0091] Figure 5C This illustrates the scope of this disclosure. Figure 5B A magnified view of a portion of the image.
[0092] As described above, in this embodiment, the medical device kit 1000 may include an upper box 100 and a lower box 200.
[0093] In some examples, the upper housing 100 can be sealed together with the lower housing 200. This allows the interiors of both the lower housing 200 and the upper housing 100 to be sealed, reducing the impact of the external environment on the internal components of the medical device kit 1000.
[0094] In some examples, such as Figure 4As shown, the upper box 100 can be a cylindrical structure with one open end, and the lower box 200 can also be a cylindrical structure with one open end. In some examples, the outer contour of the opening of the upper box 100 can match the inner contour of the opening of the lower box 200. In this case, the upper box 100 can be nested into the lower box 200 by moving the opening of the upper box 100 toward the opening of the lower box 200, thereby achieving a sealed assembly of the upper box 100 and the lower box 200. Of course, in some examples, the inner contour of the opening of the upper box 100 can also match the outer contour of the opening of the lower box 200, and a sealed assembly of the two can be achieved by nesting the lower box 200 into the upper box 100. In other examples, nesting may not be used, for example, a spiral connection can be used to achieve a sealed assembly of the upper box 100 and the lower box 200.
[0095] In some examples, the outer edge of the opening of the upper box 100 may have a rubber ring. This improves the airtightness of the upper box 100 and the lower box 200 after assembly.
[0096] refer to Figure 5A , Figure 5B and Figure 5C In some examples, the lower housing 200 may have a receiving chamber 210.
[0097] In some examples, the analyte sensor 400 may be wholly or partially housed within the lower housing 200. In some examples, the sensing portion 410 of the analyte sensor 400 may be placed within a sealed housing chamber 210. In this case, the sensing portion 410 can be isolated from the external gas, thereby reducing contamination of the sensing portion 410 by bacteria or other substances in the external gaseous environment.
[0098] In other examples, the puncture member 500 may be wholly or partially housed within the lower housing 200. In some examples, the sharp part 520 of the puncture member 500 may be placed within the receiving chamber 210, and the receiving chamber 210 is sealed. In this case, the sharp part 520 can be isolated from the external gas, thereby reducing the risk of contamination of the sharp part 520 by bacteria or other substances in the external gas environment.
[0099] In some examples, the sensing portion 410 and / or the sharp object 520 may be placed inside the receiving chamber 210, and the receiving chamber 210 may be sealed by the seal 220.
[0100] In some examples, the seal 220 may be molten wax. This allows for a seal on the receiving chamber 210, and the seal 220 can be subsequently broken by mechanical force. For example, when using the medical device kit 1000, the seal 220 can be broken by pulling out the analyte sensor 400 and / or the sharp object 520, allowing the analyte sensor 400 and / or the sharp object 520 to be removed from the receiving chamber 210.
[0101] In some examples, the analyte sensor 400 can be placed on the stage 230 in sequence, the sensing part 410 and the sharp object 520 can be inserted through the hollow part 231 and placed in the receiving chamber 210, the receiving chamber 210 can be sealed, the electronic device 300 can be assembled with the stage 230, and finally the upper box 100 can be nested into the lower box 200, so that the upper box 100 and the lower box 200 are sealed together. In some examples, after the upper box 100 and the lower box 200 are sealed together, the electronic device 300, the analyte sensor 400 and the puncture member 500 are housed in the upper box 100 (described later). Thus, the medical device kit 1000 according to this embodiment is obtained.
[0102] (Pickup by electronic device 300 and analyte sensor 400)
[0103] Figure 6A This is a schematic diagram showing the picked-up upper box 100 as described in this disclosure. Figure 6B This is a cross-sectional view showing the picked-up upper housing 100 as described in this disclosure. Figure 6A This is a side view of the upper box 100. Figure 6B yes Figure 6A A cross-sectional view along the CC' direction.
[0104] In this embodiment, the upper housing 100 may also be referred to as a sensor application device, needle applicator, needle applicator, etc. In some examples, when the analyte sensor 400 is needed, the upper housing 100 can pick up the analyte sensor 400 and apply it to the host. In some examples, the upper housing 100 is configured to pick up the electronic device 300 and apply it to the surface of the host's body. In some examples, the upper housing 100 is configured to pick up the puncture member 500, insert the puncture member 500 into the subject's skin to allow the analyte sensor 400 to penetrate the skin, and then withdraw (rebound) the puncture member 500.
[0105] In some examples, as described above, the analyte sensor 400 can be placed sequentially on the stage 230 of the lower housing 200, the sensing part 410 and the sharp object 520 can be inserted through the hollow portion 231 and placed in the receiving chamber 210, the receiving chamber 210 can be sealed, the electronic device 300 can be assembled with the stage 230, and finally the upper housing 100 can be nested into the lower housing 200, so that the upper housing 100 and the lower housing 200 are sealed together. In some examples, after the upper housing 100 and the lower housing 200 are sealed together, the upper housing 100 picks up the electronic device 300, the analyte sensor 400 and the puncture member 500, and stores the electronic device 300, the analyte sensor 400 and the puncture member 500 in the storage portion 110 of the upper housing 100 (described in detail later). Thus, the medical device kit 1000 according to this embodiment is obtained. The upper housing 100 after picking up the electronic device 300, the analyte sensor 400, and the puncture component 500 is as follows: Figure 6A and Figure 6B As shown. In some examples, such as Figure 6A As shown, projecting along the radial direction of the medical device kit 1000, the puncture member 500 is covered by the upper housing 100. In this case, the puncture member 500 is not exposed, thereby minimizing the risk of accidental injury to the user from the puncture member 500.
[0106] Specifically, in some examples, such as Figure 6B As shown, the upper box 100 may include a storage part 110, a moving body 120, a first drive mechanism 131, a second drive mechanism 132, and a pressing part 140.
[0107] In some examples, the motion body 120 may be configured to move along a defined movement path. In some examples, the motion body 120 may be releasably held in the upper housing 100, and the motion body 120 may be configured to move along the movement path defined by the upper housing 100 when released.
[0108] In some examples, the first drive mechanism 131 may be configured to act on the moving body 120 in a proximal manner (proximal refers to the end closer to the host), causing the moving body 120 to move along the movement path defined by the upper box 100.
[0109] In some examples, the first drive mechanism 131 can be applied to the moving body 120 by pressing the pressing part 140.
[0110] In some examples, the storage unit 110 can be configured to pick up and store the analyte sensor 400 and the electronic device 300 (the analyte sensor 400 and the electronic device 300 assembled together) after the upper housing 100 and the lower housing 200 are sealed together.
[0111] In some examples, the receiving unit 110 can pick up and receive the analyte sensor 400 and the electronic device 300 without disrupting the seal of the receiving chamber 210. In other words, the sealing of the receiving chamber 210 can be maintained after the upper housing 100 and the lower housing 200 are sealed together. This allows the sensing portion 410 of the analyte sensor 400 to be contained within the sealed receiving chamber 210, reducing contamination of the sensing portion 410 by the environment outside the receiving chamber 210.
[0112] In some examples, when the upper box 100 and the lower box 200 are disassembled, the sealing of the receiving chamber 210 can be disrupted simultaneously.
[0113] In some examples, when using the medical device kit 1000, the user can disassemble the upper housing 100 and the lower housing 200. The upper housing 100 is configured to apply the analyte sensor 400 and electronic device 300, housed in the storage section 110, to the host. In this case, when the user needs to use the medical device kit 1000, they can disassemble the upper housing 100 and the lower housing 200, and then apply the picked-up analyte sensor 400 and electronic device 300 to the host through the upper housing 100. This method is convenient for the user and eliminates the need for self-assembly.
[0114] In some examples, the storage unit 110 may be provided on the moving body 120, and the storage unit 110 may move when the moving body 120 moves. This allows the electronic device 300 and the analyte sensor 400 to move along a defined path.
[0115] In some examples, when the motion body 120 is released, the motion body 120 can be driven proximally by the drive mechanism 130 to push the electronic device 300, the analyte sensor 400, and the puncture member 500, housed within the storage section 110, toward the host. Additionally, the analyte sensor 400 can be at least partially placed subcutaneously in the host via the puncture member 500.
[0116] In some examples, the upper housing 100 may include a clamping portion 121. In some examples, the clamping portion 121 may be configured to clamp the main body portion 510 of the puncture member 500. Additionally, in some examples, the upper housing 100 may also include a second drive mechanism 132, which may be configured to apply force to the clamping portion 121 in a distal manner (the distal end being the end furthest from the host). When the clamping portion 121 holding the puncture member 500 is released, the clamping portion 121 may be driven distally by the second drive mechanism 132 to disengage the puncture member 500 from the host. In this case, the puncture member 500 can be disengaged from the host after puncture (rebound).
[0117] In some examples, when the medical device kit 1000 is to be used, the upper box 100 and the lower box 200 can be disassembled, that is, the upper box 100 can be pulled out of the lower box 200. At this time, the sensing part 410 and the sharp object 520 are pulled out from the receiving chamber 210. The upper box 100 after being pulled out contains the electronic device 300, the analytical sensor 400 and the puncture member 500. Then, by pressing the pressing part 140, the upper box 100 moves the electronic device 300, the analytical sensor 400 and the puncture member 500 toward the host, and the sensing part 410 of the analytical sensor 400 is implanted under the skin of the host. The electronic device 300 is attached to the body surface of the host in a manner coupled with the connection part 420 of the analytical sensor 400, and the puncture member 500 is inserted into the host and then pulled out.
[0118] In some examples, the puncture depth can be pre-configured via the upper housing 100, and the puncture component 500 can be withdrawn after puncture. This allows for rapid and painless puncture using the upper housing 100, reducing the user's pain. Furthermore, puncture via the upper housing 100 facilitates one-handed operation.
[0119] Figure 7 This is a flowchart illustrating the sterilization method of the medical device kit 1000 involved in this disclosure.
[0120] In some examples, such as Figure 7 As shown, the sterilization method of the medical device kit 1000 may include: placing the sensing portion 410 of the analyte sensor 400 into the receiving chamber 210 of the lower housing 200 and sealing the receiving chamber 210 (step S100); irradiating the lower housing 200 with an electron beam (step S200); coupling the electronic device 300 to the connection portion 420 of the analyte sensor 400 and chemically sterilizing the electronic device 300 (step S300); and sealing and assembling the upper housing 100 and the lower housing 200 (step S400).
[0121] In some examples, as described above, the sterilization method for the medical device kit 1000 may include: placing the sensing portion 410 of the analyte sensor 400 within the receiving chamber 210 of the lower housing 200 and sealing the receiving chamber 210 (step S100). In this case, the sensing portion 410 of the analyte sensor 400 can be sealed within the receiving chamber 210 of the lower housing 200, thereby isolating the sensing portion 410 from external gases and preventing contamination of the sensing portion 410 by the external gas environment.
[0122] In some examples, a seal 220 can be used to seal the receiving chamber 210. In some examples, the seal 220 can be molten wax. This allows for a seal on the receiving chamber 210, which can then be broken by mechanical force. For example, when using the medical device kit 1000, removing the analyte sensor 400 will break the seal.
[0123] In some examples, in step S100, the sharp object 520 of the piercing member 500 may be placed inside the receiving chamber 210 of the lower housing 200, and then the receiving chamber 210 may be sealed. In some examples, the entire sharp object 520 may be placed inside the receiving chamber 210. In some examples, only a portion of the sharp object 520 may be placed inside the receiving chamber 210. In these cases, the sharp object 520 can be isolated from the external gas, preventing it from being contaminated by the external gas environment.
[0124] In some examples, in step S100, a desiccant may be placed in the receiving chamber 210 and then the receiving chamber 210 may be sealed. This allows the environment inside the receiving chamber 210 to be kept dry by the desiccant, thus protecting the sensing portion 410 sealed within the receiving chamber 210 from moisture in the environment.
[0125] In some examples, as described above, the sterilization method for the medical device kit 1000 may include irradiating the housing 200 with an electron beam (step S200). In this case, the sensing portion 410 and / or the sharp object 520 sealed within the receiving chamber 210 can be sterilized using an electron beam.
[0126] In some examples, gamma radiation or X-ray radiation may also be used to irradiate the lower housing 200 in step S200.
[0127] In some examples, in step S200, the irradiation dose of the electron beam is greater than or equal to 15 kGy and less than or equal to 50 kGy. This allows for the effective killing of microorganisms sealed within the receiving chamber 210 at the sensing portion 410 and / or the sharp object 520.
[0128] In some examples, as described above, the sterilization method for the medical device kit 1000 may include: coupling the electronic device 300 to the connection portion 420 of the analyte sensor 400, and chemically sterilizing the electronic device 300 (step S300). In this case, by first sterilizing the sensing portion 410 and / or the sharp object 520 with an electron beam, and then coupling the electronic device 300 to the connection portion 420 of the analyte sensor 400, the function of the electronic device 300 can be made unaffected by the electron beam.
[0129] In some examples, during step S300, the electronic device 300 may not be exposed to the electron beam irradiation range. In some examples, the electronic device 300 may be coupled to the connection portion 420 after the electron beam irradiation has ended.
[0130] In some examples, in step S300, the electronic device 300 can be chemically sterilized by placing it in a chemical gas atmosphere. In some examples, the electronic device 300 can be coupled to the connecting portion 420, and both the lower housing 200 and the electronic device 300 can be placed in a chemical gas atmosphere. Thus, the electronic device 300 can be sterilized using chemical gases.
[0131] In some examples, the chemical gas in step S300 can be ethylene oxide. The electronic device 300 can then be chemically sterilized using ethylene oxide. In this case, since the sensing portion 410 and / or the sharp object 520 are sealed within the receiving chamber 210, the chemical gas will not enter the receiving chamber 210, and thus will not damage the components or substances in the sensing portion 410.
[0132] In some examples, as described above, the sterilization method for the medical device kit 1000 may include sealing the upper housing 100 and the lower housing 200 together (step S400).
[0133] In some examples, in step S400, the electronic device 300 can be sealed between the upper housing 100 and the lower housing 200 by the sealed assembly of the upper housing 100 and the lower housing 200, thereby reducing the impact of bacteria in the external gaseous environment on the electronic device 300.
[0134] In some examples, after step S400, the medical device kit 1000 may be sealed in a sealed bag to further ensure the airtightness of the medical device kit 1000.
[0135] The sterilization method of the medical device kit 1000 provided in this embodiment sterilizes the analyte sensor 400 and the electronic device 300 separately. The analyte sensor 400 is sterilized using an electron beam, while the electronic device 300 is sterilized using chemical sterilization. This method protects the electronic device 300 from interference from electron beam sterilization and eliminates the need for structures such as electron beam shielding to protect it, thus simplifying the structure of the medical device kit 1000. This facilitates the sterilization of the analyte sensor 400, the puncture component 500, and the electronic device 300. Furthermore, when using the medical device kit 1000, no additional assembly is required from the user; the analyte sensor 400 and the electronic device 300 can be directly applied to the host through the upper housing 100, making it convenient for the user. The sterilization method of the medical device kit 1000 in this embodiment, by sealing the sensing part 410 of the analyte sensor 400 and the sharp part 520 of the puncture member 500 in the receiving chamber 210, ensures that the sensing part 410 and the sharp part 520 are not contaminated by the external gas environment of the receiving chamber 210 after the analyte sensor 400 and the puncture member 500 are sterilized by electron beam. Furthermore, by connecting the electronic device 300 to the analyte sensor 400 after electron beam sterilization, the function of the electronic device 300 is not affected by the electron beam.
[0136] While the present disclosure has been specifically described above in conjunction with the accompanying drawings and embodiments, it is to be understood that the above description does not limit the present disclosure in any way. Those skilled in the art can make modifications and variations to the present disclosure as needed without departing from its essential spirit and scope, and all such modifications and variations fall within the scope of the present disclosure.
Claims
1. A sterilization method for a medical device kit, characterized in that, The medical device kit includes an analyte sensor, an electronic device, a puncture member, a lower housing with a receiving chamber, and an upper housing sealed to the lower housing. The analyte sensor has a sensing portion that reacts with the analyte to generate a sensing signal, and a connection portion electrically connected to the sensing portion. The electronic device is configured to be coupled to the connection portion and to receive the sensing signal generated by the sensing portion. The puncture member includes a main body and a sharp object disposed on the main body and having a receiving groove for receiving the sensing portion. The electronic device includes a through-hole, and the main body is configured to pass through the through-hole. The sterilization method includes: placing the sensing portion of the analyte sensor and the sharp object in the receiving chamber of the lower housing, sealing the receiving chamber in such a way that the sensing portion is sealed; irradiating the lower housing with an electron beam; coupling the electronic device to the connecting portion, and sealing the upper housing and the lower housing together.
2. The sterilization method as described in claim 1, characterized in that, The irradiation dose of the electron beam is greater than or equal to 15 kGy and less than or equal to 50 kGy.
3. The sterilization method as described in claim 1, characterized in that, The sharp object is sealed within the receiving cavity.
4. The sterilization method as described in claim 3, characterized in that, Projecting radially along the instrument kit, the puncture member is covered by the upper housing.
5. The sterilization method as described in claim 1, characterized in that, After coupling the electronic device to the connection portion, the method further includes placing the electronic device in a chemical gas atmosphere.
6. The sterilization method as described in claim 5, characterized in that, The chemical gas is ethylene oxide.
7. The sterilization method according to claim 1, characterized in that, The receiving chamber is sealed using molten wax.
8. The sterilization method according to claim 1, characterized in that, The electronic device is not within the irradiation range of the electron beam.
9. The sterilization method according to claim 1, characterized in that, The lower housing also includes a desiccant disposed within the receiving chamber.
10. The sterilization method according to claim 1, characterized in that, The outer contour of the upper box body matches the inner contour of the lower box body, and the outer edge of the upper box body includes a rubber ring.