CN117440633A

CN117440633A - Sealing assembly, sensor control device and assembly method of sensor control device

Info

Publication number: CN117440633A
Application number: CN202311454014.6A
Authority: CN
Inventors: 魏万成; 辛琦佶; 邬烈辉; 龚明利; 夏然
Original assignee: Shenzhen Guiji Sensing Technology Co ltd
Current assignee: Shenzhen Guiji Sensing Technology Co ltd
Priority date: 2023-06-28
Filing date: 2023-11-02
Publication date: 2024-01-23
Also published as: CN116828768A

Abstract

The present disclosure describes a closed assembly, a sensor control device, and an assembly method of the sensor control device, the closed assembly including a seal seat having a first through hole, a sensor guide module, and a sensor cap, a head of the sensor passing through a sidewall of the seal seat, a tail of the sensor passing through the first through hole, a first end of the sensor guide module passing through the first through hole and configured to receive the head of the sensor, the sensor cap configured to receive the first end of the sensor guide module, a second end of the sensor guide module configured to seal one end of the first through hole, and the sensor cap configured to seal the other end of the first through hole. Therefore, the sensor can be effectively sealed, and the sensor can be conveniently sterilized.

Description

Sealing assembly, sensor control device and assembly method of sensor control device

Technical Field

The present disclosure relates generally to the technical field of medical devices, and in particular, to a sealing assembly, a sensor control device, and an assembly method of the sensor control device.

Background

Diabetes and its chronic complications have become one of the conditions that seriously affect human health today. In order to delay and reduce chronic complications of diabetes, glucose is required to be strictly controlled, and thus a dynamic glucose monitoring system (Continuous glucose monitoring system, CGMS) for dynamically reflecting glucose fluctuations is widely used. There are a number of dynamic glucose monitoring systems currently available for FDA and/or CE certification in the united states that allow use in europe and america, most of which are minimally invasive, using subcutaneous probes to monitor interstitial fluid glucose, and few on the skin surface. The interstitial fluid glucose concentration measured by CGMS has good correlation with the venous glucose concentration and the fingertip glucose concentration, and can be used as an auxiliary glucose monitoring means.

Because subcutaneous probes are implanted in a host when in use, the probes need to be sterilized and disinfected sufficiently prior to use to ensure sterility of the probes when implanted in the host for the health and safety of the host. Further, in order to prevent colonies from spreading on the probe, it is necessary to seal the probe before or after sterilization.

At present, the sealing of the probe is generally carried out by assembling and sealing a housing with an electronic device and the probe connected with the electronic device together, and further, the electronic device and the probe need to be carried along for sterilization and disinfection when the probe is sterilized and disinfected. Sterilization of the probe is typically performed by irradiating a beam of electron radiation to the probe to effect radiation sterilization of the probe, but the irradiation of the beam of radiation may damage electronics connected to the probe.

Disclosure of Invention

The present disclosure has been made in view of the above-described circumstances, and an object thereof is to provide a sealed module, a sensor control device, and a method of assembling the sensor control device, which can be sealed effectively and sterilized easily.

To this end, a first aspect of the present disclosure provides a closure assembly comprising a seal seat having a first through hole, a sensor guide module, and a sensor cap, a head of the sensor passing through a sidewall of the seal seat, a tail of the sensor passing through the first through hole, a first end of the sensor guide module passing through the first through hole and configured to receive the tail of the sensor, the sensor cap configured to receive the first end of the sensor guide module, a second end of the sensor guide module configured to seal one end of the first through hole, and the sensor cap configured to seal the other end of the first through hole. In a first aspect of the present disclosure, the sensor can be effectively sealed by means of the second end of the sensor guide module, the sealing seat, and the sensor cap.

In addition, in the airtight assembly according to the first aspect of the present disclosure, optionally, the sealing seat includes a base and a top seat cooperatively connected with the base, and the head of the sensor is disposed between the base and the top seat. Therefore, the sensor can be conveniently assembled in the sealing seat formed by the base seat and the top seat.

In addition, in the sealing assembly according to the first aspect of the present disclosure, optionally, an extension portion formed to extend along the side wall of the seal seat is further included. In this case, the extension can provide a certain accommodation and support for the head of the sensor.

In addition, in the sealing assembly according to the first aspect of the present disclosure, the extension may have an opening, and the head of the sensor may be disposed in the opening. Thereby, the sensor can be disposed in the opening.

In addition, in the sealing assembly according to the first aspect of the present disclosure, optionally, the sensor guiding module includes a needle portion and a bearing portion connected to the needle portion, and the tail portion of the sensor is disposed in the needle portion having a slot. Thus, the sensor can be guided conveniently by the bearing part and the needle part.

In addition, in the sealing assembly according to the first aspect of the present disclosure, optionally, the sensor cap is connected to the bearing portion. Thereby, the sensor can be connected to the carrier portion of the sensor guide module.

In addition, in the airtight assembly according to the first aspect of the present disclosure, optionally, a first sealing member is further included, and the first sealing member is disposed between the second end of the sensor guiding module and one end of the first through hole. Thereby, it is possible to conveniently seal the gap between the second end of the sensor guide module and the one end of the first through hole.

In addition, in the sealing assembly according to the first aspect of the present disclosure, optionally, a second seal member is further included, and the second seal member is disposed between the sensor cap and the other end of the first through hole. Thereby, it is possible to conveniently seal the gap between the sensor cap and the other end of the first through hole.

A second aspect of the present disclosure provides a sensor control device, including an electronic assembly and the hermetic assembly of the first aspect, the electronic assembly including an electronic device and an electronic device housing for housing the electronic device, the electronic device housing having a recess for housing a seal seat, one end of the electronic device being disposed in the recess and electrically connected with a head of a sensor. In this case, the sealed assembly may be assembled with the electronic assembly after being individually sealed to form the complete sensor control device.

A third aspect of the present disclosure provides a method of assembling a sensor control device, comprising: irradiating radiation to a sensor in the containment assembly to sterilize the sensor; assembling an electronic device into an electronic device housing, and arranging one end of the electronic device in a concave part of the electronic device housing; the containment assembly is fitted to the recess of the electronics housing and the head of the sensor is electrically connected to one end of the electronics. In this case, after the sealing assembly is independently sealed and the sensor is sterilized, the sealing assembly can be assembled with the electronic assembly to form a complete sensor control device, thereby being capable of conveniently sterilizing the sensor alone; further, the electronic component and the airtight component can be conveniently assembled into the sensor control device through the recess portion.

According to the present disclosure, there are provided a sealing assembly, a sensor control device, and an assembling method of the sensor control device, which can be effectively sealed and facilitate sterilization.

Drawings

The present disclosure will now be explained in further detail by way of example only with reference to the accompanying drawings, in which:

fig. 1 is a schematic diagram showing an application scenario of a glucose monitoring device according to an example of the present disclosure.

Fig. 2 is a schematic diagram showing a perspective structure of a sensor control device according to an example of the present disclosure.

Fig. 3 is a perspective view showing a closure assembly according to an example of the present disclosure.

FIG. 4 is an exploded view illustrating one embodiment of the containment assembly involved in the example of FIG. 3.

Fig. 5 is an exploded view illustrating another embodiment of the containment assembly involved in the example of fig. 3.

Fig. 6 is a schematic diagram illustrating a structure of a sensor guide module and a sensor cap according to an example of the present disclosure.

Fig. 7 is a schematic diagram showing the structure of a sensor according to an example of the present disclosure.

Fig. 8 is a schematic view showing the structure of a seal holder according to an example of the present disclosure.

Fig. 9 is a cross-sectional view taken along a broken line showing the seal holder according to the example of fig. 8.

Fig. 10 is an exploded view showing one embodiment of a seal housing according to an example of the present disclosure.

Fig. 11 is an exploded view showing another embodiment of a seal housing according to an example of the present disclosure.

Fig. 12 is an exploded view showing still another embodiment of the seal housing according to the example of the present disclosure.

Fig. 13 is a schematic structural diagram showing a top view of an electronic component according to an example of the present disclosure.

Fig. 14 is a schematic diagram showing a structure of a bottom view of an electronic component according to an example of the present disclosure.

Fig. 15 is an exploded view showing an electronic component to which examples of the present disclosure relate.

Fig. 16 is a flowchart showing an assembling method of the sensor control device according to the example of the present disclosure.

Detailed Description

Hereinafter, preferred embodiments of the present disclosure will be described in detail with reference to the accompanying drawings. In the following description, the same members are denoted by the same reference numerals, and overlapping description thereof is omitted. In addition, the drawings are schematic, and the ratio of the sizes of the components to each other, the shapes of the components, and the like may be different from actual ones.

It should be noted that the terms "comprises" and "comprising," and any variations thereof, in this disclosure, such as a process, method, system, article, or apparatus that comprises or has a list of steps or elements is not necessarily limited to those steps or elements expressly listed or inherent to such process, method, article, or apparatus, but may include or have other steps or elements not expressly listed or inherent to such process, method, article, or apparatus.

Embodiments of the present disclosure relate to an application device of a medical device that may be used to apply the medical device to a host, such as to apply the medical device to a body surface of the host, or to place the medical device wholly or partially subcutaneously in the host, or the like. The application device according to the present embodiment can facilitate application of the medical device to a desired position.

The application device according to the present embodiment may be also referred to as, for example, a boosting device, a delivery device, an implantation device, an application device, an auxiliary device, or the like. The names are used to indicate the device for applying the medical device to the host according to the present embodiment, and should not be construed as limiting.

Fig. 1 is an application scenario diagram showing a glucose monitoring device 1 according to an example of the present disclosure.

Referring to fig. 1, in the present embodiment, the medical device may be a sensor control device 10 or a part of the sensor control device 10. The sensor control device 10 may monitor the host for glucose. The glucose monitoring device 1 to which the present disclosure relates may include a sensor control device 10, an application device 20, and a cap 30. In the present embodiment, a part of the sensor control device 10 (for example, an application portion of the sensor control device 10 for application to a host) may be applied to the host via the application device 20 and to a desired position, and the cap 30 may be used in conjunction with the application device 20 to house or seal the sensor control device 10, and the host may acquire physiological information through the application portion applied to itself.

In addition, the present disclosure also provides a monitoring system, which may include the glucose monitoring device 1 capable of acquiring physiological information of a host according to the present embodiment, and the reading apparatus 2 (see fig. 1) capable of being communicatively connected to the sensor control device 10 in the glucose monitoring device 1. The application part applied to the host can transmit the acquired physiological information to the reading device 2, for example, wirelessly, thereby enabling the host to read and monitor the physiological information itself.

In some examples, sensor control device 10 may be an analyte sensor device that may generate information of a particular analyte in a bodily fluid based on the bodily fluid, etc., such as reacting with the analyte in the bodily fluid and generating analyte information. In this case, the reaction with the analyte in the body fluid by the sensor can be performed, whereby the acquisition of the analyte information in the body fluid can be facilitated.

In this embodiment, the analyte for which the analyte sensor apparatus is directed may be one or more of glucose, acetylcholine, amylase, bilirubin, cholesterol, chorionic gonadotrophin, creatine kinase, creatine, creatinine, DNA, fructosamine, glutamine, growth hormone, ketone body, lactate, oxygen, peroxide, prostate specific antigen, prothrombin, RNA, thyroid stimulating hormone or troponin.

Hereinafter, the sensor control device 10 according to the present embodiment will be described with reference to glucose as an analyte. It should be noted that, for other analytes, those skilled in the art can analyze other analytes based on the variation of the sensor control device 10 employed by glucose.

Fig. 2 is a schematic diagram showing a perspective structure of the sensor control device 10 according to the example of the present disclosure.

Referring to fig. 2, embodiments of the present disclosure relate to a sensor control device 10. The sensor control device 10 may control the sensor implantation in the host and process and transmit the physiological information of the host to the reading apparatus 2 after the sensor detects the physiological information.

In this embodiment, the sensor control device 10 may include a containment assembly 110 and an electronic assembly 120. The sealing assembly 110 may be an assembly formed by sealing the sensor separately, and the electronic assembly 120 may be electrically connected to the sealing assembly 110 and receive physiological information of the host detected by the sealing assembly 110.

In the present embodiment, the sealing assembly 110 may be assembled with the electronic assembly 120 after the assembly is completed and the sterilization process is performed. The containment assembly 110 may form a seal against the sensor and maintain the sensor in a sterile environment after the sterilization process is performed.

The closing member 110 according to the present embodiment may be also referred to as a closing member, a sealing member, or the like, to represent that the internal space thereof is isolated from the external space. Alternatively, the containment assembly 110 may also be referred to as a sterilization assembly because the containment assembly 110 is to be brought to sterilization.

Referring to fig. 2, in some examples, from the perspective of the sensor control device 10, the containment assembly 110 may be a generally elongated structure that may be configured to be easily inserted into the skin of a host; the electronic component 120 may be composed of a case (a rectangular parallelepiped as shown) of a specific shape and an electronic device 121 enclosed in the case and configured to receive physiological information of the host detected by the hermetic component 110, and the electronic component 120 may be disposed on the hermetic component 110 and constitute the sensor control apparatus 10 with the hermetic component 110.

In some examples, the connection between the enclosure assembly 110 and the electronic assembly 120, which may be separate functional components, may be a detachable connection such as a snap-fit connection, a screw-fit connection, or the like. In this case, due to the non-reusability of the sensor and the reusability of the electronic component 120, the sealing member 110 and the electronic component 120 can be disassembled to retain the electronic component 120 after the sensor control apparatus 10 completes its detection function, whereby the reusability of the electronic component 120 can be improved.

The above-mentioned use as a separate functional component means that the sealing component 110 or the electronic component 120 can be used as a separate functional component, and a separate processing operation (for example, a sterilization operation is performed on the sealing component 110) can be performed on the sealing component 110 or the electronic component 120, and the connection of the functions of the sealing component 110 and the electronic component 120 is not affected. That is, both the hermetic assembly 110 and the electronic assembly 120 can perform normal signal transmission when they are connected.

In some examples, the connection between the hermetic assembly 110 and the electronic assembly 120 may be an adhesive, ultrasonic welding, or the like. Thereby, the sealing connection between the hermetic assembly 110 and the electronic assembly 120 can be enhanced.

Fig. 3 is a perspective view illustrating the hermetic assembly 110 according to the example of the present disclosure. Fig. 4 is an exploded view illustrating one embodiment of the containment assembly 110 involved in the example of fig. 3.

Embodiments of the present disclosure also relate to a containment assembly 110 of a glucose monitoring device 1 that is capable of being effectively sealed and convenient for sterilization.

Referring to fig. 3 and 4, in the present embodiment, the sealing assembly 110 may include a sealing seat 111, a sensor 113, a sensor guide module 112, and a sensor cap 114. The seal seat 111 may be cooperatively connected with the sensor guide module 112, the sensor cap 114 to form a seal against the sensor 113. In other words, the sensor 113 may be disposed in a sealed space formed by the mating connection of the seal holder 111, the sensor guide module 112, and the sensor cap 114. Further, after the sealing assembly 110 is removed for sterilization, the sensor 113 can be maintained in the sterile space formed by the sealing seat 111, the sensor guide module 112, and the sensor cap 114, and the sensor 113 can be maintained in a sterile state when implanted in a host.

In some examples, radiation sterilization may be employed to sterilize the sensor 113. The radiation sterilization means may be, for example, electron beam radiation, gamma radiation, X-ray radiation or a combination thereof.

In sterilizing the entire containment assembly 110, components in the containment assembly 110, such as the sensor cap 114, may be made of at least a material that allows radiation to pass through. In some examples, suitable materials for making sensor cap 114 may be non-magnetic metals, thermoplastics, ceramics, rubber, composites, or combinations thereof.

More specifically, the sensor cap 114 may be used to seal an implanted or distal portion of the sensor 113, and the seal housing 111 and the sensor guide module 112 may be used to seal a proximal portion of the sensor 113.

As shown in fig. 3, the seal seat 111 may be in close contact with the sensor guide module 112 and the sensor cap 114.

Referring to fig. 4, the sensor 113 may be fixed in the sealing seat 111. The distal portion of the sensor 113 may extend outwardly from within the seal housing 111 and protrude.

In some examples, the seal seat 111 may have a first through hole 1111. The first through hole 1111 may serve as a passage through which the distal end portion of the sensor 113 protrudes outward, and may serve as a passage through which the sensor guide module 112 protrudes downward.

In some examples, a head 1131 of the sensor 113 (or a proximal portion of the sensor 113) may exit through the sidewall 1112 of the seal housing 111, and a tail of the sensor 113 (or a distal portion of the sensor 113) may exit through the first through-hole 1111.

In some examples, a first end of the sensor guide module 112 may pass out through the first through hole 1111 and be configured to receive a tail of the sensor 113, and the sensor cap 114 may be configured to receive the first end of the sensor guide module 112.

In some examples, the second end of the sensor guide module 112 may be configured to seal one end of the first through hole 1111 (the upper end of the first through hole 1111 of fig. 4), and the sensor cap 114 may be configured to seal the other end of the first through hole 1111 (the lower end of the first through hole 1111 of fig. 4).

In the present disclosure, by effectively and conveniently sealing the sensor 113 by means of the second end of the sensor guide module 112, the sealing seat 111, and the sensor cap 114, further, the sealed sensor 113 can be taken out for sterilization, that is, the sealing assembly 110 formed by the sealing seat 111, the sensor 113, the sensor guide module 112, and the sensor cap 114 can be taken out for sterilization, thereby facilitating the sterilization process of the sensor 113 alone without assembling the sealing assembly 110 and the electronic assembly 120 into the sensor control device 10 and then sterilizing. After sterilization of the closure assembly 110, the sensor 113 can be maintained within the sterile space formed by the seal housing 111, the sensor guide module 112, and the sensor cap 114, and the sensor 113 can be maintained in a sterile state when implanted in a host.

Fig. 5 is an exploded view illustrating another embodiment of the containment assembly 110 involved in the example of fig. 3.

Referring to fig. 5, in some examples, the containment assembly 110 may also include a first seal 115. The first seal 115 may be disposed between the second end of the sensor guide module 112 and one end of the first through hole 1111. In other words, the first seal 115 may be disposed between the other end of the sensor guide module 112 and the upper surface of the seal housing 111. Thereby, the gap between the second end of the sensor guide module 112 and the upper surface of the sealing seat 111 can be conveniently sealed, the sealing effect between the second end of the sensor guide module 112 and the upper surface of the sealing seat 111 can be enhanced by means of the first sealing member 115, and bacteria or viruses can be effectively prevented from penetrating into the sensor 113 from the gap.

In some examples, the containment assembly 110 may also include a second seal 116. The second seal 116 may be disposed between the sensor cap 114 and the other end of the first through hole 1111. In other words, the second seal 116 may be disposed between the opening of the sensor cap 114 and the other end of the first through hole 1111. Thereby, it is possible to conveniently seal the gap between the opening of the sensor cap 114 and the other end of the first through hole 1111, and it is possible to enhance the sealing effect between the opening of the sensor cap 114 and the other end of the first through hole 1111 by means of the second sealing member 116, and it is possible to effectively prevent bacteria or viruses from penetrating into the sensor 113 from this gap.

In some examples, the first seal 115 and the second seal 116 may be sealing elements such as sealing gaskets or O-rings.

Fig. 6 is a schematic diagram illustrating the structure of the sensor guidance module 112 and the sensor cap 114 according to an example of the present disclosure. Fig. 7 is a schematic diagram showing the structure of the sensor 113 according to the example of the present disclosure.

Referring to fig. 6, in some examples, the sensor guide module 112 may include a needle 1121 and a carrier 1122 connecting the needle 1121. In this case, the bearing portion 1122 can function as a bearing and drive control for the needle portion 1121.

In some examples, needle 1121 may be assembled in sensor applicator 20 through carrier 1122.

In some examples, the sensor cap 114 may be tightly coupled with the carrier 1122 to seal the needle 1121 and the tail 1132 of the sensor 113. Thus, the sensor cap 114 can be connected to the carrier 1122 of the sensor guide module 112, which can facilitate sealing the tail 1132 of the sensor 113 by the tight connection of the sensor cap 114 and the carrier 1122.

In some examples, the carrier 1122 may be adjacent to a top of the electronic device housing 120. Thus, needle 1121 and sensor 113 can be implanted into a host by the pushing of carrier 1122.

In some examples, the tail 1132 of the sensor 113 may be disposed within the needle 1121. In other words, the needle 1121 may have a recessed or hollow structure that accommodates the tail 1132 of the sensor 113. Thereby, the sensor 113 can be conveniently provided in the needle 1121, and the sensor guide module 112 can conveniently guide the sensor 113.

In some examples, the carrier 1122 may include a first portion 11221, a second portion 11222, a third portion 11223, and a fourth portion 11224 connected in sequence.

In some examples, the first portion 11221, the second portion 11222, and the third portion 11223 may be three columnar structures of different diameters. Additionally, in some examples, the diameter of the second portion 11222 may be smaller than the diameter of the first portion 11221 and smaller than the diameter of the third portion 11223, thereby enabling the second portion 11222 to form an annular recess. In this case, the annular recess design can facilitate the assembly of the bearing 1122 into the sensor applicator 20.

In some examples, the third portion 11223 may be configured adjacent to a top of the electronic device housing 120. In other words, when the sensor guide module 112 (or the closure assembly 110 as a whole) is loaded onto the top of the electronics housing 120, the third portion 11223 of the sensor guide module 112 may be adjacent or in abutment with the top of the electronics housing 120.

In some examples, fourth portion 11224 can be used primarily to carry an extension of needle 1121.

In some examples, the first seal 115 may be disposed between the third portion 11223 of the carrier 1122 and the upper surface of the seal seat 111. In other words, the fourth portion 11224 of the carrier 1122 may pass through the seal 115 until the third portion 11223 of the carrier 1122 abuts the upper surface of the seal seat 111.

In some examples, an end of the fourth portion 11224 proximate to the sensor cap 114 can have a first connection structure 112241. In some examples, there may be a second connection structure 11411 at the location of the opening of the sensor cap 114 that mates with the first connection structure 112241. In this case, the first connection structure 112241 and the second connection structure 11411 are adapted to connect the sensor cap 114 to the sensor guide module 112.

In some examples, the first connection structure 112241 can be external threads disposed at an end of the fourth portion 11224 proximate to the sensor cap 114 and the second connection structure 11411 can be internal threads disposed inside the opening of the sensor cap 114.

In some examples, the number of turns of the external and internal threads may be comprehensively considered and adaptively set according to the tight fit of the sensor guide module 112 and the sensor cap 114 connection and the thickness of the sealing seat 111.

In some examples, the sensor cap 114 may include a cap body 1141 and a cap plug 1142 disposed at an end of the aperture remote from the sensor cap 114. In this case, on the one hand, the manufacture and demolding of the cap 1141 can be facilitated; on the other hand, when the sensor cap 114 is connected to the sensor guide module 112, the cap body 1141 can be connected to the fourth portion 11224 of the sensor guide module 112, and then the cap plug 1142 is inserted into the cap body 1141, so that the pressure in the inner space formed by the seal holder 111, the sensor guide module 112, and the cap body 1141 can be balanced before the cap plug 1142 is inserted, and the sensor cap 114, the seal holder 111, and the sensor guide module 112 can be assembled more easily.

Referring to fig. 7, in some examples, the sensor 113 may include a head 1131 and a tail 1132. The head 1131 of the sensor 113, as described above, and having electrical contacts, the tail 1132 of the sensor 113 may be used for implantation into a host. Thus, physiological signals measured at the host by the tail 1132 can be transmitted out through the electrical contacts of the head 1131 by the head 1131 and the tail 1132 of the sensor 113.

In some examples, the head 1131 may be provided in a flat configuration as shown in fig. 7, or the head 1131 may be designed in a flat configuration. Thus, the electrical contact can be provided to the head 1131 conveniently, the connection surface or the connection point with the electronic component 120 can be increased, and the connection stability with the electronic component 120 can be enhanced.

In some examples, the sensor 113 may further include a bend 1133 for connecting the head 1131 and the tail 1132. The bending portion 1133 may form the sensor 113 as a bent sensor.

In some examples, one side of the fourth portion 11224 of the bearing 1122 can be designed as a semi-slotted structure or a hollow structure. Also, the needle 1121 may be designed in a semi-grooved structure or a hollow structure. The half-grooved structure of the fourth portion 11224 and the half-grooved structure of the needle 1121 may be provided correspondingly. In this case, the half-grooved structure of the fourth portion 11224 and the half-grooved structure of the needle 1121 enable the tail 1132 of the sensor 113 to penetrate and be received within the half-grooved structure of the needle 1121 while enabling the head 1131 of the sensor 113 to penetrate out to connect with the electronic assembly 120. The bending portion 1133 can facilitate bending the head portion 1131 toward the tail portion 1132.

Fig. 8 is a schematic diagram showing the structure of the seal holder 111 according to the example of the present disclosure. Fig. 9 is a sectional view taken along a broken line L showing the seal holder 111 according to the example of fig. 8. Fig. 10 is an exploded view showing one embodiment of the seal housing 111 in accordance with examples of the present disclosure.

Fig. 11 is an exploded view showing another embodiment of the seal housing 111 according to the example of the present disclosure. Fig. 12 is an exploded view showing still another embodiment of the seal housing 111 according to the example of the present disclosure.

Referring to fig. 8, in some examples, the side wall 1112 of the seal seat 111 may be a section taken along the imaginary line L, that is, the section taken along the imaginary line L may be referred to as the side wall 1112.

In some examples, the right half of the cross-section taken by the dashed line L may be referred to as the seal seat 111, and correspondingly, the left half of the cross-section taken by the dashed line L may be referred to as the extension 119 of the seal seat 111. The extension 119 may be understood as a portion extending to one side thereof with respect to the seal housing 111. The sealing seat 111 may be mainly used to form a first through hole 1111 and to pass the sensor 113 and the sensor guide module 112. Extension 119 may be used to secure head 1131 of sensor 113 and may form an opening 1191 (described in greater detail below) to serve as a port through which head 1131 of sensor 113 is electrically connected to electronics assembly 120.

As shown in fig. 8, the upper surface of the seal seat 111 may be formed as a flat surface. The flat surface may facilitate a sealing fit or connection between the seal mount 111 and the carrier 1122 of the sensor guide module 112.

Specifically, the head 1131 of the sensor 113 may pass through the sidewall 1112 of the seal holder 111, and the tail 1132 of the sensor 113 may pass through the other end of the first through hole 1111.

In some examples, the seal housing 111 may include a base 1113 and a top housing 1114 cooperatively coupled to the base 1113. The head of the sensor 113 may be disposed between the base 1113 and the top 1114. Specifically, the head 1131 of the sensor 113 may be clamped between the base 1113 and the top 1114. Thus, the sensor 113 can be conveniently assembled between the base 1113 and the top 1114, while the sensor 113 can be conveniently clamped by the base 1113 and the top 1114.

In some examples, extension 119 may be formed by extending base 1113 and top 1114, respectively. Base 1113 may extend leftwardly along the cross-section taken by dashed line L to form a lower half of extension 119, and top 1114 may extend leftwardly along the cross-section taken by dashed line L to form an upper half of extension 119. That is, base 1113 and the lower half of extension 119 may be integrally formed, and top mount 1114 and the upper half of extension 119 may be integrally formed.

In some examples, extension 119 and seal seat 111 may collectively form connector 101. That is, the component shown in fig. 8 may be referred to as a connector 101. The connector 101 may be used to form a sealing engagement with the electronic assembly 120.

In some examples, base 1113 and top 1114 may be connected by one of a snap fit, an adhesive, a weld, etc.

In some examples, the materials of base 1113 and top 1114 may be different. For example, one of the base 1113 and the top 1114 may be a hard gel and the other may be a soft gel. In this case, the sensor 113 can be protected or protected better by the soft adhesive, and the rigidity of the seal holder 111 can be increased by the hard adhesive.

In other examples, the base 1113 and the top 1114 may be the same material. For example, base 1113 and top 1114 may be both hard and soft gels. Thereby, the consistency of the base 1113 and the top 1114 can be enhanced.

Referring to fig. 10 and 11, in some examples, an upper half of the extension 119 may have an opening 1191. The head of the sensor 113 may be disposed in the opening 1191. In other words, the sensor 113 may be disposed in the opening 1191 and exposed outward from the opening 1191.

In some examples, electrical contacts of sensor 113 may be disposed toward opening 1191. Thus, it can be convenient for the sensor 113 to transmit signals outwardly through the electrical contacts and through the opening 1191.

In some examples, the opening 1191 may be sized and shaped to be able to enclose at least a portion or all of the electrical contacts of the head 1131 of the sensor 113. In this case, on the one hand, it can be ensured that the head 1131 of the sensor 113 is electrically connected to the electronic assembly 120 via the electrical contacts, and another advantage can be that the openings 1191 provide an effective protection against the electrical contacts or electrical connectors 12111 (described in detail later) on the electronic assembly 120.

In some examples, the shape of the opening 1191 may be configured to fit the shape of the head 1131 of the sensor 113.

In some examples, the opening 1191 may be square, rectangular, circular, etc. in shape.

In some examples, the upper half of extension 119 may be primarily used to house head 1131 of sensor 113. In some examples, a face of the lower half of the extension 119 opposite the upper half of the extension 119 may be provided with a first recess 11131 that fits the head 1131. Thus, the head 1131 can be clamped and received by the first recess 11131 of the base 1113, and a good seal can be provided to the head 1131.

In some examples, a second groove 11132 may be formed in the base 1113 near the first through hole 1111 to engage or receive the bent portion 1133 of the sensor 113. In some examples, second groove 11132 may be configured to receive at least a portion of bend 1133. Preferably, second recess 11132 may be configured to receive all of bend 1133. Thus, the bending portion 1133 can be conveniently engaged or accommodated by the second groove 11132, and a good sealing effect can be achieved on the bending portion 1133.

In some examples, when the sensor 113 is assembled to the seal base 111, the tail 1132 of the sensor 113 may first pass through the first through hole 1111, and then the bent portion 1133 of the sensor 113 may be engaged with the second groove 11132, and the head 1131 of the sensor 113 may be loaded into the first groove 11131 of the lower half of the extension 119, so that the sensor 113 is fixed on the base 1113 first. Further, the top mount 1114 may be pressed or otherwise attached to the base 1113 to complete the mounting and semi-sealing of the sensor 113 to the seal mount 111. Semi-sealing herein may refer to sealing of the head 1131 of the sensor 113 and the bend 1133 of the sensor 113 using the compression of the first and second grooves 11131, 11132 on the base 1113 and the top 1114.

After the fixing and sealing of the sensor 113 by the sealing seat 111 are completed, the sensor guide module 112 may be inserted into the first through hole 1111. When the sensor guide module 112 is inserted into the first through hole 1111, the needle 1121 may be passed through the first through hole 1111 and configured to receive the tail 1132 of the sensor 113, while the third portion 11223 of the carrier 1122 may be abutted against the upper surface of the top seat 1114. In this case, the upper surface of the sealing seat 111 can be sealed by the third portion 11223 of the bearing portion 1122, or, alternatively, one end of the first through hole 1111 (upper end of the first through hole 1111) of the sealing seat 111 can be sealed by the third portion 11223 of the bearing portion 1122.

With the above steps, the assembly of the sensor 113, the sealing seat 111 and the sensor guide module 112 can be completed, and the sealing seat 111 and the sensor guide module 112 can simultaneously complete the partial sealing of the head 1131 of the sensor 113 and the tail 1132 of the sensor 113.

After sealing one end of the first through hole 1111 with the third portion 11223 of the carrier 1122, the sensor cap 114 may be screwed onto the fourth portion 11224 of the carrier 1122 to complete the assembly of the sensor cap 114 with the sensor guide module 112 and thus the sealing of the sensor cap 114 with the tail 1132 of the sensor 113.

More specifically, the cap body 1141 of the sensor cap 114 may be first screwed onto the fourth portion 11224 by means of the first connection structure 112241 and the second connection structure 11411, and after the cap body 1141 and the fourth portion 11224 are firmly connected, the cap plug 1142 may be plugged onto the cap body 1141. Alternatively, the cap plug 1142 may be plugged to the cap body 1141 prior to screwing the sensor cap 114 to the fourth portion 11224.

It will be appreciated that the sensor cap 114 may also be coupled to the seal housing 111 to seal the tail 1132 of the sensor 113. As an example, an internal thread may be designed on the base 1113 at the other end of the first through hole 1111 (the lower end of the first through hole 1111 as shown in fig. 8 to 10), an external thread may be designed outside the opening of the sensor cap 114, and the sensor cap 114 may be screwed to the base 1113 to complete the direct connection of the sensor cap 114 with the sealing seat 111.

Through the above steps, the encapsulation and sealing of the sensor 113 is completed by the sealing seat 111, the sensor guide module 112, and the sensor cap 114, and the sealing of the needle 1121 is also completed. In this case, the sensor 113 and the needle 1121 can be held in the sealed space formed by the seal holder 111, the sensor guide module 112, and the sensor cap 114, and the assembled sealing assembly 110 can be individually removed from the sterilization, so that the sensor 113 and the needle 1121 can be protected from the external environment after the sterilization.

Referring again to fig. 5, in addition, in some examples, to achieve a better sealing effect to the sensor 113 and the needle 1121, a first seal 115 may be provided between the third portion 11223 of the carrier 1122 and the upper surface of the body portion of the seal seat 111. In this case, by means of the first seal 115, a possible gap between the third portion 11223 of the carrier 1122 and the upper surface of the seal seat 111 can be sealed better, and one end of the first through hole 1111 can be sealed better, whereby the sensor 113 can be sealed in the space formed by the first through hole 1111 and the sensor cap 114.

Additionally, in some examples, a second seal 116 may also be provided between the lower surface of the seal housing 111 (the lower surface of the base 1113) and the sensor cap 114. In this case, by means of the second sealing member 116, a space that may exist between the lower surface of the sealing seat 111 and the opening of the sensor cap 114 can be sealed better, and the other end of the first through hole 1111 can be sealed better directly, whereby the sensor 113 can be sealed in the space formed by the first through hole 1111 and the sensor cap 114.

Referring to fig. 10, in some examples, sterilization group 110 may further include a third seal 117. The third seal 117 may be used to seal a portion of the bent portion 1133 of the sensor 113 that is connected to the head 1131, in other words, the third seal 117 may be used to seal a portion of the bent portion 1133 of the sensor 113 that is bent toward the head 1131 of the sensor 113. Thus, the third sealing member 117 serves to isolate the electrical contact and the electrical connection portion of the electronic component 120 from the tail portion 1132 of the sensor 113 for implantation into the host, in other words, to provide watertight or waterproof effect to the electrical connection portion, and also to enhance the sealing effect to the portion of the sensor 113 within the first through hole 1111.

In some examples, third seal 117 may be clamped between base 1113 and top 1114.

In some examples, the material of the third seal 117 may be silica gel, and the third seal 117 may be designed as a silica gel compact.

Referring to fig. 11 and 12, in some examples, the third seal 117 may include a first seal block 1171 and a second seal block 1172. The first and second sealing press blocks 1171 and 1172 may be disposed at upper and lower sides of the bent portion 1133, respectively. For example, a first sealing block 1171 may be disposed on an upper side of the bend 1133 and a second sealing block 1172 may be disposed on a lower side of the bend 1133. Thus, the press-fit sealing effect on the bending portion 1133 can be conveniently achieved by means of the first seal pressing block 1171 and the second seal pressing block 1172.

More specifically, the first sealing block 1171 and the second sealing block 1172 may be disposed at a location where the bent portion 1133 connects the head 1131.

In one example, a third recess 11133 may be reserved on base 1113 for receiving second seal block 1172, and a fifth recess 11141 may be reserved on top 1114 for receiving first seal block 1171. Thus, it is convenient to dispose the first seal block 1171 and the second seal block 1172 between the base 1113 and the top 1114.

In some examples, fourth groove 11134 may be reserved around the perimeter of base 1113 at first through-hole 1111. Accordingly, a flange 11142 may be provided at the bottom surface of the top base 1114 at the periphery of the first through hole 1111. In this case, base 1113 and top 1114 may be tightly coupled using the mating of fourth recess 11134 and flange 11142.

In some examples, fourth groove 11134 may be an annular groove around the perimeter of first through-hole 1111. Accordingly, the flange 11142 may be an annular flange of a mating annular groove around the perimeter of the first through-hole 1111.

Referring again to fig. 10 and 11, in some examples, the containment assembly 110 may further include a fourth seal 118 disposed at the opening 1191. In this case, when the assembled hermetic assembly 110 is connected to the electronic assembly 120, the fourth sealing member 118 may be used to seal the connection position of the two, and at the same time, the electronic device 121 in the electronic assembly 120 may be sealed and waterproof.

In some examples, the fourth seal 118 may be configured around the opening 1191.

Fig. 13 is a schematic diagram showing a top view of the electronic component 120 according to the example of the present disclosure. Fig. 14 is a schematic diagram showing a structure of a bottom view of the electronic component 120 according to the example of the present disclosure. Fig. 15 is an exploded view showing an electronic component 120 to which examples of the present disclosure relate.

Referring to fig. 13 to 15, the present disclosure also provides a sensor control device 10 of the glucose monitoring device 1. The sensor control device 10 may include an electronics assembly 120 and the above-described containment assembly 110.

In some examples, the electronic assembly 120 may include an electronic device 121 and an electronic device housing 122 for housing the electronic device 121.

In some examples, the electronics housing 122 may be rectangular parallelepiped, cylindrical, etc. in shape to facilitate application to a host's body surface. The perimeter of the electronics housing 122 may be designed with smooth rounded corners in order not to damage the host skin.

In some examples, the bottom surface of the electronics housing 122 may be provided with an adhesive patch that may provide secure adhesion of the electronic assembly 120 to the host body surface. In some examples, the bottom surface of electronics housing 122 may be the side of electronics housing 122 that conforms to the skin of the host.

In some examples, the electronics housing 122 can have a recess 1220 for receiving the seal mount 111. Alternatively, and more specifically, the electronics housing 122 may have a recess 1220 for receiving the connector 101. One end of the electronics 121 may be disposed in the recess 1220 and electrically connected to the head 1131 of the sensor 113. In this case, the hermetic assembly 110 may be assembled with the electronic assembly 120 again to form the complete sensor control apparatus 10 after being independently sealed, or the hermetic assembly 110 may be assembled with the electronic assembly 120 again to form the complete sensor control apparatus 10 after being independently sealed and sterilized, thereby enabling the sensor 113 to be conveniently sterilized separately; further, the electronic component 120 and the hermetic component 110 can be conveniently assembled into the sensor control device 10 through the recess 1220.

In some examples, a second through hole 12211 may be formed in the electronics housing 122 through the upper and lower surfaces of the electronics housing 122. The second through hole 12211 is mainly used to pass the sensor guiding module 112.

In some examples, the second through hole 12211 may be preferably disposed in the center of the electronics housing 122. In this case, the force applied can be made uniform when the electronic component 120 is applied to the host body surface.

In some examples, the second through hole 12211 and the first through hole 1111 of the seal seat 111 may collectively define a channel through which the sensor guide module 112 passes. In some examples, the diameter of the second through hole 12211 may be slightly larger than the diameter of the first through hole 1111. In some examples, the diameter of the second through hole 12211 may be slightly larger than the diameter of the third portion 11223 of the carrier 1122.

In some examples, electronics housing 122 can include an upper shell 1221 and a lower shell 1222 that is adapted to be connected to upper shell 1221. In some examples, the recess 1220 may be formed in the lower case 1222.

In some examples, protrusions 12221 may be formed on an inner surface of the lower case 1222. In some examples, the protrusion 12221 may define the recess 1220, the opening 1191, and the second through hole 12211. Specifically, a spacer 122211 may be disposed on the boss 12221, and the boss 12221 may define an opening 1191 and a second through hole 12211, respectively, using the spacer 122211. The opening 1191 may serve as a port for connecting the sensor 113 in the enclosure assembly 110 to the electronic assembly 120, and the second through hole 12211 may serve as a channel for the sensor guide module 112 in the enclosure assembly 110 to pass through.

In some examples, the electronics 121 may include a printed circuit board 1211. The printed circuit board 1211 may be used to receive and process physiological information of the host as measured by the sensor 113 for transmission to the reading device 2.

In some examples, the printed circuit board 1211 may include electrical connectors 12111. The printed circuit board 1211 may be electrically connected to the sensor 113 in the containment assembly 110 through an electrical connection 12111. Specifically, electrical connector 12111 may be passed down through opening 1191 to electrically connect with head 1131 of sensor 113.

In some examples, the electrical connection 12111 may be an electrode post. Specifically, the electrode posts may extend downward through the openings 1191 to electrically connect electrical contacts on the head 1131 of the sensor 113.

In other examples, electrode posts may also be provided on the head 1131 of the sensor 113, where the electrode posts may extend upward through the openings 1191 to connect with electrical contacts on the printed circuit board 1211.

In some examples, the electronics 121 can include a power supply 1212. The power supply 1212 may provide electrical power to the various functional devices integrated with the printed circuit board 1211.

In some examples, the power supply 1212 may be a rechargeable power supply. In some examples, the power source 1212 may be a button cell.

In some examples, the printed circuit board 1211 may be integrated with a data processing module, a switching module, and a communication module. The switch module may control the on-off of the power supply 1212, the data processing module may process physiological signals (e.g., glucose information) generated by the sensor 113, and the communication module may communicate with the reading device 2.

In some examples, after the sterilization module 110 is connected to the electronic assembly 120, glue may be dispensed at the connection of the two to make the connection stronger and to provide a watertight or waterproof effect to the electronic assembly 120. In other examples, sterilization module 110 and electronics assembly 120 may also be directly snapped together to form a secure connection.

The above completes the overall description of the sensor control device 10.

Fig. 16 is a flowchart showing an assembling method of the sensor control apparatus 10 according to the example of the present disclosure.

Referring to fig. 16, the present disclosure also provides a method of assembling the sensor control device 10, comprising: irradiating radiation to the sensor 113 in the hermetic assembly 110 to sterilize the sensor 113 (step S100); assembling the electronic device 121 into the electronic device housing 122 with one end of the electronic device 121 disposed in the recess 1220 of the electronic device housing 122 (step S200); the hermetic assembly 110 is fitted to the recess 1220, and the head 1131 of the sensor 113 is electrically connected with one end of the electronic device 121 (step S300). In this case, after the hermetic assembly 110 is independently sealed and the sensor 113 is sterilized, it can be assembled with the electronic assembly 120 again to form the complete sensor control device 10, whereby it is possible to facilitate the individual sterilization of the sensor 113; further, the electronic component 120 and the hermetic component 110 can be conveniently assembled into the sensor control device 10 through the recess 1220.

In some examples, in step S100, the radiation sterilization means may be, for example, electron beam radiation, gamma ray radiation, X-ray radiation, or a combination thereof.

In some examples, in step S200, one end of the electronic device 121 may be an electrical connector 12111 of the electronic device.

In some examples, in step S300, the closure assembly 110 may be passed through the recess 1220 and the second through hole 12211, and the connector 101 mated with the recess 1220.

In this embodiment, after sterilizing the sterilization module 110, the sterilization module 110 and the electronic component 120 may be assembled into the sensor control device 10, then the sensor control device 10 is assembled to the application device 20, and finally the applicator cap 30 is connected to the application device 20, thereby completing the complete assembly of the glucose monitoring device 1.

In use, after removal of the applicator cap 30, the electronics 120 and sensor 113 may be directly applied to the body surface of the host by the action of the applicator 20 for glucose monitoring of the host.

More specifically, structural features may be provided on the applicator cap 30 that accommodate the sensor cap 114 and that allow the sensor cap 114 to be removed altogether when the applicator cap 30 is removed. Therefore, the operation of a user can be facilitated, and the experience of the user is improved. Accordingly, the electronic component 120, the seal holder 111, and the sensor 113 can be conveniently applied to the body surface of the host by means of the applying device 20 and the sensor guide module 112, and the sensor guide module 112 can be retracted into the applying device 20 when the electronic component 120, the seal holder 111, and the sensor 113 are applied to the body surface of the host.

The specific structural design of the applicator 20 and the applicator cap 30 described above may be referred to as conventional in the art and will not be described in detail herein.

According to the present disclosure, there are provided a sealing assembly 110, a sensor control device 10, and a method of assembling the sensor control device, which can be effectively sealed and facilitate sterilization.

While the disclosure has been described in detail in connection with the drawings and examples, it is to be understood that the foregoing description is not intended to limit the disclosure in any way. Modifications and variations of the present disclosure may be made as desired by those skilled in the art without departing from the true spirit and scope of the disclosure, and such modifications and variations fall within the scope of the disclosure.

Claims

1. The utility model provides a closed assembly, its characterized in that includes sealing seat, sensor guide module and the sensor cap that has first through-hole, the head of sensor passes through the lateral wall of sealing seat is worn out, the afterbody of sensor passes through first through-hole is worn out, the first end of sensor guide module passes through first through-hole is worn out and is configured to hold the afterbody of sensor, the sensor cap is configured to hold the first end of sensor guide module, the second end of sensor guide module is configured to seal the one end of first through-hole, the sensor cap is configured to seal the other end of first through-hole.

2. The containment assembly of claim 1 wherein the seal comprises a seal,

the sealing seat comprises a base and a top seat matched and connected with the base, and the head of the sensor is arranged between the base and the top seat.

3. The containment assembly of claim 1 or 2 wherein,

and an extension part formed by extending along the side wall of the sealing seat.

4. The containment assembly of claim 3 wherein the seal comprises a seal,

the extension has an opening, the head of the sensor being disposed in the opening.

5. The containment assembly of claim 1 wherein the seal comprises a seal,

the sensor guide module includes a needle having a recessed structure that accommodates the tail of the sensor and a carrier portion connected to the needle.

6. The containment assembly of claim 5 wherein the seal comprises a seal,

the sensor cap is connected with the bearing part.

7. The containment assembly of claim 1 wherein the seal comprises a seal,

the sensor guide module further comprises a first sealing piece, wherein the first sealing piece is arranged between the second end of the sensor guide module and one end of the first through hole.

8. The containment assembly of claim 1 wherein the seal comprises a seal,

the sensor cap further comprises a second sealing piece, wherein the second sealing piece is arranged between the sensor cap and the other end of the first through hole.

9. A sensor control device comprising an electronic assembly and the closure assembly of any one of claims 1-8, the electronic assembly comprising an electronic device and an electronic device housing for receiving the electronic device, the electronic device housing having a recess for receiving a seal mount, one end of the electronic device being disposed in the recess and electrically connected to a head of a sensor.

10. A method of assembling a sensor control device, comprising: irradiating radiation to a sensor in the containment assembly to sterilize the sensor; assembling an electronic device into an electronic device housing, and arranging one end of the electronic device in a concave part of the electronic device housing; the containment assembly is assembled to the recess and the head of the sensor is electrically connected to one end of the electronics.