Sealing structure and implanting tool

Abstract

The invention relates to the technical field of medical instruments, in particular to a sealing structure which comprises a sealing cavity. The sealing structure is used for sealing a sensor, and a connecting part and an implanting part of the sensor are both located in the sealing cavity; the sealing structure is further used for sealing an implantation needle, and a needle body, used for implantation, in the implantation needle is located in the sealing cavity; the implanting part is positioned in the needle body; the sealing structure is further used for sealing an electric connection unit of the emitter, and the electric connection unit is used for being connected with the connection part. Meanwhile, the invention further provides an implanting tool. Compared with the prior art, the sealing structure and the implanting tool have the advantages that the structure can be simplified, the structural complexity can be reduced, and the assembly reliability and the sealing effect can be improved.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a sealing structure and implantation tool. Background Technology

[0002] A Continuous Glucose Monitoring System (CGMS) is used to monitor blood glucose levels in real time. It typically includes a sensor, transmitter, implantation tool, and receiver / display device. In use, the sensor is implanted subcutaneously using the implantation tool. The physiological signals detected by the sensor are transmitted via the transmitter to the receiver / display device, allowing the user to access real-time blood glucose data on devices such as smartphones (with a dedicated application), smartwatches, or dedicated handheld terminals.

[0003] Currently, some CGMS systems have a separate sensor and transmitter structure, requiring manual assembly or assembly with the aid of an implantation tool before use. After assembly, the connector on the sensor is electrically connected to the circuit board (PCBA) inside the transmitter to enable signal conduction. This type of structure requires a sealed and waterproof design around the sensor's connector. Furthermore, to ensure safety and hygiene when not in use, the implantation needle of the implantation tool and the portion of the sensor to be implanted in the human body must remain sealed.

[0004] In related technologies, separate seals are typically placed at the sensor connection point and the implantation point between the implantation needle and the sensor, as well as at the transmitter connection point. This results in a complex overall structure, increasing manufacturing and assembly difficulties. Therefore, simplifying the sealing structure to reduce complexity and improve reliability has become a pressing technical problem to be solved in this field. Summary of the Invention

[0005] To address the aforementioned technical problems, this invention provides a sealing structure that simultaneously seals the sensor's connection portion, the implantation needle and sensor's implantation portion, and the transmitter's electrical connection unit through an integrated sealing structure. Compared to related technologies that require separate sealing elements at multiple points, this invention significantly simplifies the sealing structure, reduces structural complexity, and improves the overall assembly reliability and sealing effect.

[0006] A sealing structure comprising a sealing cavity; The sealing structure is used to seal the sensor, and the connection part and the implantation part of the sensor are both located inside the sealing cavity; The sealing structure is also used to seal the implantation needle, wherein the needle body for implantation is located within the sealing cavity; The implantation site is located within the needle body; The sealing structure is also used to seal the electrical connection unit of the transmitter, which is used to connect to the connection part.

[0007] Preferably, the sealing structure is provided with a shrinkable and deformable structure so that the sealing structure can shrink and deform as a whole along the direction of movement of the implantation needle; The sealing structure has a puncturable seal on the wall opposite to the needle body. The puncturable seal is directly opposite the needle body and can be punctured by the needle body.

[0008] Preferably, the electrical connection unit is provided with an electrical connector; The electrical connector is used to connect to the connecting part after the sealing structure shrinks and deforms, so as to connect the connecting part to the circuit board of the transmitter.

[0009] Preferably, the shrinkable deformable structure is a shrinkable element disposed in the sealing structure; The sealing structure includes a first housing, a second housing, and the retractable member; The second housing and the first housing are spaced apart from each other; The retractable component is connected to the second housing and the first housing respectively, and the retractable component, the second housing and the first housing together form the sealed cavity; The sensor is mounted on the first housing; The implantation needle is detachably mounted on the first housing.

[0010] Preferably, the first housing is provided with a first needle hole, the first needle hole penetrates the first housing, and the needle enters the sealed cavity through the first needle hole; The second housing is provided with a second needle hole that penetrates the second housing. The punctureable seal is provided at the second needle hole to seal the second needle hole.

[0011] Preferably, the retractable component has a foldable structure; The retractable component includes a foldable unit, a first positioning component, and a second positioning component; Along the folding direction of the foldable unit, the first positioning member is connected to the end of the foldable unit, and the second positioning member is connected to the middle of the foldable unit.

[0012] Preferably, the first positioning member and the second positioning member have no intersection point in their orthographic projections on a plane perpendicular to the foldable direction.

[0013] Preferably, it further includes a third housing, which is connected to the second housing, and the third housing and the second housing form a sealed receiving cavity for accommodating the transmitter's circuit board; The first housing, the second housing, and the third housing are used to form the housing of the transmitter assembly; The second housing is used to house the electrical connection unit.

[0014] Preferably, the puncture-resistant seal is made of a biocompatible material.

[0015] An implantation tool having a sealing structure as described in any one of the above descriptions.

[0016] Compared with related technologies, the sealing structure provided by this invention includes a sealing cavity; the sealing structure is used to seal a sensor, with the sensor's connecting part and implantation part both located within the sealing cavity; the sealing structure is also used to seal an implantation needle, with the needle body for implantation located within the sealing cavity; the implantation part is located within the needle body; the sealing structure is also used to seal the electrical connection unit of the transmitter, which is used to connect to the connecting part. The sealing structure seals the sensor (connecting part, implantation part), the needle body for implantation, and the transmitter's electrical connection unit together within the same sealing cavity, achieving an integrated seal for multiple components. This structure not only eliminates the cumbersome design of multiple independent sealing components required in related technologies, but also simplifies the structure of the transmitter's electrical connection unit, reduces the number of parts, simplifies the overall structure, and reduces the design and manufacturing complexity; simultaneously, the integrated sealing layout simplifies the assembly process, avoiding the accumulation of errors caused by separate assembly, thereby effectively improving the reliability and stability of the seal while reducing structural complexity, and more stably and reliably ensuring the sterility of the implantation needle and sensor before storage and use. Attached Figure Description

[0017] To more clearly illustrate the technical solutions in the embodiments or related technologies of this application, the accompanying drawings used in the description of the embodiments or related technologies will be briefly introduced below. Obviously, the accompanying drawings described below are only some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0018] Figure 1 A three-dimensional structural diagram of a sealing structure provided in one embodiment; Figure 2 for Figure 1 The front view of the sealing structure shown; Figure 3 for Figure 1 Top view of the sealing structure shown; Figure 4 For along Figure 3 A schematic diagram of the cross-sectional structure of AA shown; Figure 5 A three-dimensional structural diagram of a retractable member and a second housing provided in one embodiment; Figure 6 A three-dimensional structural diagram of a first housing, a sensor, and an implantation needle provided in one embodiment; Figure 7 This is a schematic diagram of the structure of the second and third housings before assembly, according to one embodiment. Figure 8 A schematic diagram of the sealing structure provided in one embodiment when it is not in use; Figure 9 A schematic diagram of the sealing structure provided in one embodiment after needle removal. Detailed Implementation

[0019] To enable those skilled in the art to better understand the technical solutions in this application, the technical solutions in the embodiments of this application will be clearly and completely described below. Obviously, the described embodiments are only a part of the embodiments of this application, and not all of the embodiments. Based on the embodiments in this application, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this application.

[0020] It should be noted that when a component is referred to as "mounted on", "fixed on", or "set on" another component, it can be directly on or indirectly set on the other component; when a component is referred to as "connected to" another component, it can be directly connected to or indirectly connected to the other component.

[0021] It should be noted that the structures, proportions, sizes, etc., shown in the accompanying drawings are only for the purpose of assisting those skilled in the art in understanding and reading the content disclosed in the specification, and are not intended to limit the conditions under which this application can be implemented. Therefore, they have no substantial technical significance. Any modifications to the structure, changes in the proportions, or adjustments to the size should still fall within the scope of the technical content disclosed in this application, provided that they do not affect the effects and purposes that this application can produce.

[0022] This invention provides a sealing structure comprising a sealing cavity; the sealing structure is used to seal a sensor, the connecting part and the implantation part of the sensor are both located within the sealing cavity; the sealing structure is also used to seal an implantation needle, the needle body of which is located within the sealing cavity; the implantation part is located within the needle body; the sealing structure is further used to seal an electrical connection unit of a transmitter, the electrical connection unit being used to connect to the connecting part. The sealing structure seals the sensor (connecting part, implantation part), the needle body of the implantation needle, and the electrical connection unit of the transmitter together within the same sealing cavity, achieving an integrated seal for multiple components. This structure not only eliminates the cumbersome design of multiple independent sealing components required in related technologies, but also simplifies the structure of the electrical connection unit of the transmitter, reduces the number of parts, simplifies the overall structure, and reduces the design and manufacturing complexity; simultaneously, the integrated sealing layout simplifies the assembly process, avoiding the accumulation of errors caused by separate assembly, thereby effectively improving the reliability and stability of the seal while reducing structural complexity, and can more stably and reliably ensure the sterility of the implantation needle and sensor before storage and use.

[0023] Please refer to the following: Figures 1 to 9 In one embodiment, a sealing structure 10 is provided, which is a sealing structure for sealing and protecting the electrical connection unit of the sensor, the implanted needle, and the transmitter. Specifically, in one embodiment, the sensor is a blood glucose sensor used in CGMS for monitoring blood glucose, and the sealing structure 10 is a sealing structure for sealing and protecting the blood glucose sensor and the implanted needle. The sealing structure 10 is mainly used to solve the problem in related technologies where separate seals are required for different locations, resulting in a more complex overall structure.

[0024] The sealing structure 10 includes a sealing cavity 11, meaning that the sealing structure 10 contains a sealed cavity. The sealing structure 10 seals the sensor 20, with both the connecting portion 21 and the implantation portion 22 of the sensor 20 located within the sealing cavity 11. The connecting portion 21 refers to the part of the sensor 20 used for electrical connection with the transmitter's circuit board; the implantation portion 22 refers to the part of the sensor 20 used for implantation into the human body. The sealing structure 10 also seals the implantation needle 30, with the needle body 31 of the implantation needle 30 located within the sealing cavity 11. The needle body 31 of the implantation needle 30 refers to the part of the implantation needle 30 used for piercing the human body. The implantation portion 22 is located within the needle body 31. During use, the needle body 31 pierces the skin, bringing the implantation portion 22 into the subcutaneous tissue, thereby enabling the sensor 20 to detect corresponding physiological signals. The sealing structure 10 is also used to seal the electrical connection unit 50 of the transmitter, which is used to connect to the connection part 21. The electrical connection unit 50 refers to the conductive structure in the transmitter used to connect the circuit board and the sensor. When the implantation tool is used and the sensor is assembled, the electrical connection unit 50 connects the connection part 21 to the circuit board of the transmitter, enabling circuit connection between the two.

[0025] In other words, in this embodiment, the connecting part 21, the implantation part 22, and the needle body 31 are all disposed in the sealing cavity 11 and are sealed as a whole by the sealing structure 10, and the electrical connection unit 50 is also sealed by the sealing structure 10.

[0026] Understandably, in related technologies, separate seals are usually set at the connection part of the sensor, the implantation part of the implantation needle and the sensor, and the electrical connection part of the transmitter, which makes the overall structure of the implantation tool more complex and increases the difficulty of manufacturing and assembly.

[0027] The sealing structure 10 provided in this embodiment accommodates the connecting part 21, the implanted part 22, and the needle body 31 through the sealing space (i.e., the sealing cavity 11) within the sealing structure 10, thereby isolating the connecting part 21, the implanted part 22, and the needle body 31 from the external environment and ensuring that the connecting part 21, the implanted part 22, and the needle body 31 will not be contaminated when not in use.

[0028] The sealing structure 10 provides an overall seal for the connecting part 21, the implantation part 22, and the needle body 31, achieving a multi-component integrated seal. This not only reduces the number of parts and simplifies the structure, but also lowers the design and manufacturing complexity. Furthermore, the sealing structure 10 seals the electrical connection unit 50, eliminating the need for separate sealing protection for the electrical connection unit on the transmitter, thus simplifying the structure of that part. The integrated sealing layout of the sealing structure 10 also simplifies the assembly process, avoiding the accumulation of errors caused by separate assembly. Therefore, while reducing structural complexity, it effectively improves the reliability and stability of the seal, ensuring a more stable and reliable sterile state for the implantation needle 30 and the sensor 20 before storage and use.

[0029] Specifically, in one embodiment, the sensor 20 is a stand-alone sensor. A stand-alone sensor means that the sensor is not directly assembled into the transmitter and connected to the circuit board during manufacturing. Instead, the sensor 20 and the transmitter are separate structures, and the sensor 20 needs to be assembled into the transmitter structure by manual assembly or implantation tools before it can be connected to the circuit board.

[0030] Specifically, the sensor 20 and the implantation needle 30 can both be directly mounted on the sealing structure 10.

[0031] Preferably, in one embodiment, the sealing structure 10 is provided with a shrinkable and deformable structure, so that the sealing structure 10 can shrink and deform as a whole along the moving direction of the implantation needle 30, wherein the moving direction of the implantation needle 30 refers to the direction in which the implantation needle 30 needs to move to achieve implantation when used in the implantation tool. A puncturable seal 12 is provided on the wall of the sealing structure 10 opposite to the needle body 31. The puncturable seal 12 is directly opposite the needle body 31 and can be punctured by the needle body 31. That is to say, in this embodiment, the shape of the sealing structure 10 can change. The sealing structure 10 can shrink and deform under external pressure, and at least a part of the sealing structure 10 is made of a material that can be punctured by the needle body 31, so the sealing structure 10 will not obstruct the needle body 31. Therefore, when it is necessary to expose the needle body 31, it is not necessary to disassemble the sealing structure 10. Pressure can be applied directly to the sealing structure 10 to cause it to contract and deform, allowing the needle body 31 to pierce the pierceable seal 12. For example, as... Figure 4As shown in the directional angle, the implantation needle 30 moves vertically, while the sealing structure 10 can fold vertically. When the top of the sealing structure 10 is subjected to downward pressure, the implantation needle 30 and the sensor 20 move downwards, and the sidewall of the sealing structure 10 contracts and deforms. After moving a certain distance, the needle 31 punctures the puncturable seal 12 and then pierces the human skin, thereby delivering the implant 22 into the subcutaneous tissue. The contraction and deformation of the sealing structure 10 can be achieved through material selection or structural design. It simply requires that the sealing structure 10 can contract and deform under pressure, allowing the needle 31 to puncture the puncturable seal 12. Furthermore, the specific form of contraction and deformation of the sealing structure 10 can be any form such as folding or compression.

[0032] Understandably, since both the implant and the needle need to enter the human body, these two components have strict sterilization and sealing requirements during production. Currently, one sterilization method involves assembling the sensor and implant needle into a single sealed structure, which is then assembled into the implantation tool after sterilization. However, this sealed structure has a rotatable, detachable sealing sleeve at its bottom. When the user needs to implant the needle, this sleeve must be removed to expose it, making the operation inconvenient.

[0033] The sealing structure 10 provided in this embodiment adopts a shrinkable and deformable structure, which not only meets the sealing requirements when not in use, but also allows the sealing structure 10 to deform under external force after use. This causes a relative change in shape and position between the sealing structure 10 and the implantation needle 30, allowing the needle body 31 to be exposed from the sealing structure 10 by directly piercing the puncturable seal 12. This allows users to use the implantation tool without disassembling the sealing structure 10, simplifying the implantation operation and making it more convenient for users to use the implantation tool. In addition, after the implantation tool is used, when the sensor 20 and the transmitter are assembled to form the transmitter assembly, the shrinkable and deformable sealing structure 10 can also play a role in sealing and waterproofing, improving the sealing and waterproofing performance of the entire transmitter assembly. Furthermore, since the sealing structure 10 can cover the needle body 31, the user cannot see the needle body 31 throughout the use of the implantation tool, thereby improving the user experience, especially for users who are prone to needle phobia.

[0034] Preferably, in one embodiment, the electrical connection unit 50 is provided with an electrical connector 51. The electrical connector 51 is used to connect with the connecting portion 21 after the sealing structure 10 shrinks and deforms, so as to connect the connecting portion 21 to the circuit board of the transmitter. The electrical connector 51 refers to a component capable of circuit conduction, specifically made of conductive silicone or any other material capable of circuit connection. Specifically, the electrical connector 51 is at least partially located in the sealing cavity 11. That is, in this embodiment, when the implantation tool is used, the connecting portion 21 connects to the circuit board of the transmitter by connecting with the electrical connector 51, thereby achieving indirect connection. The connecting portion 21 does not need to be exposed outside the sealing structure 10 to achieve circuit conduction with the circuit board of the transmitter, thus better ensuring waterproof performance. With this structure, the sensor 20 can be directly connected to the circuit board of the transmitter through the electrical connector 51, eliminating the need for a connection socket on the transmitter, thereby reducing the number of parts on the transmitter. For example, as... Figure 4 As shown in the direction angle, when the top of the sealing structure 10 moves downward in a straight line, it will cause the sensor 20 to move downward in a straight line, ultimately allowing the sensor 20 to be connected to the electrical connector 51 in a flat pressure manner.

[0035] Specifically, in one embodiment, the retractable deformable structure is a retractable member 14 disposed in the sealing structure 10. The sealing structure 10 includes a first housing 15, a second housing 16, and the retractable member 14. The second housing 16 and the first housing 15 are spaced apart from each other (when not in use). The retractable member 14 is connected to the second housing 16 and the first housing 15 respectively. The retractable member 14, the second housing 16, and the first housing 15 together form the sealing cavity 11. The sensor 20 is disposed on the first housing 15. The implantation needle 30 is detachably disposed on the first housing 15. That is, in this embodiment, the implantation needle 30 is specifically disposed on the first housing 15, and in a certain state, the implantation needle 30 can also be separated from the first housing 15. It is understood that since the implantation tool needs to be withdrawn from the human body after use, by detachably disposing of the implantation needle 30 on the first housing 15, it is beneficial to withdraw the implantation needle 30, while allowing the first housing 15 to be selectively left in the human body. The specific detachable form of the implantation needle 30 can be selected according to actual needs. For example, it can adopt a snap-fit ​​structure or a rotation locking mechanism, as long as the implantation needle 30 can be removed from the first housing 15 when the needle is withdrawn. Rotation locking refers to one component being fastened to another component by rotation. Forward rotation of one component locks it to the other, while reverse rotation unlocks it.

[0036] Preferably, in one embodiment, the retractable member 14 is a foldable structure. That is, in this embodiment, the retractable member 14 specifically uses a foldable structure to achieve shrinkage deformation. Of course, in other embodiments, the retractable member 14 can also use compression or other methods to achieve shrinkage deformation. The use of a foldable structure to achieve shrinkage deformation in this embodiment has the following advantages: by folding, the deformation process of the retractable member 14 after being compressed will be more stable, which can better avoid the shaking of the first shell 15 caused by the retractable member 14 during deformation.

[0037] Understandably, since the implanted needle 30 is assembled onto the first housing 15, if the retractable component 14 causes the first housing 15 to vibrate during deformation, the implanted needle 30 will also vibrate. If the needle 31 has already pierced the human body at this time, it will increase the user's pain and may even cause bleeding. However, by using a folding mechanism to achieve the retractable component 14's shrinkage and deformation, it is possible to better avoid the impact of the retractable component 14 on the first housing 15 during the shrinkage and deformation process, thus better preventing the implanted needle 30 from vibrating, thereby reducing the user's pain and the probability of bleeding.

[0038] Preferably, in one embodiment, the retractable member 14 includes a foldable unit 141, a first positioning member 142, and a second positioning member 143. Along the folding direction of the foldable unit 141, the first positioning member 142 is connected to the end of the foldable unit 141, and the second positioning member 143 is connected to the middle of the foldable unit 141. The foldable unit 141 is the main component of the retractable member 14 used to realize the folding function, while the first positioning member 142 and the second positioning member 143 are mainly used to provide support and positioning for the foldable unit 141, and also to ensure that the foldable unit 141 can be folded back according to the required state, realizing the retractable member 14 folding to the designed designated empty space. In addition, the foldable unit 141 also serves to support and position the second positioning member 143.

[0039] Specifically, in one embodiment, the foldable unit 141 is made of soft rubber. Using soft rubber for the foldable unit 141 facilitates its shrinkage and deformation under pressure. Furthermore, when the foldable unit 141 is folded, its waterproof and sealing performance is further improved.

[0040] Specifically, in one embodiment, the first positioning member 142 and the second positioning member 143 can be made of hard plastic material, so that their structure is not easily deformed, thereby having a better positioning effect.

[0041] Preferably, in one embodiment, the orthographic projections of the first positioning member 142 and the second positioning member 143 onto a plane perpendicular to the folding direction do not intersect. That is, the orthographic projections of the first positioning member 142 and the second positioning member 143 onto the same plane perpendicular to the folding direction will not intersect, and there is no intersection point between them. Therefore, when the foldable unit 141 is folded, there will be no contact or interference between the second positioning member 143 and the first positioning member 142, allowing the retractable member 14 to be thinner overall after folding.

[0042] Specifically, in one embodiment, both the first positioning member 142 and the second positioning member 143 are annular positioning members, coaxially arranged, and the outer diameter of the second positioning member 143 is smaller than the inner diameter of the first positioning member 142. Therefore, when the retractable member 14 is folded, the second positioning member 143 will be located inside the first positioning member 142.

[0043] Preferably, in one embodiment, one end of the foldable unit 141 is fixedly connected to the first housing 15 via the first positioning member 142. The first positioning member 142 facilitates the fixing of the foldable unit 141 to the first housing 15, thereby ensuring the sealing structure 10 provides sealing protection for the needle body 31 and the sensor 20.

[0044] Specifically, in one embodiment, the foldable unit 141, the first positioning member 142, and the second positioning member 143 can be an integrally formed structure.

[0045] Since both the first housing 15 and the second housing 16 need to avoid the needle 31, specifically, in one embodiment, the first housing 15 is provided with a first needle passage hole 151, which penetrates the first housing 15. The second housing 16 is provided with a second needle passage hole 161, which penetrates the second housing 16. The needle 31 enters the sealing cavity 11 through the first needle passage hole 151. The second needle passage hole 161 is used for the needle 31 to pass through after the implantation tool has been used. Specifically, the puncturable seal 12 is provided at the second needle passage hole 161 to close the second needle passage hole 161.

[0046] Specifically, in one embodiment, the puncturable seal 12 may be a one-piece structure.

[0047] Specifically, in one embodiment, a step 162 extends inward from the second needle hole 161, and the puncturable seal 12 is fixed on the step 162, thereby sealing the second needle hole 161.

[0048] Specifically, in one embodiment, the implantation needle 30 includes a needle tip 32 and a needle body 31, with the needle body 31 connected to the needle tip 32. The needle tip 32 is detachably disposed on the first housing 15. Preferably, in one embodiment, an elastic sealing element 33 is provided at the bottom of the needle tip 32. After the needle tip 32 is assembled onto the first housing 15, the needle tip 32 will squeeze the elastic sealing element 33, pressing the elastic sealing element 33 tightly against the surface of the first housing 15, thereby sealing the first needle hole 151. That is, in this embodiment, the end face of the needle tip 32 does not directly contact and press against the top surface of the first housing 15, but rather the first needle hole 151 is sealed by the elastic sealing element 33 disposed on the end face of the needle tip 32. This structural design can better ensure the sealing effect on the top surface of the first housing 15 and ensure the overall sealing performance of the sealing structure 10. Specifically, the elastic sealing element 33 can be fixed to the end face of the needle tip 32. Specifically, in one embodiment, the elastic seal 33 is made of soft rubber, such as silicone.

[0049] Specifically, in one embodiment, the puncturable seal 12 is made of soft rubber.

[0050] It is understandable that, since the needle 31 needs to pierce the puncturable seal 12 and then penetrate the human body, some of the puncturable seal 12 may remain on the needle 31, leading to some of the puncturable seal 12 entering the human body. Preferably, in one embodiment, the puncturable seal 12 is made of a biocompatible material, thereby meeting biocompatibility requirements and ensuring safety. Specifically, the biocompatible soft material can be selected according to actual needs, such as using medical-grade thermoplastic polyurethane elastomer (TPU) or medical-grade silicone. Specifically, medical-grade thermoplastic polyurethane elastomer can be RXT70A, and medical-grade silicone can be Shinetsu's X-30-4424U. Of course, other biocompatible soft materials can also be used; the above selection of specific materials is only a simple illustrative introduction to the possible materials.

[0051] Preferably, in one embodiment, the Shore hardness of the foldable unit 141 is between 50 and 80 degrees, which can better ensure the foldable unit 141's own folding performance under stress, and can also better ensure the sealing and protection performance of the foldable unit 141 after folding.

[0052] In another embodiment, the Shore hardness of the punctureable seal 12 may be between 50 and 80 degrees, which may facilitate the puncture of the needle body 31.

[0053] It is understandable that if the wall thickness of the foldable unit 141 is too thick, the stability of the foldable unit 141 when it is folded and collapsed will be poor. Preferably, in one embodiment, the wall thickness of the foldable unit 141 is no greater than (less than or equal to) 0.5 mm, so as to better ensure the shrinkage and folding effect of the foldable unit 141 under force.

[0054] Furthermore, it is understood that if the wall thickness of the foldable unit 141 is too thin, it will increase the processing difficulty and may even make it difficult to manufacture the foldable unit 141 using the required process. Preferably, in one embodiment, the wall thickness of the foldable unit 141 is between 0.1 and 0.5 mm, thereby balancing production and performance.

[0055] Specifically, in one embodiment, the wall thickness of the foldable unit 141 is 0.2 mm.

[0056] Preferably, in one embodiment, the first housing 15 and the second housing 16 are used to form the housing of the transmitter assembly. That is, the first housing 15 and the second housing 16 are the housings used to form the transmitter assembly. After the implantation tool assembles the sensor 20 onto the transmitter to form the transmitter assembly, the first housing 15 and the second housing 16 are part of the housing of the transmitter assembly, so the first housing 15 and the second housing 16 can be directly left on the human skin without needing to be disassembled or separated.

[0057] Furthermore, in one embodiment, the sealing structure 10 further includes a third housing 17 connected to the second housing 16. The third housing 17 and the second housing 16 form a sealed receiving cavity for accommodating the transmitter's circuit board 40. That is, the second housing 16 and the third housing 17 form a receiving cavity, and the circuit board 40 is disposed within this cavity. Additionally, components required for the transmitter, such as a battery, can also be disposed within the receiving cavity, thus the second housing 16, the third housing 17, and the components within the receiving cavity can constitute a complete transmitter. Specifically, the third housing 17 also serves as the housing of the transmitter assembly. Therefore, after the implantation tool assembles the sensor 20 onto the transmitter to form the transmitter assembly, the third housing 17 also forms part of the housing of the transmitter assembly, allowing it to be directly left on the skin without further disassembly.

[0058] Specifically, in one embodiment, the third housing 17 is disposed at the bottom of the second housing 16.

[0059] Understandably, in existing technologies, sensors and transmitters in a split structure are usually two completely independent parts. However, in this embodiment, the sealing structure 10 is used to seal and protect the sensor 20 and transmitter as a single integrated structure. Through a deformable sealing structure 10, when not in use, the sensor 20 and the transmitter's circuit board 40 and other structures are separated. When in use, the sealing structure 10 folds, connecting the sensor 20 and transmitter to form a single transmitter assembly. The sealing structure 10 is then part of this transmitter assembly. This greatly simplifies the structure, essentially using the structure on the transmitter assembly to seal each part, thus eliminating the need for additional connecting and sealing structures.

[0060] Specifically, in one embodiment, the first housing 15 is the upper housing of the transmitter assembly, the second housing 16 is the middle housing of the transmitter assembly, and the third housing 17 is the lower cover of the transmitter assembly.

[0061] Specifically, in one embodiment, the circuit board 40 is a PCBA (Printed Circuit Board Assembly).

[0062] Preferably, in one embodiment, the second housing 16 is used to house the electrical connection unit 50, meaning the electrical connection unit 50 can be directly mounted on the second housing 16. Specifically, in one embodiment, the electrical connector 51 is disposed on the second housing 16 and connected to the circuit board 40. This structure allows the sensor 20 to be directly connected to the circuit board 40 via the electrical connector 51 after the sealing structure 10 is folded, eliminating the need for a connection socket on the transmitter and reducing the number of parts on the transmitter. Furthermore, during production, the electrical connector 51 can be directly fixed to the second housing 16 using an in-mold integral molding process, thereby reducing assembly steps and the number of parts.

[0063] Specifically, in one embodiment, the retractable component 14, the second housing 16, and the puncturable seal 12 can be integrated into one part, and then assembled with the first housing 15, which has the sensor 20 and the implantation needle 30 assembled. After assembly, an internally sealed independent sterilization body is formed. After sterilizing this sterilization body, the circuit board 40, the third housing 17, and other components are then assembled.

[0064] Understandably, the needle body 31 and the implantation part 22 require an independent sealed space before implantation into the human body to ensure that they are in a clean environment. After implantation, the entire sensor 20 and transmitter need to be placed on the surface of the human skin. The sealing structure 10, by adopting a folding method, can meet these functional requirements, ensuring a sealing effect before use, while also meeting the functional requirements of connection and sealing between the sensor 20 and the circuit board 40. The sealing structure 10 ensures that the retractable component 14 is not affected by vibrations during production assembly and transportation. In addition, after the retractable component 14 is folded and assembled to form the transmitter assembly, it can guarantee the IPX8 waterproof rating requirement.

[0065] Meanwhile, in one embodiment, an implantation tool is also provided, which incorporates the sealing structure 10.

[0066] Specifically, in one embodiment, the implantation tool may further include a housing, a ejector, and a ejection drive, wherein the ejection drive may be a spring. The housing has an open-end receiving space, and the ejector is snapped into place within the housing. The ejection drive is positioned between the ejector and the housing, and is used to move the ejector toward the opening after the ejector is disengaged. It should be noted that in this embodiment, "snap" refers to a connection between two components via a corresponding snap-fit ​​structure, allowing the two components to separate in a given state. The sealing structure 10 is mounted on the ejector; specifically, the first housing 15 may be mounted on the ejector.

[0067] Specifically, in one embodiment, the implantation tool is an implantation tool applied in CGMS.

[0068] In one embodiment, the implantation tool operates as follows: after pressing the drive button on the outer shell, the ejector disengages from the outer shell. Then, driven by the ejector drive, the ejector moves, thereby moving the first housing 15, and the retractable member 14 begins to fold. Once the ejector has moved a certain distance, the needle 31 first punctures the punctureable seal 12, then penetrates the skin to deliver the implant 22 into the subcutaneous tissue, thus completing one implantation operation.

[0069] Furthermore, the implantation tool may also be equipped with a needle withdrawal mechanism. When the implantation operation is completed, the needle withdrawal mechanism moves backward. The backward movement of the needle withdrawal mechanism will simultaneously drive the implantation needle 30 to unlock from the first housing 15, and then drive the implantation needle 30 to move backward, automatically pulling the implantation needle 30 out of the human body.

[0070] Specifically, in one embodiment, a snap-fit ​​structure is provided between the first housing 15 and the second housing 16. When the first housing 15 is moved into position, it snaps into the second housing 16, forming a stable connection. For example, the second housing 16 may have a snap-fit ​​groove, and the first housing 15 may have a corresponding snap-fit. Thus, when the pusher pushes the first housing 15 into position, the first housing 15 is fixed to the snap-fit ​​groove of the second housing 16, ensuring that the first housing 15 will not accidentally separate from the second housing 16, and also ensuring that the sealing structure 10 will not unfold again. The retractable member 14, when folded, is located in the area between the first housing 15 and the second housing 16, which can improve the sealing effect.

[0071] The above description is merely an embodiment of the present invention. It should be noted that those skilled in the art can make improvements without departing from the inventive concept of the present invention, but these improvements all fall within the protection scope of the present invention.

Claims

1. A sealing structure, characterized in that, The sealing structure includes a sealing cavity; The sealing structure is used to seal the sensor, and the connection part and the implantation part of the sensor are both located inside the sealing cavity; The sealing structure is also used to seal the implantation needle, wherein the needle body for implantation is located within the sealing cavity; The implantation site is located within the needle body; The sealing structure is also used to seal the electrical connection unit of the transmitter, which is used to connect to the connection part.

2. The sealing structure according to claim 1, characterized in that, The sealing structure is provided with a shrinkable and deformable structure so that the sealing structure can shrink and deform as a whole along the direction of movement of the implantation needle. The sealing structure has a puncturable seal on the wall opposite to the needle body. The puncturable seal is directly opposite the needle body and can be punctured by the needle body.

3. The sealing structure according to claim 2, characterized in that, The electrical connection unit is provided with an electrical connector; The electrical connector is used to connect to the connecting part after the sealing structure shrinks and deforms, so as to connect the connecting part to the circuit board of the transmitter.

4. The sealing structure according to claim 2, characterized in that, The shrinkable and deformable structure is specifically a shrinkable element disposed in the sealing structure; The sealing structure includes a first housing, a second housing, and the retractable member; The second housing and the first housing are spaced apart from each other; The retractable component is connected to the second housing and the first housing respectively, and the retractable component, the second housing and the first housing together form the sealed cavity; The sensor is mounted on the first housing; The implantation needle is detachably mounted on the first housing.

5. The sealing structure according to claim 4, characterized in that, The first housing is provided with a first needle hole, which penetrates the first housing, and the needle enters the sealed cavity through the first needle hole; The second housing is provided with a second needle hole that penetrates the second housing. The punctureable seal is provided at the second needle hole to seal the second needle hole.

6. The sealing structure according to claim 4, characterized in that, The retractable component has a foldable structure; The retractable component includes a foldable unit, a first positioning component, and a second positioning component; Along the folding direction of the foldable unit, the first positioning member is connected to the end of the foldable unit, and the second positioning member is connected to the middle of the foldable unit.

7. The sealing structure according to claim 6, characterized in that, The first positioning member and the second positioning member have no intersection point when projected onto a plane perpendicular to the foldable direction.

8. The sealing structure according to claim 4, characterized in that, It also includes a third housing, which is connected to the second housing, and the third housing and the second housing form a sealed receiving cavity for accommodating the transmitter's circuit board; The first housing, the second housing, and the third housing are used to form the housing of the transmitter assembly; The second housing is used to house the electrical connection unit.

9. The sealing structure according to claim 2, characterized in that, The puncture-resistant seal is made of a biocompatible material.

10. An implantation tool, characterized in that, The application has a sealing structure as described in any one of claims 1 to 9.

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