An implantable sensor seal structure and assembly method

Abstract

The application relates to the technical field of medical devices, in particular to an implantable sensor sealing structure and an assembling method, the implantable sensor sealing structure comprising a shaft ring, a sensor, a shell one, a steel needle, a needle sleeve, soft glue two, a silica gel plug, a shell two and a circuit board assembly; the upper surface of the shaft ring is provided with a positioning groove, and the sensor is arranged in the positioning groove; the inner side of the shell one is fixedly connected with a positioning column; the circuit board assembly is provided with a connector slot; the application adopts double-color forming sealing of the 'needle seat-soft glue' and the 'needle sleeve-soft glue' respectively, realizes independent sealing of key components, and makes the circuit board assembly not participate in the overall sterilization process through structural design, thereby optimizing the compatibility of assembly and sterilization; the application improves the sealing effect of the implantable sensor sealing structure, avoids participation of the circuit board assembly and the electronic elements thereon in the sterilization process, prevents damage of the electronic elements in the sterilization process, and guarantees the performance stability and service life of the sensor.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to an implantable sensor sealing structure and assembly method. Background Technology

[0002] Implantable medical devices are widely used in fields such as physiological parameter monitoring and drug delivery systems. For example, continuous glucose monitoring systems require specialized implantation tools (often called "needle augers") to quickly, accurately, and almost painlessly implant the sensor transmitter under the user's skin. Implantable medical devices contain sophisticated sensors and electronic components. To ensure the sterility of the devices, they typically require sterilization. However, existing implantable sensor sealing structures have significant shortcomings in terms of sterilization processes and component protection.

[0003] Existing implantable sensor sealing structures (such as Abbott's dual-color seal for intermediate components) typically employ a method of "sterilizing the entire circuit board assembly (PCBA) after assembly," which presents the following problems: the sealing structure is a single dual-color seal for the intermediate component, and the assembled circuit board assembly (PCBA) needs to participate in the sterilization process. The sterilization process can damage the electronic components on the circuit board assembly (PCBA), affecting the sensor's performance and lifespan. Summary of the Invention

[0004] The purpose of this invention is to provide an implantable sensor sealing structure and assembly method, which improves the sealing effect of the implantable sensor sealing structure, avoids the circuit board assembly and electronic components on it from participating in the sterilization process, prevents damage to electronic components during the sterilization process, and ensures the performance stability and service life of the sensor.

[0005] To achieve the above objectives, in a first aspect, the present invention provides an implantable sensor sealing structure, including a collar, a sensor, a housing, a steel needle, a needle sleeve, a soft rubber second, a silicone plug, a housing second, and a circuit board assembly.

[0006] The upper surface of the collar is provided with a positioning groove, and the sensor is disposed in the positioning groove; the lower side of the housing is connected to the sensor and is located above the sensor; a positioning post is fixedly connected to the inner side of the housing; the steel needle is disposed on the housing; the needle sleeve is disposed below the steel needle; the soft rubber second is fixedly connected to the needle sleeve and is located at the end of the needle sleeve near the collar; the silicone plug is disposed at the end of the needle sleeve away from the steel needle; the housing second is connected to both the collar and the housing first and is located below the housing first; the circuit board assembly is disposed between the housing first and the housing second, and the circuit board assembly is provided with a connector slot.

[0007] The sensor and the collar are fixedly connected by adhesive or ultrasonic welding.

[0008] The steel needle has a rotating groove located on its outer side.

[0009] The needle sleeve has two spiral buckles, which are located inside the needle sleeve.

[0010] The steel needle includes a soft rubber core and a needle base; the needle base is disposed above the needle sheath; the soft rubber core and the needle base are fixedly connected and located on the side of the needle base.

[0011] The second housing is fixedly connected to the collar and the first housing by glue or ultrasonic welding.

[0012] The housing and the collar are fixedly connected by adhesive or ultrasonic welding.

[0013] Secondly, the present invention also provides a method for assembling an implantable sensor sealing structure, comprising:

[0014] Place the sensor in the positioning slot of the collar and make the sensor straddle the collar.

[0015] The side of the sensor spanning the collar contacts the lower side of the housing and is connected and fixed by glue or ultrasonic welding.

[0016] The steel needle consists of a needle base and a soft rubber layer. One side of the soft rubber layer contacts the upper side of the housing layer to form a seal.

[0017] The soft rubber at the front end of the needle sleeve contacts the surface of the collar, and the two spiral buckles inside the needle sleeve cooperate with the rotating groove on the steel needle to lock the housing, steel needle and needle sleeve through rotational locking force.

[0018] A silicone plug is pressed into the end of the needle sheath away from the steel needle. Soft rubber one and soft rubber two are compressed and deformed to seal the entire sensor implantation end. Radiation sterilization and sealing test can then be performed.

[0019] Place the circuit board assembly with a through hole in the middle between the end of the steel needle near the soft rubber one and the end of the needle sleeve near the soft rubber two, and press it tightly against the inner side of the housing one.

[0020] After passing the needle sleeve through the second housing, it is positioned and assembled with the collar and the first housing. The second housing, the collar, and the first housing are connected by glue or ultrasonic welding to form a closed space, thus completing the assembly.

[0021] This invention discloses an implantable sensor sealing structure and assembly method. In assembling the implantable sensor sealing structure, the sensor is placed on a collar. A positioning groove on the collar secures the sensor, which spans the collar. The side of the sensor spanning the collar contacts the lower side of the housing. The sensor is bonded and fixed using adhesive or ultrasonic welding. The steel needle is composed of a needle base and a soft rubber compound. One side of the soft rubber compound contacts the upper side of the housing. The front end of the needle sleeve has a second soft rubber compound that contacts the surface of the collar. The needle sleeve, steel needle, and sensor form opposing sides. The needle sleeve contains two spiral clips that rotate to engage with the rotating groove on the steel needle. A rotational locking force locks the entire housing, steel needle, and needle sleeve in place, while a silicone plug is pressed into the other end of the needle sleeve. The compression deformation of the soft rubber compound on the steel needle and the soft rubber compound on the needle sleeve seals the entire sensor implantation end, allowing for radiation sterilization and sealing testing. The circuit board assembly is placed between the soft rubber end of the steel needle and the soft rubber end of the needle sleeve, close to the inner side of housing one, and positioned and fixed by the positioning posts of housing one. The circuit board assembly has a through hole in the middle, the size of which needs to be larger than the size of the collar to allow it to be installed on the inner side of housing one (the circuit board assembly is placed between housing one and housing two; the circuit board assembly has a through hole in the middle, which passes through the needle sleeve and collar and then closes to the inner side of housing one; housing one has two positioning posts to position the circuit board assembly). Housing two has a through hole in the middle, the size of which is larger than the size of the needle sleeve, so that housing two can ultimately avoid the needle sleeve during final installation. Housing two can pass through the needle sleeve and be positioned and assembled with the collar and housing one without interfering with the needle sleeve. The collar is on the inner side of housing one and can be bonded using a waterproof ring, glue, ultrasonic welding, or other processes. Housing two, the collar, and housing one are bonded together with glue or ultrasonic welding to form a closed space, thus completing the assembly of the entire transmitter. This invention optimizes the compatibility of assembly and sterilization by designing the circuit board assembly to prevent it from participating in the overall sterilization process, allowing only the sealing unit (such as the needle hub and needle sleeve) to be sterilized independently. This invention also improves the sealing effect of the implantable sensor's sealing structure, prevents the circuit board assembly and its electronic components from participating in the sterilization process, prevents damage to the electronic components during sterilization, and ensures the performance stability and service life of the sensor. Attached Figure Description

[0022] To more clearly illustrate the technical solutions in the embodiments of this application or the prior art, the accompanying drawings used in the description of the embodiments or the prior art will be briefly introduced below.

[0023] Figure 1 This is a schematic diagram of an implantable sensor sealing structure of the present invention, excluding the housing.

[0024] Figure 2 This is an overall cross-sectional view of an implantable sensor sealing structure according to the present invention.

[0025] Figure 3 This is a schematic diagram of the structure of the needle sleeve of the present invention.

[0026] Figure 4 This is a schematic diagram of the steel needle of the present invention.

[0027] Figure 5 This is a schematic diagram of the structure of the collar and sensor of the present invention.

[0028] Figure 6 This is a schematic diagram of the overall structure of an implantable sensor sealing structure according to the present invention.

[0029] Figure 7 This is a schematic diagram of the circuit board assembly of the present invention.

[0030] Figure 8 This is a schematic diagram of the structure of the housing and positioning post of the present invention.

[0031] Figure 9 This is a flowchart of an assembly method for an implantable sensor sealing structure according to the present invention.

[0032] 1-Axle collar, 2-Sensor, 3-Housing housing one, 4-Steel needle, 5-Needle sleeve, 6-Soft rubber two, 7-Silicone plug, 8-Housing housing two, 9-Positioning groove, 10-Rotating groove, 11-Spiral buckle, 12-Soft rubber one, 13-Needle seat, 14-Circuit board assembly, 15-Positioning post, 16-Connector slot. Detailed Implementation

[0033] The embodiments of the present invention are described in detail below. Examples of the embodiments are shown in the accompanying drawings. The embodiments described below with reference to the accompanying drawings are exemplary and intended to explain the present invention, but should not be construed as limiting the present invention.

[0034] Firstly, please refer to Figures 1-8 This invention provides an implantable sensor sealing structure, including a collar 1, a sensor 2, a housing 3, a steel needle 4, a needle sleeve 5, a soft rubber 6, a silicone plug 7, a housing 8, and a circuit board assembly 14; the steel needle 4 includes a soft rubber 12 and a needle seat 13; the aforementioned solution improves the sealing effect of the implantable sensor sealing structure, avoids the circuit board assembly 14 and its electronic components from participating in the sterilization process, prevents damage to the electronic components during sterilization, and ensures the performance stability and service life of the sensor 2.

[0035] In this specific embodiment, the upper surface of the collar 1 is provided with a positioning groove 9, and the sensor 2 is disposed in the positioning groove 9; the lower side of the housing 3 is connected to the sensor 2 and is located above the sensor 2; a positioning post 15 is fixedly connected to the inner side of the housing 3; the steel needle 4 is disposed on the housing 3; the needle sleeve 5 is disposed below the steel needle 4; the soft rubber 6 is fixedly connected to the needle sleeve 5 and is located at the end of the needle sleeve 5 near the collar 1; the silicone plug 7 is disposed at the end of the needle sleeve 5 away from the steel needle 4; the housing 8 is connected to both the collar 1 and the housing 3 and is located below the housing 3; the circuit board assembly 14 is disposed between the housing 3 and the housing 8, and the circuit board assembly 14 is provided with a connector slot 16. The sensor 2 is connected to the circuit board assembly 14 through the connector slot 16 and is located below the sensor 2.

[0036] The sensor 2 and the collar 1 are fixedly connected by glue or ultrasonic welding.

[0037] Secondly, the steel needle 4 has a rotating groove 10, which is located on the outside of the steel needle 4.

[0038] Meanwhile, the needle sleeve 5 has two spiral buckles 11, which are located inside the needle sleeve 5.

[0039] In addition, the steel needle 4 includes a soft rubber 12 and a needle seat 13; the needle seat 13 is disposed above the needle sleeve 5; the soft rubber 12 and the needle seat 13 are fixedly connected and located on the side of the needle seat 13.

[0040] Finally, the second housing 8 is fixedly connected to the collar 1 and the first housing 3 by adhesive or ultrasonic welding. The first housing 3 and the collar 1 are fixedly connected by adhesive or ultrasonic welding.

[0041] When assembling the implantable sensor sealing structure of the present invention, the sensor 2 is placed on the collar 1. The positioning groove 9 provided on the collar 1 is used to fix the sensor 2. The sensor 2 spans across the collar 1, and the side of the sensor 2 spanning the collar 1 contacts the lower side of the housing 3. It is bonded and fixed by adhesive or ultrasonic welding. The steel needle 4 is composed of a needle base 13 and soft rubber 12. One side of the soft rubber 12 contacts the upper side of the housing 3. The front end of the needle sleeve 5 has soft rubber 6, which contacts the surface of the collar 1. The needle sleeve 5, the steel needle 4, and the sensor 2 form opposite sides. There are two spiral buckles 11 inside the needle sleeve 5. The spiral buckles 11 rotate and lock the rotating groove 10 on the steel needle 4. The entire housing 3, the steel needle 4, and the needle sleeve 5 are locked by the rotational locking force. At the same time, a silicone plug 7 is pressed into the other end of the needle sleeve 5. The soft rubber 12 on the steel needle 4 and the soft rubber 6 on the needle sleeve 5 are compressed and deformed to seal the entire implantation end of the sensor 2, allowing for radiation sterilization and sealing testing. The circuit board assembly 14 (PCBA) is placed between the soft rubber ends of the steel needle 4 and the needle sleeve 5, adhering tightly to the inner side of the housing 3, and positioned and fixed by the positioning posts 15 of the housing 3. The circuit board assembly 14 (PCBA) has a through hole in the middle, the size of which needs to be larger than the size of the collar 1, so that it can be installed on the inner side of the housing 3 (the circuit board assembly 14 is placed between the housing 3 and the housing 8, and the circuit board assembly 14 has a through hole in the middle, which passes through the needle sleeve 5 and the collar 1 and adheres tightly to the inner side of the housing 3. There are two positioning posts 15 inside the housing 3 to position the circuit board assembly 14). The second housing 8 has a through hole in the middle, the size of which is larger than that of the needle sleeve 5. This allows the second housing 8 to avoid the needle sleeve 5 during final installation. The second housing 8 can pass through the needle sleeve 5 and be positioned and assembled with the collar 1 and the first housing 3 without interfering with the needle sleeve 5. The collar 1 is located on the inner side of the first housing 3 and can be bonded using a waterproof ring, glue, ultrasonic welding, or other processes. The second housing 8, collar 1, and first housing 3 are bonded together with glue or ultrasonic welding to form a closed space, thus completing the assembly of the entire transmitter.

[0042] This invention discloses an implantable sensor sealing structure that employs dual-color molding and sealing of "needle seat 13-soft rubber 12" and "needle sleeve 5-soft rubber 6" to achieve independent sealing of key components, replacing traditional integrated or single dual-color sealing structures and improving sealing reliability and assembly flexibility. Through structural design, the circuit board assembly 14 (printed circuit board) does not participate in the overall sterilization process; only the sealing units (such as needle seat 13, needle sleeve 5, etc.) are sterilized independently, optimizing the compatibility between assembly and sterilization. This invention improves the sealing effect of the implantable sensor sealing structure, preventing the circuit board assembly 14 and its electronic components from participating in the sterilization process, preventing damage to electronic components during sterilization, and ensuring the performance stability and service life of the sensor 2. This invention achieves precise positioning and fixation of components such as the sensor 2 and circuit board assembly 14 through structures such as the positioning groove 9 of the collar 1 and the positioning post 15 of the housing. Combined with the locking mechanism of the spiral buckle 11 and the rotating groove 10, it improves assembly accuracy and structural stability. The sealing structure of the present invention can be individually sterilized by radiation and tested for sealing before assembly to ensure sterility and sealing before subsequent assembly, thereby simplifying the production process and reducing the defect rate.

[0043] Secondly, please refer to Figure 9 The present invention also provides a method for assembling an implantable sensor sealing structure, comprising:

[0044] S1 places sensor 2 on positioning groove 9 of collar 1 and makes sensor 2 span across collar 1;

[0045] The side of sensor 2 spanning the collar 1 contacts the lower side of housing 3 and is connected and fixed by glue or ultrasonic welding.

[0046] The S3 steel needle 4 is composed of a needle base 13 and a soft rubber 12. One side of the soft rubber 12 contacts the upper side of the housing 3 to form a seal.

[0047] The soft rubber 6 at the front end of the S4 needle sleeve 5 contacts the surface of the collar 1. The two spiral buckles 11 inside the needle sleeve 5 cooperate with the rotating groove 10 on the steel needle 4, and lock the housing 3, steel needle 4 and needle sleeve 5 by rotational locking force.

[0048] S5 presses a silicone plug 7 into the end of the needle sleeve 5 away from the steel needle 4. Soft rubber one 12 and soft rubber two 6 are compressed and deformed to seal the entire implantation end of the sensor 2. Radiation sterilization and sealing test can then be performed.

[0049] S6 places the circuit board assembly 14 with a through hole in the middle between the end of the steel needle 4 near the soft rubber 12 and the end of the needle sleeve 5 near the soft rubber 6, and attaches it to the inner side of the housing 3.

[0050] S7 passes the housing 2 8 through the needle sleeve 5 and then positions and assembles it with the collar 1 and housing 1 3. The housing 2 8, the collar 1, and the housing 1 3 are connected by glue or ultrasonic welding to form a closed space, and the assembly is now complete.

[0051] In this embodiment, sensor 2 is placed on collar 1, and positioning groove 9 on collar 1 is used to fix sensor 2. Sensor 2 spans across collar 1, and the side of sensor 2 spanning collar 1 contacts the lower side of housing 3. It is bonded and fixed by adhesive or ultrasonic welding. Steel needle 4 is composed of needle base 13 and soft rubber 12. One side of soft rubber 12 contacts the upper side of housing 3. The front end of needle sleeve 5 has soft rubber 6, which contacts the surface of collar 1. Needle sleeve 5, steel needle 4, and sensor 2 form opposite sides. There are two spiral buckles 11 inside needle sleeve 5. The spiral buckles 11 rotate and lock into the rotating groove 10 on steel needle 4. The entire housing 3, steel needle 4, and needle sleeve 5 are locked by the rotational locking force. At the same time, a silicone plug 7 is pressed into the other end of needle sleeve 5. The soft rubber 12 on the steel needle 4 and the soft rubber 6 on the needle sleeve 5 are compressed and deformed to seal the entire implantation end of the sensor 2, allowing for radiation sterilization and sealing testing. The circuit board assembly 14 is placed between the soft rubber ends of the steel needle 4 and the needle sleeve 5, adhering tightly to the inner side of the housing 3, and positioned and fixed by the positioning posts 15 of the housing 3. The circuit board assembly 14 has a through hole in the middle, the size of which needs to be larger than the size of the collar 1, so that it can be installed on the inner side of the housing 3 (the circuit board assembly 14 is placed between the housing 3 and the housing 8; the circuit board assembly 14 has a through hole in the middle, passing through the needle sleeve 5 and the collar 1, and adhering tightly to the inner side of the housing 3; the housing 3 has two positioning posts 15 inside to position the circuit board assembly 14). The housing 8 has a through hole in the middle, the size of which is larger than the size of the needle sleeve 5, so that the housing 8 can ultimately avoid the needle sleeve 5 during final installation. The housing 8 can pass through the needle sleeve 5 and be positioned and assembled with the collar 1 and the housing 3 without interfering with the needle sleeve 5. The collar 1 is located on the inner side of housing 3 and can be bonded using methods such as waterproofing rings, adhesives, or ultrasonic welding. Housing 2 8, collar 1, and housing 3 are bonded together using adhesives or ultrasonic welding to form a closed space, thus completing the assembly of the entire transmitter.

[0052] The present invention provides an assembly method for an implantable sensor sealing structure that avoids the circuit board assembly 14 and electronic components from participating in sterilization, protects the electronic components from damage, and improves the stability of the sensor 2; adopts a two-color molding process to achieve independent sealing of multiple components, resulting in higher sealing reliability; the assembly process of the present invention (such as positioning, dispensing, pressing, testing, etc.) is more precise and controllable, reducing the production defect rate.

[0053] The above-disclosed embodiments are merely one or more preferred embodiments of this application and should not be construed as limiting the scope of this application. Those skilled in the art will understand that all or part of the processes for implementing the above embodiments and equivalent variations made in accordance with the claims of this application are still within the scope of this application.

Claims

1. A sealing structure for an implantable sensor, characterized in that, Includes a collar, sensor, housing one, steel needle, needle sleeve, soft rubber two, silicone plug, housing two, and circuit board assembly; The upper surface of the collar is provided with a positioning groove, and the sensor is disposed in the positioning groove; the lower side of the housing is connected to the sensor and is located above the sensor; a positioning post is fixedly connected to the inner side of the housing; the steel needle is disposed on the housing; the needle sleeve is disposed below the steel needle; the soft rubber second is fixedly connected to the needle sleeve and is located at the end of the needle sleeve near the collar; the silicone plug is disposed at the end of the needle sleeve away from the steel needle; the housing second is connected to both the collar and the housing first and is located below the housing first; the circuit board assembly is disposed between the housing first and the housing second, and the circuit board assembly is provided with a connector slot.

2. The implantable sensor sealing structure as described in claim 1, characterized in that, The sensor and the collar are fixedly connected by adhesive or ultrasonic welding.

3. The implantable sensor sealing structure as described in claim 1, characterized in that, The steel needle has a rotating groove located on the outside of the steel needle.

4. The implantable sensor sealing structure as described in claim 1, characterized in that, The needle sleeve has two spiral buckles, which are located inside the needle sleeve.

5. The implantable sensor sealing structure as described in claim 1, characterized in that, The steel needle includes a soft rubber core and a needle base; the needle base is disposed above the needle sheath; the soft rubber core and the needle base are fixedly connected and located on the side of the needle base.

6. The implantable sensor sealing structure as described in claim 1, characterized in that, The second housing is fixedly connected to the collar and the first housing by glue or ultrasonic welding.

7. The implantable sensor sealing structure as described in claim 1, characterized in that, The housing and the collar are fixedly connected by adhesive or ultrasonic welding.

8. A method for assembling an implantable sensor sealing structure, applied to the implantable sensor sealing structure as described in any one of claims 1-7, characterized in that, include: Place the sensor in the positioning slot of the collar and make the sensor straddle the collar. The side of the sensor spanning the collar contacts the lower side of the housing and is connected and fixed by glue or ultrasonic welding. The steel needle consists of a needle base and a soft rubber layer. One side of the soft rubber layer contacts the upper side of the housing layer to form a seal. The soft rubber at the front end of the needle sleeve contacts the surface of the collar, and the two spiral buckles inside the needle sleeve cooperate with the rotating groove on the steel needle to lock the housing, steel needle and needle sleeve through rotational locking force. A silicone plug is pressed into the end of the needle sheath away from the steel needle. Soft rubber one and soft rubber two are compressed and deformed to seal the entire sensor implantation end. Radiation sterilization and sealing test can then be performed. Place the circuit board assembly with a through hole in the middle between the end of the steel needle near the soft rubber one and the end of the needle sleeve near the soft rubber two, and press it tightly against the inner side of the housing one. After passing the needle sleeve through the second housing, it is positioned and assembled with the collar and the first housing. The second housing, the collar, and the first housing are connected by glue or ultrasonic welding to form a closed space, thus completing the assembly.

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