Airtight packaging body capable of monitoring packaging airtightness

Abstract

The invention discloses an airtight packaging body capable of monitoring packaging airtightness, which comprises a shell and a circuit board in the shell, and is characterized in that an expansion assembly and a variable resistor are arranged in the shell; the expansion assembly comprises an expansion piece, the variable resistance piece is provided with a sliding variable resistance part, and the sliding variable resistance part is connected with the expansion piece; the expansion piece absorbs water vapor in the shell to expand and pushes the sliding variable resistance part to move so as to change the electrifying resistance of the variable resistance piece; the circuit is arranged on the circuit board, and the circuit responds to the change of the resistance value of the electrified resistor and outputs a prompt signal; according to the airtight packaging body, the packaging airtightness of the implanted instrument can be monitored in a lossless and real-time mode, the humidity in a narrow airtight space can be monitored in real time, meanwhile, the dehumidification function is achieved, and the airtight packaging service life of components is effectively prolonged.

Description

Technical Field

[0001] The invention belongs to the technical field of medical devices, and in particular relates to an airtight package capable of monitoring the airtightness of packaging. Background Art

[0002] At present, active implantable devices, including cochlear implants, auditory brainstem implants, bone conduction hearing aids, artificial vision, implantable drug pumps, etc., are often equipped with components such as chips and electronic circuits to achieve their functions and treatment purposes. Since water vapor has a significant impact on the functional failure of components (for example, water vapor accelerates metal corrosion, damages leads and bonding areas, and reduces the insulation performance of components), in order to ensure the long-term effectiveness (>10 years) of active implantable devices in body fluid environments, components often need to be hermetically sealed before they can be implanted into the human body.

[0003] There are large differences in the permeability of gases in different materials. It is generally believed that: metal < ceramic < glass < fluorocarbon < epoxy resin < silicone rubber. Therefore, the components in active implantable devices are often hermetically packaged with metal (for example, pure titanium, titanium alloy) or ceramic (for example, high-purity alumina or zirconium oxide), and the packaging shell is wrapped with implantable silicone rubber to improve its comfort. Since the components after hermetic packaging still need to be electrically connected to the outside, it is impossible to achieve conductive insulation between the two by using all metal materials as the packaging shell, that is, a conductive path will be formed between the components and the shell. Optional solutions include hermetic packaging with all ceramic materials, but ceramic materials have the characteristics of hardness and brittleness, and will crack or even break under high-intensity impact, resulting in failure of the hermetic packaging. Therefore, the current mainstream hermetic packaging of active implantable devices uses a metal shell combined with a ceramic feedthrough.

[0004] In the existing requirements for implantable devices, the 10-year cumulative water vapor content of the hermetic package should be less than 5000ppm, which is equivalent to 8.1% humidity at 37°C and 16% humidity at 25°C. Under room temperature conditions, the ambient humidity generally ranges from 30% to 80%, so dehumidification is often required during hermetic packaging, and the humidity of the working environment is controlled. In theory, the risk of water vapor leakage in the package shell is extremely low, but it is still difficult to completely avoid it in practical applications. Water vapor leakage will inevitably lead to the failure of the implanted device, causing harm to the patient, and requiring a secondary operation to remove the implanted device. On the one hand, the various materials that constitute the components have different degrees of physical or chemical adsorption of water vapor. Therefore, before hermetic packaging, some of the adsorbed water can be removed by heating. However, considering the temperature tolerance of the components, the temperature should not be too high, so the adsorbed water is difficult to completely remove. The humidity of the working environment should be controlled during hermetic packaging to reduce the water vapor introduced into the package shell by the ambient humidity. On the other hand, the laser welding quality of the hermetic package has an important influence on the airtightness of the package shell. In the process of R&D or processing and production, inert gases such as helium and neon are often introduced into the packaging shell. After the packaging is completed, the packaging shell is tested for airtightness (for example, helium leakage rate) to evaluate the airtightness and packaging life of the packaging shell, and to optimize the process or structure. Finally, although the combined application of metal shell and ceramic feedthrough reduces the risk of water vapor leakage in full ceramic packaging, it is difficult to avoid it completely. The brittleness of ceramics is an inherent property. Through reasonable structural design, the ceramic feedthrough is placed in a position on the packaging shell that is less affected by external impact, which can avoid the fracture of ceramics to a certain extent. Through-type cracks are easily discovered through the airtightness test as described above, but the early non-through-type cracks or defects are difficult to detect effectively and non-destructively. Although non-through-type cracks or defects will not immediately cause water vapor leakage, the defects will develop into through-type cracks under the action of various residual stresses during subsequent processing or long-term use, and cause water vapor leakage. And the development of ceramic cracks is unpredictable.

[0005] After the hermetic packaging, the packaging shell still has multiple subsequent processing processes to complete the final implant device, such as wrapping with silicone rubber, disinfection and sterilization, transportation, etc. As mentioned above, the subsequent processing process may cause ceramic fracture and lead to water vapor leakage, and the airtightness test is not suitable for implant devices wrapped with silicone rubber on the outside. In order to ensure the airtightness of the packaging of implantable devices, it is often evaluated in a destructive way. Specifically, the implanted device is placed under simulated conditions for accelerated aging. After a certain period of time, the silicone rubber wrapped on the outside of the packaging shell is taken out and removed, the packaging shell is punctured and residual gas analysis is performed, and the water vapor content in the packaging shell is measured to determine its airtightness. The simulation conditions often use physiological saline to simulate the body fluid environment and accelerate with temperature. For example, 1 day at 80°C is equivalent to 20 days at 37°C. Based on this, the theoretical packaging life of the implantable device can be determined to guide structural optimization, product design or airtight packaging process optimization. However, the actual packaging life of the device implanted in the patient's body is difficult to effectively evaluate and monitor.

[0006] In summary, the accumulation of water vapor in the airtight package of active implantable devices will inevitably lead to the functional failure of components, thereby damaging the implantable device, causing harm to the patient, and requiring a second operation to remove the implantable device. Although the water vapor permeability of the metal and ceramic materials currently selected as airtight packages is extremely low, it is difficult to achieve complete impermeability. The ceramic material in the packaging shell has inherent brittleness. Although the airtightness of the packaging shell can be non-destructively tested, the final implantable device can only use destructive methods to detect the airtightness of the package, and it is only applicable to the research and design development of the package life. The airtightness of the package of the implantable device implanted in the patient's body cannot be monitored in real time. Although the initial defects of the ceramic material will not cause water vapor leakage, the subsequent production and processing process will lead to the development of defects, thus posing the risk of water vapor leakage. Therefore, it is still difficult to monitor the airtightness of the package of the implantable device non-destructively and in real time, especially for the implantable device that has been implanted in the patient's body.

[0007] In view of the above problems, the water vapor penetration in the airtight package can be monitored by a dew point sensor. However, the dew point sensor can only show when the water vapor enters, but it is difficult to feedback the water vapor content, and this method is not suitable for testing on the human body. Many papers disclose a method for remote wireless real-time monitoring of the humidity in the package shell by using a highly sensitive capacitive humidity sensor. Patent US4332256 discloses a remote telemetry system for humidity in a pacemaker, and patent WO2008103717A1 discloses a method for using a sensor to monitor and control the humidity in an implant. Existing solutions often rely on humidity sensors to achieve real-time monitoring of the water vapor content in the airtight package. However, high-precision, low-voltage micro sensors are often expensive, especially when they need to meet application requirements in extremely small spaces.

[0008] In summary, it is still difficult to monitor the air tightness of the packaging of implanted devices non-destructively and in real time. Summary of the invention

[0009] In order to solve the above problems, the technical solution of the present invention is as follows: an airtight package capable of monitoring the airtightness of a package, wherein an expansion assembly and a variable resistor are arranged in the shell; the expansion assembly includes an expansion assembly, and the variable resistor is provided with a sliding variable resistor portion, and the sliding variable resistor portion is connected to the expansion assembly; the expansion assembly absorbs water vapor in the shell and expands, and pushes the sliding variable resistor portion to move to change the on-resistance of the variable resistor; and also includes a circuit arranged on the circuit board, and the circuit responds to the change in the resistance value of the on-resistance and outputs a prompt signal.

[0010] Preferably, a metal feedthrough needle is provided on the shell, the metal feedthrough needle is connected to the circuit board, and the prompt signal is transmitted to the outside of the airtight package through the metal feedthrough needle.

[0011] Preferably, the expansion assembly further includes a limiting member for limiting directional expansion of the expansion member.

[0012] Preferably, the limiting member comprises a limiting shell, a limiting cavity is provided in the limiting shell, the expansion member is located in the limiting cavity, and the limiting cavity is used to make the expansion member move along the length direction of the limiting cavity when expanding; the expansion member abuts against one end of the limiting cavity.

[0013] Preferably, the sliding variable resistance part includes a sliding piece and a sliding rod, and the sliding piece is connected to the expansion piece and the sliding rod; one end of the sliding rod away from the sliding piece is in contact with the variable resistor; when the expansion piece pushes the sliding piece to move, the sliding piece drives the sliding rod to move on the variable resistor to change the on-resistance of the variable resistor.

[0014] Preferably, a sliding groove is provided on the limiting shell, a protrusion sliding on the sliding groove is provided on the sliding sheet, and the protrusion passes through the sliding groove and is connected to the sliding rod.

[0015] Preferably, it also includes a connecting portion, which is fixedly installed between the limiting member and the circuit board.

[0016] Preferably, at least two expansion members are arranged in the housing, each of the expansion members is connected to a corresponding variable resistor, and each of the variable resistors is electrically connected.

[0017] Preferably, a drying component is also provided in the shell for absorbing water vapor in the shell.

[0018] The beneficial effects of the present invention are:

[0019] 1. The airtight package of the present application can realize real-time monitoring of humidity in a small airtight space without using expensive, high-precision, low-voltage, miniature humidity sensors, and at the same time has a dehumidification function, effectively extending the airtight packaging life of components.

[0020] 2. The expansion assembly, variable resistor and circuit in the airtight package of the present application can be placed at multiple locations in the shell, thereby achieving flexible layout design.

[0021] 3. The airtight package of the present application is suitable for non-destructive testing of semi-finished packaging shells, and also meets the needs of non-destructive and online testing of final products, especially airtight packages after implantation in the human body, so as to remind users or suppliers of relevant fault conditions and issue early warnings at any time, and can be applied to active implantable devices and daily electronic products.

[0022] 4. The hermetic package of the present application has excellent dehumidification effect, and the predicted package life at 37°C under the accelerated test environment has a low water vapor content. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] Figure 1 It is a schematic diagram of the overall structure of an existing airtight package;

[0024] Figure 2 It is a schematic diagram of the overall structure of a hermetic package capable of monitoring the hermeticity of packaging according to a specific embodiment of the present invention;

[0025] Figure 3 It is a structural schematic diagram of an airtightness monitoring process of an airtight package capable of monitoring the airtightness of a package according to a specific embodiment of the present invention;

[0026] Figure 4 It is a partial structural schematic diagram of an airtight package capable of monitoring the airtightness of a package according to a specific embodiment of the present invention;

[0027] Figure 5 A schematic diagram of a sliding piece structure of an airtight package capable of monitoring the airtightness of a package according to a specific embodiment of the present invention;

[0028] Figure 6 It is a schematic diagram of a sliding rod structure of an airtight sealing package capable of monitoring the airtightness of a package according to a specific embodiment of the present invention;

[0029] Figure 7 It is a schematic diagram of an embodiment of an airtight package capable of monitoring the airtightness of a package and comparing the changes in its water vapor content. DETAILED DESCRIPTION

[0030] The preferred embodiments of the present invention will be described in detail below with reference to the accompanying drawings.

[0031] See also Figure 1 , which is an existing airtight packaging structure. Figure 1 A is a schematic diagram of the overall structure of the airtight package. Figure 1 B is a side view of the peripheral structure of the ceramic feedthrough. The airtight package 10 includes a shell and a ceramic feedthrough 130. The shell includes a metal lower shell 110 and a metal upper shell 120. The ceramic feedthrough 130 is composed of a metal feedthrough needle 1301, a ceramic 1302, and a metal flange 1303 from the inside to the outside. The ceramic 1302 in the ceramic feedthrough 130 is connected to the metal feedthrough needle 1301 and the metal flange 1303 by brazing, and there are gaps 410 / 420 that are not visible on a macro scale. The metal flange 1303 of the ceramic feedthrough 130 and the metal lower shell 110, the metal lower shell 110 and the metal upper cover 120 are connected by laser welding, and there are gaps 430 / 440 that are not visible on a macro scale. Based on the above, a complete airtight package 10 is formed.

[0032] The circuit board 20 is placed in the shell of the airtight package 10. One end of the metal feedthrough pin 1301 is connected to the circuit board 20 by a wire 30, and the other end is also connected to the receiving coil, stimulation electrode (not shown) and the like outside the airtight package 10 by a wire 30, so as to realize the communication between the inside and outside of the airtight package 10. The water vapor penetration pathway of the device provided with the airtight package 10 in an environment such as body fluid is mainly through the gap 40 and the ceramic 1302, especially the crack defect (not shown) that may exist on the ceramic 1302. Therefore, the quality of laser welding, brazing and ceramic has an important influence on the life of the airtight package. Often, the airtightness of the airtight package 10 can be determined by a non-destructive testing method such as helium leakage, so as to evaluate its packaging life or optimize the structure and processing technology. However, it is still necessary to go through multiple subsequent process steps from the airtight package 10 to the final product, and the initial non-penetrating crack of the ceramic 1302 will not lead to the failure of the helium leakage detection, but the crack will develop in the long term and it is unpredictable. Therefore, the qualified helium leakage test of the airtight package 10 cannot guarantee the qualified airtight packaging of the final product, especially the airtightness of the final product after long-term use is more difficult to effectively monitor.

[0033] See also Figure 2, an expansion assembly and a variable resistor 620 are arranged in the shell of the airtight package 10 that can monitor the airtightness of the package; the expansion assembly includes an expansion member 530, and the variable resistor 620 is provided with a sliding variable resistor part, and the sliding variable resistor part is connected to the expansion member 530; the expansion member 530 absorbs the water vapor in the shell and expands, and pushes the sliding variable resistor part to move to change the on-resistance of the variable resistor 620. It also includes a circuit 70 arranged on the circuit board 20, and the circuit 70 responds to the change in the resistance value of the on-resistance and outputs a prompt signal. One end of the metal feedthrough needle 1301 arranged on the shell of the airtight package 10 is connected to the circuit board 20 through a wire 30, and the prompt signal is transmitted to the outside of the airtight package 10 through the metal feedthrough needle 1301.

[0034] See also Figure 2 , the expansion assembly also includes a limiting member for limiting the directional expansion of the expansion member 530. Further, the limiting member includes a limiting shell 520, and the limiting shell 520 is provided with a plurality of air holes 5201, so that water vapor is absorbed by the expansion member 530 through the air holes 5201; the end of the limiting shell 520 away from the expansion member 530 can be set as an open structure, which is convenient for the expansion member 530 to be loaded, and also allows water vapor to reach the air holes 5201 more effectively. A limiting cavity is provided in the limiting shell 520, and the expansion member 530 is located in the limiting cavity. The limiting cavity is used to make the expansion member 530 move along the length direction of the limiting cavity when it expands. The expansion member 530 abuts against one end of the limiting cavity, and the diameter of the expansion member 530 is equivalent to the inner diameter of the limiting shell 520, and the length of the limiting 520 is slightly larger than the length of the expansion member 530 after it is fully expanded. The above design enables the expansion displacement of the expansion member 530 to be mainly reflected in the length direction of the limiting shell 520, further improving the sensitivity of air tightness monitoring.

[0035] Specifically, the expansion member 530 has the characteristic of absorbing water, and thus can also realize the dehumidification function in the airtight package 10, thereby extending the life of the components in the airtight package. As a supplementary means, a drying component 80 can also be selectively placed in the airtight package 10 to further improve the package life. Since the water absorption of the expansion member 530 and the drying component 80 is positively correlated with the quality of the materials used, the drying component 80 should be placed as much as possible when space permits, so as to maximize the dehumidification effect. Similar to the expansion member 530, the drying component 80 should be placed near the gap to improve the dehumidification effect.

[0036] The drying component 80 can be implemented on the inner wall of the airtight package 10 or on the circuit board 20 in various forms, such as solid, coating, etc. Further, the drying component 80 is taken as an example of solid particle form, and the drying component 80 includes a receiving cavity 810 and a desiccant 820, and the desiccant 820 is in solid form and is placed in the receiving cavity 810 for fixation. The size of the receiving cavity 810 should be slightly larger than the desiccant 820 to prevent the desiccant 820 from absorbing water and swelling. A plurality of air holes 8101 should be provided on the receiving cavity 810 so that the desiccant 820 absorbs water vapor in the airtight package 10. When the drying component 80 is implemented in the form of a coating, for example, the desiccant 820 can be mixed with a medical silicone rubber adhesive, and an appropriate amount of a volatile solvent can be added, and the desiccant 820 can be applied to the inner wall of the airtight package 10 or on the circuit board 20, and then cured.

[0037] The expansion member 530 is a water-absorbing material with high water absorption rate and high expansion rate (water absorption expansion rate>5000%). Exemplarily, it can be selected from starch grafted resins (starch-acrylonitrile grafted polymers, starch-acrylic acid copolymers, starch-acrylamide grafted copolymers), cellulose resins (cellulose grafted copolymers, cellulose derivative crosslinked products), agarose derivatives, chitin derivatives, polyacrylic acid resins (sodium polyacrylate crosslinked products), polyvinyl alcohol resins (polyvinyl alcohol crosslinked polymers) and other high water absorption and expansion resins / rubbers and their combinations. The desiccant 820 should at least contain a water-absorbing material with a low water absorption and expansion rate (<20%), which is one of MOF, zeolite, bentonite, diatomaceous earth, sepiolite, activated carbon, aluminum oxide, magnesium oxide, silicon oxide, calcium oxide, calcium chloride, calcium hydroxide and their combinations. The desiccant 820 can be a pure water-absorbing material with a low water absorption and expansion rate (<20%), or a combination of a water-absorbing material with a low water absorption and expansion rate (<20%) and other materials and additives.

[0038] The sliding variable resistance part includes a sliding piece 540 and a sliding rod 630. The sliding piece 540 is provided with a plurality of air holes 5402 for water vapor to pass through. The sliding piece 540 is connected to the expansion piece 530 and the sliding rod 630. One end of the sliding rod 630 away from the sliding piece 540 contacts the variable resistor 620; when the expansion piece 530 pushes the sliding piece 540 to move, the sliding piece 540 drives the sliding rod 630 to move on the variable resistor 620 to change the on-resistance of the variable resistor 620, thereby effectively monitoring the airtightness of the airtight package according to the change of the on-resistance.

[0039] See also Figure 2, the circuit 70 includes a power supply 710, a protective resistor 720, a voltmeter 730, and an ammeter 740. One end of the circuit 70 is connected to the variable resistor 620, and the other end is connected to the slide bar 630, so as to form a complete current path. The power supply 710 is used to supply power to the circuit 70, the voltmeter 730 and the ammeter 740 are used to indicate the change of the on-resistance of the variable resistor 620, and the protective resistor 720 is used to prevent short circuit protection due to too small on-resistance in the circuit 70. In addition, the circuit 70 is integrated on the circuit board 20, and the prompt signal such as humidity information can be transmitted to the external device (not shown) through the circuit board 20 or perform related control functions, fault alarms, etc.

[0040] See also Figure 3 , which is a specific process for monitoring the airtightness of the package of the airtight package 10. When the water vapor content in the airtight package 10 increases, the expansion piece 530 will absorb the water vapor and extend along its horizontal length direction in the limiting cavity, pushing the slide 540 to move to the right, driving the slide bar 630 to move to the right, so that the on-resistance in the access circuit 70 becomes smaller, thereby increasing the current in the circuit 70 and reducing the voltage. Since the water absorption elongation of the expansion piece 530 is related to the humidity, and the resistance / current / voltage in the circuit is related to the elongation through the variable resistor 60, the humidity can be monitored by the change of the resistance value. The prompt signal is transmitted to the in vitro device through the circuit 70 and the metal feedthrough needle 1301 to achieve monitoring.

[0041] See also Figure 4 Since the remaining space in the airtight package 10 after placing various components is often limited, the single larger expansion member 530 and variable resistor 620 can be split into multiple smaller components and placed in applicable spatial locations. Figure 4 The partial structure of an example in which two expansion members 530 and a variable resistor 620 are provided is shown. The first variable resistor 620 is connected to the sliding rod 630 of the second variable resistor 620 through a wire 30, and the sliding rod 630 of the first variable resistor 620 and the second variable resistor 620 are connected to the circuit 70, that is, the two variable resistors 60 are connected to the circuit 70 in series. Alternatively, the circuit connection can also be performed in other forms; for example, two circuits 70 are provided, and the two variable resistors 60 are connected to the two circuits 70 respectively. For example, the two variable resistors 60 are connected to one circuit 70 in parallel. When water vapor penetrates into the airtight package 10, both expansion members 530 will absorb water and expand, and the corresponding variable resistor 620 will become smaller, and the change in the resistance value in the circuit indicates the humidity condition.

[0042] Additionally, if space permits, to improve monitoring sensitivity and dehumidification effectiveness, the expansion member 530 should be placed near locations (ie, gaps) where water vapor penetration is most likely to occur, such as ceramic feedthroughs 130 and / or laser welding.

[0043] See also Figure 5 In order to make the slide 540 move better in the limiting shell 520, the limiting shell 520 is provided with a sliding groove 5202, and the slide 540 is provided with a protrusion 5401 that slides on the sliding groove 5202. The protrusion 5401 passes through the sliding groove 5202 and is connected to the slide rod 630. One of the protrusions 5401 is fixedly connected to the slide rod 630; when the slide 540 moves, the slide rod 630 will move with it. Specifically, there are at least three sliding grooves 5202 and protrusions 5401, and the number of the two is equal, and the size and position match. Specifically, Figure 5 middle, Figure 5 A is the side view of the limit shell. Figure 5 B is a cross-sectional view of the limiting shell 520, Figure 5 C is a cross-sectional view of a limit housing with four sliding grooves. Figure 5 D is the cross-sectional view of the sliding plate, Figure 5 E is a cross-sectional view of a sliding plate provided with four protrusions.

[0044] See also Figure 6 The connection between the slide bar 630 and the variable resistor 620 can be realized in various forms, and the basic requirement is that the slide bar 630 can move on the variable resistor 620 without friction or with low friction, and the contact parts of the slide bar 630 and the variable resistor 620 should not be separated from each other during the movement, and should always maintain contact. Specifically, the slide bar 630 and the variable resistor 620 can abut against each other, or the variable resistor 620 can be embedded in the slide bar 630, see Figure 6 .

[0045] See also Figure 2 The airtight package 10 further includes a connecting portion 510, which is fixedly installed between the limiting shell 520 and the circuit board 20 for fixing the limiting shell 520. It also includes a gasket 610 located between the variable resistor 620 and the circuit board 20 for conducting insulation.

[0046] Except for the expansion member 530 and the desiccant 820, which have water absorption characteristics, other components should not have obvious characteristics of absorbing or releasing water. The connecting part 510, the limiting shell 520, the sliding piece 540, the gasket 610, and the accommodating cavity 810 are insulating materials without obvious conductivity. Exemplarily, one or more of ceramic, glass, PEEK, ABS, PET, polypropylene, polyethylene, polyvinyl chloride, and polyester can be selected. The sliding rod 630 is a conductive material, which is one of copper, aluminum, steel, and a combination thereof.

[0047] The experimental effects of the present invention will be described below with reference to specific embodiments.

[0048] The size of the airtight package 10 is 20×20×5 mm, and the internal space after placing the relevant components is 1 cm 3 , filled with 70% argon + 30% helium, with an air pressure of 1 bar. The expansion member 530 is made of sodium polyacrylate cross-linked material, and its water absorption expansion rate is 5000%, or 50 times. The desiccant 820 is made of calcium oxide, and its water absorption rate is 50%, or 0.5 times. The package life is determined by an accelerated test, with physiological saline simulating the human body fluid environment, and 80°C acceleration is equivalent to 20 times at 37°C. The water vapor content in the airtight package 10 under the accelerated environment is monitored for 1 year.

[0049] Comparative Example 1: There is no water-absorbing material in the airtight package 10, and a conventional humidity sensor is used to monitor the change of the water vapor content of the shell 10 over time.

[0050] Comparative Example 2: An expansion component is placed in the airtight package 10, but the circuit 70 is not connected, and a conventional humidity sensor is used to monitor the change of the water vapor content of the shell 10 over time. The mass of the expansion component 530 is 15 mg, the radius is 3 mm, and the length is 0.2 mm.

[0051] Example 1: An expansion component is placed in the airtight package 10, connected to the circuit 70, and the change of the water vapor content in the shell over time is monitored by the method of the present invention. The mass of the expansion component 530 is 15 mg, the radius is 3 mm, and the length is 0.2 mm.

[0052] Example 2: Two expansion components are placed in the airtight package 10, connected to the circuit 70, and the method of the present invention is used to monitor the change of the water vapor content of the shell 10 over time. The mass of the two expansion components 530 is 7.5 mg, the radius is 3 mm, and the length is 0.1 mm.

[0053] Example 3: An expansion component and a drying component 80 are placed in the airtight package 10, and the circuit 70 is connected. The device of the present invention is used to monitor the change of the water vapor content of the airtight package 10 over time. The mass of the expansion component 530 is 15 mg, the radius is 3 mm, and the length is 0.2 mm. The mass of the desiccant 820 is 400 mg.

[0054] See also Figure 7 , are the water vapor contents of the comparative example and the example in a saline environment at 80°C. The water vapor content of the comparative example 1 at 180 days is 5000 ppm v , and gradually increased with time. The water vapor content of comparative example 2 was still basically 0 ppm at 180 days v, and then gradually increased with time, reaching 2000-5000ppm at 360 days v This indicates that the expansion assembly in Comparative Example 2 can absorb the water vapor entering the airtight package 10 and has a dehumidification effect, with a maximum absorption of 5000 ppm. v In Example 1, before 180 days, the water vapor content entering the airtight package 10 measured by the expansion component is close to the result measured by the humidity sensor in Comparative Example 1, indicating that the expansion component can monitor the water vapor content entering the airtight package 10 in real time. After 180 days, due to the absorption of 5000ppm by the expansion component, the water vapor content in the airtight package 10 is close to the result measured by the humidity sensor in Comparative Example 1. v After the water vapor reaches saturation, it will no longer have the function of humidity monitoring and dehumidification. At this time, a larger or more expansion components can be selected to further improve the dehumidification effect and the upper limit of humidity monitoring. It should also be noted that the water vapor content monitored in Example 1# at 180 days is 5000ppm v is the accumulated water vapor content entering the airtight package 10, rather than the water vapor content in the airtight package 10 at this time (0 ppm v About). Example 1 and Example 2 show that when the total mass of the expansion member 530 is the same, splitting a single larger expansion component into two smaller expansion components has similar humidity monitoring and dehumidification effects. In Example 3, the drying component 80 will preferentially absorb water vapor, and the expansion component will not begin to absorb water vapor until it fails. Therefore, it is difficult for the expansion component to monitor the water vapor absorbed by the drying component 80. In addition, the combined use of the drying component 80 and the expansion component can greatly improve the packaging life of the airtight package 10, and the water vapor content under accelerated conditions of 360 days is 2000ppm. v about.

[0055] The above only takes the implanted part of the active implantable device as an exemplary description. The external part of the active implantable device, as well as electronic products and related products involving hermetic packaging of components are all suitable for the hermetic packaging body capable of monitoring the hermeticity of the packaging of the present invention.

[0056] Finally, it should be noted that the above preferred embodiments are only used to illustrate the technical solutions of the present invention rather than to limit it. Although the present invention has been described in detail through the above preferred embodiments, those skilled in the art should understand that various changes can be made in form and details without departing from the scope defined by the claims of the present invention.

Claims

1. An airtight package capable of monitoring the airtightness of a package, comprising a housing and a circuit board in the housing, characterized in that: An expansion component and a variable resistor are arranged in the shell; the expansion component includes the expansion component, and the variable resistor is provided with a sliding variable resistor part, and the sliding variable resistor part is connected to the expansion component; the expansion component absorbs water vapor in the shell and expands, and pushes the sliding variable resistor part to move to change the on-resistance of the variable resistor; and also includes a circuit arranged on the circuit board, and the circuit responds to the change of the resistance value of the on-resistance and outputs a prompt signal.

2. The hermetic package capable of monitoring the air tightness of packaging according to claim 1, characterized in that: The shell is provided with a metal feed-through needle, the metal feed-through needle is connected to the circuit board, and the prompt signal is transmitted to the outside of the airtight package through the metal feed-through needle.

3. The hermetic package capable of monitoring the air tightness of packaging according to claim 1, characterized in that: The expansion assembly also includes a limiting member for limiting directional expansion of the expansion member.

4. The hermetic package capable of monitoring the air tightness of packaging according to claim 3, characterized in that: The limiting member comprises a limiting shell, a limiting cavity is arranged in the limiting shell, the expansion member is located in the limiting cavity, and the limiting cavity is used to move the expansion member along the length direction of the limiting cavity when expanding; the expansion member abuts against one end of the limiting cavity.

5. The airtight package capable of monitoring the airtightness of packaging according to claim 1 or 4, characterized in that: The sliding variable resistance part includes a sliding piece and a sliding rod, the sliding piece is connected to the expansion piece and the sliding rod; one end of the sliding rod away from the sliding piece contacts the variable resistor; when the expansion piece pushes the sliding piece to move, the sliding piece drives the sliding rod to move on the variable resistor to change the on-resistance of the variable resistor.

6. The hermetic package capable of monitoring the air tightness of packaging according to claim 5, characterized in that: The limiting shell is provided with a sliding groove, the sliding sheet is provided with a protrusion sliding on the sliding groove, and the protrusion passes through the sliding groove and is connected with the sliding rod.

7. The hermetic package capable of monitoring the air tightness of packaging according to claim 3, characterized in that: It also includes a connecting portion, which is fixedly installed between the limiting component and the circuit board.

8. The hermetic package capable of monitoring the air tightness of packaging according to claim 1, characterized in that: At least two expansion members are arranged in the shell, each of the expansion members is connected to a corresponding variable resistor, and each of the variable resistors is electrically connected.

9. The hermetic package capable of monitoring the air tightness of packaging according to claim 1, characterized in that: A drying component is also arranged in the shell for absorbing water vapor in the shell.

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