A thermal management implantable brain-machine interface device and method of packaging thereof

Abstract

The application relates to a heat management implantable brain-computer interface device and a packaging method thereof. The heat management implantable brain-computer interface device comprises a first shell in contact with scalp tissue and a second shell in contact with a skull or brain tissue; the first shell and the second shell cooperate to form a sealed outer shell packaging element, and the outer shell packaging element internally accommodates brain-computer interface device electronic elements; the first shell is made of a good thermal conductor; and the second shell is made of a poor thermal conductor. The heat management implantable brain-computer interface device provided by the application can avoid the diffusion of heat mainly to brain tissue and maximally reduce brain tissue heat damage by adopting different shell materials with different thermal properties for packaging without increasing the size of the device and reducing the performance of the device.

Description

TECHNICAL FIELD

[0001] The present application belongs to the field of medical devices, and more particularly relates to a heat management implantable brain-computer interface device and a packaging method thereof. BACKGROUND

[0002] Implantable devices refer to electronic devices implanted into the human body for a long time through surgical means, such as brain-computer interface device, for monitoring physiological characteristics or treating physiological diseases, the core of which is to directly interact with biological tissues to achieve a specific medical purpose. Implantable devices are limited by strict biocompatibility and miniaturization design requirements. The internal circuit of the implantable device generates heat when working. If the temperature is not properly controlled, it may cause damage to the surrounding tissues, especially the brain tissue which is sensitive to temperature. According to the CEM43 evaluation standard, if the brain tissue is exposed to a temperature higher than 43°C for too long, the cumulative equivalent minutes (CEM43) will be too high, which may cause irreversible thermal damage.

[0003] Current mainstream heat management solutions rely on low-power circuit design, device selection optimization, or increasing the surface area of the device to suppress temperature rise, but these methods often come at the expense of system performance or increased device size. Performance degradation, while reducing heat generation, weakens the signal acquisition and processing capabilities of the implanted device; while increasing the heat dissipation area leads to the size of the implanted device exceeding the standard, affecting the feasibility of minimally invasive surgery and the comfort of use. This limitation is particularly prominent in long-term implantation scenarios, restricting the clinical application expansion of brain-computer interface device technology.

[0004] As a powerful implantable device, the heat management of the implantable brain-computer interface device is directly related to patient safety and device reliability. The brain tissue is extremely sensitive to temperature, and at the same time, the implanted device must meet the biocompatibility standards (such as ISO10993) and have certain size limitations, which excludes the application of active heat dissipation or large-volume heat sinks. More complex is that the introduction of new technologies such as wireless power supply introduces additional heat sources, further increasing the difficulty of heat management of the implantable brain-computer interface device. SUMMARY

[0005] In view of the above defects or improvement needs of the prior art, the present application provides a heat management implantable brain-computer interface device and a packaging method thereof, which aims to use a heat management implantable brain-computer interface device, encapsulate it with shell materials having different thermal properties, achieve non-uniform heat distribution, and optimize the heat conduction path, so that heat is dissipated from the scalp side, protecting the brain tissue temperature stable, thereby solving the technical problem that the increased heat generation of the existing brain-computer interface device may cause thermal damage to the brain tissue.

[0006] To achieve the above-mentioned purpose, according to one aspect of the present application, a heat management implantable brain-computer interface device is provided, comprising: a first shell body in contact with the scalp tissue, and a second shell body in contact with the skull or brain tissue;

[0007] The first shell and the second shell cooperate to form a sealed housing package, and the brain-computer interface device electronic elements are contained inside the housing package;

[0008] The first shell is a good thermal conductor;

[0009] The second shell is a poor thermal conductor.

[0010] Preferably, the thermal conductivity of the first shell of the thermal management implantable brain-computer interface device is more than 10 times that of the second shell; the thermal conductivity of the first shell is between 5-200 W / m·K, and the thermal conductivity of the second shell is between 0.2-0.5 W / m·K.

[0011] Preferably, the specific heat capacity of the material of the first shell of the thermal management implantable brain-computer interface device is less than that of the second shell; the specific heat capacity of the material of the first shell is between 500-900 J / kg·K, and the specific heat capacity of the material of the second shell is between 1000-2300 J / kg·K.

[0012] Preferably, the material of the first shell is selected from one or more of titanium metal, medical titanium alloy, biocompatible ceramic, and aluminum nitride; and the material of the second shell is selected from one or more of polyether ether ketone, polytetrafluoroethylene, and polyethylene.

[0013] Preferably, when the material of the first shell is titanium metal, medical titanium alloy, or biocompatible ceramic, the first shell has a thermal conductive layer on the outside; and the second shell has a porous thermal insulation layer on the inside.

[0014] Preferably, the thermal conductive layer on the outside of the first shell is an aluminum nitride or silicon carbide deposition layer.

[0015] The porous thermal insulation layer on the inside of the second shell is formed by a plasma etching process.

[0016] Preferably, the wireless communication chip, power management chip, and / or logic control chip in the brain-computer interface device electronic elements are arranged close to the first shell.

[0017] Preferably, the brain-computer interface device electronic elements are soldered on a circuit board, the profile of the circuit board is adapted to the profile of the interface between the first shell and the second shell, and the circuit board is assembled on the interface between the first shell and the second shell.

[0018] Preferably, the thermal management implantable brain-computer interface device further comprises a temperature monitoring assembly, a temperature sensor of the temperature monitoring assembly is arranged close to the second shell, and the temperature monitoring assembly is an integrated thermal element or a digital temperature sensor.

[0019] According to another aspect of the present application, a packaging method of the thermal management implantable brain-computer interface device is provided, the second shell is made of organic polymer material, and the method comprises the following steps:

[0020] The first shell and the second shell are respectively pre-processed;

[0021] The pre-processed first shell and the second shell are bonded by using an adhesive to form a sealed combination.

[0022] According to another aspect of the present application, a packaging method of the thermal management implantable brain-computer interface device is provided, the second shell is made of organic polymer material, and the method comprises the following steps:

[0023] The first shell and the second shell are combined and sealed by mechanical embedding and cooperation of a medical rubber ring.

[0024] According to another aspect of the present application, a packaging method of the thermal management implantable brain-computer interface device is provided, the first shell is made of metal titanium or medical titanium alloy, the second shell is made of organic polymer material, and the method further comprises:

[0025] The first shell and the second shell are respectively pre-processed;

[0026] The pre-processed first shell and the second shell are laser welded, the second shell is locally melted after absorbing laser energy to fill the rough combination surface of the first shell, and a sealed combination is formed.

[0027] Overall, compared with the prior art, the above technical solutions conceived by the present application can achieve the following beneficial effects:

[0028] The thermal management implantable brain-computer interface device provided by the present application is packaged by using shell materials with different thermal properties, which avoids the diffusion of heat mainly to the brain tissue without increasing the size of the device and reducing its performance, and maximally reduces the thermal damage to the brain tissue. Specifically, the shell of the brain-computer interface device contacting the scalp tissue has good thermal conductivity, and the shell contacting the skull or brain tissue has good thermal insulation performance, so that heat is dissipated through the scalp side, and the temperature on the brain side is maintained stable, the capillary blood vessels of the skin tissue are utilized, and the relatively high heat tolerance of the skin tissue is utilized to maximally reduce the thermal damage to the brain tissue.

[0029] Preferably, the heat conduction path is further optimized by the heat conduction layer and the porous thermal insulation layer structure, so as to ensure that heat is preferentially dissipated along the high-thermal-conductivity material, and the accumulation of heat in the sensitive brain tissue direction is reduced.

[0030] The preferred solution involves distributing heat according to the heat generated by the internal electronic components, cleverly utilizing the circuit board to block convection, maintain heat distribution, and reduce the impact of component heating on the brain shell.

[0031] In a preferred embodiment, a temperature monitoring component is installed inside the shell near the brain to implement a temperature monitoring mechanism. When the detected heat exceeds the set safety threshold, the device is driven to stop working or change its working mode to reduce heat generation and prevent heat retention from causing tissue damage. Attached Figure Description

[0032] Figure 1 This is a schematic diagram of the structure of the thermal management implantable brain-computer interface device provided by the present invention;

[0033] Figure 2 This is the appearance of the thermally managed implantable brain-computer interface device provided in Embodiment 1 of the present invention;

[0034] Figure 3 This is the appearance of the thermal management implantable brain-computer interface device provided in Embodiment 2 of the present invention.

[0035] In all the accompanying drawings, the same reference numerals are used to denote the same elements or structures, wherein: 1 is the first housing, 2 is the second housing, 3 is the circuit board, 31 is the wireless communication chip, 32 is the power management chip, 33 is the logic control chip, 34 is the temperature monitoring component, 35 is the electrode, and 36 is the coil. Detailed Implementation

[0036] To make the objectives, technical solutions, and advantages of this invention clearer, the invention will be further described in detail below with reference to embodiments. It should be understood that the specific embodiments described herein are merely illustrative and not intended to limit the invention. Furthermore, the technical features involved in the various embodiments of this invention described below can be combined with each other as long as they do not conflict with each other.

[0037] Existing implantable brain-computer interface devices mostly use the same material for encapsulation. The heat generated by the internal components diffuses relatively evenly to the scalp, skull, and brain tissue, without taking into account the different temperature tolerances of different tissues. This invention, without increasing the size of the device or reducing its performance, uses materials with different thermal properties for directional heat dissipation, directing heat towards the scalp and preventing heat from diffusing mainly to the brain tissue. This minimizes the risk of thermal damage to the brain tissue and achieves thermal management.

[0038] The thermal management implantable brain-computer interface device provided by this invention, such as... Figure 1 As shown, it includes a first housing that contacts the scalp tissue and a second housing that contacts the skull or brain tissue. The two housings work together to form a sealed outer casing that houses the electronic components of the brain-computer interface device.

[0039] The material of the first shell is a good thermal conductor, i.e., a material with a thermal conductivity greater than 0.5 W / m·K, generally an inorganic material with good biocompatibility, such as biocompatible ceramics or metals, with a thermal conductivity of 5-200 W / m·K and a specific heat capacity of 500-900 J / kg·K. The first shell with high thermal conductivity can quickly conduct heat from the inside of the device to the scalp tissue, dissipate heat through its abundant capillaries, and the relatively small specific heat capacity makes the temperature change of the first shell more sensitive, which is conducive to the release of heat and avoids the diffusion of heat mainly to the brain tissue, thereby minimizing the thermal damage to the brain tissue. The specific material selection of the first shell can be selected from one or more of titanium, medical titanium alloy, biocompatible ceramic, and aluminum nitride.

[0040] The material of the second shell is a poor thermal conductor, i.e., a material with a thermal conductivity less than or equal to 0.5 W / m·K, generally an organic polymer material with good biocompatibility, with a thermal conductivity of 0.2-0.5 W / m·K and a specific heat capacity of 1000-2300 J / kg·K. In a preferred embodiment, the thermal conductivity of the first shell is more than 10 times that of the second shell, and the second shell with low thermal conductivity effectively blocks the transmission of heat to the brain tissue, maintaining the stability of the brain temperature. The specific material selection of the second shell can be one or more of polyether ether ketone (PEEK), polytetrafluoroethylene (PTFE, Teflon), and polyethylene.

[0041] In a preferred embodiment, the heat management of the device is further enhanced from the perspective of heat conduction: when the material of the first shell is titanium, medical titanium alloy, or biocompatible ceramic, a thermal conductive layer is formed on the outer surface of the first shell to enhance heat conduction and promote the transfer of heat from the first shell to the scalp tissue; a porous thermal insulation layer is formed on the inner side of the second shell to reduce heat conduction from the second shell to the brain side.

[0042] Specifically, when the material of the first shell is titanium, medical titanium alloy, or biocompatible ceramic, a thin layer of aluminum nitride (AlN) or silicon carbide (SiC) is deposited on the outer surface to form a thermal conductive layer;

[0043] A porous thermal insulation layer is formed on the inner side of the second shell using a plasma etching process.

[0044] The thermal conductivity, the specific heat capacity affect the thermal diffusivity. The formula of the thermal diffusivity α is: α=k / (ρ·c), wherein k is the thermal conductivity, c is the specific heat capacity, and ρ is the density. When the specific heat capacity is high, the thermal diffusivity is reduced, the heat conduction speed is slow, the material responds to the temperature change slowly, and the heat conduction performance may be "delayed" or "buffered". When the specific heat capacity is low, the thermal diffusivity is improved, the heat conduction is faster, and the heat conduction performance is more "instantaneous". In the application, the first shell is designed to dissipate heat, and the second shell is designed to be slightly and slowly heated, so that the specific heat capacity of the first shell is relatively small, and the thermal conductivity is relatively large, so that the thermal diffusivity of the first shell is relatively high, and the heat conduction is faster.

[0045] The relatively high heat generating elements such as the wireless communication chip, the power management chip and / or the logic control chip are arranged close to the first shell, and other low heat generating elements such as sensors are arranged close to the second shell in the brain-computer interface device electronic element contained in the shell package. Through the position setting of the heat source and the design of the heat conduction path, the heat distribution can be further effectively controlled, and the influence of the heat generated by the brain-computer interface device during operation on the internal brain tissue is reduced.

[0046] The brain-computer interface device electronic element contained in the shell package is generally welded on the circuit board, the circuit board profile is adapted to the interface profile between the first shell and the second shell, and is assembled on the interface, so that the convection caused by uneven heat distribution can be hindered, and the temperature difference of the implanted brain-computer interface device can be maintained.

[0047] The implanted brain-computer interface device is fixed on the skull or embedded through the skull and buried under the scalp. The first shell contacts the scalp, and the second shell faces the brain tissue. During the operation of the device, heat is lost in a directional manner through the first shell, and the second shell acts as a heat insulation barrier, macroscopically realizing that heat is preferentially diffused along the high-thermal-conductivity path, and significantly reducing the risk of thermal damage to the brain tissue.

[0048] Preferably, the implanted brain-computer interface device also has a temperature monitoring assembly, a temperature sensor of the temperature monitoring assembly is arranged close to the second shell, and the temperature monitoring assembly is an integrated thermal sensitive element or a digital temperature sensor. The temperature monitoring assembly monitors the working temperature in real time, and when the safety threshold (such as 39°C) is exceeded and a certain time length is reached, the device is automatically driven to stop working or switched to a low-power mode, and the response time is less than 100 ms, so as to prevent thermal damage.

[0049] The thermal expansion coefficients and surface properties of the first shell and the second shell are different, and the biocompatibility and the implant environment tolerance are considered, and the optional combination mode is limited. In order to realize the sealed packaging of the first shell and the second shell, the application provides a packaging method of the thermal management implanted brain-computer interface device, which is suitable for the case that the second shell is made of organic polymer material.

[0050] Scheme one includes the following steps:

[0051] The first shell and the second shell are respectively pre-processed to respectively enhance the interfacial bonding strength with the adhesive;

[0052] The pre-processed first shell and the second shell are bonded using the adhesive to form a sealed combination.

[0053] Scheme two includes the following steps:

[0054] The first shell and the second shell are combined and sealed by mechanical embedding and cooperation of the medical rubber ring.

[0055] And when the material of the first shell is medical titanium alloy (Ti-6Al-4V) or metal titanium, the packaging method can also be:

[0056] The first shell and the second shell are respectively pre-processed to roughen the bonding surface of the first shell and the second shell;

[0057] The pre-processed first shell and the second shell are laser welded, and the second shell bonding surface absorbs laser energy and locally melts to fill the rough bonding surface of the first shell to form a sealed combination.

[0058] The following is an example:

[0059] Example 1: Heat management implantable brain-computer interface device with built-in coil

[0060] The heat management implantable brain-computer interface device provided in this embodiment, as shown in Figure 2 The first shell in contact with the scalp tissue and the second shell in contact with the skull or brain tissue cooperate to form a sealed housing package that accommodates the brain-computer interface device electronic components inside. The coil in this embodiment is arranged inside the housing package.

[0061] The material of the first shell is biocompatible ceramic (such as Al2O3) or aluminum nitride; wherein the thermal conductivity of biocompatible ceramic (such as Al2O3) is about 170-200 W / (m·K), the specific heat capacity is about 880-900 J / kg·K, the thermal conductivity of aluminum nitride is 20-30 W / (m·K), and the specific heat capacity is about 740-800 J / kg·K.

[0062] To further realize heat conduction to the first shell and avoid heat mainly diffusing to the brain tissue, when the material of the first shell is biocompatible ceramic (such as Al2O3), a thin layer of aluminum nitride (AlN) or silicon carbide (SiC) can be deposited on the outer surface of the first shell to form a thermal conduction layer to optimize the heat conduction path.

[0063] The material of the second shell is polyether ether ketone (PEEK), polytetrafluoroethylene (PTFE, Teflon) or ultra-high molecular weight polyethylene (UHMWPE); wherein the polyether ether ketone has a thermal conductivity of 0.25-0.3 W / m·K, a specific heat capacity of 1300-1800 J / kg·K, the polytetrafluoroethylene has a thermal conductivity of 0.25-0.27 W / m·K, a specific heat capacity of 1000-1050 J / kg·K, and the ultra-high molecular weight polyethylene has a thermal conductivity of 0.41-0.45 W / (m·K), a specific heat capacity of 1800-2300 J / kg·K.

[0064] To further avoid the heat mainly spreading to the brain tissue, a porous thermal insulation layer can be formed in the inner side of the second shell by using a plasma etching process.

[0065] It should be noted that the thermal conductivity of various materials may vary due to different component purities, and the present embodiment is only described with this data and is not limited.

[0066] To further effectively control the heat distribution and avoid the heat mainly spreading to the brain tissue, the relatively high heat generating elements such as coils, wireless communication chips, power management chips and logic control chips can be arranged close to the first shell, and other low heat generating elements such as sensors can be arranged close to the second shell among the brain-computer interface device electronic elements accommodated in the shell package.

[0067] Further, the brain-computer interface device electronic elements accommodated in the shell package are generally welded on the circuit board, and the circuit board profile is adapted to the interface profile between the first shell and the second shell and is assembled on the interface, thereby hindering the convection caused by uneven heat distribution and helping to maintain the temperature difference of the implanted brain-computer interface device.

[0068] The implanted brain-computer interface device also has a temperature monitoring assembly, and the temperature sensor of the temperature monitoring assembly is arranged close to the second shell. The temperature monitoring assembly is an integrated thermal element or a digital temperature sensor. The temperature monitoring assembly monitors the working temperature in real time, and when the safety threshold such as 39°C is exceeded, the device is automatically driven to stop working or switch to a low-power consumption mode, and the response time is less than 100 ms.

[0069] The heat management implanted brain-computer interface device in the present embodiment can be made by using various packaging methods. Taking scheme one as an example, the specific steps are as follows:

[0070] S1, pre-process the first shell and the second shell respectively.

[0071] Specifically, when the material of the first shell is biocompatible ceramic (such as Al2O3) or aluminum nitride, a micron-level rough bonding surface is formed by chemical etching or laser texturing; when the second shell is an organic polymer material, ion treatment or chemical etching is used to increase the roughness and hydrophilicity of the bonding surface.

[0072] S2, the first shell and the second shell after pre-processing are tightly bonded using an adhesive.

[0073] By selecting a suitable adhesive and a bonding surface pre-treatment method, the thermal stress caused by the difference in the thermal expansion coefficient can be effectively alleviated, and the bonding strength, biocompatibility, and sealing performance can be maintained.

[0074] Specifically, the electronic elements of the brain-computer interface device are welded on the circuit board, so that the wireless communication chip, the power management chip, and the logic control chip are located on one side of the circuit board, the coil and the integrated thermal element are arranged on the other side of the circuit board, and other elements can be designed according to the space requirement.

[0075] The profile of the circuit board is adapted to the profile of the interface between the first shell and the second shell, and is assembled on the interface, and then the first shell and the second shell after pre-processing are tightly bonded using an adhesive. Preferably, the adhesive can be medical silicone glue such as Nusil MED-1137, or medical epoxy glue, which can achieve a connection strength of >15 MPa and in-vivo stability of >10 years.

[0076] The thermal management implantable brain-computer interface device provided in the embodiment can also be made in the packaging mode of scheme two, specifically: the first shell and the second shell are combined and sealed by mechanical embedding and cooperation of a medical rubber ring.

[0077] In detail, the first shell and the second shell are embedded to realize combination and sealing according to the material hardness and mechanical strength of the first shell and the second shell, and cooperation of a medical rubber ring. For example, when the first shell is biocompatible ceramic (such as Al2O3) or aluminum nitride, and the second shell is PEEK (polyether ether ketone), the inner side wall of the biocompatible ceramic (such as Al2O3) or aluminum nitride shell with higher hardness can be designed as a ring-shaped clamping groove, the outer side wall of the PEEK shell with lower hardness can be designed as a ring-shaped tenon, a medical rubber ring (such as a silicone ring) is placed in the first shell clamping groove, additional buffering is provided while the sealing is strengthened, hard contact between the tenon and the clamping groove is prevented, the PEEK tenon is inserted into the first shell clamping groove, the tenon and the clamping groove are tightly cooperated, and finally the first shell and the second shell are tightly combined. The embodiment is only used for illustration, and is not limited.

[0078] Similarly, the electronic components of the brain-computer interface device are welded on the circuit board, so that the wireless communication chip, the power management chip, and the logic control chip are on one side of the circuit board, the coil is built-in, the temperature monitoring component is an integrated thermal element, and is arranged on the other side of the circuit board, and other components can be designed according to the space requirement. The profile of the circuit board is adapted to the profile of the interface between the first shell and the second shell, and is assembled on the interface, then a medical rubber ring is placed in the clamping groove of the first shell, and the first shell and the second shell are combined and sealed by mechanical embedding.

[0079] Example 2: Heat management of an implanted brain-computer interface device with an external coil

[0080] The heat management implanted brain-computer interface device provided in this embodiment, as shown in FIG. 1, includes a first shell in contact with the scalp tissue and a second shell in contact with the skull or brain tissue, which cooperate to form a sealed housing package that accommodates the electronic components of the brain-computer interface device. The coil of this embodiment is arranged outside the housing package for wireless signal and power transmission. Figure 3

[0081] The material of the first shell can be the biocompatible ceramic (such as Al2O3) or aluminum nitride mentioned in Example 1, or a medical titanium alloy (Ti-6Al-4V) or metal titanium. The thermal conductivity of the medical titanium alloy (Ti-6Al-4V) is 6-7 W / (m·K), and the specific heat capacity is 520-560 J / kg·K. The thermal conductivity of the metal titanium is 18-20 W / (m·K), and the specific heat capacity is 523-600 J / kg·K. The first shell of this embodiment is made of an electrically conductive material, which cooperates with the external coil design to avoid temperature rise caused by eddy currents. When the material of the first shell is a biocompatible ceramic (such as Al2O3), a medical titanium alloy (Ti-6Al-4V), or a metal titanium, a thin layer of aluminum nitride (AlN) or silicon carbide (SiC) can be deposited on the outer surface of the first shell to form a thermal conduction layer, thereby optimizing the heat conduction path and preventing heat from mainly spreading to the brain tissue.

[0082] The material of the second shell is the same as that of Example 1, which will not be described here.

[0083] It should be noted that the thermal conductivity of various materials may vary depending on the purity of the components, and this embodiment only uses this data for illustration and is not limited.

[0084] Among the electronic components of the brain-computer interface device accommodated in the housing package, the heat-generating components such as the wireless communication chip, the power management chip, and the logic control chip are arranged close to the first shell, and other low-heat components such as sensors are arranged close to the second shell.

[0085] ​The outer shell package contains brain-computer interface device electronic components inside, which are generally welded on the circuit board. The circuit board profile is adapted to the interface profile between the first shell and the second shell, and is assembled on the interface, thereby hindering the convection caused by uneven heat distribution and helping to maintain the temperature difference of the implanted brain-computer interface device.

[0086] The thermal management implanted brain-computer interface device provided by the embodiment can be made by various packaging methods. The scheme one and the scheme two mentioned in the above embodiment 1 can be applied in the embodiment. When the material of the first shell of the embodiment is medical titanium alloy (Ti-6Al-4V) or metal titanium, the following packaging method can also be used:

[0087] S1, pre-process the first shell and the second shell respectively.

[0088] Specifically, when the first shell is made of medical titanium alloy (Ti-6Al-4V) or metal titanium, acid etching or laser treatment is used to form a micron-level rough joint surface. Preferably, laser etching is used to form a micro-groove structure on the joint surface. If the second shell is made of organic polymer material, ion treatment or chemical etching is used to increase the roughness and hydrophilicity of the joint surface.

[0089] S2, the pre-processed first shell and the second shell are sealed by laser welding technology.

[0090] Specifically, after the circuit board profile is adapted to the interface profile between the first shell and the second shell and assembled on the interface, the first shell and the second shell are butted, under the protection of argon, using a 1064nm pulse laser welding device, the laser power is set to 60-80W, the pulse frequency is 8-15kHz, the scanning speed is 8-15mm / s, the process time is controlled in 5-10 minutes, the inert gas flow is 12-18L / min, the first shell and the second shell are laser welded, the second shell joint surface absorbs laser energy and locally melts, fills the rough joint surface of the first shell, and forms a sealed joint.

[0091] Similarly, the electronic components of the brain-computer interface device are welded on the circuit board, so that the wireless communication chip, the power management chip, and the logic control chip are on one side of the circuit board, the temperature monitoring component is an integrated thermal element, and is arranged on the other side of the circuit board, and other components can be designed according to space requirements. The profile of the circuit board is adapted to the profile of the interface between the first shell and the second shell after pre-processing, and is assembled on the interface, then under the protection of argon, a 1064nm pulse laser welding device is used, the laser power is set to 60-80W, the pulse frequency is 8-15kHz, the scanning speed is 8-15mm / s, the process time is controlled to be 5-10 minutes, the inert gas flow is 12-18L / min, the first shell and the second shell are laser welded, the second shell bonding surface absorbs laser energy and locally melts, fills the rough bonding surface of the first shell, and forms a sealed bonding.

[0092] Those skilled in the art will easily understand that the above description is only a preferred embodiment of the present application, and is not intended to limit the present application, and any modifications, equivalent replacements and improvements made within the spirit and principles of the present application shall be included in the protection scope of the present application.

Claims

1. A thermally managed implantable brain-machine interface device, comprising: The thermal management implantable brain-computer interface device is fixed on the skull or embedded through the skull and buried under the scalp, comprising a first shell in contact with the scalp tissue and a second shell in contact with the skull or brain tissue; The first shell and the second shell cooperate to form a sealed housing package, and the brain-computer interface device electronic elements are contained inside the housing package; The first shell is a good thermal conductor, and the thermal conductivity of the first shell is between 5-200 W / m·K; The second shell is a poor thermal conductor, and the thermal conductivity of the second shell is between 0.2-0.5 W / m·K.

2. The thermally managed implantable brain-machine interface device of claim 1, wherein, The thermal conductivity of the first shell is more than 10 times that of the second shell.

3. The thermally managed implantable brain-machine interface device of claim 2, wherein, The specific heat capacity of the first shell material is less than that of the second shell material, and the specific heat capacity of the first shell material is between 500-900 J / kg·K, and the specific heat capacity of the second shell material is between 1000-2300 J / kg·K.

4. The thermally managed implantable brain-machine interface device of claim 3, wherein, The first shell material is selected from one or more of titanium, medical titanium alloy, biocompatible ceramic, and aluminum nitride; and the second shell material is selected from one or more of polyether ether ketone, polytetrafluoroethylene, and polyethylene.

5. The thermally managed implantable brain-machine interface device of claim 1, wherein, When the first shell material is titanium, medical titanium alloy, or biocompatible ceramic, the first shell has a heat-conducting layer on the outside; and the second shell has a porous heat-insulating layer on the inside.

6. The thermally managed implantable brain-machine interface device of claim 5, wherein, The heat-conducting layer on the outside of the first shell is an aluminum nitride or silicon carbide deposition layer. The porous heat-insulating layer on the inside of the second shell is formed by a plasma etching process.

7. The thermally managed implantable brain-machine interface device of claim 1, wherein, The wireless communication chip, power management chip, and / or logic control chip in the brain-computer interface device electronic elements are arranged close to the first shell.

8. The thermally managed implantable brain-machine interface device of claim 7, wherein, The brain-computer interface device electronic elements are soldered on a circuit board, and the profile of the circuit board is adapted to the profile of the interface between the first shell and the second shell and is assembled on the interface between the first shell and the second shell.

9. The thermally managed implantable brain-machine interface device of claim 1, wherein, A temperature monitoring assembly is included, and a temperature sensor of the temperature monitoring assembly is arranged close to the second shell. The temperature monitoring assembly is an integrated thermal element or a digital temperature sensor.

10. The method of packaging a thermal management implantable brain-machine interface device according to any one of claims 1 to 9, wherein, The second shell material is an organic polymer material, comprising the following steps: The first shell and the second shell are respectively pre-processed; The pre-processed first shell and the second shell are bonded using an adhesive to form a sealed combination.

11. The method of packaging a thermal management implantable brain-machine interface device according to any one of claims 1 to 9, wherein, The second shell material is an organic polymer material, comprising the following steps: The first shell and the second shell are combined and sealed by mechanically embedding and cooperating with a medical rubber ring.

12. The method of packaging a thermal management implantable brain-machine interface device according to any one of claims 1 to 9, wherein, The first shell material is titanium or medical titanium alloy, and the second shell material is an organic polymer material, further comprising: The first shell and the second shell are respectively pre-processed; The pre-processed first shell and the second shell are laser welded, and the second shell bonding surface absorbs laser energy to locally melt and fill the rough bonding surface of the first shell to form a sealed combination.

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