A flexible electronics device implant and an implantation method

Abstract

An embodiment of the present specification provides a method for implanting a flexible electronic device, which includes placing an implant in a collapsed state into a target part of a target object through an implantation hole, wherein the implantation hole is obtained by opening a hole in the target part or selecting a hole in the target part as the implantation hole, and the implant is composed of a deformation driver connected to an electronic device, wherein the deformation driver is made of a shape memory material, and the phase change temperature of the shape memory material is the internal body temperature of the target object; the implant generates a temperature-induced shape memory effect at the target part, completing a spontaneous transition from a collapsed state to an extended state; the deformation driver and the electronic device are separable, so that the deformation driver can be removed from the target part through the implantation hole.

Description

Technical Field

[0001] This specification relates to the fields of neuroscience and neuroengineering, and in particular to a flexible electronic device implant and an implantation method. Background Art

[0002] To better understand the mechanisms of the nervous system and regulate neural activity, electrodes are needed to collect signals from corresponding areas, such as neural activity signals within the skull or spine, and interact with the nervous system on a larger spatial scale. However, implanting large-area surface neural electrodes within the skull or spine inevitably requires the removal of large areas of skull and vertebrae, which not only compromises the accuracy of electrophysiological recordings but also causes serious damage to the experimental subjects. Patients undergoing craniotomy and other surgeries also face the potential risk of surgical complications such as brain edema, hematoma, and cerebrospinal fluid leakage. Large-scale vertebral removal can lead to spinal cord deformation, tissue damage, spinal cord edema, and hematoma.

[0003] The longitudinal fissure, due to its unique location between the two cerebral hemispheres, has been shown to be associated with various visceral activities, such as pulse, respiration, gastrointestinal motility, and glandular secretions. However, currently widely used intracranial electrodes are unable to penetrate deeply into the cerebral raphe. Current signal acquisition via implanted intracranial electrodes limits the acquisition of high-density electrophysiological information over a large area.

[0004] Therefore, minimally invasive implantation of large-area intracranial electrodes or intraspinal electrodes remains a difficult problem that needs to be solved urgently. Summary of the Invention

[0005] One or more embodiments of this specification provide a method for implanting a flexible electronic device. The method for implanting a flexible electronic device includes:

[0006] An implant in a collapsed state is placed into a target part of a target object through an implant hole, wherein the implant hole is obtained by opening a hole in the target part or selecting a hole in the target part as the implant hole, and the implant is composed of a deformation driver connected to an electronic device, wherein the deformation driver is made of a shape memory material, and the phase change temperature of the shape memory material is the internal body temperature of the target object; the implant generates a temperature-induced shape memory effect at the target part, completing a spontaneous transition from a collapsed state to an extended state; the deformation driver and the electronic device are separable, so that the deformation driver can be removed from the target part through the implant hole; in response to the implant being converted from the collapsed state to the extended state at the target part or the target part, and the deformation driver being separated from the electronic device, the deformation driver is removed from the target part or the target part through the implant hole.

[0007] One of the embodiments of this specification provides an implant, which includes: an electronic device, and a deformation driver connected to the electronic device, wherein the deformation driver is made of a shape memory material, and the phase change temperature of the shape memory material is the internal body temperature of the target object. When the ambient temperature of the implant is lower than the internal body temperature, the implant is compressed into a contracted state, and when the ambient temperature is raised to the internal body temperature, the implant is converted from the contracted state to an extended state. BRIEF DESCRIPTION OF THE DRAWINGS

[0008] This specification will be further described in the form of exemplary embodiments, which will be described in detail with reference to the accompanying drawings. These embodiments are not limiting, and in these embodiments, like numbers represent like structures, wherein:

[0009] Figure 1A is a schematic diagram of an implant in an extended state according to some embodiments of the present specification;

[0010] Figure 1B is a schematic diagram of an implant in a collapsed state according to some embodiments of the present specification;

[0011] Figure 2 is an exemplary schematic diagram of a nickel-titanium alloy wire recovering from a martensite phase to an austenite phase at a phase transition temperature according to some embodiments of the present specification;

[0012] Figure 3A is an exemplary flow chart for preparing an implant according to some embodiments of the present specification;

[0013] Figure 3B is an exemplary flow chart of a method for manufacturing an electronic device according to some embodiments of this specification;

[0014] Figure 3C is another exemplary flow chart of a method for manufacturing an electronic device according to some embodiments of this specification;

[0015] Figure 3D is an exemplary flow chart of connecting an electronic device to a deformation actuator according to some embodiments of this specification;

[0016] Figure 4 is an exemplary flow chart of an implant implantation process according to some embodiments of the present specification;

[0017] Figure 5 is an exemplary schematic diagram of an implant implantation process according to some embodiments of the present specification;

[0018] Figure 6is an exemplary flow chart of target site positioning for an electronic device according to some embodiments of this specification;

[0019] Figure 7 is an exemplary schematic diagram of collecting rat epilepsy signals using electronic devices according to some embodiments of this specification;

[0020] Figure 8 Schematic diagram of comparison of signal recordings collected by electronic devices according to some embodiments of this specification in a beagle dog in an anesthetized state (left) and during the process of anesthesia to awakening (right); DETAILED DESCRIPTION

[0021] Flexible electronics utilize electronic components fabricated on flexible or malleable plastic or thin metal substrates. Electrocortical electrograms recorded using flexible electronics minimize the influence of structures such as the scalp and skull on electrophysiological activity, producing images that accurately reflect nerve cell activity. Cortical electrodes are also widely used in disease diagnosis and treatment, such as accurately locating epileptic lesions.

[0022] The embodiments of this specification provide an implant prepared based on electronic devices and deformation actuators. The electronic devices in the implant can be applied to multiple target locations in the body, for example, the target locations can be on the dura mater, below the dura mater, in the sulcus, in the longitudinal fissure of the brain, on the dura mater, below the dura mater in the spinal cord, in the thoracic viscera, etc.

[0023] The electronic devices provided in the embodiments of this specification may be applied to, but not limited to, implantable devices, electrical signal recording and stimulation, biochemical detection sensing, pressure sensing, and other fields.

[0024] To more clearly illustrate the technical solutions of the embodiments of this specification, the following briefly describes the drawings required for describing the embodiments. Obviously, the drawings described below are merely examples or embodiments of this specification. Those skilled in the art can apply this specification to other similar scenarios based on these drawings without inventive effort. Unless otherwise apparent from the context or otherwise noted, the same reference numerals in the figures represent the same structure or operation.

[0025] As used in this specification and claims, unless the context clearly indicates otherwise, the words "a," "an," "an," and / or "the" do not refer to the singular but also include the plural. Generally speaking, the terms "comprises" and "include" only indicate the inclusion of the steps and elements specifically identified, and these steps and elements do not constitute an exclusive list. A method or apparatus may also include other steps or elements.

[0026] Flowcharts are used throughout this specification to illustrate the operations performed by systems according to embodiments of this specification. It should be understood that preceding or following operations do not necessarily need to be performed in exact order. Instead, the steps may be processed in reverse order or simultaneously. Furthermore, other operations may be added to these processes, or one or more operations may be removed from these processes.

[0027] An implant is a flexible neuroelectronic device that is implanted in a target subject to monitor corresponding cellular activity. In some embodiments, the implant can be made of biocompatible materials. In some embodiments, neural signals captured by the implant from a target site of the target subject can be transmitted to an external processing device for further analysis and processing. For example, the processing device can retrieve neural signals stored in a storage device and convert the electrical signals into image information for display on a terminal.

[0028] The target object is an object whose target part is to be monitored by the implant. In some embodiments, the target object can include a human body, an animal, or any combination thereof. In some embodiments, the target object can include a specific part of the human body, such as the motor cortex, the sensory cortex, etc.

[0029] The target site is the site where the implant is implanted. In some embodiments, the target site may include a site such as the brain or spine where neural signals can be collected, and the foregoing examples are not intended to be limiting.

[0030] Figure 1A and Figure 1B is a schematic diagram of an implant according to some embodiments of this specification. Figure 1A Schematic diagram of the implant in the extended state. Figure 1B Schematic diagram of the implant in a collapsed state.

[0031] like Figure 1A and Figure 1B As shown, in some embodiments, the implant 3 may include an electronic device 2 and a deformable actuator 1 connected to the electronic device 2. The deformable actuator 1 is made of a shape memory material. The phase transition temperature of the shape memory material can be the internal body temperature of the target subject. When the ambient temperature of the implant 3 is lower than the internal body temperature of the target subject, the implant 3 is compressed into a collapsed state. When the ambient temperature rises to the internal body temperature of the target subject, the implant 3 transitions from the collapsed state to the extended state.

[0032] It should be noted that Figure 1A The shapes of the electronic device 2 and the deformation actuator 1 are used as examples for illustrative purposes. The electronic device 2 and the deformation actuator 1 may also have other shapes.

[0033] An electronic device refers to an electronic component that can collect electrical signals. In some embodiments, the electronic device may be a flexible electronic device, which refers to an electronic device that can be bent, folded, twisted, compressed, stretched, or even deformed into any shape while maintaining high electrical performance, reliability, and integration. For example, the electronic device may include an electrode array, a semiconductor transistor array, an integrated circuit, or a biosensor.

[0034] In some embodiments, as Figure 1A As shown, the electronic device 2 is provided with a recording site 21 and a connecting portion 22 , wherein the connecting portion 22 can be used to achieve the connection between the deformation actuator 1 and the electronic device 2 .

[0035] Recording sites are signal acquisition points on an electronic device used to collect signals. In some embodiments, the electronic device can include multiple recording sites for simultaneously recording neural signals in different brain regions, such as electrophysiological signals such as local field potentials and action potentials. Multiple recording sites on an electronic device can be fabricated in a variety of ways. For example, existing micro-nanofabrication techniques can be combined to achieve the fabrication of large-area, high-density recording sites on the electronic device, meeting the requirements for large-area, multi-site recording of neural activity in current neural network research.

[0036] The connection portion refers to the part of the electronic device used to connect to the deformation actuator. The connection portion can be a part of the electronic device, or it can be another component independent of the electronic device and the deformation actuator. The connection portion can connect the electronic device at any position of the deformation actuator, or connect the deformation actuator at any position of the electronic device. In some embodiments, the connection portion is located on both sides of the electronic device. For example, Figure 1A As shown, the connecting portion 22 is located at the wings on both sides of the base of the electronic device 2 and is a part of the electronic device 2 .

[0037] In some embodiments, the connection portion, electronic device, and deformation actuator can be fixedly connected using an adhesive. For example, deformation actuator 1 is bonded to connection portion 22 on electronic device 2. The adhesive can be a water-soluble solvent, for example. For example, a PEO concentration of 0.8g PEO / 3g HO can be used as a soluble solvent to connect the electronic device and deformation actuator. For more information about soluble solvents, see step 330.

[0038] In some embodiments, the edge of the electronic device can be connected to the deformation actuator, and the shape of the edge of the electronic device can be configured to be an ear of wheat. For example, the connection portion 22 can be the ear-shaped edge of the electronic device 2, and the deformation actuator can be bonded to the ear-shaped edge of the electronic device using an adhesive. For more information on the connection between the deformation actuator and the electronic device, see step 330.

[0039] The wheat-ear shape can significantly increase the contact area between the electronic device and the deformation actuator. By trimming the edge of the electronic device perpendicular to the edge of the electronic device, the edge can be trimmed to create a plurality of wheat-ear-shaped strips of a certain width. In some embodiments of this specification, the edge of the electronic device is engraved into a wheat-ear shape to facilitate connection between the electronic device and the deformation actuator.

[0040] A deformable actuator is a support material used to mount electronic devices and assist in their implantation into a target subject. In some embodiments, the deformable actuator can assist in implanting the electronic device into a target subject in a predetermined shape (e.g., a shape that closely conforms to the cerebral cortex). In some embodiments, the deformable actuator can be made of a shape-memory material.

[0041] Shape memory materials are a class of materials that exhibit a shape memory effect. This effect refers to the ability of a shape memory material to deform from a preset shape and then return to the preset shape through external stimulation, such as heating. In some embodiments, the preset shape of the shape memory material can be achieved through methods such as melting, casting, cold or hot working, and so on.

[0042] In some embodiments, the shape memory material can be one of nickel-titanium alloy, copper-nickel alloy, copper-aluminum alloy, copper-zinc alloy, and iron-based alloy (e.g., iron-manganese-silicon alloy, iron-palladium alloy). For example, a shape-shifting actuator can be prepared based on nickel-titanium alloy.

[0043] In some embodiments, the shape memory effect of the shape memory material can be explained based on the principle of martensitic phase transformation. Martensitic phase transformation refers to the reversible phase change between the martensite phase and the parent phase (austenite phase) at an appropriate temperature. For example, in a low temperature environment, the shape memory material is in the martensite phase, at which time the shape memory material is easily deformed under external force. When the temperature gradually increases and reaches its phase transition temperature, the shape memory material will undergo a spontaneous transformation from the martensite phase to the austenite phase, which is manifested as shape recovery on a macroscopic scale.

[0044] In some embodiments, the shape of the matrix of the shape memory material obtained by heat treatment can be any shape. The matrix shape of the shape memory material can determine the final deployed shape of the electronic device in the body. For example, Figure 1A In the embodiment, when the ambient temperature is adjusted to the phase transition temperature of the shape memory material, the deformation actuator 1 in the implant 3 is in an extended state, that is, the extended state is the state when the deformation actuator 1 is in the parent phase. Driven by the deformation actuator 1, the electronic device 2 also exhibits an extended state similar to that of the deformation actuator 1; Figure 1B After adjusting the ambient temperature to make it lower than the phase transition temperature, the implant 3 can be compressed. Figure 1AThe implant 3 in the extended state is compressed to Figure 1B In some embodiments, the compressed implant 3 may be further subjected to a shaping process to maintain the deformation actuator 1 in the implant 3 in a compressed state. This condensed state is the state of the deformation actuator 1 in the martensite phase. At this time, the electronic device 2 also exhibits a similar condensed state as the deformation actuator 1 in the condensed state. For more information on the compression and shaping process of the implant, please refer to step 410 and its description.

[0045] Ambient temperature refers to the temperature of the environment in which the implant resides. Ambient temperature can affect the shape of the implant. For example, when the ambient temperature is adjusted to a value above the phase transition temperature of the shape-shifting actuator, the implant's shape can return to the shape corresponding to the shape-shifting actuator in its parent phase.

[0046] The internal body temperature of the target subject refers to the temperature inside the implant site of the target subject. For example, if the implant is to be implanted in the brain of a rat, the internal body temperature is the temperature inside the rat's brain.

[0047] The phase transition temperature (PST) is the temperature at which a shape memory material transforms from martensite to austenite. This temperature can be controlled by adjusting the heat treatment time and temperature. The higher the temperature and the longer the heating time, the higher the PST.

[0048] In some embodiments, the phase transition temperature of the shape memory material can be the internal body temperature of the target subject.

[0049] In some embodiments of the present specification, by setting the phase change temperature of the shape memory material to the internal body temperature of the target object, after the implant is implanted into the target object, the phase change process of the shape memory material from martensite to austenite can be achieved without further regulating the temperature of the target object, so that the implantation process of the implant can be completed at normal physiological temperature.

[0050] In some embodiments, when the deformation actuator 1 in the implant 3 is in the martensite phase and in the austenite phase, the corresponding morphology of the implant 3 may be different. Figure 1A and Figure 1B As shown, when the deformation actuator 1 is in the martensite phase, the corresponding shape of the implant 3 is a contracted state. When the deformation actuator 1 is in the austenite phase, the corresponding shape of the implant 3 is an extended state. When the ambient temperature of the implant 3 is lower than the phase transition temperature (such as the internal body temperature of the target subject), the implant 3 is compressed into the contracted state. When the ambient temperature is raised to the phase transition temperature, the implant 3 can be transformed from the contracted state to the extended state.

[0051] The collapsed state refers to the implant being in a smaller volume. When the shape memory material is in the martensite phase, the implant can be compressed to a preset shape and volume by an external force (e.g., manual compression). Figure 1B In some embodiments, the preset volume is related to the target object. For example, the smaller the target object, the smaller the implant hole, and the smaller the preset volume of the implant.

[0052] In some embodiments, the implant can be compressed in a variety of ways to achieve a collapsed state, for example, by using a compression device or a compression mold. Figure 4 .

[0053] The extended state refers to the state of the implant after it is stretched. Figure 1A The implant 3 is in the expanded sheet form.

[0054] In some embodiments, the phase change temperature of the implant can be determined based on the target object, and then the shape change of the implant can be controlled based on the control of the ambient temperature of the implant.

[0055] The following takes the nickel-titanium alloy wire with a phase transition temperature of 37°C as an example to illustrate the deformation process of the nickel-titanium alloy wire when the ambient temperature rises from the phase transition temperature to the phase transition temperature. Figure 2 FIG2 is an exemplary schematic diagram of the deformation of a nickel-titanium alloy wire when it recovers from a martensite phase to an austenite phase at a phase transformation temperature according to some embodiments of the present specification.

[0056] First, the nickel-titanium alloy wire is heat-treated to shape the mother phase of the nickel-titanium alloy wire into a right-angle shape. Then, dry ice is used to cool the shaped nickel-titanium alloy wire. After the temperature drops, the nickel-titanium alloy wire transforms into a martensite phase. The nickel-titanium alloy wire is deformed to increase the angle of the nickel-titanium alloy wire to be greater than 90° to obtain the following Figure 2 Then put the nickel-titanium alloy wire on the hot plate, control the temperature of the hot plate to 37℃, and record the deformation process of the nickel-titanium alloy wire from 0s to 0.4s. Figure 2 As shown in the figure, the white dotted line represents the shape and position of the nickel-titanium alloy wire in the martensite phase, and the black solid line represents the shape and position change of the nickel-titanium alloy wire in the austenite phase at the phase transformation temperature. The nickel-titanium alloy wire exhibits deformation ability at body temperature (37°C): at 0s, the shape of the nickel-titanium alloy wire in the martensite phase is greater than 90°; at 0.4s, the shape of the nickel-titanium alloy wire in the austenite phase returns to a 90° right angle shape.

[0057] In some embodiments, the electronic device may be a mesh structure or a thin film structure.

[0058] In some embodiments, photolithography can be used to make the electronic device present different patterns, and different patterns correspond to different structures of the electronic device. For example, the mesh structure of the electronic device can be etched by etching the template aluminum. For more information about the photolithography and etching process, please refer to Figure 3B And related instructions.

[0059] In some embodiments of the present specification, the mesh structure of the electronic device makes the entire electronic device more flexible, and even if the signal collection surface of the target part is an irregular surface, it can still fit well, such as better fitting with the curved surface of the brain or the curved surface of the spine, thereby improving the signal recording stimulation and sensing capabilities of the electronic device.

[0060] In some embodiments, the shape-shifting actuator is made of a filamentary shape-memory material.

[0061] In some embodiments of this specification, the shape-shifting actuator utilizes a nickel-titanium shape memory alloy guidewire. The filamentous shape of the shape-shifting actuator allows for a tighter connection between the shape-shifting actuator and the electronic device. In some embodiments, after the implant is implanted in a target object, the filamentous shape of the shape-shifting actuator facilitates separation of the electronic device from the shape-shifting actuator, simplifying the implantation procedure.

[0062] In some embodiments, the electronic device and the deformation actuator are connected via a water-soluble polymer material, and the deformation actuator and the electronic device can be separated under the action of a solvent.

[0063] The water-soluble polymer material includes one of a water-soluble resin and a water-soluble polymer. In some embodiments, the water-soluble polymer material can be polyethylene oxide (PEO). For more information about the water-soluble polymer material, see step 330.

[0064] The dissolving agent is capable of dissolving the water-soluble polymer material used to connect the deformable actuator and the electronic device. In some embodiments, the dissolving agent may be saline. Flushing the water-soluble polymer material with the dissolving agent dissolves the water-soluble polymer material, thereby separating the deformable actuator from the electronic device. After separation, the deformable actuator can be removed, while the electronic device remains within the subject for subsequent physiological signal acquisition.

[0065] Some embodiments of this specification adjust the phase change temperature of the deformation actuator to near body temperature. When the implant is implanted in the brain, the ambient temperature of the deformation actuator is the ambient temperature of the brain. When the phase change temperature of the deformation actuator is reached, the deformation actuator will spontaneously deform, return to the preset shape, and drive the electronic device connected to it to expand at the target location. By expanding the deformation actuator in the longitudinal fissure area under the blood vessels, it is possible to reach areas that are inaccessible to traditional neuroelectronic devices, such as the longitudinal fissure of the brain, the inside of the sulcus, and the dura mater in the spinal cord. The expansion process of the electronic device is not only limited to the direction of the implant path, but can also be expanded on a large scale in the direction perpendicular to the implant path. Therefore, it has the ability to expand several to dozens of times the implant area, thereby achieving large-area high-density recording.

[0066] Figure 3A is an exemplary flow chart for preparing an implant according to some embodiments of the present specification.

[0067] like Figure 3A As shown, the process 300 includes the following steps.

[0068] Step 310: Prepare an electronic device. For example, the electronic device can be a carbon nanotube electrode or a Pt / Au electrode. A carbon nanotube electrode is an electrode whose conductive layer contains carbon nanotubes. Carbon nanotubes have radial dimensions on the order of nanometers and axial dimensions on the order of micrometers, resulting in a large specific surface area effect and good biocompatibility. A Pt / Au electrode is an electrode whose conductive layer contains either platinum or gold.

[0069] Figure 3B This is an exemplary process 3100 of a method for preparing an electronic device according to some embodiments of this specification. In some embodiments, when the electronic device to be prepared is a carbon nanotube electrode, step 310 can be implemented based on process 3100. Process 3100 includes the following steps:

[0070] Step S11 , nickel is plated on the silicon wafer as a sacrificial layer; and photoresist is photoetched on the sacrificial layer to obtain a photoresist pattern as an insulating layer of the carbon nanotube electrode.

[0071] The sacrificial layer serves as a separation layer. It can be made of copper or nickel, and its thickness can range from 1000 angstroms to 2 microns. Carbon nanotube electrodes and silicon wafers are prone to adhesion, so a sacrificial layer is deposited between the silicon wafer and the carbon nanotube electrodes to facilitate subsequent separation.

[0072] The photoresist used in photolithography can be a negative photoresist SU-8. After the SU-8 layer is spin-coated on the silicon wafer, the silicon wafer is placed on a photolithography machine for exposure and developed in a developer to obtain a silicon wafer containing a photoresist pattern.

[0073] In step S12, a carbon nanotube film is spread on the insulating layer, and a photolithographic metal pattern is evaporated on the film to serve as a mask for etching the carbon nanotube film, which serves as a conductive layer of the electronic device.

[0074] The mask will not be etched by the plasma, and the carbon nanotube electrode pattern is covered by the mask, so that subsequent etching only affects the area outside the carbon nanotube electrode pattern.

[0075] Step S13 , etching away excess carbon nanotube film to obtain a conductive layer pattern of the carbon nanotube electrode.

[0076] During etching, due to the covering effect of the metal mask in S12, the covered carbon nanotube film is not etched, so that the conductive layer of the carbon nanotube electrode forms the same pattern as the insulating layer.

[0077] Step S14: vapor-depositing a base organic matter on the conductive layer to obtain a base material layer of the carbon nanotube electrode.

[0078] The base organic material includes one of Parylene, polyacrylamide (PI) or polydimethylsiloxane (PDMS). The thickness of the base material layer can be between 1000 angstroms and 50 microns.

[0079] Step S15, etching the sacrificial layer with ferric chloride to release the carbon nanotube electrode from the silicon wafer; and repeatedly washing with deionized water to obtain the prepared carbon nanotube electrode.

[0080] After the electronic device is fabricated, the sacrificial layer is dissolved with ferric chloride to release the carbon nanotube electrode from the silicon wafer. The sacrificial layer prepared in step S11 allows the carbon nanotube electrode to be separated from the silicon wafer. A thin-film electronic device can be obtained based on the aforementioned steps.

[0081] In some embodiments, if the electronic device to be obtained is a mesh structure, process 3100 may further include step S141 (not shown in the figure). Step S141 is after step S14, first obtaining a mesh-shaped photoresist pattern by photolithography technology, vapor-depositing a layer of metal aluminum thereon, and then stripping the photoresist to obtain a mesh-shaped metal aluminum mask. Dry etching technology, such as ion reactive etching, is used to remove organic matter from the substrate to obtain a mesh-shaped carbon nanotube electrode. Finally, the sacrificial layer and the aluminum film can be etched based on the ferric chloride in step S15. An electronic device with a mesh-shaped carbon nanotube electrode can be obtained.

[0082] Understandably, Figure 3B This is only an example of preparing a carbon nanotube electrode, and other methods of preparing a carbon nanotube electrode are also applicable to this specification.

[0083] Figure 3C This is another exemplary process 3101 of the method for preparing an electronic device according to some embodiments of this specification. In some embodiments, when the electronic device to be prepared is a Pt / Au electrode, step 310 can be implemented based on process 3101. In some embodiments, process 3101 can include the following steps:

[0084] In step S21 , a layer of water-soluble polymer is spin-coated on the surface of the silicon wafer as a sacrificial layer.

[0085] In some embodiments, the water-soluble polymer includes one of: dextran, polyvinyl alcohol, and polyethylene oxide. For example, the water-soluble polymer can be dextran.

[0086] Step S22 , vapor-depositing a base organic matter on the sacrificial layer as a base material layer.

[0087] In step S23 , the base material layer is subjected to positive photolithography to form a first insulating layer of the electronic device, and a metal Pt / Au electrode conductive layer pattern is obtained by magnetron sputtering to form a conductive layer of the electronic device.

[0088] The photoresist used in the positive photolithography is a positive photoresist, for example, the photoresist may be AR-P 5350.

[0089] Step S24 , negative photolithography is performed on the Pt / Au electrode pattern to obtain a second insulating layer.

[0090] The photoresist used in the photolithography may be negative photoresist SU-8.

[0091] In step S25 , the silicon wafer is immersed in water, and the water-soluble polymer is dissolved to obtain a Pt / Au electrode.

[0092] Based on the above steps, an electronic device based on Pt / Au electrodes can be obtained.

[0093] In some embodiments, if the desired electronic device has a mesh structure, a grid-like photoresist pattern is first obtained using photolithography. A layer of aluminum is then evaporated on top of the pattern. The photoresist is then stripped to obtain a mesh-like aluminum mask. Dry etching techniques, such as reactive ion etching, are then used to remove organic matter from the substrate, resulting in a mesh-like carbon nanotube electrode. Finally, the aluminum mask is etched with ferric chloride, and the sacrificial layer is dissolved with deionized water to obtain the mesh-like electronic device.

[0094] Understandably, Figure 3C This is only an example of preparing a Pt / Au electrode, and other methods of preparing a Pt / Au electrode are also applicable to this specification.

[0095] In some embodiments, when implanting electronic devices, the width of the surgical opening should not be too large, so there are requirements for the thickness, Young's modulus and size of the target opening of the electrode substrate of the electronic device. For example, when the bending stiffness of the electrode substrate is less than 1.12×10 -9 N·m 2 When the electrode is not directly inserted into the target object, it will not be possible to perform a flexibility assessment on the prepared electronic device to determine whether it meets the implantation requirements. In some embodiments, the processing device can evaluate the flexibility of the electronic device by calculating the bending stiffness of the electrode.

[0096] In some embodiments, the bending stiffness K satisfies the following formula:

[0097]

[0098] Among them, E1 is the Young's modulus of the insulating layer, h1 is the thickness of the second insulating layer; E2 is the Young's modulus of the conductive layer, h2 is the thickness of the conductive layer; E3 is the Young's modulus of the mask, h3 is the thickness of the first insulating layer; E4 is the Young's modulus of the base material layer, h4 is the thickness of the base material layer, and w is the width of the electrode.

[0099] The above formula (1) is merely an example and does not limit the method for calculating the bending stiffness. Other methods for determining the bending stiffness may be applied to this embodiment. For example, the bending stiffness of the electronic device at the average width may be calculated by multiplying the elastic modulus by the moment of inertia of the section.

[0100] The bending stiffness of the electronic device prepared in this embodiment at the average width is calculated using formula (1) to be 21.492×10 -9 N·m 2 , indicating that the prepared electronic devices have high flexibility.

[0101] Step 320: Prepare a deformation actuator.

[0102] The shape-memory actuator can be made from a shape-memory alloy. For example, the shape-memory alloy can be a 100 μm diameter nickel-titanium alloy wire. The nickel-titanium alloy wire is nickel-rich (55.61 wt%), contains carbon (0.016 wt%), oxygen (0.026 wt%), nitrogen (0.001 wt%), and hydrogen (0.00029 wt%), with the remainder being titanium and other metals. The specific composition is shown in Table 1.

[0103] Table 1 Chemical composition of nickel-titanium alloy wire raw materials

[0104] chemical composition Ni C O N H Co / Cr / Cu / Fe / Nb Ti Percentage content (%) 55.61 0.016 0.026 0.001 0.00029 ＜0.010 margin

[0105] In some embodiments, based on the diameters of different shape memory materials and different heat treatment process parameters, deformation actuators of different specifications can be made for different demand scenarios. In some embodiments, the diameter of the shape memory material can be between 80um and 1mm. In some embodiments, when the preset shape of the shape memory material is set by heat treatment, the heat treatment heating temperature of the shape memory material can be between 200°C and 800°C. In some embodiments, the heat treatment heating time of the shape memory material can be between 5min and 3 hours. For example, taking the preparation of a deformation actuator with a 100um diameter nickel-titanium alloy wire as an example, when preparing the deformation actuator, the nickel-titanium alloy wire needs to be wound on a stainless steel mold to fix the shape. Heat at 480°C in a heating furnace for 40min, and the heating time is 5min. After the heating is completed, water-cooled quenching is performed to obtain the finalized shape memory alloy guide wire, which can be used as a deformation actuator.

[0106] Step 330: Connect the electronic device and the deformation actuator to obtain an implant.

[0107] Figure 3D This is an exemplary process 3300 for connecting an electronic device to a deformation actuator according to some embodiments of this specification. In some embodiments, step 330 can be implemented based on process 3300. In some embodiments, process 3300 can include the following steps:

[0108] Step S31: fish out the electronic components released into the water using a coated glass sheet.

[0109] In some embodiments, the coating on the glass sheet can be one of PDMS, Ecoflex, and silicone. The coating on the glass sheet is used to isolate the glass sheet from the flexible connector used in the subsequent hot pressing process to prevent the two from sticking together during the subsequent hot pressing process.

[0110] Step S32: When the water evaporates, hot-press the flexible connector onto the insulating layer of the electronic device.

[0111] A flexible connector is an electronic device used to achieve circuit connectivity in an electronic device. In some embodiments, one side of the flexible connector is connected to an interface, and the other side is connected to the insulating layer of the electronic device. After heat pressing melts the glue on the side of the flexible connector that contacts the electronic device, electrical connectivity is achieved between the interface and the electronic device. The interface can be used to connect the electronic device to an external circuit. For example, the interface can connect the electronic device to an amplifier, computer, power supply, or other device. In some embodiments, the interface can be directly connected to a terminal, allowing the physiological signals collected by the electronic device to be displayed on the terminal.

[0112] In some embodiments, the flexible connector includes one of zebra paper, a flexible printed circuit (FPC), and an anisotropic wire.

[0113] In some embodiments, the hot pressing temperature is between 100°C and 200°C.

[0114] In some embodiments, the hot pressing time is between 3-30 seconds.

[0115] Step S33: encapsulate the electronic components and the flexible connector with bio-silicone.

[0116] In some embodiments, encapsulating the electronic device and the flexible connector includes encapsulating the hot-pressed portions of the electronic device and the flexible connector. The hot-pressed portions of the electronic device and the flexible connector refer to portions where the electronic device and the flexible connector are hot-pressed and portions where the flexible connector is hot-pressed.

[0117] Taking zebra paper as a flexible connector as an example, the zebra paper is protected by hot-melt adhesive before hot pressing, making it non-conductive when in contact with external materials. After the zebra paper is hot-pressed onto the electronic device, the hot-melt adhesive in the hot-pressed area melts, allowing the conductive layer in the zebra paper to come into contact with the electronic device, thus enabling electrical signal transmission. Therefore, to prevent conductivity in areas outside of the direct contact area between the zebra paper and the electronic device, the entire hot-pressed area needs to be encapsulated with bio-glue to prevent leakage. Specifically, the outer surface of the entire hot-pressed area of the electronic device can be coated with an insulating bio-glue.

[0118] Step S34: Connecting the nickel-titanium alloy wire and the electronic device with a soluble solvent on the surface where the base material layer of the electronic device is located.

[0119] The soluble solvent includes a water-soluble polymer or a soluble silica gel. In some embodiments, the water-soluble polymer is concentrated PEO. The concentration of concentrated PEO ranges from 0.3g PEO / 3g H2O to 2g PEO / 3g H2O. In some embodiments, a solvent with a PEO concentration range of 0.5g PEO / 3g H2O to 1g PEO / 3g H2O can be used as the soluble solvent. For example, a PEO concentration of 0.8g PEO / 3g H2O can be used as the soluble solvent for connecting the nickel-titanium alloy wire and the electronic device. In some embodiments, the soluble silica gel is a silicone resin.

[0120] In some embodiments of this specification, thick PEO is used to connect the nickel-titanium alloy wire and the electronic device. It is non-toxic and non-irritating, can ensure a firm connection, and can be dissolved by a solvent, so as to facilitate the separation of the deformation actuator and the electronic device. For more instructions on separation, please refer to step 420.

[0121] In some embodiments, the edge of the electronic device is carved into a wheat ear shape to make the connection more secure. For more information about the wheat ear shape, please refer to the above content.

[0122] The flexible electronic devices fabricated in some embodiments of this specification are compatible with existing micro-nanofabrication techniques, enabling the fabrication of large-area, high-density recording sites. This meets the requirements for large-area, multi-site recording of neural activity in current neural network research, providing sufficient temporal and spatial resolution for the study of dynamic neural networks. The specific type of electronic device and the spatial distribution of its working sites can be customized based on application requirements. The shape of the shape memory alloy guidewire can also be tailored to specific usage conditions, enriching the diversity of deformable implantable electronic devices.

[0123] Figure 4 FIG. 1 is an exemplary flow chart of an implant implantation process according to some embodiments of the present invention. Figure 4 As shown, process 400 includes the following steps.

[0124] In step 410, the implant in the collapsed state is placed into the target part of the target object through the implant hole. The implant hole is obtained by opening a hole in the target part or selecting a hole in the target part as the implant hole. The implant is composed of a deformation driver connected to an electronic device. The deformation driver is made of a shape memory material. The phase change temperature of the shape memory material is the internal body temperature of the target object.

[0125] The collapsed state refers to the state of the implant when it is in a smaller volume. In some embodiments, the collapsed state can be the corresponding state of the implant when the deformation actuator is in the martensite phase after deformation. For more information about the collapsed state, see Figure 1B .

[0126] The implant can be compressed to a collapsed state in a variety of ways. For example, the implant can be cooled in vitro by freezing the implant and then compressed by manually deforming the deformation actuator. In another example, the implant can be compressed in a cryogenic environment by squeezing the deformation actuator using a mechanical device (such as a manipulator).

[0127] In some embodiments, the aforementioned compression, extrusion, and other operations on the implant are performed at a temperature lower than the phase transition temperature of the shape memory material.

[0128] An implant hole is a hole drilled into or formed at a target site for implantation. In some embodiments, the target site may be within the subject's skull, and the implant hole may be created by drilling a hole in the skull. In some embodiments, the target site may be the subject's spine, and holes between spinal segments may be selected as implant holes.

[0129] In some embodiments, the location of the implant hole is related to the target location to be monitored. For example, if the target location is within the brain of the target subject, the implant hole can be located in different functional areas such as the motor cortex, sensory cortex, and visual cortex, thereby monitoring different neural activities. The implant hole can also be located through the dura mater, achieving subdural implantation.

[0130] The opening area of the implant hole is related to the volume of the implant. For example, the opening area can be 1.5mm 2 The opening shape can be set according to surgical needs.

[0131] In some embodiments, before the implant in the collapsed state is implanted into the implantation hole, the implant in the collapsed state may be shaped using a water-soluble polymer material.

[0132] In some embodiments, after the electronic device and the shape-shifting actuator are aggregated together, a thinner PEO can be used to further shape the aggregated electronic device and the shape-shifting actuator.

[0133] In some embodiments, the dilute PEO concentration ranges from 0.03 g PEO / 3 g H2O to 0.3 g PEO / 3 g H2O. A solvent having a PEO concentration range of 0.05 g PEO / 3 g H2O to 0.2 g PEO / 3 g H2O can be used as a soluble solvent. For example, a PEO concentration of 0.1 g PEO / 3 g H2O can be used as a soluble solvent for connecting nickel-titanium alloy wires and electronic devices.

[0134] In some embodiments of the present specification, the implant in a collapsed state is further shaped in vitro before being implanted into the implant hole, so that the volume of the implant is further reduced and the shape of the implant is more in line with surgical requirements, thereby facilitating subsequent implantation surgery.

[0135] In step 420, in response to the implant being transformed from the collapsed state to the expanded state and the shape memory material being separated from the electronic device, the shape memory material is removed from the target site through the implant hole.

[0136] The extended state refers to the state of the implant after implantation into the target object. In some embodiments, the extended state may correspond to the shape of the implant when the deformation actuator in the implant is in the austenite phase. For further description of the extended state, please refer to Figure 1A In some embodiments, since the phase transition temperature of the shape memory material used to prepare the deformation actuator is the internal temperature of the target subject, such as the temperature of the target site, after the implant in the collapsed state is implanted into the target site, the ambient temperature reaches the phase transition temperature of the deformation actuator, and the deformation actuator drives the electronic device to enter the extended state.

[0137] In some embodiments, after the implant enters the extended state, it is necessary to separate the electronic device from the deformable actuator and remove the deformable actuator from the target site. In some embodiments, the implant at the target site can be flushed with a dissolving agent through the implant hole to separate the deformable actuator and the electronic device.

[0138] In some embodiments, the dissolving agent used is physiological saline.

[0139] In some embodiments, the implant can be rinsed multiple times to dissolve the soluble solvent connecting the deformation actuator and the electronic device, thereby achieving separation of the electronic device from the deformation actuator. In some embodiments, the rinsing time can be between 30 minutes and 60 minutes.

[0140] After the electronic device and the deformation actuator are separated, the separated deformation actuator can be removed from the target site. In some embodiments, the opening can be fixed with bio-silicone, and the opening (e.g., implant hole) can be cured with a fixing material. The fixing material is a material that can replace the biological tissue defect at the opening. For example, in the case of the target site being the intracranial region of the target subject, the fixing material can be a photosensitive resin, etc.

[0141] In some embodiments, after the deformation actuator is pulled out, the electronic device remaining in the target area needs to be positioned to determine the signal collection position corresponding to the electronic device. For detailed instructions on positioning, see Figure 6 .

[0142] Figure 5 FIG. 5 is an exemplary schematic diagram of a process 500 for implanting an implant into the skull according to some embodiments of this specification. This embodiment is merely an example of a target implant site and does not limit the target site. Process 500 includes the following steps.

[0143] Step 501: implant an implant into the brain 4 through a tiny opening in the skull. The implant includes an electronic device 2 in a collapsed state and a deformation actuator 1 in a collapsed state. The implanted tissue includes either the dura mater or the subdura mater.

[0144] In step 502, after the implant is implanted into the brain tissue, the deformation actuator 1 in the collapsed state receives heat from the brain, reaches its phase transition temperature, and deforms back to its parent phase shape. The electronic device 2 in the collapsed state is expanded into an extended state with the help of the deformation actuator 1, and is closely attached to the surface of the brain.

[0145] Step 503: Take out the deformation actuator 1 through the skull opening, and only the electronic device 2 remains on the brain surface.

[0146] In some embodiments, the electronic device 2 remaining on the brain surface needs to be further positioned.

[0147] In some embodiments, the Figure 3A The implant prepared by the method was implanted into the dura mater of rats through minimally invasive implantation surgery. The specific steps are as follows:

[0148] The rat was fixed on a stereotaxic apparatus, and the hair, scalp and other membranes were removed to expose the skull.

[0149] A hole was drilled in the cerebellum or contralateral brain area of the rat and a skull nail was inserted to serve as the ground electrode.

[0150] Mannitol was injected into the tail vein to induce brain dehydration in rats.

[0151] An acupuncture needle was used for positioning to determine the shape and position of the implantation hole on the skull, and the implantation hole was drilled. The opening area of the implantation hole was 2 mm × 1.5 mm.

[0152] The rat's snout was adjusted to create an oblique head profile, and the implant, already in its collapsed state, was inserted through the implant port. The implant deployed intracranially with the help of a deformation actuator, taking less than a minute. The electronic device, when deployed, measured approximately 6 mm x 6 mm.

[0153] After the implantation process is completed, the front end of the stereotaxic instrument is adjusted, and the implant is rinsed with saline several times, and the PEO connecting the deformation actuator and the electronic device is allowed to dissolve. The PEO dissolving time is 30 to 60 minutes.

[0154] Pull out the separated deformation driver from the skull.

[0155] After the skull is replaced and the skull gap at the opening is fixed with bio-silicone, the skull gap is further solidified with materials such as photosensitive resin or toothpaste cement.

[0156] Figure 7 This is an exemplary schematic diagram of an electronic device collecting rat epilepsy signals according to some embodiments of this specification.

[0157] In some embodiments, the epilepsy-inducing drug 4-AP is dripped onto the rats implanted with electronic devices in the aforementioned step to induce epilepsy-like signals in the rats. Figure 7 It can be seen that the electronic device implanted by the minimally invasive method provided in the embodiments of this specification can record high-quality epileptic signals with clear characteristics.

[0158] In some embodiments, the Figure 3A The implant prepared by the method was implanted under the dura mater of the beagle dog through minimally invasive implantation surgery. The specific steps are as follows:

[0159] The beagle dog was fixed on a stereotaxic apparatus, and the body hair, scalp, and other membranes were removed to expose the skull.

[0160] A hole was drilled in the cerebellum or contralateral brain area of the beagle dog and a skull nail was inserted to serve as the ground electrode.

[0161] Mannitol was injected into the forearm vein to maintain stable intracranial pressure in the beagle dogs.

[0162] First, a 3cm x 2.5cm cranial window was created in the beagle dog's skull. A 6mm slit was cut in the dog's dura mater, and the implant, already in its collapsed state, was inserted through the slit. The implant was deployed beneath the dura mater using a deformation actuator in less than one minute. The electronic device, when deployed, measured 2cm x 1.5cm.

[0163] After the implantation process is completed, the implant is rinsed with saline several times, and the PEO connecting the deformation actuator and the electronic device is allowed to dissolve. The PEO dissolving time is 30 to 60 minutes.

[0164] Pull out the separated deformation actuator from under the dura mater.

[0165] After the skull is replaced and the skull gap at the opening is fixed with bio-silicone, the skull gap is further solidified with materials such as photosensitive resin or toothpaste cement.

[0166] Figure 8 1 is an exemplary schematic diagram of signal recording of a beagle dog in an anesthetized state (left) and during the transition from anesthesia to awakening (right) using an electronic device according to some embodiments of the present specification.

[0167] The beagle dogs implanted with electronic devices in the previous steps were anesthetized and awakened, combined with Figure 8 It can be seen that the electronic device implanted by the minimally invasive method provided in the embodiments of this specification can record stable electrophysiological signals with clear characteristics during anesthesia and awakening.

[0168] The embodiments of this specification utilize a minimal cranial or dura mater opening to implant a large-area electronic device, significantly reducing damage to biological tissue and improving the biocompatibility of the electronic device, thereby facilitating the acquisition of signal characteristics closer to those found in normal physiological conditions. Once implanted and deployed through the small opening, the electronic device can adhere tightly to the surface of biological tissue over a large area, forming a seamless neural interface. This improves the quality and stability of neural signal stimulation and recording, enabling dynamic monitoring of electrophysiological signal changes over a large area of the cerebral cortex.

[0169] In some embodiments, the processing device may locate the electronic device in the target object in a variety of ways.

[0170] For example, the processing device may locate the electronic device based on a variety of imaging technologies, such as postoperative X-ray computed tomography (CT) imaging or intraoperative photography.

[0171] In some embodiments, the processing device may locate the electronic device in the skull using a neuronavigation system.

[0172] In some embodiments, the neuronavigation system can be implemented based on a variety of systems with imaging or navigation functions. For example, the neuronavigation system can include a magnetic resonance imaging system.

[0173] When the electronic device is positioned using a magnetic resonance imaging system, the prepared electronic device may be an electronic device having a magnetic metal interlayer. For example, the electronic device may be an electronic device having an additional magnetic metal interlayer with a thickness of 100 nm.

[0174] The following example uses an MRI system to locate an electronic device within the skull. MRI scanning can be used to image the subject's head. The resulting head image is processed using software such as itk-SNAP to obtain the device's location information. This processing involves locating the device based on the contrast between the area where the device resides and brain tissue in the head image.

[0175] In some embodiments, a metal interlayer may be located between the SU-8 insulating layer and the base material layer.

[0176] In some embodiments, the metal interlayer may be a magnetic material that can be visualized under magnetic resonance imaging, including but not limited to iron, cobalt, nickel, and the like.

[0177] In some embodiments, the thickness of the metal interlayer can be adjusted according to actual positioning requirements, for example, greater than 100 nm.

[0178] In order to clearly explain how to locate the target part of the electronic device, the following Figure 6 The positioning process is described by taking the intracranial target site as an example. This description does not limit the specific location of the target site.

[0179] Figure 6 FIG. 1 is an exemplary flow chart of intracranial positioning of electronic devices according to some embodiments of this specification. Figure 6As shown, the process 600 includes the following steps: In some embodiments, the process 600 can be performed by a neuronavigation system.

[0180] Step 610: Determine first positioning information and characteristic information of at least a portion of the area in the skull based on the robotic arm passing through the implant hole.

[0181] The at least partial area is an area on the electronic device that is exposed through the implant hole and from which information can be collected by the robotic arm. In some embodiments, the at least partial area can include multiple sites, and the sites in the at least partial area can be referred to as sampling sites. For example, the at least partial area can include three or five sampling sites.

[0182] The first positioning information refers to the position information of the electronic device in the three-dimensional simulated surgical space. In some embodiments, the first positioning information may be the position information of the electronic device within the three-dimensional simulated skull. For example, a first coordinate system is constructed based on the three-dimensional simulated surgical space, and the first positioning information can be identified in the first coordinate system, where the first coordinate system is a three-dimensional coordinate system. If at least a portion of the area includes multiple sampling points, the coordinate values of the multiple sampling points can be represented in the first coordinate system to represent the first positioning information of the sampling points.

[0183] Feature information refers to topographic information associated with a specific location or region of an electronic device. In some embodiments, feature information can be used to distinguish different regions of the electronic device. For example, site 1 of the electronic device may have a convergence of several straight lines, site 2 may have a square structure, and site 3 may be a circular neural signal recording site.

[0184] In some embodiments, the position of at least a portion of the area on the electronic device can be determined by presetting characteristic information of the electronic device when preparing the electronic device and matching the preset characteristic information with the collected characteristic information of at least a portion of the area.

[0185] In some embodiments, the robotic arm may determine the characteristic information of at least a portion of the area in a variety of ways, such as by photographing at least a portion of the area with a camera and determining the characteristic information of the at least portion of the area through image recognition.

[0186] In some embodiments, the robotic arm can determine the first positioning information of at least a portion of the area in a variety of ways. For example, the three-dimensional simulated surgical space corresponds to the first coordinate system, the real surgical space corresponds to the second coordinate system, and a common coordinate system is established at the same time. The second coordinate system and the common coordinate system are three-dimensional coordinate systems. There can be a mapping relationship between the first coordinate system and the second coordinate system and the common coordinate system. The coordinates of the sample site collected by the robotic arm in the real surgical space in the second coordinate system can be converted into coordinates in the common coordinate system, and the coordinates in the first coordinate system can be further obtained, that is, the first positioning information in the three-dimensional simulated surgical space is obtained.

[0187] In some embodiments, the robotic arm can be mounted on a neuronavigation system, which includes a storage device. In some embodiments, the robotic arm can execute motion instructions stored in the storage device, move to the implant hole, and identify and collect first positioning information and feature information of a portion of the electronic device.

[0188] Step 620: Determine second positioning information of at least a portion of the region on the electronic device based on the characteristic information of at least a portion of the region.

[0189] The second positioning information refers to the position information of at least a portion of the electronic device on the electronic device. In some embodiments, the second positioning information includes the position information of multiple sampling points on the electronic device in at least a portion of the region. For example, the second positioning information may be the two-dimensional position coordinates of sampling point 1 on the electronic device relative to the electronic device. The coordinate system constructed based on the electronic device is the third coordinate system, which is a two-dimensional coordinate system.

[0190] Based on the above process (such as Figure 4 、 Figure 5 After the electronic device is implanted into the skull of the target subject according to the process described above, at least a portion of the sampling sites on the electronic device can be exposed through the translucent dura mater and the skull opening. The robotic arm can then collect the coordinates of the exposed sampling sites in the three-dimensional simulated surgical space and record them in the neuronavigation system. The neuronavigation system can determine the position information of at least a portion of the region on the electronic device based on the characteristic information of at least a portion of the region on the electronic device obtained by the robotic arm.

[0191] For example, there is a unique dot pattern corresponding to the sampling site N. After the characteristic information (i.e., the dot pattern) of the sampling site N on the electronic device is obtained by the robotic arm, the dot pattern can be matched with its corresponding two-dimensional coordinates (1, 2) on the electronic device, that is, the two-dimensional coordinates of the sampling site N on the electronic device are determined to be (1, 2).

[0192] Step 630: Determine the first positioning information of other areas of the electronic device based on the second positioning information of at least a portion of the area and the first positioning information of at least a portion of the area.

[0193] In some embodiments, sites located in other areas may be referred to as sites to be tested.

[0194] In some embodiments, the second positioning information of other regions can be determined based on the second positioning information of at least a portion of the region. For example, the second positioning information of other regions can be determined based on the actual positional relationship between at least a portion of the region and other regions on the electronic device. Furthermore, the first positioning information of other regions can be determined based on the second positioning information of other regions and the first positioning information of at least a portion of the region.

[0195] In some embodiments, the neuronavigation system can determine the first positioning information of the target site in other areas of the electronic device in the three-dimensional simulated surgical space based on the second positioning information of other areas and the first positioning information of at least part of the area through stereotactic calculation.

[0196] For example, the stereotactic calculation process is as follows:

[0197] The stereotactic process can be considered as the process of converting the two-dimensional coordinates (x n ,y n ) corresponds to the three-dimensional coordinates in the three-dimensional simulated surgical space The solution process is as follows:

[0198] Through any three non-collinear points A(x a ,y a ), B(x b ,y b ), C(x c ,y c ), find the unit normal vector of the plane (plane ABC) where points A, B, and C are located. The first positioning information of points A, B, and C (i.e., the coordinates in the first coordinate system corresponding to the three-dimensional simulated surgical space) can be obtained based on step 610 and stored in the neuronavigation system. The second positioning information of points A, B, and C (i.e., the coordinates in the third coordinate system) can be obtained based on step 620. Based on the known two-dimensional coordinates of any one of points A, B, and C and the positional relationship between that point and the site to be measured on the electronic device, the two-dimensional coordinates of the site to be measured on the electronic device can be obtained.

[0199] Determine the direction of the x-axis of the transformed coordinate system based on the x-axis basis vector (assuming the x-axis basis vector is The x-axis basis vector can be the vector between any two points among A, B, and C (for example, vector ) is rotated by a known angle θ in plane ABC, and the vector For example, vector and the x-axis basis vectors The angle θ between them can be expressed as follows:

[0200]

[0201] Solve the following equations to find the x-axis basis vectors

[0202]

[0203] Based on the obtained x-axis basis vector, the y-axis basis vector can be determined Then we can determine the z-axis basis vector

[0204] The standard orthogonal basis of the coordinate system (i.e. the first coordinate system) of the three-dimensional simulated surgical space Then W=R 0 ·R -1 Obtain the rotation transformation matrix W (where R is the standard orthogonal basis before the coordinate system transformation, which is the third-order unit matrix E).

[0205] Expand the two-dimensional coordinates of the sampling site and the site to be measured (i.e., the coordinates in the third coordinate system) into three-dimensional vectors. Specifically, keep the x-axis and y-axis coordinate values unchanged and set the z-axis component to 0. For example, the two-dimensional coordinates of points A, B, and C before rotation transformation are A(x a ,y a ), B(x b ,y b ), C(x c ,y c ), the three-dimensional vectors corresponding to the coordinates of points A, B, and C are After the three-dimensional vectors corresponding to each site (including known sites and sites to be measured) are transformed by the rotation transformation matrix W, the three-dimensional coordinates of the three-dimensional simulated surgical space corresponding to each site in the rotation transformed coordinate system are obtained.

[0206] Based on the three-dimensional coordinates of at least one sampling site (for example, sampling site A) after being transformed by the rotation transformation matrix W and the three-dimensional coordinates of sampling site A in the three-dimensional simulated surgical space (determined by step 610), the displacement of sampling site A in the three coordinate axis directions is determined, and the three-dimensional coordinates after the rotation transformation corresponding to the test site are displaced as a whole, that is, the absolute position of each site in the real surgical space is obtained.

[0207] The above-described method of obtaining the position coordinates of other parts of an electronic device through stereotactic calculation is merely an example and does not limit the method for locating a target portion of an electronic device. Other methods for determining position information may be applied to this embodiment, for example, based on a position model, where the input of the position model includes the first positioning information and the second positioning information of at least a portion of the region, and the output is the first positioning information of other regions.

[0208] In some embodiments of the present specification, improvements are made to existing neuronavigation systems, so that the entire electronic device does not need to be exposed to the field of view. That is, the positioning information of other areas of the electronic device can be determined based on at least a partial area through stereotactic calculation methods, thereby achieving precise positioning of the electronic device, which is of great significance for analyzing neural activity.

[0209] It should be noted that the above descriptions of processes 300, 400, and 600 are for illustration and purpose only and do not limit the scope of application of this specification. Those skilled in the art may, under the guidance of this specification, make various modifications and alterations to processes 300, 400, and 600. However, such modifications and alterations remain within the scope of this specification.

[0210] While the basic concepts have been described above, it will be apparent to those skilled in the art that the detailed disclosure is merely illustrative and does not limit this specification. Although not explicitly stated herein, various modifications, improvements, and revisions to this specification may be made by those skilled in the art. Such modifications, improvements, and revisions are suggested in this specification and remain within the spirit and scope of the exemplary embodiments of this specification.

[0211] This specification also uses specific terms to describe the embodiments of this specification. For example, "one embodiment," "an embodiment," and / or "some embodiments" refer to a feature, structure, or characteristic associated with at least one embodiment of this specification. Therefore, it should be emphasized and noted that references to "one embodiment," "an embodiment," or "an alternative embodiment" two or more times in different locations in this specification do not necessarily refer to the same embodiment. Furthermore, certain features, structures, or characteristics of one or more embodiments of this specification may be appropriately combined.

[0212] In addition, unless expressly stated in the claims, the order of the processing elements and sequences, the use of alphanumeric characters, or the use of other names described in this specification are not intended to limit the order of the processes and methods of this specification. Although the above disclosure discusses some of the invention embodiments currently considered useful through various examples, it should be understood that such details are for illustrative purposes only, and the appended claims are not limited to the disclosed embodiments. On the contrary, the claims are intended to cover all modifications and equivalent combinations that are consistent with the spirit and scope of the embodiments of this specification. For example, although the system components described above can be implemented by hardware devices, they can also be implemented only by software solutions, such as installing the described system on an existing server or mobile device.

[0213] Similarly, it should be noted that, in order to simplify the presentation of this specification and thus facilitate understanding of one or more embodiments of the invention, the foregoing descriptions of the embodiments of this specification sometimes combine multiple features into a single embodiment, figure, or description thereof. However, this disclosure method does not imply that the subject matter of this specification requires more features than those recited in the claims. In fact, an embodiment may have fewer features than all of the features of a single disclosed embodiment.

[0214] In some embodiments, numbers are used to describe the quantity of components and attributes. It should be understood that such numbers used in the description of the embodiments are modified by the modifiers "about", "approximately" or "substantially" in some examples. Unless otherwise stated, "about", "approximately" or "substantially" indicate that the numbers are allowed to vary by ±20%. Accordingly, in some embodiments, the numerical parameters used in the description and claims are approximate values, which may change according to the required characteristics of individual embodiments. In some embodiments, the numerical parameters should take into account the specified significant digits and adopt the general method of retaining digits. Although the numerical domains and parameters used to confirm the breadth of their range in some embodiments of this specification are approximate values, in specific embodiments, the settings of such numerical values are as accurate as possible within the feasible range.

[0215] Each patent, patent application, patent application publication, and other materials, such as articles, books, specifications, publications, and documents, cited in this specification is hereby incorporated by reference in its entirety. This includes application history documents that are inconsistent with or conflict with the content of this specification, as well as documents (currently or subsequently attached to this specification) that limit the broadest scope of the claims of this specification. It should be noted that if the descriptions, definitions, and / or terminology used in the accompanying materials are inconsistent or conflicting with the content of this specification, the descriptions, definitions, and / or terminology used in this specification will control.

[0216] Finally, it should be understood that the embodiments described in this specification are intended only to illustrate the principles of the embodiments of this specification. Other variations may also fall within the scope of this specification. Therefore, by way of example and not limitation, alternative configurations of the embodiments of this specification may be considered consistent with the teachings of this specification. Accordingly, the embodiments of this specification are not limited to the embodiments explicitly described and illustrated in this specification.

Claims

1. An implant, characterized in that: The implant comprises: An electronic device having a mesh structure or a thin film structure, comprising a recording site and a connecting portion, wherein the recording site collects neural signals; the connecting portion is provided on wings on both sides of a base of the electronic device, and the connecting portion has an ear-shaped edge; The deformation actuator is connected to the electronic device via the connecting portion, wherein: The deformation actuator is made of a shape memory material, the phase transition temperature of the shape memory material is the internal body temperature of the target subject, when the ambient temperature of the implant is lower than the internal body temperature, the implant is compressed into a contracted state, and when the ambient temperature is raised to the internal body temperature, the implant spontaneously transforms from the contracted state to an extended state; The electronic device further includes a sampling area including a plurality of sampling points, wherein different sampling areas have different characteristic information, and the characteristic information refers to morphological information related to a specific position or area of the electronic device; The electronic device and the deformation actuator are connected via a water-soluble polymer material. Under the action of a solvent, the deformation actuator and the electronic device can be separated.

2. The implant according to claim 1, wherein The deformation driver is made of the filamentous shape memory material.

3. A navigation imaging system, characterized in that: The navigation imaging system comprises the implant according to claim 1 and a neuronavigation system; The electronic device further comprises a magnetic metal interlayer; The neuronavigation system is configured to: Determining first positioning information and characteristic information of at least a portion of the region at the target site based on the robotic arm passing through the implant hole; Determining second positioning information of the at least partial area on the electronic device based on the characteristic information; The first positioning information of other areas of the electronic device is determined based on the second positioning information and the first positioning information.

Images