Cell guiding device

Abstract

The embodiment of the invention provides a cell guiding device, and the device comprises a receiving coil which is used for receiving a radio frequency signal transmitted by an in-vitro energy supply device; the stimulator is electrically connected with the receiving coil and is used for generating an electrical stimulation pulse according to the radio frequency signal; the electrode array is used for being arranged in the cochlea and electrically connected with the stimulator; the electrode array is used for applying the electrical stimulation pulse to hair cells in the cochlea so as to stimulate the hair cells to proliferate and differentiate. According to the technical scheme provided by the embodiment of the invention, the electrical stimulation pulse is generated according to the in-vitro radio frequency signal and is applied to the hair cells in the cochlea, so that accurate and efficient electrical stimulation on the hair cells can be realized. Meanwhile, the implanted design is adopted to directly act on the hair cells in the cochlea, so that the trauma to the body can be reduced, and the safety and comfort of treatment are improved.

Description

Technical Field

[0001] This application relates to the field of implantable medical device technology, and more particularly to a cell guiding device and method. Background Technology

[0002] Sensorineural hearing loss is a hearing impairment, one of the main causes of which is damage or loss of hair cells in the cochlea. Hair cells are key sensory cells in the cochlea responsible for converting sound signals into nerve impulses; damage to them can lead to hearing loss or even complete hearing loss.

[0003] Treatment options for sensorineural hearing loss include medication, hearing aids, and cochlear implantation; however, these methods have limitations, such as limited hearing recovery and the inability to cure the condition. With advancements in stem cell technology and bioelectronics, treating hearing loss using cell regeneration and precise guidance techniques has become possible. However, how to safely and efficiently guide the hair cells within the cochlea precisely to restore hearing function remains a key technical challenge that needs to be addressed.

[0004] It should be noted that the above content is not necessarily prior art, nor is it intended to limit the scope of patent protection of this application. Summary of the Invention

[0005] This application provides a cell-guided device and method to solve or alleviate one or more of the technical problems mentioned above.

[0006] As one aspect of this application, this application provides a cell-guided device for implantation into the human body, comprising: A receiving coil is used to receive radio frequency signals emitted by an external power supply device; A stimulator, electrically connected to the receiving coil, is used to generate electrical stimulation pulses based on the radio frequency signal; An electrode array is disposed inside the cochlea and electrically connected to the stimulator; The electrode array is used to apply the electrical stimulation pulses to the hair cells in the cochlea to stimulate hair cell proliferation and differentiation.

[0007] Optionally, the stimulator includes: A detection module, electrically connected to the receiving coil, is used to extract stimulus-encoded signals from the radio frequency signals; The processor, electrically connected to the detection module, is used to decode the stimulus-encoded signal to obtain a stimulus-decoded signal; A stimulation generation circuit, electrically connected to the processor, is used to generate the electrical stimulation pulse based on the stimulation decoding signal.

[0008] Optionally, the stimulator further includes: A digital logic chip, electrically connected to the processor and the stimulus generation circuit, is used to verify the stimulus decoding signal and, when the verification passes, trigger the stimulus generation circuit to generate the electrical stimulation pulse.

[0009] Optionally, the stimulator further includes: The power management module is electrically connected to the receiving coil and the power-consuming components in the stimulator, and is used to extract electrical energy from the radio frequency signal to power the stimulator.

[0010] Optionally, it also includes: A drug delivery pump is electrically connected to the stimulator and fluidly communicated with the electrode array; The drug delivery pump is used to deliver the hair cell suspension in the drug delivery pump to the electrode array according to the radio frequency signal, so as to deliver the hair cell suspension into the cochlea through the electrode array.

[0011] Optionally, the drug delivery pump is provided with: The lower cavity is used to contain the thermal phase change material; A resistance thermometer is disposed in the lower cavity and electrically connected to the stimulator for controllably heating the thermal phase change material, causing it to expand or contract in volume; An upper cavity, located above the lower cavity, is used to contain the hair cell suspension; A fluid conduit connects the upper cavity and the electrode array; A piston, which is sealed and slidably disposed between the lower cavity and the upper cavity, is used to move upward when the thermal phase change material expands, thereby delivering the hair cell suspension in the upper cavity to the electrode array through the fluid conduit.

[0012] Optionally, the electrode array includes: Hollow electrode wires, with an internal infusion channel connected to the fluid conduit, are used to deliver the hair cell suspension; Multiple drug delivery ports are distributed on the hollow electrode wires for releasing the hair cell suspension into the cochlea.

[0013] Optionally, the device further includes: An inner magnet, embedded at the geometric center of the receiving coil, is used for magnetic coupling with an outer magnet in the external power supply device to position the receiving coil.

[0014] Optionally, the receiving coil includes: Coil body; A silicon capsule, disc-shaped, is used to enclose the coil body; and A magnet base is embedded inside the silicon capsule, and the magnet base has internal threads; The inner magnet is provided with an external thread, and the magnet base is screwed onto the inner magnet by the thread.

[0015] Another aspect of this application provides a cell guidance method, based on the cell guidance device according to the above embodiments, comprising: The receiver coil receives radio frequency signals emitted by the external power supply device. The stimulator generates electrical stimulation pulses based on the radio frequency signal; The electrical stimulation pulses are applied to the hair cells in the cochlea through an electrode array to stimulate hair cell proliferation and differentiation.

[0016] The embodiments of this application employing the above-described technical solution may include the following advantages: by generating electrical stimulation pulses based on radio frequency signals from outside the body and applying them to the hair cells within the cochlea, precise and efficient electrical stimulation of the hair cells can be achieved. Simultaneously, the implantable design, acting directly on the hair cells within the cochlea, can reduce trauma to the body and improve safety and comfort. Attached Figure Description

[0017] In the accompanying drawings, unless otherwise specified, the same reference numerals throughout the various drawings denote the same or similar parts or elements. These drawings are not necessarily drawn to scale. It should be understood that these drawings depict only some embodiments disclosed in this application and should not be construed as limiting the scope of this application.

[0018] Figure 1 This is a schematic diagram of the structure of the cell guidance device provided in the embodiments of this application; Figure 2 This is a top view of an exemplary stimulator; Figure 3 This is a side view of an exemplary stimulator; Figure 4 This is a schematic diagram of the drug delivery pump; Figure 5 This is a side view of an exemplary internal magnet; Figure 6 This is a top view of an exemplary internal magnet; Figure 7 This is a schematic diagram of the unfolded structure of the hollow electrode wire; Figure 8 This is a schematic diagram of the cross-section of a hollow electrode wire; Figure 9 This is a schematic diagram illustrating the combined effect of the inner magnet, silicon capsule, coil body, and magnet base; Figure 10 This is a flowchart of the cell guidance method according to Embodiment 2 of this application.

[0019] Explanation of reference numerals in the attached figures: Receiving coil 1; coil body 11; silicon capsule 12; magnet base 13; stimulator 2; shell 21; back cover 22; electrode array 3; drug delivery pump 4; lower chamber 41; thermal resistance sheet 42; upper chamber 43; fluid conduit 44; piston 45; inner magnet 5. Detailed Implementation

[0020] To make the objectives, technical solutions, and advantages of this application clearer, the following detailed description is provided in conjunction with the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative and not intended to limit the scope of this application. All other embodiments obtained by those skilled in the art based on the embodiments in this application without inventive effort are within the scope of protection of this application.

[0021] It should be noted that the descriptions involving "first," "second," etc., in the embodiments of this application are for descriptive purposes only and should not be construed as indicating or implying their relative importance or implicitly specifying the number of technical features indicated. Therefore, a feature defined with "first" or "second" may explicitly or implicitly include at least one of that feature. Furthermore, the technical solutions of the various embodiments can be combined with each other, but this must be based on the ability of those skilled in the art to implement them. If the combination of technical solutions is contradictory or impossible to implement, it should be considered that such a combination of technical solutions does not exist and is not within the scope of protection claimed in this application.

[0022] It should be noted that, in any stage of this application involving the collection, storage, use, transmission, and processing of data, each stage strictly adheres to the laws, regulations, industry standards, and regulatory requirements of the data source, usage location, and relevant countries and regions to ensure the legality and compliance of data activities. In the collection stage, the purpose, method, and scope of collection are clearly communicated to the data subject in a prominent manner. Collection is conducted only after obtaining the data subject's legal authorization, ensuring that the collection process follows the "minimum necessary" principle and does not exceed the scope of data collection. In the storage stage, storage periods are limited, and data is promptly deleted or anonymized / encrypted after the storage purpose is achieved. In the usage stage, a strict data security protection mechanism is implemented, using field-level desensitization technology and processing the original data according to preset desensitization rules. For different types of data, multiple desensitization strategies, such as data generalization, data anonymization, and data encryption, are employed to effectively mitigate the risk of sensitive information leakage and ensure that all data used is securely processed and desensitized, comprehensively protecting the rights and interests of data subjects and data security. In the transmission and processing stages, the confidentiality and security of data are ensured during transmission and processing.

[0023] In the description of this application, it should be understood that the numerical labels before the steps do not indicate the order of the steps, but are only used to facilitate the description of this application and to distinguish each step, and therefore should not be construed as a limitation of this application.

[0024] First, a definition of the terminology used in this application is provided: Radio frequency signal (RF signal): refers to electromagnetic signals with a frequency range between 3kHz and 300GHz.

[0025] Stimulator: A medical device used to stimulate human tissues such as nerves and muscles, such as a nerve stimulator.

[0026] Electrical stimulation pulse: a technique that achieves a specific function by applying a brief, periodically changing electrical signal to biological tissue or electronic device.

[0027] Hair cells: Sensory epithelial cells in the inner ear, distributed in the cochlea and vestibular organs, are responsible for converting mechanical stimuli caused by sound wave vibrations into nerve impulses, which are then transmitted to the brain, enabling organisms to perceive sound.

[0028] Proliferation: refers to the process by which the number of cells in an organism increases, and the organism grows or reproduces.

[0029] Differentiation: refers to the process by which offspring produced by the proliferation of one or more cells in an organism exhibit stable differences in morphology, structure, and physiological function during the organism's development.

[0030] Detection: A signal processing procedure used to recover the original low-frequency signal from an amplitude-modulated signal.

[0031] Bandpass filter: A signal processing device that allows signals within a specific frequency range to pass through smoothly, while attenuating signals below or above that frequency range.

[0032] Suspension: A mixture formed by the dispersion of solid particles in a liquid medium.

[0033] Microfluidic valve: A device for precisely controlling the flow rate of minute fluids, enabling precise regulation of fluids at extremely low flow rates (such as microliters per second or even nanoliters per second).

[0034] Permanent magnet: A material that can maintain its magnetism for a long time.

[0035] Secondly, to facilitate understanding of the technical solutions provided in the embodiments of this application by those skilled in the art, the relevant technologies are described below: Sensorineural hearing loss is a hearing disorder primarily caused by damage or death of hair cells in the cochlea. Hair cells are key receptors in the auditory system; once damaged, they cannot regenerate naturally, leading to hearing loss or even complete deafness. The main treatments for sensorineural hearing loss include medication, hearing aids, and cochlear implantation. However, these methods all have limitations: medication has limited effectiveness and cannot cure the condition; hearing aids only amplify sound and cannot restore the damaged auditory system; while cochlear implants can partially restore hearing, their effectiveness depends on electrical stimulation signals and cannot fully simulate natural hearing, and they also carry surgical risks and compatibility issues.

[0036] With the development of stem cell technology and biomaterials science, hair cell regeneration and transplantation have emerged as a potential curative therapy. However, hair cell regeneration and transplantation technology faces many challenges: on the one hand, the technology for precise hair cell transplantation and colonization is still immature, making it impossible to achieve efficient delivery and functional reconstruction of hair cells within the cochlea; on the other hand, the power management efficiency of the devices is low, resulting in large device size, complex implantation surgery, and poor postoperative patient comfort.

[0037] Therefore, this application provides a cell-guided device technical solution. In this technical solution, (1) by generating electrical stimulation pulses based on radio frequency signals from outside the body and applying them to the hair cells in the cochlea, precise and efficient electrical stimulation of the hair cells can be achieved; (2) by adopting an implantable design that directly acts on the hair cells in the cochlea, trauma to the body can be reduced, and safety and comfort can be improved; (3) by extracting electrical energy from the radio frequency signals from outside the body through a power management module to power the stimulator, the problem of limited battery life in implantable devices can be effectively solved. At the same time, because no built-in power supply is required, the volume of the cell-guided device can be reduced, improving the convenience of the cell-guided device implantation process and the comfort of use; (4) by delivering hair cell suspension to the cochlea through a drug delivery pump to achieve hair cell implantation, the accuracy of the delivery volume and delivery position of the hair cell suspension can be ensured, improving the precision and efficiency of hair cell transplantation, thereby improving the success rate of hair cell transplantation and the therapeutic effect. See below for details.

[0038] Exemplary embodiments according to this application will now be described in more detail with reference to the accompanying drawings. It should be understood that these exemplary embodiments may be implemented in many different forms and should not be construed as being limited to the embodiments set forth herein.

[0039] Example 1 Figure 1 A schematic diagram of a cell guiding device according to Embodiment 1 of this application is shown.

[0040] like Figure 1As shown, this cell-guided device is intended for implantation into a living organism (such as the human body) and may include: a receiving coil, a stimulator, and an electrode array.

[0041] A receiving coil is used to receive radio frequency signals emitted by an external power supply device. In some embodiments, the receiving coil can be circular or polygonal and can be pre-embedded under the skin behind the ear. The diameter of the receiving coil can be 30.0 mm ± 1.0 mm, and the thickness can be 3.40 mm ± 0.5 mm. The body of the receiving coil can be made of conductive materials such as medical-grade copper alloy or silver alloy and is housed in a silicone capsule made of medical-grade silicone.

[0042] A stimulator is electrically connected to the receiving coil. The housing of the stimulator can be square, and its thickness can be set within the range of 3.90mm ± 0.5mm. In some embodiments, the housing of the stimulator can be made of materials such as titanium alloy and laser-encapsulated. A top view and a side view of an exemplary stimulator are shown below. Figure 2 and Figure 3 As shown, 21 is the housing and 22 is the back cover. The stimulator is used to generate electrical stimulation pulses based on the radio frequency signal. The electrical stimulation pulses can be unipolar pulses, bipolar pulses, or complex pulse sequences. In some embodiments, the electrical stimulation pulses can include multiple electrical stimulation channels, each corresponding to a different region within the cochlea (such as the apex, middle, or basal cochlea).

[0043] An electrode array is disposed within the cochlea and electrically connected to the stimulator. The electrode array is used to apply the electrical stimulation pulses to the hair cells within the cochlea to stimulate hair cell proliferation and differentiation. In some embodiments, the electrode array may consist of linearly arranged electrode bundles, each bundle having multiple saddle-shaped electrode contacts, each contact having a theoretical contact area between 0.16 and 0.28 mm². In other embodiments, biocompatible materials may be coated onto the electrode surfaces, and highly insulating silicone or other materials may be used for insulation between the electrodes.

[0044] In this embodiment, by generating electrical stimulation pulses based on radio frequency signals from outside the body and applying them to the hair cells within the cochlea, precise and efficient electrical stimulation of the hair cells can be achieved. Furthermore, the implantable design, which directly targets the hair cells within the cochlea, reduces trauma to the body and improves safety and comfort.

[0045] In an optional embodiment, the stimulator includes a detection module, a processor, and a stimulus generation circuit, wherein: A detection module, electrically connected to the receiving coil, is used to extract stimulus-encoded signals from the radio frequency signals; The processor, electrically connected to the detection module, is used to decode the stimulus-encoded signal to obtain a stimulus-decoded signal; A stimulation generation circuit, electrically connected to the processor, is used to generate the electrical stimulation pulse based on the stimulation decoding signal.

[0046] The detection module can be configured to use synchronous detection technology. In some embodiments, a bandpass filter can be included in the detection module to filter out noise and interference signals in the radio frequency signal. The processor can be a multi-core processor to process multiple stimulus-encoded signals simultaneously. An adaptive decoding algorithm can also be configured in the processor to automatically adjust the decoding strategy according to different stimulus-encoded signal formats. The stimulus generation circuit can generate electrical stimulation pulses with adjustable amplitude, frequency, and pulse width based on the stimulus decoding signal. The stimulus generation circuit may also include a pulse shaping module for optimizing the waveform of the electrical stimulation pulses.

[0047] In this embodiment, by decoding the stimulation encoding signal in the radio frequency signal to generate an electrical stimulation pulse, precise control of the electrical stimulation pulse can be achieved. The parameters of the stimulation pulse can be flexibly adjusted according to different treatment needs and the specific condition of the patient, thereby improving the accuracy and flexibility of cell guidance.

[0048] Depending on the specific needs, various other functional modules can also be incorporated into the stimulator. Several exemplary functional modules are provided below.

[0049] In an optional embodiment, the stimulator further includes a digital logic chip. The digital logic chip is electrically connected to the processor and the stimulus generation circuit, and is used to verify the stimulus decoding signal, and trigger the stimulus generation circuit to generate the electrical stimulation pulse when the verification passes.

[0050] In some embodiments, the digital logic chip can check and verify the data obtained at each step of the decoding process. In some embodiments, the digital logic chip can also perform integrity checks and encryption processing on the stimulus decoding signal. In other embodiments, the digital logic chip can also perform self-tests on the stimulator, monitor its own operating status in real time, and issue alarms when a fault occurs.

[0051] In this embodiment, generating an electrical stimulation pulse based on the stimulation decoding signal verified by the digital decoding chip can effectively improve the accuracy and reliability of the electrical stimulation pulse, thereby avoiding errors or interference in the transmission and processing of the stimulation decoding signal.

[0052] In an optional embodiment, the stimulator further includes a power management module. The power management module is electrically connected to the receiving coil and the electrical components in the stimulator, and is used to extract electrical energy from the radio frequency signal to power the stimulator.

[0053] In some embodiments, the power management module may include a rectifier circuit, a filter circuit, a voltage regulator circuit, etc., which can convert the radio frequency signal sensed by the receiving coil into stable DC power. The power management module may have multiple independent power output ports, each capable of providing power at different voltage levels to meet the power requirements of different electrical components in the stimulator. The power management module may also include overvoltage protection circuits and overcurrent protection circuits to automatically cut off the power supply when the input voltage is too high or the output current is too high.

[0054] In this embodiment, the power management module extracts electrical energy from the radio frequency signal from outside the body to power the stimulator, effectively solving the problem of limited battery life in implantable devices. Simultaneously, because no built-in power supply is required, the size of the cell-guided device can be reduced, improving the convenience and comfort of the implantation process.

[0055] In an optional embodiment, the device further includes a drug delivery pump. The drug delivery pump is electrically connected to the stimulator and in fluid communication with the electrode array; the drug delivery pump is used to deliver a hair cell suspension in the drug delivery pump to the electrode array according to the radio frequency signal, so as to deliver the hair cell suspension into the cochlea through the electrode array.

[0056] The drug delivery pump can deliver the hair cell suspension using electrochemical, electromagnetic, or piezoelectric actuation methods. In some embodiments, the drug storage chamber can have a multi-layered structure, with the inner layer made of a biocompatible material to prevent contamination of the hair cell suspension. In other embodiments, multiple independent drug storage units can be provided inside the drug storage chamber, each unit capable of storing different concentrations or types of drugs, which are then selectively delivered based on radio frequency signals. In some embodiments, the drug delivery pump can also be used to store other drug solutions.

[0057] In this embodiment, hair cell implantation is achieved by delivering hair cell suspension into the cochlea via a drug delivery pump. This ensures the accuracy of the delivery volume and delivery location of the hair cell suspension, improving the precision and efficiency of hair cell transplantation, thereby increasing the success rate of hair cell transplantation.

[0058] In an optional embodiment, the drug delivery pump includes: a lower chamber, a thermal resistance element, an upper chamber, a fluid conduit, and a piston. Wherein: The lower cavity is used to contain the thermal phase change material; A resistance thermometer is disposed in the lower cavity and electrically connected to the stimulator for controllably heating the thermal phase change material, causing it to expand or contract in volume; An upper cavity, located above the lower cavity, is used to contain the hair cell suspension; A fluid conduit connects the upper cavity and the electrode array; A piston, which is sealed and slidably disposed between the lower cavity and the upper cavity, is used to move upward when the thermal phase change material expands, thereby delivering the hair cell suspension in the upper cavity to the electrode array through the fluid conduit.

[0059] The outer layers of the upper and lower cavities can be encased in titanium metal shells. In some embodiments, the thermal phase change material can be a low-melting-point paraffin mixture or fatty acid-alcohol eutectic, etc., and graphite powder or titanium dioxide can be dispersed in the thermal phase change material to improve thermal conductivity and shorten response time. The piston can be made of titanium alloy or ceramic, and coated with a coating to reduce the coefficient of friction. A miniature thermistor can be installed on the inner wall of the lower cavity to feed back temperature signals to the stimulator for temperature control. A pressure detection device can also be installed on the side of the piston near the upper cavity to detect the hydraulic pressure of the hair cell suspension in real time and prevent hair cell inactivation. A capacitive liquid level electrode can also be installed on the side wall of the upper cavity to detect the volume of the remaining hair cell suspension and issue a replenishment prompt when the volume is lower than a preset threshold. The fluid conduit can be made of biocompatible materials such as medical-grade silicone or polytetrafluoroethylene and extends from the administration port at the top of the administration pump. In some embodiments, multiple fluid channels or microfilters can also be provided in the fluid conduit to prevent impurities in the hair cell suspension from clogging the fluid conduit. The resistance thermometer can be made of bio-inert metal foil or thin-film resistors, and is connected to the stimulator via platinum-iridium alloy electrode wires. In some embodiments, the stimulator can control the temperature of the resistance thermometer based on radio frequency signals, thereby precisely controlling parameters such as drug delivery frequency, drug delivery cycle, and total drug delivery amount. The drug delivery pump can be structured as follows: Figure 4 As shown, 41 is the lower cavity (containing a thermal phase change material), 42 is a thermal resistance element, 43 is the upper cavity (containing a hair cell suspension), 44 is a fluid conduit, and 45 is a piston.

[0060] In this embodiment, the thermal phase change material expands due to the heating of the thermal resistance sheet, thereby pushing the piston upward to push the hair cell suspension through the fluid conduit to the electrode array. This enables precise control and delivery of the hair cell suspension, ensuring that the drug or hair cell suspension can accurately reach the target position in the cochlea, thus improving the working effect of the cell guidance device.

[0061] In an optional embodiment, the electrode array includes hollow electrode wires and multiple drug delivery ports.

[0062] Hollow electrode wires, with an internal infusion channel connected to the fluid conduit, are used to deliver the hair cell suspension; Multiple drug delivery ports are distributed on the hollow electrode wires for releasing the hair cell suspension into the cochlea.

[0063] The hollow electrode wire can be made of medical-grade silicone. In some embodiments, the length of the hollow electrode wire can be 30 cm, the number of drug delivery ports can be 12, and the pore size of each drug delivery port can be 100-200 μm. In some embodiments, a microfluidic valve can be installed at the drug delivery port to prevent backflow, and a hydrophilic material coating can be used to cover the inner wall of the infusion channel and the drug delivery port to prevent the capillary suspension from blocking the infusion channel. The unfolded structure and cross-sectional schematic diagram of the hollow electrode wire can be shown in the figure below. Figure 7 and Figure 8 As shown.

[0064] In this embodiment, hair cell suspension is delivered into the cochlea through hollow electrode wires and multiple drug delivery ports, enabling precise multi-point release of the hair cell suspension across the entire frequency band within the cochlea, covering the apex, middle, and basal cochlea, thereby improving the accuracy of hair cell delivery and the effectiveness of hair cell transplantation.

[0065] In an optional embodiment, the device further includes an internal magnet 5. For example... Figure 9 The inner magnet 5 is embedded in the geometric center of the receiving coil and is used to magnetically couple with the outer magnet in the external power supply device to position the receiving coil.

[0066] In some embodiments, a permanent magnet can be made using high-energy-density neodymium iron boron rare-earth permanent magnet material, and the permanent magnet can be encased in a titanium alloy shell as the inner magnet. A titanium oxide layer can also be formed on the surface of the titanium alloy shell through anodizing. The inner magnet can be designed as a polygonal cylinder. The inner magnet can be magnetized in a left-right direction, and the outer magnet can be magnetized in a magnetization direction orthogonal to the radial magnetization direction of the inner magnet. A side view and top view of an exemplary inner magnet can be shown as follows: Figure 5 and Figure 6 As shown.

[0067] In this embodiment, by setting an inner magnet coupled to an outer magnet at the geometric center of the receiving coil for positioning, the receiving coil can be precisely positioned and stably coupled through magnetic attraction, thereby ensuring efficient energy transmission and signal alignment between the external power supply device and the receiving coil.

[0068] In an optional embodiment, the receiving coil includes: a coil body, a silicon capsule, and a magnet base.

[0069] like Figure 9 The silicon capsule 12 is disc-shaped and is used to enclose the coil body 11. A magnet base 13 is embedded within the silicon capsule and has internal threads. The inner magnet has external threads, and the magnet base is screwed onto the inner magnet via these threads.

[0070] In some embodiments, the external and internal threads can be fine-pitch threads with a pitch between 0.25 and 0.5 mm. In some embodiments, the external and internal threads can be right-hand threads with at least 3 turns. In some embodiments, a thread-locking agent or elastic washer can be provided between the magnet base and the inner magnet to prevent loosening after implantation. The magnet base can be made of polyetheretherketone (PEEK) and completely encapsulated by the silicone capsule, without being removed from the human body.

[0071] In this embodiment, by screwing the inner magnet into the receiving coil via a thread, displacement or flipping of the inner magnet under the influence of a strong external magnetic field (such as in an MRI scan) can be prevented, ensuring the safety of the cell guidance device. Simultaneously, the threaded connection allows for easy removal or replacement of the inner magnet, improving the ease of use and maintainability of the cell guidance device.

[0072] Example 2 Figure 10 A flowchart illustrating a cell guidance method according to Embodiment 2 of this application is shown schematically.

[0073] like Figure 10 As shown, this cell guidance method is based on the cell guidance device implemented according to Embodiment 1. Specific technical details can be found in Embodiment 1. The cell guidance method may include steps S1000-S1004, wherein: Step S1000: Receive radio frequency signals emitted by the external power supply device through the receiving coil.

[0074] Step S1002: The stimulator generates an electrical stimulation pulse based on the radio frequency signal.

[0075] Step S1004: The electrical stimulation pulses are applied to the hair cells in the cochlea through the electrode array to stimulate hair cell proliferation and differentiation.

[0076] The cell-guided method provided in this embodiment generates electrical stimulation pulses based on radio frequency signals from outside the body and applies them to the hair cells in the cochlea, achieving precise and efficient electrical stimulation of the hair cells. Furthermore, the implantable design, which directly targets the hair cells in the cochlea, reduces trauma to the body and improves safety and comfort.

[0077] It should be noted that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the exemplary embodiments according to this application. As used herein, the singular form is intended to include the plural form as well, unless the context clearly indicates otherwise. Furthermore, it should be understood that when the terms "comprising" and / or "including" are used in this specification, they indicate the presence of features, steps, operations, devices, components, and / or combinations thereof.

[0078] For ease of description, directional terms such as "front, back, up, down, left, right," "horizontal, vertical, horizontal," and "top, bottom" generally indicate orientations or positional relationships based on the orientations or positional relationships shown in the accompanying drawings. These terms are used solely for the convenience of describing this application and simplifying the description. Unless otherwise stated, these directional terms do not indicate or imply that the device or element referred to must have a specific orientation or be constructed and operated in a specific orientation, and therefore should not be construed as limiting the scope of protection of this application. The directional terms "inner" and "outer" refer to the inner or outer contours relative to the components themselves. For example, if a device in the drawings is inverted, a device described as "above" or "on top of" other devices or structures will subsequently be positioned as "below" or "under" other devices or structures. Thus, the exemplary term "above" can include both "above" and "below." The device may also be positioned in other different ways (rotated 90 degrees or in other orientations), and the spatial relative descriptions used herein are interpreted accordingly.

[0079] Unless otherwise expressly specified and limited, the terms "installation," "connection," "linking," and "fixing," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection, an electrical connection, or a communication connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components. Those skilled in the art can understand the specific meaning of the above terms in this application according to the specific circumstances.

[0080] Unless otherwise expressly specified and limited, "above" or "below" the second feature can include direct contact between the first and second features, or contact between the first and second features through another feature between them. Furthermore, "above," "over," and "on top" of the second feature includes the first feature directly above or diagonally above the second feature, or simply indicates that the first feature is at a higher horizontal level than the second feature. "Below," "below," and "under" the second feature includes the first feature directly above or diagonally above the second feature, or simply indicates that the first feature is at a lower horizontal level than the second feature.

[0081] Unless otherwise specifically stated, the relative arrangement, numerical expressions, and values ​​of the components and steps described in these embodiments do not limit the scope of this application. It should also be understood that, for ease of description, the dimensions of the various parts shown in the drawings are not drawn to actual scale. Techniques, methods, and devices known to those skilled in the art may not be discussed in detail, but where appropriate, such techniques, methods, and devices should be considered part of the specification. In all examples shown and discussed herein, any specific values ​​should be interpreted as merely exemplary and not as limitations. Therefore, other examples of exemplary embodiments may have different values. It should be noted that similar reference numerals and letters in the following drawings denote similar items; therefore, once an item is defined in one drawing, it need not be further discussed in subsequent drawings.

[0082] It should also be noted that the terms "one embodiment," "another embodiment," or "embodiment" used in this specification refer to specific features, structures, or characteristics described in connection with that embodiment, which are included in at least one embodiment described in the general description of this application. The appearance of the same expression in multiple places in the specification does not necessarily refer to the same embodiment. Furthermore, when a specific feature, structure, or characteristic is described in connection with any embodiment, the intention is to suggest that implementing such a feature, structure, or characteristic in conjunction with other embodiments also falls within the scope of this application.

[0083] In the above embodiments, the descriptions of each embodiment have different focuses. For parts not described in detail in a certain embodiment, please refer to the relevant descriptions in other embodiments.

[0084] It should also be noted that the above are merely preferred embodiments of this application and do not limit the scope of patent protection of this application. Any equivalent structural or procedural changes made using the content of this application’s specification and drawings, or direct or indirect applications in other related technical fields, are similarly included within the scope of patent protection of this application.

Claims

1. A cell guiding device, characterized in that, The device comprises: a receiving coil for receiving a radio frequency signal emitted by an external power supply device; a stimulator electrically connected to the receiving coil for generating an electric stimulation pulse according to the radio frequency signal; an electrode array arranged in the inner ear and electrically connected to the stimulator; the electrode array is used for applying the electric stimulation pulse to the hair cells in the inner ear to stimulate the hair cells to proliferate and differentiate.

2. The apparatus of claim 1, wherein, The stimulator comprises: a detection module electrically connected to the receiving coil for extracting a stimulation coded signal from the radio frequency signal; a processor electrically connected to the detection module for decoding the stimulation coded signal to obtain a stimulation decoded signal; a stimulation generation circuit electrically connected to the processor for generating the electric stimulation pulse according to the stimulation decoded signal.

3. The apparatus of claim 2, wherein, The stimulator further comprises: a digital logic chip electrically connected to the processor and the stimulation generation circuit for verifying the stimulation decoded signal, and triggering the stimulation generation circuit to generate the electric stimulation pulse when the verification is passed.

4. The apparatus of claim 2, wherein, The stimulator further comprises: a power management module electrically connected to the receiving coil and the power-consuming components in the stimulator for extracting electric energy from the radio frequency signal to power the stimulator.

5. The apparatus of claim 1, wherein, Further comprising: a drug delivery pump electrically connected to the stimulator and in fluid communication with the electrode array; the drug delivery pump is used to deliver a hair cell suspension in the drug delivery pump to the electrode array according to the radio frequency signal, so that the hair cell suspension is delivered to the inner ear through the electrode array.

6. The apparatus of claim 5, wherein, The drug delivery pump is provided with: a lower cavity for containing a thermal phase change material; a thermal resistance sheet arranged in the lower cavity and electrically connected to the stimulator for controllably heating the thermal phase change material to expand or shrink in volume; an upper cavity arranged above the lower cavity for containing the hair cell suspension; a fluid conduit connecting the upper cavity and the electrode array; a piston sealingly and slidably arranged between the lower cavity and the upper cavity, the piston being used to move upward in the case of expansion of the thermal phase change material, so that the hair cell suspension in the upper cavity is delivered to the electrode array through the fluid conduit.

7. The apparatus of claim 6, wherein, The electrode array comprises: a hollow electrode lead wire with an internal infusion channel and in communication with the fluid conduit for delivering the hair cell suspension; a plurality of drug delivery ports distributed on the hollow electrode lead wire for releasing the hair cell suspension into the inner ear.

8. The apparatus of any one of claims 1-7, wherein, The device further comprises: an inner magnet embedded in the geometric center of the receiving coil for magnetically coupled with an outer magnet arranged in the external power supply device to position the receiving coil.

9. The apparatus of claim 8, wherein, The receiving coil comprises: a coil body; a silica gel capsule in the shape of a disc for wrapping the coil body; and a magnet base embedded in the silica gel capsule, the magnet base being provided with an internal thread; wherein the inner magnet is provided with an external thread, and the magnet base and the inner magnet are screwed together through the threads.

10. A method of cell guidance, comprising, Based on the cell guiding device according to any one of claims 1 to 9, the method comprises: receiving a radio frequency signal emitted by an external power supply device through a receiving coil; generating electrical stimulation pulses from the radio frequency signal by a stimulator; applying the electrical stimulation pulses to hair cells within the cochlea by an electrode array to stimulate hair cell proliferation differentiation.

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