Artificial cochlea electrode implantation system and method

Abstract

The invention provides an artificial cochlea electrode implantation system and method, and relates to the technical field of artificial cochlea electrode implantation, the artificial cochlea electrode implantation system comprises a data layer and an execution layer, the data layer comprises an image processing module and a postoperative evaluation module, and the image processing module comprises an image acquisition unit, a data processing unit, a model construction unit and a data integration unit. The postoperative evaluation module comprises a data analysis unit and a result storage unit, the execution layer comprises a high-precision grinding module and an intelligent control module, the high-precision grinding module comprises an electric drill unit, a navigation unit and a robot surgery unit, and the intelligent control module comprises a computer auxiliary unit, a sensor unit and an alarm unit; under the guidance of preoperative image data and a navigation system, an electric drill is used for grinding an electrode implantation passage, meanwhile, the operation efficiency can be improved, the electrode implantation does not need to pass through a retroauricular incision, and only an intraauricular incision needs to be made to implant the electrode into the cochlea, so that the success rate of an artificial cochlea operation and the life quality of a patient are improved.

Description

Technical Field

[0001] The present invention relates to the technical field of cochlear implant electrodes, and in particular to a cochlear implant electrode implant system and method. Background Art

[0002] A cochlear implant is an electronic device consisting of two parts: an implant and a speech processor. The external speech processor receives sound and converts it into an electrical pulse signal in a certain coded form. The electrical pulse signal is received by the receiving coil implanted in the body, and the spiral ganglion is stimulated by the stimulating electrode implanted in the body, transmitting continuous sound signals to the auditory nerves, which are connected to the central nervous system, where the electrical pulses are interpreted as sound signals to restore or reconstruct the hearing function of the hearing-impaired.

[0003] Cochlear implants stimulate the auditory nerve through electrodes, helping patients regain some hearing. Traditional cochlear implant surgery usually requires an incision at the back of the ear, followed by grinding a bone path to allow the electrode to be successfully implanted into the inner ear. However, existing grinding technology has the following significant drawbacks:

[0004] (1) Insufficient grinding precision: The precision of traditional grinding tools is limited, which may lead to an unclear path, affect the implantation position and stability of the electrode, and further affect the function of the electrode and the patient's hearing recovery effect;

[0005] (2) Surgical risks: During the grinding process, doctors need to be careful to avoid damaging surrounding tissues and nerves. However, existing technologies still have certain risks during operation, which may cause damage to important structures such as the auditory nerve and facial nerve, increasing surgical risks and postoperative complications;

[0006] (3) Operational complexity: The existing grinding technology requires surgeons to have high operational skills and rich experience, which increases the difficulty and time of the operation. At the same time, the complex operation process may also lead to uncertainty in the operation and affect the results of the operation. Therefore, the present invention proposes a cochlear implant electrode implantation system and method to solve the problems existing in the prior art. Summary of the invention

[0007] In view of the above problems, the purpose of the present invention is to propose a cochlear implant electrode implant system and method. Under the guidance of preoperative CT and navigation system, the cochlear implant electrode implant system and method use an electric drill to intelligently grind out the electrode implantation path, which is highly targeted and can solve the problems existing in the prior art.

[0008] To achieve the purpose of the present invention, the present invention is implemented through the following technical solutions: a cochlear electrode implant system, including a data layer and an execution layer, the data layer and the execution layer are connected wirelessly, the data layer includes an image processing module for acquiring and processing data and a postoperative evaluation module for postoperative data analysis, the image processing module includes an image acquisition unit, a data processing unit, a model building unit and a data integration unit, the postoperative evaluation module includes a data analysis unit and a result storage unit, the execution layer includes a high-precision grinding module for performing grinding and an intelligent control module for control, the high-precision grinding module includes an electric drill unit, a navigation unit and a robotic surgery unit, and the intelligent control module includes a computer-aided unit, a sensor unit and an alarm unit.

[0009] A further improvement is that the image acquisition unit acquires CT image data and CBCT image data, and the image acquisition unit transmits the data to the data processing unit, the data processing unit integrates and processes them, and transmits the integrated data to the model construction unit, the model construction unit constructs a three-dimensional model based on the integrated data, and transmits the three-dimensional model to the navigation unit.

[0010] A further improvement is that the specific method of the integration processing is to use an elastic registration algorithm to spatially register the CT image data and the CBCT image data to integrate them into unified three-dimensional data.

[0011] A further improvement is that the navigation unit includes a path planning subunit and a model display subunit, the path planning subunit is used to construct a grinding path according to the three-dimensional model displayed by the model display subunit, and transmit the grinding path to the robotic surgery unit and the data integration unit, the grinding path includes a grinding starting point and a grinding end point.

[0012] A further improvement is that the computer-aided unit is connected to the robotic surgery unit, and the computer-aided unit is responsible for controlling the working state of the robotic surgery unit, the robotic surgery unit is connected to the electric drill unit, the electric drill unit is connected to the sensor unit, the sensor unit includes a force sensor unit, an optical position sensor unit, a temperature sensor unit and a vibration sensor unit, the sensor unit transmits data to a data integration unit, and the data integration unit is used to integrate and match the real-time position of the electric drill unit with the constructed grinding path.

[0013] A further improvement is that the alarm unit is connected to the sensor unit, and alarm rules are preset in the alarm unit. The alarm rules set corresponding thresholds according to the data sensed by the force sensor unit, the optical position sensor unit, the temperature sensor unit and the vibration sensor unit, compare the sensed data with the corresponding thresholds, and issue a corresponding alarm.

[0014] A further improvement is that the data layer also includes an interactive operation module for system interaction and a data visualization module for displaying the integrated data of the data integration unit.

[0015] A method for using a cochlear implant electrode system comprises the following steps:

[0016] Step 1: Obtaining data and processing

[0017] The image acquisition unit acquires the patient's preoperative CT image data and CBCT image data, which are then processed by the data processing unit and enter the model building unit to build a three-dimensional model;

[0018] Step 2: Construct the grinding path

[0019] The doctor uses the navigation unit to construct the polishing path based on the constructed 3D model and confirms it;

[0020] Step 3: Start polishing

[0021] The robotic surgery unit operates the electric drill unit to perform grinding according to the grinding path constructed in the navigation unit;

[0022] Step 4: Implantation of electrodes

[0023] After polishing, the electric drill unit is returned to its original position, and the patient is transferred to the surgical operation platform. The doctor performs cochlear implant electrode implantation with the assistance of the Delon ear endoscope system.

[0024] Step 5: Post-implantation analysis

[0025] After implantation, the patient's postoperative CT image data and CBCT image data are obtained to evaluate and analyze the position of the electrode after implantation.

[0026] A further improvement is that in the step 2, during the construction of the grinding path, the principle of avoiding damage to the posterior wall of the external auditory canal and the facial nerve should be followed.

[0027] The beneficial effects of the present invention are as follows: the cochlear implant electrode implant system provided by the present invention, under the guidance of preoperative CT and navigation system, uses an electric drill to intelligently grind out the electrode implantation path, effectively solving some problems existing in the current cochlear implant surgery. At the same time, in terms of operation time, the system can also improve the efficiency of the surgery. Electrode implantation no longer requires an incision behind the ear, and only an incision inside the ear is required to implant the electrode into the cochlea. Therefore, the present invention has the advantages of high precision, low risk and easy operation, while meeting the advantages of minimal invasiveness and homogeneity, and can improve the success rate of cochlear implant surgery and the quality of life of patients. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] Figure 1 It is a schematic diagram of the system structure provided by the present invention.

[0029] Figure 2 It is a schematic diagram of preoperative CT scanning imaging provided by Embodiment 2 of the present invention.

[0030] Figure 3 It is a schematic diagram of preoperative CBCT scanning imaging provided by the second embodiment of the present invention.

[0031] Figure 4 This is a schematic diagram of polishing path planning provided in the second embodiment of the present invention. DETAILED DESCRIPTION

[0032] In order to deepen the understanding of the present invention, the present invention will be further described in detail below in conjunction with examples. The examples are only used to explain the present invention and do not constitute a limitation on the protection scope of the present invention.

[0033] In the following embodiments, a 3D slicer image computing platform is used, which is an open source cross-platform software widely used in medical image analysis, visualization and three-dimensional modeling. It supports the extraction of anatomical structure information from images such as CT, MRI, CBCT, and provides powerful tools for preoperative planning, intraoperative navigation and research work. The Delon ear endoscope system involved in Example 2 is a high-precision endoscopic device designed specifically for ear surgery and is widely used in ear surgery and diagnosis. It combines optical imaging, surgical navigation and minimally invasive operation technology to help doctors achieve efficient and safe operations in ear surgery. The Image J software program involved in Example 2 is an open source image processing software program widely used in image analysis tasks in biomedicine, scientific research and engineering fields. Its flexibility, plug-in support and powerful image processing functions make it a versatile image analysis tool.

[0034] The electrode is part of the cochlear implant. The core of cochlear implant surgery is to implant the electrode into the cochlea. However, in the process of implanting the electrode into the cochlea, it is inevitable to affect the fine structure of the cochlea to a greater or lesser extent, which may cause the patient's residual hearing to be damaged. In addition, many well-known scholars have chosen implantation surgical pathways including the external auditory canal approach, the tympanic sinus approach, the facial nerve recess approach, and the middle cranial fossa approach, but the most commonly used surgical approach is the facial nerve recess approach. Due to the limitations of the human body, there are several technical bottlenecks that need to be broken through through the development of robots, such as the accuracy of the implantation process, the minimally invasive nature of the surgery, and the homogeneity of the surgery. At this stage, the existing robotic cochlear implant surgery mainly focuses on the various independent links in cochlear implant surgery, such as the research of the University of Hannover to verify the reliability and stability of the automatic insertion of electrodes into the inner ear structure.

[0035] Therefore, the present invention is based on Figure 1-Figure 4 As shown, and based on the following embodiments, a cochlear implant electrode implant system and method are provided.

[0036] Embodiment 1

[0037] This embodiment proposes a cochlear implant electrode system, including a data layer and an execution layer. The data layer and the execution layer are connected wirelessly to ensure efficient transmission of information and stable operation of the system.

[0038] The data layer includes:

[0039] An image processing module for acquiring and processing data, the image processing module includes an image acquisition unit, a data processing unit, a model building unit and a data integration unit, wherein the image acquisition unit acquires CT image data and CBCT image data, and the image acquisition unit transmits the data to the data processing unit, and the data processing unit integrates and processes the data. The specific method of the integration processing is: using an elastic registration algorithm to spatially align the CT image data and the CBCT image data, integrating them into unified three-dimensional data, and transmitting the integrated data to the model building unit, the model building unit constructs a three-dimensional model based on the integrated data, and transmits the three-dimensional model to the navigation unit.

[0040] A postoperative evaluation module is used for postoperative data analysis. The postoperative evaluation module includes a data analysis unit and a result storage unit. The data analysis uses postoperative imaging data to evaluate the accuracy of the grinding path and the implantation effect, while the result storage unit is used to store relevant analysis data.

[0041] The interactive operation module used for system interaction is used for doctors to interact with this system.

[0042] The data visualization module is used to display the integrated data of the data integration unit. The data visualization module is mainly used to facilitate doctors to directly observe the working status of the system, such as the grinding path and the working status of the electric drill unit.

[0043] The execution layer includes:

[0044] A high-precision grinding module for performing grinding, the high-precision grinding module includes an electric drill unit, a navigation unit and a robotic surgery unit. The electric drill unit corresponds to an electric drill. This system uses an electric drill, combined with a navigation unit and image guidance technology (the three-dimensional image data obtained by the image processing module in this embodiment), and then uses a robotic surgery unit (the robotic surgery unit corresponds to a robot) to perform the grinding, thereby achieving higher grinding accuracy, ensuring smooth access and accurate electrode implantation. At the same time, in this system, the image processing module obtains the patient's preoperative data, thereby performing path planning based on the patient's specific head structure. The paths for different patients are different and highly targeted, which can improve the doctor's surgical success rate to a certain extent. The navigation unit includes a path planning subunit and a model display subunit. The path planning subunit is used to construct a grinding path (also known as a pathway grinding planning path) according to the three-dimensional model displayed by the model display subunit, and transmit the grinding path to the robotic surgery unit and the data integration unit. The grinding path includes a grinding start point and a grinding end point. In this embodiment, a doctor interacts with the system to plan the grinding path through the path planning subunit. The construction of the grinding path is based on the doctor's settings rather than the computer's algorithm settings. It can formulate relevant plans based on the differences in cochlear structure of different patients (such as congenital abnormalities or pathological changes), ensure that the path is more in line with individual needs, improve the success rate of implantation, and avoid "one-size-fits-all" algorithm design. Under the guidance of experienced doctors, the path design is more reliable and the patient's postoperative recovery effect is better.

[0045] The intelligent control module for control includes a computer-aided unit, a sensor unit and an alarm unit. The computer-aided unit is connected to the robot surgery unit, and the computer-aided unit is responsible for controlling the working state of the robot surgery unit, and its execution program is set up by the computer-aided unit. The robot surgery unit is connected to the electric drill unit, so the robot surgery unit executes the instructions of the computer-aided unit to complete high-precision surgical operations. Further, the electric drill unit is connected to the sensor unit, and the sensor unit includes a force sensor unit, an optical position sensor unit, a temperature sensor unit and a vibration sensor unit. In this embodiment, the electric drill unit corresponds to an electric drill. Therefore, the contact pressure of the electric drill unit during the grinding process is detected in real time by the force sensor unit, so as to prevent the tool from applying excessive pressure to the cochlea, temporal bone and other tissues, causing damage, and the optical position sensor unit adopts an optical positioning method (infrared camera and reflective marker) to realize real-time monitoring of the position of the electric drill unit, and the temperature sensor unit monitors the temperature changes generated during the grinding process. The vibration sensor unit detects the vibration amplitude and frequency during the grinding process, monitors the running state of the tool in real time, and determines whether there is an abnormality. The corresponding sensor unit transmits the data to the data integration unit, which is used to integrate and match the real-time position of the electric drill unit with the constructed grinding path, while other data are integrated and transmitted and then displayed through the data visualization module.

[0046] The alarm unit is connected to the sensor unit, and the alarm unit has preset alarm rules. The alarm rules set corresponding thresholds according to the data sensed by the force sensor unit, the optical position sensor unit, the temperature sensor unit and the vibration sensor unit, and compare the sensed data with the corresponding thresholds to make corresponding alarms. Taking the temperature sensor unit as an example, a temperature threshold of 46°C is set (no damage to the nerves will be caused at this temperature). When the temperature sensor unit senses the grinding process and the sensed temperature exceeds the threshold, the alarm unit sends out corresponding alarm information, which is directly displayed through the data visualization module. In actual applications, the thresholds corresponding to each sensor unit are set according to actual needs. Therefore, the temperature values ​​involved in this embodiment are only used as examples to illustrate the alarm rules of the alarm unit.

[0047] Embodiment 2

[0048] A method for using a cochlear implant electrode system comprises the following steps:

[0049] Step 1: Obtaining data and processing

[0050] The image acquisition unit is used to obtain the patient's preoperative CT image data and CBCT image data, wherein the CT image acquisition unit provides high-resolution anatomical structures of soft tissues and hard tissues, and obtains the bones, nerve channels and soft tissue details around the cochlea. The CBCT image acquisition unit provides high-resolution bone structures in the cochlear region, focusing on the local details of the surgical area as an important reference for path planning. The data processing unit is used to use a registration algorithm (rigid body registration) for spatial registration, integrating the two data into a unified three-dimensional data set, and then using an edge enhancement algorithm to improve the image quality and clearly display the anatomical details. After being processed by the data processing unit, the data enters the model building unit to build a three-dimensional model. The model building unit uses a 3D slicer image computing platform to segment the data in the three-dimensional data set, extract the cochlea, auditory nerve, temporal bone and key soft tissue structures, and avoid damage to adjacent blood vessels or nerves, thereby based on the segmentation results;

[0051] Step 2: Construct the grinding path

[0052] The doctor uses the navigation unit to construct the polishing path based on the constructed 3D model. The polishing path is also based on the 3Dslicer image computing platform and is confirmed. During the construction of the polishing path, the principle of avoiding damage to the posterior wall of the external auditory canal and the facial nerve should be followed.

[0053] Step 3: Start polishing

[0054] The robotic surgery unit operates the electric drill unit to perform grinding according to the grinding path constructed in the navigation unit;

[0055] Step 4: Implantation of electrodes

[0056] After polishing, the electric drill unit is returned to its original position, and the patient is transferred to the surgical operation platform. The doctor performs cochlear implant electrode implantation with the assistance of the Delon ear endoscope system.

[0057] Step 5: Post-implantation analysis

[0058] After implantation, the patient's postoperative CT image data and CBCT image data are obtained to evaluate and analyze the position of the electrode after implantation.

[0059] In this embodiment, a simplified experiment is performed using a cadaver head. The preoperative CT and preoperative CBCT image acquisition is the first step in this embodiment. After scanning, the results are imported into the Image J software program and the 3D slicer for viewing. Figure 2 and Figure 3 As shown, further, the starting point and end point of the drilling of the surgical approach are marked. Under the guidance of an experienced doctor, the round window niche of the cochlea is selected as the grinding end point, and the mastoid bone is selected as the starting point. Figure 4As shown in the figure, the selection of the starting point should be careful, and the line connecting this position and the grinding end point should avoid damaging the posterior wall of the external auditory canal and the facial nerve. After confirming the grinding path of the drill, grinding can be performed according to the planned path with the help of the robotic surgery system. The grinding process and the return of the drill bit take about 1 minute in total.

[0060] After the CBCT polishing was completed, the fixation was removed and the cadaver head was carefully transferred from the robotic surgery platform to the surgical operation platform. The operation was performed by an experienced doctor, and the cochlear implant electrode was implanted with the assistance of the Delon ear endoscope system. The experimental electrode used in this operation was Cochlear's Slim Straight Practice Cochlear (model Z339831), which is designed to simulate the real implantation process to ensure the smooth progress of the operation.

[0061] The surgical steps are as follows: First, the doctor removes the bone powder produced by the drilling on the surface of the mastoid bone to ensure the cleanliness and visualization of the surgical area. Then, with the assistance of an otoscope, the external auditory canal is carefully explored to remove residual earwax and abnormal secretions. After cleaning, the tympanic membrane is visible to ensure a clear surgical field of view. After exposing the tympanic membrane, the doctor uses a stripper to free the fiber ring at the edge of the tympanic membrane from the tympanic groove to reveal the structure in the tympanic cavity. Through careful observation, the doctor found a hole drilled by the surgical robot in the round window niche. This structure is consistent with the postoperative CBCT imaging results, providing an important basis for subsequent operations.

[0062] Next, the doctor gently removes the experimental electrode using microscopic triangular forceps, and slowly and carefully delivers it into the tympanic cavity along the path drilled by the electric drill to avoid any damage to the electrode. After confirming that the tip of the electrode has successfully entered the tympanic cavity, the doctor once again uses the ear endoscope to explore to ensure that the electrode is in the correct position. Subsequently, use wheat grain forceps or microscopic forceps to gently clamp the electrode that has entered the tympanic cavity and deliver it into the cochlea from the round window niche, ensuring that the electrode marker is visible to confirm the accuracy of the implantation position.

[0063] After the operation, the doctor performed CBCT and CT imaging examinations to ensure that the electrodes were implanted in place and in the correct position.

[0064] The above shows and describes the basic principles, main features and advantages of the present invention. It should be understood by those skilled in the art that the present invention is not limited by the above embodiments. The above embodiments and descriptions are only for explaining the principles of the present invention. Without departing from the framework and scope of application of the present invention, the present invention may have various changes and improvements, which fall within the scope of the present invention to be protected. The scope of protection of the present invention is defined by the attached claims and their equivalents.

Claims

1. A cochlear implant electrode system, characterized in that: It includes a data layer and an execution layer, and the data layer and the execution layer are connected wirelessly. The data layer includes an image processing module for acquiring and processing data and a postoperative evaluation module for postoperative data analysis. The image processing module includes an image acquisition unit, a data processing unit, a model building unit and a data integration unit. The postoperative evaluation module includes a data analysis unit and a result storage unit. The execution layer includes a high-precision grinding module for performing grinding and an intelligent control module for control. The high-precision grinding module includes an electric drill unit, a navigation unit and a robot surgery unit. The intelligent control module includes a computer-aided unit, a sensor unit and an alarm unit.

2. A cochlear implant electrode system according to claim 1, characterized in that: The image acquisition unit acquires CT image data and CBCT image data, and the image acquisition unit transmits the data to the data processing unit, the data processing unit integrates and processes the data, and transmits the integrated data to the model construction unit, the model construction unit constructs a three-dimensional model according to the integrated data, and transmits the three-dimensional model to the navigation unit.

3. A cochlear implant electrode system according to claim 2, characterized in that: The specific method of the integration processing is: using an elastic registration algorithm to perform spatial registration on the CT image data and the CBCT image data, and integrating them into unified three-dimensional data.

4. The cochlear implant electrode system according to claim 1, characterized in that: The navigation unit includes a path planning subunit and a model display subunit. The path planning subunit is used to construct a grinding path according to the three-dimensional model displayed by the model display subunit, and transmit the grinding path to the robotic surgery unit and the data integration unit. The grinding path includes a grinding starting point and a grinding end point.

5. The cochlear implant electrode system according to claim 1, characterized in that: The computer-aided unit is connected to the robotic surgery unit, and the computer-aided unit is responsible for controlling the working state of the robotic surgery unit. The robotic surgery unit is connected to the electric drill unit, and the electric drill unit is connected to the sensor unit. The sensor unit includes a force sensor unit, an optical position sensor unit, a temperature sensor unit and a vibration sensor unit. The sensor unit transmits data to a data integration unit, and the data integration unit is used to integrate and match the real-time position of the electric drill unit with the constructed grinding path.

6. The cochlear implant electrode system according to claim 5, characterized in that: The alarm unit is connected to the sensor unit, and alarm rules are preset in the alarm unit. The alarm rules set corresponding thresholds according to the data sensed by the force sensor unit, the optical position sensor unit, the temperature sensor unit and the vibration sensor unit, compare the sensed data with the corresponding thresholds, and issue corresponding alarms.

7. The cochlear implant electrode system according to claim 1, characterized in that: The data layer also includes an interactive operation module for system interaction and a data visualization module for displaying data integrated by the data integration unit.

8. A method for using a cochlear implant electrode system as claimed in claim 1, characterized in that: The following steps are involved: Step 1: Obtaining data and processing The image acquisition unit acquires the patient's preoperative CT image data and CBCT image data, which are then processed by the data processing unit and enter the model building unit to build a three-dimensional model; Step 2: Construct the grinding path The doctor uses the navigation unit to construct the polishing path based on the constructed 3D model and confirms it; Step 3: Start polishing The robotic surgery unit operates the electric drill unit to perform grinding according to the grinding path constructed in the navigation unit; Step 4: Implantation of electrodes After polishing, the electric drill unit is returned to its original position, and the patient is transferred to the surgical operation platform. The doctor performs cochlear implant electrode implantation with the assistance of the Delon ear endoscope system. Step 5: Post-implantation analysis After implantation, the patient's postoperative CT image data and CBCT image data are obtained to evaluate and analyze the position of the electrode after implantation.

9. The method for using the cochlear implant electrode system according to claim 8, characterized in that: In the step 2, during the construction of the grinding path, the principle of avoiding damage to the posterior wall of the external auditory canal and the facial nerve should be followed.

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