WO2023109003A1

WO2023109003A1 - Delivery system, implantation system for cochlear implant, control method, and storage medium

Info

Publication number: WO2023109003A1
Application number: PCT/CN2022/092769
Authority: WO
Inventors: 吴勇; 王昊; 王丞阳; 王�华; 郑浩
Original assignee: 微创投资控股有限公司
Priority date: 2021-12-16
Filing date: 2022-05-13
Publication date: 2023-06-22
Also published as: CN116328178A

Abstract

The present application relates to a delivery system (20), comprising a support tube (21), a sheath (22), a balloon (23) and a stimulation array (24). The support tube (21) is configured to support a stent (11). The sheath (22) is sleeved outside the support tube (21), an accommodation space for accommodating the stent (11) is provided between the sheath (22) and the support tube (21), and the sheath (22) and the support tube (21) are configured to be capable of moving relative to each other in an axial direction to open or close the accommodation space, so as to release or accommodate the stent (11). The balloon (23) is sleeved outside the sheath tube (22), and the balloon (23) has a contracted state and an expanded state in which the balloon (23) is configured to fit an inner wall of the cochlea. The stimulation array (24) is arranged on an outer surface of the balloon (23), and the stimulation array (24) is configured to send stimulation signals to the cochlea and collect electrical signals fed back by the cochlea.

Description

Delivery system, cochlear implant system, control method and storage medium

technical field

The present application relates to the technical field of medical devices, in particular to a delivery system, a cochlear implant system, a control method and a storage medium.

Background technique

A cochlear implant is an implantable hearing aid, including an external device part and an implanted device part. The extracorporeal device part consists of a microphone, a speech processor, and a signal transmitter for sending instructions to the implanted device part. The implant device part is composed of a signal receiving and decoding module, and an electrode array. The electrode array is implanted in the cochlea, and the electrode array is distributed on the side of the cochlea inner cavity where the neurons are distributed. Through the electrode parts of the electrode array, the cochlea The auditory nerve with intact internal function is stimulated by signals, so that patients with severe deafness can produce certain sound perception. Specifically, after the electrode array is energized, the current in the electrode array flows out from the positive electrode with higher voltage and flows to the surrounding area with lower voltage. The current flowing through nearby auditory neurons will induce electrical activity in the auditory neurons, thereby prompting the patient to produce hearing.

However, in practical applications, due to individual differences in patients, the internal shape of the cochlea varies from patient to patient, and the electrode array after traditional cochlear implantation is not tightly attached to the cochlea, so that the electrode array cannot directly contact the inner wall of the cochlea, which affects The stimulation effect, and even the cochlear implant will be displaced, causing the electrode array to not be in the intended position, and the signal stimulation effect will be even worse. Based on this, stent-type cochlear implants with stents are gradually developed. The stent-type cochlear implants support the cochlear implants through helical supports, so as to ensure accurate positioning of the cochlear implants and ensure that the electrode array of the cochlear implant fits closely with the cochlea. close. However, there is no effective implantation method for stent-type cochlear implants. Traditional cochlear implantation operations are mostly performed with the experience of doctors, which leads to inaccurate implantation positions of cochlear implants and easy damage to the cilia at the cochlear modiole. Therefore, traditional artificial Cochlear implants are not suitable for stented cochlear implants.

Contents of the invention

Based on this, it is necessary to provide a delivery system, a cochlear implant system, a control method and a storage medium.

In one aspect, the present application provides a delivery system for delivering a cochlear implant scaffold, comprising:

support tube;

a sheath tube, the sheath tube is sheathed outside the support tube, there is a storage space for accommodating the stent between the sheath tube and the support tube, and the sheath tube and the support tube are configured as can move relative to the axial direction to open or close the storage space;

a balloon, the balloon is sleeved outside the sheath, the balloon has a contracted state and an expanded state, and the balloon in the expanded state is used to fit the inner wall of the cochlea; and,

A stimulation array, the stimulation array is arranged on the outer surface of the balloon, and the stimulation array is used to send stimulation signals to the cochlea and collect electrical signals fed back by the cochlea.

In one embodiment, the stimulation array includes at least two stimulation units, and all the stimulation units are arranged at intervals on the outer surface of the balloon along the axial direction of the sheath.

In one embodiment, the stimulation unit includes electrodes; or, the stimulation unit includes LEDs; or, the stimulation unit includes electrodes and LEDs.

In one embodiment, an electrode array is arranged on the support; when the support is placed in the storage space, the position of the stimulation array corresponds to the position of the electrode array of the support.

In one of the embodiments, the support tube is provided with a guide wire hole for passing a guide wire.

On the other hand, the present application also provides a cochlear implant system, including:

Medical imaging equipment for obtaining a three-dimensional model of the patient's cochlea;

A data processing module, configured to output, according to the three-dimensional model of the cochlea, the model of the cochlear implant that is compatible with the three-dimensional model of the cochlea;

In one of the embodiments, the data processing module is configured to perform the following steps:

Marking the proximal and distal development points of the stent in the cochlea three-dimensional model, and calculating the intermediate development point of the stent according to the proximal and distal development points;

Obtaining the maximum diameter and the minimum diameter of the lumen of the cochlea at three positions of the proximal visualization point, the distal visualization point and the intermediate visualization point to output the diameter range of the stent;

obtaining the actual distance between the proximal visualization point and the distal visualization point to output the length of the stent;

Determine the reasonable placement position of the driver of the cochlear implant according to the cochlear three-dimensional model, and output according to the position of the reasonable placement position, the position of the proximal development point and the cochlear window of the cochlear three-dimensional model the length of the connecting wire of the cochlear implant;

The model of the cochlear implant is output according to the diameter range of the bracket, the length of the bracket and the length of the connecting wire.

In one of the embodiments, the data processing module is also configured to perform the following steps:

According to the model of the cochlear implant, the three-dimensional model of the bracket of the corresponding model and in the crimping state is obtained from the database, and the three-dimensional model of the bracket is fused with the three-dimensional model of the cochlea to obtain all the three-dimensional models in the crimping state. The spatial position relationship between each development point on the three-dimensional model of the stent and the three-dimensional model of the cochlea, so as to output the predetermined release position;

Obtain the three-dimensional model of the bracket corresponding to the model and in the unfolded state from the database, fuse the three-dimensional model of the bracket with the three-dimensional model of the cochlea, and obtain each development point and the relationship between the three-dimensional model of the bracket in the unfolded state. The spatial position relationship of the three-dimensional model of the cochlea to output the predetermined deployment position.

In one of the embodiments, the data processing module is further configured to output the model of the guide wire and the model of the delivery system according to the model of the cochlear implant; and output the The intended implantation location of the guide wire;

The delivery system is also configured for delivering the stent along the guidewire to the predetermined release location.

In one embodiment, the stimulation array is configured to send stimulation signals to different regions of the inner wall of the cochlea, and collect electrical signals fed back by the cochlea to locate the auditory functional area.

In one of the embodiments, it also includes an execution module for driving the conveying system, the execution module is configured to perform the following steps:

driving the delivery system to deliver the stent to the predetermined release position;

driving the support tube and the sheath to move relative to each other in the axial direction to partially release the stent;

Observing the deployment process of the stent in real time through the medical imaging device;

retracting the stent into the delivery system when the partially deployed stent fails to deploy to the predetermined deployment position or when the electrode array of the partially deployed stent fails to face the auditory functional area;

After adjusting the position of the delivery system, the stent is partially released again until the partially deployed stent can be deployed to the predetermined deployment position and the electrode array of the stent faces the auditory functional area;

The stent is completely released, so that the stent is freely deployed to the predetermined deployment position.

In one of the embodiments, after the support is completely released, the execution module is further configured to perform the following steps:

deflate the balloon to the deflated state, and drive the delivery system to extend the balloon into the deployed stent;

Inflating the balloon to the expanded state, allowing the balloon to support the stent, so that the stent is fully deployed and adheres to the lumen wall of the cochlea.

On the other hand, the present application also provides a cochlear implant control method for controlling the cochlear implant system, comprising the following steps:

Obtain a three-dimensional model of the patient's cochlea;

Outputting the model of the cochlear implant compatible with the three-dimensional model of the cochlea according to the three-dimensional model of the cochlea;

delivering the cochlear implant bracket to a predetermined release position through a delivery system;

pre-stimulating the inner wall of the cochlea to localize the auditory functional region of the cochlea;

The stent is released at the predetermined release position, and the electrode array of the stent faces the auditory function area after the stent is deployed to a predetermined deployment position.

In one of the embodiments, the step of outputting the model of the cochlear implant adapted to the three-dimensional model of the cochlea according to the three-dimensional model of the cochlea includes the following steps:

In one of the embodiments, the following steps are also included:

According to the model of the cochlear implant, the three-dimensional model of the cochlear implant frame corresponding to the model in the database is fused with the three-dimensional model of the cochlea, and the predetermined release position and the predetermined deployment position are output.

In one of the embodiments, the following steps are also included:

Outputting the model of the guide wire and the model of the delivery system according to the model of the cochlear implant; and outputting the predetermined implantation position of the guide wire according to the three-dimensional model of the patient's cochlea;

The delivery system is controlled to deliver the stent along the guidewire to the predetermined release location.

In one of the embodiments, the step of pre-stimulating the inner wall of the cochlea to locate the auditory functional area of the cochlea comprises:

Stimulating signals are sent to different areas of the inner wall of the cochlea, and electrical signals fed back by the cochlea are collected to locate the auditory functional area.

In one of the embodiments, the step of releasing the stent at the predetermined release position, and deploying the stent to the predetermined deployment position after the electrode array of the stent faces the auditory functional area includes:

Observing the deployment process of the stent in real time;

In one of the embodiments, after the stent is completely released, the following steps are further included:

Shrinking the balloon of the delivery mechanism to a contracted state, driving the delivery system to make the balloon extend into the expanded stent;

On the other hand, the present application also provides a storage medium, where the storage medium includes a stored program, wherein the program can execute the above-mentioned method for controlling a cochlear implant.

Description of drawings

The drawings constituting a part of the application are used to provide further understanding of the application, and the schematic embodiments and descriptions of the application are used to explain the application, and do not constitute an improper limitation to the application.

In order to more clearly illustrate the technical solutions in the embodiments of the present application, the drawings that need to be used in the description of the embodiments will be briefly introduced below. Obviously, the drawings in the following description are only some embodiments of the present application. For those skilled in the art, other drawings can also be obtained based on these drawings without creative effort.

Fig. 1 is the structural representation of the support of an embodiment;

Fig. 2 is a structural schematic diagram of a delivery system of an embodiment;

Fig. 3 is the structural explosion diagram of conveying system shown in Fig. 2;

Fig. 4 is a schematic structural view of the delivery system of an embodiment when the airbag is in a contracted state;

Fig. 5 is a schematic structural view of the delivery system of an embodiment when the airbag is in an inflated state;

FIG. 6 is a schematic structural view of a partially released stent in a delivery system according to an embodiment;

FIG. 7 is a schematic structural view of a delivery system that fully releases a stent according to an embodiment;

Fig. 8 is a schematic structural view of a cochlear implant in a patient's cochlea according to an embodiment;

Fig. 9 is a schematic diagram of the diameters of the three-dimensional model of the cochlea in three positions of the proximal development point, the distal development point and the middle development point of the stent;

Fig. 10 is a schematic diagram of the length of the bracket and the length of the connecting wire of the cochlear implant according to an embodiment;

Fig. 11 is a schematic diagram of the structure after the fusion of the three-dimensional model of the cochlea and the three-dimensional model of the bracket in the crimping state according to one embodiment;

Fig. 12 is a structural schematic diagram of the fusion of the three-dimensional model of the cochlea and the three-dimensional model of the bracket in the unfolded state according to an embodiment;

Fig. 13 is a schematic diagram of the structure after the guide wire is inserted into the cochlea according to an embodiment;

Fig. 14 is a structural schematic diagram of a delivery system sending a stent into the cochlea according to an embodiment;

Fig. 15 is a structural schematic diagram of a delivery system releasing part of a stent in an embodiment;

Fig. 16 is a schematic structural view of the delivery system of an embodiment after the stent is fully released.

Explanation of reference signs:

11. Bracket; 111. Electrode array; 112. Near-end developing point; 113. Far-end developing point; 114. Intermediate developing point; 12. Driver; 13. Connecting line; 20. Conveyor system; 21. Support tube; 22. 23. Balloon; 24. Stimulation array; 25. Guide wire; 30. Three-dimensional model of cochlea; 31. Cochlear window.

Detailed ways

In order to make the above-mentioned purpose, features and advantages of the present application more obvious and understandable, the specific implementation manners of the present application will be described in detail below in conjunction with the accompanying drawings. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the application. However, the present application can be implemented in many other ways different from those described here, and those skilled in the art can make similar improvements without departing from the connotation of the present application, so the present application is not limited by the specific embodiments disclosed below.

Specifically, the present application provides, on the one hand, a delivery system 20 for precisely implanting a stent-type cochlear implant into the patient's cochlea, thereby stimulating the auditory nerve in the patient's cochlea, and then promoting the patient to produce hearing. Specifically, referring to Fig. 1 and Fig. 8, the stent-type cochlear implant includes a stent 11, a connecting wire 13, and a driver 12. The stent 11 is a helical tubular structure formed by coiling monofilaments. The material of the stent 11 is memory metal, and the stent 11 has a In the crimped state in the delivery system 20 , the stent 11 can be automatically expanded to form an expanded state after detaching from the delivery system 20 . The surface of the bracket 11 is provided with an electrode array 111, through which the signal stimulation is applied to the auditory function area where the auditory nerve is distributed in the cochlea, so that the severely deaf patients can have a certain sound perception. Furthermore, the electrode array 111 can also be developed by the medical image, and presented in the form of developed dots in the medical image, thereby showing the position and shape of the stent 11 . The driver 12 is used to drive the electrode array 111 of the support 11 , and the connecting wire 13 is used to connect the support 11 and the driver 12 .

Further, referring to FIG. 2 and FIG. 7 , a delivery system 20 of an embodiment is used to deliver the stent 11 of a stent-type cochlear implant. Specifically, the delivery system 20 of an embodiment includes a support tube 21 , a sheath tube 22 , and a balloon 23 and stimulus array 24 . Wherein, the support tube 21 is used to support the bracket 11 . The sheath tube 22 is sheathed outside the support tube 21, and there is a storage space between the sheath tube 22 and the support tube 21 for accommodating the stent 11, and the sheath tube 22 and the support tube 21 are configured to be relatively movable in the axial direction to open or close storage space, so as to realize the release or storage of the bracket 11. Referring to FIG. 4 and FIG. 5 , the balloon 23 is sheathed outside the sheath tube 22 , the balloon 23 has a contracted state and an expanded state, and the balloon 23 in the expanded state is used to fit the inner wall of the cochlea. The stimulation array 24 is arranged on the outer surface of the balloon 23, and the stimulation array 24 is used for sending stimulation signals to the cochlea and collecting electrical signals fed back by the cochlea.

Further, the stimulation array 24 is used to locate the auditory function area of the cochlea, specifically, by making the stimulation array 24 send stimulation signals to different areas in the cochlea, when the cochlea can feed back corresponding electrical signals, it means that the stimulation array 24 is facing The area of the cochlea is the auditory function area. Preferably, when the bracket 11 is pressed and held in the storage space, the position of the electrode array 111 on the bracket 11 can be made to correspond to the position of the stimulation array 24, so that when the stimulation array 24 is positioned on the auditory functional area of the cochlea, the driving The supporting tube 21 and the sheath tube 22 move relative to each other in the axial direction to release the stent 11. At this time, the electrode array 111 of the stent 11 faces the auditory function area of the cochlea. The auditory function area is used to send stimulation signals to the auditory neurons in the auditory function area, so as to restore the patient's hearing. Of course, it is worth noting that the position of the electrode array 111 of the bracket 11 and the position of the stimulation array 24 may also have a certain deviation angle. Releasing the bracket 11 at an angle corresponding to the angle can also make the electrode array 111 accurately face the auditory functional area after the bracket 11 is released.

Specifically, before use, the stent 11 is pressed and held in the storage space, and the balloon 23 is in a contracted state at this time. After the delivery system 20 transports the stent 11 to the predetermined release position, the balloon 23 is inflated into an expanded state by filling the balloon 23 with liquid or air, so that the stimulation array 24 on the balloon 23 adheres to the inner cavity wall of the cochlea, and then Then, by rotating the delivery system 20, the stimulation array 24 sends stimulation signals to different areas in the cochlea. When the cochlea can feed back the corresponding electrical signal, it indicates that the area facing the stimulation array 24 is the auditory functional area of the cochlea. The stent 11 is released by driving the support tube 21 and the sheath tube 22 to move relative to each other in the axial direction, so that the electrode array 111 of the stent 11 faces the auditory function area of the cochlea. The auditory functional area of the cochlea sends stimulation signals to the auditory neurons in the auditory functional area, thereby restoring the patient's hearing.

The above-mentioned delivery system 20 is provided with an expandable and contractible balloon 23 outside, and a stimulation array 24 is arranged on the surface of the balloon 23, and the stimulation array 24 sends stimulation signals to different regions in the cochlea and receives electrical signals fed back by the cochlea, so that it can Accurately locate the auditory functional area of the cochlea, thereby ensuring that after the delivery system 20 releases the support 11, the electrode array 111 on the support 11 can accurately fit the auditory functional area of the inner wall of the cochlea, so that the electrode array 111 can provide hearing to the auditory functional area in the auditory functional area. The neurons send out stimulating signals, which in turn restore some hearing to the patient.

Further, referring to FIG. 4 and FIG. 5 , the stimulation array 24 includes at least two stimulation units, and all the stimulation units are arranged at intervals on the outer surface of the balloon 23 along the axial direction of the sheath tube 22 . For example, in this embodiment, the stimulation array 24 includes a plurality of stimulation units, and all the stimulation units are arranged at intervals on the outer surface of the balloon 23 along the axial direction of the sheath tube 22 . Since the auditory functional area of the cochlea is located on the side of the cochlea with neuron distribution, at least two stimulation units distributed along the axial interval are arranged on the balloon 23 to improve the accuracy of positioning of the auditory functional area of the cochlea by the delivery system 20 sex.

Specifically, the stimulating unit is an electrode or an LED. Further, the electrode may be a metal electrode, and the metal electrode is used to send out electrical stimulation, and the electrical stimulation can stimulate the auditory neurons in the auditory function area, thereby causing the auditory neurons to send out electrical signals. The LED may be a micro-LED, and the micro-LED is used for emitting light stimulation, and the light stimulation can stimulate the auditory neurons in the auditory functional area, thereby causing the auditory neurons to emit electrical signals.

Further, referring to FIG. 2 , the support tube 21 is provided with a guide wire hole for passing a guide wire 25 , so that the guide wire 25 is pre-pierced in the cochlea before the implant operation, and the support tube is inserted into the cochlea during the implant operation. 21 passes through the guide wire 25, so that the delivery system 20 can accurately deliver the stent 11 to the predetermined release position along the guide wire 25.

Further, the distal end of the support tube 21 is also provided with a conical head, which has the function of guiding and expanding, so as to prevent the delivery system 20 from scratching human tissues when moving.

Another aspect of the present application also provides a cochlear implant system, the cochlear implant system includes a medical imaging device, a data processing module, and the delivery system 20 of any one of the above-mentioned embodiments. Wherein the medical imaging equipment is used to acquire the three-dimensional model 30 of the patient's cochlea. Preferably, the medical imaging equipment can be CT. The data processing module is used to output the model of the cochlear implant that matches the three-dimensional cochlear model 30 according to the three-dimensional cochlear model 30 . The above delivery system 20 is used for delivering the cochlear implant stent 11 to a predetermined release position under the real-time imaging of the medical imaging equipment, and deploying the stent 11 to the predetermined deployment position after releasing the stent 11 at the predetermined release position. The stimulation array 24 of the delivery system 20 is configured to pre-stimulate the inner wall of the cochlea to locate the auditory functional area of the cochlea, so as to ensure that the electrode array 111 of the stent 11 can be directed towards the auditory functional area after release.

Further, the cochlear implant system may also include an execution module. The execution module is used to perform various operations such as driving the delivery system 20 to move, rotate, release the stent 11 , retract the stent 11 , and inflate or depressurize the balloon 23 . Preferably, the execution module can be a robot. Of course, it is worth noting that, in some of the embodiments, the execution module may also be omitted, and the operation may be performed manually.

Further, the cochlear implant system is configured to be able to recommend a cochlear implant model that matches the patient's cochlea, and the control method for controlling the cochlear implant system includes the following steps:

S110: Obtain the patient's cochlea three-dimensional model 30;

Specifically, the patient's head image is obtained by medical imaging equipment, and the three-dimensional model of the patient's cochlea and its possible approach paths are reconstructed to obtain a three-dimensional cochlea model 30 .

S120: Select a suitable type of cochlear implant according to the cochlear three-dimensional model 30;

Specifically, the reconstructed three-dimensional cochlear model 30 can be measured by the data processing module and output the measurement result, and the data processing module can recommend a suitable type of cochlear implant according to the measurement result. Specifically, in this embodiment, the data processing module is configured to perform the following steps:

S121: Mark the proximal development point 112 and the distal development point 113 of the desired cochlear implant stent 11 in the cochlear three-dimensional model 30, and obtain the intermediate development of the stent 11 according to the proximal development point 112 and the distal development point 113 point 114;

Specifically, referring to FIG. 9 , the data processing module marks the approximate positions of the proximal development point 112 and the distal development point 113 after the desired cochlear implant bracket 11 is implanted in the cochlear three-dimensional model 30, and the data processing module then passes The positions of the proximal development point 112 and the distal development point 113 automatically generate the middle development point 114 of the stent 11 . Wherein, the proximal developing point 112 , the distal developing point 113 and the middle developing point 114 respectively correspond to the proximal electrode, the distal electrode and the middle electrode of the cochlear implant frame 11 .

S122: Obtain the maximum diameter and the minimum diameter of the lumen of the cochlea at three positions of the proximal visualization point 112, the distal visualization point 113, and the middle visualization point 114 to obtain the diameter range of the stent 11;

Specifically, continue referring to FIG. 9 , after determining the positions of the proximal development point 112, the distal development point 113, and the middle development point 114 of the stent 11 after cochlear implantation, the data processing module measures the inner cavity of the cochlea at these three positions. The maximum diameter and the minimum diameter at the location, the diameter range of the stent 11 after deployment can be determined according to the maximum diameter and the minimum diameter.

S123: Obtain the length of the bracket 11 according to the actual distance L1 between the proximal developing point 112 and the distal developing point 113;

Specifically, referring to FIG. 10 , the actual distance L1 between the proximal visualization point 112 and the distal visualization point 113 refers to the distance between the proximal visualization point 112 and the distal visualization point 113 along the extension direction of the inner cavity of the cochlea.

S124: Determine the reasonable placement position of the driver 12 of the cochlear implant according to the cochlear three-dimensional model 30, and obtain the connection of the cochlear implant according to the position of the reasonable placement position, the position of the proximal development point 112 and the position of the cochlear window 31 of the cochlear three-dimensional model 30 the length L2 of the line 13;

Specifically, referring to FIG. 11 , the cochlear window 31 is a circular hole on the inner wall of the middle ear of the human body. The connecting wire 13 of the cochlear implant passes through the cochlear window 31 , and the connecting wire 13 is respectively connected to the proximal end of the driver 12 and the bracket 11 . After the data processing module determines the reasonable placement position of the driver 12 of the cochlear implant, according to the position of the reasonable placement position of the driver 12 of the cochlear implant, the position of the proximal development point 112 of the bracket 11 and the cochlear window 31 of the cochlear three-dimensional model 30 The position can be calculated to obtain the length L2 of the connecting line 13 of the cochlear implant.

S125: Output the model of the cochlear implant according to the diameter range of the bracket 11, the length L1 of the bracket 11, and the length L2 of the connecting wire 13.

Specifically, the data processing module automatically recommends a cochlear implant model that matches the patient's cochlea according to the diameter range of the bracket 11 , the length L1 of the bracket 11 and the length L2 of the connecting wire 13 .

The cochlear implant system is also configured to be able to plan the predetermined release position of the stent before the operation and the predetermined deployment position after the stent is deployed, so as to guide the actual implantation operation, including the following steps:

S130: The data processing module fuses the three-dimensional model of the corresponding cochlear implant bracket in the database with the cochlear three-dimensional model 30, so as to determine the scheduled release position of the bracket 11 and the scheduled deployment position after deployment;

Specifically, referring to FIG. 11 , in order to plan the predetermined release position of the stent before the operation and the predetermined deployment position after deployment after the cochlear implant model is determined, the data processing module is further configured to perform the following steps:

S131: Obtain the three-dimensional model of the bracket of the corresponding model and in the crimped state from the database, fuse the three-dimensional model of the bracket with the three-dimensional model of the cochlea 30, and obtain each development point on the three-dimensional model of the bracket in the crimped state and the three-dimensional model of the cochlea 30, to determine the predetermined release position of the bracket 11 in the crimping state;

S132: Obtain the three-dimensional model of the bracket corresponding to the model and in the unfolded state from the database, fuse the three-dimensional model of the bracket with the three-dimensional model of the cochlea 30, and obtain the coordinates of each development point on the three-dimensional model of the bracket in the unfolded state and the three-dimensional model of the cochlea 30 The spatial position relationship is used to determine the predetermined deployment position of the stent 11 in the deployment state.

By fusing the three-dimensional model of the cochlear implant stent with the cochlear three-dimensional model 30, the positions of the electrodes on the cochlear implant stent 11 when released and the final shape of the stent after deployment can be determined, so as to visually display the release position of the stent 11 and the stent after release. The relationship between the cochlear inner wall and the fitting result provides visual navigation for subsequent implantation and reduces the difficulty of surgery. It is worth noting that, in another embodiment, before the operation, the predetermined release position of the stent and the predetermined deployment position after deployment can also be planned manually on the cochlear three-dimensional model 30 based on experience.

The delivery system 20 of any of the above embodiments can deliver the cochlear implant stent 11 of the corresponding model to the predetermined release position, and the image information of the delivery system 20 and the stent 11 can be obtained in real time through medical imaging equipment.

When the delivery system 20 cooperates with the guide wire delivery stent, the cochlear implant system is also configured to be able to plan the predetermined implantation position of the guide wire 25 before the operation.

Specifically, referring to FIG. 13, the data processing module is also configured to perform the following steps:

S141: output the model of the guide wire 25 and the model of the delivery system 20 according to the model of the cochlear implant;

S142: According to the patient's cochlear three-dimensional model 30, plan the predetermined implantation position of the guide wire 25 before the operation.

During the implantation process, in conjunction with the real-time display of the medical imaging equipment, after the operator puts the guide wire 25 into the predetermined implantation position planned before surgery, the delivery system 20 can deliver the stent 11 to the predetermined release position along the guide wire 25 .

Specifically, the guide wire 25 is delivered along the outer wall of the inner cavity of the cochlea to the predetermined implantation position planned before operation by way of guide wire catheter exchange. Under the real-time display of medical imaging equipment such as CT, the position of the guide wire 25 in the patient's cochlea and the frictional contact point of the tip can be seen in real time, so as to prevent the guide wire 25 and the catheter from touching and scratching the ciliated cells at the cochlear modiolus of the patient's cochlear cavity . Eventually the catheter is removed, leaving the guide wire 25 positioned as the path for cochlear implant 11 delivery.

The guide wire 25 is passed through the support tube 21 , and the delivery system 20 is driven to deliver the stent 11 in the crimped state to a predetermined release position along the guide wire 25 .

Specifically, during the delivery process, the medical imaging equipment obtains the image information of the delivery system 20 and the support 11 in real time, so as to observe the movement of multiple development points on the support 11 of the cochlear implant, and then ensure that each development point on the support 11 after delivery is in place It is consistent with the predetermined release position determined before operation. The above steps of driving the transport system 20 to move can be completed by the execution module, or manually completed.

Stimulation array 24 of delivery system 20 is configured to pre-stimulate the inner wall of the cochlea to target the auditory functional region of the cochlea. Specifically, in this embodiment, the specific steps of pre-stimulating the inner wall of the cochlea are as follows:

S151: make the balloon 23 of the delivery system 20 in an inflated state, and stimulate the array 24 to fit the inner wall of the cochlea;

Specifically, after the delivery system 20 transports the stent 11 to the predetermined release position, the balloon 23 can be inflated into an expanded state by filling the balloon 23 with liquid or air, preferably, by injecting the balloon 23 with a The liquid inflates the balloon 23 , so that the balloon 23 can be visualized by medical images, so that the doctor can observe the position and shape of the balloon 23 .

S152: The stimulation array 24 sends stimulation signals to different areas of the inner wall of the cochlea and collects electrical signals fed back by the cochlea to locate the auditory functional area.

Specifically, when the balloon 23 is inflated until the stimulation array 24 fits the inner cavity wall of the cochlea, the delivery system 20 is rotated so that the stimulation array 24 can send stimulation signals to different regions in the cochlea, and when the cochlea can feed back corresponding electrical signals , it indicates that the region facing the stimulation array 24 at this time is the auditory functional region of the cochlea.

After being positioned at the auditory functional area of the cochlea, the delivery system 20 can release the stent 11 and make the electrode array 111 of the stent 11 face the auditory functional area.

Specifically, referring to FIG. 14 to FIG. 16 , in order to ensure that the predetermined release position of the stent 11 and the deployed state after release are consistent with the preoperative plan, in this embodiment, the execution module is configured to perform the following steps:

S161: Drive the support tube 21 and the sheath tube 22 to move relative to each other in the axial direction to partially release the stent 11;

S162: Observing the deployment process of the stent 11 in real time through medical imaging equipment;

S163: If the partially deployed stent 11 fails to deploy to the predetermined deployment position and/or the electrode array 111 of the stent 11 fails to face the auditory functional area, withdraw the stent 11 to the delivery system 20;

S164: After adjusting the position of the delivery system 20, partially release the stent 11 again until the partially deployed stent 11 can be deployed to a predetermined deployment position and the electrode array 111 of the stent 11 faces the auditory function area;

Specifically, referring to FIG. 15 , the position of the delivery system 20 can be finely adjusted by moving or rotating, and then repeat the above steps S171 to S173 until the partially deployed stent 11 can be correctly deployed to the predetermined deployment position of the preoperative plan and ensure The electrode array 111 of the bracket 11 faces the auditory functional area, thereby ensuring the functional effect of the cochlear implant.

S170: Release the stent 11 completely, so that the stent 11 is freely expanded to a predetermined deployment position, and the electrode array 111 of the stent 11 fits the auditory function area.

In some cases, after the stent 11 is fully released, the stent 11 may not be fully deployed, and at this time, a balloon can be used to assist the stent 11 to further expand. Specifically, referring to FIG. 16 , in order to fully expand the stent 11 , the balloon 23 can be used to assist in the deployment of the stent 11 , and the execution module is also configured to perform the following steps:

S171: Make the balloon 23 in a deflated state, drive the delivery system 20 to make the balloon 23 extend into the deployed stent 11;

S172: Inflate the balloon 23 to an inflated state, and make the balloon 23 support the stent 11, so that the stent 11 is fully expanded and attached to the inner cavity wall of the cochlea.

After the implantation of the stent 11 is completed, the delivery system 20 can be removed, and the driver 12 of the cochlear implant can be placed according to the reasonable placement position of the driver 12 planned before operation, and the driver 12 and the stent 11 can be connected through the connecting wire 13 .

The present application also provides a storage medium, which includes a stored computer program, wherein the computer program executes the cochlear implant control method in any one of the above embodiments.

Those of ordinary skill in the art can understand that all or part of the flow in the control method of the above-mentioned embodiments can be completed by instructing related hardware through a computer program, and the computer program can be stored in a non-volatile computer-readable When the computer program is executed, the computer program may include the processes of the embodiments of the control methods described above. Wherein, any references to memory, storage, database or other media used in the various embodiments provided in the present application may include non-volatile and/or volatile memory. Nonvolatile memory can include read only memory (ROM), programmable ROM (PROM), electrically programmable ROM (EPROM), electrically erasable programmable ROM (EEPROM), or flash memory. Volatile memory can include random access memory (RAM) or external cache memory. By way of illustration and not limitation, RAM is available in many forms such as Static RAM (SRAM), Dynamic RAM (DRAM), Synchronous DRAM (SDRAM), Double Data Rate SDRAM (DDRSDRAM), Enhanced SDRAM (ESDRAM), Synchronous Chain Synchlink DRAM (SLDRAM), memory bus (Rambus) direct RAM (RDRAM), direct memory bus dynamic RAM (DRDRAM), and memory bus dynamic RAM (RDRAM), etc.

The above-mentioned cochlear implant system, cochlear implant control method and storage medium solve the problem that the stent-type cochlear implant does not have a matching implant method, and by reconstructing the patient's cochlear three-dimensional model 30 before the operation, according to the patient's cochlear three-dimensional model The size parameter of 30 selects the suitable cochlear implant model, which ensures that the cochlear implant fits the patient's cochlea after implantation. And by fusing the three-dimensional model of the cochlear implant in the database with the patient's cochlear three-dimensional model 30 before the operation, the position of the electrode on the scaffold 11 of the cochlear implant when it is released and the final shape after deployment can be determined, so as to provide medical advice to doctors. Visually display the release site of the stent 11 and the fit result after release, so as to provide visual navigation for subsequent operations. At the same time, during the implantation operation, the position and shape of the stent 11 are displayed in real time through medical imaging equipment, which ensures the accuracy of the release position of the stent 11 and the deployment position after deployment, and avoids damage to the cilia at the modiolus. At the same time, before releasing the stent 11, the cochlear implant is pre-stimulated through the stimulation array 24 of the delivery system 20, so as to accurately locate the auditory functional area of the patient's cochlea, and then ensure that the electrode array on the released stent 11 can accurately fit the cochlea. The auditory function area, and then ensure the functional effect of the cochlear implant to restore the patient's hearing.

The technical features of the above-mentioned embodiments can be combined arbitrarily. To make the description concise, all possible combinations of the technical features in the above-mentioned embodiments are not described. However, as long as there is no contradiction in the combination of these technical features, should be considered as within the scope of this specification.

The above-mentioned embodiments only represent several implementation modes of the present application, and the description thereof is relatively specific and detailed, but it should not be construed as limiting the scope of the patent for the invention. It should be noted that those skilled in the art can make several modifications and improvements without departing from the concept of the present application, and these all belong to the protection scope of the present application. Therefore, the scope of protection of the patent application should be based on the appended claims.

In the description of the present application, it should be understood that the terms "center", "longitudinal", "transverse", "length", "width", "thickness", "upper", "lower", "front", " Back", "Left", "Right", "Vertical", "Horizontal", "Top", "Bottom", "Inner", "Outer", "Clockwise", "Counterclockwise", "Axial" , "radial", "circumferential" and other indicated orientations or positional relationships are based on the orientations or positional relationships shown in the drawings, and are only for the convenience of describing the application and simplifying the description, rather than indicating or implying the referred device or Elements must have certain orientations, be constructed and operate in certain orientations, and thus should not be construed as limiting the application.

In addition, the terms "first" and "second" are used for descriptive purposes only, and cannot be interpreted as indicating or implying relative importance or implicitly specifying the quantity of indicated technical features. Thus, the features defined as "first" and "second" may explicitly or implicitly include at least one of these features. In the description of the present application, "plurality" means at least two, such as two, three, etc., unless otherwise specifically defined.

In this application, terms such as "installation", "connection", "connection" and "fixation" should be interpreted in a broad sense, for example, it can be a fixed connection or a detachable connection, unless otherwise clearly specified and limited. , or integrated; it may be mechanically connected or electrically connected; it may be directly connected or indirectly connected through an intermediary, and it may be the internal communication of two components or the interaction relationship between two components, unless otherwise specified limit. Those of ordinary skill in the art can understand the specific meanings of the above terms in this application according to specific situations.

In the present application, unless otherwise clearly specified and limited, a first feature being "on" or "under" a second feature may mean that the first and second features are in direct contact, or that the first and second features are indirect through an intermediary. touch. Moreover, "above", "above" and "above" the first feature on the second feature may mean that the first feature is directly above or obliquely above the second feature, or simply means that the first feature is higher in level than the second feature. "Below", "beneath" and "beneath" the first feature may mean that the first feature is directly below or obliquely below the second feature, or simply means that the first feature is less horizontally than the second feature.

It should be noted that when an element is referred to as being “fixed on” or “disposed on” another element, it may be directly on the other element or there may be an intervening element. When an element is referred to as being "connected to" another element, it can be directly connected to the other element or intervening elements may also be present. As used herein, the terms "vertical", "horizontal", "upper", "lower", "left", "right" and similar expressions are for the purpose of illustration only and are not intended to represent the only embodiments.

Claims

A delivery system for delivering a cochlear implant stent, characterized in that it comprises:

support tube;

a sheath tube, the sheath tube is sheathed outside the support tube, there is a storage space for accommodating the stent between the sheath tube and the support tube, and the sheath tube and the support tube are configured as can move relative to the axial direction to open or close the storage space;

a balloon, the balloon is sleeved outside the sheath, the balloon has a contracted state and an expanded state, and the balloon in the expanded state is used to fit the inner wall of the cochlea; and,

A stimulation array, the stimulation array is arranged on the outer surface of the balloon, and the stimulation array is used to send stimulation signals to the cochlea and collect electrical signals fed back by the cochlea.
The delivery system according to claim 1, wherein the stimulation array comprises at least two stimulation units, and all the stimulation units are arranged at intervals on the outer surface of the balloon along the axial direction of the sheath.
The delivery system according to claim 2, characterized in that:

the stimulation unit comprises electrodes; or,

the stimulation unit comprises an LED; or,

The stimulation unit includes electrodes and LEDs.
The delivery system according to claim 1, wherein an electrode array is arranged on the support; when the support is placed in the storage space, the position of the stimulation array corresponds to the position of the electrode array .
The delivery system according to claim 1, wherein the support tube is provided with a guide wire hole for passing a guide wire.
A cochlear implant system, characterized in that it comprises:

Medical imaging equipment for obtaining a three-dimensional model of the patient's cochlea;

A data processing module, configured to output, according to the three-dimensional model of the cochlea, the model of the cochlear implant that is compatible with the three-dimensional model of the cochlea;

The delivery system according to any one of claims 1-5, used to deliver the cochlear implant stent to a predetermined release position under the real-time visualization of the medical imaging equipment, and release it at the predetermined release position After the stent, the stent is deployed to a predetermined deployment position; the stimulation array of the delivery system is configured to pre-stimulate the inner wall of the cochlea to locate the auditory functional area of the cochlea.
The cochlear implant system according to claim 6, wherein the data processing module is configured to perform the following steps:

Marking the proximal and distal development points of the stent in the cochlea three-dimensional model, and calculating the intermediate development point of the stent according to the proximal and distal development points;

Obtaining the maximum diameter and the minimum diameter of the lumen of the cochlea at three positions of the proximal visualization point, the distal visualization point and the intermediate visualization point to output the diameter range of the stent;

obtaining the actual distance between the proximal visualization point and the distal visualization point to output the length of the stent;

Determine the reasonable placement position of the driver of the cochlear implant according to the cochlear three-dimensional model, and output according to the position of the reasonable placement position, the position of the proximal development point and the cochlear window of the cochlear three-dimensional model the length of the connecting wire of the cochlear implant;

The model of the cochlear implant is output according to the diameter range of the bracket, the length of the bracket and the length of the connecting wire.
The cochlear implant system according to claim 6, wherein the data processing module is further configured to generate a three-dimensional model of the cochlear implant frame corresponding to the model in the database according to the model of the cochlear implant and performing fusion with the three-dimensional model of the cochlea to output the predetermined release position and the predetermined deployment position.
The cochlear implant system according to claim 8, wherein the data processing module is also configured to perform the following steps:

According to the model of the cochlear implant, the three-dimensional model of the bracket of the corresponding model and in the crimping state is obtained from the database, and the three-dimensional model of the bracket is fused with the three-dimensional model of the cochlea to obtain all the three-dimensional models in the crimping state. The spatial position relationship between each development point on the three-dimensional model of the stent and the three-dimensional model of the cochlea, so as to output the predetermined release position;

Obtain the three-dimensional model of the bracket corresponding to the model and in the unfolded state from the database, fuse the three-dimensional model of the bracket with the three-dimensional model of the cochlea, and obtain each development point and the relationship between the three-dimensional model of the bracket in the unfolded state. The spatial position relationship of the three-dimensional model of the cochlea to output the predetermined deployment position.
The cochlear implant system according to claim 6, characterized in that:

The data processing module is further configured to output the model of the guide wire and the model of the delivery system according to the model of the cochlear implant; and output the scheduled implantation of the guide wire according to the three-dimensional model of the patient's cochlea Location;

The delivery system is also configured for delivering the stent along the guidewire to the predetermined release location.
The cochlear implant system according to claim 6, wherein the stimulation array is configured to send stimulation signals to different areas of the inner wall of the cochlea, and collect electrical signals fed back by the cochlea to locate The auditory functional area.
The cochlear implant system according to claim 6, further comprising an execution module for driving the delivery system, the execution module is configured to perform the following steps:

driving the delivery system to deliver the stent to the predetermined release position;

driving the support tube and the sheath to move relative to each other in the axial direction to partially release the stent;

Observing the deployment process of the stent in real time through the medical imaging device;

retracting the stent into the delivery system when the partially deployed stent fails to deploy to the predetermined deployment position or when the electrode array of the partially deployed stent fails to face the auditory functional area;

After adjusting the position of the delivery system, the stent is partially released again until the partially deployed stent can be deployed to the predetermined deployment position and the electrode array of the stent faces the auditory functional area;

The stent is completely released, so that the stent is freely deployed to the predetermined deployment position.
The cochlear implant system according to claim 12, characterized in that, after the support is completely released, the execution module is further configured to perform the following steps:

deflate the balloon to the deflated state, and drive the delivery system to extend the balloon into the deployed stent;

Inflating the balloon to the expanded state, allowing the balloon to support the stent, so that the stent is fully deployed and adheres to the lumen wall of the cochlea.
A method for controlling a cochlear implant, for controlling the cochlear implant system according to any one of claims 6-13, characterized in that it comprises the following steps:

Obtain a three-dimensional model of the patient's cochlea;

Outputting the model of the cochlear implant compatible with the three-dimensional model of the cochlea according to the three-dimensional model of the cochlea;

delivering the cochlear implant bracket to a predetermined release position through a delivery system;

pre-stimulating the inner wall of the cochlea to localize the auditory functional region of the cochlea;

The stent is released at the predetermined release position, and the electrode array of the stent faces the auditory function area after the stent is deployed to a predetermined deployment position.
The control method for cochlear implantation according to claim 14, characterized in that the step of outputting the model of the cochlear implant that is compatible with the three-dimensional model of the cochlea according to the three-dimensional model of the cochlea includes the following steps:

Marking the proximal and distal development points of the stent in the cochlea three-dimensional model, and calculating the intermediate development point of the stent according to the proximal and distal development points;

Obtaining the maximum diameter and the minimum diameter of the lumen of the cochlea at three positions of the proximal visualization point, the distal visualization point and the intermediate visualization point to output the diameter range of the stent;

obtaining the actual distance between the proximal visualization point and the distal visualization point to output the length of the stent;

Determine the reasonable placement position of the driver of the cochlear implant according to the cochlear three-dimensional model, and output according to the position of the reasonable placement position, the position of the proximal development point and the cochlear window of the cochlear three-dimensional model the length of the connecting wire of the cochlear implant;

The model of the cochlear implant is output according to the diameter range of the bracket, the length of the bracket and the length of the connecting wire.
The control method for cochlear implantation according to claim 14, further comprising the following steps:

According to the model of the cochlear implant, the three-dimensional model of the cochlear implant frame corresponding to the model in the database is fused with the three-dimensional model of the cochlea, and the predetermined release position and the predetermined deployment position are output.
The control method for cochlear implantation according to claim 16, further comprising the following steps:

According to the model of the cochlear implant, the three-dimensional model of the bracket of the corresponding model and in the crimping state is obtained from the database, and the three-dimensional model of the bracket is fused with the three-dimensional model of the cochlea to obtain all the three-dimensional models in the crimping state. The spatial position relationship between each development point on the three-dimensional model of the stent and the three-dimensional model of the cochlea, so as to output the predetermined release position;

Obtain the three-dimensional model of the bracket corresponding to the model and in the unfolded state from the database, fuse the three-dimensional model of the bracket with the three-dimensional model of the cochlea, and obtain each development point and the relationship between the three-dimensional model of the bracket in the unfolded state. The spatial position relationship of the three-dimensional model of the cochlea to output the predetermined deployment position.
The control method for cochlear implantation according to claim 14, further comprising the following steps:

Outputting the model of the guide wire and the model of the delivery system according to the model of the cochlear implant; and outputting the predetermined implantation position of the guide wire according to the three-dimensional model of the patient's cochlea;

The delivery system is controlled to deliver the stent along the guidewire to the predetermined release location.
The control method for cochlear implantation according to claim 14, characterized in that the step of pre-stimulating the inner wall of the cochlea to locate the auditory functional area of the cochlea comprises:

Stimulating signals are sent to different areas of the inner wall of the cochlea, and electrical signals fed back by the cochlea are collected to locate the auditory functional area.
The control method for cochlear implantation according to claim 14, wherein the stent is released at the predetermined release position, and the electrode array of the stent faces toward the The steps in the auditory ribbon include:

Observing the deployment process of the stent in real time;

retracting the stent into the delivery system when the partially deployed stent fails to deploy to the predetermined deployment position or when the electrode array of the partially deployed stent fails to face the auditory functional area;

After adjusting the position of the delivery system, the stent is partially released again until the partially deployed stent can be deployed to the predetermined deployment position and the electrode array of the stent faces the auditory functional area;

The stent is completely released, so that the stent is freely deployed to the predetermined deployment position.
The control method for cochlear implantation according to claim 20, further comprising the following steps after the support is completely released:

shrinking the balloon of the delivery mechanism to a contracted state, driving the delivery system to make the balloon extend into the expanded stent;

Inflating the balloon to the expanded state, allowing the balloon to support the stent, so that the stent is fully deployed and adheres to the lumen wall of the cochlea.
A storage medium, characterized in that the storage medium includes a stored computer program, wherein the computer program can execute the cochlear implant control method according to any one of claims 14 to 21.