阅读说明：本技术 塑形模具和脑皮层电刺激器的制作方法、存储介质 (Shaping die, manufacturing method of cerebral cortex electric stimulator and storage medium ) 是由 马克·霍默恩 戴聿昌 庞长林 于 2020-05-19 设计创作，主要内容包括：本发明公开了一种塑形模具和脑皮层电刺激器的制作方法、存储介质。该方法包括：采集患者的脑部影像数据；对所述脑部影像数据进行3D建模,获得所述塑形模具的三维数据；基于所述三维数据,控制3D打印机进行3D打印或控制精密机械加工设备进行精密机械加工,得到用于对脑皮层电刺激器的柔性电极进行塑形的所述塑形模具。该方法中,塑形模具的三维数据与患者的脑皮层区域的沟壑及褶皱曲率或凹凸表面的形状等信息一致,使用该塑形模具对脑皮层电刺激器的柔性电极塑形,实现了不同患者的脑皮层电刺激器的定制化,进而提高了对脑皮层的电流刺激效果。本发明尤其适用于视觉皮层电刺激器,用以改善视盲患者的视觉感受。(The invention discloses a shaping die, a manufacturing method of a cerebral cortex electric stimulator and a storage medium. The method comprises the following steps: collecting brain image data of a patient; 3D modeling is carried out on the brain image data, and three-dimensional data of the shaping mold is obtained; and based on the three-dimensional data, controlling a 3D printer to perform 3D printing or controlling a precision machining device to perform precision machining to obtain the shaping die for shaping the flexible electrode of the cerebral cortex electric stimulator. In the method, the three-dimensional data of the shaping die is consistent with information such as gully and fold curvature of a cortex region of a patient or the shape of a concave-convex surface, and the flexible electrode of the cortex electric stimulator is shaped by using the shaping die, so that the customization of the cortex electric stimulators of different patients is realized, and the current stimulation effect on the cortex is further improved. The invention is particularly suitable for the visual cortex electric stimulator and is used for improving the visual perception of the blind patients.)

1. A manufacturing method of a flexible electrode shaping mold is characterized by comprising the following steps:

collecting brain image data of a patient;

3D modeling is carried out on the brain image data, and three-dimensional data of the shaping mold is obtained;

and based on the three-dimensional data, controlling a 3D printer to perform 3D printing or controlling a precision machining device to perform precision machining to obtain the shaping die for shaping the flexible electrode of the cerebral cortex electric stimulator.

2. The method of claim 1, wherein before the 3D modeling of the brain image data to obtain the three-dimensional data of the shaping mold, the method further comprises:

and carrying out image segmentation on the brain image data to obtain brain visual cortex image data.

3. The method of claim 2, wherein the visual cortical brain image data comprises:

image data of a visual cortex V1 part of the brain, image data of a visual cortex V2 part of the brain and image data of a visual cortex V3 part of the brain; or

Image data of a visual cortex V1 part of the brain and image data of a visual cortex V2 part of the brain; or

Image data of visual cortex of brain V1 part and image data of visual cortex of brain V3 part.

4. The method of claim 1, wherein the 3D modeling of the brain image data to obtain three-dimensional data of the shaping mold comprises:

and 3D modeling is carried out on the brain image data, and male die three-dimensional data and/or female die three-dimensional data of the shaping die are/is obtained respectively.

5. The manufacturing method according to claim 4, wherein the controlling of a 3D printer for 3D printing or a precision machining device for precision machining based on the three-dimensional data to obtain the shaping mold for shaping the flexible electrode of the electrical stimulator for cortex comprises:

controlling 3D printing or precision machining to obtain a convex shaping die based on the three-dimensional data of the male die; and/or

And controlling 3D printing or precision machining to obtain a concave shaping die based on the three-dimensional data of the female die.

6. The method of any one of claims 1 to 5, wherein the acquiring brain image data of the patient comprises:

acquiring brain image data of the patient by magnetic resonance imaging and/or CT scan imaging.

7. The manufacturing method according to any one of claims 1 to 5, characterized in that 3D printing is performed by a metal additive technology or precision machining is performed by a multi-axis multi-linkage precision machining center.

8. A method for manufacturing an electrical stimulator for cerebral cortex is characterized by comprising the following steps:

manufacturing the shaping die according to the manufacturing method of the shaping die of any one of claims 1 to 7;

clamping a flexible electrode by using the shaping mold, heating the shaping mold and the flexible electrode in a vacuum environment, and shaping the flexible electrode to obtain the shaped flexible electrode;

and packaging the leading-in part of the flexible electrode, the integrated circuit chip and the discrete component into a packaging structure to obtain the cerebral cortex electric stimulator.

9. The method of manufacturing according to claim 8, wherein the heating temperature for heating the shaping mold and the flexible electrode in a vacuum environment comprises: 150 ℃ and 250 ℃.

10. A computer readable storage medium storing computer instructions which, when executed, implement a method of making a flexible electrode shaping mold according to any one of claims 1 to 7.

Technical Field

The invention relates to the technical field of medical equipment manufacturing, in particular to a shaping mold, a manufacturing method of a cerebral cortex electrical stimulator and a storage medium.

Background

Visual reconstruction can be roughly divided into three levels, the retina, the optic nerve and the visual cortex. Visual reconstruction of the visual cortex is an important direction of research for patients whose retina and optic nerve have already been damaged. In the related art, a visual perception is formed by inducing a photic illusion in a visually blind patient by applying a stimulating current to the visual cortex. Namely, the electrode array is directly implanted into the brain of a patient, and stimulation current is applied to the most downstream visual path of visual cortex through the electrode array, so that the visual perception of the patient is generated. However, unlike the regular arc structure of the retinal portion, the visual cortex has a complex shape of ravines. How to achieve effective implantation of the electrode array to ensure the stimulation effect of each stimulation electrode is a challenge for those skilled in the art.

In addition, other types of functional recovery and disease treatment (such as pain treatment, addiction disease treatment, botanic awakening and the like) can be realized by electrically stimulating other areas of the cerebral cortex, and the problem of effective implantation of the electrode array also needs to be solved.

Disclosure of Invention

In view of the above problems, an object of the present invention is to provide a shaping mold and a method for manufacturing a cortical electrostimulator, so as to achieve customization of the cortical electrostimulators of different patients, and improve the current stimulation effect of the cortical electrostimulator on the cortex of the patient.

According to an aspect of the present invention, there is provided a method of manufacturing a flexible electrode shaping mold, the method comprising:

collecting brain image data of a patient;

3D modeling is carried out on the brain image data, and three-dimensional data of the shaping mold is obtained;

and based on the three-dimensional data, controlling a 3D printer to perform 3D printing or controlling a precision machining device to perform precision machining to obtain the shaping die for shaping the flexible electrode of the cerebral cortex electric stimulator.

Preferably, before the 3D modeling of the brain image data and obtaining the three-dimensional data of the shaping mold, the method further includes:

and carrying out image segmentation on the brain image data to obtain brain visual cortex image data.

Preferably, the visual cortical brain image data includes:

image data of a visual cortex V1 part of the brain, image data of a visual cortex V2 part of the brain and image data of a visual cortex V3 part of the brain; or

Image data of a visual cortex V1 part of the brain and image data of a visual cortex V2 part of the brain; or

Image data of visual cortex of brain V1 part and image data of visual cortex of brain V3 part.

Preferably, the 3D modeling of the brain image data, obtaining three-dimensional data of the shaping mold comprises:

and 3D modeling is carried out on the brain image data, and male die three-dimensional data and/or female die three-dimensional data of the shaping die are/is obtained respectively.

Preferably, the step of controlling a 3D printer to perform 3D printing or controlling a precision machining device to perform precision machining based on the three-dimensional data to obtain the shaping mold for shaping the flexible electrode of the cortical electrostimulator includes:

controlling 3D printing or precision machining based on the three-dimensional data of the male die to obtain a convex shaping die; and/or

And controlling 3D printing or precision machining based on the three-dimensional data of the female die to obtain the concave shaping die.

Preferably, the acquiring brain image data of the patient comprises:

acquiring brain image data of the patient by magnetic resonance imaging and/or CT scan imaging.

Preferably, the 3D printing is performed by using a metal additive technology, or the precision machining is performed by using a multi-axis multi-linkage precision machining center.

According to another aspect of the present invention, there is provided a method for manufacturing an electrical stimulator for cerebral cortex, comprising:

the shaping die is manufactured by adopting the manufacturing method of the shaping die;

clamping a flexible electrode by using the shaping mold, heating the shaping mold and the flexible electrode in a vacuum environment, and shaping the flexible electrode to obtain the shaped flexible electrode;

and packaging the leading-in part of the flexible electrode, the integrated circuit chip and the discrete component into a packaging structure to obtain the cerebral cortex electric stimulator.

Preferably, the heating temperature for heating the shaping mold and the flexible electrode in the vacuum environment includes: 150 ℃ and 250 ℃.

According to yet another aspect of the present invention, there is provided a computer readable storage medium storing computer instructions which, when executed, implement the method of making a flexible electrode shaping mold as described above.

The embodiment provided by the invention has the following advantages or beneficial effects:

the method comprises the steps of collecting brain image data of a patient, carrying out 3D modeling on the brain image data, obtaining three-dimensional data of a shaping mold, controlling a 3D printer to carry out 3D printing based on the three-dimensional data, or using a precision machining mode to obtain the shaping mold used for shaping flexible electrodes of a cortex electric stimulator, wherein the three-dimensional data of the shaping mold is consistent with information such as gullies, fold curvatures or shapes of concave-convex surfaces of cortex regions of the patient, shaping the flexible electrodes of the cortex electric stimulator by using the shaping mold, customizing of the cortex electric stimulators of different patients is realized, and then the current stimulation effect on the cortex of the patient is improved.

Drawings

The above and other objects, features and advantages of the present invention will become more apparent from the following description of the embodiments of the present invention with reference to the accompanying drawings, in which:

fig. 1 shows a flow chart of a method of making a shaping mold according to an embodiment of the invention;

fig. 2 illustrates an implantation state diagram of a cortical electrostimulator in accordance with an embodiment of the present invention;

FIG. 3 shows a schematic structural diagram of a flexible electrode of one embodiment of the present invention;

fig. 4 shows a flow chart of a method of making a shaping mold according to another embodiment of the invention;

FIG. 5 illustrates a flow chart of a method of fabricating a cortical electrostimulator in accordance with an embodiment of the present invention;

FIG. 6 shows a schematic structural view of a shaping die and a compression die of one embodiment of the present invention;

fig. 7 is a block diagram showing a manufacturing control apparatus of a shaping mold according to an embodiment of the present invention.

List of reference numerals

210 electrode array

220 cable

230 packaging structure

231 lead-in part

300 flexible electrode

610 protruding type shaping die

620 concave type shaping mould

630 lower pressing die

640 upper pressing die

700 manufacturing control device

710 processor

720 memory

730 image data acquisition equipment

740 mould processing equipment

Detailed Description

Various embodiments of the present invention will be described in more detail below with reference to the accompanying drawings. Like elements in the various figures are denoted by the same or similar reference numerals. For purposes of clarity, the various features in the drawings are not necessarily drawn to scale.

The following detailed description of embodiments of the present invention is provided in connection with the accompanying drawings and examples.

Fig. 1 is a flow chart of a method of making a shaping mold according to an embodiment of the invention. The method specifically comprises the following steps:

in step S110, brain image data of the patient is acquired.

In this step, a brain region of the patient may be scanned by magnetic resonance imaging and/or CT scan imaging, and brain image data of the patient may be acquired based on the scanning result. The brain image data may be image data of the entire brain structural region of the patient, or image data of a part of the brain structural region of the patient. As an embodiment, for a visually blind patient, the brain image data comprises at least image data of a visual cortical region of the visually blind patient. Since the anatomical structures of the visual cortical areas of the visually blind patients are different from each other, information such as the ravines and the fold curvatures of the visual cortical areas of the visually blind patients, the shapes of the concave-convex surfaces, and the like can be obtained based on the image data of the visual cortical areas.

In step S120, 3D modeling is performed on the brain image data to obtain three-dimensional data of the shaping mold.

In this step, the brain image data may be imported into modeling software for 3D modeling, so as to obtain three-dimensional data of the shaping mold. The three-dimensional data of the shaping mold is consistent with information such as gullies and fold curvatures in the cerebral cortical region of the patient or the shape of the concave-convex surface.

In step S130, based on the three-dimensional data, controlling a 3D printer to perform 3D printing or controlling a precision machining device to perform precision machining, so as to obtain the shaping mold for shaping the flexible electrode of the cortical electrostimulator.

Alternatively, fig. 2 illustrates an implantation state diagram of the cortical electrostimulator of an embodiment of the present invention, as shown in fig. 2, the cortical electrostimulator includes an implant device implanted in the patient's cortex and an external device (not shown) in communication with the implant device, the implant device including the flexible electrodes 300. The flexible electrode 300 includes a stimulation portion, a cable 220, and a lead-in portion 231 (refer to fig. 3). The lead-in 231 connects the integrated circuit chip and a discrete component (not shown) and is packaged to form a package structure 230. The implanted device is used for receiving an electrical stimulation signal sent by an external device, such as video information of the surrounding environment of a visually-blind patient, and the stimulation part in the flexible electrode 300 is directly acted on the cerebral cortex in an electrical stimulation mode, so that the purposes of visual perception, pain treatment, addiction disease treatment or plant man awakening and the like are achieved. The stimulation portion is preferably an array of electrodes 210 arranged in rows and columns, and may be configured in other possible configurations as desired. The present invention is directed to shaping of the stimulation portion that is directed to contact with the cortex.

Specifically, fig. 3 shows a schematic structural diagram of a flexible electrode according to an embodiment of the present invention. As shown in fig. 3, the flexible electrode 300 of the cortical electrostimulator of this embodiment includes: electrode array 210, cable 220, and lead-in 231. The number of electrodes in electrode array 210 is typically tens or hundreds or even thousands. The cable 220 is internally formed with a plurality of wires respectively connected to the electrode arrays 210 for electrically connecting the electrode arrays 210 and the lead-in portions 231. The lead-in 231 is used to connect an integrated circuit or discrete components. The electrode array 210 may be shaped by clamping the electrode array 210 of the flexible electrode 300 with a shaping mold.

Based on the three-dimensional data, the 3D printer is controlled to perform 3D printing, or a precision machining mode is adopted, and the obtained shaping die is consistent with information such as gully, fold curvature or shape of concave-convex surface of a cerebral cortex region of a patient, so that the flexible electrode 300 of the cerebral cortex electric stimulator is shaped by using the shaping die, the fitting degree of the flexible electrode 300 and the cerebral cortex region of the patient can be improved, the current stimulation effect on the cerebral cortex of the patient can be further improved, and the method is particularly suitable for the visual cortex electric stimulator and used for improving the visual perception of a blind patient.

Fig. 4 is a flowchart of a method for manufacturing a shaping mold according to another embodiment of the present invention, which specifically includes the following steps:

in step S110, brain image data of the patient is acquired.

In step S121, the image segmentation is performed on the brain image data to obtain visual cortical brain image data.

The brain image data may also be preprocessed, e.g., de-noised and formatted, before image segmentation. Specifically, the visual cortical brain image data includes: image data of a visual cortex V1 part of the brain, image data of a visual cortex V2 part of the brain and image data of a visual cortex V3 part of the brain; or image data of a visual cortex V1 part of the brain and image data of a visual cortex V2 part of the brain; or the image data of the visual cortex of the brain V1 part and the image data of the visual cortex of the brain V3 part.

In step S122, 3D modeling is performed on the brain image data, and male mold three-dimensional data and/or female mold three-dimensional data of the shaping mold are obtained respectively.

In step S131, controlling 3D printing or precision machining to obtain a convex shaping mold based on the three-dimensional data of the male mold; and/or controlling 3D printing or precision machining to obtain a concave shaping die based on the three-dimensional data of the female die. For example, 3D printing is performed using a metal additive technology, or precision machining is performed using a multi-axis multi-linkage precision machining center.

The convex and concave shaping molds may be matched to form the same shape as the curvature of the gullies and folds or the concave and convex surfaces of the patient's cerebral cortex, or the convex or concave shaping mold may be used alone and combined with another plastic component to shape the stimulation portion of the flexible electrode 300.

Fig. 5 shows a flow chart of a method of fabricating a cortical electrostimulator in accordance with an embodiment of the invention.

In step S510, the shaping mold is manufactured by using the manufacturing method of the shaping mold.

In this step, a shaping mold is manufactured by using the manufacturing method of the shaping mold shown in fig. 1 or fig. 4.

In step S520, the flexible electrode 300 is clamped by the shaping mold, and the shaping mold and the flexible electrode 300 are heated in a vacuum environment, and after a certain shaping time, the shaped flexible electrode 300 is obtained.

Optionally, the electrode array 210 in the flexible electrode 300 includes a first thin film insulating layer, a metal layer and a second thin film insulating layer, the metal layer is located between the first thin film insulating layer and the second thin film insulating layer, and a thin film-metal-thin film sandwich structure is formed. The electrode array 210 is fabricated using a MEMS process by chemical vapor deposition, sputtering, plating, evaporation, plasma etching, patterning, or a combination thereof. The materials of the first thin film insulating layer and the second thin film insulating layer include: polymethyl methacrylate, teflon, silicone, polyimide, poly (terephthalic acid), poly (phenylephrine). The parylene may be deposited by chemical vapor deposition, so that the thickness of the electrode array 210 is as thin as several hundred, several tens to several micrometers, and the electrode array is easier to be molded.

Fig. 6 shows a schematic structural view of a shaping mold and a pressing mold according to an embodiment of the present invention. The shaping mold comprises: protruding type moulding mould 610 and concave type moulding mould 620, the compression mould includes: a lower compaction mold 630 and an upper compaction mold 640. The lower and upper compression molds 630 and 640 serve to flatten the lead-in portion 231 of the flexible electrode 300 and the cable 220. The male molding die 610 is detachably connected to the lower compression die 630. That is, the embodiment only needs to perform customized printing or precision machining of the convex shaping mold 610 and the concave shaping mold 620 for different patients, and the lower compression mold 630 and the upper compression mold 640 can be used commonly. Further, for assembly, after clamping the flexible electrode 300, the female type shaping mold 620 is fixed to the male type shaping mold 610 by screws.

Specifically, the flexible electrode 300 is placed at a specific position of the lower pressing mold 630 and the convex shaping mold 610, so that the electrode array 210 of the flexible electrode 300 is position-matched with the convex shaping mold 610; the upper pressing mold 640 and the female shaping mold 620 are respectively installed at corresponding positions of the lower pressing mold 630 and the male shaping mold 610, such that the lower pressing mold 630 and the upper pressing mold 640 clamp the lead-in portion 231 of the flexible electrode 300 and the cable 220, and the male shaping mold 610 and the female shaping mold 620 clamp the electrode array 210 fixing the flexible electrode 300; and (3) placing the fixed assembly into a vacuum oven for high-temperature treatment at the temperature of 150 ℃ and 250 ℃, and obtaining the shaped flexible electrode 300 after a set time.

In step S530, the lead-in portion 231 of the flexible electrode 300, the integrated circuit chip and the discrete components are packaged into a package structure, so as to obtain the cortical electrostimulator.

The cerebral cortex electric stimulator can be used for achieving the purposes of visual perception, pain treatment, addiction disease treatment or plant person awakening and the like, is particularly suitable for the visual cortex electric stimulator, is used for treating blindness eye diseases caused by glaucoma, diabetic retinopathy, high myopia fundus diseases, eye trauma and the like, and can also be used as a substitute treatment scheme for Retinitis Pigmentosa (RP) and senile macular degeneration (AMD). The visual cortex electrical stimulator may continue to retain all of the residual vision of the visually blind patient compared to the retinal electrical stimulator.

Generally, an implant device of a cortical electrostimulator is surgically implanted in the brain of a patient. When the implantation operation is performed, a doctor firstly removes a part of skull of a patient to form a hollow part. The hollowed-out portion is sufficient to provide a space for the electrode array 210 to pass through. The doctor implants the implantation device of the cortical electrostimulator into the hollowed part of the skull of the patient or on the skull or under the scalp through a tool, and implants the electrode array 210 of the flexible electrode 300 of the cortical electrostimulator into the surface of the cortex. In general, for blind patients, electrode array 210 may be implanted in the V1 region of the visual cortex of the brain, or may partially cover the V2 region of the visual cortex of the brain or the V3 region of the visual cortex of the brain. After the surgery is completed, the skull bone around the flexible electrode 300 may heal.

The external device of the visual cortex electric stimulator comprises a camera shooting unit, a video processing unit and a wireless transmission unit. The camera shooting unit collects video information of the surrounding environment of the blind patient, the video processing unit carries out data conversion on the video information, and the wireless transmission unit transmits the video information after the data conversion to the implantation device. The electrode array 210 of the flexible electrode 300 of the visual cortex electrical stimulator directly acts on the visual cortex by means of electrical stimulation, so that the patient can obtain visual perception. The invention realizes the customization of the cortex electrical stimulator of different blind patients and can improve the visual perception of the blind patients.

For other types of cortical electrostimulators, the external device is configured accordingly, but with the function of sending an electrostimulation signal to the implanted device, reference may be made in particular to the existing and improved technology.

Fig. 7 is a block diagram of a molding die production control apparatus 700 according to an embodiment of the present invention. The apparatus shown in fig. 7 is only an example and should not limit the functionality and scope of use of embodiments of the present invention in any way.

Referring to fig. 7, the apparatus includes a processor 710, a memory 720, an image data collecting device 730, and a mold processing device 740 connected through a bus. Memory 720 includes Read Only Memory (ROM) and Random Access Memory (RAM), with various computer instructions and data required to perform system functions being stored in memory 720, and with various computer instructions being read by processor 710 from memory 720 to perform various appropriate actions and processes. The image data acquisition device 730 may be a magnetic resonance imaging device or a CT scanning imaging device. The image data acquisition device 730 acquires brain image data of the patient. The mold processing device 740 is, for example, a 3D printer or a precision machining device. The mold processing device 740 performs 3D printing based on the three-dimensional data of the shaping mold, or uses a precision machining technique to obtain a shaping mold for shaping the flexible electrode 300 of the cortical electrostimulator. The memory 720 further stores computer instructions to complete the method of manufacturing the plastic mold according to the embodiment of the invention.

Accordingly, an embodiment of the present invention provides a computer-readable storage medium, which stores computer instructions, and when the computer instructions are executed, the computer instructions implement the manufacturing method of the above-mentioned shaping mold.

While embodiments in accordance with the invention have been described above, these embodiments are not intended to be exhaustive or to limit the invention to the precise embodiments described. Obviously, many modifications and variations are possible in light of the above teaching. The embodiments were chosen and described in order to best explain the principles of the invention and the practical application, to thereby enable others skilled in the art to best utilize the invention and various embodiments with various modifications as are suited to the particular use contemplated. The invention is limited only by the claims and their full scope and equivalents.