Balloon patch surface implantation electrode device and signal transmitting method thereof

Abstract

The invention discloses a balloon spot surface implantation electrode device and a signal transmitting method thereof in the field of vestibular function repair.The balloon spot surface implantation electrode device comprises a base plate, an inner electrode array, an outer electrode array and micro-grain marked lines, the inner electrode array and the outer electrode array are arranged in the base plate, the base plate comprises a base plate handle and a base plate racket, the edge of the base plate racket is in close contact with the inner wall of a balloon inner membrane, and the micro-grain marked lines are arranged on the base plate handle. The lower plane is in close contact with otolith on the surface of a sacculus spot, the base plate handle penetrates through the sacculus shell, the micro-grain marked line is located on the surface of the base plate or in the base plate, and the micro-grain marked line coincides with micro-grains on the surface of the sacculus spot in position and is the same as the micro-grains on the surface of the sacculus spot in shape. An electronic signal passes through the implanted electrode and is transmitted to the surface of a balloon spot to stimulate sensory cilia cells in the balloon, so that an artificial otolith organ feeling is generated.

Description

Technical Field

[0001] The present invention belongs to the technical field of vestibular function restoration, and in particular relates to a device for implanting an electrode on the surface of a saccule plaque and a signal transmission method thereof. Background Art

[0002] The saccule is a flat, pear-shaped structure that, along with the utricle, is collectively known as the vestibular otolith organ. Its primary function is to sense gravity and linear acceleration of the head. The otolith organ's receptors are located in the epithelial thickening of the anterior-superior wall of the saccule, called the macula. Its surface is covered by a stack of tiny otoliths, beneath which lies a glial layer called the otolith membrane, and at its base, a supporting cell layer. The sensory ciliated cells have bundles of cilia at their tips, embedded in the otolith membrane. These bundles are arranged in a polarized pattern (directed from the stereocilia toward the motile cilia). When the stereocilia press against the motile cilia, the ciliated cells depolarize, becoming excited and increasing their firing rate. When the motile cilia press against the stereocilia, the ciliated cells hyperpolarize, becoming inhibited and decreasing their firing rate.

[0003] The surface of the macula has a concave band called the microstriae, along which the polarization of ciliated cells is aligned. The polarization of ciliated cells in the utricle points toward the microstriae, while that of ciliated cells in the saccule points away from them. When the entire macula deflects in the same direction, the ciliated cells on either side of the microstriae, while deflecting in the same direction, depolarize on one side and hyperpolarize on the other, generating diametrically opposed neural signals.

[0004] When the human head is subjected to linear acceleration, centripetal acceleration, and gravitational acceleration, the otoliths, with their greater specific gravity, move in opposite directions due to inertia, causing the cilia at the top of the ciliated cells to bend and deform, triggering a neural response and generating corresponding neural signals. Based on these neural signals, the brain uses these signals to orient itself in space and maintain balance, and to generate linear eye movement reflexes to maintain stable vision.

[0005] When the human body suffers from bilateral vestibular dysfunction due to accidental injury or vestibular system disease, it manifests as oscillopsia, postural instability, chronic balance disorders, falls and cognitive impairment. Severe patients cannot encode head movements due to damage to the peripheral conduction pathways of the vestibular system, which has a great impact on their daily life and may even make them unable to stand and walk. With the aging population, the number of patients increases year by year. Although existing treatments can alleviate the condition of severe patients, current medical means are still unable to completely restore their vestibular function. Summary of the Invention

[0006] The purpose of the present invention is to provide an electrode device implanted on the surface of the saccule and a signal transmission method thereof, which transmits electronic signals to the surface of the saccule through the implanted electrodes, stimulates the sensory ciliary cells in the saccule, and produces artificial otolith organ sensation.

[0007] To achieve the above-mentioned objectives, the present invention adopts the following technical solution: a device for implanting electrodes on the surface of a saccule plaque, comprising a substrate, an inner electrode array and an outer electrode array arranged in the substrate, and micro-groove markings. The substrate comprises a substrate handle and a substrate paddle. The edge of the substrate paddle is in close contact with the inner wall of the saccule intima, and the lower plane is in close contact with the otoliths on the surface of the saccule plaque. The substrate handle passes through the outer shell of the balloon. The micro-groove markings are located on the surface or inside of the substrate. The micro-groove markings coincide with the position of the micro-groove on the surface of the saccule plaque and have the same shape as the micro-groove on the surface of the saccule plaque.

[0008] As a further improvement of the technical solution of the present invention, the inner electrode array and the outer electrode array each include at least one electrode extending from the substrate handle to the substrate racket, and the inner electrode array and the outer electrode array are respectively located on the inner and outer sides of the micro-groove marking line. The electrode core at the end of each electrode in the inner electrode array and the outer electrode array is a straight line and is perpendicular to the local curve at the corresponding position of the micro-groove marking line.

[0009] As a further improvement of the technical solution of the present invention, the electrode includes a main body segment and a straight end, the main body segment includes an electrode core, an insulating layer, a shielding layer and an insulating layer arranged in sequence from the inside to the outside, the straight end includes an electrode core, the main body segment is arranged inside the substrate, and the straight end is embedded in the surface of the substrate and is in direct contact with the surface of the balloon plaque.

[0010] As a further improvement of the technical solution of the present invention, the cross-sectional shape of the electrode inner core is circular, elliptical, oval or polygonal, with a cross-sectional size of 1µm~100µm, and is made of gold, platinum alloy, titanium alloy or iridium oxide material.

[0011] As a further improvement to the technical solution of the present invention, the substrate is in the shape of a table tennis racket and is made of a flexible non-toxic polymer material and is transparent or translucent.

[0012] As a further improvement of the technical solution of the present invention, the micro-line marking is a colored curve or a curve with a concave surface, and its shape is a semicircular structure with the same shape as the micro-line of the human saccule, and its width is 10µm~500µm.

[0013] Optionally, the transmission signals of the outer electrode array and the inner electrode array are both sinusoidal currents, with the same frequency and opposite phases, and the electrodes in the same array have the same frequency, phase, and amplitude, or different amplitudes.

[0014] Optionally, the transmission signals of the outer electrode array and the inner electrode array are both square wave currents, with the same frequency and opposite phases, and the electrodes in the same array have the same frequency, phase, and amplitude, or different amplitudes.

[0015] The working principle of the present invention is that when the sacculus organ in the human vestibular system develops a lesion, the ciliated sensory cells in the macula cannot generate neural signal encoding, making the human body unable to perceive linear acceleration of the head. When a linear acceleration sensor (the MPU6050 six-dimensional accelerometer produced by InvenSense Corporation in the United States is used in this invention) senses linear acceleration of the head, the physical signal of head movement is converted into a sinusoidal or square wave current signal. This signal is then input to the surface of the macula through the present electrode device and transmitted to the higher nervous system through the ciliated sensory cells, enabling the human body to perceive linear acceleration of the head. When the human head is subjected to linear acceleration, because the polarity of the sensory ciliated cells in the macula is opposite on either side of the micro-striae, all sensory ciliated cells on both sides of the micro-striae will generate neural signals with opposite phases. The two sets of electrodes in the present invention, namely the outer electrode array and the inner electrode array, also output current signals with opposite phases. After receiving the current signals, the sensory ciliated cells in the sacculus maculae transmit the signals to the upper nervous tissue, thus enabling the brain to perceive linear acceleration of the head. The electrode arrangement position, signal transmission frequency, phase and pattern of the present invention are highly similar to those of the human body. After being implanted into the human body, it can easily produce the same function as a balloon.

[0016] Compared with the existing technology, the present invention has the following significant advantages: 1. By grouping the electrodes, the outer and inner electrode groups of the micro-groove output current signals with opposite phases, which is more in line with the neural signal characteristics of the sensory ciliary cells in the saccule maculae of the human body; 2. The end of each electrode is a straight electrode core exposed on the surface of the substrate. The straight line direction is perpendicular to the micro-groove marking line at the corresponding position and is the same as the polar arrangement direction of the sensory ciliary cells at the corresponding position of the human body, which can better stimulate the sensory ciliary cells; 3. A shielding layer is added around the electrode to prevent the electrode from interfering with the sensory ciliary cells passing through, and also to prevent other electrode signals from interfering with its own signals; 4. Since the saccule maculae is at the bottom of the saccule and has a small area, the electrode substrate of the present invention is in close contact with the inner wall of the saccule, making it easier for the electrode substrate to be positioned and adhered to the surface of the saccule maculae to achieve the corresponding function. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] Figure 1 This is a structural diagram of embodiment 1 of the present invention.

[0018] Figure 2 Schematic diagram of the structure of the substrate in embodiment 1 of the present invention.

[0019] Figure 3 This is a cross-sectional view of the substrate in Example 1 of the present invention.

[0020] Figure 4 This is a cross-sectional view of the electrode main body section in Example 1 of the present invention.

[0021] Figure 5This is the current signal output by the outer electrode array in the second embodiment of the present invention.

[0022] Figure 6 This is the current signal output by the inner electrode array in the second embodiment of the present invention.

[0023] Figure 7 This is the current signal output by the outer electrode array in the third embodiment of the present invention.

[0024] Figure 8 This is the current signal output by the inner electrode array in the third embodiment of the present invention.

[0025] Among them, 1 substrate, 101 substrate handle, 102 substrate racket, 2 electrodes, 201 electrode inner core, 202 insulating layer, 203 shielding layer, 204 insulating layer, 3 micro-groove marking lines, 11 outer electrode array, 12 inner electrode array. DETAILED DESCRIPTION Example

[0026] like Figure 1-2 As shown, a device for implanting electrodes on the surface of a saccule macule is shown, comprising a ping-pong paddle-shaped substrate 1, an inner electrode array 12 and an outer electrode array 11 disposed within the substrate 1, and micro-groove markings 3 sprayed with color inside. The substrate 1 is made of a flexible, non-toxic polymer material and is transparent or translucent, and comprises a substrate handle 101 and a substrate paddle 102. When the device is installed on the surface of a saccule macule inside a human saccule, the edge of the substrate paddle 102 is in close contact with the inner wall of the saccule's inner membrane, thereby providing positioning. The lower plane of the substrate paddle 102 is in close contact with the otoliths on the surface of the saccule macule, and the substrate handle 101 passes through the outer shell of the saccule. The micro-groove markings 3 coincide with and have the same shape as the micro-groove on the surface of the saccule macule, thereby verifying the installation position of the electrode 2.

[0027] The inner electrode array 12 and the outer electrode 2 array 11 each include five electrodes 2 extending from the substrate handle 101 to the substrate racket 102. The inner electrode array 12 and the outer electrode 2 array 11 are respectively located on the inner and outer sides of the micro-groove marking line 3. The electrode core 201 at the end of each electrode 2 is a straight line shape and is perpendicular to the local curve at the corresponding position of the micro-groove marking line 3.

[0028] The electrode 2 includes a main body section and a straight end. The main body section includes an electrode core 201, an insulating layer 204202, a shielding layer 203 and an insulating layer 204202 arranged in sequence from the inside to the outside, as shown in Figure 3; the straight end includes an electrode core 201, the main body section is arranged inside the substrate 1, and the straight end is embedded in the surface of the substrate 1 and directly contacts the surface of the balloon plaque, as shown in Figure 3. Figure 4As shown, it can be understood that only the electrode core 201 is exposed at the straight end of electrode 2, with the surface of electrode core 201 exposed on the surface of substrate 1. Except for the straight end, the rest of electrode 2 is completely contained within substrate 1. After electrode 2 is implanted on the surface of the saccule, the straight end of electrode 2 aligns with the polarity of the sensory ciliated cells in the corresponding saccule.

[0029] In this embodiment, the cross-sectional shape of the electrode core 201 is circular. In other embodiments, the cross-sectional shape of the electrode core 201 may be elliptical, oval, or polygonal, which is not limited here. The cross-sectional size is 1µm~100µm, and it is made of gold, platinum alloy, titanium alloy, or iridium oxide.

[0030] In other embodiments, the micro-groove marking line 3 is a curve formed by the indentation on the surface of the substrate 1. The width varies from person to person and is within the range of 10µm to 500µm. It completely overlaps with the physiological micro-groove on the surface of the saccule in terms of depth and direction, and can provide a physical spatial anchor point to ensure the rigid positioning of the electrode 2 array relative to the micro-groove. Example

[0031] The present invention provides a signal transmission method of an electrode 2 device implanted on the surface of a saccule plaque. When the implanted electrode 2 transmits current to the saccule plaque of a human body, the current of the outer electrode 2 array 11 is a sinusoidal current signal, such as Figure 5 As shown, the current of the inner electrode array 12 is also a sinusoidal current signal, such as Figure 6 As shown, the current signal of the outer electrode array 11 and the current signal of the inner electrode array 12 have the same frequency, but opposite phases. Example

[0032] The present invention also provides a signal transmission method of an electrode 2 device implanted on the surface of a saccule plaque. When the implanted electrode 2 transmits current to the saccule plaque of a human body, the current of the outer electrode 2 array 11 is a square wave current signal, such as Figure 7 As shown, the current of the inner electrode array 12 is also a square wave current signal, such as Figure 8 As shown, the current signal of the outer electrode array 11 and the current signal of the inner electrode array 12 have the same frequency, but opposite phases.

[0033] During use, the present invention implants electrodes 2 to stimulate the sensory ciliary cells of the otolith organs, mimicking the sensory function of the human otolith organs to help patients partially restore otolith sensation and alleviate symptoms. This is an effective treatment method, similar in principle to the auditory restoration of deaf patients by cochlear implants. It should be noted that the present implanted electrode 2 device and signal transmission method can be applied not only to restore the function of the saccule, but also to restore the sensory function of the utricle.

[0034] The present invention is not limited to the above-mentioned embodiments. On the basis of the technical solutions disclosed in the present invention, those skilled in the art can make some substitutions and modifications to some of the technical features therein according to the disclosed technical content without creative labor, and these substitutions and modifications are all within the protection scope of the present invention.

Claims

1. A device for implanting an electrode on the surface of a saccule, characterized in that: The invention comprises a substrate, an inner electrode array and an outer electrode array arranged in the substrate, and micro-groove marking lines. The substrate comprises a substrate handle and a substrate paddle. The edge of the substrate paddle is in close contact with the inner wall of the saccule intima, and the lower plane is in close contact with the otolith on the surface of the saccule maculae. The substrate handle passes through the outer shell of the saccule. The micro-groove marking lines are located on the surface or inside of the substrate. The micro-groove marking lines coincide with the micro-groove positions on the surface of the saccule maculae and have the same shape as those on the saccule maculae.

2. The balloon-plaque surface implantation electrode device according to claim 1, characterized in that: The inner electrode array and the outer electrode array each include at least one electrode extending from the substrate handle to the substrate beater. The inner electrode array and the outer electrode array are respectively located on the inner and outer sides of the micro-groove marking line. The inner core of each electrode end in the inner electrode array and the outer electrode array is a straight line and is perpendicular to the local curve at the corresponding position of the micro-groove marking line.

3. The balloon-plaque surface implantation electrode device according to claim 2, characterized in that: The electrode includes a main body section and a straight end. The main body section includes an electrode core, an insulating layer, a shielding layer and an insulating layer arranged in sequence from the inside to the outside. The straight end includes an electrode core. The main body section is arranged inside a substrate. The straight end is embedded in the surface of the substrate and is in direct contact with the surface of the balloon plaque.

4. The balloon-plaque surface implantation electrode device according to claim 2 or 3, characterized in that: The cross-sectional shape of the electrode inner core is circular, elliptical, oval or polygonal, with a cross-sectional size of 1µm to 100µm, and is made of gold, platinum alloy, titanium alloy or iridium oxide.

5. The balloon-plaque surface implantation electrode device according to claim 1, characterized in that: The substrate is in the shape of a table tennis racket and is made of a flexible non-toxic polymer material and is transparent or translucent.

6. The balloon-plaque surface implantation electrode device according to claim 1, characterized in that: The micro-grain marking line is a colored curve or a curve with a concave surface, and its shape is a semicircular structure that is the same as the micro-grain shape of the human body's saccule plaque, and its width is 10µm~500µm.

7. The signal transmission method of the balloon-plaque surface implantation electrode device according to any one of claims 1 to 6, characterized in that: The transmission signals of the outer electrode array and the inner electrode array are both sinusoidal currents with the same frequency and opposite phases. The electrodes in the same array output signals with the same frequency, phase, and amplitude, or different amplitudes.

8. The signal transmission method of the balloon plaque surface implantation electrode device according to any one of claims 1 to 6, characterized in that: The transmission signals of the outer electrode array and the inner electrode array are both square wave currents, with the same frequency and opposite phases. The output signals of the electrodes in the same array have the same frequency, phase, and amplitude, or they may be the same or different.

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