Visual cortex implanted electrode assembly and implantable visual information reconstruction system

Abstract

The invention discloses a visual cortex implanted electrode assembly and an implanted visual information reconstruction system, and the visual cortex implanted electrode assembly is characterized in that the visual cortex implanted electrode assembly comprises an electrode which comprises a chip and an electrode site, the chip and the electrode site are electrically connected through an electrical connecting line, the electrode site can generate a stimulation signal, and the stimulation signal is transmitted to the chip through the electrical connecting line; the chip is electrically connected with an implantation device outside the brain; one end of the supporting frame can be connected with and separated from the flexible catheter, the supporting frame at least comprises a first state and a second state, the supporting frame is shrunk when in the first state, the outer diameter of the shrunk supporting frame is smaller than the inner diameter of a target blood vessel, and the supporting frame is expanded when in the second state and is combined and locked with a target area. The supporting frame is delivered through the flexible catheter, the electrode is delivered to the effective action area of the visual cortex in a vascular intervention mode, stable arrangement of the electrode is achieved through the form change of the supporting frame, operation wounds are reduced, and the implantation precision of the electrode is improved.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of visual reconstruction, in particular to a visual cortex implant electrode assembly and an implantable visual information reconstruction system. BACKGROUND

[0002] The visual reconstruction technology aims to restore or improve the visual function of blind or visually impaired patients through different means. The current visual reconstruction technology usually adopts external electrical stimulation technology to provide stimulation to the cerebral cortex through scalp electrodes, or adopts implantable electrical stimulation technology to precisely act on the deep area of the visual cortex. However, the external electrical stimulation technology has limited intervention effect on the deep area of the visual cortex, and its long penetration path leads to poor stability of the treatment effect. In addition, the traditional electrode implantation process causes great trauma and has high surgical risk, and produces long recovery time and prolongs the treatment cycle.

[0003] Therefore, how to improve the action accuracy of the visual reconstruction system in the deep area of the visual cortex and reduce the surgical trauma and recovery time is a problem that needs to be solved by those skilled in the art. SUMMARY

[0004] Therefore, how to improve the action accuracy of the visual reconstruction system in the deep area of the visual cortex and reduce the surgical trauma and recovery time is a problem that needs to be solved by those skilled in the art.

[0005] To achieve the above-mentioned purpose, the present application provides the following technical solutions:

[0006] A visual cortex implant electrode assembly, comprising:

[0007] An electrode comprising a chip and an electrode site, the chip and the electrode site being electrically connected by an electrical connection line, the electrode site being capable of generating a stimulation signal, and the chip being electrically connected with an implant device outside the brain;

[0008] A support frame carrying the electrode, one end of the support frame being capable of being connected with and separated from a flexible catheter, the support frame comprising at least a first state and a second state, the support frame being contracted when in the first state, and the outer diameter of the support frame after contraction being smaller than the inner diameter of a target blood vessel, and the support frame being expanded and combined with and locked to a target region when in the second state.

[0009] Preferably, in the visual cortex implant electrode assembly, the target implantation region of the electrode is the inner wall of a blood vessel close to the visual cortex, and the outer diameter of the support frame when in the second state is not less than the inner diameter of the target blood vessel.

[0010] Preferably, in the visual cortex implant electrode assembly, the support frame is made of bioabsorbable material and gradually degrades after expanding in the blood vessel; the electrodes are electrostatically adsorbed to the inner wall cortex of the blood vessel.

[0011] Preferably, in the visual cortex implant electrode assembly, the material of the support frame is one or a combination of polylactic acid, polyglycolic acid, poly-lactic-co-glycolic acid, magnesium alloy and zinc alloy.

[0012] Preferably, in the visual cortex implant electrode assembly, the support frame is made of bio-inert material and permanently anchored to the inner wall of the blood vessel; the electrode array is attached to the surface of the support frame.

[0013] Preferably, in the visual cortex implant electrode assembly, the outer diameter of the expanded support frame is not less than 120% of the inner diameter of the target blood vessel.

[0014] Preferably, in the visual cortex implant electrode assembly, the material of the support frame is one or a combination of nickel-titanium alloy, zirconia ceramic and aluminum oxide.

[0015] Preferably, in the visual cortex implant electrode assembly, the support frame is a mesh structure and the surface is nano-porous treated.

[0016] Preferably, in the visual cortex implant electrode assembly, the support frame has a hexagonal or rhombic mesh shape, and the mesh porosity of the support frame is 30%-60%.

[0017] Preferably, in the visual cortex implant electrode assembly, the target implantation area of the electrode is the visual cortex area; the support frame further includes a third state, when the support frame is in the third state, it can single-point pierce the blood vessel cortex and drive the electrode to move to the outside of the blood vessel.

[0018] Preferably, in the visual cortex implant electrode assembly, the support frame is a shape memory wire, and the support frame is spirally unwound relative to the first state when it is in the third state.

[0019] Preferably, in the visual cortex implant electrode assembly, the support frame is coated with a micro-wire, and a plurality of groups of electrodes are arranged on the micro-wire at intervals and spirally attached to the visual cortex area.

[0020] Preferably, in the visual cortex implant electrode assembly, the blood vessel cortex pierced by the support frame is located at the junction of the transverse sinus and the sigmoid sinus, and the target implantation area of the electrode is the V1 area of the visual cortex.

[0021] Preferably, in the visual cortex implant electrode assembly, the chip establishes bidirectional communication with the implant device through wireless connection, or the chip is connected with the implant device through a connecting wire.

[0022] Preferably, in the visual cortex implant electrode assembly, the electrode further comprises a metal substrate and a flexible encapsulation layer, the chip and the electrode sites are located on the metal substrate, and opposite sides of the metal substrate are encapsulated by the flexible encapsulation layer.

[0023] Preferably, in the visual cortex implant electrode assembly, the electrode sites are uniformly arranged along both sides of the chip and comprise first electrode sites and second electrode sites, the first electrode sites are used for generating stimulation signals, and the second electrode sites are used for recording electrical signals.

[0024] Preferably, in the visual cortex implant electrode assembly, the electrode is implanted in the region of the internal occipital vein, and the stimulation region of the electrode covers the V1 region of the visual cortex.

[0025] Preferably, in the visual cortex implant electrode assembly, the electrode is implanted in the region of the arteria temporalis posterior, the stimulation region of the electrode covers the V1 region of the visual cortex, or the electrode is implanted in the region of the arteria temporalis posterior, the stimulation region of the electrode covers the V2 and V3 joint regions of the visual cortex.

[0026] An implantable visual information reconstruction system comprises the visual cortex implant electrode assembly according to any one of the above.

[0027] Preferably, in the implantable visual information reconstruction system, further comprising an image acquisition device, a first wireless communication device, and an implantable pulse generator, the implantable pulse generator is provided with a second wireless communication device; the image acquisition device is in communication connection with the first wireless communication device, the first wireless communication device is in communication connection with the implantable pulse generator through the second wireless communication device; and the implantable pulse generator is in electrical connection with the visual cortex implant electrode assembly.

[0028] Preferably, in the implantable visual information reconstruction system, further comprising a first coil in electrical connection with the image acquisition device, the implantable pulse generator is provided with a second coil, and the first coil and the second coil can realize mutual induction power supply in a target positional relationship to supply power to the implantable pulse generator and the visual cortex implant electrode assembly.

[0029] Preferably, in the implantable visual information reconstruction system, further comprising a host computer, a third wireless communication device, and an implantable pulse generator.

[0030] The implantable pulse generator is provided with a second wireless communication device, the upper computer is in communication connection with the third wireless communication device, and the third wireless communication device is in communication connection with the implantable pulse generator through the second wireless communication device; and the implantable pulse generator is in electrical connection with the visual cortex implant electrode assembly.

[0031] Preferably, in the above-mentioned implantable visual information reconstruction system, the implantable pulse generator is implanted and fixed at the pectoralis major muscle position of the human body.

[0032] From the above technical solution, one aspect of the present disclosure provides a visual cortex implant electrode assembly, which mainly comprises an electrode and a support frame, wherein the electrode comprises a chip and an electrode site electrically connected by an electrical connection line, the chip is electrically connected with an implanted device outside the brain to realize signal transmission, and the electrode site can generate a stimulation signal; the electrode stimulates the visual cortex through the electrode site when it is located in the effective action area of the visual cortex; the support frame is used to carry the electrode, and one end of the support frame can be connected with and separated from a flexible catheter; the support frame can be delivered to the target area through the flexible catheter; at the same time, the support frame at least includes a first state in a contracted form and a second state in an expanded form; when the support frame is in the first state, the outer diameter of the support frame after contraction is smaller than the inner diameter of the target blood vessel, and the target blood vessel is determined according to the implantation requirement; the flexible catheter can smoothly deliver the support frame in the first state in the blood vessel; and the support frame can be switched to the second state after being delivered to the target area to realize expansion and combination with the target area to be locked, so that the electrode remains fixed in the relative position in the body and can exert stable stimulation signals on the visual cortex. The above structure changes the form of the support frame, so that it can be intervened in the blood vessel through the flexible catheter, delivered from the blood vessel to the effective influence area of the visual cortex, and the form of the support frame is changed to enable the electrode to be stably anchored in the target area and perform electrical stimulation; unlike traditional electrode implantation, the implantation process of vascular intervention has a smaller surgical incision, which improves the recovery rate of the patient; at the same time, the vascular intervention method can enable the electrode to stimulate the visual cortex in the body, has higher stimulation precision compared with external electrical stimulation, and has more excellent stimulation effect. BRIEF DESCRIPTION OF DRAWINGS

[0033] In order to more clearly illustrate the technical solutions in the embodiments of the present application or the prior art, the following will briefly introduce the drawings needed to be used in the embodiments or prior art description. Obviously, the drawings in the following description are only some embodiments of the present application, and those skilled in the art can also obtain other drawings according to these drawings without creative labor.

[0034] Figure 1 The delivery structure schematic diagram of the support frame provided by an embodiment of the present application in the first state;

[0035] Figure 2 Structure diagram of the support frame in the second state according to an embodiment of the present application;

[0036] Figure 3 Structure diagram of the permanently anchored support frame according to an embodiment of the present application;

[0037] Figure 4 Structure diagram of the support frame after degradation in the blood vessel according to an embodiment of the present application;

[0038] Figure 5 Structure diagram of the electrode wire connection structure delivery process according to an embodiment of the present application;

[0039] Figure 6 Structure diagram of the electrode wire connection structure after fixation according to an embodiment of the present application;

[0040] Figure 7 Structure diagram of the support frame penetrating the blood vessel skin according to an embodiment of the present application;

[0041] Figure 8 Structure diagram of the electrode attached to the visual cortex according to an embodiment of the present application; Figure 7

[0042] Figure 9 Structure diagram of the metal substrate packaging according to an embodiment of the present application;

[0043] Figure 10 Structure diagram of the chip and electrode on the metal substrate according to an embodiment of the present application;

[0044] Figure 11 Structure diagram of the electrode combined with the support frame according to an embodiment of the present application;

[0045] Figure 12 Structure diagram of the electrode venous intervention according to an embodiment of the present application;

[0046] Figure 13 Structure diagram of the electrode arterial intervention according to an embodiment of the present application;

[0047] Figure 14 Structure diagram of the implantable visual information reconstruction system according to an embodiment of the present application;

[0048] Figure 15 Information transmission path diagram of the implantable visual information reconstruction system according to an embodiment of the present application.

[0049] Wherein:

[0050] ​10 - Electrode; 110 - Chip; 120 - Electrode site; 1210 - First electrode site; 1220 - Second electrode site; 130 - Electrical connection line; 140 - Connecting wire; 150 - Metal substrate; 160 - Flexible packaging layer;

[0051] 20-Support frame;

[0052] 30 - Miniature wire;

[0053] 40 - Internal jugular vein; 41 - Transverse sinus; 42 - Sigmoid sinus; 43 - Confluence of sinuses; 44 - Straight sinus; 45 - Internal occipital vein;

[0054] 50 - Internal carotid artery; 51 - Posterior communicating artery; 52 - Posterior cerebral artery; 53 - Calcarine artery; 54 - Occipitotemporal artery;

[0055] 60 - Flexible catheter; 61 - Vascular cortex;

[0056] 70-Image acquisition device; 71-First wireless communication device; 72-Implantable pulse generator; 73-Visual cortex implanted electrode assembly; 74-First coil; 75-Second coil; 76-Host computer. Detailed Implementation

[0057] The core of this application is to disclose a visual cortex implantable electrode assembly and an implantable visual information reconstruction system, so as to improve the accuracy of the visual reconstruction system in the deep region of the visual cortex and reduce surgical trauma and recovery time.

[0058] To enable those skilled in the art to better understand the present application, embodiments of the present application will be described below with reference to the accompanying drawings. Furthermore, the embodiments shown below do not limit the scope of the invention as described in the claims. Additionally, the complete contents of the structures represented in the following embodiments are not limited to those necessary for the solution of the invention described in the claims.

[0059] like Figure 1 and Figure 2 As shown, one aspect of this disclosure provides a visual cortical implantable electrode assembly, which mainly includes an electrode 10 and a support frame 20. The electrode 10 is supported by the support frame 20, and one end of the support frame 20 can be connected to and disconnected from a flexible catheter 60, so that the electrode 10 can be delivered intravascularly by the flexible catheter 60 with the help of the support frame 20. After delivery, the electrode 10 is implanted internally by disconnecting the support frame 20 from the flexible catheter 60.

[0060] Specifically, in the embodiments provided in this disclosure, the electrode 10 mainly includes a chip 110 and an electrode site 120. The chip 110 is electrically connected to an implanted device outside the brain to achieve signal transmission. This electrical connection can be achieved through wired or wireless means so that signal transmission can be achieved between the chip 110 and the implanted device.

[0061] The electrode site 120 is electrically connected to the chip 110 via an electrical connection line 130. Specifically, the electrode site 120 is able to conduct electricity with the chip 110 to provide power and perform signal transmission. Based on this, the electrode site 120 can generate stimulation signals. After the electrode 10 assembly provided in this embodiment is implanted in the target area, the electrode site 120 on the electrode 10 is in the effective action area. At this time, the electrode site 120 can apply electrical stimulation to the visual cortex for visual therapy or reconstruction.

[0062] Furthermore, the support frame 20 is used to support the electrode 10 so as to drive the electrode 10 to be set in the target area. Specifically, the support frame 20 can be connected and disconnected from the flexible conduit 60 at one end, and it also includes at least a first state and a second state.

[0063] Specifically, such as Figure 1 As shown, the support frame 20 is in a contracted state when it is in the first state, and the outer diameter of the support frame 20 after contraction is smaller than the inner diameter of the target blood vessel. It should be noted that the target blood vessel here specifically refers to the blood vessel into which the electrode 10 assembly provided in this embodiment needs to be implanted, as well as the blood vessel along the path between the electrode 10 assembly at the intervention incision site and the implanted blood vessel. The outer diameter of the support frame 20 in the first state is smaller than the inner diameter of the aforementioned blood vessel to ensure that the support frame 20 can smoothly drive the electrode 10 to the implantation area under the delivery action of the flexible catheter 60 without damaging the blood vessel structure of the path and the endpoint.

[0064] Furthermore, such as Figure 2 As shown, the support frame 20 is in an expanded state in the second state to achieve expansion and locking with the target area, thus keeping the electrode 10 in a fixed relative position within the body and enabling the application of a stable stimulation signal to the visual cortex. It should be noted that the switching between the first and second states of the support frame 20 can be achieved by the guide wire on the flexible conduit 60 actuating the mechanical locking structure on the support frame 20, or by triggering a shape change in the shape memory metal through body fluid temperature.

[0065] In the above embodiment, the support frame 20 maintains a first state to remain connected to the flexible catheter 60 and be able to move within the blood vessel, thereby moving the electrode 10 within the blood vessel. After the support frame 20 moves the electrode 10 into place, it disengages from the flexible catheter 60 and undergoes a shape change, switching from the first state to the second state, thereby achieving a stable setting of the electrode 10 at the target position.

[0066] The visual cortex implantable electrode assembly provided in this embodiment allows for vascular intervention via a flexible catheter 60 through morphological changes in the support frame 20. This enables delivery from the blood vessel to the effective area of ​​influence in the visual cortex. The morphological changes in the support frame 20 also allow the electrode 10 to be stably anchored in the target area for electrical stimulation. Unlike traditional electrode implantation methods, the vascular intervention implantation process results in a smaller surgical incision, reducing surgical trauma and improving patient recovery. Compared to external electrical stimulation, the vascular intervention method allows the electrode 10 to stimulate the visual cortex within the body, providing a closer stimulation distance and higher stimulation precision, resulting in a superior stimulation effect.

[0067] Furthermore, in some embodiments of this disclosure, the target implantation area of ​​the electrode 10 is the inner wall of a blood vessel near the visual cortex. During implantation, the electrode 10 only needs to be moved from within the blood vessel through an incision and fixed to the inner wall of the blood vessel near the visual cortex. This allows electrical stimulation to be applied to a relatively small area of ​​the visual cortex from within the blood vessel wall, reducing the number of punctures and lowering the difficulty of the surgical procedure. Based on this, to ensure that the electrode 10 can be successfully fixed to the inner wall of the blood vessel, the support frame 20, in its second state, has an outer diameter not smaller than the inner diameter of the target blood vessel, allowing it to abut against the blood vessel wall and maintain its position, thereby achieving the fixation and containment of the electrode 10.

[0068] Based on the above embodiments, in order to reduce the problem of long-term foreign body irritation caused by the implantation of electrode 10 components in blood vessels, such as... Figure 2 and Figure 4 As shown, in some embodiments, the support frame 20 is made of bioabsorbable material. After the support frame 20 expands inside the blood vessel, it adheres to the inner wall of the blood vessel and forms a mechanical anchoring structure. The electrode 10 contacts the inner wall of the blood vessel and forms a stable electrical coupling with the inner wall dermis of the blood vessel through electrostatic adsorption, thus fixing it to the inner wall of the blood vessel. At the same time, after the support frame 20 is fully expanded, it gradually degrades in the body, allowing the electrode 10 to independently adhere to the inner wall of the blood vessel and perform subsequent electrical stimulation treatment actions.

[0069] Further, in the visual cortex implant electrode assembly provided in the above embodiment, the support frame 20 is made of bioabsorbable material, which can be one or a combination of polylactic acid (PLA), polyglycolic acid (PGA), or poly-lactic-glycolic acid copolymer (PLGA) bioabsorbable polymer material, and can also be one or a combination of degradable metal materials such as magnesium alloy and zinc alloy, so as to gradually degrade in the blood vessel and reduce the risk of human body rejection caused by a large number of foreign bodies.

[0070] It should be noted that in some embodiments of the present disclosure, the electrode 10 can be entirely coated with a bioabsorbable coating to inhibit thrombosis in the early stage of implantation, improve the success rate of interventional surgery, and reduce the risk of intervention.

[0071] In other embodiments of the present disclosure, in order to improve the stability of the electrode 10 assembly implanted on the inner wall of the blood vessel, as shown in Figure 2 and Figure 3 , the support frame 20 is made of bioinert material, which abuts against the inner wall of the blood vessel on the inner side of the blood vessel after switching from the first state to the second state, thereby keeping the position of the electrode 10 assembly fixed. Since the support frame 20 is made of bioinert material, the support frame 20 can be permanently anchored and left in the inner wall of the blood vessel. Correspondingly, the electrode 10 is in an array structure attached to the surface of the support frame 20. The arrayed electrodes 10 can more uniformly and stably apply electric stimulation signals, and the surface attached to the support frame 20 can keep the position fixed by means of the permanently anchored support frame 20, thereby improving the accuracy of the position setting in the blood vessel.

[0072] On the basis of the above embodiment, the outer diameter of the expanded support frame 20 is not less than 120% of the inner diameter of the target blood vessel, so as to ensure that the support frame 20 can maintain sufficient support force with the inner wall of the blood vessel during the permanent anchoring process, thereby maintaining the stability of the position setting. Meanwhile, the material of the support frame 20 in the above embodiment is one or a combination of nickel-titanium alloy, zirconia ceramic, and aluminum oxide, so as to reduce the human body rejection reaction and have sufficient anchoring time.

[0073] For the support frame 20 that needs to be permanently anchored, in order to improve the anchoring rate and fixing strength of the support frame 20 and the inner wall of the blood vessel, in some embodiments, the surface of the support frame 20 is nano-porous treated, so as to promote the epidermal cells of the inner wall of the blood vessel to quickly cover and combine with the support frame 20 when the support frame 20 is in contact with the inner wall of the blood vessel in the second state.

[0074] It should be noted that in some embodiments, the support frame 20 is a mesh structure, and specifically, the mesh structure of the support frame 20 can be made by a hollow weaving or laser cutting process, and the support frame 20 has less deformation when expanded, and the connection area between the structures is small, thereby reducing the risk of structural damage during expansion, and the elastic deformation of the multiple unit meshes has a more uniform stress during the overall expansion process, avoiding excessive compression of the local blood vessel wall.

[0075] Further, for the mesh support frame 20, the mesh form can be hexagonal or diamond-shaped, so that the single mesh unit has a uniform circumferential expansion force, and the mesh porosity of the support frame 20 is 30%-60%, which can reduce the obstruction to blood flow while meeting the load bearing requirements of the support frame 20 for the electrode 10, so that the blood flow has a larger passage to reduce the risk of thrombosis, and provides a channel for endothelial cell migration, thereby improving the bonding rate of the inner wall of the blood vessel and the support frame 20.

[0076] Further, in some embodiments of the present disclosure, as shown in Figure 2 The support frame 20 is provided as a variable cross-section structure along its axial direction, and specifically, the diameter of the support frame 20 towards one end of the flexible catheter 60 is slightly smaller than the diameter of the distal end away from the flexible catheter 60, so as to form a gradual structure, and the smaller end has less resistance when combined with and separated from the flexible catheter 60, thereby avoiding excessive displacement of the support frame 20 when separated from the flexible catheter 60; and the larger area can be more easily in contact with the inner wall of the blood vessel when expanded. In addition, the edges of both ends of the support frame 20 along its axial direction are rounded or coated with a flexible polymer such as polydimethylsiloxane (PDMS), so as to reduce the risk of the support frame 20 piercing the blood vessel during self-expansion, thereby reducing the risk of thrombosis or bleeding.

[0077] The foregoing embodiments disclose the implantation of the electrode 10 assembly into the inner wall of the blood vessel, and the treatment method of applying electrical stimulation to the visual cortex in the effective area, and in order to further improve the accuracy of the electrical signal stimulation treatment, as shown in Figure 7 and Figure 8 In some embodiments of the present disclosure, the target implantation area of the electrode 10 is the visual cortex area, that is, the electrode 10 assembly reaches the visual cortex area by penetrating the blood vessel in the blood vessel after blood vessel intervention, and is directly implanted into the target area on the visual cortex to achieve direct electrical stimulation treatment. Correspondingly, as shown in Figure 7As shown, the support frame 20 further comprises a third state, and it is to be noted that the third state is an expanded state relative to the first state. The support frame 20 is kept in the first state and delivered via the flexible catheter 60 to carry the electrode 10 to the target blood vessel position. The support frame 20 is converted from the first state to the third state, and the linear single-point sustained expansion is unfolded. The single point pierces the blood vessel cortex 61 during the unfolding process and moves the electrode 10 to the outside of the blood vessel. On this basis, the support frame 20 is switched from the first state to the third state at the target blood vessel position close to the target implantation area, pierces the blood vessel cortex 61 and moves the electrode 10 to the outside of the blood vessel. The unfolded support frame 20 is directly attached to the visual cortex area, so that the electrode 10 can also directly contact the visual cortex area and directly stimulate the visual cortex area.

[0078] On the basis of the above embodiment, the support frame 20 is preferably made of a shape memory metal wire such as a nickel-titanium alloy wire. The preset shape of the support frame 20 in the third state is a spiral structure. After the support frame 20 reaches the target blood vessel position in the first state, it is converted to the third state and unfolded in the form of a spiral involute relative to the first state. The electrodes 10 arranged at intervals on the extension structure of the support frame 20 can be attached to the visual cortex in a spiral shape, thereby having a greater range of electrical stimulation on the visual cortex.

[0079] Further, for the spiral support frame 20, the outer periphery is covered with a micro wire 30 to realize the conduction of the electrode 10. The micro wire 30 can be an insulating gold wire made of polyimide (PI) material. The electrodes 10 are arranged at intervals to be attached to the visual cortex in a spiral shape. In this embodiment, the electrode 10 can be a ring-shaped electrode 10 made of platinum-iridium alloy, and the number of electrodes 10 on the support frame 20 can be increased or decreased according to actual surgical needs.

[0080] In a specific embodiment of the present disclosure, as shown in Figure 8 The target implantation area of the visual cortex implant electrode assembly is the V1 area of the visual cortex. Correspondingly, the target blood vessel that needs to be pierced by the support frame 20 is located at the junction of the transverse sinus 41 and the sigmoid sinus 42, so as to have a closer distance to the V1 area of the visual cortex. The support frame 20 can be smoothly attached to the V1 area of the visual cortex during the piercing and spiral unfolding process.

[0081] It should be noted that the V1 region of the visual cortex is the primary visual cortex, which is located on both sides of the calcarine sulcus in the medial surface of the occipital lobe, is the core area of the visual cortex with the most rear position, and is the first processing site after the visual signal is transmitted to the brain. It receives visual information transmitted from the lateral geniculate body (LGN), converts optical signals into neural electrical signals, and can preliminarily analyze the basic characteristics of vision, including light and dark contrast, edge contour, simple orientation (such as horizontal / vertical lines), and retinal corresponding "spatial topological mapping". The "signal source" of the subsequent V2, V3 and other advanced visual cortexes, if the function of the V1 region is damaged, it will directly lead to serious visual impairment, such as blindness or visual field defect.

[0082] Further, in the visual cortex implant electrode assembly provided by the embodiments of the present disclosure, the chip 110 in the electrode 10 needs to realize signal transmission with the implant device to receive the stimulation signal that needs to be released. It should be noted that in some embodiments, the chip 110 establishes bidirectional communication with the implant device through a wireless connection. The flexible catheter 60 is separated from the support frame 20 after completing the delivery of the support frame 20 and only releases the support frame 20 in the target area. In other embodiments, as shown in Figure 5 and Figure 6 , the chip 110 is connected with the implant device through the connecting wire 140. The connecting wire 140 is arranged through the flexible catheter 60 and passes through the support frame 20 to connect with the chip 110 to realize signal transmission. Correspondingly, after releasing the support frame 20, the flexible catheter 60 leaves the biocompatible connecting wire 140 during the process of moving out of the blood vessel, so as to maintain the communication connection between the support frame 20, the electrode 10 and the distal implant device.

[0083] Further, in the visual cortex implant electrode assembly provided by the embodiments of the present disclosure, as shown in Figure 9 , Figure 10 and Figure 11 , the electrode 10 further comprises a metal substrate 150 and a flexible encapsulation layer 160. Specifically, the chip 110 and the electrode site 120 are fixed or etched on the metal substrate 150 to maintain stable shape, and the opposite sides of the metal substrate 150 are encapsulated by the flexible encapsulation layer 160, which is generally made of flexible materials such as polydimethylsiloxane (PDMS) or polyimide (PI). The encapsulated electrode 10 can reduce the damage risk of the chip 110 and the electrode site 120, and can maintain stable adhesion with the support frame 20.

[0084] In addition, in some embodiments of the present disclosure, the electrode sites 120 are evenly arranged along both sides of the chip 110 and include first electrode sites 1210 and second electrode sites 1220, it should be noted that the size of the first electrode sites 1210 is larger than that of the second electrode sites 1220, and the first electrode sites 1210 are used to generate stimulation signals, while the second electrode sites 1220 are used to record electrical signals, and the chip 110 is electrically connected with the first electrode sites 1210 and the second electrode sites 1220 at the same time to control the output of the stimulation signals of the first electrode sites 1210 and the transmission of the recorded information of the second electrode sites 1220.

[0085] Further, in the visual cortex implant electrode assembly provided in the embodiments of the present disclosure, the implantation of the electrode 10 assembly can be through venous vascular intervention or arterial vascular intervention. As shown in Figure 12 In some embodiments, the electrode 10 is implanted in the region of the internal occipital vein 45, and the stimulation region of the electrode 10 covers the V1 region of the visual cortex. Specifically, the intervention path of the electrode assembly driven by the flexible catheter 60 can pass through the internal jugular vein 40, the sigmoid sinus 42, the transverse sinus 41, the torcular herophili 43, the straight sinus 44 in sequence, and then reach the internal occipital vein 45, and the electrode 10 stimulation covering the V1 region of the visual cortex is applied in the internal occipital vein 45.

[0086] It should be noted that the process of venous intervention has higher surgical safety and lower operation difficulty. Because the lumen of the venous system, especially the dural sinuses such as the sigmoid sinus 42 and the transverse sinus 41, is thick, the blood flow speed is slow, and the intravascular pressure is low, the resistance of the support frame 20 during delivery through the flexible catheter 60 is small, and the risk of deviation is small. At the same time, the required force for fixing the support frame 20 to the intravascular wall is small, which reduces the fixing difficulty of the support frame 20, and is suitable for the structure of the electrode 10 for long-term implantation.

[0087] And as shown in Figure 13 In some other embodiments of the present disclosure, the electrode 10 is implanted in the region of the distal artery 53 or the occipital temporal artery 54 through the artery. Specifically, the electrode 10 can be intervened through the internal carotid artery 50, pass through the posterior communicating artery 51, the posterior cerebral artery 52 in sequence, and then reach the distal artery 53 through the branch, at this time the stimulation region of the electrode 10 can cover the V1 region of the visual cortex; Similarly, the electrode 10 can also be intervened through the internal carotid artery 50, pass through the posterior communicating artery 51, the posterior cerebral artery 52 in sequence, and then reach the occipital temporal artery 54 through the branch, at this time the stimulation region of the electrode 10 can cover the V2 and V3 joint regions of the visual cortex.

[0088] It should be noted that the process of arterial intervention can enable the implantation of the electrode 10 to cover a wider functional area, and cooperate to achieve personalized treatment, which can not only stimulate and treat individual areas of the visual cortex, but also treat patients with V1 and V2 / V3 joint area disorders, such as improving the basic visual field, restoring object shape recognition, motion trajectory judgment and other functions, and achieving more comprehensive treatment needs; at the same time, due to the close relationship of the arterial blood vessels, the stimulation efficiency of the electrode 10 is high, the electrical stimulation signal can directly reach the brain tissue through the blood vessel wall and act on the cortex through the direct conduction path, the signal attenuation rate is lower than that of venous intervention, and the activation efficiency of the deep visual cortex is higher.

[0089] It should be further noted that in the visual cortex, the V2 area is the secondary visual cortex, which is distributed around the V1 area, located in the medial and lateral surfaces of the occipital lobe, and has a band structure wrapping the V1 area. It is an intermediate hub for the transmission of visual signals from the V1 area to the higher cortex. It further integrates visual features based on the preliminary processing in the V1 area, realizes signal advanced analysis, and integrates signals to form more complex visual elements such as texture, color contrast, and simple shape. The integrated signals of the V2 area are transmitted in two ways, one to the V3 area to strengthen spatial information processing, and the other to the temporal lobe (responsible for object recognition) or parietal lobe (responsible for spatial positioning) to lay the foundation for advanced visual functions. Patients with impaired V2 area function may have difficulty distinguishing different textures or color combinations, leading to feature recognition disorders.

[0090] The V3 area is the tertiary visual cortex, which is located outside the V2 area and further extends to the junction of the parietal lobe and the temporal lobe. It is divided into a dorsal V3 area near the parietal lobe, which focuses on spatial information, and a ventral V3 area near the temporal lobe, which focuses on object features. The overall structure is a semi-circular ring surrounding the V2 area, which is an important area for the fusion of visual signal space and features. It can further integrate signals transmitted by the V2 area and strengthen visual information. Patients with impaired V3 area function may have motion perception disorders, such as difficulty judging the speed of object motion, or spatial positioning disorders, such as difficulty accurately judging the distance between objects and themselves.

[0091] As shown in Figure 14 and Figure 15 Another aspect of the embodiments of the present disclosure also discloses an implantable visual information reconstruction system, which comprises the visual cortex implant electrode assembly 73 provided by any of the above embodiments as the release end of the electrical stimulation signal. It should be noted that since the visual cortex implant electrode assembly 73 has the technical effects provided by any of the above embodiments, the implantable visual information reconstruction system also has the technical effects provided by any of the above embodiments, which will not be described here.

[0092] Further, in some embodiments of the present disclosure, the implantable visual information reconstruction system further comprises an image acquisition device 70, a first wireless communication device 71 and an implantable pulse generator 72, wherein the image acquisition device 70 can be a camera, or an augmented reality glasses (AR glasses) integrated with a camera, so as to be able to acquire external image information.

[0093] The image acquisition device 70 is in communication connection with the first wireless communication device 71, which can be achieved by wireless transmission or wire connection, and the first wireless communication device 71 contains an image processing module and a neural coding converter, so as to be able to convert the original image information into a stimulation parameter matrix conforming to the visual cortex spatial mapping after receiving the image information of the image acquisition device 70, and to be able to process the collected electrophysiological signals.

[0094] Correspondingly, the implantable pulse generator 72 is an in-vivo implanted device, and the implantable pulse generator 72 is provided with a second wireless communication device, and the first wireless communication device 71 is in communication connection with the implantable pulse generator 72 through the second wireless communication device, so as to be able to realize signal transmission, and it should be noted that the implantable pulse generator 72 is electrically connected with the visual cortex implanted electrode assembly 73; through the connection of the first wireless communication device 71 through the second wireless communication device, the implantable pulse generator 72 can receive the stimulation parameters conforming to the visual cortex spatial mapping, and transmit them to the visual cortex implanted electrode assembly 73, so as to adjust the visual cortex implanted electrode assembly 73 to execute the corresponding stimulation signals; at the same time, the feedback signals recorded by the visual cortex implanted electrode assembly 73 can be fed back to the first wireless communication device 71 through the second wireless communication device, so as to be processed and fed back to the operator.

[0095] On the basis of the above-mentioned embodiments, the implantable visual information reconstruction system can realize power supply for the implantable pulse generator 72 implanted in the body through wired or wireless mode, in order to avoid the risk of accidental pulling of the wire passing through the human body, in some embodiments, the implantable visual information reconstruction system further comprises a first coil 74 electrically connected with the image acquisition device 70, and the implantable pulse generator 72 is provided with a second coil 75, and it should be noted that the first coil 74 and the second coil 75 can realize mutual inductive power supply under the target position relationship, wherein the target position relationship can be set as close to a certain distance and maintain parallel state, and the first coil 74 and the second coil 75 realize mutual inductive power supply, and the first coil 74 electrically connected with the image acquisition device 70 can receive external power supply and realize mutual inductive power supply for the second coil 75 to supply power for the implantable pulse generator 72 and the visual cortex implanted electrode assembly 73, thereby meeting the smooth operation of the implantable pulse generator 72 and the visual cortex implanted electrode assembly 73 in the body.

[0096] In some embodiments of the present disclosure, the implantable visual information reconstruction system further comprises a host computer 76, a third wireless communication device, and an implantable pulse generator 72, specifically, the second wireless communication device is arranged in the implantable pulse generator 72, and the host computer 76 is in communication connection with the third wireless communication device, the third wireless communication device is in communication connection with the implantable pulse generator 72 through the second wireless communication device, the host computer 76 can realize signal transmission through the third wireless communication device and the second wireless communication device, thereby realizing signal transmission to the implantable pulse generator 72. At the same time, the implantable pulse generator 72 is in electrical connection with the visual cortex implanted electrode assembly 73, and the host computer 76 can accurately adjust the electrical stimulation parameters such as current, frequency, intensity and phase through automatic or manual control, and transmit them to the second wireless communication device through the third wireless communication device, thereby realizing signal transmission to the implantable pulse generator 72 and transmitting them to the visual cortex implanted electrode assembly 73 to adjust the visual cortex implanted electrode assembly 73 to execute the corresponding stimulation signals.

[0097] It should be further pointed out that, on the basis of the above-mentioned embodiments, the host computer 76 can run visual reconstruction control software and has at least two mode control interfaces, specifically, a parameter configuration mode, which can edit and generate electrode 10 stimulation timing logic and specific parameters, and a monitoring mode, which can display real-time cortical electrophysiological signal spectrum graph to feedback the operator for real-time monitoring.

[0098] It should be pointed out that the first wireless communication device 71, the second wireless communication device and the third wireless communication device can realize communication through Bluetooth, wireless sensor and the like.

[0099] In addition, in some embodiments, for the implantable visual information reconstruction system provided with the image acquisition device 70, the first wireless communication device 71 and the host computer 76 at the same time, the implantable pulse generator 72 can receive two-way instruction input of the first wireless communication device 71 and the host computer 76 at the same time, at this time, the implantable pulse generator 72 executes the signal indication of the host computer 76 with higher priority.

[0100] Further, in the implantable visual information reconstruction system provided by the embodiments of the present disclosure, the implantable pulse generator 72 is implanted and fixed at the pectoralis major muscle position of the human body, instead of the structure of the prior art in which the coil is arranged near the skull, so as to reduce the invasiveness of the intervention surgery, and has the minimally invasive feature, thereby reducing the surgical trauma and risk. It should be noted that the pectoralis major muscle belongs to the superficial muscle region of the trunk, and only a small incision needs to be made on the chest wall during the surgery, without the need to touch the skull or intracranial tissue, so that the coil fixing can be completed, and the trauma is far less than that of the surgery near the skull. In addition, the blood vessel and nerve distribution in the pectoralis major muscle region is more dispersed than that in the head, and the risk of bleeding and nerve damage during the surgery is lower, and after the coil is fixed, there is no obvious appearance influence, and the patient has a more free range of motion, thereby improving the smoothness of the recovery process.

[0101] The terms "first", "second", "left", "right", and the like as used in the description and the claims of the present application and the above drawings mean for the purpose of distinguishing different objects, and are not intended to signify a particular order or sequence. Also, the terms "comprises", "comprising", "includes", "including" and the like are intended to cover a non-exclusive inclusion, such that a process, method, system, product or apparatus that comprises, has, includes or includes elements that do not recite the excluding elements are still within the scope of the present application.

[0102] The above description of disclosed embodiments allows a person skilled in the art to implement or use the present application. Various modifications to these embodiments will be apparent to those skilled in the art, and the general principles defined herein can be implemented in other embodiments without departing from the spirit or scope of the present application. Therefore, the present application will not be limited to the embodiments shown herein, but will conform to the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. A visual cortex implantable electrode assembly, characterized in that, include: An electrode includes a chip and an electrode site, the chip and the electrode site being electrically connected via an electrical connection line, the electrode site being capable of generating a stimulation signal, and the chip being electrically connected to an implantable device outside the brain. A support frame that carries the electrode, one end of which can be connected to and detached from a flexible catheter, the support frame having at least a first state and a second state, wherein the support frame is contracted in the first state and its outer diameter after contraction is smaller than the inner diameter of the target blood vessel, and the support frame is expanded and locked to the target area in the second state.

2. The visual cortex implanted electrode assembly as described in claim 1, characterized in that, The target implantation area of ​​the electrode is the inner wall of a blood vessel near the visual cortex, and the outer diameter of the support frame in the second state is not less than the inner diameter of the target blood vessel.

3. The visual cortex implanted electrode assembly as described in claim 2, characterized in that, The support frame is made of bioabsorbable material and gradually degrades after expanding inside the blood vessel; the electrode is electrostatically adsorbed onto the endothelial layer of the blood vessel wall.

4. The visual cortex implanted electrode assembly as described in claim 3, characterized in that, The support frame is made of one or a combination of polylactic acid, polyglycolic acid, polylactic acid-glycolic acid copolymer, magnesium alloy, and zinc alloy.

5. The visual cortex implanted electrode assembly as described in claim 2, characterized in that, The support frame is made of a bio-inert material and is permanently anchored to the inner wall of the blood vessel; the electrodes are attached in an array to the surface of the support frame.

6. The visual cortex implanted electrode assembly as described in claim 5, characterized in that, The outer diameter of the expanded support frame is not less than 120% of the inner diameter of the target blood vessel.

7. The visual cortex implanted electrode assembly as described in claim 5, characterized in that, The support frame is made of one or a combination of nickel-titanium alloy, zirconium oxide ceramic, and aluminum oxide.

8. The visual cortex implanted electrode assembly as described in claim 5, characterized in that, The support frame has a mesh structure and its surface is treated with nanoporous coating.

9. The visual cortex implanted electrode assembly as described in claim 8, characterized in that, The support frame has a hexagonal or rhomboid mesh shape, and the mesh porosity of the support frame is 30%-60%.

10. The visual cortex implanted electrode assembly as described in claim 1, characterized in that, The target implantation area of ​​the electrode is the visual cortex region; the support frame also includes a third state, in which the support frame can puncture the vascular cortex at a single point and move the electrode to the outside of the blood vessel.

11. The visual cortex implanted electrode assembly as described in claim 10, characterized in that, The support frame is a shape memory metal wire, and when the support frame is in the third state, it spirals out relative to the first state.

12. The visual cortex implanted electrode assembly as described in claim 11, characterized in that, The support frame is covered with micro-wires, and multiple sets of electrodes are arranged at intervals on the micro-wires and spirally attached to the visual cortex region.

13. The visual cortex implanted electrode assembly as described in claim 10, characterized in that, The vascular cortex punctured by the support frame is located at the junction of the transverse sinus and the sigmoid sinus, and the target implantation area of ​​the electrode is located in the V1 zone of the visual cortex.

14. The visual cortex implanted electrode assembly as described in claim 1, characterized in that, The chip establishes bidirectional communication with the implanted device via a wireless connection, or the chip is connected to the implanted device via a connecting wire.

15. The visual cortex implanted electrode assembly as described in claim 1, characterized in that, The electrode also includes a metal substrate and a flexible encapsulation layer. The chip and electrode sites are located on the metal substrate, and the opposite sides of the metal substrate are encapsulated by the flexible encapsulation layer.

16. The visual cortex implanted electrode assembly as described in claim 1, characterized in that, The electrode sites are evenly arranged along both sides of the chip and include a first electrode site and a second electrode site. The first electrode site is used to generate a stimulation signal, and the second electrode site is used to record an electrical signal.

17. The visual cortex implanted electrode assembly as claimed in claim 1, characterized in that, The electrode is implanted in the occipital vein region, and the stimulation area of ​​the electrode covers the V1 area of ​​the visual cortex.

18. The visual cortex implanted electrode assembly as described in claim 1, characterized in that, The electrode is implanted in the calcarine artery region, and the stimulation area of ​​the electrode covers the V1 area of ​​the visual cortex; or, the electrode is implanted in the occipitotemporal artery region, and the stimulation area of ​​the electrode covers the V2 and V3 junction area of ​​the visual cortex.

19. An implantable visual information reconstruction system, characterized in that, Includes the visual cortex implanted electrode assembly as described in any one of claims 1-18.

20. The implantable visual information reconstruction system as described in claim 19, characterized in that, It also includes an image acquisition device, a first wireless communication device, and an implantable pulse generator, wherein the implantable pulse generator is provided with a second wireless communication device; the image acquisition device is communicatively connected to the first wireless communication device, and the first wireless communication device is communicatively connected to the implantable pulse generator through the second wireless communication device; the implantable pulse generator is electrically connected to the visual cortex implanted electrode assembly.

21. The implantable visual information reconstruction system as described in claim 20, characterized in that, It also includes a first coil electrically connected to the image acquisition device, and a second coil is provided in the implantable pulse generator. The first coil and the second coil can achieve mutual inductance power supply under the target position relationship, so as to power the implantable pulse generator and the visual cortex implanted electrode assembly.

22. The implantable visual information reconstruction system as described in claim 19, characterized in that, It also includes a host computer, a third wireless communication device, and an implantable pulse generator; The implantable pulse generator is equipped with a second wireless communication device. The host computer is communicatively connected to the third wireless communication device, and the third wireless communication device is communicatively connected to the implantable pulse generator through the second wireless communication device. The implantable pulse generator is electrically connected to the visual cortex implanted electrode assembly.

23. The implantable visual information reconstruction system as described in claim 20, characterized in that, The implantable pulse generator is implanted and fixed in the pectoralis major muscle of the human body.

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