Functional device, guiding catheter, biological interface system, and method for placing functional device

Abstract

Provided is a functional device that enables at least one among measuring the activity of tissue of a living body with high resolution and applying fine stimulation to tissue of a living body, while being minimally invasive. This functional device 1 is indwelled inside a blood vessel of a living body and performs at least one among measurement of the activity of tissue outside the blood vessel and stimulation to the tissue. The functional device 1 comprises: a sheet-like flexible substrate 3; at least one functional part formed on the substrate 3; and a wiring 12 formed on the substrate 3 and connected to the functional part, wherein at least one among at least a portion of the surface of the substrate 3 and at least a portion of the surface of the functional part is covered with an antithrombotic material.

Description

[Technical Field]

[0001] The present invention relates to a functional device for measuring biological signals such as electroencephalograms, and a functional device for applying stimulation to blood vessels in a living body such as cerebral veins. [Background technology]

[0002] One technique for measuring the activity of biological tissues is to place electrodes inside blood vessels. Patent Document 1 describes a technique in which an intravascular device with a core made of ultra-fine stainless steel wire is used as the electrode. [Prior art documents] [Patent documents]

[0003] [Patent Document 1] Japanese Patent Publication No. 2022-121975 Summary of the Invention [Problem to be solved by the invention]

[0004] Conventional techniques use metal wire as the core material of the electrode, which is highly invasive to the body because it places a steel material inside the blood vessel.

[0005] To minimize invasiveness, it is possible to place electrodes on the outside of the skull. However, when electrodes are placed on the outside of the skull, the distance from the area generating biological signals increases, making it difficult to measure the activity of biological tissues with high resolution.

[0006] As described above, with conventional techniques, it is difficult to simultaneously achieve low invasiveness to the living body and high-resolution measurement of the activity of living tissue.

[0007] Furthermore, with conventional techniques, it is difficult to apply precise stimulation to tissues of a living body while reducing invasiveness to the living body.

[0008] The present invention aims to provide a functional device that is minimally invasive and yet enables at least one of measuring the activity of biological tissue with high resolution and applying precise stimuli to biological tissue. [Means for solving the problem]

[0009] The functional device of the present invention is a functional device that is placed inside a blood vessel of a living body and is used to measure the activity of tissue outside the blood vessel and / or stimulate the tissue, and includes a sheet-like, flexible substrate, one or more functional units formed on the substrate, and wiring formed on the substrate and connected to the functional units, and at least one of at least a portion of the surface of the substrate and at least a portion of the surface of the functional units is covered with an antithrombotic material. [Effects of the Invention]

[0010] According to the present invention, it is possible to provide a functional device that is minimally invasive and yet enables at least one of measuring the activity of biological tissue with high resolution and applying precise stimuli to biological tissue. [Brief explanation of the drawings]

[0011] [Figure 1A] FIG. 1 is a diagram illustrating a functional device of the present invention. [Figure 1B] 1A and 1B are diagrams showing the form of the functional device of the present invention when placed inside a blood vessel. [Figure 1C] FIG. 10 is a diagram illustrating a part of another example of a functional device. [Figure 2A] FIG. 1 is a diagram illustrating an overview of the brain. [Figure 2B] FIG. 2B is an enlarged view of a portion of FIG. 2A. [Figure 3A] FIG. 2 illustrates an example of a functional device. [Figure 3B] FIG. 3B is an enlarged view of a portion of FIG. 3A. [Figure 3C] FIG. 3B is an enlarged view of a portion of FIG. 3A. [Figure 4A]FIG. 2 is a cross-sectional view of a functional device. [Figure 4B] FIG. 10 is a cross-sectional view of a functional device having another configuration. [Figure 5] FIG. 1 illustrates a transport device. [Figure 6A] FIG. 1 is a diagram showing a state in which a guiding catheter is inserted into a body from outside the body. [Figure 6B] FIG. 1 shows a guiding catheter and a guidewire inside a blood vessel. [Figure 6C] FIG. 1 illustrates a functional device inside a blood vessel. [Figure 7A] FIG. 1 is a diagram showing a portion of a biological interface system. [Figure 7B] FIG. 1 is a diagram showing a portion of a biological interface system. [Figure 7C] FIG. 1 is a diagram showing the entire biological interface system. [Figure 8] FIG. 1 is a block diagram showing a circuit arrangement in a biological interface system. [Figure 9A] FIG. 10 is a diagram showing a modified example of the functional device of the present invention. [Figure 9B] FIG. 9B is a diagram showing the form of the functional device shown in FIG. 9A when placed inside a blood vessel. DETAILED DESCRIPTION OF THE INVENTION

[0012] Before describing the configuration of the functional device of the present invention, the significance of the present invention will be explained. In the following description, an example will be taken of a case where the tissue measured by the functional device is tissue surrounding a superficial cerebral vein. However, the biological tissue to be measured is not limited to these tissues. It may also be cerebral blood vessels other than superficial cerebral veins (for example, cerebral venous sinus, deep cerebral vein, cerebral artery, etc.) or their surrounding tissues, or tissues other than blood vessels (subdural space, cerebrospinal cavity, ventricle, cerebral aqueduct, cistern, internal organ, etc.).

[0013] Technologies that involve brain measurement include non-invasive BMI (Brain Machine Interface) and invasive BMI.

[0014] Non-invasive BMI uses wearable devices. Examples of wearable devices include headgear-type devices and devices attached to the scalp. Non-invasive BMI does not require craniotomy. Therefore, non-invasive BMI can be easily applied to subjects.

[0015] The electrical activity of the brain is known as electroencephalography (EEG). In addition to its use in the medical field, EEG is also becoming more commonly used in non-medical fields. Technology that uses EEG in non-medical fields is called BrainTech.

[0016] Non-invasive BMI is characterized by its ease of use. However, it is difficult to investigate advanced brain activity in detail using non-invasive BMI. This is because the spatial and temporal resolution of non-invasive BMI is insufficient. This is due to the increased distance from the biosignal generator and the high electrical resistance of the skull. The skull acts as a shield when measuring EEG.

[0017] As such, non-invasive BMI has the problem of low measurement accuracy when performing advanced measurements of brain activity.

[0018] Invasive BMI involves the use of implantable devices, which are placed inside the skull, enabling high-resolution and highly accurate measurements.

[0019] Invasive BMI allows communication with patients with amyotrophic lateral sclerosis (ALS). Invasive BMI also allows patients with amyotrophic lateral sclerosis (ALS) to operate prosthetic limbs with advanced capabilities.

[0020] On the other hand, invasive BMI involves placing an implant-type device under the dura mater inside the skull. Therefore, invasive BMI requires craniotomy. Invasive BMI imposes a heavy mental and physical burden on the subject. Due to the heavy burden on the subject, the use of invasive BMI is extremely limited.

[0021] As described above, in existing BMI technology, there is a trade-off between the minimally invasive nature of measuring EEG signals through the skull and highly accurate measurement with high temporal and spatial resolution. The present invention simultaneously achieves both of these contradictory characteristics. In other words, the present invention makes it possible to achieve high measurement accuracy with minimal invasiveness.

[0022] The functional device of the present invention is flexible and has an extremely small diameter. The functional device is softer than blood vessels and is thin enough to be placed inside blood vessels. This makes it possible to access the brain via the blood vessels that run throughout the body. As a result, the functional device does not require craniotomy to place the functional device in the brain. Because the functional device of the present invention does not require craniotomy, it can be said to be an extremely minimally invasive functional device.

[0023] The greatest risk in placing an artificial object inside a blood vessel, and in accessing the brain from inside the blood vessel and placing it at a specific location, is vascular occlusion due to a blood clot. The risk of vascular occlusion is particularly high in arterial blood vessels, because the downstream side of arterial blood vessels is narrow, making it easy for a blood clot to clog the blood vessel.

[0024] One possible method for reducing the risk of cerebral infarction due to vascular occlusion is to place functional devices in cerebral veins. This is because veins are located downstream of brain tissue, so the risk of cerebral infarction or vascular occlusion due to blood clot dispersal is low. However, compared to arteries, venous walls are very thin and highly tortuous, so there are almost no medical devices placed in cerebral veins or endovascular treatments using them.

[0025] As a device for performing brain measurements, the functional device of the present invention enables placement of the functional device in the cerebral surface venous blood vessels. Here, the following two points are essential to access the brain and place the functional device in the cerebral surface venous blood vessels without damaging the cerebral surface venous blood vessels.

[0026] One is a very thin delivery device that enables the delivery of functional devices within the superficial cerebral venous blood vessels. The present invention realizes this delivery device using a guidewire and a guiding catheter.

[0027] The other is a flexible, extremely thin functional device that can be placed in the superficial cerebral venous blood vessels. The present invention realizes this extremely thin functional device. The following will explain each in turn.

[0028] An embodiment of a functional device 1 of the present invention will be described with reference to Fig. 1A to Fig. 4. Fig. 1A is a diagram showing the functional device 1 of the present invention. Fig. 1B is a diagram showing the form of the functional device 1 when it is placed inside a blood vessel.

[0029] As shown in FIG. 1A, the functional device 1 has a long, narrow rectangular shape when viewed from above. The short side of the rectangle is 0.1 mm or more and 100 mm or less, and the long side of the rectangle is 1 mm or more and 2000 mm or less. The ratio of the long side to the short side of the rectangle is preferably 2 or more and 2000 or less. As will be described later, the functional device 1 is arranged in a blood vessel while being curled up in a helical shape. When the ratio of the long side to the short side of the rectangle is 2 or more and 2000 or less, the functional device 1 is likely to function over a wide area in the blood vessel when arranged in a helical shape. The functional device 1 includes a substrate 3 and a functional unit formed on the substrate 3. The substrate 3 will be described later with reference to FIG. 4.

[0030] The functional unit has the function of at least one of a sensor unit and a stimulation unit. The functional device 1 may include multiple types of functional units. In the following description, the functional unit is an electrode 14 serving as a sensor unit. The electrode 14 functions as a sensor that senses potential fluctuations in a living body.

[0031] A plurality of electrodes 14 are formed on the substrate 3. The plurality of electrodes 14 can be arranged regularly, such as in a matrix. Connection lines 60 are connected to the electrodes 14. The connection lines 60 are not shown in FIG. 1A but are shown in FIG. 2B.

[0032] The functional device 1 is a sheet-like, flexible component. Therefore, the functional device 1 can be rolled up into a helical shape, as shown in FIG. 1B. The functional device 1 can have a spiral electrode. In the helically rolled state, the electrode 14 is located on the outer surface of the substrate 3.

[0033] The functional device 1 is placed in a blood vessel in a helically rolled state. FIG. 2A is a diagram showing an overview of a brain 80. FIG. 2B is an enlarged view of a circled area 90 in FIG. 2A. As shown in FIG. 2A, there are multiple blood vessels 82 on the surface of the brain 80. The blood vessels 82 include venous sinuses 84 and superficial venous vessels 86. The venous sinuses 84 are hard veins that run between the dura mater. The superficial venous vessels 86 are soft veins that branch off from the venous sinuses 84.

[0034] As shown in Figure 2B, the functional device 1 is placed in a blood vessel in a helical rolled state. The functional device 1 is placed in a thin and soft cerebral surface venous vessel 86. The functional device 1 is thin and flexible. Therefore, the functional device 1 can be placed in a thin and soft blood vessel such as the cerebral surface venous vessel 86.

[0035] FIG. 3A is a diagram showing an example of a functional device 1. As shown in FIG. 3A, the functional device 1 includes a substrate 3 and a conductive material arrangement portion 10 formed on at least one surface of the substrate 3. The substrate 3 is a portion of the functional device 1 that functions as a support. The conductive material arrangement portion 10 is a portion where conductive materials, such as electrodes, wiring, and circuits, are arranged to perform electrical functions. FIG. 3A shows a portion of the substrate 3 where wiring is formed. FIG. 3A shows the wiring portion when wiring is drawn out from each of multiple electrodes arranged on the substrate 3.

[0036] The thickness of the substrate 3 can be 0.5 μm or more and 50 μm or less, and the Young's modulus (the proportional constant of strain-stress calculated from tension, compression, etc., or the stress at 100% strain) of the functional device 1 can be 100 MPa or less.

[0037] The rigidity of the substrate 3 is determined by the thickness and Young's modulus of the substrate 3 described above. The degree of self-expansion of the functional device 1 inside the blood vessel 82 is affected by the rigidity of the substrate 3. The degree of self-expansion of the functional device 1 is also affected by the thickness of the substrate 3. A preferred range of thickness for the substrate 3 is, for example, 0.5 μm or more and 50 μm or less. Self-expansion refers to the functional device 1 expanding due to its own force of expansion when it is discharged into the blood vessel 82.

[0038] 3B is an enlarged view of the rectangular box 92 in FIG. 3A. As shown in FIG. 3B, a plurality of fine wirings 12 are formed on the substrate 3. For example, when the functional device 1 is configured to be capable of detecting signals in 64 channels, the line width of the wirings 12 can be set to 300 μm or the like. Furthermore, depending on the size of the functional device 1 or the circuit configuration, the line width of the wirings 12 can be set to 10 μm or less.

[0039] 3C is a diagram showing the state of the functional device 1 when the functional device 1 shown in FIG. 3A is stretched in the direction of arrow 96 in FIG. 3A. As shown in FIG. 3C, a conductive material such as wiring 12 formed on the substrate 3 can follow the expansion and contraction of the substrate 3. In other words, when the conductive material is an electrode, it can be made into an electrode that similarly follows the expansion and contraction.

[0040] The layer structure of the functional device 1 will be described with reference to Figures 4A and 4B. Both Figures 4A and 4B are cross-sectional views of the functional device 1. The layer structure of the functional device 1 shown in Figure 4A and the layer structure of the functional device 1 shown in Figure 4B differ in the layer on which the electrodes 14 are arranged. However, Figures 4A and 4B are merely examples of the layer structure of the functional device 1, and the functional device 1 can employ various other layer structures.

[0041] The functional device 1 as a whole has flexibility, such as extensibility and stretchability. Therefore, the functional device 1 can be rolled up to a small diameter. This allows the functional device 1 to be placed in a small blood vessel.

[0042] As shown in FIGS. 4A and 4B, the functional device 1 includes a flexible substrate 3, wiring 12, electrodes 14, an insulating member 5, and a cover member 7. The functional device 1 is generally in the form of a flat sheet. In particular, the layer structure shown in FIG. 4A has a high degree of surface flatness. However, even with the layer structure shown in FIG. 4B, the surface is generally flat. This is because the electrodes 14 are thin.

[0043] In the functional device 1, the difference in thickness between the portion where the electrodes 14 are arranged and the portion where the insulating member 5 is arranged is, for example, 50 μm or less.

[0044] The substrate 3 is formed in a sheet shape. The material of the substrate 3 is a flexible resin material containing an elastomer (urethane resin, acrylic resin, ester resin, silicone resin, modified silicone resin, imide resin, epoxy resin, xylene resin, ethylene resin, vinyl resin, cellulose, etc.). The substrate 3 has extensibility and stretchability in the in-plane direction when subjected to an external force.

[0045] The substrate 3 may be provided with an opening that does not obstruct blood flow. An example of the opening is a through-hole 91 that penetrates the substrate 3. Fig. 9A is a diagram showing a modified example of the functional device 1 in which a through-hole 91 is formed. Fig. 9B is a diagram showing the form when the functional device 1 shown in Fig. 9A is placed inside a blood vessel 82.

[0046] By forming the through-holes 91 in the substrate 3, when the functional device 1 is placed on the inner wall of the blood vessel 82, red blood cells in the blood can pass through the through-holes. This allows red blood cells to flow to blood vessels branching from the blood vessel 82 in which the functional device 1 is placed. From the viewpoint of allowing red blood cells to pass through, the diameter of the through-holes 91 is preferably 10 μm or more. The diameter of the through-holes 91 is more preferably 20 μm or more. However, if the diameter of the through-holes 91 is too large, there is a risk that the self-expansion described above will be inhibited. The diameter of the through-holes 91 is preferably 1000 μm or less. Furthermore, if the sum of the areas of all the through-holes 91 is too large relative to the area of ​​the substrate 3, there is a risk that the self-expansion will be inhibited. The sum of the areas of the through-holes 91 is preferably 50% or less of the area of ​​the substrate 3.

[0047] There is no particular limitation on the number of through holes 91 formed in the base material 3. The number of through holes 91 can also be determined depending on the thickness of the base material 3.

[0048] The arrangement of the through-holes 91 is not particularly limited. A preferred arrangement of the through-holes 91 is that the through-holes 91 are dispersed at a substantially constant density. This allows red blood cells to flow smoothly into blood vessels branching from the blood vessel 82. The through-holes 91 may be arranged regularly, for example, in a linear or matrix pattern, or may be arranged randomly. The through-holes 91 may also be arranged regularly together with other components such as the electrodes 14, as shown in FIG. 9A. The number and / or arrangement of the through-holes 91 is preferably such that the functional device 1 does not prevent the functional device 1 from forming a helical structure as shown in FIG. 9B inside the blood vessel 82.

[0049] The opening is not limited to a round hole such as the through-hole 91. The opening may be, for example, a polygonal hole or a linear notch.

[0050] The wiring 12 is made of a conductive material. The conductive material is a bulk material containing only a conductor, or a composite material in which a conductor is dispersed in a resin material used as a binder. The wiring 12 is arranged on the substrate 3 in accordance with the shape of the electrode or circuit.

[0051] The conductive material has a low Young's modulus. The Young's modulus of the conductive material can be 100 GPa or less, or 1 GPa or less. Because the conductive material has a low Young's modulus, the wiring 12 can extend and contract. The wiring 12 can expand and contract in accordance with the expansion and contraction of the substrate 3 in the in-plane direction. The wiring 12 can be patterned and formed on the substrate 3 by lithography, printing, or the like. The bulk material can be structurally flexible, such as in a horseshoe shape, honeycomb shape, or mesh shape. The composite material can be one that exhibits flexibility itself.

[0052] The electrodes 14 are formed from the same conductive material as the wiring 12. The electrodes 14 can be formed in any shape, such as a circle in a plan view. The positions at which the electrodes 14 are arranged and the number of electrodes 14 can be set arbitrarily. The wiring 12 is connected to each electrode 14. An amplifier circuit composed of transistors may be built between each electrode 14 and the wiring 12. Flexible thin-film transistors such as organic field-effect transistors and organic electrochemical transistors can be used as the transistors.

[0053] The electrode 14 can expand and contract like the wiring 12. The electrode 14 can follow the expansion and contraction of the substrate 3. The electrode 14 can be patterned on the substrate 3 by lithography, printing, or other methods. Bulk materials can be made flexible by structural patterning into shapes such as a horseshoe, honeycomb, or mesh. Composite materials can exhibit flexibility due to the mechanical properties of the material itself.

[0054] The insulating member 5 is a sheet-like cover. The insulating member 5 is placed on the surfaces of the base material 3, the wiring 12, the electrodes 14, etc. The insulating member 5 is a member for suppressing unwanted conduction between adjacent conductors. A through hole 9 is formed in the insulating member 5 at a position where the insulating member 5 overlaps the electrode 14. The through hole 9 refers to a hole formed in the insulating member 5. A portion of the electrode 14 is exposed through the through hole 9. The insulating member 5 is made of a flexible resin material or the like. The insulating member 5 can follow the expansion and contraction of the base material 3.

[0055] The cover member 7 is disposed so as to cover the wiring 12. The cover member 7 prevents the wiring 12 from being unnecessarily electrically connected to the outside. The cover member 7 can be formed from a flexible resin material, similar to the insulating member 5. The cover member 7 can follow the expansion and contraction of the base material 3. The insulating member 5 and the cover member 7 can be formed from a single member.

[0056] The functional device 1 is placed inside the blood vessels of a living body. Because the functional device 1 is thin and flexible, it can be placed in thin and weak blood vessels such as the superficial cerebral venous vessels 86. Because the functional device 1 is flat, it is less likely to damage the inner walls of blood vessels.

[0057] Since the functional device 1 has extensibility and stretchability, the functional device 1 can bend to match the shape of the blood vessel and come into close contact with the inner wall of the blood vessel.

[0058] When the functional device 1 is placed in the cerebral surface vein 86, it becomes possible to measure electroencephalograms with high resolution.

[0059] In addition to the electrodes 14, the functional device 1 may include a signal processing circuit for purposes such as signal amplification and noise removal, or an electrical circuit for a sensor element. FIG. 1C is a diagram showing an example of an electrical circuit 15 included in the functional device 1. The electrical circuit shown in FIG. 1C includes a transistor circuit 16 and a sensor element 20. The transistor circuit 16 includes a gate electrode 17, a source electrode 18, and a drain electrode 19. The sensor element 20 is formed on the drain electrode 19 side of the transistor circuit 16. The sensor element 20 functions as a different type of sensor from the electrodes 14 that sense potential fluctuations, and may be, for example, a pressure-sensitive rubber sensor.

[0060] The sensor element 20 can be a sensor that detects pressure, vibration, blood flow, current, voltage, electric field, magnetic field, temperature, light, chemical quantities, etc. Chemical quantities include oxygen concentration, glucose metabolism, amyloid beta, NO metabolites, nitrate ions, glial cell metabolites, etc.

[0061] The functional device 1 can include a plurality of electric circuits 15. When the functional device 1 includes a plurality of electric circuits 15, the electric circuits 15 can be arranged in a matrix. In this case, the functional device 1 can include gate wiring connected to a plurality of gate electrodes 17 arranged in the same row or the same column. The functional device 1 can also include source wiring connected to a plurality of source electrodes 18 arranged in the same row or the same column. A plurality of gate wirings and a plurality of source wirings can each be arranged to form a matrix.

[0062] In the functional device 1 of this embodiment, at least a portion of the surface of the functional device 1 is covered with an antithrombogenic material. For example, at least a portion of the surface of the substrate 3, at least a portion of the surface of the cover member 7, and at least a portion of the surface of the electrode 14 are covered with the antithrombogenic material. The entire surface of the functional device 1 may be covered with the antithrombogenic material. Examples of the antithrombogenic material include polyvinylpyrrolidone, polyethylene glycol, 2-methacryloyloxyethyl phosphorylcholine, polyacrylic acid esters (poly(2-methoxyethyl acrylate), poly-(ω-methoxyalkyl acrylate), etc.), organic sulfur compounds with anticoagulant activity (heparin, heparin derivatives, etc.), block copolymers using polyalkylene glycol (copolymerized with polyhydroxyalkanoic acid, aliphatic polyester, etc.), and nitrogen-containing polymers with alkylsulfonic acid groups.

[0063] When an artificial object such as an electrode is placed inside a blood vessel, a blood clot may form, clogging the inside of the blood vessel. In the functional device 1 of this embodiment, at least a portion of the surface of the functional device 1 is covered with an antithrombotic material. This allows the functional device 1 to be placed inside a blood vessel without interfering with endothelialization, and to suppress the formation of a blood clot inside the blood vessel.

[0064] The functional device 1 will be described in more detail below. The thickness of the substrate 3 is 0.5 μm or more and 100 μm or less, preferably 10 μm or less. The thickness of the functional device 1 is preferably 300 μm or less.

[0065] The maximum elongation of the substrate 3 is preferably 50% or more, and more preferably 500% or more. Here, the maximum elongation of the substrate 3 refers to the maximum value among the elongations of the substrate 3 in various in-plane directions. The elongation of the substrate 3 means the ratio of elongation in the in-plane direction when a force is applied to the dimension when no force is applied. An elongation of 50% means that the dimension when a force is applied is 1.5 times the dimension when no force is applied.

[0066] The Young's modulus of the substrate 3 can be set to 10 GPa or less, preferably 50 MPa or less.

[0067] The base material 3, the insulating member 5, and the cover member 7 can be formed from the same resin material. By forming these from the same resin material, the functional device 1 can be produced without impairing the extensibility and stretchability of the base material 3.

[0068] The conductor contained in the conductive material such as the wiring 12 and the electrode 14 can be silver, gold, platinum, carbon, copper, aluminum, cobalt, nickel, titanium, iridium, conductive polymer, gel, ionic liquid, or an alloy (composite) thereof. The conductive material may be in the form of particles. Specific particle shapes include spherical, needle-like, flake-like, and nanowire-like shapes. The aspect ratio of the particles is preferably 1 or more and 1000 or less, and more preferably 1 or more and 500 or less. Here, the aspect ratio is the ratio between the longest dimension and the shortest dimension of a three-dimensional object.

[0069] The electrode 14 may be subjected to a surface treatment. Examples of surface treatments include oxygen plasma treatment, corona discharge treatment, and coating with an antithrombogenic material. By subjecting the electrode 14 to a surface treatment, the adhesion between the inner wall of the blood vessel 82 and the electrode 14 can be improved. Improved adhesion between the inner wall of the blood vessel 82 and the electrode 14 reduces the contact impedance between the inner wall of the blood vessel 82 and the electrode 14, making it possible to measure even weak brain waves. Other effects include suppressing the formation of blood clots. The preferred range of contact impedance between the inner wall of the blood vessel 82 and the electrode 14 is 10 kΩ or less.

[0070] The resin binder used for conductive materials such as the wiring 12 and the electrodes 14 can be a flexible resin material including elastomers such as urethane resin, acrylic resin, ester resin, silicone resin, modified silicone resin, imide resin, epoxy resin, xylene resin, ethylene resin, vinyl resin, and cellulose.

[0071] The Young's modulus of the resin binder is preferably equal to or smaller than the Young's modulus of the substrate 3. The Young's modulus of the resin binder is preferably 50 MPa or less. The resin binder may contain only one type of flexible resin material, or may contain multiple types of flexible resin materials.

[0072] Conductive materials such as the wiring 12, electrodes 14, and circuits can be formed on the substrate 3 by a printing method. Specific examples of printing methods include screen printing, inkjet printing, gravure printing, offset printing, dispenser printing, and mask printing. Among these printing methods, screen printing is preferred because it has excellent fine resolution and thick film stability.

[0073] When forming conductive materials such as the wiring 12 and the electrodes 14 by a printing method, first, a conductive paste containing the above-mentioned conductive particles, a resin binder, and an organic solvent is prepared. Then, the prepared conductive paste is printed on the surface of the substrate 3 or the like.

[0074] After printing and drying, the conductive paste has extensibility and stretchability. The wiring 12, electrodes 14, circuits, etc. preferably have an elongation rate of 50% or more.

[0075] The thickness of the wiring 12 and the electrodes 14 is preferably 50 μm or less, and more preferably 15 μm or less.

[0076] The functional device 1 is placed inside a blood vessel and functions as an extremely thin electroencephalogram measuring device.

[0077] A method for placing the functional device 1 inside a blood vessel will be described. The placement of the functional device 1 inside a blood vessel is performed using a transport device. The transport device 30 will be described based on FIG. 5. FIG. 5 is a diagram showing the transport device 30. As shown in FIG. 5, the transport device 30 includes a guiding catheter 32 and a guidewire 50.

[0078] The guiding catheter 32 includes a catheter 34 , an electrode 36 , a pressure-sensitive conductive material 38 , a readout circuit 40 , and an anti-thrombogenic protective coating 44 .

[0079] The catheter 34 is a hollow tube having a cavity 48 therein.

[0080] The electrodes 36 are disposed around the catheter 34. The electrodes 36 may be gold electrodes or the like.

[0081] A pressure-sensitive conductive material 38 is disposed to cover the electrodes 36. A readout circuit 40 is also disposed to cover the pressure-sensitive conductive material 38.

[0082] The electrodes 36, the pressure-sensitive conductive material 38, and the readout circuit 40 constitute a multilayered thin-film sensor array 42. The multilayered thin-film sensor array 42 can function as a biosensor for detecting pressure, blood flow, electric field, magnetic field, temperature, and chemical quantities, such as oxygen concentration, glucose metabolism, amyloid beta, NO metabolites, nitrate ions, and glial cell metabolites.

[0083] The antithrombogenic protective film 44 is disposed so as to cover the readout circuit 40. The antithrombogenic protective film 44 inhibits the formation of thrombi inside blood vessels.

[0084] A guide wire 50 is disposed inside the catheter 34. The guide wire 50 is disposed in the cavity 48 of the catheter 34.

[0085] The guidewire 50 can freely change the direction of its tip 52. An actuator 54 may be provided at the tip 52 of the guidewire 50. By providing the actuator 54 at the tip 52, the guidewire 50 can more freely change the direction of its tip 52.

[0086] A sensor similar to the multilayered thin film sensor array 42 described above may be disposed on the surface of the guidewire 50 near its tip. A different type of sensor, such as a piezoelectric sensor, may be disposed on the surface of the guidewire 50 near its tip. Also, a similar sensor and a different type of sensor may be disposed on the surface of the guidewire 50 near its tip. Also, an antithrombogenic protective film similar to the antithrombogenic protective film 44 described above may be disposed on the outermost surface of the guidewire 50.

[0087] The method for placing the functional device 1 inside a blood vessel includes two steps: the first step is a guiding catheter placement step, and the second step is a functional device placement step.

[0088] The guiding catheter placement step is a step of placing the first end 46 of the guiding catheter 32 at a predetermined position inside the blood vessel.

[0089] The functional device placement step is a step in which, after the first end 46 of the guiding catheter 32 is placed at a predetermined position inside the blood vessel, the functional device 1 is placed inside the blood vessel by ejecting the functional device 1 into the blood vessel from the first end 46 of the guiding catheter 32. The steps will be described in order below.

[0090] The guiding catheter 32 can be inserted into the body through the jugular vein, femoral vein, etc. Fig. 6A is a diagram showing a state in which the guiding catheter 32 is inserted into the body from outside the body. Fig. 6A shows a state in which the guiding catheter 32 is inserted into the femoral vein 87 through a catheter insertion port 88.

[0091] After the guiding catheter 32 is inserted into the body, the functional device 1 is placed in the brain in the following procedure, enabling measurement of an electrocorticogram (ECoG) 89. In addition to the electrocorticogram, it also becomes possible to measure local field potential (LFP) signals in the brain.

[0092] FIG. 6B is a diagram showing the guiding catheter 32 and the guidewire 50 inside a blood vessel 82. As shown in FIG. 6B , in the guiding catheter placement step, the guiding catheter 32 is guided by the guidewire 50 and placed at a predetermined position inside the blood vessel. The tip 52 of the guidewire 50 can freely change its direction. As shown in FIG. 2A , blood vessels 82 in the brain 80 are complex. When the functional device 1 is placed in a superficial cerebral vein 86, for example, it is necessary to place the first end 46 of the guiding catheter 32 at a predetermined position by going around the small branches of the blood vessel 82. At this time, the guidewire 50 advances inside the blood vessel 82 ahead of the first end 46 of the guiding catheter 32. Then, the guiding catheter 32 advances inside the blood vessel 82, guided by the guidewire 50. This allows the first end 46 of the guiding catheter 32 to advance to a predetermined position even when the blood vessel 82 branches continuously, branches in multiple directions, or requires a sharp change of course at a branch.

[0093] FIG. 6C is a diagram showing the functional device 1 inside a blood vessel 82. After the first end 46 of the guiding catheter 32 is placed at a predetermined position, the functional device 1 is ejected from the first end 46 of the catheter 34 into the blood vessel 82. Before being ejected into the blood vessel 82, the functional device 1 is located near the first end 46 in the cavity 48 of the catheter 34. When the functional device 1 is ejected from the cavity 48 of the catheter 34 into the blood vessel 82, it expands in a helical shape inside the blood vessel 82, as shown in FIG. 6C. This is because when the functional device 1 is ejected into the blood vessel 82, a force acts on the functional device 1, causing it to expand. The expanded functional device 1 comes into contact with the inner wall of the blood vessel 82. The functional device 1 is then placed at a predetermined position inside the blood vessel 82.

[0094] The above-mentioned expansion due to the force of the self-expansion is also called self-expansion. In order for the self-expanded functional device 1 to be pressed against the inner wall of the blood vessel 82 with an appropriate pressure, it is preferable to set the thickness, Young's modulus, rigidity, size, etc. of the base material 3 described above within appropriate ranges.

[0095] When placed inside the blood vessel 82, the electrodes of the functional device 1 can be made to face the inner wall of the blood vessel 82. Furthermore, the functional device 1 is in planar contact with the inner wall of the blood vessel 82. Therefore, the stress applied to the blood vessel 82 from the functional device 1 is dispersed, reducing the burden on the blood vessel 82. The planar functional device 1 adheres closely to the blood vessel and can induce endothelialization.

[0096] The procedure for discharging the functional device 1 from the cavity 48 of the catheter 34 into the blood vessel 82 is not particularly limited. With the first end 46 of the guiding catheter 32 placed at a predetermined position, the functional device 1 can be inserted into the cavity 48. Alternatively, with the functional device 1 placed inside the cavity 48 in advance, the first end 46 of the guiding catheter 32 may be placed at a predetermined position inside the blood vessel 82. The following describes each procedure in order.

[0097] The procedure for inserting the functional device 1 into the guiding catheter 32 after the guiding catheter 32 has been placed inside the blood vessel 82 will be described. Of the two ends of the guiding catheter 32, the other end that is not the first end 46 is referred to as the second end 47. The second end 47 is shown in FIG. 6A.

[0098] In the functional device placement step, the functional device 1 is inserted from the second end 47 of the guiding catheter 32 into the cavity 48 inside the guiding catheter 32. The functional device 1 is placed inside the cavity 48 in a helically rolled state. Then, the functional device 1 is pushed by a piston-shaped member (not shown) or the like to move the functional device 1 inside the cavity 48. Then, the functional device 1 is moved to the first end 46 in the cavity 48. Thereafter, the functional device 1 is discharged from the first end 46 into the inside of the blood vessel 82.

[0099] In order to place the functional device 1 at an appropriate position inside the body, it is preferable to be able to determine the position of the functional device 1 inside the body using X-rays. In order to determine the position of the functional device 1 using X-rays, it is preferable to form a portion in the functional device 1 that is opaque to X-rays. This portion that is opaque to X-rays is called a marker 93 (X-ray marker). Figures 9A and 9B show an example of a functional device 1 provided with a marker 93.

[0100] The markers 93 can be formed of a material that is opaque to X-rays, such as gold or platinum, i.e., a material that blocks X-rays. The markers 93 can also be formed of an alloy of platinum and iridium, tantalum, or the like. The size of the markers 93 provided on the functional device 1 can be, for example, 10 μm or more in diameter. Furthermore, the thickness of the markers 93 can be, for example, 10 μm or more from the viewpoint of blocking X-rays. Furthermore, by making the thickness of the markers 93 10 μm or less, flexibility of the functional device 1 can be ensured. The positions at which the markers 93 are provided can be, for example, the front and rear positions of the functional device 1, or positions on both sides in the width direction. Here, the front and rear and width directions refer to the direction of insertion into the blood vessel 82 as the front, and the direction intersecting the front and rear directions as the width direction. Alternatively, the markers 93 can be regularly arranged together with other components such as the electrodes 14, as shown in FIGS. 9A and 9B .

[0101] The marker 93 is not connected to the wiring 12 or the connection line 60 and may not function electrically. In addition, when the electrode 14 is made of a material that is opaque to X-rays, such as gold or platinum, the electrode 14 may also serve as a marker.

[0102] When the first end 46 of the guiding catheter 32 is to be positioned at a predetermined position with the functional device 1 placed inside the cavity 48, the functional device 1 is inserted into the guiding catheter 32 as described above, and the functional device 1 is moved to the first end 46 using a piston-shaped member or the like before inserting the guiding catheter 32 into the body.

[0103] 2B, a connection line 60 is connected to the functional device 1 placed inside the blood vessel 82. The connection line 60 is a wiring that connects the functional device 1 to equipment outside the blood vessel, which will be described later.

[0104] In the above description, the guiding catheter 32 includes the multilayered thin-film sensor array 42. However, the guiding catheter 32 may also include only the catheter 34. The transport device 30 can function as the transport device 30 by including the catheter 34 and the guidewire 50.

[0105] The entire ultra-fine diameter intravascular measurement system, including the functional device 1 and the equipment placed outside the blood vessel, is referred to as the biological interface system 62. The biological interface system 62 will be described based on Figs. 7A to 7C. Figs. 7A and 7B are diagrams showing a portion of the biological interface system 62. Fig. 7C is a diagram showing the entire biological interface system 62. Fig. 7A shows the signal transmission path from the functional device 1 to the repeater 64. Fig. 7B shows the external receiving equipment 66 and antenna 68 placed outside the body. In Figs. 7B and 7C, arrow 98 indicates a wireless connection.

[0106] The biological interface system 62 is a system that transmits the brain waves measured by the functional device 1 to an analysis device or the like. The biological interface system 62 includes a repeater 64, an external receiving device 66, and an antenna 68. The repeater 64 is placed outside the blood vessel 82. The external receiving device 66 and the antenna 68 are placed outside the body.

[0107] Note that the transmission using high frequency waves or the like using the external receiving device 66 and antenna 68 described below is an example of wireless transmission. Another example of wireless transmission is infrared communication. In the case of infrared communication, the internal repeater 64 can be configured with a light-emitting element using a light-emitting diode. The external antenna 68 and external receiving device 66 can be configured with a light-receiving element using a photodiode. For example, pulse width modulation (PWM) can be used as a method of modulating analog signals in infrared communication.

[0108] The advantages of using infrared communication include the following: Infrared light has good penetration properties inside the body. It is applicable to both low frequency analog signals and AD data streams. This allows for pinpoint communication between transmitting and receiving devices, which means that an antenna, which requires a large area, is not required, and the installation area can be reduced. Communications are not affected by electromagnetic interference from the surrounding area. There are no restrictions on radiated signal strength under the Radio Law. The driving circuit and receiving circuit can be simplified.

[0109] 7A, the repeater 64 is connected to the functional device 1 placed in the cerebral surface venous vessel 86 via a connection line 60. The repeater 64 is the first device connected to the functional device 1. The repeater 64 has at least one function of amplifying the signal from the functional device 1, removing noise from the signal from the functional device 1, wirelessly transmitting the signal to an external receiver placed outside the body, etc.

[0110] The repeater 64 can be placed subcutaneously in the neck or the like. It is preferable to amplify the signal and remove noise from the signal near the signal source. Therefore, the connection line 60 is pulled out of the blood vessel 82 in the jugular vein and connected to the repeater 64 placed subcutaneously in the neck. This allows for efficient amplification of the signal and removal of noise from the signal. The repeater 64 can also be placed in a location other than the neck.

[0111] An external receiving device 66 is wirelessly connected to the repeater 64. The external receiving device 66 is placed on the chest, for example, as shown in FIG. 7B . The repeater 64 and the external receiving device 66 can also be connected via subcutaneous wiring. The external receiving device 66 has at least one function of a central processing unit (CPU), an analog-to-digital converter (ADC), a wireless communication circuit (including a registered trademark) such as Bluetooth Low Energy (BLE), other signal processing, power control, etc. The external receiving device 66 can have a power supply function in addition to the signal processing and communication processing described above. The external receiving device 66 may be equipped with a battery.

[0112] As shown in FIG. 7B, an antenna 68 is connected to the external receiving device 66 via a wiring 70. The antenna 68 is placed on the chest or the like. The antenna 68 is preferably placed near the external receiving device 66. The wiring 70 can be placed outside the body. The antenna 68 receives signals measured by the functional device 1 to an analyzer or the like. The antenna 68 can also be responsible for wireless power transmission to the repeater 64.

[0113] For the wireless power transmission, for example, electromagnetic induction power feeding or magnetic resonance power feeding can be used. The battery described above may also be provided in the internal repeater 64. The battery provided in the repeater 64 may be, for example, a button battery or a chip battery.

[0114] 7C shows an example of the overall layout of the biological interface system 62. The functional device 1 is placed in the brain, the repeater 64 is placed in the neck, and the external receiving device 66 and antenna 68 are placed in the chest. The functional device 1 and the connecting wire 60 are placed inside a blood vessel. The repeater 64 and the external receiving device 66 are connected via radio waves or the like via the antenna 68. The external receiving device 66 and antenna 68 are placed outside the body.

[0115] The above-described biological interface system 62 can transmit the electrocortical electroencephalogram (ECoG) and local field potential (LFP) signals measured by the functional device 1, particularly in the deep brain, to an analysis device or the like.

[0116] The configuration of the bio-interface system 62, the devices included in the bio-interface system 62, the device arrangement, device functions, and device connection methods are merely examples. The configuration of the bio-interface system 62 can be changed as appropriate. The ground potential in the circuit can be set to the potential on the human body, such as the ear.

[0117] The biological interface system 62 may receive signals from external devices in addition to transmitting signals to an analysis device, etc. The functional device 1 may receive a control signal from an external device when applying a stimulus to biological tissue, for example.

[0118] An example of circuits included in the repeater 64 and the external receiving device 66 will be described with reference to Fig. 8. Fig. 8 is a block diagram showing the circuit arrangement in the biological interface system 62. As shown in Fig. 8, the repeater 64 includes a filter 71, a low-noise amplifier 72, a multiplexer 73, and a wireless transmitter 75, which are connected in series. A power source 74, such as a battery, is connected to the low-noise amplifier 72.

[0119] The device may include a plurality of filters 71 and a plurality of low-noise amplifiers 72. The filter 71 may include a plurality of low-pass filters (LPFs) or band-pass filters (BPFs). When acquiring an electroencephalogram using the functional device 1, the cutoff frequency of the LPF is typically 50 Hz or less, and the bandwidth of the BPF is 0.5 Hz to 50 Hz. The low-noise amplifier 72 may be, for example, an amplifier with a noise of 5 nV / √Hz@f=10 Hz or less.

[0120] The number of connection lines 60 and wirings 70 indicated by arrows 97 can be set to correspond to the number of channels of the functional device 1. Here, the number is assumed to be n.

[0121] The external receiving device 66 performs various signal processing. The external receiving device 66 includes a wireless receiver 76, an analog / digital converter 77, a signal processing circuit 78, and a data transmission circuit 79. These are connected in series. The wireless receiver 76 may be a high-frequency wireless receiver using a frequency band between 100 MHz and 5 GHz, for example. Alternatively, optical communication such as infrared light may be used instead of high-frequency wireless. An antenna 68 is connected to the wireless receiver 76. The signal that has undergone various processing in the signal processing circuit 78 is connected to a control device such as a PC via a data transmission circuit 79. Note that transmission of the data signal to the PC is not limited to being wired, but may also be wireless.

[0122] The wireless connection indicated by arrow 98 does not need to use n radio waves because multiplexer 73 multiplexes the signals onto a single signal line.

[0123] The features and effects of the present invention are described below. Blood vessels are extremely soft tissues. Therefore, there is a risk of perforation when artificial objects are inserted into blood vessels. In the present invention, a measurement device and its transport mechanism are fabricated using a functional organic material that is as soft as a gel. This reduces the risk of damaging tissues inside the body, such as blood vessels.

[0124] When an artificial object is placed inside a blood vessel, there is a risk that a blood clot may form inside the blood vessel and cause the blood vessel to become clogged. In the present invention, the surface of the component inserted into the blood vessel is coated with an antithrombotic material. This makes it possible to prevent the formation of a blood clot inside the blood vessel.

[0125] According to the present invention, it becomes possible to use various medical devices inside blood vessels, and to provide advanced medical care without significantly invasiveness to the living body.

[0126] Furthermore, the present invention will enable minimally invasive surgical procedures through the advancement of treatment inside blood vessels. Furthermore, amid a rapid increase in the number of patients with brain-related diseases such as dementia worldwide, the present invention will meet the need for medical technology that can measure the inside of the brain minimally invasively and with high accuracy. There are also various ways to use the functional device 1. For example, the functional device 1 can be placed in a person's cerebral surface venous blood vessels only during surgery and then removed after the surgery. Alternatively, the functional device 1 can be placed in a person's cerebral surface venous blood vessels and continue to acquire biosignals such as electroencephalograms during the person's daily life.

[0127] As described above, the measurement system for intravascular ultrathin vessels according to the present invention enables minimally invasive access to a wide area of ​​the brain surface via cerebral surface venous vessels. The measurement system for intravascular ultrathin vessels includes an ultrathin bioinsulation and stimulation device and a transport device. Furthermore, the measurement system for intravascular ultrathin vessels enables the placement of functional devices in soft cerebral surface venous vessels, rather than in the venous sinuses, which are hard veins that pass through the dura mater.

[0128] The ultrathin functional device is placed inside the cerebral venous vessels, and enables long-term recording of brain activity from the cerebral venous vessels via flexible helical electrodes.

[0129] The delivery device delivers the ultra-thin functional device to the cerebral surface venous vessels and leaves the functional device there. The delivery device also enables minimally invasive measurement from the cerebral surface venous vessels and minimally invasive electrical stimulation to the cerebral surface venous vessels via a guide wire equipped with electrodes.

[0130] Cerebral blood vessels are extremely thin and have complex shapes. Veins, in particular, have complex shapes. Therefore, it is very difficult to access the inside of cerebral blood vessels. Furthermore, placing a foreign object inside a blood vessel carries the risk of vascular occlusion due to the formation of a blood clot.

[0131] In the present invention, the ultrathin film sensor and the guidewire that also functions as an actuator ensure both safety and operability inside blood vessels. Furthermore, the antithrombogenic material reduces the risk of vascular occlusion due to the placement of the ultrathin film electrode and sensor inside the cerebral venous blood vessels.

[0132] In addition, the ultra-flexible spiral electrode, which utilizes polymer technology, makes it possible to place the electrode in veins where the blood vessels are fragile and therefore not suitable for stent placement.

[0133] By incorporating a sensor into the guidewire, it becomes possible to measure ECoG and LFP within a blood vessel for a short period of time, such as during surgery. The sensor may cover only the tip of the guidewire, or may cover the entire guidewire.

[0134] The ultra-small diameter functional device may have multiple channels, such as 16 channels.

[0135] Both the guidewire and the guiding catheter may be equipped with sensors. The combined use of a sensor-equipped guidewire and a sensor-equipped guiding catheter in a complementary manner allows for safer delivery of devices inside blood vessels and enables more complex surgical procedures.

[0136] In addition, sensor-equipped guidewires or sensor-equipped guiding catheters enable real-time measurement of displacement, speed, direction, stress, blood flow, etc., multimodal measurement by simultaneously installing multiple types of sensors, and control of neural activity by electrical stimulation.

[0137] Furthermore, sensor-equipped guidewires utilize their thinness to enable access to narrow blood vessels, while sensor-equipped guiding catheters utilize their internal space to enable the delivery of devices, drugs, and the like.

[0138] Although the embodiments of the present invention have been described above, the present invention is not limited to the above-described embodiments, and various changes, modifications, and combinations are possible.

[0139] The functional device 1 of the present invention measures potential fluctuations via electrodes 14, but the potential fluctuations to be measured are not limited to potential fluctuations derived from electroencephalograms. Furthermore, the location where the functional device 1 is placed is not limited to the cerebral surface venous blood vessels. The location where the functional device 1 is placed may be a cerebral venous blood vessel or an arterial blood vessel other than the cerebral surface venous blood vessels, or a blood vessel in a region other than the brain. Furthermore, the location where the functional device 1 is placed may be tissue other than blood vessels, such as the spinal cavity, ventricles, cerebral aqueduct, cisterns, or internal organs. The functional device 1 can be used as a device for measuring various potential fluctuations within the body.

[0140] Furthermore, the functional device 1 can be used for various applications and devices that require the measurement of potential fluctuations in the body. For example, it is possible to determine various biological conditions by signal processing of the brain waves measured via the functional device 1. Specifically, it is possible to analyze sleep and mental states by analyzing the frequency components contained in the brain waves.

[0141] Furthermore, the functional device 1 can be used in a BMI device. In a BMI device, brain waves are used as a control signal for moving a prosthetic arm or the like. By using the functional device 1 in a BMI device, an extremely minimally invasive BMI can be realized.

[0142] Furthermore, the biological signals measured by the functional device 1 are not limited to signals derived from potential fluctuations, such as electroencephalograms or electrocardiograms, but may also be signals derived from mechanical vibrations or light-derived signals such as blood oxygen levels. For example, the sensor unit as the functional unit is not limited to an electrode, but may also be a vibration detection unit (piezoelectric element, etc.) that detects mechanical vibrations, or a light detection unit (photodiode, etc.) that detects light.

[0143] The functional device 1 may not be a device that measures biosignals, but may also be a device that has a stimulating unit that applies stimuli to a living organism. For example, the stimulating unit may be an electrode for applying electrical stimuli. Furthermore, the stimuli applied by the stimulating unit of the functional device 1 may be, in addition to electrical stimuli, mechanical vibrations from a piezoelectric element or the like, such as ultrasonic vibrations, or optical stimuli from a photodiode or the like. The functional device 1 may also be a device that measures biosignals and applies stimuli to a living organism. The functional device 1 may also be a device that has a sensor unit and a stimulating unit. The shape of the functional device 1 does not have to be rectangular, but may be square, elliptical, or the like. Furthermore, it is desirable for the functional device 1 to have a uniform thickness, but it may also have holes in some parts. For example, the functional device 1 does not have to be arranged helically within a blood vessel. The functional device 1 may simply be arranged so as to function within the blood vessel.

[0144] (1) It is placed inside the blood vessels of the living body, A functional device for performing at least one of measuring activity of a tissue outside the blood vessel and stimulating the tissue, A flexible substrate in sheet form, One or more functional parts formed on the substrate; wiring formed on the base material and connected to the functional unit; At least one of at least a portion of a surface of the base material and at least a portion of a surface of the functional portion is covered with an antithrombogenic material. Functional device.

[0145] (2) The functional unit has at least one function of an electrode and a sensor. (1) The functional device according to (1).

[0146] (3) the sensor detects at least one of vibration, pressure, current, voltage, and light; The functional device according to (1) or (2).

[0147] (4) The thickness of the substrate is 0.5 μm or more and 50 μm or less. A functional device according to any one of (1) to (3).

[0148] (5) Young's modulus is 1 kPa or more and 10 GPa or less. A functional device according to any one of (1) to (4).

[0149] (6) The blood vessel is a superficial cerebral vein, the tissue is neural tissue; A functional device according to any one of (1) to (5).

[0150] (7) A flexible guiding catheter having an internal cavity, The functional device according to any one of (1) to (6) is disposed in the cavity. Guiding catheter.

[0151] (8) The functional device is placed in the cavity in a helically rolled state. (7) A guiding catheter according to (7).

[0152] (9) A repeater connected to the functional device according to any one of (1) to (6) and disposed outside the blood vessel; an external receiving device wirelessly connected to the repeater and placed outside the body; an antenna connected to the external receiving device and placed outside the body; Biological interface system.

[0153] (10) At least one of the repeater and the external receiving device performs at least one of amplifying the signal from the functional device and removing noise from the signal. (9) A biological interface system according to (9).

[0154] (11) a guiding catheter placement step of placing a first end of the guiding catheter at a predetermined position inside the blood vessel; a functional device placement step of placing the functional device inside the blood vessel by ejecting a sheet-shaped flexible functional device from inside the guiding catheter into the blood vessel at the first end, How functional devices are placed.

[0155] (12) The guiding catheter includes a guidewire, In the guiding catheter placement step, the guiding catheter is led by the guide wire and placed at a predetermined position inside the blood vessel. A method for placing the functional device described in (11).

[0156] (13) When the two ends of the guiding catheter are the first end and the second end, In the functional device placement step, inserting the functional device into an internal cavity of the guiding catheter from the second end of the guiding catheter; After moving the functional device to the first end of the guiding catheter, ejecting the functional device into the blood vessel. A method for placing a functional device according to (11) or (12).

[0157] (14) In the guiding catheter placement step, the first end of the guiding catheter is placed at a predetermined position inside a blood vessel with the functional device pre-positioned at the first end in an internal cavity of the guiding catheter; A method for placing a functional device according to (11) or (12). [Explanation of symbols]

[0158] 1 Functional Device 3 Base material 5. Insulating material 7 Cover member 9 through holes 10 Conductive material arrangement part 12 Wiring 14 electrodes 16 Transistor Circuits 17 Gate electrode 18 Source electrode 19 Drain electrode 20 Sensor element 30 Transportation Devices 32 Guiding catheter 34 Catheter 36 electrodes 38 Pressure-sensitive conductive materials 40 Readout circuit 42 Multilayered Thin Film Sensor Array 44 Antithrombotic protective membrane 46 First end 47 Second end 48 Cavity 50 Guidewire 52 Tip 54 Actuator 60 connecting wire 62 Biological Interface System 64 Repeater 66 External receiving device 68 Antenna 70 Wiring 71 filters 72 Low Noise Amplifier 73 Multiplexer 74 Power supply 75 Radio transmitter 76 Radio receiver 77 Analog / Digital Converter 78 Signal Processing Circuit 79 Data transmission circuit 80 Brain 82 Blood vessels 84 venous sinus 86 Cerebral superficial veins 87 femoral vein 88 Catheter insertion port 89 Cerebral Cortical Electroencephalogram 91 Through hole 93 Marker

Claims

1. It is placed inside the blood vessels of the living body, A functional device for performing at least one of measuring activity of a tissue outside the blood vessel and stimulating the tissue, A flexible substrate in sheet form, One or more functional parts formed on the substrate; wiring formed on the base material and connected to the functional unit; At least one of at least a portion of a surface of the base material and at least a portion of a surface of the functional portion is covered with an antithrombogenic material. Functional device.

2. The functional unit has at least one function of an electrode or a sensor. The functional device according to claim 1 .

3. The sensor senses at least one of pressure, vibration, blood flow, current, voltage, electric field, magnetic field, temperature, light, and chemical quantity. The functional device according to claim 2 .

4. The thickness of the substrate is 0.5 μm or more and 50 μm or less.

3. The functional device according to claim 1.

5. Young's modulus is 1 kPa or more and 10 GPa or less.

3. The functional device according to claim 1.

6. the blood vessel is a cerebral superficial vein, the tissue is neural tissue; 3. The functional device according to claim 1.

7. The substrate has a plurality of through holes having a diameter of 10 μm or more and 1000 μm or less formed therein.

3. The functional device according to claim 1.

8. The substrate is provided with an X-ray marker formed of an X-ray shielding material.

3. The functional device according to claim 1.

9. A flexible guiding catheter having an internal cavity, The functional device according to claim 1 or 2 is disposed in the cavity. Guiding catheter.

10. the functional device is placed in the cavity in a helically rolled state; The guiding catheter according to claim 9.

11. a repeater connected to the functional device according to claim 1 or 2 and disposed outside the blood vessel; an external receiving device wirelessly connected to the repeater and placed outside the body; an antenna connected to the external receiving device and placed outside the body; Biological interface system.

12. a relay connected to the functional device according to claim 1 or 2, disposed outside the blood vessel, and including a light-emitting element; an external receiving device connected to the repeater via infrared communication, disposed outside the body, and including a light receiving element; Biological interface system.

13. At least one of the repeater and the external receiving device amplifies the signal from the functional device and removes noise from the signal. The biological interface system according to claim 11.

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