Transcarotid intracranial electroencephalogram signal detection catheter

Abstract

The utility model discloses a transcarotid intracranial electroencephalogram signal detection catheter, which comprises a connecting seat, a three-way side branch tube, a near-end tube, a far-end tube, a quick exchange cavity, an electrode pair and a developing ring, wherein the connecting seat is used for connecting equipment; the three-way side branch pipe is used for injecting liquid in the diagnosis process; the near-end tube is used for moving in a blood vessel; the far-end tube is used for entering a blood vessel and collecting electroencephalogram signals; the quick exchange cavity is used for quickly entering or withdrawing the guide wire; the electrode pair is used for collecting electroencephalogram signals; the developing ring is used for identifying the position of the catheter head end in the blood vessel; according to the scheme, tissue damage or inflammatory response can be minimized, the problems that a scalp electroencephalogram recording signal is attenuated and distorted, electrode implantation needs craniotomy, a deep cortex area cannot be reached, and related tissue damage is easily caused are solved, the risk of doctors and patients is reduced, and the working efficiency is improved. And the recording and stimulation capability of the electroencephalogram signal similar to that of a traditional scheme is provided.

Description

Technical Field

[0001] The utility model relates to an intracranial electroencephalogram (EEG) signal detection catheter, in particular to a transcarotid intracranial detection catheter, belonging to the field of EEG signal monitoring. Background Art

[0002] EEG is the spontaneous, rhythmic electrophysiological activity of neurons in the human central nervous system. EEG signals are the overall response of the synchronized activity of large populations of neurons in the cerebral cortex and scalp. Any changes in brain function caused by physiological or pathological changes in the nervous system will affect the electrical activity characteristics of neurons, which in turn will be reflected in changes in EEG signals. Currently, EEG is used clinically to assist in the diagnosis of many neurological diseases and monitor human status, including paroxysmal disorders such as epilepsy, intracranial space-occupying lesions such as chronic subdural hematomas, postoperative monitoring of brain surgery, sleep monitoring, and depth of anesthesia monitoring, as well as depression, schizophrenia, and attention deficit hyperactivity disorder. Therefore, in-depth processing and analysis of EEG signals is of great significance for understanding the workings of the brain, studying brain function, and diagnosing and treating neurological diseases.

[0003] Three different types: scalp electroencephalogram (EEG), electrocorticogram (ECoG), and local field potential (LFP), which record the differences in the recording technology of brain electrical activity. EEG electrodes are placed non-invasively on the surface of the scalp, and multiple electrodes record brain electrical signals simultaneously. The information area is large, but it is easily affected by the skull and other intermediate tissues, resulting in signal attenuation and distortion. ECoG electrodes are placed on the surface of the cerebral cortex or on the dura mater to avoid signal distortion caused by electrical signals passing through the skull and other intermediate tissues. By using closely spaced grid electrodes or strip electrodes, the spatial resolution of the recorded electric field can be greatly improved. LFP microelectrodes are placed inside the cerebral cortex and can record a wider frequency band of electrical signals from a very small population of neurons, including postsynaptic potentials (LFPs) and action potentials (MURs). The spatial resolution is very high. Because the distance between the recording point and the current source is very short, the microelectrode has little effect on brain tissue. When the density of recording sites is large enough, LFP can almost accurately record all electrical activities of a small number of neuronal populations. Although traditional EEG signal recording methods have achieved significant clinical progress and research results, they also have some limitations: electrode implantation requires craniotomy, which poses greater risks to doctors and patients; there are deep cortical areas that subdural and epidural electrodes cannot reach, such as grooved folds that may represent rich information; deeply penetrating wires and microelectrodes may cause irreversible damage to the tissues in their implantation path or introduce new complications.

[0004] The intravascular lumen is a natural pathway similar to the central nervous system to reach deep and superficial targets. The development of intravascular intervention technology has enabled more brain areas to be accessed through intravascular access, providing similar recording and stimulation capabilities. It is a safer invasive method than implanting electrodes and can minimize tissue damage or inflammatory response. Utility Model Content

[0005] In response to the shortcomings of the existing technology, the utility model provides a transcarotid intracranial EEG signal detection catheter that can minimize tissue damage or inflammatory response, solves the problems of attenuation and distortion of scalp EEG recording signals, and the problem that electrode implantation requires craniotomy, cannot reach deep cortical areas, and is prone to causing related tissue damage, reduces the risks for doctors and patients, and provides similar recording and stimulation capabilities for EEG signals to traditional solutions.

[0006] The utility model is achieved through the following technical solutions:

[0007] A transcarotid intracranial EEG signal detection catheter comprises a connecting seat, a three-way side branch tube, a proximal tube, a distal tube, a rapid exchange cavity, an electrode pair, and a developing ring; wherein the connecting seat is used to connect equipment; the three-way side branch tube is used to inject liquids such as physiological saline, heparin, and therapeutic drugs during the diagnosis process; the proximal tube is used to move within the blood vessel; the distal tube is connected to the proximal tube and is used to enter the blood vessel and collect EEG signals; the rapid exchange cavity provides a guidewire channel for rapid entry or withdrawal of the guidewire; the electrode pair contacts the blood vessel wall or soft tissue to form an electrical signal loop for collecting EEG signals; and the developing ring is arranged between the distal tube and the electrode pair and is used to mark the position of the catheter tip in the blood vessel.

[0008] Furthermore, the electrode pair includes a head electrode pair or a terminal head end, which is used to dilate blood vessels and guide the catheter to the target position.

[0009] Furthermore, the three-way side branch pipe includes a three-way valve and a side branch pipe.

[0010] Furthermore, the proximal tube is a single-lumen tube structure with a length ranging from 30 cm to 70 cm, an outer diameter ranging from 1.6 mm to 2.2 mm, and an inner diameter ranging from 1.0 mm to 2.0 mm.

[0011] Furthermore, the distal tube includes a quick exchange outlet, a liquid hole and a wire hole, the quick exchange outlet is connected to the quick exchange cavity, and the liquid hole and the wire hole are in communication with the three-way side branch tube.

[0012] Furthermore, the distal tube is a straight structure or a preset curved structure.

[0013] Furthermore, the distal tube is a variable diameter or single diameter structure, and the diameter change is a multi-stage continuous diameter change or a multi-stage discrete diameter change.

[0014] Furthermore, the rapid exchange chamber is designed as a multi-layer structure, which is divided into an outermost layer, a middle layer, and an innermost layer.

[0015] Furthermore, the outermost layer of the rapid exchange chamber is made of Pebax, PU or Peek, and the innermost layer is made of fluorine material; the middle layer is one or more layers, and the material is a metal wire braided layer or an inner and outer layer transition material.

[0016] The electrode pair is a ring electrode-head electrode pair or a ring electrode pair.

[0017] Compared with the prior art, the technical solution of the utility model has the following beneficial effects:

[0018] 1. The utility model provides a transcarotid intracranial EEG signal detection catheter. The intravascular electrodes follow the blood vessels within these natural folds to detect signals in brain regions traditionally used for recording and regulating treatment, minimizing tissue damage or inflammatory response.

[0019] 2. Due to the limited thickness of the blood vessel wall, catheter electrodes usually record LFPs or other low-frequency local signals from tissues within a few millimeters of the electrode; intravascular electrodes follow the blood vessels within these natural folds to detect signals from brain regions traditionally used for recording and regulating treatment. For example, the catheter enters the temporal structure targeting the middle meningeal artery along the M1 segment (horizontal segment) until it reaches the M2 segment (insular segment) to detect EEG signals in this area, and can even cross the M2-M3 segment (sylvian fissure segment) bend structure to reach the M4 segment (cortical segment). BRIEF DESCRIPTION OF THE DRAWINGS

[0020] Figure 1 This is a front view of the overall structure of the straight structure transcarotid artery intracranial electrical signal detection catheter of Example 1 of the present utility model;

[0021] Figure 2 This is a top view of the overall structure of the intracranial electrical signal detection catheter via the carotid artery in Example 1 of the present utility model;

[0022] Figure 3 This is a cross-sectional view of the intracranial electrical signal detection catheter via the carotid artery along the AA perspective of Example 1 of the present invention;

[0023] Figure 4 This is a structural diagram of the tip end of a catheter for detecting intracranial electrical signals via the carotid artery according to Example 1 of the present utility model;

[0024] Figure 5 This is a projection diagram of the first perspective of the intracranial electrical signal detection catheter via the carotid artery in Example 1 of the present utility model;

[0025] Figure 6 This is a front view of the overall structure of the transcarotid intracranial electrical signal detection catheter according to Example 1 of the present utility model;

[0026] Figure 7 This is a cross-sectional view of the overall structure of the intracranial electrical signal detection catheter via the carotid artery according to Example 1 of the present invention taken along the BB perspective;

[0027] Figure 8 A front view of the overall structure of the intracranial electrical signal detection catheter with a preset curved structure for transcarotid artery detection according to Example 2 of the utility model;

[0028] Among them: 10, connecting seat; 101, bending control knob; 102, internal needle pin; 20, three-way side branch tube; 30, proximal tube; 40, distal tube; 401, straight structure; curved structure 402; 4011, quick exchange outlet; 4012, liquid hole; 4013, catheter central cavity; 4014, wire hole; 50, quick exchange cavity; 60, electrode pair; 602, head electrode; 70, development ring; 80, terminal head end. DETAILED DESCRIPTION

[0029] The following will clearly and completely describe the technical solutions of this application in conjunction with the embodiments. Obviously, the embodiments described are only part of the embodiments of this application, not all of them. Based on the embodiments in this application, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of this application.

[0030] In the description of this utility model, it should be noted that terms such as "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer" are used to indicate positions or locations based on the positions or locations shown in the accompanying drawings. These terms are intended solely to facilitate the description of this utility model and simplify the description. They are not intended to indicate or imply that the devices or components referred to must have a specific orientation, be constructed, or operate in a specific orientation. Therefore, they should not be construed as limitations on this utility model. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0031] In the description of this utility model, it should be noted that, unless otherwise expressly specified or limited, the terms "mounted," "connected," and "connected" should be understood broadly. For example, they may refer to fixed, detachable, or integral connections; mechanical or electrical connections; direct or indirect connections through an intermediary; and internal communication between two components. Those skilled in the art will understand the specific meanings of these terms in this utility model based on the specific circumstances.

[0032] In this application, the “proximal end” may be considered as the end closer to the operator, and the “distal end” may be considered as the end farther away from the operator.

[0033] The utility model of the intracranial EEG signal detection catheter via the carotid artery is as follows: Figure 1 Its structure mainly includes a connecting seat 10, a three-way side branch tube 20, a proximal tube 30, a distal tube 40, a rapid exchange chamber 50, an electrode pair 60, a developing ring 70 and a terminal head end 80.

[0034] The connector 10 is a Lemo plug for connecting devices. The number of internal pins 102 is related to the number of electrode pairs 60. A bending knob 101 is provided on the surface for controlling the bending of the catheter. This structure can be configured according to the clinical usage scenario.

[0035] The three-way side branch tube 20 mainly includes a three-way valve and a side branch tube, and is used for the injection of liquids such as normal saline, heparin, and therapeutic drugs during the diagnosis process;

[0036] The proximal tube 30 is a single-lumen tube with a length ranging from 30cm to 70cm, an outer diameter ranging from 1.6mm to 2.2mm, and an inner diameter ranging from 1.0mm to 2.0mm. It is made of high-strength / hardness, low-friction materials such as segmented polyetheramide elastomer (Pebax), polyetheretherketone (Peek), and polyethylene (PE). It is mainly used to move in thicker blood vessels. The larger tube diameter and wall thickness further improve the catheter's pushability, support, and torsion / bending resistance.

[0037] The distal tube 40 has two structural forms, namely a straight structure 401 and a preset curved structure 402. Both have a rapid exchange outlet 4011, a liquid hole 4012 and a wire hole 4014. The rapid exchange outlet 4011 is connected to the rapid exchange cavity 50 by bonding or welding; the liquid hole 4012 is connected to the central cavity 4013 of the catheter and the three-way side branch 20, and liquid is injected through the three-way side branch 20; the surface of the electrode wire and the bending control wire is insulated to ensure that there is no interference between them, and they share the wire hole 4013; the preset curved structure 402 is used to enter curved blood vessels, such as the middle meningeal artery The M2-M4 segment, with its pre-set curve, provides better contact with the vessel wall, increasing the accuracy and effectiveness of EEG signal acquisition. Several curvature values ​​corresponding to the M2-M4 segment of the middle meningeal artery are available, such as R1 for the M3-M4 curve, R2 for the M2-M3 curve, and R3 for the M1-M2 curve. Because different curvatures are applied to different vascular locations, they require different material strength and flexibility. The distal tube 40 can be variable or single-diameter, with multiple continuous or discrete steps to accommodate the varying morphologies and diameters of the target vessel, ensuring a smooth and safe delivery process. Furthermore, it closely matches the lumen of the target vessel, improving the accuracy and precision of EEG signal acquisition. The distal tube 40 has an outer diameter ranging from 0.8mm to 2mm, an inner diameter ranging from 0.5mm to 1.7mm, and a total length ranging from 20cm to 50cm. The distal tube 40 is connected to the proximal tube by bonding, welding, soldering, heat shrinking, etc., and the connection is smooth. The surface of the distal tube 40 is coated with a hydrophilic coating to reduce the friction coefficient of the catheter surface and improve the passability of the catheter.

[0038] The rapid exchange cavity 50 is prone to "fish mouth" phenomenon and tearing failure at the rapid exchange outlet due to the frequent contact and friction between the entire lumen and the guide wire. A single-layer or multi-layer structural design is adopted to ensure the support and flexibility of the rapid exchange cavity 50. When passing through the curved part of the blood vessel, it fits well with the guide wire and there is no "fish mouth" phenomenon or tearing failure. The outermost layer can be made of materials such as Pebax, PU and Peek, which have good flexibility and certain strength; the innermost layer can be made of fluorine materials such as FEP, PTFE, etc., which have less friction with the guide wire and better tracking performance; the middle layer can be one or more layers, and can be made of metal wire braided layers, inner and outer layer transition materials, etc., which can not only regulate the strength of the entire structure, but also provide a medium to make the outermost layer and the innermost layer easy to combine.

[0039] The electrode pair 60 can be set with different numbers of electrode pairs according to the area or length of the actual EEG signal collection area, the inner diameter is related to the outer diameter of the distal tube, the wall thickness range is 0.05mm-0.2mm, and the width is 0.5mm-3mm; the head electrode pair can adopt a ring electrode-head electrode pair or a ring electrode pair. When the ring electrode-head electrode pair is adopted, it is suitable for stenosis of blood vessels in the target area, and the catheter cannot or does not need to be pushed further. The head electrode structure has a larger signal collection range; when the ring electrode pair is adopted, it is suitable for blood vessels in the target area with a suitable diameter, and the collection area is located in the radial position of the blood vessel. The head end structure is the terminal head end 80, and the conical structure makes it easier to gradually expand the blood vessels and reduce damage to the blood vessel walls. It should be noted that the use scenarios of the above two structures can overlap with each other, depending on clinical needs.

[0040] The number of electrode pairs ranges from 1 to 20, and the number of electrodes ranges from 2 to 40, corresponding to the number of pins inside the Lemo plug. A greater number of electrode pairs results in denser and more accurate signal acquisition, but also reduces the catheter's ability to navigate corners. For less curved vessels, such as the M1-M2 segment of the middle cerebral artery, 10 to 16 electrode pairs are preferred for more accurate signal acquisition. For more curved vessels, such as the M2-M3 and M3-M4 segments of the middle cerebral artery, 2 to 5 electrode pairs are preferred to ensure both passability and accuracy.

[0041] The developing ring 70, positioned between the distal tube 40 and the tip electrode 602 / terminal tip 80, is opaque and, under radiographic conditions, highlights the catheter tip, facilitating clinical identification of the catheter tip's position within the blood vessel. The ring is constructed from a low-transparency metal material such as platinum, iridium, tantalum, or their alloys.

[0042] The present technical solution is now further described in conjunction with the embodiments: Example

[0043] A transcarotid intracranial EEG signal detection catheter, primarily used clinically for placement at the middle cerebral artery (M1), but also at the M2. Its structure primarily includes a connector 10, a three-way side branch 20, a proximal tube 30, a distal tube 401, a rapid exchange lumen 50, an electrode pair 60, a development ring 70, and a distal tip 80.

[0044] The connector 10 is a Lemo plug for connecting devices. There are five electrode pairs 60, including four ring electrode pairs and one ring electrode-head electrode pair, corresponding to ten internal pins 102. A bend control knob 101 is provided on the surface for controlling the bend of the catheter, facilitating entry into the M2 bending structure.

[0045] The three-way side branch tube 20 mainly includes a three-way valve and a side branch tube. The three-way valve is made of polycarbonate (PC) and the side branch tube is made of PU (polyurethane). It is used for the injection of liquids such as normal saline, heparin, and therapeutic drugs during the diagnosis process;

[0046] The proximal tube 30 is a single-lumen tube structure with a length of 40 cm, an outer diameter of 1.8 mm, and an inner diameter of 1.2 mm. It is made of polyetheretherketone (PEK), which has high strength / hardness and low friction. It mainly moves within the femoral vein-iliac artery-aorta. The large tube diameter and wall thickness further improve the catheter's pushability, support, and torsion / bending resistance.

[0047] The distal tube 40 is a straight structure 401, made of segmented polyetheramide elastomer Pebax, and includes a rapid exchange outlet 4011, a liquid hole 4012 and a wire hole 4014. The rapid exchange outlet 4011 is connected to the rapid exchange cavity 50 by bonding; the liquid hole 4012 is connected to the central cavity 4013 of the catheter and the three-way side branch 20, and liquid is injected through the three-way side branch 20. Heparin is injected regularly to prevent thrombosis in the central cavity, and other related drugs can also be injected as needed; the surface of the electrode wire and the bending control wire are insulated to ensure that there is no interference between them, and they share the wire hole 4013; the distal tube 40 can be a variable diameter structure, consisting of two sections of variable diameter, the proximal variable diameter length range is 20 cm, the outer diameter is 1.8 mm, and the inner diameter is 1.2 mm, and it is butt-connected to the proximal tube, the distal variable diameter length range is 30 cm, the outer diameter is 1.4 mm, and the inner diameter range is 0.8 mm, with a smooth transition to the proximal variable diameter end to reduce friction and stress concentration;

[0048] The Rapid Exchange Lumen 50 features a three-layer design, ensuring support and flexibility. When passing through curved blood vessels, it adheres well to the guidewire, preventing "fishmouthing" and tearing. The outermost layer is Pebax, which offers excellent flexibility and strength. The innermost layer is PTFE, which minimizes friction with the guidewire and improves tracking. The middle layer is LDPE, serving as a transition layer connecting the outer Pebax and PTFE layers.

[0049] Electrode pairs 60 are provided with four ring electrode pairs and one ring electrode-tip electrode pair. The ring electrode dimensions are 1.4mm inner diameter, 1.5mm outer diameter, and 1.4mm tip electrode diameter. The ring electrode-tip electrode pair is suitable for use in cases where the target blood vessels are narrow and the catheter cannot or does not need to be pushed further. The tip electrode structure has a wider signal acquisition range. The ring electrode pair is suitable for use in cases where the target blood vessels have an appropriate diameter and the acquisition area is located radially from the vessel.

[0050] The developing ring 70 is arranged between the distal tube 40 and the head electrode 602 / the terminal head end 80. It is made of tantalum metal material in an annular structure with a length of 2 mm and a wall thickness of 0.07 mm. It is opaque and can be highlighted under radiation conditions, which is convenient for marking the position of the catheter tip in the blood vessel in clinical practice. Example

[0051] A transcarotid intracranial EEG signal detection catheter is mainly used in clinical practice to be placed at the position of the middle cerebral artery M3 or even M4. The main structure is the change of the distal tube 402, such as Figure 8 As shown, R1 corresponds to the arc of M3-M4 with a radius of 5mm, R2 corresponds to the arc of M2-M3 with a radius of 2mm, and R3 corresponds to the arc of M1-M2 with a radius of 6mm. This provides better contact with the blood vessel wall, increasing the accuracy and effectiveness of EEG signal acquisition. Because different arcs are located in different blood vessels, the strength and flexibility of the material are different. The distal tube 402 is a continuously variable structure, consisting of two sections. The proximal variable diameter ranges from 20cm in length, with an outer diameter of 1.8mm and an inner diameter of 1.2mm. It is connected to the proximal tube and has a distal variable diameter range of 30cm in length, an outer diameter range of 1.4-0.8mm, and an inner diameter of 0.8-0.5mm. The distal variable diameter section and the proximal variable diameter end have a smooth transition to reduce friction and stress concentration.

[0052] The above-described embodiments are only specific implementation methods of the present application, which are used to illustrate the technical solutions of the present application, rather than to limit them. The scope of protection of the present application is not limited thereto. Although the present application has been described in detail with reference to the above-mentioned embodiments, those skilled in the art should understand that any person skilled in the art can still modify the technical solutions described in the above-mentioned embodiments within the technical scope disclosed in the present application, or can easily think of changes, or make equivalent replacements for some of the technical features therein; and these modifications, changes or replacements do not deviate from the essence of the corresponding technical solutions from the spirit and scope of the technical solutions of the embodiments of the present application, and should all be included in the scope of protection of the present application. Therefore, the scope of protection of the present application shall be based on the scope of protection of the claims.

Claims

1. A transcarotid intracranial EEG signal detection catheter, characterized in that: It includes a connecting seat, a three-way side branch tube, a proximal tube, a distal tube, a rapid exchange chamber, an electrode pair, and a developing ring; wherein, Connecting socket, used to connect equipment; Three-way side branch tube, used for the injection of normal saline, heparin, and therapeutic drugs during the diagnosis process; a proximal tube, used for navigation within the blood vessel; The distal tube is connected to the proximal tube and is used to enter the blood vessels to collect EEG signals; Rapid exchange chamber provides a guidewire channel for rapid entry or withdrawal of the guidewire; The electrode pair contacts the blood vessel wall or soft tissue to form an electrical signal loop for collecting EEG signals; The developing ring is arranged between the distal tube and the electrode pair and is used to mark the position of the catheter tip in the blood vessel.

2. The carotid artery intracranial EEG signal detection catheter according to claim 1, characterized in that: The electrode pair includes a head electrode pair or a terminal head end, which is used to dilate blood vessels and guide the catheter to the target position.

3. The carotid artery intracranial EEG signal detection catheter according to claim 2, characterized in that: The three-way side branch pipe includes a three-way valve and a side branch pipe.

4. The carotid artery intracranial EEG signal detection catheter according to claim 3, characterized in that: The proximal tube is a single-lumen tube structure with a length ranging from 30 cm to 70 cm, an outer diameter ranging from 1.6 mm to 2.2 mm, and an inner diameter ranging from 1.0 mm to 2.0 mm.

5. The carotid artery intracranial EEG signal detection catheter according to claim 4, characterized in that: The distal tube comprises a rapid exchange outlet, a liquid hole and a wire hole; the rapid exchange outlet is connected to the rapid exchange cavity; the liquid hole and the wire hole are in communication with the three-way side branch tube.

6. The carotid artery intracranial EEG signal detection catheter according to claim 5, characterized in that: The distal tube is a straight structure or a preset curved structure.

7. The carotid artery intracranial EEG signal detection catheter according to claim 6, characterized in that: The distal end tube is of a variable diameter or single diameter structure, and the diameter change is a multi-stage continuous diameter change or a multi-stage discrete diameter change.

8. The carotid artery intracranial EEG signal detection catheter according to claim 7, characterized in that: The rapid exchange chamber is designed as a multi-layer structure, divided into the outermost layer, the middle layer and the innermost layer.

9. The carotid artery intracranial EEG signal detection catheter according to claim 8, characterized in that: The outermost layer of the rapid exchange chamber is made of Pebax, PU or Peek, and the innermost layer is made of fluorine material; the middle layer is one or more layers, and the material is a metal wire braided layer or an inner and outer layer transition material.

10. The carotid artery intracranial EEG signal detection catheter according to claim 9, characterized in that: The electrode pair is a ring electrode-head electrode pair or a ring electrode pair.

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