Intelligent pressure monitoring guide wire system for thrombus removal

Abstract

The invention relates to the field of medical instruments, and discloses a pressure guide wire for thrombus removal. The pressure guide wire comprises a guide wire body and a control handle, the guide wire body is provided with an outer-layer polymer covering film, an inner-layer metal pipe, a core, a pressure sensor and a sensor wire, and the control handle comprises a handle body, a locking device, a pushing rod, a circuit board, an indicator lamp and a switch. The pressure sensor is configured to detect the pressure change in the blood vessel in real time in the thrombus removal operation and is used for recognizing the thrombus position, and when the detected pressure exceeds a preset threshold value, the circuit board controls the indicator light to emit light to provide instant thrombus position feedback information for an operator. According to the pressure guide wire, thrombus can be accurately positioned, the success rate and safety of thrombus removal operation are improved, and operation risks are reduced.

Description

Technical Field

[0001] The present application relates to the field of medical devices, and in particular to a pressure guidewire technology used for thrombectomy. Background Art

[0002] Thrombosis is a serious vascular disease that can lead to organ ischemia, embolism, and other serious complications. With the development of interventional treatment technology, mechanical thrombectomy (PMT) has become one of the important means of treating thrombosis. However, existing thrombectomy technology still faces some challenges.

[0003] Traditional thrombectomy usually relies on contrast agents and X-ray imaging to locate thrombi, which not only increases the patient's radiation exposure and kidney burden, but also makes it difficult to monitor the precise location of thrombi in real time. In addition, in complex vascular structures, it is difficult to accurately determine the specific location and range of thrombi by relying solely on imaging methods, which may lead to incomplete removal or unnecessary damage to healthy vascular tissue.

[0004] Existing pressure guidewires are mainly used to measure vascular indicators and have not yet been widely used in thrombectomy. Simple suction devices often lack the ability to accurately locate thrombi, which may lead to excessive suction and increase patient blood loss. At the same time, the design of traditional guidewires is difficult to take into account the applicability and maneuverability in blood vessels of different calibers, limiting their application in complex vascular environments.

[0005] In addition, the existing technology lacks a thrombus localization method that can provide real-time and intuitive feedback, making it difficult for operators to adjust surgical strategies in a timely manner. The durability and stability of pressure sensors are also an issue that needs to be addressed, as they are easily damaged when repeatedly crossing narrow blood vessels, affecting the accuracy of detection.

[0006] In terms of operation, existing guidewire control devices often lack fine adjustment capabilities, making it difficult to achieve precise positioning and stable control in complex vascular environments. At the same time, the lack of an intelligent pressure threshold adjustment system makes it difficult to flexibly adjust according to different patients and vascular conditions, affecting the personalization and precision of the surgery.

[0007] Finally, existing technologies generally lack the ability to perceive the pressure distribution in the cross-section of the blood vessel, making it difficult to fully assess the impact of thrombus on the blood vessel wall, which may lead to inaccurate formulation of clearance strategies.

[0008] In view of the above problems, there is an urgent need for a new type of pressure guidewire that can accurately locate thrombus, adapt to different vascular environments, provide real-time feedback, ensure long-term stability, reduce the risk of vascular injury, improve operational convenience, support intelligent control and fully perceive vascular pressure distribution, so as to improve the success rate and safety of thrombectomy. Summary of the invention

[0009] The purpose of the present application is to provide an intelligent pressure monitoring guidewire system for thrombectomy to solve the problems raised in the above-mentioned background technology.

[0010] The present application discloses an intelligent pressure monitoring guidewire system for thrombus removal, comprising:

[0011] A guidewire having a proximal end and a distal end, comprising:

[0012] An outer polymer film with a lubricating coating;

[0013] An inner metal tube is coaxially disposed in the outer polymer coating;

[0014] A core, coaxially disposed in the inner metal tube;

[0015] A pressure sensor, disposed at the distal end of the guidewire, for detecting pressure changes in the blood vessel;

[0016] A sensor wire, electrically connected to the pressure sensor, radially arranged between the inner metal tube and the outer polymer coating, and extending along the axial direction of the guide wire;

[0017] A control handle is detachably connected to the proximal end of the guide wire, and the control handle comprises:

[0018] A handle body, with a guide wire passage extending therethrough, for slidably accommodating and guiding the guide wire;

[0019] a locking device, adjustably disposed on the handle body, for selectively fixing the position of the guide wire in the guide wire channel;

[0020] A push rod connected to the proximal end of the guide wire and used to control the axial pushing and retraction of the guide wire;

[0021] A circuit board is disposed in the handle body and is electrically connected to the proximal end of the sensor wire;

[0022] An indicator light, disposed on the outer surface of the handle body and electrically connected to the circuit board;

[0023] A switch, disposed on the outer surface of the handle body and electrically connected to the circuit board, for controlling the working state of the pressure guide wire;

[0024] The pressure sensor is configured to detect the pressure changes in the blood vessel in real time during thrombus removal surgery to identify the location of the thrombus. When the detected pressure exceeds a preset threshold, the sensor wire transmits a signal to the circuit board, and the circuit board controls the indicator light to provide the operator with instant feedback information on the location of the thrombus, thereby assisting in the precise implementation of the thrombus removal surgery.

[0025] In a preferred embodiment, the inner metal tube comprises:

[0026] A distal flexible tube, disposed at the distal end of the guide wire;

[0027] A proximal support tube, arranged at the proximal end of the guide wire;

[0028] A connecting portion, used to connect the distal flexible tube to the proximal support tube;

[0029] Among them, the distal flexible tube includes a distal spring tube or a distal metal-free tube; the proximal support tube includes a proximal snake tube or a braided tube; the connecting part adopts at least one of welding, bonding or mechanical connection to realize the connection between the distal flexible tube and the proximal support tube.

[0030] In a preferred embodiment, the pressure sensor is a microelectronic sensor or a thin film sensor;

[0031] The sensing area of ​​the pressure sensor is set to be slightly lower than the highest point of its outer protective layer to avoid direct contact with the blood vessel wall and cause misjudgment;

[0032] The pressure sensor is fixed between the inner metal tube and the outer polymer film by glue dispensing, and the protective layer formed by glue dispensing is hemispherical.

[0033] In a preferred embodiment, it is characterized in that:

[0034] The pressure sensor is fixed between the inner metal tube and the outer polymer film by glue dispensing;

[0035] The dispensing forms a hemispherical protective structure, which covers the pressure sensor;

[0036] The sensing area of ​​the pressure sensor is arranged at a position slightly below the highest point of the hemispherical protective structure;

[0037] The hemispherical protective structure is used to protect the pressure sensor, while allowing the sensing area to effectively sense the pressure changes in the blood vessel and avoid direct contact with the blood vessel wall to cause misjudgment.

[0038] In a preferred embodiment, the core is made of nickel-titanium alloy or stainless steel wire, or is welded from a front nickel-titanium alloy and a rear stainless steel wire.

[0039] In a preferred embodiment, the locking device comprises:

[0040] A locking knob rotatably disposed on the handle body;

[0041] A support platform, fixedly disposed in the handle body and located directly below the locking knob;

[0042] A through channel vertically penetrates the locking knob and the support platform to form a part of the guide wire channel;

[0043] Wherein, the bottom of the locking knob and the top of the support platform are both provided with a groove for accommodating the guide wire, and the groove is connected to the through channel;

[0044] When the locking knob is rotated downward, the groove at the bottom of the locking knob is relatively closed with the groove at the top of the support platform, thereby controllably clamping the guide wire to achieve adjustable fixation of the guide wire;

[0045] The cross section of the groove is semicircular or V-shaped, and its shape and size are designed to evenly distribute pressure in the locked state to avoid damage to the guide wire to the greatest extent;

[0046] The locking knob is also provided with an anti-slip texture, which facilitates the operator to perform fine adjustments.

[0047] In a preferred example, it is characterized in that: the circuit board is configured to set multiple pressure thresholds according to the blood vessel type, wherein the circuit board includes a microprocessor and a memory; the memory pre-stores multiple pressure threshold levels corresponding to different blood vessel types and pathological states; the microprocessor is configured to:

[0048] receiving and processing the pressure signal from the pressure sensor in real time;

[0049] Automatically selects applicable vessel type and lesion status based on user input or preset algorithms;

[0050] Calling the corresponding pressure threshold level according to the selected blood vessel type and lesion status;

[0051] dynamically comparing the real-time pressure signal to a selected pressure threshold;

[0052] When the detected pressure exceeds a selected threshold, immediately triggering the indicator light to illuminate in a specific pattern and optionally generating an audible alarm;

[0053] The control handle also includes a user interface electrically connected to the circuit board, and the user interface includes:

[0054] A display screen, used to display pressure values ​​and selected blood vessel type information in real time;

[0055] Control buttons allow the operator to manually select or fine-tune the pressure threshold level;

[0056] Wherein, the pressure threshold level can be remotely updated and optimized based on the latest clinical data and usage feedback through a wireless communication interface;

[0057] The microprocessor is also configured to record pressure change trends and generate a pressure change report after surgery to assist in postoperative analysis and treatment evaluation.

[0058] In a preferred embodiment, it also includes:

[0059] A light source is disposed in the handle body;

[0060] an optical fiber, disposed in the guide wire, one end of which is optically connected to the light source and the other end of which extends to the distal end of the guide wire;

[0061] an optical window, disposed at the distal end of the guidewire and optically connected to the distal end of the optical fiber;

[0062] A light source control switch, disposed on the handle body and electrically connected to the light source;

[0063] A light detector, used for detecting a light signal returned by the sensor, and for outputting a signal;

[0064] in,

[0065] The optical fiber is used to transmit the optical signal from the light source;

[0066] The optical window is used to emit a light signal from the inside of the guide wire to indicate the location of the thrombus;

[0067] The wavelength and intensity of the light source are optimized to provide a clearly visible light signal within the blood vessel while minimizing thermal effects on surrounding tissue;

[0068] The light source control switch is used to control the opening and closing of the light source and adjust the light intensity;

[0069] When the pressure sensor detects that the pressure exceeds a preset threshold, the circuit board can automatically trigger the light source to turn on, and send out a light signal through the optical fiber and the optical window, which cooperates with the indicator light to provide the operator with a double thrombus position indication.

[0070] In a preferred embodiment, it is characterized in that:

[0071] The pressure sensor includes two independent sensor units, which are respectively arranged on the left and right sides of the distal end of the guide wire;

[0072] Each sensor unit consists of:

[0073] Pressure-sensitive element, used to sense local blood vessel pressure;

[0074] A signal processing circuit, used for preliminarily processing the pressure signal collected by the pressure-sensitive element;

[0075] The two sensor units are electrically connected to the circuit board via independent sensor wires;

[0076] The circuit board is configured as:

[0077] Respectively receiving and processing pressure signals from two sensor units;

[0078] Compare the pressure difference between the two sensor cells;

[0079] Calculate the pressure distribution on the cross-section of the blood vessel based on the pressure difference;

[0080] in,

[0081] The arrangement of two sensor units enables the pressure guidewire to detect differences in pressure distribution across the cross section of the blood vessel;

[0082] By analyzing the difference in pressure distribution, the location of the thrombus can be more accurately located and the extent of the thrombus's impact on the blood vessel wall can be assessed;

[0083] The design can also be used to detect other vascular pathologies such as vascular stenosis or malformations.

[0084] In a preferred embodiment, it is characterized in that:

[0085] The outer polymer film is made of at least one of the following materials:

[0086] Polyethylene (PE);

[0087] Thermoplastic polyurethane (TPU);

[0088] Polytetrafluoroethylene (PTFE);

[0089] Nylon;

[0090] Polyamide (PA);

[0091] Polyether block amide (PEBA);

[0092] in,

[0093] The outer polymer coating may be a single-layer structure or a multi-layer composite structure;

[0094] When it is a multi-layer composite structure, it can be composed of different materials to optimize the comprehensive performance of the coating;

[0095] The thickness of the outer polymer coating ranges from 0.01 mm to 0.1 mm;

[0096] The selected materials have been tested for biocompatibility to ensure safety in long-term contact with human tissue;

[0097] The surface of the outer polymer coating may be treated to be hydrophilic or hydrophobic to improve its sliding performance in the blood vessel.

[0098] In a preferred embodiment, the outer diameter of the guide wire ranges from 0.2 mm to 1 mm, and the total length ranges from 100 cm to 300 cm;

[0099] The guide wire comprises a distal portion, a proximal portion, a soft tip and a transition section; wherein,

[0100] The outer coating of the soft tip is doped with developing materials such as barium sulfate and bismuth trioxide for intraoperative development;

[0101] The distal portion includes a section where the pressure sensor is located, has an outer diameter ranging from 0.2 mm to 1 mm, and a length of not less than 30 cm;

[0102] The outer diameter of the proximal part can be gradually increased, but the maximum outer diameter does not exceed 0.889 mm. It is made of high-strength alloy material to provide pushability and torsion control;

[0103] The soft tip is located at the distal end of the guidewire, with a length of 1 cm to 5 cm. The outer diameter gradually decreases from the proximal end to the distal end, and can be as small as 0.204 mm. It is made of highly soft polymer or alloy material.

[0104] The transition section is located between the soft tip and the pressure sensor and is used to achieve a gradual change in the stiffness of the guidewire;

[0105] Among them, the above-mentioned size parameters can be adjusted within the range of ±10% according to different blood vessel types and interventional surgery requirements to adapt to various clinical application scenarios.

[0106] Compared with the prior art, the embodiments of the present application have at least the following differences and effects:

[0107] The present application provides an intelligent pressure monitoring guidewire system for thrombectomy, which has the following significant technical effects in thrombectomy:

[0108] Accurately locate the thrombus and improve the success rate of the operation: In thrombectomy, quickly and accurately locating the thrombus is the key to successful removal. Through the pressure sensor set at the distal end of the guide wire, the present application can detect the pressure changes in the blood vessel in real time, especially the pressure fluctuations caused by the thrombus site. When the pressure sensor detects abnormally high pressure, it can accurately identify the location of the thrombus. This real-time pressure monitoring significantly improves the accuracy of thrombus positioning and provides the operator with important surgical reference information, thereby improving the success rate of the operation.

[0109] Flexible size design to adapt to different vascular environments: The blood vessels involved in thrombectomy may include arteries, veins, and even tiny peripheral blood vessels. In order to cope with different vascular environments, the present application provides a guidewire design with adjustable outer diameter and length range to ensure that the guidewire can be smoothly guided in blood vessels of different sizes. The small outer diameter of the distal part enables the guidewire to enter narrow or blocked vascular areas, while the larger outer diameter of the proximal part provides sufficient rigidity to facilitate the operator to accurately control the push and retraction of the guidewire. This flexible size design enables the guidewire to achieve ideal results in different types of thrombectomy surgeries.

[0110] Intelligent adjustment of multiple pressure thresholds and personalized surgical plans: During thrombectomy, different patients have different vascular conditions and thrombus characteristics. The pressure guidewire of this application is equipped with an intelligent circuit board, which can flexibly set multiple pressure thresholds according to vascular type, lesion site and surgical requirements. The operator can manually select or rely on a preset algorithm to automatically match the appropriate pressure threshold level. This personalized adjustment function ensures that the guidewire can achieve optimal monitoring accuracy in different clinical scenarios, improves the personalization level of the operation, and reduces the risk of misoperation due to inappropriate pressure monitoring.

[0111] Dual feedback mechanism provides real-time intraoperative guidance: In thrombus removal surgery, timely and accurate feedback is crucial for the operator. This application provides real-time intraoperative guidance to the operator through a dual feedback mechanism of vision and optics. When the guidewire passes through the thrombus area, the abnormal pressure detected by the pressure sensor will send a warning signal through the indicator light on the handle, prompting the operator to take appropriate actions. At the same time, the light source at the end of the guidewire transmits the light signal to the thrombus position through the optical fiber, intuitively displaying the specific location of the thrombus. This dual feedback mechanism not only improves the operator's control accuracy of the guidewire position, but also avoids misjudgment, ensuring that every step in the operation is accurately guided.

[0112] The protection design of the pressure sensor ensures long-term stability: The guidewire in thrombectomy needs to repeatedly pass through narrow or diseased blood vessel areas, which places extremely high demands on the durability of the guidewire. The hemispherical protection structure formed by the dispensing method in this application effectively wraps the pressure sensor to prevent it from direct contact with the blood vessel wall and avoid physical damage or wear. At the same time, the sensing area of ​​the sensor is set slightly below the highest point of the protective layer, which can not only achieve sensitive pressure detection, but also reduce misjudgment. This protection design greatly improves the durability and stability of the sensor, ensuring that the guidewire remains efficient during long-term surgery and will not affect the progress of the operation due to sensor failure.

[0113] Soft tip and transition section design to reduce vascular damage: During thrombus removal, the guidewire usually needs to pass through narrow, tortuous diseased blood vessels. Especially when approaching a thrombus, the softness of the guidewire is crucial. The present application designs a soft tip at the farthest end of the guidewire and achieves a gradual change in stiffness through the transition section. This design effectively prevents mechanical damage to the vessel wall when the guidewire passes through a tortuous part of the vessel or near a thrombus, reduces the risk of thrombus rupture or vascular damage, and ensures the safety of the operation.

[0114] Flexible guidewire fixing and pushing device improves the convenience of operation: Thrombectomy requires high precision in the positioning and pushing of the guidewire. This application designs an adjustable locking device and a pushing rod. The operator can accurately fix the position of the guidewire through the locking knob and control the advancement or withdrawal of the guidewire through the pushing rod. This design simplifies the operation process, ensures the stability of the guidewire, enables the operator to more accurately control the movement of the guidewire in the blood vessel, and improves the operation efficiency of the operation.

[0115] Visual operation reduces surgical complexity: During thrombus removal, the light source signal transmitted by the optical fiber can send out optical indications at the end of the guidewire, helping the operator to confirm the position of the guidewire in the blood vessel in real time, especially providing powerful guidance in complex vascular pathways. This visual operation mode enables the operator to intuitively judge whether the thrombus area has been approached, avoiding the risks brought by blind operation, and greatly reducing the complexity and uncertainty of the operation.

[0116] Intelligent control and remote update to adapt to different clinical needs: The circuit board of this application can flexibly set the pressure threshold level through the microprocessor and memory, and supports remote update through the wireless communication interface. In this way, the guidewire can be optimized in real time according to the latest clinical data and usage feedback to adapt to different clinical scenarios and lesion states. This intelligent control and adaptive update function ensures that the pressure guidewire can always keep pace with clinical needs, improving the success rate and safety of the operation.

[0117] Multi-sensor layout improves spatial pressure perception capabilities: During thrombectomy, pressure changes in blood vessels occur not only in the longitudinal position of the thrombus, but also involve pressure distribution on the cross section. This application arranges two pressure sensors on both sides of the distal end of the guidewire to accurately sense the pressure distribution on the cross section of the blood vessel, helping the operator to better understand the overall impact of the thrombus on the blood vessel. This multi-sensor layout not only improves the accuracy of pressure detection, but also more accurately assesses the degree of compression of the thrombus on the blood vessel wall, helping operators to formulate thrombus removal strategies more effectively.

[0118] In summary, the pressure guidewire of the present application shows excellent technical effects in thrombus removal. Its pressure sensor, adjustable size design, dual feedback mechanism, soft tip and transition design, and intelligent control system provide strong support for the precise positioning, rapid removal and intraoperative operation of thrombus. Through the application of this guidewire, the operator can perform surgery accurately and flexibly in a complex vascular environment, reduce surgical risks, improve the success rate, and provide patients with safer and more effective treatment options.

[0119] A large number of technical features are recorded in the specification of this application, which are distributed in various technical solutions. If all possible combinations of technical features of this application (i.e., technical solutions) are to be listed, the specification will be too long. In order to avoid this problem, the various technical features disclosed in the above invention content, the various technical features disclosed in the various embodiments and examples below, and the various technical features disclosed in the accompanying drawings can be freely combined with each other to form various new technical solutions (these technical solutions are all deemed to have been recorded in this specification), unless such a combination of technical features is technically infeasible. For example, in one example, feature A+B+C is disclosed, and in another example, feature A+B+D+E is disclosed, and features C and D are equivalent technical means that play the same role. Technically, only one can be used, and it is impossible to use them at the same time. Feature E can be combined with feature C technically. Then, the solution of A+B+C+D should not be deemed to have been recorded because it is technically infeasible, and the solution of A+B+C+E should be deemed to have been recorded. BRIEF DESCRIPTION OF THE DRAWINGS

[0120] Figure 1 It is a schematic structural diagram of an intelligent pressure monitoring guidewire system for thrombectomy according to the first embodiment of the present application.

[0121] Figure 2 It is a schematic diagram of the overall structure of an intelligent pressure monitoring guidewire system for thrombectomy according to the first embodiment of the present application.

[0122] Figure 3It is a top view of the control handle of the intelligent pressure monitoring guidewire system for thrombectomy according to the first embodiment of the present application.

[0123] Figure 4 It is a schematic diagram of the cross-sectional structure of a control handle of an intelligent pressure monitoring guidewire system for thrombectomy according to the first embodiment of the present application.

[0124] Throughout the drawings, the same reference numerals are used to denote the same elements or structures, wherein:

[0125] 10 Guidewire system

[0126] 11 Outer polymer coating

[0127] 12 Inner metal tube

[0128] 13 Core

[0129] 14. Pressure Sensor

[0130] 15 Sensor wire

[0131] 16 Wire interface

[0132] 17. Piercing

[0133] 18 Housing

[0134] 19 Dispensing head

[0135] 20 Control handle system

[0136] 21 handle body

[0137] 211 Guidewire Channel

[0138] 22 Locking device

[0139] 221 Locking knob

[0140] 222 Support table

[0141] 223 Screw

[0142] 23 Push rod

[0143] 24 Circuit Board

[0144] 25 indicator lights DETAILED DESCRIPTION

[0145] In the following description, many technical details are provided to help readers better understand the present application. However, those skilled in the art can understand that the technical solution claimed in the present application can be implemented even without these technical details and various changes and modifications based on the following embodiments.

[0146] Explanation of terms

[0147] Guidewire: A guidewire is a thin, flexible medical device used to guide other equipment (such as a catheter) into a blood vessel, cavity or lumen during interventional surgery. The guidewire in this application is specifically designed to guide other equipment through a blood vessel to the location of a thrombus during thrombectomy.

[0148] Pressure sensor: A pressure sensor is a device that can detect and convert physical pressure signals, and is usually used to sense changes in blood pressure in a blood vessel. The pressure sensor in this application is installed at the distal end of the guidewire to monitor the pressure fluctuations in the blood vessel in real time, especially the pressure changes at the thrombus blockage, so as to accurately locate the thrombus.

[0149] Thrombectomy: Thrombectomy is an interventional treatment technique that is mainly used to remove blood clots in blood vessels to restore blood flow. The guidewire design in this application is particularly suitable for such surgery, and the pressure monitoring and feedback mechanism are used to improve the accuracy and safety of the surgery.

[0150] Soft tip: The soft tip of the guidewire is the most distal part of the guidewire, made of flexible material, and can safely pass through narrow or curved blood vessels, reducing damage to the blood vessel wall. The soft tip in this application is designed to have a gradually decreasing outer diameter to ensure that the guidewire does not cause mechanical damage to the blood vessel when approaching a thrombus. Optionally, the outer coating of the soft tip is doped with developing materials such as barium sulfate and bismuth trioxide for intraoperative development.

[0151] Transition section: The transition section is the part between the soft tip and the main body of the guidewire, and its function is to achieve a gradual change in the stiffness of the guidewire. The transition section in this application is designed in length and material to ensure that the guidewire has sufficient flexibility and maintains a certain degree of operational control when passing through complex blood vessels.

[0152] Light source: A light source is a low-temperature light source that is commonly used in medical equipment to provide lighting or signal indication. The light source in this application is used to transmit signals to the end of the guidewire through optical fiber to help the operator confirm the specific position of the guidewire and the thrombus situation in real time during surgery.

[0153] Optical fiber: Optical fiber is a thin and long material that can transmit light signals, usually used in the field of communication or lighting. The optical fiber in this application is used to transmit the light signal generated by the light source to the end of the guidewire, helping the operator to determine the location of the thrombus through the visual signal.

[0154] Locking device: The locking device is a structure used to fix the position of the guide wire to ensure that the guide wire remains stable during surgery. The locking device in this application achieves precise positioning of the guide wire through a knob and other structures to prevent unintentional movement or sliding.

[0155] Push rod: The push rod is a component used to push the guide wire forward or backward in the blood vessel. The push rod in this application is connected to the guide wire, and the operator can adjust the advance and retreat of the guide wire through the push rod to ensure that the guide wire can accurately reach the thrombus position.

[0156] Pressure threshold: The pressure threshold refers to the preset value of the pressure range detected by the pressure sensor. When the guidewire enters the high-pressure area where the thrombus is located, the pressure exceeds the set threshold, and the system will prompt through the feedback mechanism. The pressure threshold in this application can be adjusted according to different blood vessel types and surgical requirements to achieve personalized surgical operations.

[0157] Glue-dispensing structure: Glue-dispensing structure refers to applying adhesive or protective material to specific parts to fix and protect them. This application forms a hemispherical protective structure by glue dispensing to protect the pressure sensor from direct contact with the blood vessel wall, extend the service life of the sensor and improve monitoring accuracy.

[0158] Microprocessor: A microprocessor is an electronic chip used to perform calculations and logical operations. The microprocessor in this application is installed on the circuit board of the control handle to process the signal of the pressure sensor and adjust the pressure threshold and feedback mechanism according to the preset algorithm.

[0159] Vascular occlusion: Vascular occlusion refers to the partial or complete blockage of the blood flow channel due to the presence of thrombus or other substances, resulting in restricted or interrupted blood flow. The pressure guidewire of the present application can effectively identify the specific location of vascular occlusion by monitoring the pressure changes in the blood vessel in real time.

[0160] In order to make the objectives, technical solutions and advantages of the present application clearer, the implementation methods of the present application will be further described in detail below in conjunction with the accompanying drawings.

[0161] First embodiment

[0162] See also Figures 1 to 4 The intelligent pressure monitoring guidewire system 10 for thrombectomy of this embodiment includes:

[0163] A guidewire having a proximal end and a distal end, comprising:

[0164] The outer polymer coating 11 has a lubricating coating;

[0165] An inner metal tube 12 is coaxially disposed in the outer polymer film 11;

[0166] The core 13 is coaxially arranged in the inner metal tube 12;

[0167] A pressure sensor 14 is disposed at the distal end of the guidewire and is used to detect pressure changes in the blood vessel;

[0168] A sensor wire 15 is electrically connected to the pressure sensor 14, radially arranged between the inner metal tube 12 and the outer polymer coating 11, and extends along the axial direction of the guide wire;

[0169] A control handle 20 is detachably connected to the proximal end of the guide wire, and the control handle 20 includes:

[0170] The handle body 21 is provided with a guide wire channel 211 therein for slidably accommodating and guiding the guide wire;

[0171] A locking device 22, adjustably disposed on the handle body 21, for selectively fixing the position of the guide wire in the guide wire channel 211;

[0172] A push rod 23, connected to the proximal end of the guide wire, for controlling the axial pushing and retraction of the guide wire;

[0173] A circuit board 24 is disposed in the handle body 21 and is electrically connected to the proximal end of the sensor wire 15;

[0174] An indicator light 25 is disposed on the outer surface of the handle body 21 and is electrically connected to the circuit board 24;

[0175] A switch, which is disposed on the outer surface of the handle body 21 and is electrically connected to the circuit board 24, and is used to control the working state of the pressure guide wire;

[0176] The pressure sensor 14 is configured to detect the pressure changes in the blood vessel in real time during thrombus removal surgery to identify the location of the thrombus. When the detected pressure exceeds a preset threshold, the sensor wire 15 transmits a signal to the circuit board 24. The circuit board 24 controls the indicator light 25 to illuminate, so as to provide the operator with instant feedback information on the location of the thrombus, thereby assisting in the precise implementation of the thrombus removal surgery.

[0177] Specifically, the intelligent pressure monitoring guidewire system 10 for thrombectomy of this embodiment is mainly composed of two parts: a guidewire and a control handle 20. The guidewire is the core part of the entire system, having a proximal end and a distal end, and its structure includes an outer polymer coating 11, an inner metal tube 12 and a core 13 from the outside to the inside. The outer polymer coating 11 has a lubricating coating, which helps the guidewire to move smoothly in the blood vessel. The inner metal tube 12 is coaxially arranged in the outer coating to provide rigid support for the guidewire. The core 13 is coaxially arranged in the inner metal tube 12, which further enhances the strength and controllability of the guidewire.

[0178] A pressure sensor 14 is provided at the distal end of the guidewire for real-time detection of pressure changes in the blood vessel. A sensor wire 15 electrically connected to the pressure sensor 14 is radially arranged between the inner metal tube 12 and the outer polymer coating 11 and extends along the axial direction of the guidewire to ensure effective signal transmission.

[0179] Optionally, the wire interface 16 is a connection point between the sensor wire 15 and a circuit board inside the control handle 20 .

[0180] Optionally, the perforation 17 serves as a passage for the guidewire inside the handle. Specifically, the perforation 17 is a carefully designed structure that allows the guidewire to move axially inside the handle while limiting movement in other directions. This design has two main functions: first, the guiding function. The perforation 17 ensures that the guidewire can only move along a predetermined axial path, improving the accuracy and stability of the operation. This is essential for delicate operations in complex vascular environments; second, the supporting function. When the locking mechanism is activated, the perforation 17 provides support for both ends of the guidewire locked area. This supporting effect significantly reduces the risk of guidewire sliding and enhances the reliability of the locking effect. By providing stable support on both sides of the locking point, the perforation 17 effectively disperses the force acting on the guidewire and prevents damage to the guidewire that may be caused by local stress concentration.

[0181] The control handle 20 is detachably connected to the proximal end of the guidewire and is the main interface for the operator to interact with the guidewire system. A guidewire channel 211 is provided inside the handle body 21 for slidably accommodating and guiding the guidewire. The locking device 22 is adjustably arranged on the handle body 21, so that the operator can fix the position of the guidewire in the guidewire channel 211 as needed. The push rod 23 is connected to the proximal end of the guidewire and is used to control the axial push and retraction of the guidewire to achieve precise guidewire control.

[0182] The circuit board 24 is disposed in the handle body 21 and is electrically connected to the proximal end of the sensor wire 15, and is the signal processing center of the entire system. The indicator light 25 and the switch are disposed on the outer surface of the handle body 21 and are electrically connected to the circuit board 24. The indicator light 25 is used to provide visual feedback to the operator, and the switch is used to control the working state of the pressure guide wire.

[0183] The core function of the system is that the pressure sensor 14 is configured to detect the pressure changes in the blood vessel in real time during thrombus removal surgery to identify the location of the thrombus. When the detected pressure exceeds the preset threshold, the sensor wire 15 transmits the signal to the circuit board 24, which then controls the indicator light 25 to light up, providing the operator with instant feedback information on the location of the thrombus. This real-time and intuitive feedback mechanism greatly improves the accuracy of thrombus removal surgery, allowing the operator to more accurately locate and remove thrombi, thereby improving the success rate and safety of the surgery.

[0184] Optionally, the inner metal tube 12 includes:

[0185] A distal flexible tube, disposed at the distal end of the guide wire;

[0186] A proximal support tube, arranged at the proximal end of the guide wire;

[0187] A connecting portion, used to connect the distal flexible tube to the proximal support tube;

[0188] Among them, the distal flexible tube includes a distal spring tube or a distal metal-free tube (the periphery is completely filled with polymer); the proximal support tube includes a proximal snake tube or a braided tube; the connecting part adopts at least one of welding, bonding or mechanical connection to realize the connection between the distal flexible tube and the proximal support tube.

[0189] Specifically, in this embodiment, the structure of the inner metal tube 12 is further optimized to improve the adaptability and performance of the guide wire in different vascular locations. The inner metal tube 12 includes three main parts: a distal spring tube, a proximal snake tube, and a connecting part.

[0190] The distal spring tube is set at the distal part of the guidewire. This design gives the distal end of the guidewire greater flexibility and flexibility, allowing it to pass through the curved parts of the blood vessels more easily and reduce stimulation to the blood vessel wall. The spring tube structure can also provide good resilience while maintaining sufficient support, helping the operator to accurately control the movement of the guidewire.

[0191] The proximal snake is set at the proximal part of the guidewire. The snake structure usually has good torsion transmission performance and pushing performance, which enables the operator to better control the rotation and advancement of the guidewire. This design helps to improve the maneuverability of the guidewire in complex vascular pathways, allowing the operator to more accurately guide the guidewire to the target location.

[0192] The purpose of the connection part is to effectively connect the distal spring tube and the proximal snake tube together to form a unified inner metal tube 12 structure. This connection can be achieved in a variety of ways, including at least one of welding, bonding or mechanical connection. Welding provides a high-strength permanent connection; bonding can achieve connection without affecting the original properties of the material; and mechanical connection may provide better detachability and adjustability.

[0193] This segmented inner metal tube 12 design cleverly combines the advantages of different structures. The distal spring tube provides the necessary flexibility and agility, which is conducive to the navigation of the guidewire in complex blood vessels; the proximal snake tube ensures good pushability and torsion control, allowing the operator to accurately control the guidewire. Through a reasonable connection method, the two structures are organically combined to form an inner metal tube 12 with balanced performance and strong adaptability. This design not only improves the adaptability of the guidewire in different vascular environments, but also enhances the control accuracy and efficiency of the entire system in thrombectomy.

[0194] Optionally, the pressure sensor 14 is a microelectronic sensor or a thin film sensor;

[0195] The sensing area of ​​the pressure sensor 14 is set to be slightly lower than the highest point of its outer protective layer to avoid direct contact with the blood vessel wall and cause misjudgment;

[0196] The pressure sensor 14 is fixed between the inner metal tube 12 and the outer polymer coating 11 by glue dispensing, and the protective layer formed by glue dispensing is hemispherical (see Figure 1 The dispensing head 19).

[0197] Specifically, in this embodiment, the selection and installation of the pressure sensor 14 are carefully designed to ensure its accuracy and reliability in thrombus removal. The pressure sensor 14 can be a microelectronic sensor or a thin-film sensor, both of which have the characteristics of small size and high sensitivity, and are very suitable for integration in the limited space of the guide wire.

[0198] Of particular note is the setting of the sensing area of ​​the pressure sensor 14. This area is cleverly designed to be slightly lower than the highest point of its outer protective layer. The purpose of this design is to prevent the sensor from directly contacting the blood vessel wall. If the sensor directly contacts the blood vessel wall, it may cause misjudgment due to the pressure generated by physical contact, affecting the accuracy of the measurement. By slightly lowering the sensing area, it can be ensured that the sensor mainly senses the blood pressure without being affected by direct contact with the blood vessel wall, thereby improving the accuracy and reliability of the pressure measurement.

[0199] The fixing method of the pressure sensor 14 has also been carefully considered. The sensor is fixed between the inner metal tube 12 and the outer polymer film 11 by dispensing glue. This fixing method can not only firmly fix the sensor in the appropriate position, but also provide necessary protection. In particular, the protective layer formed by dispensing glue is hemispherical. This hemispherical design has several important advantages:

[0200] First, the hemispherical structure can better disperse external pressure, reduce direct impact on the sensor itself, and improve the durability of the sensor. Secondly, this shape can smooth the transition of the guidewire surface, reduce the resistance of the guidewire when it moves in the blood vessel, and improve the passing performance of the guidewire. Furthermore, the hemispherical structure can also protect the sensor from direct contact with blood and other body fluids to a certain extent, extending the service life of the sensor.

[0201] This design fully considers the complexity of the intravascular environment and the precise need for pressure measurement. Through the clever setting of the sensing area and the hemispherical protective layer design, not only the accuracy of pressure measurement is improved, but also the durability and reliability of the sensor are enhanced. This is crucial for long-term pressure monitoring in a complex vascular environment, and can provide continuous and accurate pressure data for thrombectomy, thereby supporting the precise implementation of the operation.

[0202] Optionally, the pressure sensor 14 is fixed between the inner metal tube 12 and the outer polymer film 11 by glue dispensing;

[0203] The glue dispensing forms a hemispherical protective structure, which covers the pressure sensor 14;

[0204] The sensing area of ​​the pressure sensor 14 is arranged at a position slightly below the highest point of the hemispherical protective structure;

[0205] The hemispherical protective structure is used to protect the pressure sensor 14, while allowing the sensing area to effectively sense the pressure changes in the blood vessel and avoid direct contact with the blood vessel wall to cause misjudgment.

[0206] Specifically, in this embodiment, the installation and protection of the pressure sensor 14 are carefully designed to ensure that it can work accurately and reliably in a complex vascular environment. The pressure sensor 14 is fixed between the inner metal tube 12 and the outer polymer film 11 by glue dispensing. This fixing method can not only firmly fix the sensor in an appropriate position, but also provide necessary protection and insulation for the sensor.

[0207] During the dispensing process, a unique hemispherical protective structure is formed, which completely covers the pressure sensor 14. The hemispherical design has multiple advantages: first, it can better disperse the external pressure and reduce the direct impact on the sensor itself, thereby improving the durability of the sensor; second, this shape can smooth the transition of the guidewire surface, reduce the resistance of the guidewire when it moves in the blood vessel, and improve the passing performance of the guidewire; third, the hemispherical structure can also protect the sensor from direct contact with blood and other body fluids to a certain extent, extending the service life of the sensor.

[0208] Of particular note is the clever placement of the sensing area of ​​the pressure sensor 14. The sensing area is precisely placed slightly below the highest point of the hemispherical protective structure. The purpose of this design is multifaceted: it ensures that the sensing area can effectively sense pressure changes within the blood vessel while avoiding direct contact with the vessel wall. If the sensor directly contacts the vessel wall, it may cause misjudgment due to the pressure generated by physical contact, affecting the accuracy of the measurement. By slightly lowering the sensing area, it can be ensured that the sensor mainly senses blood pressure without being affected by direct contact with the vessel wall.

[0209] This design fully considers the complexity of the intravascular environment and the precise requirements for pressure measurement. The hemispherical protective structure not only protects the sensor, but also optimizes its working environment. The precise positioning of the sensing area ensures the accuracy and reliability of pressure measurement. This design is essential for long-term pressure monitoring in a complex vascular environment, and can provide continuous and accurate pressure data for thrombectomy, thereby supporting the precise implementation of the operation.

[0210] Overall, this design cleverly balances the needs of protection, precise measurement, and reliability, providing an efficient and reliable solution for pressure monitoring during thrombectomy. It not only improves the accuracy of pressure measurement, but also enhances the adaptability and durability of the entire guidewire system in complex vascular environments.

[0211] Optionally, the core 13 is made of nickel-titanium alloy or stainless steel wire, or is welded from a front nickel-titanium alloy and a rear stainless steel wire.

[0212] Specifically, in this embodiment, the material selection and structural design of the core 13 are carefully considered to optimize the overall performance and applicability of the guidewire. The core 13 is the central support structure of the guidewire and plays a vital role in the mechanical properties of the guidewire. The present design provides three optional core 13 material configurations, each of which has its own unique advantages and can be selected according to specific clinical needs.

[0213] First, the core 13 can be made entirely of nickel-titanium alloy. Nickel-titanium alloy, also known as "memory alloy", has excellent superelasticity and shape memory properties. This material can quickly return to its original shape after bending or twisting, and is very suitable for use in complex and curved vascular paths. This property of nickel-titanium alloy can significantly improve the flexibility and controllability of the guidewire, allowing it to pass more easily through narrow or curved vascular sites while maintaining sufficient pushing force.

[0214] Secondly, the core 13 can also be made entirely of stainless steel wire. Stainless steel has good strength and rigidity, and can provide excellent pushing performance and torsion control. This material is particularly suitable for situations where high pushing force and precise control are required, such as in straight blood vessel segments or scenarios where greater resistance needs to be overcome. The stainless steel core 13 can ensure that the guidewire maintains good linearity and stability during advancement.

[0215] The third option is a composite structure made by welding the front nickel-titanium alloy and the rear stainless steel wire. This design cleverly combines the advantages of the two materials: the front nickel-titanium alloy provides the necessary flexibility and flexibility, which is conducive to the navigation of the guide wire tip in complex blood vessels; while the rear stainless steel wire ensures good pushability and torsion control, allowing the operator to precisely manipulate the guide wire. This composite structure design enables the guide wire to perform excellent performance in different vascular environments.

[0216] The application of welding technology ensures a firm connection between the two materials while maintaining a smooth transition of the guidewire to avoid the risk of breakage or separation during use. This seamless connection design can also minimize the resistance of the guidewire when passing through the blood vessel and improve the overall operating performance.

[0217] This variety of core 13 material options provides greater flexibility for thrombectomy. Doctors can choose the most appropriate core 13 configuration based on specific surgical needs, vascular conditions, and personal operating preferences. For example, if you need to pass through extremely curved or narrow blood vessels, you may choose a full nickel-titanium alloy core 13; if you need stronger pushing force, you may choose a stainless steel core 13 or a composite structure.

[0218] In general, this core 13 design fully considers the various complex situations that may be encountered during thrombectomy. Through the reasonable selection and combination of materials, the adaptability and control accuracy of the guidewire in different vascular environments are improved, thereby enhancing the performance and reliability of the entire intelligent pressure monitoring guidewire system in thrombectomy.

[0219] Optionally, the locking device 22 includes:

[0220] A locking knob 221 is rotatably disposed on the handle body 21;

[0221] The support platform 222 is fixedly disposed in the handle body 21 and is located directly below the locking knob 221;

[0222] A through channel vertically penetrates the locking knob 221 and the support platform 222 to form a part of the guide wire channel 211;

[0223] The bottom of the locking knob 221 and the top of the support platform 222 are both provided with a groove for accommodating the guide wire, and the groove is connected to the through channel;

[0224] When the locking knob 221 is rotated downward, the groove at the bottom of the locking knob 221 is relatively closed with the groove at the top of the support platform 222, thereby controllably clamping the guide wire to achieve adjustable fixation of the guide wire;

[0225] The cross section of the groove is semicircular or V-shaped, and its shape and size are designed to evenly distribute pressure in the locked state to avoid damage to the guide wire to the greatest extent;

[0226] The locking knob 221 is also provided with an anti-slip texture to facilitate the operator to perform fine adjustment.

[0227] Specifically, in this embodiment, the design of the locking device 22 embodies a combination of precision engineering and ergonomics, aiming to provide an accurate, reliable and easy-to-operate guidewire fixing mechanism. This design is crucial for accurately controlling the guidewire position during thrombectomy.

[0228] The core components of the locking device 22 include a locking knob 221, a support platform 222, and a through channel. The locking knob 221 is rotatably arranged on the handle body 21. This design allows the operator to adjust the locking force by a simple rotation action. The support platform 222 is fixedly arranged in the handle body 21, directly below the locking knob 221, providing a solid foundation for the entire locking mechanism. The through channel vertically passes through the locking knob 221 and the support platform 222, forming a part of the guide wire channel 211, ensuring that the guide wire can smoothly pass through the entire locking mechanism.

[0229] The key design of the locking mechanism lies in the grooves provided at the bottom of the locking knob 221 and the top of the support platform 222. These grooves are connected to the through channel and are specifically used to accommodate the guide wire. When the locking knob 221 is rotated downward, the groove at the bottom of the knob gradually approaches the groove at the top of the support platform 222 and finally closes relatively. This design allows the operator to accurately control the clamping force of the guide wire by rotating the locking knob 221, thereby achieving adjustable fixation of the guide wire position. More specifically, the screw 223 may allow the locking mechanism to be fine-tuned. By adjusting the tightness of the screw, the spacing or pressure between the locking knob 221 and the support platform 222 can be fine-tuned to optimize the locking effect.

[0230] The design of the grooves has also been carefully considered. The cross-section of the grooves can be semicircular or V-shaped. The purpose of this shape design is to evenly distribute the pressure when the lock is tightened. Even pressure distribution is essential to avoid damage to the guidewire, because excessive concentrated pressure may cause the guidewire to deform or damage. With this design, the structural integrity of the guidewire can be protected to the greatest extent even in the tightened state.

[0231] In addition, the surface of the locking knob 221 is also provided with an anti-slip texture. This texture design greatly improves the operator's control over the knob, allowing fine adjustments to be made even when wearing surgical gloves. This detail reflects the designer's in-depth consideration of the actual surgical environment, aiming to improve the accuracy and comfort of the operation.

[0232] The design of the locking device 22 fully considers the need for precise control of the guidewire position during thrombectomy. It allows the operator to quickly and accurately adjust the position of the guidewire during the operation, and can firmly fix the guidewire to prevent it from accidentally moving at a critical moment. At the same time, through a carefully designed pressure distribution mechanism, it is ensured that the guidewire will not be damaged during the fixation process.

[0233] In general, the design of the locking device 22 reflects comprehensive consideration of accuracy, reliability and ease of use. It not only improves the accuracy of guidewire manipulation during thrombus removal surgery, but also enhances the controllability and safety of the entire surgical process, providing an important guarantee for the successful implementation of the surgery.

[0234] Optionally, the circuit board 24 is configured to set multiple pressure thresholds according to the blood vessel type, wherein the circuit board 24 includes a microprocessor and a memory; the memory pre-stores multiple pressure threshold levels corresponding to different blood vessel types and pathological states; the microprocessor is configured to:

[0235] Receive and process the pressure signal from the pressure sensor 14 in real time;

[0236] Automatically selects applicable vessel type and lesion status based on user input or preset algorithms;

[0237] Calling the corresponding pressure threshold level according to the selected blood vessel type and lesion status;

[0238] dynamically comparing the real-time pressure signal to a selected pressure threshold;

[0239] When the detected pressure exceeds a selected threshold, the indicator light 25 is immediately triggered to emit light in a specific pattern and optionally generate an audible alarm;

[0240] The control handle 20 also includes a user interface, which is electrically connected to the circuit board 24. The user interface includes:

[0241] A display screen, used to display pressure values ​​and selected blood vessel type information in real time;

[0242] Control buttons allow the operator to manually select or fine-tune the pressure threshold level;

[0243] Wherein, the pressure threshold level can be remotely updated and optimized based on the latest clinical data and usage feedback through a wireless communication interface;

[0244] The microprocessor is also configured to record pressure change trends and generate a pressure change report after surgery to assist in postoperative analysis and treatment evaluation.

[0245] Specifically, this embodiment describes a highly intelligent pressure monitoring system specifically designed for accurate pressure monitoring and thrombus localization during thrombectomy.

[0246] First, the circuit board 24 is equipped with a microprocessor and a memory, which enables the system to have complex data processing and storage capabilities. The memory pre-stores multiple pressure threshold levels corresponding to different blood vessel types and pathological conditions. For example, for the coronary artery, the normal pressure range may be 80-120 mmHg, while for the pulmonary artery, the normal range may be 15-30 mmHg. The system will determine whether the pressure in the blood vessel is abnormal based on these preset values.

[0247] Exemplary functions of the microprocessor may include:

[0248] Real-time data processing: It can receive and process signals from the pressure sensor 14 in real time. For example, it may receive 100 pressure readings per second and perform real-time analysis.

[0249] Intelligent selection: Based on user input or preset algorithms, the system can automatically select the applicable vessel type and lesion status. For example, if the operator inputs that a coronary artery procedure is being performed, the system will automatically call the corresponding pressure threshold range.

[0250] Dynamic comparison: The system dynamically compares the real-time pressure signal with the selected threshold. For example, during coronary artery surgery, if the pressure is detected to suddenly rise to 140mmHg, exceeding the preset threshold of 120mmHg, the system will respond immediately.

[0251] Alarm triggering: When the pressure exceeds the threshold, the system triggers the indicator light 25 to light up in a specific pattern and may also sound an audible alarm. For example, the indicator light 25 may flash red quickly and sound a beep at the same time to alert the doctor that the thrombus may be approaching.

[0252] The system also includes a user interface that provides more interactive and information display functions:

[0253] Display: Displays the pressure value and the selected blood vessel type information in real time. For example, the display may show "Current pressure: 135mmHg, Blood vessel type: Coronary artery".

[0254] Control buttons: Allow the operator to manually adjust the settings. For example, if the doctor believes that the current case requires a higher alarm threshold, the threshold can be adjusted from 120mmHg to 130mmHg via a button.

[0255] An important feature of the system is its updatability. Through the wireless communication interface, the pressure threshold levels can be remotely updated and optimized based on the latest clinical data. For example, if new research shows that the normal pressure range for a certain type of blood vessel should be adjusted, this update can be pushed to the device remotely.

[0256] Finally, the microprocessor also has data logging and report generation capabilities. It can record pressure trends throughout the surgery and generate a detailed report after the surgery. This report may include a chart of pressure changes over time, the number of times and duration of thresholds exceeded, and other information, providing doctors with valuable postoperative analysis data.

[0257] Overall, this system provides a highly accurate, reliable and easy-to-use pressure monitoring solution for thrombectomy by combining advanced hardware and intelligent software. It not only provides real-time and accurate feedback during the procedure, but also provides important basis for improving future treatment strategies through data analysis and report generation functions.

[0258] Optionally, the system further includes:

[0259] A light source is disposed in the handle body 21;

[0260] an optical fiber, disposed in the guide wire, one end of which is optically connected to the light source and the other end of which extends to the distal end of the guide wire;

[0261] an optical window, disposed at the distal end of the guidewire and optically connected to the distal end of the optical fiber;

[0262] A light source control switch, disposed on the handle body 21 and electrically connected to the light source;

[0263] A light detector, used for detecting a light signal returned by the sensor, and for outputting a signal;

[0264] in,

[0265] The optical fiber is used to transmit the optical signal from the light source;

[0266] The optical window is used to emit a light signal from the inside of the guide wire to indicate the location of the thrombus;

[0267] The wavelength and intensity of the light source are optimized to provide a clearly visible light signal within the blood vessel while minimizing thermal effects on surrounding tissue;

[0268] The light source control switch is used to control the opening and closing of the light source and adjust the light intensity;

[0269] When the pressure sensor 14 detects that the pressure exceeds a preset threshold, the circuit board 24 can automatically trigger the light source to turn on, and send out a light signal through the optical fiber and the optical window, which cooperates with the indicator light 25 to provide the operator with a double thrombus position indication.

[0270] Specifically, this optional embodiment describes an innovative optical indication system as a supplementary means of pressure monitoring during thrombus removal. This system cleverly combines optical technology and pressure monitoring to provide a more intuitive and accurate method for thrombus location during surgery. Specifically, it includes:

[0271] Light source: The light source disposed in the handle body 21 is the core of the entire optical system. The use of a light source has several important advantages: it generates less heat, which can minimize thermal damage to surrounding tissues; at the same time, it can generate a stable and long-lasting light signal, which is suitable for long-term surgical operations.

[0272] Fiber optics: The fiber optics are cleverly placed inside the guidewire, with one end connected to a light source and the other end extending to the distal end of the guidewire. This design allows light signals to be transmitted from the handle to the tip of the guidewire without increasing the outer diameter of the guidewire or affecting its flexibility. The use of fiber optics ensures that light signals can be accurately delivered to the location that needs to be observed.

[0273] Optical window: The optical window at the distal end of the guidewire is optically connected to the distal end of the optical fiber. The function of this window is to emit light signals from the inside of the guidewire to directly indicate the possible location of thrombus. The design of the optical window needs to take into account the scattering and transmission characteristics of light to ensure that a clear and visible signal can still be provided in the blood environment.

[0274] Light source control switch: The light source control switch provided on the handle body 21 is electrically connected to the light source, allowing the operator to manually control the light source to be turned on and off and adjust the light intensity. This provides flexible operation options, allowing the doctor to adjust the intensity of the light signal according to specific circumstances.

[0275] More specifically, the working principle and characteristics of the system are as follows:

[0276] Optical signal transmission: The optical fiber is responsible for transmitting the optical signal generated by the light source from the handle to the distal end of the guidewire. This transmission method can ensure the strength and clarity of the signal, and maintain a good indication effect even after long-distance transmission.

[0277] Thrombus location indication: The light signal emitted through the optical window is used to directly indicate the location of the thrombus. In the blood vessel, this light signal can clearly mark the area where the thrombus may exist, providing doctors with intuitive visual guidance.

[0278] Optimized light source characteristics: The wavelength and intensity of the light source are specially optimized to provide a clearly visible light signal in the intravascular environment. At the same time, this optimization also takes into account the minimization of thermal effects on surrounding tissues to ensure the safety of surgery.

[0279] Intelligent linkage: A key feature of the system is the intelligent linkage between pressure monitoring and optical indication. When the pressure sensor 14 detects that the pressure exceeds the preset threshold, the circuit board 24 automatically triggers the light source to turn on. This automated dual indication system (pressure indicator light 25 plus optical indication) provides the operator with more comprehensive and reliable information on the location of the thrombus.

[0280] Manual control option: Although the system has an automatic trigger function, the operator can still manually adjust the light source through the light source control switch. This flexibility allows the doctor to use the optical indication system according to the specific situation and personal preference.

[0281] The design of this optical indication system embodies the innovative thinking of multidisciplinary integration. It not only provides intuitive visualization of the location of the thrombus, but also greatly improves the accuracy and reliability of thrombus positioning through intelligent integration with the pressure monitoring system. This dual feedback mechanism (visual and pressure) can significantly improve the accuracy and success rate of surgery, and may also reduce the operation time and the risk of complications.

[0282] In general, this optical indication system is an important supplement and innovation to traditional pressure guidewires, providing more advanced and comprehensive technical support for thrombectomy, and is expected to significantly improve the effectiveness and safety of the operation.

[0283] Optionally, the pressure sensor 14 includes two independent sensor units, which are respectively arranged on the left and right sides of the distal end of the guide wire;

[0284] Each sensor unit consists of:

[0285] Pressure-sensitive element, used to sense local blood vessel pressure;

[0286] A signal processing circuit, used for preliminarily processing the pressure signal collected by the pressure-sensitive element;

[0287] The two sensor units are electrically connected to the circuit board 24 via independent sensor wires 15;

[0288] The circuit board 24 is configured as follows:

[0289] Respectively receiving and processing pressure signals from two sensor units;

[0290] Compare the pressure difference between the two sensor cells;

[0291] Calculate the pressure distribution on the cross-section of the blood vessel based on the pressure difference;

[0292] in,

[0293] The arrangement of two sensor units enables the pressure guidewire to detect differences in pressure distribution across the cross section of the blood vessel;

[0294] By analyzing the difference in pressure distribution, the location of the thrombus can be more accurately located and the extent of the thrombus's impact on the blood vessel wall can be assessed;

[0295] The design can also be used to detect other vascular pathologies such as vascular stenosis or malformations.

[0296] Specifically, in this embodiment, the design of the pressure guidewire can selectively include two independent pressure sensor 14 units, which are located on the left and right sides of the distal end of the guidewire. Each sensor unit is equipped with a pressure-sensitive element and a signal processing circuit. The pressure-sensitive element is responsible for sensing the pressure changes in the local blood vessel and transmitting these detected signals to the signal processing circuit, which processes and filters these preliminary pressure signals to ensure the accuracy and stability of the signal.

[0297] Each sensor unit is connected to the circuit board 24 via an independent sensor wire 15, and the circuit board 24 is designed to receive and process the pressure signals from the two sensor units respectively. This means that the circuit board 24 can not only receive the pressure data of a single sensor, but also compare the pressure difference between the two sensor units. By comparing the pressure values ​​detected by the sensors on the left and right sides, the circuit board 24 can calculate the pressure distribution on the cross section of the blood vessel.

[0298] This dual-sensor design enables the guidewire to detect differences in pressure distribution in the cross-section of the blood vessel. By analyzing the pressure difference between the left and right sides, the operator can more accurately locate the location of the thrombus. For example, a thrombus usually causes abnormal pressure in the local blood vessel, and by comparing the pressure difference between the two sensor units, the specific location of the thrombus can be more accurately determined. In addition, this pressure distribution analysis can also evaluate the degree of compression of the thrombus on the blood vessel wall, helping the operator understand the impact of the thrombus on the local blood vessel.

[0299] This design is not only suitable for precise positioning during thrombectomy, but can also be used to detect other vascular lesions, such as vascular stenosis or malformation. By evaluating the pressure distribution on the cross-section of the blood vessel, the operator can obtain more comprehensive vascular health information and formulate more effective surgical strategies. This multi-sensor layout design significantly improves the detection accuracy of the guidewire and the success rate of the operation, while reducing the uncertainty and risk during the operation.

[0300] Optionally, the outer polymer coating 11 is made of at least one of the following materials:

[0301] Polyethylene (PE);

[0302] Thermoplastic polyurethane (TPU);

[0303] Polytetrafluoroethylene (PTFE);

[0304] Nylon;

[0305] Polyamide (PA);

[0306] Polyether block amide (PEBA);

[0307] in,

[0308] The outer polymer coating 11 may be a single-layer structure or a multi-layer composite structure;

[0309] When it is a multi-layer composite structure, it can be composed of different materials to optimize the comprehensive performance of the coating;

[0310] The thickness of the outer polymer coating 11 ranges from 0.01 mm to 0.1 mm;

[0311] The selected materials have been tested for biocompatibility to ensure safety in long-term contact with human tissue;

[0312] The surface of the outer polymer coating 11 may be treated to be hydrophilic or hydrophobic to improve its sliding performance in the blood vessel.

[0313] Specifically, in this embodiment, the outer polymer coating 11 of the guidewire can be made of at least one of a variety of different materials. These materials include polyethylene (PE), thermoplastic polyurethane (TPU), polytetrafluoroethylene (PTFE), nylon (Nylon), polyamide (PA) and polyether block amide (PEBA). Each material has unique physical and chemical properties and is suitable for different medical application scenarios.

[0314] The outer polymer coating 11 can be designed as a single-layer structure or a multi-layer composite structure. If a multi-layer composite structure is used, the designer can combine different materials according to the needs to optimize the comprehensive performance of the coating. For example, a material with high strength and a material with high lubricity can be combined to achieve a guidewire that is both durable and easy to slide in the blood vessel. The design of this multi-layer composite structure is intended to maximize the performance of the guidewire, ensuring that it can provide good mechanical support, reduce the friction of the guidewire in the blood vessel, and reduce damage to the blood vessel wall.

[0315] The thickness of the outer polymer coating 11 ranges from 0.01 mm to 0.1 mm. The design of this thickness range takes into account the operation requirements of the guidewire in the blood vessel. While maintaining sufficient strength and durability, the thickness of the film cannot be too thick to ensure that the guidewire has sufficient flexibility and maneuverability.

[0316] In addition, the selected materials have undergone rigorous biocompatibility testing to ensure that they will not cause adverse reactions when in long-term contact with human tissue. This is particularly important because the guidewire will be in contact with the inner wall of the blood vessel for a long time during thrombectomy, so the biocompatibility of the material is an important factor in ensuring the safety of the procedure.

[0317] In order to further improve the operating performance of the guidewire in the blood vessel, the surface of the outer polymer coating 11 can also be treated to be hydrophilic or hydrophobic. The hydrophilic treatment helps to increase the lubricity of the guidewire in the blood vessel, making it easier to pass through narrow or curved blood vessels; while the hydrophobic treatment can reduce the adhesion of blood to the surface of the guidewire and reduce the resistance of the guidewire during surgery. These surface treatment technologies can be selected according to specific surgical requirements to maximize the sliding performance of the guidewire and improve the operating efficiency and success rate of the surgery.

[0318] In summary, this diversified material selection, composite structure design, precise thickness control and surface treatment methods enable the outer polymer coating 11 of the guide wire to have excellent mechanical properties, biocompatibility and sliding properties, and can adapt to various complex vascular environments to ensure safety and effectiveness during surgery.

[0319] Optionally, the outer diameter of the guide wire ranges from 0.2 mm to 1 mm, and the total length ranges from 100 cm to 300 cm;

[0320] The guide wire comprises a distal portion, a proximal portion, a soft tip and a transition section; wherein,

[0321] The outer coating of the soft tip is doped with developing materials such as barium sulfate and bismuth trioxide for intraoperative development;

[0322] The distal portion includes the section where the pressure sensor 14 is located, and its outer diameter ranges from 0.2 mm to 1 mm, and its length is not less than 30 cm;

[0323] The outer diameter of the proximal part can be gradually increased, but the maximum outer diameter does not exceed 0.889 mm. It is made of high-strength alloy material to provide pushability and torsion control;

[0324] The soft tip is located at the distal end of the guidewire, with a length of 1 cm to 5 cm. The outer diameter gradually decreases from the proximal end to the distal end, and can be as small as 0.204 mm. It is made of highly soft polymer or alloy material.

[0325] The transition section is located between the soft tip and the pressure sensor 14 and is used to achieve a gradual change in the stiffness of the guidewire;

[0326] Among them, the above-mentioned size parameters can be adjusted within the range of ±10% according to different blood vessel types and interventional surgery requirements to adapt to various clinical application scenarios.

[0327] Specifically, in this embodiment, the design parameters of the guidewire are precisely controlled to ensure that it can operate smoothly in various complex vascular environments. First, the outer diameter range of the guidewire is set to 0.2mm-1mm, which ensures that the guidewire can adapt to vascular structures from tiny to large and achieve smooth guidance. At the same time, the total length of the guidewire ranges from 100 cm to 300 cm, which can meet the needs of different types of vascular interventional surgeries. For example, in longer peripheral blood vessels or arteries, the length of the guidewire is sufficient to cover the entire surgical area.

[0328] The structural design of the guidewire includes a distal portion, a proximal portion, a soft tip, and a transition section. The distal portion is one of the most critical parts of the guidewire because it contains the pressure sensor 14. The outer diameter of this portion ranges from 0.2mm to 1mm, and the length is not less than 30 cm. The design of this section takes into account the flexibility of the guidewire in the blood vessel and the ability to accurately locate thrombi. The thinner outer diameter ensures that the guidewire can pass flexibly in narrow or blocked blood vessel areas, and the pressure sensor 14 can accurately detect local pressure changes.

[0329] The outer diameter of the proximal part of the guidewire gradually increases, but the maximum outer diameter does not exceed 0.889 mm. This part is made of high-strength alloy material and is mainly used to provide pushability and torsion control of the guidewire. This means that during surgery, the operator can apply sufficient thrust and torsion force through the proximal part to push the guidewire forward or change its direction in complex blood vessels without affecting its overall structural stability.

[0330] The soft tip is located at the farthest end of the guidewire, with a length of 1 cm to 5 cm. The outer diameter gradually decreases from the proximal end to the distal end, and the minimum outer diameter can reach 0.204 mm. This design ensures that the guidewire can pass more smoothly when entering extremely narrow or curved areas of the blood vessel without causing damage to the blood vessel wall. The soft tip is made of highly soft polymer or alloy material, which makes it have good adaptability and safety when contacting the blood vessel wall, avoiding damage to vascular tissue due to excessive hardness.

[0331] The transition section is located between the soft tip and the pressure sensor 14, and optionally has a length of 5 cm to 15 cm. This transition section is designed to achieve a gradual change in the stiffness of the guide wire, so that the guide wire gradually transitions from the softer tip portion to the more rigid sensor portion. Through this gradual change design, the guide wire can provide good pushing force and control force while maintaining sufficient flexibility to adapt to different surgical needs.

[0332] In addition, these size parameters can be adjusted within a range of ±10% according to different blood vessel types and specific interventional surgical requirements. This flexible design allows the guidewire to be customized according to different clinical application scenarios to ensure that it can perform optimally in a variety of vascular environments. For example, in some special vascular surgeries, the outer diameter or length of the guidewire may need to be appropriately increased or decreased to better adapt to the patient's anatomical structure and lesion characteristics.

[0333] In summary, the size and structural design of the guidewire fully consider the complexity and diversity of intravascular surgery, and can ensure that the guidewire provides good controllability and safety in different clinical application scenarios, thereby improving the success rate of the operation and the patient's prognosis.

[0334] Working principle:

[0335] The intelligent pressure monitoring guidewire system 10 for thrombus removal in the above embodiment mainly assists in the precise positioning of thrombus by real-time detection of pressure changes in blood vessels and provides real-time feedback for surgery. Its working principle is as follows:

[0336] Insertion of the guidewire into the blood vessel: At the beginning of the operation, the doctor inserts the guidewire system into the patient's blood vessel. The outer polymer coating 11 of the guidewire has a lubricating coating to ensure that the guidewire slides smoothly in the blood vessel and reduces friction on the blood vessel wall. The proximal and distal ends of the guidewire have different functions. The proximal end provides pushing force and controllability, while the distal end is responsible for pressure sensing.

[0337] The pressure sensor 14 detects the blood vessel pressure: The distal part of the guidewire is provided with a pressure sensor 14, which can sense the pressure changes in the blood vessel in real time. When the guidewire passes through the normal blood vessel area, the pressure value detected by the pressure sensor 14 usually remains stable. However, when the guidewire approaches or passes through the thrombus area, the local pressure will increase significantly due to the obstruction of blood flow by the thrombus. The sensor can capture this pressure change and transmit the signal to the control system at the proximal end of the guidewire.

[0338] Signal transmission and processing: The pressure sensor 14 transmits the pressure signal to the circuit board 24 in the control handle 20 through the sensor wire 15. The circuit board 24 is responsible for receiving and processing these signals and analyzing the pressure changes in the blood vessels in real time. If the guidewire is equipped with a dual sensor design, the circuit board 24 will also compare the pressure difference between the sensors on the left and right sides and calculate the pressure distribution on the cross-section of the blood vessel. In this way, the system can more accurately locate the position of the thrombus and evaluate its impact on the blood vessel wall.

[0339] Instant feedback: When the circuit board 24 detects that the pressure in the blood vessel exceeds the preset threshold, it will send a signal through the indicator light 25 on the control handle 20 to inform the operator that the guidewire has entered or is close to the thrombus area. This instant feedback mechanism enables doctors to adjust surgical strategies in a timely manner to avoid blind operations. In addition, the guidewire can also be equipped with an optional light source and fiber optic system. When the pressure sensor 14 detects abnormal pressure, the light source will be automatically triggered, and the optical signal will be emitted from the far end of the guidewire through the optical fiber to further indicate the location of the thrombus. The dual feedback mechanism of the light signal and the indicator light 25 greatly improves the accuracy of thrombus positioning.

[0340] Pressure threshold adjustment and intelligent control: The circuit board 24 in the control handle 20 is programmed to set multiple pressure threshold levels according to different blood vessel types and pathological conditions. The doctor can manually select the most appropriate pressure threshold through the control button on the handle, or the system can automatically select the appropriate threshold level according to the preset algorithm. By dynamically comparing the real-time pressure signal with the preset threshold, the system can trigger the indicator light 25 or generate an audible and visual alarm when the pressure exceeds the threshold, reminding the doctor to proceed to the next step.

[0341] The role of the soft tip and transition section: The soft tip and transition section of the guidewire also play an important role in the entire operation. The soft tip can smoothly pass through the narrow or curved parts of the blood vessel without damaging the vessel wall. The transition section ensures that the stiffness of the guidewire changes smoothly between different areas, so that the guidewire can maintain sufficient flexibility while providing the necessary pushability and torsion control force to ensure that the guidewire remains stable in complex vascular structures.

[0342] Post-operative data analysis: After the operation, the system can also generate a report on pressure changes. The microprocessor in the circuit board 24 can record and store the trend data of pressure changes during the operation. This data can be used for post-operative analysis and treatment evaluation, helping doctors better understand the effect of thrombectomy and provide a basis for subsequent treatment.

[0343] Remote Update and Optimization: The system is also designed to support wireless communication interfaces. By regularly updating the latest clinical data and feedback, doctors can remotely optimize pressure threshold levels and operation strategies to ensure that the guidewire system maintains optimal performance in various application scenarios.

[0344] In summary, the working principle of the guidewire system is based on the real-time detection of intravascular pressure by the pressure sensor 14, combined with intelligent signal processing and feedback mechanism, which can accurately locate the thrombus position and provide timely operation guidance for doctors. Through this innovative design, the system not only improves the success rate of thrombus removal, but also reduces the damage to healthy vascular tissue during the operation, greatly improving the safety and effectiveness of the operation.

[0345] The advantages of the above implementation are as follows:

[0346] Accurately locate the thrombus and improve the success rate of the operation: In thrombectomy, quickly and accurately locating the thrombus is the key to successful removal. Through the pressure sensor set at the distal end of the guide wire, the present application can detect the pressure changes in the blood vessel in real time, especially the pressure fluctuations caused by the thrombus site. When the pressure sensor detects abnormally high pressure, it can accurately identify the location of the thrombus. This real-time pressure monitoring significantly improves the accuracy of thrombus positioning and provides the operator with important surgical reference information, thereby improving the success rate of the operation.

[0347] Flexible size design to adapt to different vascular environments: The blood vessels involved in thrombectomy may include arteries, veins, and even tiny peripheral blood vessels. In order to cope with different vascular environments, the present application provides a guidewire design with adjustable outer diameter and length range to ensure that the guidewire can be smoothly guided in blood vessels of different sizes. The small outer diameter of the distal part enables the guidewire to enter narrow or blocked vascular areas, while the larger outer diameter of the proximal part provides sufficient rigidity to facilitate the operator to accurately control the push and retraction of the guidewire. This flexible size design enables the guidewire to achieve ideal results in different types of thrombectomy surgeries.

[0348] Intelligent adjustment of multiple pressure thresholds and personalized surgical plans: During thrombectomy, different patients have different vascular conditions and thrombus characteristics. The pressure guidewire of this application is equipped with an intelligent circuit board, which can flexibly set multiple pressure thresholds according to vascular type, lesion site and surgical requirements. The operator can manually select or rely on a preset algorithm to automatically match the appropriate pressure threshold level. This personalized adjustment function ensures that the guidewire can achieve optimal monitoring accuracy in different clinical scenarios, improves the personalization level of the operation, and reduces the risk of misoperation due to inappropriate pressure monitoring.

[0349] Dual feedback mechanism provides real-time intraoperative guidance: In thrombus removal surgery, timely and accurate feedback is crucial for the operator. This application provides real-time intraoperative guidance to the operator through a dual feedback mechanism of vision and optics. When the guidewire passes through the thrombus area, the abnormal pressure detected by the pressure sensor will send a warning signal through the indicator light on the handle, prompting the operator to take appropriate actions. At the same time, the light source at the end of the guidewire transmits the light signal to the thrombus position through the optical fiber, intuitively displaying the specific location of the thrombus. This dual feedback mechanism not only improves the operator's control accuracy of the guidewire position, but also avoids misjudgment, ensuring that every step in the operation is accurately guided.

[0350] The protection design of the pressure sensor ensures long-term stability: The guidewire in thrombectomy needs to repeatedly pass through narrow or diseased blood vessel areas, which places extremely high demands on the durability of the guidewire. The hemispherical protection structure formed by the dispensing method in this application effectively wraps the pressure sensor to prevent it from direct contact with the blood vessel wall and avoid physical damage or wear. At the same time, the sensing area of ​​the sensor is set slightly below the highest point of the protective layer, which can not only achieve sensitive pressure detection, but also reduce misjudgment. This protection design greatly improves the durability and stability of the sensor, ensuring that the guidewire remains efficient during long-term surgery and will not affect the progress of the operation due to sensor failure.

[0351] Soft tip and transition section design to reduce vascular damage: During thrombus removal, the guidewire usually needs to pass through narrow, tortuous diseased blood vessels. Especially when approaching a thrombus, the softness of the guidewire is crucial. The present application designs a soft tip at the farthest end of the guidewire and achieves a gradual change in stiffness through the transition section. This design effectively prevents mechanical damage to the vessel wall when the guidewire passes through a tortuous part of the vessel or near a thrombus, reduces the risk of thrombus rupture or vascular damage, and ensures the safety of the operation.

[0352] Flexible guidewire fixing and pushing device improves the convenience of operation: Thrombectomy requires high precision in the positioning and pushing of the guidewire. This application designs an adjustable locking device and a pushing rod. The operator can accurately fix the position of the guidewire through the locking knob and control the advancement or withdrawal of the guidewire through the pushing rod. This design simplifies the operation process, ensures the stability of the guidewire, enables the operator to more accurately control the movement of the guidewire in the blood vessel, and improves the operation efficiency of the operation.

[0353] Visual operation reduces surgical complexity: During thrombus removal, the light source signal transmitted by the optical fiber can send out optical indications at the end of the guidewire, helping the operator to confirm the position of the guidewire in the blood vessel in real time, especially providing powerful guidance in complex vascular pathways. This visual operation mode enables the operator to intuitively judge whether the thrombus area has been approached, avoiding the risks brought by blind operation, and greatly reducing the complexity and uncertainty of the operation.

[0354] Intelligent control and remote update to adapt to different clinical needs: The circuit board of this application can flexibly set the pressure threshold level through the microprocessor and memory, and supports remote update through the wireless communication interface. In this way, the guidewire can be optimized in real time according to the latest clinical data and usage feedback to adapt to different clinical scenarios and lesion states. This intelligent control and adaptive update function ensures that the pressure guidewire can always keep pace with clinical needs, improving the success rate and safety of the operation.

[0355] Multi-sensor layout improves spatial pressure perception capabilities: During thrombectomy, pressure changes in blood vessels occur not only in the longitudinal position of the thrombus, but also involve pressure distribution on the cross section. This application arranges two pressure sensors on both sides of the distal end of the guidewire to accurately sense the pressure distribution on the cross section of the blood vessel, helping the operator to better understand the overall impact of the thrombus on the blood vessel. This multi-sensor layout not only improves the accuracy of pressure detection, but also more accurately assesses the degree of compression of the thrombus on the blood vessel wall, helping operators to formulate thrombus removal strategies more effectively.

[0356] In summary, the pressure guidewire of the present application shows excellent technical effects in thrombus removal. Its pressure sensor, adjustable size design, dual feedback mechanism, soft tip and transition design, and intelligent control system provide strong support for the precise positioning, rapid removal and intraoperative operation of thrombus. Through the application of this guidewire, the operator can perform surgery accurately and flexibly in a complex vascular environment, reduce surgical risks, improve the success rate, and provide patients with safer and more effective treatment options.

[0357] It should be noted that all documents mentioned in this application are cited as references in this application, just as each document is cited as reference separately. In addition, it should be understood that after reading the above teaching content of this application, those skilled in the art can make various changes or modifications to this application, and these equivalent forms also fall within the scope defined by the claims attached to this application.

Claims

1. An intelligent pressure monitoring guidewire system for thrombectomy, characterized in that: include: A guidewire having a proximal end and a distal end, comprising: An outer polymer film with a lubricating coating; An inner metal tube is coaxially disposed in the outer polymer coating; A core, coaxially disposed in the inner metal tube; A pressure sensor, disposed at the distal end of the guidewire, for detecting pressure changes in the blood vessel; A sensor wire, electrically connected to the pressure sensor, radially arranged between the inner metal tube and the outer polymer coating, and extending along the axial direction of the guide wire; A control handle is detachably connected to the proximal end of the guide wire, and the control handle comprises: A handle body, with a guide wire passage extending therethrough, for slidably accommodating and guiding the guide wire; a locking device, adjustably disposed on the handle body, for selectively fixing the position of the guide wire in the guide wire channel; A push rod connected to the proximal end of the guide wire and used to control the axial pushing and retraction of the guide wire; A circuit board is disposed in the handle body and is electrically connected to the proximal end of the sensor wire; An indicator light, disposed on the outer surface of the handle body and electrically connected to the circuit board; A switch, disposed on the outer surface of the handle body and electrically connected to the circuit board, for controlling the working state of the pressure guide wire; The pressure sensor is configured to detect the pressure changes in the blood vessel in real time during thrombus removal surgery to identify the location of the thrombus. When the detected pressure exceeds a preset threshold, the sensor wire transmits a signal to the circuit board, and the circuit board controls the indicator light to provide the operator with instant feedback information on the location of the thrombus, thereby assisting in the precise implementation of the thrombus removal surgery.

2. The system according to claim 1, characterized in that The inner metal tube comprises: A distal flexible tube, disposed at the distal end of the guide wire; A proximal support tube, arranged at the proximal end of the guide wire; A connecting portion, used to connect the distal flexible tube to the proximal support tube; Among them, the distal flexible tube includes a distal spring tube or a distal metal-free tube; the proximal support tube includes a proximal snake tube or a braided tube; the connecting part adopts at least one of welding, bonding or mechanical connection to realize the distal flexible tube.

3. The system according to claim 1, characterized in that The pressure sensor is a microelectronic sensor or a thin film sensor; The sensing area of ​​the pressure sensor is set to be slightly lower than the highest point of its outer protective layer to avoid direct contact with the blood vessel wall and cause misjudgment; The pressure sensor is fixed between the inner metal tube and the outer polymer film by glue dispensing, and the protective layer formed by glue dispensing is hemispherical.

4. The system according to claim 1, characterized in that: The pressure sensor is fixed between the inner metal tube and the outer polymer film by glue dispensing; The dispensing forms a hemispherical protective structure, which covers the pressure sensor; The sensing area of ​​the pressure sensor is arranged at a position slightly below the highest point of the hemispherical protective structure; The hemispherical protective structure is used to protect the pressure sensor, while allowing the sensing area to effectively sense the pressure changes in the blood vessel and avoid direct contact with the blood vessel wall to cause misjudgment.

5. The system according to claim 1, characterized in that The core is made of nickel-titanium alloy or stainless steel wire, or is welded by a front nickel-titanium alloy and a rear stainless steel wire.

6. The system according to claim 1, characterized in that The locking device comprises: A locking knob rotatably disposed on the handle body; A support platform, fixedly disposed in the handle body and located directly below the locking knob; A through channel vertically penetrates the locking knob and the support platform to form a part of the guide wire channel; Wherein, the bottom of the locking knob and the top of the support platform are both provided with a groove for accommodating the guide wire, and the groove is connected to the through channel; When the locking knob is rotated downward, the groove at the bottom of the locking knob is relatively closed with the groove at the top of the support platform, thereby controllably clamping the guide wire to achieve adjustable fixation of the guide wire; The cross section of the groove is semicircular or V-shaped, and its shape and size are designed to evenly distribute pressure in the locked state to avoid damage to the guide wire to the greatest extent; The locking knob is also provided with an anti-slip texture, which facilitates the operator to perform fine adjustments.

7. The system according to claim 1, characterized in that: The circuit board is configured to set multiple pressure thresholds according to the blood vessel type, wherein the circuit board includes a microprocessor and a memory; the memory pre-stores multiple pressure threshold levels corresponding to different blood vessel types and pathological states; the microprocessor is configured to: receiving and processing the pressure signal from the pressure sensor in real time; Automatically selects applicable vessel type and lesion status based on user input or preset algorithms; Calling the corresponding pressure threshold level according to the selected blood vessel type and lesion status; dynamically comparing the real-time pressure signal to a selected pressure threshold; When the detected pressure exceeds a selected threshold, immediately triggering the indicator light to illuminate in a specific pattern and optionally generating an audible alarm; The control handle also includes a user interface electrically connected to the circuit board, and the user interface includes: A display screen, used to display pressure values ​​and selected blood vessel type information in real time; Control buttons allow the operator to manually select or fine-tune the pressure threshold level; Wherein, the pressure threshold level can be remotely updated and optimized based on the latest clinical data and usage feedback through a wireless communication interface; The microprocessor is also configured to record pressure change trends and generate a pressure change report after surgery to assist in postoperative analysis and treatment evaluation.

8. The system according to claim 1, characterized in that Also includes: A light source is disposed in the handle body; an optical fiber, disposed in the guide wire, one end of which is optically connected to the light source and the other end of which extends to the distal end of the guide wire; An optical window, disposed at the distal end of the guidewire and optically connected to the distal end of the optical fiber; A light source control switch, disposed on the handle body and electrically connected to the light source; A light detector, used to detect the light signal returned by the sensor and output a signal; in, The optical fiber is used to transmit the optical signal from the light source; The optical window is used to emit a light signal from the inside of the guide wire to indicate the location of the thrombus; The wavelength and intensity of the light source are optimized to provide a clearly visible light signal within the blood vessel while minimizing thermal effects on surrounding tissue; The light source control switch is used to control the opening and closing of the light source and adjust the light intensity; When the pressure sensor detects that the pressure exceeds a preset threshold, the circuit board can automatically trigger the light source to turn on, and send out a light signal through the optical fiber and the optical window, which cooperates with the indicator light to provide the operator with a double thrombus position indication.

9. The system according to claim 1, characterized in that: The pressure sensor includes two independent sensor units, which are respectively arranged on the left and right sides of the distal end of the guide wire; Each sensor unit consists of: Pressure-sensitive element, used to sense local blood vessel pressure; A signal processing circuit, used for preliminarily processing the pressure signal collected by the pressure-sensitive element; The two sensor units are electrically connected to the circuit board via independent sensor wires; The circuit board is configured as: Respectively receiving and processing pressure signals from two sensor units; Compare the pressure difference between the two sensor cells; Calculate the pressure distribution on the cross-section of the blood vessel based on the pressure difference; in, The arrangement of two sensor units enables the pressure guidewire to detect differences in pressure distribution across the cross section of the blood vessel; By analyzing the difference in pressure distribution, the location of the thrombus can be more accurately located and the extent of the thrombus's impact on the blood vessel wall can be assessed; The design can also be used to detect other vascular pathologies such as vascular stenosis or malformations.

10. The system according to claim 1, characterized in that: The outer polymer coating is made of at least one of the following materials: polyethylene; thermoplastic polyurethane; polytetrafluoroethylene; nylon; polyamide; polyether block amide; wherein, The outer polymer coating is a single-layer structure or a multi-layer composite structure. When it is a multi-layer composite structure, it is composed of different materials. The thickness of the outer polymer coating ranges from 0.01 mm to 0.1 mm; The selected materials have been tested for biocompatibility to ensure safety in long-term contact with human tissue; The surface of the outer polymer coating may be treated to be hydrophilic or hydrophobic to improve its sliding performance in the blood vessel.

11. The system according to claim 1, characterized in that The outer diameter of the guide wire ranges from 0.2 mm to 1 mm, and the total length ranges from 100 cm to 300 cm; The guide wire comprises a distal portion, a proximal portion, a soft tip and a transition section; wherein, The outer coating of the soft tip is doped with developing materials such as barium sulfate and bismuth trioxide for intraoperative development; The distal portion includes a section where the pressure sensor is located, has an outer diameter ranging from 0.2 mm to 1 mm, and a length of not less than 30 cm; The outer diameter of the proximal part can be gradually increased, but the maximum outer diameter does not exceed 0.889 mm. It is made of high-strength alloy material to provide pushability and torsion control; The soft tip is located at the distal end of the guidewire, with a length of 1 cm to 5 cm. The outer diameter gradually decreases from the proximal end to the distal end, with a minimum of 0.204 mm. It is made of highly soft polymer or alloy material. The transition section is located between the soft tip and the pressure sensor and is used to achieve a gradual change in the stiffness of the guidewire.

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