Controllable steering catheter and guide wire system for vascular interventional operation and use method of controllable steering catheter and guide wire system

Abstract

The invention relates to the technical field of medical treatment, and discloses a controllable steering catheter and guide wire system for a vascular interventional operation and a use method of the controllable steering catheter and guide wire system. At least one group of guide structures is arranged in the guide pipe, each guide structure comprises three blades which are uniformly distributed at 120 degrees, and a guide part is arranged at the end part of the inner side of each blade; and the guide wire is provided with a spiral structure matched with the guide part. The blade is provided with a reserved section close to the root, and movable hinge is formed through a frame embedded in the wall of the guide pipe and a hinge type structure. The system further comprises a driving mechanism which comprises control wires and a control device, and each set of blades corresponds to three control wires. The blades can swing inwards when being controlled and are matched with the spiral structure of the guide wire to achieve accurate steering. The guide structure is arranged at the far end of the catheter, the problems of force transmission and control precision caused by the fact that a control device is far away from the working end in the prior art are solved, and the catheter is particularly suitable for interventional operations of complex blood vessel forms such as III-type aortic arches.

Description

Technical Field

[0001] The present invention relates to the field of medical device technology, and specifically to a controllable steering catheter guidewire system for vascular intervention surgery and a method of using the same, and in particular to a guidewire precision steering control device that can be used in complex aortic arch cerebral angiography surgery. The system is mainly used in neurointerventional surgery, such as whole brain angiography, intracranial aneurysm embolization, cerebral artery stenosis balloon dilatation stent placement, cerebral artery thrombectomy and other surgical procedures. Background Art

[0002] Cerebral angiography is the "gold standard" for diagnosing cerebrovascular diseases, and its access methods mainly include transfemoral artery (TFA) and transradial artery (TRA). The catheter guidewire system in the prior art mainly includes a propulsion device and a steering device, but these devices are usually set at the proximal end of the catheter, far away from the distal end of the guidewire, which has significant technical defects.

[0003] Currently, there are multiple technical challenges in TRA surgery for patients with type III aortic arches. The primary problem is that the catheter needs to adapt to the complex vascular morphology, and the same catheter needs to perform different functions in different parts, which creates a "support-flexibility" contradiction. This contradiction is particularly prominent when there is a conflict between the blood flow direction and the catheter travel direction.

[0004] Specifically, the existing technology faces the following technical difficulties: at the front end of the catheter, it is necessary to meet the different requirements of three positions at the same time, which requires both steering capability and prevention of vascular damage; at the middle section of the catheter, it is necessary to ensure good transmission of the pushing force and adapt to the bending of the arch, while preventing folding and deformation; at the rear section of the catheter, it is necessary to ensure reliable transmission of the pushing force and maintenance of overall stability. These requirements restrict each other and are difficult to be solved by simple structural design.

[0005] The existing catheter guidewire system has problems such as force transmission attenuation, control response lag, and cumulative error due to the long distance between the control device and the working end. Although some improvement schemes have appeared on the market, such as the use of "J" type guidewire or Simmons catheter, these schemes still do not fundamentally solve the above technical difficulties, especially the precise control problem when dealing with complex vascular morphology. Summary of the invention

[0006] The purpose of the present invention is to solve the shortcomings of the prior art. The present invention provides a controllable steering system that cooperates with a guidewire spiral structure and a unique three-blade guide structure in the catheter, thereby achieving precise angle control of the guidewire end in vascular interventional surgery. The system is particularly suitable for surgical operations on complex vascular morphologies such as type III aortic arches.

[0007] In order to solve the above problems, the present invention adopts the following solution: a controllable steering catheter guidewire system for vascular intervention surgery, comprising: A catheter and a guide wire; at least one set of guide structures is arranged in the catheter, the guide structure comprises three blades evenly distributed at 120 degrees, the blades can swing inwards when driven, and the inner ends of the blades are provided with guide parts; the guide wire is provided with a spiral structure matched with the guide parts.

[0008] Beneficial effects: Through the structural design of three evenly distributed blades, combined with the cooperation of the guide part and the spiral structure, precise angle control of the guide wire end is achieved, thereby improving the accuracy of surgical operations.

[0009] Preferably, the blade has a reserved section near the root, and the reserved section is hinged by a frame pre-buried in the conduit wall and a hinge structure.

[0010] Beneficial effects: The combined design of the reserved segment, frame and hinged structure ensures the stability and fatigue resistance of the blade swing and improves the reliability of the system.

[0011] Preferably, an annular groove section is provided on the inner annular surface of the frame, and a rigid ring is embedded in the annular groove section.

[0012] Beneficial effects: Through the design of the rigid ring, the overall rigidity of the guide structure is improved, the synchronization of the blade movement is ensured, and a stable guide channel is provided for the control wire.

[0013] Preferably, it further comprises a driving mechanism, which comprises a control wire and a control device, wherein the control wire is arranged along the catheter wall, and each group of blades corresponds to three control wires.

[0014] Beneficial effects: Through the uniform arrangement of the three control wires, precise control of the blades is achieved, making the system more controllable and reliable.

[0015] Preferably, the guide structure comprises three groups of scale assemblies, each group of scale assemblies comprises 3-5 scales hinged in sequence, the scales are made of shape memory alloy material, and a microelectrode is arranged on each scale.

[0016] Beneficial effects: The use of shape memory alloy materials and electronic control methods achieves more precise deformation control, a more compact structure, and small space occupation.

[0017] A method for performing vascular intervention surgery using the above-mentioned controllable steering catheter guidewire system for vascular intervention surgery comprises the following steps: S1. Determine the aortic arch type based on the patient's vascular CTA images and select the appropriate catheter and guidewire combination; S2. Place the catheter and guidewire into the target vessel via the radial or femoral artery; S3. Activate the guide mechanism to control the blade to swing to a preset angle; S4. Advance the guidewire so that its spiral structure engages with the guide portion for precise guidance.

[0018] The execution order of step S3 and step S4 can be interchanged, that is, the guide wire can be first pushed to the guide part position so that the starting section of its spiral structure is located at the predetermined matching position with the guide part, and then the guide mechanism is activated to control the blade to swing inward so that the guide part is engaged with the spiral structure, and the guide wire is continued to be pushed to achieve precise angle control. This flexible operation sequence can be selected according to the specific surgical situation and the operator's habits, which improves the adaptability and operational convenience of the system.

[0019] In addition, during the execution of step S3 or S4, the swing angle of the blades can be adjusted or the advancement of the guide wire can be paused at any time according to actual needs to ensure the accuracy of the guiding effect and the safety of the surgical operation.

[0020] Beneficial effects: It provides a systematic and standardized operation method, which improves the repeatability and success rate of the operation.

[0021] Preferably, in step S3, when the catheter needs to turn, the blades located on the outer side of the bend are selectively controlled to remain in contact with the catheter wall, and only the blades on the inner side of the bend are activated to swing inwards.

[0022] Beneficial effects: Differentiated control of the catheter during turns is achieved, improving the adaptability of the system in complex vascular pathways.

[0023] Preferably, the method further comprises the step of utilizing blood flow to assist the advancement: When advancing in the forward direction, the blades are controlled to be in a semi-retracted state; when retracting, the blades are controlled to be fully extended.

[0024] Beneficial effects: Utilizing blood flow force to assist catheter movement reduces the pressure on the blood vessel wall caused by manual operation and improves surgical safety.

[0025] Preferably, the force applied to the blades is continuously monitored during the execution of the steps to ensure that the deployment angle of the guide structure is within a safe range.

[0026] Beneficial effects: Through real-time monitoring and control, the safety of the surgical process is ensured and the risk of complications is reduced. Compared with the prior art, the technical solution of the present invention has the following advantages: The controllable steering catheter guidewire system and its use method provided by the present invention realize precise angle control of the guidewire end by setting a unique three-blade guide structure in the catheter and cooperating with the guidewire spiral structure, combined with the multi-level support design of the frame, hinge and rigid ring. The system can not only realize the precise swing of the blades by mechanical control, but also provide an electric control scheme based on shape memory alloy to make the structure more compact. In practical applications, the system can realize differentiated control of the blades to ensure the flexibility of the catheter in complex vascular pathways; at the same time, it can use blood flow force to assist the movement of the catheter and reduce damage to the vascular wall. Through standardized operating procedures and real-time monitoring mechanisms, the accuracy, safety and success rate of the operation are significantly improved, and it is particularly suitable for interventional surgery with complex vascular morphology such as type III aortic arch. The design of the system fully considers the actual clinical needs, and the various components cooperate closely to achieve stable and reliable performance output, which is of great significance to the development of cerebral angiography. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the figures required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the figures described below are only some embodiments of the present application. For ordinary technicians in this field, other figures can be obtained based on these figures without paying creative work.

[0028] Figure 1 It is a schematic diagram of the overall structure of the controllable steering catheter guidewire system of the present invention; Figure 2 for Figure 1 A partial enlarged view of the guide structure at A in the middle; Figure 3 Another angle view of the controllable steering catheter guidewire system of the present invention; Figure 4 for Figure 3 The enlarged schematic diagram of the blade support guide wire matching structure at B in the middle; Figure 5 A schematic diagram showing the internal structure of the catheter of the present invention after partial removal; Figure 6 for Figure 5 A partial enlarged view of the blade assembly at C in the middle; Figure 7 It is a schematic diagram of the structure after the frame, hinge structure and blades are assembled; Figure 8 It is a schematic diagram of the structure after the blade and guide wire are matched.

[0029] Reference numerals: The catheter 10 , the guide wire 20 , the guide structure 30 , the blade 31 , the guide portion 311 , the reserved section 312 , the guide groove 313 , the frame 32 , the annular groove section 321 , the rigid ring 322 , the hinge structure 33 , the control wire 34 , the control device 35 , and the spiral structure 21 . DETAILED DESCRIPTION

[0030] The following will be combined Figure 1-Figure 8 The preferred embodiments of the present invention are described in detail. It should be noted that the following description is only a preferred embodiment of the present invention, rather than a limitation of the present invention. Those skilled in the art should understand that various modifications and variations can be made to the present invention without departing from the spirit and scope of the present invention. The scope of protection of the present invention shall be subject to the attached claims.

[0031] Example 1 The present invention provides a controllable steering catheter guidewire system for vascular intervention surgery, which is particularly suitable for cerebral angiography surgery of complex aortic arches (such as type III arches). The system mainly includes two main parts: a catheter 10 and a guidewire 20.

[0032] The catheter 10 is made of elastic material, suitable for radial artery and femoral artery access, such as 4-6F medical grade elastic material. At least one group of guide structures 30 is evenly arranged along the inner wall circumference within 2-10cm near the distal end. The main body of each group of guide structures 30 is three thin-sheet blades 31 evenly distributed at 120°. The size of the blades 31 can be, for example: the basic length is 20mm, the width is 3mm, the thickness is 0.3-0.6mm, and it is made of alloy material. The blades 31 are close to the inner wall of the catheter under normal conditions, and can swing inward to a preset angle when driven. The swing angle can be adjusted according to clinical needs, usually within the range of 15-45°. The inner end of the blade 31 is designed with a guide portion 311, and the inner surface of the guide portion 311 is processed with a micron-level groove with a depth of 0.1-0.2mm. The guide portions 311 of the three blades 31 are combined to form a complete and balanced guide support structure to stably contact and cooperate with the guide wire 20.

[0033] The blade 31 has a reserved section 312 near the root, and the middle section of the reserved section 312 is directly connected to the frame 32 and the hinge structure 33 embedded in the catheter wall to form a movable hinge to ensure the rotation stability and fatigue resistance of the blade 31. The frame 32 can be made of medical stainless steel and embedded in the catheter wall through an injection molding process. The reserved section 312 is also used to connect with an actuator that drives the blade 31 to move, such as connecting a control wire 34.

[0034] The driving mechanism of the guide structure 30 includes a control wire 34 arranged along the catheter wall and a control device arranged at the proximal end of the catheter (the control device can adopt the conventional design of the surgical instrument control device commonly used in the art). Each group of blades 31 corresponds to three evenly distributed control wires 34, and the control wires 34 are made of high-strength nylon material and are arranged through micro-pipes preset in the catheter wall. The control device usually includes an adjustment knob and a locking mechanism. For example, a cam is used to convert linear motion into rotation. By rotating the adjustment knob, the control wire 34 can be driven to produce axial displacement, thereby driving the blades 31 to swing inward. The locking mechanism is used to fix the adjustment knob or a corresponding mechanism to position the deployment angle of the blades 31.

[0035] The guide wire 20 is designed with a special spiral structure 21 at the section corresponding to the guide portion 311 of the blade 31. The spiral structure 21 has a spiral angle of 20°, a pitch of 4mm, and a spiral groove depth of 0.3mm. The surface of the spiral section is hardened by plasma spraying to improve wear resistance. The end of the guide wire 20 adopts the "J" type design that is currently the most commonly used in clinical practice, which can effectively reduce damage to the blood vessel wall. The material of the guide wire 20 can be medical stainless steel, and the surface is coated with a hydrophilic coating to improve its passing performance in the blood vessel.

[0036] In order to enhance the rigidity of the guide structure 30 when it is used as a guide support, in some embodiments, an annular groove section 321 is cut out on the inner annular surface of the three frames 32, and a rigid ring (not shown in the figure) is embedded in the annular groove section 321 to form an integral support structure. The rigid ring can be made of medical titanium alloy material, and its outer diameter matches the inner diameter of the annular groove section 321, and is fixed by interference fit. The cross section of the rigid ring can be circular, rectangular or a special-shaped structure with chamfers to ensure a reliable connection between it and the annular groove section 321. This design not only improves the overall rigidity of the guide structure 30, but also ensures the synchronization and stability of the three blades 31 when they are in action. At the same time, the presence of the rigid ring also provides a stable guide channel for the control wire 34, which can further improve the control accuracy of the system.

[0037] The controllable steering catheter guidewire system of the present invention achieves precise guidewire direction control in the following ways: 1. Basic guidance control: When the catheter 10 reaches the target blood vessel, the operator drives the control wire 34 through the adjustment knob of the control device. The control wire 34 produces axial displacement, driving the blades 31 connected thereto to swing inward. The three blades 31 swing inward synchronously to form a balanced guide support structure, and the guide portion 311 on the inner side thereof forms a complete guide ring, which precisely matches the spiral structure 21 of the guide wire 20. At this time, the guide wire 20 is pushed forward, and the spiral structure 21 engages with the groove of the guide portion 311, driving the guide wire 20 to rotate in a directional manner during the advancement process, thereby achieving precise angle control of the end of the guide wire.

[0038] 2. Stiffness guarantee mechanism: To ensure the stability of the guiding process, the system adopts a multi-support structure: The frame 32 is embedded in the conduit wall by injection molding to provide basic support for the blades 31; The ring groove section 321 of the inner ring surface of the frame 32 is embedded in the rigid ring, connecting the three independent frames 32 into a whole; The hinge structure 33 ensures that the swing of the blade 31 is stable and controllable; This multi-level support design ensures the rigidity and stability of the guide structure 30 during operation.

[0039] 3. Precise positioning control: The swing angle of the blade 31 can be precisely adjusted within the range of 15-45°; The locking mechanism can fix the blade 31 at any desired angle; The micrometer-scale grooves of the guide portion 311 ensure stable cooperation with the spiral structure 21 of the guide wire 20; The spiral structure 21 of the guide wire 20 is designed with a 4 mm pitch to achieve precise angle conversion.

[0040] Through the synergistic effect of the above mechanisms, this system can achieve precise guidance control of the guidewire in complex vascular environments (especially type III aortic arch), improving the accuracy and safety of surgical operations. The design of the system fully considers the actual clinical needs, and the various components work closely together to achieve stable and reliable performance output.

[0041] In this embodiment, the independent control of the three blades 31 has important advantages. When the catheter 10 needs to turn inside the blood vessel, the blades 31 located on the outside of the bend can be selectively controlled to remain in contact with the catheter wall, while only the blades 31 on the inside of the bend and in the neutral position are activated to swing inward. This differentiated control is achieved by the control device driving the corresponding control wires 34 respectively. For example, when the catheter 10 needs to bend toward the 9 o'clock direction, the blade 31 located at the 3 o'clock position can be kept in contact with the wall, and only the blades 31 located at the 11 o'clock and 7 o'clock positions can be driven to swing inward. This design ensures the flexibility of the catheter 10 when turning, avoids unnecessary constraints on the bending of the catheter 10 by the blades 31, and can still provide sufficient guiding support through the remaining deployed blades 31.

[0042] This differentiated control mechanism not only improves the adaptability of the system in complex vascular pathways, but also allows the flexible adjustment of the guiding support mode and strength according to the needs of different vascular anatomical structures. This feature is especially important for navigating complex vascular morphologies such as type III aortic arches.

[0043] In some embodiments of the present invention, the three blades 31 of the guide structure 30 can also assist the advancement or withdrawal of the catheter by cooperating with the blood flow. The specific working principle is as follows: When it is necessary to move forward in the direction of blood flow, the three blades 31 can be controlled to be in a semi-contracted state (for example, swinging inward 15-20 degrees), and the blades 31 form a parachute-like structure. The pressure generated by the blood flow acts on the back of the blades 31, pushing the catheter forward. This design utilizes the natural thrust of blood flow and can reduce the pressure on the blood vessel wall during manual advancement.

[0044] When withdrawal is required, the blades 31 can be controlled to fully expand (for example, swing inward 30-45 degrees), and the impact force of blood reflux on the front of the blades 31 can be used to assist the catheter to move backward. This method helps to safely withdraw the catheter and reduce the risk of damage to the blood vessel wall.

[0045] In order to better achieve this function, the shape of the blade 31 can be designed to be a slightly curved fan-shaped to increase the effective area in contact with the blood flow. At the same time, a number of guide grooves can be set on the surface of the blade 31 to optimize the blood flow direction and improve the efficiency of advancement or withdrawal.

[0046] Through this design, the present invention can not only achieve precise steering control of the guidewire, but also achieve auxiliary advancement and withdrawal of the catheter with the help of blood flow force, further improving the safety and convenience of surgical operations.

[0047] Example 2 In another embodiment of the present invention, the guide structure 30 is designed with an electrically controlled scale. Specifically, at least one group of guide structures 30 is evenly arranged along the inner wall circumference within 2-20 cm near the distal end of the catheter 10. Each group of guide structures 30 includes three groups of scale components evenly distributed at 120°.

[0048] Each set of scale components includes 3-5 slender scales that are hinged in sequence. The size of each scale can be: 3mm in length, 2mm in width, and 0.2-0.4mm in thickness. The scales are made of shape memory alloy materials (such as nickel-titanium alloy). A guide block is provided at the innermost end of the scale component. The inner surface of the guide block is processed with a micron-level groove with a depth of 0.1-0.2mm. The guide blocks of the three sets of scale components together form a complete guide ring. Adjacent scales are connected by micro hinges, which enable them to achieve flexible bending similar to snake scales.

[0049] Each scale is provided with a micro-electrode, which is connected to the proximal control device through a wire buried in the catheter wall. The control device includes a power module, a control circuit and an operation interface. When a weak current is passed through the electrode, the shape memory alloy material undergoes a phase change, driving the scale to produce a preset bending deformation. By controlling the power-on time and the current size, the bending degree of the scale assembly can be precisely adjusted.

[0050] In order to provide stable support, a frame structure is set at the root of the scale assembly. The frame is made of flexible circuit board material, which can not only provide support for the scale assembly, but also serve as a wiring substrate for the electrode. The frame is embedded in the conduit wall through the injection molding process, and its radial support strength is enhanced by annular reinforcement ribs.

[0051] The unique advantages of this embodiment are: achieving precise electric control adjustment, having better flexibility and compliance, being able to achieve segmented control and complex movements, having a more compact structure, and occupying less space.

[0052] Example 3 A method for performing vascular intervention surgery using the above-mentioned controllable steering catheter guidewire system comprises the following steps: S1 Preoperative preparation Determine the aortic arch type based on the patient's vascular CTA images; Select the appropriate size catheter and guidewire combination; Carry out hydrophilic treatment on the surface of catheters and guide wires; S2 catheter insertion and initial positioning The catheter is placed into the target vessel via the radial or femoral artery; Under X-ray guidance, the catheter is pushed near the aortic arch; Maintain the guidewire's initial position within the catheter; Activation and adjustment of the S3 guide mechanism For Example 1 (Mechanical Control Solution): The corresponding control wire is driven by the adjusting knob of the control device; Precisely control the blade's swing angle (adjustable from 15-45°); Selectively activate blades in different positions as needed; For Example 2 (Electronic Control Solution): Passing current to the target scale group through the control device; The phase change characteristics of shape memory alloys are used to achieve scale bending; The degree of deformation is controlled by adjusting the current parameters; Precise guidance of the S4 guidewire Advancing the guidewire so that its helical structure engages with the guide portion; The rotation angle is controlled by the advancement distance of the guidewire; Adjust the support angle of the guide mechanism if necessary; S5 blood flow assisted propulsion (when applicable) When advancing in the forward direction: control the blades to be in a semi-retracted state (15-20°); When retracting: control the blades to fully expand (30-45°); Use blood flow pressure to assist catheter movement; S6 Special Case Handling When you encounter a bend in the blood vessel: Keep the outer blades in close contact with the duct wall; Only the inner blades are activated to provide guiding support; Ensure that the flexible bending of the catheter is not affected; S7 Safety Measures Continuously monitor the forces on the leaves or scales; Ensure that the deployment angle of the guide structure is within a safe range; Enable emergency recycling when necessary.

[0053] The advantages of this method are: adapting to different types of aortic arch morphology, providing precise guidewire direction control, reducing the difficulty of surgical operation, reducing the risk of damage to the blood vessel wall, and improving surgical efficiency and success rate.

Claims

1. A controllable steerable catheter guidewire system for vascular intervention surgery, characterized in that: include: A catheter and a guide wire; at least one set of guide structures is arranged in the catheter, the guide structure comprises three blades evenly distributed at 120 degrees, the blades can swing inwards when driven, and the inner ends of the blades are provided with guide parts; the guide wire is provided with a spiral structure matched with the guide parts.

2. The controllable steerable catheter guidewire system for vascular interventional surgery according to claim 1, characterized in that: The blade has a reserved section near the root, and the reserved section is hinged by a frame pre-buried in the conduit wall and a hinge structure.

3. The controllable steerable catheter guidewire system for vascular interventional surgery according to claim 2, characterized in that: An annular groove section is provided on the inner annular surface of the frame, and a rigid ring is embedded in the annular groove section.

4. The controllable steerable catheter guidewire system for vascular interventional surgery according to claim 1, characterized in that: It also includes a driving mechanism, which includes a control wire and a control device. The control wire is arranged along the catheter wall, and each group of blades corresponds to three control wires.

5. The controllable steerable catheter guidewire system for vascular interventional surgery according to claim 1, characterized in that: The guide structure includes three groups of scale components, each group of scale components includes 3-5 scales hinged in sequence, the scales are made of shape memory alloy material, and a micro electrode is arranged on each scale.

6. A method for performing vascular intervention surgery using the controllable steering catheter guidewire system for vascular intervention surgery according to any one of claims 1 to 5, characterized in that: The following steps are involved: S1. Determine the aortic arch type based on the patient's vascular CTA images and select the appropriate catheter and guidewire combination; S2. The catheter is placed into the target vessel via the radial or femoral artery; S3. Activate the guide mechanism to control the blade to swing to a preset angle; S4. Advance the guidewire so that its spiral structure engages with the guide portion for precise guidance.

7. The method for performing vascular interventional surgery using a steerable catheter guidewire system according to claim 6, characterized in that: In the S3 step, When the catheter needs to turn, the blades on the outer side of the curve are selectively controlled to keep in contact with the catheter wall, and only the blades on the inner side of the curve are activated to swing inwards.

8. The method for performing vascular interventional surgery using a steerable catheter guidewire system according to claim 1, characterized in that: It also includes the use of blood flow to assist the advancement step: When advancing in the forward direction, the blades are controlled to be in a semi-retracted state; when retracting, the blades are controlled to be fully extended.

9. The method for performing vascular intervention surgery using a steerable catheter guidewire system according to claim 1, characterized in that: The force condition of the blade is continuously monitored during the execution of the steps to ensure that the deployment angle of the guide structure is within a safe range.

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