Intelligent tactile feedback guide wire

Abstract

The invention provides an intelligent tactile feedback guide wire. The intelligent tactile feedback guide wire comprises a developing spring, an outer-layer protective tube, a head end sensor, a main body core wire and a near-end handle, the near end part of the developing spring is sleeved on the far end part of the main body core wire; the outer layer protective tube is sleeved on the far end part of the main body core wire and the developing spring; the head end sensor is arranged at the far end of the developing spring through a connecting block, overhangs and protrudes out of the outer layer protection tube, and is connected with the signal processing module through a wire; the main body core wire is provided with an inner cavity or a notch groove which extends along the axial direction and is used for a lead to penetrate through; and the near-end handle is connected with the near end of the main body core wire, is internally provided with a tactile feedback module connected with the signal processing module, and is used for feeding back the magnitude of the contact force. According to the invention, adaptive design is carried out on a basic structure of an existing nerve intervention guide wire, and innovative design of sensing and feedback devices is combined, so that a novel guide wire capable of sensing the contact force between the guide wire and a blood vessel in real time and feeding back the contact force to an operator is researched and developed.

Description

Technical Field

[0001] The present invention relates to the technical field of neurointerventional guidewires, and in particular to an intelligent tactile feedback guidewire. Background Art

[0002] Neurointerventional guidewires are core tools in cerebrovascular interventional surgeries. During the treatment of various intracranial vascular diseases, the guidewires play a role in path exploration and channel establishment.

[0003] Traditional interventional guidewires rely on the operator to observe the position of the guidewire through DSA angiography equipment, but there are the following defects: the contact force between the guidewire and the blood vessel wall cannot be transmitted back to the operator's hand through the core wire, and the operator can only rely on visual feedback, resulting in operation blind spots; the angiography equipment may have delays due to limited conditions and cannot reflect the dynamics of the guidewire in real time; the lack of tactile feedback easily causes the guidewire to scratch the blood vessel or puncture the tumor body, increasing the surgical risk. At the same time, the structure of the existing neurointerventional guidewire (such as the distal end of the head end, the visualization spring, and the outer sheath are fixedly connected) cannot directly add detection sensor devices, or rather, it brings many difficulties to the design of sensing and feedback devices.

[0004] Therefore, it is urgent to adaptively design the basic structure of the existing neurointerventional guidewire and at the same time combine the innovative design of sensing and feedback devices to develop a new type of guidewire that can sense the contact force between the guidewire and the blood vessel in real time and feedback it to the operator. Summary of the Invention

[0005] The purpose of the present invention is to provide an intelligent tactile feedback guidewire to solve the above-mentioned technical problems.

[0006] To solve the above technical problems, the technical solution of the present invention is as follows:

[0007] The present invention provides an intelligent tactile feedback guidewire, including a visualization spring, an outer sheath tube, a head end sensor, a main body core wire, and a proximal handle; the proximal end of the visualization spring is sleeved on the distal end of the main body core wire; the outer sheath tube is sleeved on the distal end of the main body core wire and the visualization spring; the head end sensor is arranged at the distal end of the visualization spring through a connecting block, and protrudes out of the outer sheath tube, and is connected to a signal processing module through a wire; the main body core wire has an axially extending inner cavity or groove for threading the wire; the proximal handle is connected to the proximal end of the main body core wire, and a tactile feedback module connected to the signal processing module is built in for feeding back the magnitude of the contact force.

[0008] Further, the tactile feedback module adopts a vibration feedback module, and its vibration intensity is proportional to the magnitude of the contact force detected by the head end sensor.

[0009] Further, the head end sensor adopts a resistance strain sensor or a nano-polymer sensor.

[0010] Further, the head-end sensor is in the form of an axially-extended circular ring or a conical spring.

[0011] Further, the nano-polymer sensor includes a support substrate and a nano-coating; the support substrate includes a wire portion and a force-deformable portion connected to each other, and another wire portion disposed separately from the force-deformable portion; the nano-coating covers the wire portion and the force-deformable portion, and is connected to the other wire portion through a connection wire.

[0012] Further, the portion of the support substrate coated with the nano-coating is subjected to polarization treatment to serve as one pole of the sensor electrode, and the outer surface of the nano-coating serves as the other pole of the electrode.

[0013] Further, a metal film is adhered to the nano-coating of the wire portion for connection to the other wire portion through a connection wire.

[0014] Further, the outer sheath is provided with a plurality of layers of radial cuts at axial intervals, each layer of radial cuts being divided into a plurality of circumferential cut segments, and axial connection segments being formed between the circumferential cut segments.

[0015] Further, the plurality of axial connection segments are spirally spaced along the axis.

[0016] Further, the head end of the guide wire is formed into a certain curvature through a pre-plastic process.

[0017] Compared with the prior art, the present invention has at least the following beneficial effects:

[0018] 1. In the present application, the tactile feedback module is embedded in the proximal handle of the guide wire, and the head-end contact force is converted into a tactile signal (such as vibration change) that can be perceived by the operator in real time, enabling the operator to more intuitively feel the force feedback of the guide wire, breaking through the limitations of traditional guide wires that rely on vision (such as X-ray imaging) and operator experience, and avoiding scratching the blood vessel or puncturing the tumor with the guide wire; such a force feedback closed-loop system has forward-looking in the field of minimally invasive interventional procedures, and can significantly improve the operation accuracy and safety, especially in complex vascular path navigation. In addition, the guide wire of the present invention provides a feasible method for the safe operation of the guide wire by a surgical robot in a blood vessel.

[0019] 2. In the present application, the head-end sensor directly projects out of the outer sheath, thus reducing or even avoiding the contact interference of the outer sheath during detection; at the same time, the head-end sensor not only replaces / serves as the head of the guide wire, but also serves as a detection sensor, directly contacting the blood vessel wall to achieve in-situ force detection, thereby simplifying and optimizing the structural design.

[0020] 3. In the present application, the developing spring not only provides visibility under X-rays but also serves as an elastic support structure for the sensor, buffering the transmission of mechanical forces (such as torque or axial stress), thereby reducing the risk of damage to the vascular intima.

[0021] 4. In the present application, the inner cavity or grooves are processed in the core wire to accommodate the wire. This design avoids an increase in the diameter of the guide wire while maintaining its flexibility. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] In order to more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the following will briefly introduce the drawings required for use in the description of the specific embodiments or the prior art. Obviously, the drawings in the following description are some embodiments of the present invention. For those of ordinary skill in the art, without creative efforts, other drawings can also be obtained based on these drawings.

[0023] Figure 1 It is an assembly diagram of the guide wire. 1 is the head-end sensor, 2 is the developing spring, 3 is the outer sheath, 4 is the hydrophilic coating covering the outer layer, and 5 is the main body core wire.

[0024] Figure 2 It is a cross-sectional view of the assembly diagram of the guide wire. 6 is the hollow structure of the guide wire core wire.

[0025] Figure 3 (3A, 3B) is a schematic diagram of different perspectives of the spiral sensor. 7 is the highly sensitive spiral / tower spring-shaped sensor, 14 is the circumferential cut section, and 15 is the axial connection section.

[0026] Figure 4 It is a partial cross-sectional view of the distal end of the guide wire. 2 is the developing spring.

[0027] Figure 5 It is a schematic diagram of the shaping of the head end of the guide wire.

[0028] Figure 6 It is a schematic diagram of the nano-polymer / coating sensor structure. 8 is the nano-coating, 9 is the support substrate, 10 is the conductive metal film, 11 is another wire part, 12 is the connecting wire, and 13 is the tin solder joint.

[0029] Figure 7 It is a schematic diagram of the resistive strain sensor.

[0030] Figure 8 It is a schematic diagram of the proximal handle.

[0031] Figure 9 (9A, 9B) is the logic for realizing the vibration feedback of the guide wire under different sensors. DETAILED DESCRIPTION OF THE EMBODIMENTS

[0032] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present invention. Apparently, the described embodiments are some, but not all, of the embodiments of the present invention. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without creative efforts shall fall within the protection scope of the present invention.

[0033] In the description of the present invention, it should also be noted that, unless otherwise clearly defined and limited, the terms "arrange", "install", "connect", and "couple" should be understood in a broad sense. For example, it may be a fixed connection, a detachable connection, or an integral connection; it may be a mechanical connection or an electrical connection; it may be directly connected, or indirectly connected through an intermediate medium, and it may be the communication inside two elements. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to specific situations.

[0034] The following will describe in detail some embodiments of the present invention with reference to the accompanying drawings. Without conflict, the following embodiments and the features in the embodiments can be combined with each other.

[0035] This embodiment provides an intelligent tactile feedback guide wire. Please refer to Figure 1-8 as shown in the figure, which includes a developing spring 2, an outer sheath 3, a tip sensor 1, a main body core wire 5, and a proximal handle; the proximal end of the developing spring 2 is sleeved on the distal end of the main body core wire 5; the outer sheath 3 is sleeved on the distal end of the main body core wire 5 and the developing spring 2; the tip sensor 1 is arranged at the distal end of the developing spring 2 through a connecting block, and protrudes out of the outer sheath 3 and is connected to a signal processing module through a wire; the main body core wire 5 has an axially extending inner cavity or groove for threading the wire; the proximal handle is connected to the proximal end of the main body core wire 5, and a tactile feedback module connected to the signal processing module is built in for feeding back the magnitude of the contact force.

[0036] Specifically, the developing spring 2 is made of precious metal materials, and the materials can be platinum-tungsten, platinum-iridium, platinum-nickel, pure gold, etc.; among them, the outer protective tube 3 can be a metal tube with cuts as shown in Figure 3, or a spring made of metal wire, and the material can be stainless steel, etc.; in addition, the outer protective tube 3 is coated with a hydrophilic coating 4 on the outer layer, and the hydrophilic coating 4 can be selected from polyvinylpyrrolidone. Among them, the head-end sensor 1 should not exceed the maximum outer diameter of the overall guide wire, and the outer diameter of the guide wire can be designed to be 0.014”, 0.016”, 0.018”, 0.024”, 0.035” and other sizes. Among them, the wire is an enameled wire, and the enameled wire is arranged in the hollow main body core wire 5 to connect the electrical signal of the distal sensor with the proximal signal processing module, and the proximal signal processing module can be arranged in the proximal handle or in the proximal device. Among them, the proximal main body core wire 5 can be a hollow pipe material, and is processed to different diameter segments through a grinding process according to the size design. It is preferably ground more at the distal end than at the proximal end, and the ground pipe material can be stainless steel, nitinol alloy, etc. The main body core wire 5 can also be a solid wire material, and grooves are engraved after grinding for wire placement. The main body core wire 5, that is, the ground wire, can be selected from stainless steel, nitinol alloy, etc.

[0037] In this embodiment, the tactile feedback module adopts a vibration feedback module, and its vibration intensity is proportional to the magnitude of the contact force detected by the head-end sensor 1.

[0038] Specifically, the proximal handle of the guide wire has vibration feedback, and the strength of the vibration depends on the magnitude of the force value after the distal sensor transmits and analyzes. Among them, the vibration intensity of the proximal handle is linearly positively correlated with the contact force detected by the head-end sensor 1, realizing hierarchical force signal transmission and feedback. When the operator holds the guide wire handle to operate, the operator can more intuitively feel the touch and changes of the guide wire, so as to adjust the operation.

[0039] In this embodiment, the head-end sensor 1 adopts a resistance strain sensor or a nano-polymer sensor.

[0040] Specifically, when the head-end sensor 1 adopts a resistance sensor, the materials can be copper-nickel alloy, nickel-chromium alloy, iron-chromium aluminum alloy. At this time, the sensor packaging structure design is shown in Figure 7 , the two wires of the sensor are a continuous and non-disconnected structure, and the head-end circular or head-end spiral spring type sensor changes its shape after being stressed, thereby causing a change in resistance value. According to the formula:

[0041]

[0042] In the formula, ρ is the resistivity of the resistance wire material (Ω·mm2 / m); l is the length of the resistance wire (m); S is the cross-sectional area of the resistance wire (mm2). The present invention only designs the guide wire structure and the sensor structure, and does not expand on the sensor measurement circuit; the implementation logic is shown in Figure 9A .

[0043] In this embodiment, the head-end sensor 1 is in the form of an axially extending circular ring or tower spring.

[0044] Specifically, the head-end sensor 1 is in the form of an axially extending spiral or circular ring, as Figure 1 shown in FIGS. 3, etc. It has high flexibility, is not prone to stress concentration, has strong resistance to bending fatigue, is not easily deformed after long-term use, and is suitable for the deformation requirements of frequent access at the guide wire head end; in addition, the spiral structure generates a continuous deformation gradient when stressed, and can output a smooth change in resistance or piezoelectric signal, which is beneficial for the proximal device to analyze the magnitude of the force value and feedback the vibration intensity more delicately. In addition, other shapes can also be used, such as a smooth square, trapezoid or other non-standard shapes.

[0045] In this embodiment, the nano-polymer sensor (i.e., nano-coated sensor) includes a support substrate 9 and a nano-coating 8; the support substrate 9 includes a wire portion and a force-deformation portion connected to each other, and another wire portion 11 disposed separately from the force-deformation portion; the nano-coating 8 covers the wire portion and the force-deformation portion, and is connected to the other wire portion 11 through a connection wire 12. The portion of the support substrate 9 coated with the nano-coating 8 is subjected to polarization treatment and serves as one pole of the sensor electrode, and the outer surface of the nano-coating 8 serves as the other pole of the electrode. A metal film is bonded to the nano-coating 8 on the wire portion for connection to the other wire portion 11 through the connection wire 12.

[0046] Specifically, the head-end sensor 1 can be coated with nano-piezoelectric particle coating, as Figure 6 shown, including a nano-coating 8, a support substrate 9, a conductive metal film 10, another wire portion 11, a connection wire 12 and a solder joint 13. The preparation process is as follows: the nano-coating 8 is coated on the support substrate 9 through an immersion coating process, and then the coated substrate is subjected to polarization treatment. The substrate serves as one pole of the sensor electrode, and the outer surface of the coating serves as the other pole of the electrode. In order to lead out the current on the coating surface, the high temperature of soldering will damage the coating, so a conductive metal film 10 is bonded on the coating surface, and a connection wire 12 is soldered on the metal film to connect the current on the outer surface of the coating to the other wire portion 11 through the connection wire 12. To ensure the structural strength, this part is encapsulated, and only the wire is led out at the proximal end. The shape of the substrate can be designed as a spiral spring / tower spring shape, and the formed substrate is made of materials such as stainless steel and copper. This sensor generates different levels of current according to the amount of deformation, which can be recognized and detected by the proximal handle, and then through an amplification and filtering circuit, the generated analog signal is given to the microprocessor, and the microprocessor outputs a modulated PWM to drive the vibration motor through the driver. The implementation logic is shown in Figure 9B .

[0047] In this embodiment, please refer to Figure 1 , 3AAs shown, the outer protective tube 3 is provided with multiple layers of radial incisions at axial intervals. Each layer of radial incisions is divided into multiple circumferential incision segments 14, and axial connection segments 15 are formed between the circumferential incision segments.

[0048] Specifically, the axial connection segments 15 can ensure the basic axial support strength and stability of the outer protective tube 3, while the existence of the circumferential incision segments 14 provides a certain deformability for the protective tube. This enables the intelligent tactile feedback guide wire to balance accuracy and flexibility in complex usage environments, better adapt to bending and torsion, and improve the operability and flexibility of the guide wire.

[0049] In this embodiment, the multiple layers of axial connection segments 15 are spirally spaced along the axis.

[0050] Specifically, the multiple layers of axial connection segments 15 are spirally spaced along the axis. Please refer to Figure 1 As shown, that is, the multiple layers of radial incisions are arranged in a staggered manner, which limits the rigidity and flexibility of the outer protective tube 3 to a certain extent, and ensures the uniformity, stability of its support and deformation, and the adaptability to blood vessels.

[0051] In this embodiment, the head end of the guide wire is pre-shaped by a pre-plastic process to a certain curvature.

[0052] Specifically, during the use of the guide wire, in order to super-select blood vessels, the head end needs to be shaped into a shape with a certain angle. The shaping effect is shown in Figure 5 As shown. The operator can change the bending direction of the head end by rotating the proximal handle of the core wire to drive the core wire to rotate. To avoid damage to the sensor caused by differences in the operator's shaping techniques, the guide wire will include a pre-plastic process part at the beginning of the design. The pre-plastic angles can include 45° and 90°. Among them, the pre-plastic process can include: applying a bending force at a specific angle (such as 45°) to the head end of the core wire using a mold or fixture, and locking the shape by combining heat treatment (such as for nitinol alloy). For complex angles, precise bending is achieved through laser cutting or local heat treatment. After shaping, an optical measurement device can be used to verify the pre-shaping angle error (such as within ±1°), and the passage of the guide wire in a simulated blood vessel can be tested.

[0053] Finally, it should be noted that: the above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit them; although the present invention has been described in detail with reference to the foregoing embodiments, those of ordinary skill in the art should understand that: they can still modify the technical solutions recorded in the foregoing embodiments, or perform equivalent replacements on some or all of the technical features; and these modifications or replacements do not make the essence of the corresponding technical solutions deviate from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. An intelligent tactile feedback guidewire, characterized in that: It comprises a developing spring (2), an outer protective tube (3), a head end sensor (1), a main body core wire (5) and a proximal handle; The proximal end portion of the developing spring (2) is sleeved on the distal end portion of the main body core wire (5); The outer protective tube (3) is sleeved on the distal end of the main core wire (5) and the developing spring (2); The head end sensor (1) is arranged at the distal end of the developing spring (2) via a connecting block, is cantilevered and protrudes from the outer protective tube (3), and is connected to the signal processing module via a wire; The main body core wire (5) has an inner cavity or a groove extending along the axial direction for passing a wire; The proximal handle is connected to the proximal end of the main body core wire (5), and has a built-in tactile feedback module connected to the signal processing module, for providing feedback on the magnitude of the contact force.

2. The intelligent tactile feedback guidewire according to claim 1, characterized in that: The tactile feedback module adopts a vibration feedback module, and its vibration intensity is proportional to the contact force detected by the head end sensor (1).

3. The intelligent tactile feedback guidewire according to claim 1, characterized in that: The head end sensor (1) adopts a resistance strain sensor or a nano polymer sensor.

4. The intelligent tactile feedback guidewire according to claim 1, characterized in that: The head end sensor (1) is in the shape of an axially extending circular ring or a tower spring.

5. The intelligent tactile feedback guidewire according to claim 3, characterized in that: The nano polymer sensor comprises a supporting substrate (9) and a nano coating (8); The supporting substrate (9) comprises a conductive wire portion and a force-bearing deformation portion connected to each other, and another conductive wire portion (11) disconnected from the force-bearing deformation portion; The nano coating (8) covers the one conductor portion and the force-bearing deformation portion, and is connected to the other conductor portion (11) via a connecting wire (12).

6. The intelligent tactile feedback guidewire according to claim 5, characterized in that: The portion of the support substrate (9) coated with the nano coating (8) is subjected to polarization treatment and serves as one electrode of the sensor, and the outer surface of the nano coating (8) serves as the other electrode of the electrode.

7. The intelligent tactile feedback guidewire according to claim 5, characterized in that: A metal film is bonded onto the nano coating (8) of one conductor portion, and is used to be connected to another conductor portion (11) via a connecting wire (12).

8. The intelligent tactile feedback guidewire according to any one of claims 1 to 7, characterized in that: The outer protective tube (3) is provided with multiple layers of radial cuts at intervals along the axial direction, each layer of radial cuts is divided into a plurality of circumferential cut sections (14), and axial connecting sections (15) are formed between the circumferential cut sections.

9. The intelligent tactile feedback guidewire according to claim 8, characterized in that: The multiple layers of axial connecting sections (15) are distributed in a spiral manner along the axial direction.

10. The intelligent tactile feedback guidewire according to any one of claims 1 to 7 and 9, characterized in that: The guide wire tip is molded into a certain curvature through a pre-molding process.

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