CN114470487B

CN114470487B - Medical guide wire and interventional medical equipment

Info

Publication number: CN114470487B
Application number: CN202111583806.4A
Authority: CN
Inventors: 胡涛; 张志军; 卜军; 刘朝生; 陶凌; 葛均波
Original assignee: Guangdong Bomai Medical Technology Co Ltd
Current assignee: Guangdong Bomai Medical Technology Co Ltd
Priority date: 2021-12-22
Filing date: 2021-12-22
Publication date: 2023-02-14
Anticipated expiration: 2041-12-22
Also published as: CN114470487A

Abstract

The application belongs to the technical field of interventional medical treatment, and particularly relates to a medical guide wire and interventional medical equipment, wherein the medical guide wire comprises a sheath, an end head, a core wire, a mandrel and a plurality of electrode plates, the core wire is arranged in the sheath in a penetrating manner, and the end head is arranged at the far end of the sheath and is connected with the far end of the core wire; the mandrel is arranged at the near end of the sheath and is connected with the near end of the core wire; each electrode plate is arranged in the sheath and distributed along the length direction of the sheath; the electrode slice heats the local part of the sheath after being electrified so as to bend the heated sheath. The sheath is heated through the electrified electrode plates, so that the heated sheath is bent, the electrode plates can provide a plurality of bending angles for the medical guide wire, the medical guide wire is controlled to be bent in a human body to adapt to complicated pore canals and vascular veins, an auxiliary catheter and other interventional medical equipment safely and conveniently reach focuses in the human body and leave the human body, and the efficiency of interventional therapy is greatly improved.

Description

Medical guide wire and interventional medical equipment

Technical Field

The application belongs to the technical field of interventional medical treatment, and particularly relates to a medical guide wire and interventional medical equipment.

Background

Interventional therapy is minimally invasive therapy carried out by modern high-tech means, and under the guidance of medical imaging equipment, precise instruments such as special catheters, medical guide wires and the like are introduced into a human body to diagnose and locally treat internal diseases. Before the medical guide wire enters a human body, the head of the medical guide wire is required to be bent to enable the medical guide wire to have a proper angle, and the pore canal and the blood vessel in the human body are complicated and have a plurality of branches, so that the bending angle of the medical guide wire is required to be frequently adjusted in the operation process to meet the requirements of various pore canals and blood vessel branches, the operation is complicated, and the interventional therapy efficiency is low.

Disclosure of Invention

The application aims to provide a medical guide wire and interventional medical equipment, and aims to solve the technical problem that the interventional treatment efficiency is low in the prior art.

In order to achieve the purpose, the technical scheme adopted by the application is as follows: a medical guide wire comprises a sheath, an end head, a core wire, a mandrel and a plurality of electrode plates, wherein the core wire is arranged in the sheath in a penetrating manner, and the end head is arranged at the far end of the sheath and is connected with the far end of the core wire; the core shaft is arranged at the proximal end of the sheath and is connected with the proximal end of the core wire; each electrode plate is arranged in the sheath and distributed along the length direction of the sheath; the electrode plate heats the local part of the sheath after being electrified so as to bend the heated sheath.

Further, in a direction from the distal end of the sheath to the proximal end of the sheath, the sheath is divided into a curved section and a connecting section, and the electrode sheet is disposed in the curved section.

Further, the bending section is a shape memory alloy sleeve section.

Further, the electrode plate comprises a first electrode plate and a second electrode plate, and the first electrode plate and the second electrode plate are respectively located at two ends of the bending section.

Furthermore, a first through hole is formed in the first electrode piece, a second through hole is formed in the second electrode piece, and the core wire is arranged in the first through hole and the second through hole in a penetrating manner.

Furthermore, the core wire comprises a first core wire, a second core wire and a third core wire which are sequentially connected in the length direction, and the first core wire, the second core wire and the third core wire are arranged in the bending section in a penetrating manner;

the first core wire is connected with the end head and penetrates through the first penetrating hole, and the third core wire penetrates through the second penetrating hole;

the diameter of the first core wire and the diameter of the third core wire are both smaller than the diameter of the second core wire.

Further, the first core wire and the third core wire are both conical bodies, the diameter of the first core wire is gradually increased in the direction from the first core wire to the second core wire, and the maximum diameter of the first core wire is equal to the diameter of the second core wire;

the diameter of the third core wire is gradually reduced in the direction from the second core wire to the third core wire, and the maximum diameter of the third core wire is equal to the diameter of the second core wire.

Further, the medical guide wire further comprises an electrode controller, a threading hole is formed in the mandrel, the electrode sheet is connected with a lead, and the lead penetrates out of the threading hole and then is connected with the electrode controller.

Further, the sheath is in a cylindrical spiral shape.

One or more technical solutions in the medical guide wire provided by the present application have at least one of the following technical effects: when the medical guide wire is used, the bending angle of the medical guide wire does not need to be frequently adjusted outside a human body to adapt to various pore canals and branches of blood vessels, one end provided with the end head is inserted into the human body, when the end head reaches the branches of the pore canals and the blood vessels, the sheath is heated through the electrified electrode plates, so that the heated sheath is bent, and the electrode plates can provide a plurality of bending angles for the medical guide wire, so that the bending of the medical guide wire is controlled in the human body to adapt to the complicated pore canals and blood vessel veins, an auxiliary catheter and other interventional medical equipment can safely and conveniently arrive at a focus in the human body and leave the human body, and the interventional treatment efficiency is greatly improved.

In order to achieve the purpose, the technical scheme adopted by the application further provides interventional medical equipment which comprises the medical guide wire.

One or more technical solutions in the interventional medical device provided by the present application have at least one of the following technical effects: when the medical guide wire bending device is used, the bending angle of the medical guide wire does not need to be frequently adjusted outside a human body to adapt to branches of various ducts and blood vessels, one end provided with the end head is inserted into the human body, when the end head reaches the branches of various ducts and blood vessels, the sheath is heated through the electrified electrode plates, so that the heated sheath is bent, and the electrode plates can provide a plurality of bending angles for the medical guide wire, so that the bending of the medical guide wire in the human body is controlled to adapt to complicated ducts and blood vessel veins, the interventional medical device can safely and conveniently arrive at a focus in the human body and leave the human body, and the interventional treatment efficiency is greatly improved.

Drawings

In order to more clearly illustrate the technical solutions in the embodiments of the present application, the drawings required to be used in the embodiments or the prior art description will be briefly described below, and it is obvious that the drawings in the following description are only some embodiments of the present application, and for those skilled in the art, other drawings may be obtained according to these drawings without inventive labor.

Fig. 1 is a cross-sectional view of a medical guidewire provided in an embodiment of the present application in a straight shape.

Fig. 2 is a cross-sectional view of the medical guidewire of fig. 1 in a curved shape.

Fig. 3 is a cross-sectional view of the medical guidewire shown in fig. 1 within a bend section.

Fig. 4 is a cross-sectional view of the medical guidewire of fig. 1 within a connecting segment.

Fig. 5 isbase:Sub>A cross-sectional view of the medical guidewire of fig. 3 taken along linebase:Sub>A-base:Sub>A.

Fig. 6 is a cross-sectional view of the medical guidewire shown in fig. 3 taken along line B-B.

Fig. 7 is a schematic diagram of an operation method and steps of an interventional medical device according to an embodiment of the present application.

Fig. 8 is a schematic diagram of another method and steps of operation of the interventional medical device of fig. 7.

Wherein, in the figures, the various reference numbers:

1. a sheath; 2. a tip; 3. core yarn; 4. a mandrel; 5. an electrode sheet; 6. coating; 7. a wire; 8. an electrode controller; 9. a medical guide wire; 10. a conduit;

11. a curved section; 12. a connecting section;

31. a first core wire; 32. a second core filament; 33. a third core wire; 34. a fourth core wire; 35. a fifth core wire; 36. a sixth core wire;

41. threading holes;

51. a first electrode sheet; 511. a first through hole; 52. a second electrode sheet; 521. a second through hole;

71. a first conductive line; 72. a second conductive line;

100. a first vessel segment; 200. a second vessel segment; 300. a third vessel segment.

Detailed Description

Reference will now be made in detail to embodiments of the present application, examples of which are illustrated in the accompanying drawings, wherein like or similar reference numerals refer to the same or similar elements or elements having the same or similar function throughout. The embodiments described below with reference to the drawings are exemplary and intended to be used for explaining the present application and should not be construed as limiting the present application.

In the description of the present application, it is to be understood that the terms "length," "width," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," and the like, as used herein, refer to an orientation or positional relationship indicated in the drawings, which is for convenience and simplicity of description, and does not indicate or imply that the referenced device or element must have a particular orientation, be constructed and operated in a particular orientation, and thus, is not to be considered as limiting.

Furthermore, the terms "first", "second" and "first" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature. In the description of the present application, "a plurality" means two or more unless specifically limited otherwise.

In this application, unless expressly stated or limited otherwise, the terms "mounted," "connected," "secured," and the like are to be construed broadly and encompass, for example, both fixed and removable connections or integral parts thereof; can be mechanically or electrically connected; either directly or indirectly through intervening media, either internally or in any other relationship. The specific meaning of the above terms in the present application can be understood by those of ordinary skill in the art as appropriate.

In the related art, the guide wire plays a role of guiding various interventional catheters and implantation instruments into a target site of a lumen of a living body during an interventional therapy, for example, in a percutaneous peripheral angioplasty operation, a cardiovascular disease interventional therapy, and the like. The guide wire plays the roles of leading in, supporting, opening and exchanging in the interventional operation. The guide wire can guide and support the catheter to enter the blood vessel through the puncture hole through subcutaneous tissues, vessel walls and other soft tissues; the guide wire can guide the catheter to pass through the tortuous and hardened blood vessels and selectively or super-selectively enter the examined blood vessel branches; the guide wire can strengthen the rigidity of the catheter, and is beneficial to operating the catheter and the like.

However, in the process of using the guide wire in a complicated vascular vein, a situation that two branch vessels converge at a certain position to form a main vessel is usually encountered, so that the head of the guide wire needs to be bent to have a fixed angle before entering the body of a patient, and then the two branch vessels need to be dredged, so that the bending angle of the head of the guide wire needs to be frequently adjusted in the operation process to meet various pore canals and branches of the vessels. Meanwhile, since the curved shape of the guide wire head cannot be changed, the head of the guide wire is often easy to hook a catheter port or even damage the catheter wall when the guide wire is drawn out. These drawbacks of guide wires result in time and labor consuming interventional medical procedures, prolonged procedure times, resulting in more X-ray radiation to the patient and the medical personnel, high surgical risks, and a shortened effective treatment window for the patient.

Because the guide wire can not controllably deflect, the embodiment of the application provides a controllable micro steering mechanism, and the controllable micro steering mechanism is used as a medical guide wire for medical intervention, an auxiliary catheter and other interventional medical devices can conveniently steer in various pore canals and blood vessels and reach focuses, and can safely separate from a human body. The specific structure of the medical guide wire can be described in detail as follows:

referring to fig. 1 to 4 together, an embodiment of the present application provides a medical guidewire, including a sheath 1, an end tip 2, a core wire 3, a core shaft 4, and a plurality of electrode plates 5, wherein the core wire 3 is inserted into the sheath 1, and the end tip 2 is mounted at a distal end of the sheath 1 and connected to a distal end of the core wire 3; the mandrel 4 is arranged at the near end of the sheath 1 and is connected with the near end of the core wire 3; each electrode plate 5 is arranged in the sheath 1 and distributed along the length direction of the sheath 1; the electrode sheet 5 heats the sheath 1 locally after being energized, so that the heated sheath 1 is bent.

It should be noted that reference to "proximal" in the above description and in the following description generally refers to the end of the medical device that is near the operator during normal operation, and "distal" generally refers to the end of the medical device that first enters the patient during normal operation.

When the medical guide wire is used, the bending angle of the medical guide wire does not need to be frequently adjusted outside a human body to adapt to branches of various ducts and blood vessels, one end of the medical guide wire, provided with the end head 2, is inserted into the human body, when the end head 2 reaches the branches of various ducts and blood vessels, the sheath 1 is heated through the electrified electrode plates 5, so that the heated sheath 1 is bent, and the electrode plates 5 can provide a plurality of bending angles for the medical guide wire, so that the medical guide wire is controlled to bend in the human body to adapt to complicated ducts and complicated blood vessel veins, an auxiliary catheter and other interventional medical equipment safely and conveniently reach focuses in the human body and leave the human body, and the efficiency of interventional treatment is greatly improved.

In the embodiment of the application, the sheath 1 can restore to the original shape after being cooled, and the medical guide wire is drawn out in the process that the sheath 1 restores to the straight shape from the bent shape, so that the problem that the tip 2 hooks a catheter port or even damages the catheter wall can be avoided, and the medical guide wire can be safely separated from a human body.

In the embodiment of the application, the medical guide wire has good torque transmissibility, support property, super elasticity, tracking property, durability and the like. Torque transmissibility refers to the ability of the medical guidewire to transmit torque; the support refers to the ability of the medical guide wire to provide support force; the superelasticity refers to the ability of the medical guide wire to bend when encountering resistance and automatically recover to the original shape when the resistance is eliminated; trackability refers to the ability of the medical guide wire to travel along a blood vessel and resist self-twisting and twisting during travel; durability refers to the fatigue strength and life of the medical guidewire. In addition, the surface of the medical guide wire is smooth and clean and has no burrs, scars, cracks, scratches and the like, so that the potential risk of human body injury is avoided, and the safety of interventional therapy is improved.

In the embodiment of the application, the far end of the core wire 3 is connected with the end head 2, so that the penetrating power and the trafficability of the medical guide wire in resistance are improved, the tactile feedback of the medical guide wire is improved, and an operator can better sense the activity of the medical guide wire.

In the present embodiment, the core wire 3 may be made of one or more materials of nickel-titanium alloy, stainless steel, cobalt-based alloy, ferromanganese alloy, zinc-copper alloy, and nickel-iron alloy.

In the embodiment of the present application, the electrode sheet 5 has good thermal conductivity, and may be made of one or more materials selected from gold, silver, copper, chromium, indium tin oxide, nichrome, silicon carbide, lanthanum chromate, zirconium oxide, molybdenum trisilicide, aluminum-doped zinc oxide, iron-chromium-aluminum alloy, and iron-nickel-cerium alloy.

In the embodiment of the application, the end head 2 is hemispherical, the surface is smooth, the catheter and the blood vessel of the human body are not easy to be damaged, and the safety of interventional therapy is improved.

In the embodiment of the present application, the diameter of the sheath 1 is 0.3 to 1mm, specifically, the diameter of the sheath 1 is 0.3mm, 0.4mm, 0.5mm, 0.6mm, 0.7mm, 0.8mm, 0.9mm or 1mm, and the diameter of the sheath 1 is set in the above range, which satisfies the diameter of the sheath 1 required in most cases in the interventional operation. The diameter of the mandrel 4 is 0.3-1 mm, specifically, the diameter of the mandrel 4 is 0.3mm, 0.4mm, 0.5mm, 0.6mm, 0.7mm, 0.8mm, 0.9mm or 1mm, and the diameter of the mandrel 4 is set within the above range, which can satisfy the diameter of the mandrel 4 required in most cases in interventional surgery. The length of the core wire 3 is 15 to 60mm, specifically, the length of the core wire 3 is 15mm, 20mm, 25mm, 30mm, 35mm, 40mm, 45mm, 50mm, 55mm or 60mm, and the length of the core wire 3 is set within the above range, which can satisfy the length of the core wire 3 required in most cases in the interventional operation. The length of the mandrel 4 is 1200 to 3000mm, specifically, the length of the mandrel 4 is 1200mm, 1300mm, 1400mm, 1500mm, 1600mm, 1700mm, 1800mm, 1900mm, 2000mm, 2100mm, 2200mm, 2300mm, 2400mm, 2500mm, 2600mm, 2700mm, 2800mm, 2900mm, or 3000mm, and the length of the mandrel 4 is set within the above range, which can satisfy the length of the mandrel 4 required in most cases in an interventional operation.

In another embodiment of the present application, as shown in fig. 1, the sheath 1 of the medical guide wire is provided with a coating 6, which can reduce the friction of the surface, improve the trackability and the trafficability of the medical guide wire, and thus improve the efficiency of the interventional treatment.

In the embodiment of the present application, the coating 6 is preferably a PTFE coating (polytetrafluoroethylene), and PTFE has the advantages of low water absorption, surface non-stick property, corrosion resistance, high temperature resistance, excellent electrical insulation, high strength, light weight, good flexibility, long service life, and the like.

In another embodiment of the present application, the tip 2 of the medical guidewire is provided to be coated with a lubricious material to reduce surface friction and improve tracking and passing of the medical guidewire, or not coated with a lubricious material to provide more precise tactile feedback.

In another embodiment of the present application, the tip 2 and the sheath 1 of the medical guide wire are provided with an electrical insulating material coated thereon, so as to prevent the current applied to the electrode plate 5 from causing damage to the human body and improve the safety of interventional therapy. The electrically insulating material is preferably a PTFE coating or a hydrogel.

In another embodiment of the present application, as shown in fig. 1, a sheath 1 of the medical guidewire is provided in a cylindrical spiral shape. The sheath 1 of the medical guide wire adopts a cylindrical spiral structure, so that the support, the maneuverability and the tracking of the medical guide wire are improved, the visibility and the tactile feedback of the medical guide wire are enhanced, and an operator is helped to better position the medical guide wire entering a human body and perceive the activity condition of the medical guide wire.

In particular embodiments, the sheath 1 is a single strand cylindrical helical structure or a multi-strand cylindrical helical structure. When the sheath 1 is a multi-strand cylindrical helical structure, the rotation direction of the sheath 1 can be a single rotation direction or a staggered rotation direction.

In another embodiment of the present application, as shown in fig. 1 and 2, the sheath 1 is divided into a curved section 11 and a connecting section 12 in a direction from the distal end of the sheath 1 to the proximal end of the sheath 1, and the electrode tabs 5 are disposed in the curved section 11. The bending section 11 is led into the human body in advance, and the connecting section 12 is led into the human body in the rear to provide pushing force for the bending section 11. The electrode plate 5 is arranged in the bending section 11, the electrode plate 5 can generate heat when being electrified and transmit the heat to the bending section 11, so that the temperature of the bending section 11 is increased, the heated bending section 11 can be bent, and the bending of the medical guide wire in a human body is controlled.

In another embodiment of the present application, the number of the electrode sheets 5 may be two, three, or more than three, and the electrode sheets 5 are uniformly distributed at intervals along the length direction of the bending section 11 to realize bending at more angles, and the specific number thereof may be selected according to actual needs, and is not limited herein.

In another embodiment of the present application, as shown in fig. 1 and 2, the curved section 11 of the medical guidewire is provided as a shape memory alloy sleeve section. The shape memory alloy sleeve section is made of shape memory alloy, the shape memory alloy is a material with shape memory effect, a memory shape can be generated after training, when the temperature of the bending section 11 reaches a phase transformation point, the bending section 11 is bent in a direction deviating from the original axial direction, the straight line shape in the conventional state is changed into the bent shape in the memory shape, at the moment, the shape memory alloy is transformed from martensite to austenite phase, the Young modulus is increased, and the hardness is increased; when the temperature of the bent portion 11 is lower than the transformation point, the bent portion 11 is transformed from the bent shape in the memory shape to the straight shape in the normal state and returns to the original axial direction, and at this time, the shape memory alloy is transformed from the austenite phase to the martensite phase, the young's modulus is reduced, and the hardness is reduced. The medical guide wire utilizes the characteristics of the shape memory alloy, controls the temperature of the bending section 11 through the electrode plate 5, thereby controlling the shape of the bending section 11, carrying out the transformation of the straight line shape and the bending shape on the bending section 11 according to the structures of the pore canal and the blood vessel, assisting the catheter and other interventional medical equipment to conveniently reach the focus in the human body, and greatly improving the efficiency of interventional therapy. In addition, when the medical guide wire is pulled out of the human body, the electrode plate 5 is stopped to be electrified, the electrode plate 5 does not heat the bent section 11 any more, the bent section 11 dissipates heat in flowing blood, and the medical guide wire is pulled out of the human body in the process that the bent section 11 is restored to be in a straight line shape, so that the problem that the end 2 hooks a catheter port or even damages the catheter wall can be avoided, the medical guide wire can be safely separated from the human body, and the safety of interventional therapy is greatly improved.

In the embodiment of the application, the shape memory alloy is made of biocompatible materials such as nickel-titanium alloy and copper-based alloy, so that harm to a human body can be avoided, and the safety of interventional therapy is improved. If the phase change point of the shape memory alloy is lower than the normal temperature of the human body too much, the medical guide wire can be automatically bent under the influence of the body temperature after entering the human body, so that the bending of the medical guide wire is difficult to control, the medical guide wire is not beneficial to the implementation of interventional operation, and the operation risk is increased; if the total phase transition point of the shape memory is too high compared with the normal temperature of the human body, a large current needs to be applied to the electrode plate 5 to heat the bending section 11, which is not beneficial to human body safety, and the bent bending section 11 needs more cooling time to be restored to a linear shape, which is not beneficial to improving the efficiency of interventional therapy.

In another embodiment of the present application, the medical guidewire is further provided that includes a visualization element. In the contrast operation of the hospital instrument, the developing element can display a shadow, and provide accurate position information of the medical guide wire for an operator, including the depth of the medical guide wire entering a vessel of a human body; meanwhile, the developing site is also a boundary site of different hardness of the medical guide wire.

In the embodiment of the application, the developing element is made of developing material which is not transparent to X-ray, and the developing material is one or more of gold, tungsten, platinum and platinum-iridium alloy.

In the embodiment of the application, the developing element can be a cylindrical spiral developing coil, a developing ring or a developing coating coated on the outermost layer of the medical guide wire.

In the embodiment of the application, the number of the developing elements is greater than or equal to 2, and the developing elements are arranged on the bent section 11 and distributed along the length direction of the bent section 11.

Illustratively, the developing elements include a first developing element located between the head 2 and the first electrode sheet 51, and a second developing element located between the second electrode sheet 52 and the connecting section 12. Set up first development component and second development component respectively at the both ends of crooked section 11, can help the operator to catch the position of crooked section 11 fast accurately and judge the crooked degree of crooked section 11, then make this medical seal wire accurately enter into the blood vessel branch of target, improved intervention treatment's efficiency and reliability greatly.

In another embodiment of the present application, as shown in fig. 3, the electrode pads 5 of the medical guidewire are provided to include a first electrode pad 51 and a second electrode pad 52, and the first electrode pad 51 and the second electrode pad 52 are respectively located at two ends of the bending section 11. When the first electrode plate 51 is separately electrified, the first electrode plate 51 heats one end of the bending section 11 where the first electrode plate is located, and one end of the bending section 11 is bent when the temperature of the bending section reaches a phase change point, so that the requirement of small-angle bending of the medical guide wire in interventional therapy can be met; when the first electrode plate 51 and the second electrode plate 52 are electrified, two ends of the bending section 11 are heated and bent when the temperature reaches the phase change point, so that the requirement of bending the medical guide wire at a large angle in interventional therapy can be met.

In the embodiment of the present application, when the temperatures of both ends of the bent section 11 reach the phase transformation point, both ends of the bent section 11 are bent in the same direction in the same plane, or bent in different directions in the same plane, or bent in different planes, depending on the memory shape of the shape memory alloy when the bent section 11 is trained.

In the embodiment of the present application, the interval between the first electrode sheet 51 and the second electrode sheet 52 is 10 to 50mm. Specifically, the interval between the first electrode plate 51 and the second electrode plate 52 is 10mm, 15mm, 20mm, 25mm, 30mm, 35mm, 40mm, 45mm or 50mm, and the distance between the first electrode plate 51 and the second electrode plate 52 is set within the above range, so that the bending radius of the medical guide wire required by most situations in the interventional operation can be met, and if the interval is set too small and too large, the development of the interventional operation is not facilitated. Further, when the first electrode sheet 51 or the second electrode sheet 52 is energized alone, the bending angle of the medical guidewire is 0 to 60 °, specifically, 5 °, 10 °, 15 °, 20 °, 25 °, 30 °, 35 °, 40 °, 45 °, 50 °, 55 °, or 60 °. The bending angle of the medical guide wire is set in the range, so that the bending angle of the medical guide wire required by most conditions in the interventional operation can be met, and if the bending angle is set too large, the medical guide wire is not beneficial to the development of the interventional operation.

In another embodiment of the present application, as shown in fig. 3, 5 and 6, a first through hole 511 is formed in the first electrode plate 51, a second through hole 521 is formed in the second electrode plate 52, and the core wire 3 is inserted into the first through hole 511 and the second through hole 521. The first electrode plate 51 and the second electrode plate 52 are both of an annular structure, so that the support performance of the medical guide wire is improved, and meanwhile, when the bending section 11 is heated after being electrified, the bending section 11 can be heated more uniformly.

In another embodiment of the present application, as shown in fig. 3, the core wire 3 of the medical guide wire is provided to include a first core wire 31, a second core wire 32 and a third core wire 33 connected in sequence along the length direction thereof, wherein the first core wire 31, the second core wire 32 and the third core wire 33 are arranged in the bending section 11; the first core wire 31 is connected with the end head 2 and is arranged in the first through hole 511 in a penetrating way, and the third core wire 33 is arranged in the second through hole 521 in a penetrating way; the diameter of the first core wire 31 and the diameter of the third core wire 33 are both smaller than the diameter of the second core wire 32. The diameters of the first core wire 31 and the third core wire 33 are smaller, so that the flexibility and the tracking performance of the medical guide wire are improved, the bending section 11 is easier to bend, and a space is left for installing the first electrode plate 51 and the second electrode plate 52, so that the structure of the medical guide wire is more compact; the second core wire 32 is connected between the first core wire 31 and the third core wire 33, so that the bending radius of the medical guide wire is increased, and the diameter of the second core wire 32 is larger, so that the support property and the torque transmission property of the medical guide wire are improved.

In another embodiment of the present application, as shown in fig. 3, the first core wire 31 and the second core wire 32 of the medical guide wire are provided as cones, the diameter of the first core wire 31 gradually increases in the direction from the first core wire 31 to the second core wire 32, and the maximum diameter of the first core wire 31 is equal to the diameter of the second core wire 32; the diameter of the third core wire 33 is gradually reduced in the direction from the second core wire 32 to the third core wire 33, and the maximum diameter of the third core wire 33 is equal to the diameter of the second core wire 32. The transition between the joint of the first core wire 31 and the second core wire 32 and the joint of the second core wire 32 and the third core wire 33 is smooth, so that the loss of torque transmission and stress concentration generated during bending of the medical guide wire can be reduced. In addition, the first core wire 31, the second core wire 32 and the third core wire 33 form a streamline structure, and the trackability of the medical guide wire is improved.

In the present embodiment, the first core wire 31 and the second core wire 32, and the second core wire 32 and the third core wire 33 can be connected and fixed by any one of connection methods such as soldering, laser welding, resistance welding, ultrasonic welding, pressure welding, and adhesion.

In another embodiment of the present application, as shown in fig. 4, the medical guidewire further includes a fourth core wire 34, a fifth core wire 35 and a sixth core wire 36 connected in sequence, wherein the fourth core wire 34, the fifth core wire 35 and the sixth core wire 36 are disposed through the connecting section 12; the sixth core wire 36 is connected with the core shaft 4; the fourth core wire 34 is connected with the third core wire 33, the diameter of the fourth core wire 34 is equal to the minimum diameter of the third core wire 33, and the diameter of the fourth core wire 34 is equal to the minimum diameter of the fifth core wire 35; in the direction from the fifth core wire 35 to the sixth core wire 36, the diameter of the fifth core wire 35 gradually increases, and the maximum diameter of the fifth core wire 35 is equal to the diameter of the sixth core wire 36. The transition of the joint of the third core wire 33 and the fourth core wire 34, the joint of the fourth core wire 34 and the fifth core wire 35 and the joint of the fifth core wire 35 and the sixth core wire 36 is smooth, so that the loss of torque transmission and stress concentration generated during bending of the medical guide wire can be reduced; in addition, the fourth core wire 34, the fifth core wire 35 and the sixth core wire 36 form a streamline structure, and the trackability of the medical guide wire is improved. The sixth core wire 36 has a larger diameter, which improves the support and torque transmission of the medical guide wire.

In the embodiment of the present application, the third core wire 33 and the fourth core wire 34, the fourth core wire 34 and the fifth core wire 35, and the fifth core wire 35 and the sixth core wire 36 may be connected and fixed by any one of connection methods such as soldering, laser welding, resistance welding, ultrasonic welding, crimping, and bonding.

In another embodiment of the present application, as shown in fig. 1, the medical guidewire further includes an electrode controller 8, the mandrel 4 is provided with a threading hole 41, the electrode plates 5 are all connected with wires 7, and the wires 7 are connected with the electrode controller 8 after penetrating out of the threading hole 41. The lead 7 comprises a first lead 71 and a second lead 72, the electrode controller 8 is electrically connected with the first electrode plate 51 through the first lead 71, the electrode controller 8 is electrically connected with the second electrode plate 52 through the second lead 72, remote control over the medical guide wire is achieved, and the first electrode plate 51 and the second electrode plate 52 work independently and are not interfered.

In the embodiment of the application, when the medical guide wire needs to be bent at a small angle, the electrode controller 8 is turned on to control the switch of the first electrode plate 51, the electrode controller 8 transmits current to the first electrode plate 51 through the first wire 71, the first electrode plate 51 after being electrified generates heat and transfers the heat to one end of the bending section 11 where the first electrode plate 51 is located, one end of the bending section 11 is heated and is bent when the temperature of the bending section reaches a phase change point, and meanwhile, the first core wire 31 penetrating through the first through hole 511 is also bent; when the medical guide wire needs to be bent at a large angle, the electrode controller 8 is turned on to control the switches of the first electrode plate 51 and the second electrode plate 52, the electrode controller 8 respectively transmits current to the first electrode plate 51 and the second electrode plate 52 through the first lead 71 and the second lead 72, the first electrode plate 51 and the second electrode plate 52 generate heat after being electrified, the two ends of the bent section 11 are heated and are bent when the temperature of the bent section reaches a phase change point, and meanwhile, the first core wire 31 penetrating the first through hole 511 and the third core wire 33 penetrating the second through hole 521 are bent.

The embodiment of the application also provides interventional medical equipment, which comprises the medical guide wire 9 provided by each embodiment.

In the embodiment of the present application, the interventional medical device further comprises a catheter 10, and the medical guide wire 9 is insertable into the catheter 10.

A method of use and steps of the interventional medical device will now be described with reference to fig. 7, 3 and 4: the medical guide wire 9 and the catheter 10 are placed together in the blood vessel of the patient, and the medical guide wire 9 is ensured to be positioned at the front end of the port of the catheter 10. The blood vessel is composed of a first blood vessel section 100, a second blood vessel section 200 and a third blood vessel section 300, the first blood vessel section 100, the second blood vessel section 200 and the third blood vessel section 300 forming a Y-shaped passage. Now that the catheter 10 needs to be advanced from the first vessel section 100 into the second vessel section 200, the medical guidewire 9 needs only a small bending angle to meet the requirements. In a first step, the medical guide wire 9 in a straight shape is advanced together with the catheter 10 in the first vessel section 100, and when reaching the branch of the second vessel section 200 and the third vessel section 300, the medical guide wire 9 is turned to have a suitable angle, which is ready for subsequent heating of the medical guide wire 9 to bend and get in the second vessel section 200 smoothly. And secondly, turning on the electrode controller 8 to control the switch of the first electrode plate 51, wherein the electrode controller 8 transmits current to the first electrode plate 51 through the first lead 71, the electrified first electrode plate 51 generates heat and transmits the heat to one end of the bending section 11 where the first electrode plate 51 is located, and one end of the bending section 11 is heated and deviates from the original axial direction to be bent when the temperature of the bending section reaches a phase change point. Thirdly, the bending section 11 is in an austenite phase, the young's modulus is increased, the hardness is increased, and the catheter 10 can be bent along the bending direction of the medical guide wire 9 when being continuously pushed along the medical guide wire 9 and smoothly enters the second blood vessel section 200. In the process, the medical guide wire 9 can ensure the blood circulation in the blood vessel without blockage. Fourthly, after the catheter 10 smoothly enters the second blood vessel section 200, the electrode controller 8 stops electrifying the first electrode plate 51, the first electrode plate 51 does not heat the bending section 11 any more, the bending section 11 dissipates heat in flowing blood, the temperature is reduced to be below a phase change point, the bending section 11 is in a martensite phase, the Young modulus is reduced, the hardness is reduced, and the original axial direction is recovered, and in the phase change process, the medical guide wire 9 can be safely and smoothly withdrawn to the outside of the patient along the catheter 10 without damaging the inner wall of the catheter 10. Finally, the specific interventional medical device is advanced along the catheter 10 that has been shaped in the patient to the lesion and the lesion is treated. In the whole process, the insulating material on the surface of the medical guide wire 9 can prevent the medical guide wire 9 from short circuit in a solution or blood environment, and can also play a role in reducing drag and lubricating.

Referring now to fig. 8, 3 and 4, another method of use and steps of the interventional medical device will be described: now the catheter 10 needs to enter the second vessel section 200 from the third vessel section 300, the medical guide wire 9 needs a larger bending angle to meet the requirement. In a first step, the medical guide wire 9 in a linear shape and the catheter 10 are advanced together in the third blood vessel section 300, and when reaching the branch of the first blood vessel section 100 and the second blood vessel section 200, the medical guide wire 9 is rotated to have a proper angle, and the proper angle is ready for heating the medical guide wire 9 to bend and smoothly enter the second blood vessel section 200. And step two, simultaneously opening the electrode controller 8 to control the on and off of the first electrode plate 51 and the second electrode plate 52, enabling the electrode controller 8 to respectively convey current to the first electrode plate 51 and the second electrode plate 52 through a first lead 71 and a second lead 72, enabling the electrified first electrode plate 51 and the electrified second electrode plate 52 to generate heat, and enabling two ends of the bending section 11 to be heated and to be bent in a direction deviating from the original axial direction when the temperature of the bending section reaches a phase change point. And thirdly, the catheter 10 is continuously pushed along the medical guide wire 9 and is bent along the bending direction of the medical guide wire 9, and the catheter smoothly enters the second blood vessel section 200. Fourthly, after the catheter 10 smoothly enters the second blood vessel section 200, the electrode controller 8 stops energizing the first electrode plate 51 and the second electrode plate 52, the first electrode plate 51 and the second electrode plate 52 do not heat the bent section 11 any more, the bent section 11 dissipates heat in flowing blood, the temperature is reduced to be below the phase transformation point, and the bent section 11 is restored to the original axial direction. Finally, the specific interventional medical device is advanced along the catheter 10 that has been shaped in the patient to the lesion and the lesion is treated.

When the interventional medical equipment provided by the embodiment of the application is used, the bending angle of the medical guide wire 9 does not need to be frequently adjusted outside a human body to adapt to branches of various ducts and blood vessels, one end provided with the end 2 is inserted into the human body, when the end 2 reaches the branches of various ducts and blood vessels, the sheath 1 is heated through the electrified electrode plates 5, so that the heated sheath 1 is bent, and the electrode plates 5 can provide a plurality of bending angles for the medical guide wire 9, so that the medical guide wire 9 is controlled to be bent in the human body to adapt to complicated ducts and blood vessel veins, the interventional medical equipment can conveniently and safely reach focuses in the human body and leave the human body, and the interventional treatment efficiency is greatly improved. In addition, the interventional medical device has other technical effects of the medical guide wire 9 provided by the above embodiments, and the details are not repeated herein.

The above description is only a preferred embodiment of the present application and should not be taken as limiting the present application, and any modifications, equivalents, improvements, etc. made within the spirit and principle of the present application should be included in the protection scope of the present application.

Claims

1. A medical guidewire, characterized by: the electrode plate comprises a sheath, an end head, a core wire, a mandrel and a plurality of electrode plates, wherein the core wire is arranged in the sheath in a penetrating manner, and the end head is arranged at the far end of the sheath and is connected with the far end of the core wire; the mandrel is arranged at the proximal end of the sheath and is connected with the proximal end of the core wire; each electrode plate is arranged in the sheath and distributed along the length direction of the sheath; the electrode plate is used for locally heating the sheath after being electrified so as to bend the heated sheath;

the electrode plates comprise a first electrode plate and a second electrode plate, the first electrode plate and the second electrode plate are both of annular structures, the sheath comprises a bending section, the first electrode plate and the second electrode plate are respectively positioned at two ends of the bending section, a first through hole is formed in the first electrode plate, and a second through hole is formed in the second electrode plate; the interval between the first electrode plate and the second electrode plate is 10-50 mm, and when the first electrode plate or the second electrode plate is electrified independently, the bending angle of the medical guide wire is 0-60 degrees;

the core wire comprises a first core wire, a second core wire and a third core wire which are sequentially connected along the length direction of the core wire, the first core wire, the second core wire and the third core wire are arranged in the bending section in a penetrating mode, the first core wire is connected with the end and arranged in the first penetrating hole in a penetrating mode, the third core wire is arranged in the second penetrating hole in a penetrating mode, and the diameter of the first core wire and the diameter of the third core wire are smaller than the diameter of the second core wire.

2. The medical guidewire of claim 1, wherein: the sheath is divided into the bending section and a connecting section in a direction from the distal end of the sheath to the proximal end of the sheath.

3. The medical guidewire of claim 2, wherein: the bending section is a shape memory alloy sleeve section.

4. The medical guidewire of claim 1, wherein: the first core wire and the third core wire are both cones, the diameter of the first core wire is gradually increased in the direction from the first core wire to the second core wire, and the maximum diameter of the first core wire is equal to the diameter of the second core wire;

the diameter of the third core wire is gradually reduced in a direction from the second core wire to the third core wire, and the maximum diameter of the third core wire is equal to the diameter of the second core wire.

5. The medical guidewire of any one of claims 1-4, wherein: the medical guide wire further comprises an electrode controller, a thread hole is formed in the mandrel, the electrode pieces are all connected with a lead, and the lead penetrates out of the thread hole and then is connected with the electrode controller.

6. The medical guidewire according to any one of claims 1 to 4, wherein: the sheath is cylindrical and spiral.

7. An interventional medical device, characterized by: comprising the medical guidewire of any one of claims 1-6.