Medical guide wire

Abstract

The invention discloses a medical guide wire which comprises a pushing core wire, a control enhancing structure and a magnetic part, and the pushing core wire penetrates through the whole guide wire; the control enhancing structure is at least arranged at the far end of the pushing core wire in a sleeving manner; the magnetic part wraps the outer side of the far end of the pushing core wire and is used for controlling the head end of the pushing core wire to freely turn under an external magnetic field; the magnetic part is arranged at the position, close to the far end of the pushing core wire, of the control reinforcing structure, and the hardness of the pushing core wire is larger than that of the control reinforcing structure. According to the medical guide wire, the operation difficulty of guide wire steering is reduced, the operation time is shortened, use is more convenient, and damage to blood vessels is small.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a medical guide wire. Background Art

[0002] Vascular interventional medical surgery is a surgical method with low trauma and good prognosis, and has been widely used to treat vascular diseases in various parts of the body. Interventional treatment of intracranial blood vessels (also known as neurovascular vessels) has high surgical risks and is difficult to operate due to the small diameter of the blood vessels, long distances, and tortuous paths. It is currently less popular than vascular interventional surgery in other parts of the body.

[0003] In order to treat neurovascular diseases through interventional surgery, it is necessary to establish a "track" through a guidewire to introduce other implantable products such as catheters, balloons, and stents into the designated vascular lesion site for surgical treatment. Traditional guidewires are set as a profile structure with variable stiffness, with a flexible part at the head end to maintain good trackability and torque transmission in tortuous neurovascular vessels, and have the ability to bend into a curved shape similar to the lesion site.

[0004] Existing guidewires are usually complex in structure, expensive, and poor in flexibility, making it difficult to achieve a smaller bending radius. In addition, the structure of nerves and blood vessels is complex. Once the tracking and twisting control does not meet expectations, it is very easy to cause damage to the blood vessels, leading to more serious medical accidents. Summary of the invention

[0005] In view of this, the present invention provides a medical guide wire, which reduces the operational difficulty of guide wire steering, reduces operation time, is more convenient to use, and causes less damage to blood vessels.

[0006] To achieve the above object, the present invention provides the following technical solutions:

[0007] A medical guide wire, comprising:

[0008] Push the core wire through the entire guide wire setting;

[0009] A control enhancement structure is at least sleeved on the distal end of the pushing core wire;

[0010] The magnetic part is wrapped around the outer side of the distal end of the pushing core wire and is used to control the free turning of the head end of the pushing core wire under an external magnetic field;

[0011] The magnetic part is arranged at a distal end of the control enhancement structure close to the pushing core wire, and the hardness of the pushing core wire is greater than the hardness of the control enhancement structure.

[0012] Optionally, the magnetic part includes a magnetic block and / or a magnetic powder area;

[0013] The magnetic powder area includes magnetic powder, and the magnetic powder is uniformly mixed at a position of the control enhancement structure close to the distal end of the push core wire;

[0014] The magnetic block is one of a magnetic ring, a magnetic bar or a magnetic block, and the magnetic block is arranged around the distal end of the pushing core wire.

[0015] Optionally, the material of the magnetic part is one or more of neodymium iron boron alloy, samarium cobalt alloy, samarium iron nitrogen alloy, aluminum nickel cobalt alloy or ferrite.

[0016] Optionally, the material of the magnetic ring is neodymium iron boron alloy, the material of the magnetic rod or magnetic block is samarium cobalt alloy, and the material of the magnetic powder is one or more of neodymium iron boron alloy powder, samarium iron nitrogen alloy powder or ferrite powder.

[0017] Optionally, the control enhancement structure at least includes a covering head end wrapped around the distal end of the pushing core wire, and the magnetic part is arranged on the covering head end;

[0018] The covering head end is made of polymer material.

[0019] Optionally, the control enhancement structure includes a covering head end and a covering body connected together, the covering head end is wrapped around the distal end of the pushing core wire, and the covering body is wrapped around part or all of the pushing core wire except the end.

[0020] Optionally, the covering body includes one or more of a polymer coating layer, a bellows, a spiral coil, a hypotube or a woven mesh.

[0021] Optionally, the covering body includes a spiral coil and a polymer coating layer, the spiral coil is a spiral structure wound around the outside of the pushing core wire, the inner side of the spiral coil does not contact the outer surface of the pushing core wire, and the polymer coating layer is filled between adjacent spiral structures of the spiral coil to connect adjacent spiral structures.

[0022] Optionally, the outer diameter of the polymer coating layer is not greater than the outer diameter of the spiral coil;

[0023] The outer diameter of the polymer coating layer is the same as the outer diameter of the spiral coil, or the outer diameter of the polymer coating layer is smaller than the outer diameter of the spiral coil by a set distance, and the set distance is 0.01-0.05 mm.

[0024] Optionally, the spiral coil is a spiral structure wound by a metal wire, the diameter of the metal wire is 0.01 to 0.3 mm, and the pitch of adjacent spiral structures is 1.5 to 2 times the diameter of the metal wire.

[0025] Optionally, a transition portion is further included, one end of which is connected to the push core wire, and the other end of which is connected to the proximal end of the control enhancement structure.

[0026] Optionally, the transition portion is a spiral metal wire or a metal braided mesh;

[0027] The diameter of the spiral metal wire is not less than the diameter of the spiral coil of the control enhancement structure, the pitch of the spiral metal wire is 1.5 to 2 times of its diameter, and the length is 100 to 500 mm.

[0028] Optionally, the spiral metal wire is made of stainless steel alloy, nickel-titanium alloy or cobalt-chromium alloy.

[0029] Optionally, the pushing core wire is a rod body of an integral structure, and the proximal end size of the rod body is larger than the distal end size of the rod body;

[0030] The rod body comprises a plurality of segmented rod bodies, and the segmented rod body comprises at least one gradual change segment.

[0031] Optionally, the cross-section of the pushing core wire is circular or square, or the cross-section of the pushing core wire includes circular and square.

[0032] Optionally, the push core wire is made of one or more of stainless steel alloy, nickel-titanium alloy or cobalt-chromium alloy;

[0033] Alternatively, the pushing core wire is made of one or more of nylon fiber, polyester fiber, carbon fiber or glass fiber.

[0034] Optionally, the different branch rods are connected by welding, melting, cladding or bonding;

[0035] When the branch rods are made of metal, the different branch rods are laser welded or plasma welded;

[0036] When the branch rods are made of polymer material, different branch rods are bonded by light curing;

[0037] When the adjacent branch rods are made of polymer material or metal material respectively, the adjacent branch rods are connected by melting and cladding.

[0038] Optionally, the surface is coated with a coating for reducing the surface friction coefficient in a water-based liquid environment, and the coating is a hydrophilic coating or a hydrophobic coating.

[0039] It can be seen from the above technical scheme that the medical guidewire provided by the present invention includes a push core wire, a control enhancement structure and a magnetic part. The push core wire and the control enhancement structure together serve as the structural basis of the medical guidewire, so that the medical guidewire has extremely strong transmission and extremely high sensitivity to the force applied to the tail end of the in vitro guidewire, which significantly improves the control performance of the guidewire by the mechanical force. By setting the magnetic part at the distal end of the control enhancement structure close to the push core wire, the head end of the medical guidewire can be controlled to deflect freely by non-contact magnetic field force, so that the guidewire has a more outstanding bending ability, which greatly facilitates the guidewire to cross the tortuous blood vessels to reach the specified position. Compared with the pure mechanical force control of the traditional guidewire, the difficulty of the guidewire steering operation is reduced, the operation time is reduced, the use is more convenient, the damage to the blood vessels is small, and the risk of medical accidents caused by blood vessel damage is reduced. BRIEF DESCRIPTION OF THE DRAWINGS

[0040] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0041] Figure 1 A schematic diagram of the structure of a medical guide wire provided in an embodiment of the present invention;

[0042] Figure 2 A schematic diagram of the structure of a magnetic part provided by an embodiment of the present invention;

[0043] Figure 3 for Figure 2 A schematic cross-sectional structure diagram of the magnetic part in FIG.

[0044] Figure 4 A schematic structural diagram of a magnetic part provided by another embodiment of the present invention;

[0045] Figure 5 for Figure 4 A schematic cross-sectional structure diagram of the magnetic part in FIG.

[0046] Figure 6 A schematic diagram of a control enhancement structure provided by an embodiment of the present invention;

[0047] Figure 7 A schematic diagram of a control enhancement structure provided by another embodiment of the present invention;

[0048] Figure 8 A schematic structural diagram of a control enhancement structure provided by yet another embodiment of the present invention;

[0049] Fig. 9A schematic diagram of the structure of a push core wire provided in an embodiment of the present invention;

[0050] Fig.10 A schematic diagram of a magnetic part provided by an embodiment of the present invention passing through a curved pipeline under the action of an external magnetic field B;

[0051] Fig.11 A schematic diagram of a magnetic part provided in another embodiment of the present invention passing through a curved pipeline under the action of an external magnetic field B.

[0052] in:

[0053] 1. Push the core wire,

[0054] 101, core wire head end, 102, core wire body,

[0055] 2. Control enhancement structure,

[0056] 201, covering body, 2011, spiral coil, 2012, polymer coating layer, 2013, threaded tube body, 2014, hypotube, 202, covering head end, 2021, mounting through hole, 2022, tapered end, 2023, cylindrical end,

[0057] 3. Magnetic part,

[0058] 301, magnetic powder, 302, magnetic ring, 303, magnetic block,

[0059] 4. Transition part. DETAILED DESCRIPTION

[0060] The invention discloses a medical guide wire, which reduces the operational difficulty of guide wire steering, reduces operation time, is more convenient to use, and has little damage to blood vessels.

[0061] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0062] See also Figures 1 to 9The medical guidewire of the present invention comprises a push core wire 1, a control enhancement structure 2 and a magnetic part 3. The push core wire 1 is the core skeleton of the medical guidewire, which runs through the overall setting of the guidewire to facilitate the smooth advancement of the guidewire in the body. The control enhancement structure 2 is the outer layer material of the guidewire, which is used to enhance the torsion control performance of the guidewire in the blood vessel, and is at least sleeved on the distal end of the push core wire 1. The magnetic part 3 is wrapped around the outer side of the distal end of the push core wire 1. It is a magnetic material attached to the head of the guidewire and is used to control the free steering of the head end of the push core wire 1 under an external magnetic field. The magnetic part 3 is arranged at the distal end position of the control enhancement structure 2 close to the push core wire 1. Among them, the above-mentioned distal end refers to the end away from the medical operator. The hardness of the push core wire 1 is greater than the hardness of the control enhancement structure 2. The strength of the push core wire 1 is higher, and the flexibility of the control enhancement structure 2 is better.

[0063] The medical guidewire of the present invention comprises a push core wire 1, a control enhancement structure 2 and a magnetic part 3. The push core wire 1 and the control enhancement structure 2 together serve as the structural basis of the medical guidewire, so that the medical guidewire has extremely strong transmission and extremely high sensitivity to the force applied to the tail end of the in vitro guidewire, which significantly improves the control performance of the guidewire by the mechanical force. By arranging the magnetic part 3 at the distal end of the control enhancement structure 2 close to the push core wire 1, the head end of the medical guidewire can be controlled to deflect freely by non-contact magnetic field force, so that the guidewire has a more excellent bending ability, which greatly facilitates the guidewire to cross the tortuous blood vessels to reach the specified position. Compared with the pure mechanical force control of the traditional guidewire, it reduces the difficulty of operation, reduces the operation time, is more convenient to use, causes less damage to the blood vessels, and reduces the risk of medical accidents caused by blood vessel damage.

[0064] Specifically, the magnetic part 3 includes a magnetic block and / or a magnetic powder area. The magnetic powder area includes magnetic powder, and the magnetic powder is uniformly mixed in the control enhancement structure 2 near the distal end of the push core wire 1. The magnetic block is one of a magnetic ring, a magnetic rod or a magnetic block, and the magnetic block is arranged around the distal end of the push core wire 1, that is, the magnetic block is arranged at the head end of the guide wire. The material of the magnetic part 3 is one or more of neodymium iron boron alloy, samarium cobalt alloy, samarium iron nitrogen alloy, aluminum nickel cobalt alloy or ferrite. Among them, the material of the magnetic ring is neodymium iron boron alloy, the material of the magnetic rod or the magnetic block is samarium cobalt alloy, and the material of the magnetic powder is one or more of neodymium iron boron alloy powder, samarium iron nitrogen alloy powder or ferrite powder.

[0065] The control enhancement structure 2 at least includes a covering head end 202 wrapped around the distal end of the pushing core wire 1, and the magnetic part 3 is arranged on the covering head end 202. The covering head end 202 is made of polymer material.

[0066] In a specific embodiment, referring to Figure 2 and Figure 3As shown, the magnetic part 3 includes a magnetic ring 302 and a magnetic powder area, wherein the magnetic powder area is mixed with magnetic powder 301, and the magnetic powder 301 is mixed with the matrix area of ​​the control enhancement structure 2 sleeved on the distal end of the push core wire 1. The magnetic ring 302 is arranged at a position close to the end of the control enhancement structure 2. The magnetic powder 301 is pre-mixed with the polymer material covering the head end 202 and carried on the head of the guide wire. The magnetization of the magnetic powder 301 on the covering head end 202 can be carried out after the guide wire is manufactured. In addition, the magnetic powder 301 can also be pre-oriented to enhance the overall magnetic strength of the magnetic powder 301, and the pre-orientation can be carried out during or after one or more of the processes of pre-mixing, granulation, and melt coating. The volume ratio of the magnetic powder 301 to the polymer material covering the head end 202 is 10 to 90%. The magnetic ring 302 is a hollow cylindrical structure with a wall thickness of 0.05 to 0.15 mm and a length of 1 to 5 mm. The magnetic ring 302 is embedded in the cover head end 202. Preferably, the magnetic ring 302 is embedded in the head end of the guide wire. The magnetic ring 302 can also be used as a radiopaque marker of the guide wire head end, used to mark the real-time position of the guide wire head end under intraoperative X-ray irradiation, so that the operator can observe it in real time during the operation.

[0067] In another embodiment, if Figure 4 and Figure 5 As shown, the magnetic part 3 includes a magnetic block 303 and a magnetic powder area, wherein the magnetic powder area is mixed with magnetic powder 301, and the magnetic powder 301 is mixed with the base area of ​​the control enhancement structure 2 sleeved on the far end of the push core wire 1. The magnetic block 303 is arranged at a position close to the end of the control enhancement structure 2. Figure 4 As shown, a plurality of magnetic blocks 303 are provided, and the plurality of magnetic blocks 303 are evenly distributed around the pushing core wire 1 .

[0068] Preferably, the control enhancement structure 2 includes a covering head end 202 and a covering body 201 connected together, the covering head end 202 is wrapped around the distal end of the pushing core wire 1, and the covering body 201 is wrapped around part or all of the pushing core wire 1 except the end. The magnetic part 3 is arranged in the covering head end 202 area of ​​the control enhancement structure 2. The covering body 201 includes one or more of a polymer coating layer, a bellows, a spiral coil, a sea wave tube or a braided mesh. The material of the covering body 201 is one or more of stainless steel alloy, nickel-titanium alloy, platinum-tungsten alloy, platinum, polyether block amide, thermoplastic polyurethane elastomer, nylon, polytetrafluoroethylene, and perfluoroethylene propylene. Among them, the covering head end 202 includes a conical end 2022 and a cylindrical end 2023 connected together, such as Figures 2 to 5As shown. The large end of the conical end 2022 is connected to the covering body 201, and the small end is connected to the cylindrical end 2023. The outer diameter of the cylindrical end 2023 is the same as the outer diameter of the small end of the conical end 2022, so as to achieve a smooth transition connection between the covering body 201 and the covering head end 202. The outer diameter of the cylindrical end 2023 of the covering head end 202 is smaller than the outer diameter of the covering body 201, so as to facilitate the end of the covering head end 202 away from the covering body 201 to pass through the tortuous blood vessel structure. The covering head end 202 is provided with a mounting through hole 2021, as shown in FIG. Figure 3 and Figure 5 As shown, the mounting through hole 2021 is arranged along the axial direction of the covering head end 202, and the core wire head end 101 of the pushing core wire 1 is fixedly mounted in the mounting through hole 2021, and the fixed mounting here can be bonding.

[0069] In one embodiment, the covering body 201 only includes a threaded tube 2013 wound around the outer side of the pushing core wire 1. Figure 6 The threaded tube body 2013 is a metal wire tightly wound structure, the outer diameter of the threaded tube body 2013 is not greater than the maximum outer diameter of the tail end of the push core wire 1, the metal wire diameter of the threaded tube body 2013 is 0.01-0.25 mm, and the pitch is generally a tightly wound pitch, which is the metal wire diameter plus 0.003 mm. The tightly wound structure has a sufficiently small pitch, and the friction between the tightly wound structure and the blood vessel is very low, so a polymer layer may not be provided.

[0070] In another embodiment, the cover 201 includes a spiral coil 2011 and a polymer coating layer 2012, such as Figure 7As shown, the spiral coil 2011 is a spiral structure wound around the outside of the push core wire 1, and the inner side of the spiral coil 2011 does not contact the outer surface of the push core wire 1. The polymer coating layer 2012 is filled between the adjacent spiral structures of the spiral coil 2011, and is used to connect the adjacent spiral structures. The polymer coating layer 2012 is a polymer layer formed after melt coating, and the polymer coating layer 2012 here does not contain magnetic powder or magnetic body. In order to eliminate the gap and reduce the friction, the polymer coating layer 2012 is filled between the spiral coil 2011 and the push core wire 1 in the form of a polymer layer, which better connects the push core wire 1 and the spiral coil 2011, while eliminating the gap between them, reducing the friction between the guide wire and the blood vessel, and improving the smoothness of the overall push of the guide wire. The spiral coil 2011 is a spiral structure wound by a metal wire, and the diameter of the metal wire used is 0.01-0.3 mm, and the pitch is 1.5-2 times the diameter of the metal wire used. After the polymer coating layer 2012 is melt-coated, it will be filled into the spiral coil 2011, and the outer diameter of the filled polymer coating layer 2012 is not greater than the outer diameter of the spiral coil 2011. Preferably, the outer diameter of the polymer coating layer 2012 is the same as the outer diameter of the spiral coil 2011. The outer diameter of the polymer coating layer 2012 can also be smaller than the outer diameter of the spiral coil 2011 by a set distance, and the set distance is 0.01-0.05mm. Preferably, the outer diameter of the polymer coating layer 2012 is 0.01mm smaller than the outer diameter of the spiral coil 2011. In this embodiment, the tapered end 2022 is connected to the polymer coating layer 2012.

[0071] In another embodiment, the control enhancement structure 2 is a preformed planar corrugated tube, on which corrugations extending along the length of the tube are provided, the overall length of the corrugations is 10 mm to 500 mm, the number of periods is 1 to 10 groups, and the distance from the crest to the trough is 1 to 10 times the diameter of the guidewire. Preferably, the overall length of the corrugations is 50 to 100 mm, the number of periods is 2 to 4 groups, and the distance from the crest to the trough is 3 to 5 times the diameter of the guidewire. More preferably, the distance from the crest to the trough decreases as the position of the guidewire approaches the head end. The planar corrugated tube structure can improve the deformation strength of the overall structure of the guidewire when the guidewire itself is sufficiently flexible, and at the same time improve the contact point between the guidewire and the blood vessel wall during intravascular delivery, so that the pushing force applied at the tail end can be better transmitted to the guidewire head end, thereby improving the push controllability of the guidewire. The covering body 201 can also be a sea wave tube 2014, such as Figure 8 shown.

[0072] The medical guide wire of the present invention also includes a transition part 4, one end of which is connected to the push core wire 1, and the other end is connected to the proximal end of the control enhancement structure 2. The transition part 4 is a spiral metal wire or a metal braided mesh. When the transition part 4 is a spiral metal wire structure, the diameter of the spiral metal wire is not less than the diameter of the spiral coil of the control enhancement structure 2, the pitch of the spiral metal wire is 1.5 to 2 times its diameter, and the length is 100 to 500 mm. The transition part 4 plays a role in improving the conduction of the push and torsion control force at the structural transformation. The end of the transition part 4 close to the push core wire 1 is fixed with epoxy resin thermosetting glue, and the transition part 4 and the control enhancement structure 2 can also be fixed with epoxy resin thermosetting glue. The covering body 201 and the covering head end 202 are transitioned using an epitaxial polymer layer. The length of the transition section is 5 mm to 50 mm. The material of the spiral coil 2011 and the transition part 4 is stainless steel alloy, nickel-titanium alloy or cobalt-chromium alloy. Preferably, the spiral metal wire of the transition part 4 is a stainless steel alloy wire. The spiral coil 2011, the threaded tube body 2013 or the hypotube 2014 are made of nickel-titanium alloy. The transition portion 4 can also be replaced by a hypotube made of stainless steel alloy. The notch width of the hypotube is the wire diameter of the metal wire used in the original spiral structure, and the notch gap is the pitch of the original spiral structure. Preferably, the notch gap can be set gradually from 0.00001mm to 0.001mm according to the size of the pitch and the total length.

[0073] Specifically, the push core wire 1 is a rod body of an integral structure, and the proximal end size of the rod body is larger than the distal end size of the rod body, where the proximal end refers to the end close to the medical staff and the end away from the patient. The rod body includes a plurality of segmented rod bodies, and the segmented rod bodies include at least one gradient segment. The cross section of the push core wire 1 is one of circular or square, or the cross section of the push core wire 1 includes circular and square, that is, the push core wire 1 includes a circular rod segment and a square rod segment.

[0074] Among them, the push core wire 1 can be made of metal materials and polymer materials. The metal materials used include one or more of stainless steel alloys, nickel-titanium alloys, and cobalt-chromium alloys; the polymer materials used include one or more of nylon fibers, polyester fibers, carbon fibers, and glass fibers. The "multiple" mentioned above refers to two or more types. The different branch rods are welded, melt-coated, connected, or bonded. Specifically, when the branch rods are made of metal, the different branch rods are laser welded or plasma welded; when the branch rods are made of polymer materials, the different branch rods are photocured and bonded; when adjacent branch rods are made of polymer materials and metal materials, respectively, the adjacent branch rods are melt-coated and connected.

[0075] The push core wire 1 is the basic skeleton of the entire guide wire. It is a continuous slender rod. The push core wire 1 extends from the tail end to the head end, forming a gradually tapered gradient structure, gradually changing from 0.010-0.014 inches at the tail end to 0.003-0.006 inches at the head end. This gradient structure is formed by combining multiple gradient segments with different lengths and tapers. Some non-gradient straight segments can be added to the gradient structure. In the overall gradient structure, the gradient structure starts with a gradient segment, or starts with a straight segment; ends with a straight segment, or ends with a gradient segment. In one embodiment, the push core wire 1 includes a core wire head end 101 and a core wire body 102. Fig. 9 As shown, the core wire head 101 is made of nickel-titanium alloy with a length of 5 to 500 mm, the core wire body 102 is made of stainless steel alloy, and the core wire head 101 and the core wire body 102 are connected together by welding. More preferably, the stainless steel alloy and the nickel-titanium alloy are connected together by plasma welding.

[0076] In order to improve the overall pushability of the guidewire, it is necessary to add a super-lubricating coating to reduce the surface friction coefficient on the surface of the guidewire. Specifically, the surface of the guidewire is coated with a coating for reducing the surface friction coefficient in a water-based liquid environment, and the coating is a hydrophilic coating or a hydrophobic coating. The coating material is a hydrophilic coating including polyvinyl pyrrolidone, polyacrylic acid, polyacrylamide, polyacrylic acid-acrylamide copolymer, and polyethylene glycol; or, the coating material is a hydrophobic coating including polytetrafluoroethylene, perfluoroalkane, and perfluoroethylene propylene.

[0077] Preferably, a PTFE hydrophobic coating is added to a length of 10 to 300 cm at the tail end of the guide wire, and a polyvinyl pyrrolidone hydrophilic coating is added to a length of 10 to 100 cm at the head end of the guide wire.

[0078] In the prior art, when passing through a blood vessel path or other cavity with a large bending angle, the traditional guidewire cannot directly control the direction of the guidewire tip, and it is often necessary to apply a torsional force combined with a push-pull force at the tail end of the guidewire to indirectly control the guidewire tip to turn in the body. When the traditional guidewire controls the turning, due to the delay and lag in the guidewire torsion control transmission, the guidewire tail end is often unable to produce 1:1 real-time control of the tip when controlling it in vitro. During the use of the medical guidewire of the present invention, refer to Fig.10 and Fig.11 Since there is a magnetic part 3 at the tip of the guide wire, when encountering a path with a large degree of curvature, a magnetic field B parallel to the target path can be applied in vitro as shown by the arrow in the figure. The magnetic field B will guide the magnetic part 3 of the magnetic guide wire to twist, and the twisted magnetic part 3 will lead the guide wire tip to deflect in the direction of the target path, as shown in FIG. Fig. 9 and Fig.10The dotted part in the figure. At this time, when the tail end of the guide wire is controlled in vitro, since the head end of the guide wire has been deflected in the target direction under the action of the magnetic field and the magnetic part, only a thrust needs to be applied at this time, and the guide wire as a whole can enter the target path under the guidance of the head end after deflection. If you encounter the next path with a large angle bend, you only need to adjust the direction of the magnetic field in vitro as shown by the arrow in the figure, so that the direction of the magnetic field is turned to be parallel to the next target path. At this time, the magnetic part 3 of the magnetic guide wire will be deflected again under the action of the transformed magnetic field. At this time, a thrust is applied to the tail end of the magnetic guide wire in vitro, and it can cross the curved path again to enter.

[0079] The medical guidewire of the present invention is a magnetic guidewire, which can be applied to neurovascular surgery, and can also be used for any interventional, diagnostic and / or therapeutic surgery of the human body or other animal body. In addition to neurovascular applications, it also includes blood vessels in other locations, such as the coronary arteries of the heart, the thoracic aorta, the femoral artery, and the vena cava; it can also be applied to cavities in the external environment, such as the esophagus, the gastrointestinal tract, the urethra, etc. In one embodiment, the maximum outer diameter of the magnetic guidewire used in neurovascular surgery is about 0.008 inches to about 0.018 inches. Other diameter specifications, such as about 0.021 inches to 0.038 inches, are expected to be used in other arteriovenous blood vessels and external environment cavities. The diameter of the magnetic guidewire can remain relatively constant over most of the guidewire length. However, the head end includes a basic tapered structure, and the gradient length and gradient method between different parts are also different, so that the magnetic guidewire can pass through a tortuous vascular structure.

[0080] The medical guidewire of the present invention, the high-strength push core wire 1 and the highly flexible control enhancement structure 2 together serve as the structural basis of the magnetic guidewire, so that the entire guidewire has extremely strong transmission and extremely high sensitivity to the force applied to the tail end of the guidewire in vitro, thereby improving the controllability of the guidewire by the mechanical force. The magnetic part 3 on the guidewire facilitates the control of the guidewire by non-contact magnetic field force, and at the same time controls the guidewire head end to deflect freely by the magnetic field, so that the guidewire has more outstanding bending ability, facilitates the guidewire to cross tortuous blood vessels to reach the specified position, reduces the difficulty of operation, and reduces the operation time. The magnetic guidewire can be used in combination with an external magnetic field in a traditional way, and can also be used together with a corresponding surgical robot or other equipment. It has high compatibility and increases the convenience and selectivity of the operation.

[0081] In the description of this solution, it should be understood that the terms "upper", "lower", "vertical", "inside", "outside", etc., indicating the orientation or position relationship are based on the orientation or position relationship shown in the accompanying drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on this solution.

[0082] In addition, the terms "first" and "second" are used for descriptive purposes only and should not be understood as indicating or implying relative importance or implicitly indicating the number of the indicated technical features. Therefore, the features defined as "first" and "second" may explicitly or implicitly include one or more of the features. In the description of this solution, the meaning of "plurality" is two or more, unless otherwise clearly and specifically defined.

[0083] The various embodiments in this specification are described in a progressive manner, and each embodiment focuses on the differences from other embodiments. The same or similar parts between the various embodiments can be referenced to each other.

[0084] The above description of the disclosed embodiments enables one skilled in the art to implement or use the present invention. Various modifications to these embodiments will be apparent to one skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the present invention. Therefore, the present invention will not be limited to the embodiments shown herein, but rather to the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. A medical guide wire, characterized in that: include: Push the core wire through the entire guide wire setting; A control enhancement structure is at least sleeved on the distal end of the pushing core wire; The magnetic part is wrapped around the outer side of the distal end of the pushing core wire and is used to control the free turning of the head end of the pushing core wire under an external magnetic field; The magnetic part is arranged at a distal end of the control enhancement structure close to the pushing core wire, and the hardness of the pushing core wire is greater than the hardness of the control enhancement structure.

2. The medical guide wire according to claim 1, characterized in that: The magnetic part includes a magnetic block and / or a magnetic powder area; The magnetic powder area includes magnetic powder, and the magnetic powder is uniformly mixed at a position of the control enhancement structure close to the distal end of the push core wire; The magnetic block is one of a magnetic ring, a magnetic bar or a magnetic block, and the magnetic block is arranged around the distal end of the pushing core wire.

3. The medical guide wire according to claim 2, characterized in that: The material of the magnetic part is one or more of neodymium iron boron alloy, samarium cobalt alloy, samarium iron nitrogen alloy, aluminum nickel cobalt alloy or ferrite.

4. The medical guide wire according to claim 2, characterized in that: The material of the magnetic ring is neodymium iron boron alloy, the material of the magnetic rod or magnetic block is samarium cobalt alloy, and the material of the magnetic powder is one or more of neodymium iron boron alloy powder, samarium iron nitrogen alloy powder or ferrite powder.

5. The medical guide wire according to claim 1, characterized in that: The control enhancement structure at least includes a covering head end wrapped around the distal end of the pushing core wire, and the magnetic part is arranged on the covering head end; The covering head end is made of polymer material.

6. The medical guide wire according to claim 5, characterized in that: The control enhancement structure includes a covering head end and a covering body connected together, wherein the covering head end is wrapped around the distal end of the pushing core wire, and the covering body is wrapped around part or all of the pushing core wire except the end.

7. The medical guide wire according to claim 6, characterized in that: The covering body includes one or more of a polymer coating layer, a bellows, a spiral coil, a hypotube or a braided mesh.

8. The medical guide wire according to claim 7, characterized in that: The covering body includes a spiral coil and a polymer coating layer. The spiral coil is a spiral structure wound around the outside of the pushing core wire. The inner side of the spiral coil does not contact the outer surface of the pushing core wire. The polymer coating layer is filled between adjacent spiral structures of the spiral coil and is used to connect adjacent spiral structures.

9. The medical guide wire according to claim 8, characterized in that: The outer diameter of the polymer coating layer is not greater than the outer diameter of the spiral coil; The outer diameter of the polymer coating layer is the same as the outer diameter of the spiral coil, or the outer diameter of the polymer coating layer is smaller than the outer diameter of the spiral coil by a set distance, and the set distance is 0.01-0.05 mm.

10. The medical guide wire according to claim 8 or 9, characterized in that: The spiral coil is a spiral structure formed by winding a metal wire, the diameter of the metal wire is 0.01-0.3 mm, and the pitch of adjacent spiral structures is 1.5-2 times the diameter of the metal wire.

11. The medical guide wire according to claim 1, characterized in that: It also includes a transition part, one end of which is connected to the pushing core wire, and the other end of which is connected to the proximal end of the control enhancement structure.

12. The medical guide wire according to claim 11, characterized in that: The transition part is a spiral metal wire or a metal braided mesh; The diameter of the spiral metal wire is not less than the diameter of the spiral coil of the control enhancement structure, the pitch of the spiral metal wire is 1.5 to 2 times of its diameter, and the length is 100 to 500 mm.

13. The medical guide wire according to claim 12, characterized in that: The spiral metal wire is made of stainless steel alloy, nickel-titanium alloy or cobalt-chromium alloy.

14. The medical guide wire according to claim 1, characterized in that: The pushing core wire is a rod body of an integrated structure, and the proximal end size of the rod body is larger than the distal end size of the rod body; The rod body comprises a plurality of segmented rod bodies, and the segmented rod body comprises at least one gradual change segment.

15. The medical guide wire according to claim 14, characterized in that: The cross section of the pushing core wire is one of circular and square, or the cross section of the pushing core wire includes circular and square.

16. The medical guide wire according to claim 14, characterized in that: The material of the push core wire is one or more of stainless steel alloy, nickel-titanium alloy or cobalt-chromium alloy; Alternatively, the pushing core wire is made of one or more of nylon fiber, polyester fiber, carbon fiber or glass fiber.

17. The medical guide wire according to claim 14, characterized in that: The different branch rods are welded, melt-coated, connected or bonded; When the branch rods are made of metal, the different branch rods are laser welded or plasma welded; When the branch rods are made of polymer material, different branch rods are bonded by light curing; When the adjacent branch rods are made of polymer material or metal material respectively, the adjacent branch rods are connected by melting and cladding.

18. The medical guide wire according to claim 14, characterized in that: The surface of the composite material is coated with a coating for reducing the surface friction coefficient in a water-based liquid environment, and the coating is a hydrophilic coating or a hydrophobic coating.

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