CN115920206A

CN115920206A - guide wire

Info

Publication number: CN115920206A
Application number: CN202211607739.XA
Authority: CN
Inventors: 王杨; 袁俊怡; 姚康平; 刘雪美
Original assignee: Weiya Lingdong Medical Technology Suzhou Co ltd
Current assignee: Weiya Lingdong Medical Technology Suzhou Co ltd
Priority date: 2022-12-14
Filing date: 2022-12-14
Publication date: 2023-04-07

Abstract

The invention discloses a guide wire, comprising: the core wire comprises a flexible section, a transition section and a support section, wherein two ends of the transition section are respectively connected with the flexible section and the support section; the diameter of the core wire increases from the distal end of the flexible section to the proximal end of the transition section; the spring comprises a first spring section and a second spring section, and the inner diameter and the outer diameter of the spring of the first spring section are smaller than those of the spring of the second spring section; the first spring section is sleeved on the flexible section, and the second spring section is sleeved on the transition section; two ends of the first spring section and the second spring section are respectively fixedly connected with the core wire; the periphery of the first spring section is coated with a magnetic body, and the magnetic body is composed of an elastomer material used as a base material and nano-scale superfine soft or hard magnetic powder added in the elastomer material; the ball head is arranged at the distal end of the flexible section; the outer surface of the magnetic body and the ball head are coated with hydrophilic coatings; the outer peripheral surface of the support section is coated with a hydrophobic coating.

Description

Guide wire

Technical Field

The invention relates to the technical field of medical instruments, in particular to a guide wire for vascular intervention operation.

Background

The guide wire is used as a diagnosis and treatment tool for minimally invasive vascular intervention operation, and plays a role in lifting weight in the whole minimally invasive intervention diagnosis and treatment process. Especially when a tortuous small blood vessel, a tiny intracranial artery or an abnormal hemangioma is faced, correct selection of the guide wire is the key for success of minimally invasive intervention diagnosis and treatment, and accurate control, accurate positioning, good trafficability and trackability are the prerequisites of minimally invasive intervention diagnosis and treatment operation of the guide wire technology.

In clinical practice, for blood vessels with tortuous small long blood vessels and malformation, the failure rate of pushing the existing guide wire in place is over 60 percent, particularly when minimally invasive interventional embolization treatment is carried out in cerebral aneurysm blood vessels, the hard guide wire is selected to easily pass through the malformed blood vessels, but the blood vessels can be poked through by carelessness, particularly intracranial aneurysms, once the death rate is extremely high, the death rate of primary bleeding generally reaches 30 percent, and the death rate of secondary bleeding reaches 80 percent. The physician therefore does not choose this mode, and the alternative is nitinol and the head end can be shaped with a guidewire to address, but push misplacement, stuck, mis-positioning and poor control are still ongoing.

Disclosure of Invention

In order to solve the defects, the invention provides the guide wire, the far end of the guide wire is a magnetic body, the magnetic body of the guide wire can be guided to accurately pass through a blood vessel with complicated tortuous lesions at an angle of 0-360 degrees by adopting neodymium magnetite and the like, the operation is convenient, the positioning is accurate, and the controllability is good.

To achieve the above object, the present invention provides a guidewire comprising:

a core wire comprising a flexible section at a distal end, a transition section at a proximal end of the flexible section, and a support section continuous with the transition section and extending distally of the core wire; two ends of the transition section are respectively connected with the flexible section and the support section in a smooth transition way; the diameter of the core wire increases from the distal end of the flexible section to the proximal end of the transition section;

the spring comprises a first spring section and a second spring section, and the inner diameter and the outer diameter of the first spring section are respectively smaller than those of the second spring section; said first spring section is sleeved over said flexible section, said second spring section is sleeved over a portion of said transition section, or said second spring section is sleeved over substantially the entire transition section; the far end of the first spring section spring is fixedly connected with the far end head of the flexible section, and the near end of the second spring section spring is fixedly connected with the core wire; the near end of the first spring section is fixedly connected with the far end of the second spring section, or the near end of the first spring section and the far end of the second spring section are respectively fixedly connected with the core wire;

the periphery of the first spring section is coated with a magnetic body, and the magnetic body is composed of an elastomer material used as a base material and nanoscale ultrafine soft or hard magnetic powder added into the elastomer material;

the bulb is arranged at the distal end of the flexible section and is connected with the distal end of the magnetic body;

the outer surface of the magnetic body and the ball head are coated with hydrophilic coatings; or the peripheral surface of the magnetic body is coated by a protective tube or a protective coating, and the outer surface of the protective tube or the protective coating and the ball head are coated with hydrophilic coatings; or the outer peripheral surfaces of the bulb and the magnetic body are coated by a protective tube or a protective coating, and the outer surface of the protective tube or the protective coating is coated with a hydrophilic coating; and

the outer peripheral surface of the support section is coated with a hydrophobic coating.

Compared with the prior art, the technical scheme of the invention has the following technical effects:

according to the novel guide wire, the flexible section at the far end and the transition section adjacent to the flexible section are arranged, so that the guide wire is gradually softened from the near end to the far end, and the flexibility of the far end is ensured; independent springs matched with the flexibility of the flexible section and the transition section are respectively assembled on the flexible section and the transition section, so that the shape retention performance, the pushing performance, the tracking performance, the bending resistance performance, the control positioning performance, the torque transmission performance and the follow-up performance of the guide wire are effectively improved, the flexibility is better, and the guide wire can better adapt to the path change of blood vessels; the advance, retreat and angle adjustment and steering of the guide wire can be carried out by attracting a magnetic body arranged at the distal end by using external magnetite and the like, and the guide wire is ensured to accurately reach the diseased part of a patient through a tortuous diseased blood vessel in the operation process.

In addition, through establish protection tube or protective coating at the magnetic substance periphery cover, prevented effectively that magnetic particle from droing, avoided the risk that probably having the magnetic particle of corrosivity is detained in the human body from this.

Drawings

FIG. 1A is a cross-sectional view illustrating the general structure of a guidewire according to a first embodiment of the present invention;

FIG. 1B is an enlarged partial cross-sectional view of the distal portion of the guidewire shown in FIG. 1A;

FIG. 2 is a cross-sectional view of a core wire of the guidewire of the present invention;

FIG. 3 is a cross-sectional view of the core wire of the guidewire of the present invention, illustrating the first spring section sleeved over the flexible section;

FIG. 4 is a cross-sectional view of a core wire of the guidewire of the present invention, illustrating a first spring segment and a second spring segment sleeved over the flexible segment and the transition segment, respectively; and

fig. 5 is a schematic view illustrating the practical application of the guide wire of the present invention in an interventional procedure.

Detailed Description

The guide wire of the present invention will be described in detail below with reference to the accompanying drawings. It should be noted herein that the present embodiments are merely exemplary, which are merely illustrative of the principles of the present invention and are not to be construed as limiting the present invention.

Reference is first made to fig. 1A and 1B, wherein fig. 1A is a cross-sectional view illustrating the general structure of a guide wire according to a first embodiment of the present invention; fig. 1B is an enlarged partial cross-sectional view of the distal portion of the guidewire shown in fig. 1A. As shown in fig. 1A, the guide wire according to the first embodiment of the present invention is divided into a distal end and a proximal end in the longitudinal direction, the distal end refers to the end of the guide wire on the side of the patient, and the proximal end refers to the end of the guide wire on the side away from the patient. As shown in fig. 1A and 1B, the guide wire of the present invention includes a core wire 1, a ball head 10 at a distal end of the core wire, a spring 2, a magnetic body 3, a protective tube 4, a hydrophilic coating 5, and a hydrophobic coating 6.

As shown in fig. 2, the core wire 1 comprises a flexible segment 7 at the distal end of the core wire, a transition segment 9 disposed adjacent to the flexible segment 7, and a support segment 8 extending towards the proximal end of the core wire, continuing from the transition segment 9. Wherein the flexible section 7 and the transition section 9 of the core wire are basically in a continuous cylindrical shape, the support section 8 is also in a cylindrical shape, the diameter of the flexible section 7 is smaller than that of the transition section 9, and the diameter of the transition section 9 is smaller than that of the support section 8. The flexible section 7 is connected with the transition section 9 via a conical section 12 in a smooth transition manner, and the transition section 9 is connected with the support section 8 via a conical section 13 in a smooth transition manner. The diameter of the flexible section can be selected to be 0.03-0.10 mm, and the length can be selected to be 20-50 mm; the diameter of the transition section can be selected to be 0.15-0.30 mm, and the length of the transition section can be selected to be 200-400 mm; the length of the conical section 12 can be selected to be 50-100 mm, and the length of the conical section 13 can be selected to be 50-300 mm; the diameter of the support section can be selected to be 0.24-0.42 mm, and the total length of the core wire can be selected to be 1500-3500 mm. It should be noted that the above listed size ranges are only preferred size ranges to illustrate and not limit the specific size of the segments of the core wire of the present invention.

The structural division of the core wire 1 is not limited to the specific case described above. The flexible section may comprise a cylindrical section and a conical section 12 at the distal end or the flexible section may comprise a portion of a cylindrical section and a conical section 12 at the distal end; similarly, the transition section may comprise a cylindrical section and a conical section 12 or the transition section may comprise a portion of a cylindrical section and a conical section 12, or the transition section may comprise a portion of a cylindrical section and a conical section 13, and so on.

The structure of the core wire 1 may also take other forms. For example, the flexible and transition sections of the core wire may also take the form of: the cylindrical sections and the conical sections are arranged in a staggered mode, for example, the structures from the far end of the core wire are respectively conical sections, cylindrical sections and conical sections \8230and \8230orthe structures from the far end of the core wire are respectively cylindrical sections, conical sections and cylindrical sections \8230and \8230, and the diameter of the whole structure from the far end head of the flexible section to the near end head of the transition section is gradually increased and the sections include supporting sections and smooth transition connection. Furthermore, the flexible section of the core wire may be cylindrical while the transition section is conical; alternatively, the flexible section and the transition section of the core wire may be continuously conical.

Thus, in this specification, "increasing the diameter from the distal tip of the compliant segment to the proximal tip of the transition segment" includes both the situation shown in FIG. 2 and the situations described previously.

The core wire can be made of any one or any combination of materials such as platinum-iridium alloy, gold, tantalum-plated stainless steel, nickel-titanium alloy, tungsten, nylon (PA), stainless steel and the like, a coreless grinding machine is adopted to grind from a near end to become thinner to a far end to be in a core rod shape, and a supporting section 8, a transition section 9 and a flexible section 7 which are connected with each other are formed, so that the far end of the guide wire is more flexible, the head end of the guide wire is ensured to be elastic and smoothly intervene in a human blood vessel.

As shown in fig. 1A, 1B and 4, the spring 2 is fitted over the flexible section 7 of the core wire 1 and a part of the transition section 9, or over the flexible section 7 of the core wire 1 and substantially the entire transition section 9. The spring 2 comprises two sections, a first spring section 21 and a second spring section 22, respectively, the first spring section 21 being arranged on the flexible section 7 and the second spring section 22 being arranged on the transition section 9 or a part of the transition section 9 in the embodiment shown. With continued reference to fig. 1A, 1B, 3 and 4, one end of the first spring segment 21 is adjacent to one end of the second spring segment 22, and the two adjacent ends are connected to each other using a welding means such as laser welding, fiber welding, plasma welding, etc.; the other end of the first spring segment 21 away from the second spring segment 22 is fixedly connected with the end of the core wire flexible segment 7 by welding such as laser welding, fiber welding, plasma welding, etc., and the welded part is formed into a ball head shape and is ground smoothly to form the ball head end 15, as shown in fig. 1B and 3. The end of the second spring segment 22 facing away from the first spring segment 21 is secured to the core wire by welding means such as laser welding, fiber welding, plasma welding, etc.

In the described embodiment, the ends of the first and

second spring segments

21 and 22 adjacent to each other are connected to each other, but the present invention is not limited thereto. The alternative solution comprises: the ends adjacent to one another are connected to one another and fixed there to the core wire, or the ends adjacent to one another are each fixed separately to the core wire.

The material of the first spring section 21 can be selected from platinum iridium alloy, gold, tantalum-plated stainless steel, nickel titanium alloy, tungsten, nylon (PA) or stainless steel; the material of the second spring segment 22 may be selected from platinum-iridium alloy, gold, tantalum-plated stainless steel, nickel-titanium alloy, tungsten, nylon (PA), or stainless steel. The wire diameter of the first spring section 21 can be selected to be 0.03-0.1 mm, the inner diameter can be selected to be 0.08-0.15 mm, and the length can be selected to be 20-50 mm; the wire diameter of the second spring section 22 may be selected to be 0.05-0.1 mm, the inner diameter may be selected to be 0.2-0.35 mm, and the length may be selected to be 200-500 mm. Preferably, the first spring section 21 is arranged on the flexible section of the core wire, and the second spring section 22 is arranged on a part of the transition section of the core wire or on substantially the entire transition section 9.

Through setting up flexible section 7 to establish first spring section 21 on it, make the tip portion of seal wire have good tortuous tolerance performance and bending property, improved the nature controlled of seal wire greatly. The second spring section 22 is sleeved on at least one part of the transition section 9, so that the part of the guide wire has better flexibility. Preferably, the wire diameter of the second spring section is greater than the wire diameter of the first spring section, thereby making the first spring section more flexible than the second spring section.

By adopting the technical scheme of the invention, the diameter of the guide wire from the distal end to the proximal end of the transition section is gradually increased, and the flexible section and the transition section (or a part of the transition section) are sleeved with the springs, so that the guide wire is gradually hardened from the distal end to the proximal end of the transition section, the flexibility and the shape maintaining performance of the distal end of the guide wire are ensured, and the guide wire can be ensured to accurately reach the lesion part of a patient and pass through a tortuous lesion blood vessel in the operation process.

Referring to fig. 1A and 1B, the magnetic body 3 is disposed at the distal end of the guide wire, and uniformly covers the periphery of the first spring section 21, and the diameter of the magnetic body may be 0.2-04mm. The magnetic body is composed of an elastomer material as a base material and nano-scale ultra-fine soft or hard magnetic powder added to the elastomer material in a certain ratio, for example, 20% to 95% (mass ratio). The elastomeric material may be selected from elastomeric polyurethane (TPU), thermoplastic polyolefin elastomer (TPO), thermoplastic elastomer (TPE), silicone rubber, or the like. The nanometer ultrafine magnetic powder material can be selected from Fe ₃ O ₄ 、Y-Fe ₂ O ₃ 、CrO ₂ NeFeB, and combinations of two or more of these materials. The uniform mixture of elastomer substrate and magnetic powder can be extruded or vulcanized to coat the periphery of the first spring section 21 to form a magnetic body region.

Preferably, as shown in fig. 1A and 1B, the ball head 10 may be disposed at the distal end of the core wire, the ball head 10 may be connected to the magnetic body by means of bonding or welding, the material of the ball head may be an elastomer material, and a smooth and soft ball head may be disposed to achieve good protection of the vascular wall. Preferably, a certain proportion of developer can be added into the elastomer material for manufacturing the ball head, and the developing material can be selected from tungsten powder, barium sulfate, bismuth trioxide, bismuth subcarbonate and calcium tungstate, and two or a combination of several of the materials.

During use, the guidewire is often bent and rubbed against a blood vessel wall or the like, so that there is a risk that magnetic particles fall off from the magnetic body and remain in the human body. Therefore, as a preferable mode, referring to fig. 1A and 1B, the distal end of the core wire may be covered with a protection tube 4, and the protection tube 4 is covered on the outer circumferential surface of the magnetic body 3, and preferably, the outer diameter of the protection tube 4 is substantially the same as the outer diameter of the second spring section 22, thereby forming a continuous outer surface. The protective tube is made of polymer material, and the wall thickness of the tube wall can be selected to be 0.01-0.05 mm. Because the magnetic powder may have corrosivity, through utilizing the protection tube cladding magnetic substance periphery, can ensure that the magnetic substance does not directly touch with the blood vessel, avoid the magnetic powder to drop and get into human blood vessel when guaranteeing magnetism. The high polymer material of the protection tube can be selected from Polyethylene (PE), polytetrafluoroethylene (PTFE), ethylene Propylene Diene Monomer (EPDM), perfluoroethylene propylene copolymer (FEP), polyethylene terephthalate (PET) and polyvinylidene fluoride film.

(PVDF), ethylene-vinyl acetate copolymer (EVA), or polyolefin copolymer (PO), and the like.

As an alternative solution, the magnetic body 3 may also be uniformly coated on the peripheries of the core wire flexible section 7 and the transition section 9, in which case, the protection tube 4 is also coated on the magnetic body 3 on the peripheries of the core wire flexible section 7 and the transition section 9.

In addition, instead of the protective tube, a coating layer (also referred to as a protective coating layer herein) that prevents the magnetic body from touching the blood vessel and prevents the magnetic powder particles from falling off may be used, in which a coating layer such as parylene-N (parylene-N) is coated on the outer periphery of the magnetic body after the magnetic body is set.

With continued reference to fig. 1A and 1B, a hydrophilic coating 5 may be applied to the outer surface of the protective tube 4 (or protective coating) and the ball head 10 and/or the outer surface of the second spring section 22, and by applying the hydrophilic coating to the outer periphery of the distal portion of the guide wire, the guide wire passage resistance is reduced, further enhancing the passage performance of the guide wire. The hydrophilic coating material can be selected from Polyethyleneimine (PAM), polyvinylpyrrolidone (PVP) or maleic acid, and the thickness of the coating can be 1-10 μm.

The hydrophobic coating 6 may be coated on the outer circumferential surface of the support section of the core wire 1. The hydrophobic coating is coated on the peripheral surface of the guide wire supporting section, so that the friction force of the guide wire passing through a blood vessel is reduced, and the tracking performance of the guide wire can be further enhanced. The material of the hydrophobic coating 6 can be selected from high-density polytetrafluoroethylene or Parylene and the like, and the thickness of the coating can be 0.005-0.1mm.

In the above-described embodiment, the hydrophilic coating 5 is coated on the outer surfaces of the protection tube 4 and the second spring segment 22, and the hydrophobic coating 6 is coated on the outer circumferential surface of the support segment of the core wire 1, but the present invention is not intended to limit the coating ranges of the hydrophilic coating and the hydrophobic coating, and the boundary point between the hydrophilic coating and the hydrophobic coating may be selected according to actual circumstances.

In the above embodiment, the outer peripheral surface of the core wire magnetic body 3 is covered with the protective tube 4, but the protective tube 4 may be omitted. Further, without the protection tube 4, in the case where the magnetic powder has corrosiveness, as a preferable aspect, the magnetic powder particles may be coated with a thin shell of a non-corrosive material including, for example, silica, parylene C, epoxy resin, or the like.

In the above embodiment, the springs sleeved on the flexible section 7 and the transition section 9 of the core wire comprise two independent springs: the first spring section 21 and the second spring section 22 are different from each other in size and/or wire diameter. Alternatively, the first spring section 21 and the second spring section 22 may use the same wire diameter.

In the above embodiment, the ball head 10 is connected as a separate member to the magnetic body by bonding, welding, or the like. As an alternative, the ball head 10 may also be formed directly from a magnetic body, in which case the protective tube 4 (or protective coating) also encloses the ball head 10. Further, the guidewire of the present invention comprises a micro-guidewire.

The operation of the guidewire of the present invention is described below. As shown in fig. 5, during the vascular interventional operation, the guide wire passes through the blood vessel of the human body under the control of the interventional surgeon or the interventional operation robot, when the guide wire needs to be bent and turned, the running direction of the guide wire is guided and controlled by utilizing the neodymium magnetite 18 and the like which are positioned outside the human body, and the neodymium magnetite generates magnetic force on the magnetic body of the guide wire, so that the guide wire is controlled to be turned. The guide wire can accurately pass through a blood vessel with complicated circuitous lesion at an angle of 0-360 degrees.

The present invention has been described above in connection with the specific embodiments with reference to the accompanying drawings, but this is for illustrative purposes only and the present invention is not limited thereto. Therefore, it is apparent to those skilled in the art that various changes and modifications can be made within the technical spirit and scope of the present invention, and these changes and modifications should also be construed as falling within the scope of the present invention, which is defined by the claims and their equivalents.

Claims

1. A guidewire, comprising:

the spring comprises a first spring section and a second spring section, and the inner diameter and the outer diameter of the first spring section are respectively smaller than those of the second spring section; said first spring section is sleeved on said flexible section, said second spring section is sleeved on a portion of said transition section, or said second spring section is sleeved on substantially the entire transition section; the far end of the first spring section spring is fixedly connected with the far end head of the flexible section, and the near end of the second spring section spring is fixedly connected with the core wire; the near end of the first spring section is fixedly connected with the far end of the second spring section, or the near end of the first spring section and the far end of the second spring section are respectively fixedly connected with the core wire;

the outer surface of the magnetic body and the ball head are coated with hydrophilic coatings; or the peripheral surface of the magnetic body is coated by a protective tube or a protective coating, and the outer surface of the protective tube or the protective coating and the ball head are coated with hydrophilic coatings; or the outer peripheral surfaces of the ball head and the magnetic body are coated by a protective tube or a protective coating, and the outer surface of the protective tube or the protective coating is coated with a hydrophilic coating; and

2. The guidewire of claim 1, wherein the flexible section comprises a first cylindrical section and the transition section comprises a second cylindrical section, the first cylindrical section having a diameter less than a diameter of the second cylindrical section, the first cylindrical section and the second cylindrical section being joined by a smooth transition of a tapered section.

3. The guidewire of claim 2, wherein the flexible segment further comprises a portion of the tapered segment at the distal end.

4. The guidewire of claim 1, wherein the outer circumferential surface of the magnetic body is coated with a protective tube or a protective coating, the outer surface of the protective tube or the protective coating and the ball head being coated with a hydrophilic coating; the ball head is made of an elastomer material and is connected with the magnetic body through bonding or welding.

5. The guidewire of claim 4, wherein a proportion of a contrast agent is added to the elastomeric material of the bulb.

6. The guide wire according to claim 1, wherein the outer peripheral surfaces of the ball head and the magnetic body are covered with a protective tube or a protective coating, an outer surface of which is coated with a hydrophilic coating; the bulb is made of the same material as the magnetic body and is integrally formed with the magnetic body.

7. A guide wire as in claim 2 or 3, wherein the first cylindrical section has a diameter of 0.03 to 0.10mm and a length of 20 to 50mm; the diameter of the second cylindrical section is 0.15-0.30 mm, and the length is 200-400 mm; the diameter of the support section is 0.24-0.42 mm.

8. The guidewire of claim 1, wherein the core wire is selected from the group consisting of platinum iridium, gold, tantalum plated stainless steel, nickel titanium alloy, tungsten, nylon (PA), stainless steel, and any combination thereof.

9. The guidewire of claim 1, wherein the wire diameter of the first spring segment is smaller than the wire diameter of the second spring segment.

10. The guidewire of claim 9, wherein the first spring section has a wire diameter of 0.03-0.1 mm, an inner diameter of 0.08-0.15 mm, and a length of 20-50 mm; the wire diameter of the second spring section is 0.05-0.1 mm, the inner diameter is 0.2-0.35 mm, and the length is 200-500 mm.

11. The guidewire of claim 1, wherein the spring is selected from the group consisting of platinum iridium, gold, tantalum plated stainless steel, nickel titanium alloy, tungsten, nylon (PA), and stainless steel.

12. The guidewire of claim 1, wherein the elastomeric material is selected from elastomeric polyurethane, thermoplastic polyolefin elastomer, thermoplastic elastomer, or silicone rubber; the nanoscale ultrafine soft or hard magnetic powder is selected from Fe ₃ O ₄ 、Y-Fe ₂ O ₃ 、CrO ₂ NeFeB and combinations of two or more of these materials; the addition ratio of the nanometer-grade superfine soft or hard magnetic powder is 20-95% by mass ratio.

13. The guide wire according to any one of claims 4 to 6, wherein the wall thickness of the protective tube or the layer thickness of the protective coating is 0.01 to 0.05mm.

14. The guide wire of claim 1, wherein the hydrophilic coating (7) is one of Polyethyleneimine (PAM) or polyvinylpyrrolidone (PVP) or maleic acid, and the coating thickness is 1-10 μm.

15. The guide wire of claim 1, wherein the hydrophobic coating (8) is polytetrafluoroethylene or Parylene, and the coating thickness is 0.005-0.1mm.

16. The guidewire of claim 1, wherein the guidewire is a micro-guidewire.

17. The guide wire of claim 1, wherein the protective tube is made of a polymer material selected from Polyethylene (PE), polytetrafluoroethylene (PTFE), ethylene Propylene Diene Monomer (EPDM), perfluoroethylene propylene copolymer (FEP), polyethylene terephthalate (PET), and polyvinylidene fluoride (PVDF) film.

18. The guidewire of claim 1, wherein the protective coating comprises a parylene N powder coating.