CN116196530A

CN116196530A - Interventional guide wire

Info

Publication number: CN116196530A
Application number: CN202211607731.3A
Authority: CN
Inventors: 刘建民; 杨鹏飞; 李强; 赵瑞; 王杨
Original assignee: First Affiliated Hospital of Naval Military Medical University of PLA
Current assignee: First Affiliated Hospital of Naval Military Medical University of PLA
Priority date: 2022-12-14
Filing date: 2022-12-14
Publication date: 2023-06-02

Abstract

The invention discloses an interventional guide wire, comprising: the core wire comprises a flexible section, a transition section and a supporting section; two ends of the transition section are in smooth transition connection with the flexible section and the support section; the diameter of the core wire increases progressively from the distal end of the flexible section to the proximal end of the transition section; a wrap spring wound on the flexible segment; the distal end of the winding spring is fixedly connected with the distal end head of the flexible section, and the proximal end of the winding spring is fixedly connected with the core wire; the periphery of the winding spring is coated with a magnetic body, and the magnetic body is composed of an elastomer material serving as a base material and nano-scale superfine soft or hard magnetic powder added into the elastomer material; the ball head is arranged at the distal end of the flexible section and is connected with the distal end of the magnetic body; the outer peripheral surface of the magnetic body is covered by a protective tube or a protective coating, the outer surface of the protective tube or the protective coating and the ball head are coated with a hydrophilic coating, and the outer peripheral surface of the supporting section is coated with a hydrophobic coating.

Description

Interventional guide wire

Technical Field

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

Background

The interventional guide wire is used as a diagnosis and treatment tool for the vascular minimally invasive interventional operation, and plays a role in the whole minimally invasive interventional diagnosis and treatment process. Especially when facing the small blood vessel, tiny intracranial artery or malformed hemangioma of meandering and detouring, the accurate selection intervenes the seal wire and is the key of the success of the minimally invasive intervention diagnosis and treatment, accurate control, accurate location, good trafficability and traceability are the precondition of the minimally invasive intervention diagnosis and treatment operation of the intervention seal wire technology.

In the clinic, the current failure rate of pushing the existing interventional guide wire to the position is above 60 percent against the blood vessels such as tortuous tiny long blood vessel deformity and the like, particularly when the cerebral aneurysm blood vessel minimally invasive interventional embolism treatment is carried out, the hard interventional guide wire is selected to easily pass through the malformed blood vessel, but the blood vessels can be poked and broken by a little careless, particularly the intracranial aneurysm, once the rupture mortality rate is extremely high, the general primary bleeding mortality rate reaches 30 percent, and the secondary bleeding mortality rate reaches 80 percent. Therefore, the doctor cannot select the mode, the nickel-titanium elasticity is selected alternatively, the head end can be shaped to be inserted into the guide wire to solve the problem, but the dislocation, the clamping, the inaccurate positioning and the poor control of the pushing occur continuously.

Disclosure of Invention

In order to solve the defects, the invention aims to provide the medical intervention guide wire, the distal end of which is a magnetic body, and the medical intervention guide wire magnetic body can be guided to precisely pass through a blood vessel with complicated pathological changes at an angle of 0-360 degrees by adopting neodymium magnetite and the like, so that the operation is convenient, the positioning is precise and the control is good. The periphery of the magnetic body is sleeved with a protective tube or a protective coating, so that the magnetic powder particles are effectively prevented from falling off.

To achieve the above object, the present invention provides an interventional guide wire 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 extending distally of the transition section Xiang Xin wire; two ends of the transition section are respectively connected with the flexible section and the support section in a smooth transition manner; the diameter of the core wire increases progressively from the distal end of the flexible section to the proximal end of the transition section;

a wrap spring wound on the flexible segment; the distal end of the winding spring is fixedly connected with the distal end head of the flexible section, and the proximal end of the winding spring is fixedly connected with the core wire;

the periphery of the winding spring is coated with a magnetic body, and the magnetic body is composed of an elastomer material serving as a base material and nano-scale superfine soft or hard magnetic powder added into the elastomer material;

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

the outer peripheral surface of the magnetic body is covered 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 a hydrophilic coating; or the outer peripheral surfaces of the ball head and the magnetic body are covered by a protective tube or a protective coating, and the outer surfaces of the protective tube or the protective coating are 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 interventional guide wire, the flexible section positioned at the far end and the transition section adjacent to the flexible section are arranged, so that the interventional guide wire becomes soft gradually from the near end to the far end, and the flexibility of the far end is ensured; the shape retention performance, pushing performance, tracking performance, bending resistance, control positioning performance, torque transmission performance and follow-up performance of the interventional guide wire are effectively improved by arranging the winding spring on the flexible section, the flexibility is better, and the interventional guide wire can better adapt to the path change of blood vessels; the magnetic body arranged at the far end is attracted by utilizing the external magnet stone and the like to carry out advancing, retreating and angle adjustment steering of the interventional guide wire, so that the interventional guide wire can accurately reach the lesion part of the patient through the tortuous lesion blood vessel in the operation process.

In addition, by sleeving the protective tube or the protective coating on the periphery of the magnetic body, the falling off of the magnetic powder particles is effectively prevented, and thus the risk that the magnetic powder particles possibly having corrosiveness are detained in the human body is avoided.

Drawings

FIG. 1A is a cross-sectional view illustrating the general structure of an interventional 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 interventional guidewire of FIG. 1A;

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

FIG. 3 is a cross-sectional view of the core wire of the interventional guide wire of the present invention illustrating a wrap spring wrapped around a flexible segment; and

fig. 4 is a schematic view illustrating the practical application of the interventional guidewire of the present invention in interventional procedures.

Detailed Description

The interventional guide wire according to the present invention will be described in detail with reference to the accompanying drawings. It should be noted herein that the embodiments of the present invention are merely illustrative, which are merely illustrative of the principles of the present invention and not in limitation thereof.

Referring first to fig. 1A and 1B, wherein fig. 1A is a cross-sectional view illustrating the general structure of an interventional guidewire according to a first embodiment of the present invention; fig. 1B is an enlarged partial cross-sectional view of a distal portion of the interventional guidewire of fig. 1A. As shown in fig. 1A, the interventional guide wire of the first embodiment of the present invention is divided into a distal end and a proximal end in the length direction, the distal end referring to the end of the interventional guide wire on the patient side, and the proximal end referring to the end of the interventional guide wire on the patient side. As shown in fig. 1A and 1B, the interventional guide wire of the present invention comprises a core wire 1, a ball head 10 at the distal tip of the core wire, a wrap spring 2, a magnetic body 3, a protective tube 4, a hydrophilic coating 5, a hydrophobic coating 6 and a coating 22.

As shown in fig. 2, the core wire 1 comprises a flexible section 7 at the distal end of the core wire, a transition section 9 arranged adjacent to the flexible section 7, and a support section 8 extending towards the proximal end of the core wire in succession to the transition section 9. Wherein the flexible section 7 and the transition section 9 of the core wire are substantially in the shape of a continuous cylinder, the support section 8 is also in the shape of a cylinder, the diameter of the flexible section 7 is smaller than the diameter of the transition section 9, and the diameter of the transition section 9 is smaller than the diameter of the support section 8. The flexible section 7 is in smooth transition with the transition section 9 via a conical section 12, while the transition section 9 is in smooth transition with the support section 8 via a conical section 13. 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 can be selected to be 200-400 mm; the diameter of the supporting 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 herein that the above listed size ranges are only preferred size ranges, and are intended to illustrate and not limit the specific sizes of the segments of the core wire of the present invention.

Regarding the structural division of the core wire 1, it 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, etc.

The structure of the core wire 1 may take other forms as well. 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 manner, for example, the structures from the distal end of the core wire are respectively the conical section, the cylindrical section and the conical section … …, or the structures from the distal end of the core wire are respectively the cylindrical section, the conical section and the cylindrical section … …, so long as the overall structure increases gradually from the distal end of the flexible section to the proximal end of the transition section, and the sections comprise the supporting section and are connected in a smooth transition manner. Furthermore, the flexible section of the core wire may be cylindrical, while the transition section is conical; alternatively, the flexible and transition sections of the core wire may be continuously conical.

Thus, in this specification, the "increasing diameter from the distal tip of the flexible segment to the proximal tip of the transition segment" includes both the case shown in FIG. 2 and the various cases described hereinabove.

The core wire can be made of any one or any combination of platinum iridium alloy, gold, tantalum-plated stainless steel, nickel titanium alloy, tungsten, nylon (PA), stainless steel and the like, and is ground from a proximal end to a tapered shape to a distal end by adopting a coreless grinding machine to form a core rod shape, so that a support section 8, a transition section 9 and a flexible section 7 which are mutually connected are formed, the distal end of the interventional guide wire is more flexible, and the head end of the interventional guide wire is ensured to be elastic and smoothly intervened in a human blood vessel.

As shown in fig. 1A, 1B and 3, the wrap spring 2 is wound on the flexible section 7 of the core wire 1, and the proximal end of the wrap spring 2 is fixed on the core wire by welding means such as laser welding, fiber welding, plasma welding and the like; the distal end of the wrap spring 2 is fixedly connected with the end of the core wire flexible section 7 by adopting a welding mode such as laser welding, fiber welding, plasma welding and the like, and the welding part forms a ball head shape and is polished smoothly to form a ball head end 15.

The material of the winding spring 2 can 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 winding spring 2 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. A coating 22, such as a tungsten powder containing TPU (elastomeric polyurethane) or PU (polyurethane) material, may be applied over a portion of the transition section of the core wire or over substantially the entire transition section 9.

By arranging the flexible section 7 and winding the wrap spring 2 thereon, the head end part of the interventional guide wire has good bending tolerance performance and bending performance, and the operability of the interventional guide wire is greatly improved.

By adopting the technical scheme of the invention, the diameter of the interventional guide wire from the distal end head to the proximal end of the transition section gradually becomes larger, and the winding spring is wound on the flexible section, so that the interventional guide wire gradually becomes hard from the distal end head to the proximal end of the transition section, the flexibility and the shape retention performance of the distal end of the interventional guide wire are ensured, and the interventional guide wire can accurately reach the lesion part of a patient in the operation process and pass through a tortuous lesion blood vessel.

Referring to fig. 1A and 1B, the magnetic body 3 is disposed at the distal end of the interventional guide wire, uniformly coated on the periphery of the wrap spring 2, and has a diameter of 0.2-0.4 mm. The magnetic body is made of elastomer material as base material and nano superfine powder added into the elastomer material according to a certain proportionThe soft or hard magnetic powder may be added in a proportion of, 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 nano-scale superfine magnetic powder material can be selected from Fe ₃ O ₄ 、Y-Fe ₂ O ₃ 、CrO ₂ NeFeB, and two or a combination of materials among these. The uniform mixture of the elastomer base material and the magnetic powder may be coated on the outer circumference of the wrap spring 21 by extrusion or vulcanization molding to form a magnetic region.

As a preferred solution, as shown in fig. 1A and 1B, a ball head 10 may be disposed at the distal end of the core filament, the ball head 10 may be connected with a magnetic body by means of bonding or welding, an elastomer material may be selected as a material, and good protection of the vessel wall may be achieved by disposing a round and soft ball head. Preferably, a certain proportion of developing agent can be added into the elastomer material used 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 a plurality of materials.

During use of the interventional guide wire, there is a risk that the magnetic powder particles fall off from the magnetic body and remain in the human body due to bending and friction with the vessel wall or the like. Thus, as a preferred option, referring to fig. 1A and 1B, the distal end of the core wire may be covered with a protective tube 4, the protective tube 4 covering the outer peripheral surface of the magnetic body 3, preferably the outer diameter of the protective tube 4 being substantially the same as the outer diameter of the transition piece coating 22, thereby forming a continuous outer surface. The material of the protective tube is polymer material, and the wall thickness of the tube wall can be selected to be 0.01-0.05 mm. Because the magnetic powder has corrosiveness, the periphery of the magnetic body is coated by the protective tube, so that the magnetic body is prevented from directly touching the blood vessel, and the magnetic powder is prevented from falling off and entering the blood vessel of a human body while the magnetism is ensured. The polymer material of the protective tube can be selected from Polyethylene (PE), polytetrafluoroethylene (PTFE), ethylene Propylene Diene Monomer (EPDM), perfluoroethylene propylene copolymer (FEP), polyethylene terephthalate (PET), 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 periphery of both the core wire flexible section 7 and the transition section 9, in which case the protective tube 4 is also coated on the magnetic body 3 on the periphery of both the wire flexible section 7 and the transition section 9, and the transition section 9 does not need to be additionally coated with other coating layers.

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

With continued reference to fig. 1A and 1B, a hydrophilic coating 5 may be applied to the outer surfaces of the protective tube 4 (or protective coating) and the bulb 10 and/or the outer surface of the transition section coating to reduce the resistance to passage of the interventional guidewire and further enhance the performance of passage of the interventional guidewire by applying a hydrophilic coating to the outer circumference of the distal portion of the interventional guidewire. The hydrophilic coating material can be selected from Polyethylenimine (PAM), polyvinylpyrrolidone (PVP) or maleic acid, and the thickness of the coating can be 1-10 mu m.

The hydrophobic coating 6 may be coated on the outer circumferential surface of the support section of the core wire 1. By coating the outer peripheral surface of the interventional guide wire supporting section with a hydrophobic coating, the friction force of the interventional guide wire passing through a blood vessel is reduced, and the tracking performance of the micro-interventional guide wire can be further enhanced. The material of the hydrophobic coating 6 can be polytetrafluoroethylene or Parylene, etc., 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 surface of the protection tube 4 and the hydrophobic coating 6 is coated on the outer circumferential surface of the support section of the core wire 1, but the present invention is not intended to limit the coating range 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 practical situations.

In the above embodiment, the outer peripheral surface of the core wire magnetic body 3 is covered with the protective tube 4 or the protective coating, but the protective tube 4 or the protective coating may be omitted. Without the protective tube 4 or the protective coating, as the nano-sized ultra-fine magnetic powder is generally corrosive, as a preferred solution, the magnetic powder particles may be coated with a thin shell of non-corrosive materials, including for example silica, parylene C, epoxy, etc.

In the above embodiment, the ball head 10 is connected to the magnetic body as a separate member by bonding or welding or the like. Alternatively, the ball head 10 may be formed directly of a magnetic material, in which case the protective tube 4 (or protective coating) also covers the ball head 10. Furthermore, the interventional guide wire of the present invention includes an interventional microcatheter.

The operation of the interventional guide wire of the present invention is described below. As shown in fig. 4, during a vascular intervention operation, an intervention guide wire passes through a human body blood vessel under the control of an intervention surgeon or an intervention operation robot, and when the intervention guide wire needs to be bent and turned, the running direction of the intervention guide wire is guided and controlled by using a neodymium magnet stone 18 and the like which are positioned outside the human body, and the neodymium magnet stone generates magnetic acting force on a magnetic body of the intervention guide wire, so that the intervention guide wire is controlled to realize turning. The intervention guide wire can precisely pass through a blood vessel with complicated tortuous lesions at an angle of 0-360 degrees.

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

Claims

1. An interventional guidewire, comprising:

2. The interventional guide wire of claim 1, wherein the flexible segment comprises a first cylindrical segment, the transition segment comprises a second cylindrical segment, the first cylindrical segment has a smaller diameter than the second cylindrical segment, and the first cylindrical segment and the second cylindrical segment are joined by a smooth transition of a tapered segment.

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

4. The interventional guide wire according to claim 1, wherein the outer circumferential surface of the magnetic body is covered with a protective tube or a protective coating, the outer surface of which and the bulb are 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 interventional guide wire of claim 4, wherein a proportion of a developer is added to the elastomeric material of the bulb.

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

7. An interventional guide wire according to claim 2 or 3, wherein the first cylindrical section has a diameter of 0.03-0.10 mm and a length of 20-50 mm; the diameter of the second cylindrical section is 0.15-0.30 mm, and the length is 200-400 mm; the diameter of the supporting 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 alloy, gold, tantalum-plated stainless steel, nickel titanium alloy, tungsten, nylon (PA), stainless steel, and any combination thereof.

9. The interventional guide wire according to claim 1, wherein the wire diameter of the wrap spring is 0.03-0.1 mm, the inner diameter is 0.08-0.15 mm, and the length is 20-50 mm.

10. The interventional guide wire according to claim 1, wherein the material of the wrap spring is selected from platinum iridium alloy, gold, tantalum plated stainless steel, nickel titanium alloy, tungsten, nylon (PA) or stainless steel.

11. The interventional guide wire according to claim 1, wherein the elastomeric material is selected from the group consisting of elastomeric polyurethane, thermoplastic polyolefin elastomer, thermoplastic elastomer or silicone rubber; the nanometer level superfine soft or hard magnetic powder is selected from Fe ₃ O ₄ 、Y-Fe ₂ O ₃ 、CrO ₂ Two of these materials or a combination of several materials; the addition proportion of the nanoscale ultrafine soft or hard magnetic powder is 20-95% by mass.

12. The interventional guide wire according to any one of claims 1-6, wherein the wall thickness of the protective tube or the layer thickness of the protective coating is 0.01-0.05 mm.

13. The interventional guide wire according to claim 1, wherein the hydrophilic coating (7) is one of Polyethylenimine (PAM) or polyvinylpyrrolidone (PVP) or maleic acid, the coating thickness being 1-10 μm.

14. The interventional guide wire according to claim 1, wherein the hydrophobic coating (8) is polytetrafluoroethylene or Parylene with a coating thickness of 0.005-0.1mm.

15. The interventional guidewire of claim 1, wherein the interventional guidewire is an interventional microcatheter.

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

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

18. The interventional guidewire of claim 1, wherein a coating is applied over a portion of the transition section of the core wire or over the entire transition section.

19. The interventional guidewire of claim 18, wherein the coating applied over a portion of the transition section of the core wire or over the entire transition section is a PU coating or a tungsten powder containing TPU coating.