Interventional operation magnetic control guide wire capable of repeating magnetic orientation and preparation method of interventional operation magnetic control guide wire

Abstract

The invention provides an interventional operation magnetic control guide wire capable of repeating magnetic orientation. The interventional operation magnetic control guide wire comprises a core wire and a coating layer, the core wire is coated with the coating layer; the coating layer comprises magnetic composite particles and a first high-molecular polymer; the magnetic composite particles comprise magnetic powder and a low-temperature phase change material compounded on the surface of the magnetic powder. Compared with the prior art, the magnetic control guide wire provided by the invention can perform magnetic orientation after the guide wire is prepared, and magnetic field orientation does not need to be performed in the guide wire forming process, so that the guide wire preparation difficulty is simplified from the process; and meanwhile, magnetic orientation treatment can be carried out again according to requirements. The magnetic control guide wire is simple in production process, capable of achieving repeated magnetic orientation, excellent in magnetic response performance and operation flexibility and suitable for various minimally invasive surgeries and interventional therapy.

Description

Technical Field

[0001] The present invention belongs to the technical field of interventional medical devices, and in particular relates to an interventional surgery magnetically controlled guide wire with repeatable magnetic orientation and a preparation method thereof. Background Art

[0002] Minimally invasive surgery and interventional therapy are important branches in the field of modern medicine. They enter the human body through smaller incisions or vascular routes, reducing the trauma and recovery time caused by traditional open surgery. In such surgeries, it is crucial to accurately navigate and position medical devices to the lesion site. Magnetic control guidewires have become an effective solution to achieve this goal due to their unique magnetic properties and operability.

[0003] With the development of medical technology, the performance requirements for magnetic wires are getting higher and higher. Surgeons need magnetic wires to have sufficient magnetic response capabilities while ensuring flexibility and safety of operation. This requires that the design of magnetic wires can adjust their mechanical properties and magnetic characteristics according to surgical needs to adapt to different surgical environments and treatment goals.

[0004] In practical applications, magnetic wires need to pass through blood vessels or other channels in the body to reach the target location, which requires the magnetic wires to have good synergy between mechanical properties (flexibility, rigidity) and magnetic properties to adapt to complex anatomical structures. At the same time, the head of the magnetic wire needs to have sufficient magnetic response capabilities to achieve precise positioning under the guidance of an external magnetic field.

[0005] However, the magnetic materials currently used in magnetic conductive wires are mostly neodymium iron boron permanent magnet materials, and it is technically difficult to obtain anisotropic neodymium iron boron magnetic powder with small size, round morphology and strong magnetic properties. Therefore, it is difficult to use it for the preparation of high flexibility and high uniformity magnetically controlled flexible micro-conductive wires.

[0006] At the same time, the existing magnetically controlled guidewires can only magnetize the guidewire head along the length of the guidewire, so that during actual use, the guidewire can only perform passive bending with uncontrolled shape, and cannot achieve highly customized matching for the conditions of different patients.

[0007] In summary, the magnetic guide wires in the existing technology still have many shortcomings in meeting the needs of minimally invasive surgery and interventional treatment. There is an urgent need for a new type of magnetic guide wire that can not only provide excellent magnetic response performance, but also ensure operational flexibility and safety, while being able to be customized according to patient characteristics and having long-term stability and biocompatibility. Summary of the invention

[0008] In view of this, the technical problem to be solved by the present invention is to provide an interventional surgery magnetically controlled guide wire with repeatable magnetic orientation and a preparation method thereof.

[0009] The present invention provides a magnetically controlled guide wire for interventional surgery with repeatable magnetic orientation, comprising: a core wire and a cladding layer;

[0010] The coating layer is coated on the outside of the core wire;

[0011] The coating layer includes magnetic composite particles and a first high molecular polymer;

[0012] The magnetic composite particles include magnetic powder and a low-temperature phase change material composited on the surface of the magnetic powder.

[0013] Preferably, the coating layer includes a magnetic coating layer segment and a non-magnetic coating layer segment along the length direction of the interventional surgery magnetically controlled guide wire, and the magnetic coating layer is located at the distal end of the interventional surgery magnetically controlled guide wire.

[0014] Preferably, the material of the core wire is selected from metal and / or a second high molecular polymer;

[0015] The first high molecular polymer is selected from one or more of polydimethylsiloxane, thermoplastic polyurethane elastomer rubber, silica gel, polyolefin elastomer, ethylene propylene diene monomer rubber and ethylene-vinyl acetate copolymer;

[0016] The magnetic powder is samarium iron nitrogen magnetic powder;

[0017] The low-temperature phase change material is polyethylene glycol or paraffin.

[0018] Preferably, the diameter of the core wire is 0.01 to 0.3 mm;

[0019] The particle size of the magnetic powder is 0.1 to 100 μm;

[0020] The diameter of the interventional surgery magnetically controlled guide wire is 0.25 to 1 mm;

[0021] The length of the interventional surgery magnetically controlled guide wire is 500 to 3000 mm.

[0022] Preferably, the mass ratio of the magnetic powder to the low-temperature phase change material is 1:5 to 5:1;

[0023] The particle size of the magnetic composite particles is 0.15 to 120 μm.

[0024] Preferably, a protective coating is provided outside the coating layer; the protective coating is a biocompatible material.

[0025] Preferably, a hydrophilic coating is also provided outside the coating layer.

[0026] The present invention also provides a method for preparing a magnetically controlled guide wire for interventional surgery with repeatable magnetic orientation, comprising the following steps:

[0027] S1) mixing magnetic composite particles with a first high molecular polymer to obtain a magnetic composite slurry; the magnetic composite particles include magnetic powder and a low temperature phase change material composited on the surface of the magnetic powder;

[0028] S2) injecting the magnetic composite slurry into a molding mold, placing a core wire in the molding mold, and allowing it to solidify, thereby obtaining an interventional surgery magnetically controlled guide wire with repeatable magnetic orientation.

[0029] Preferably, the magnetic composite particles are prepared according to the following method:

[0030] Mixing magnetic powder and low-temperature phase change material, and heating to the melting temperature of the low-temperature phase change material to obtain a mixed slurry;

[0031] The mixed slurry is cooled, solidified, crushed and ground to obtain magnetic composite particles.

[0032] Preferably, the step S2) further comprises: before solidification, orienting the magnetic composite particles in the magnetic composite slurry in a magnetic field.

[0033] The present invention provides a magnetically controlled guidewire for interventional surgery with repeatable magnetic orientation, comprising: a core wire and a coating layer; the coating layer is coated on the outside of the core wire; the coating layer comprises magnetic composite particles and a first high molecular polymer; the magnetic composite particles comprise magnetic powder and a low-temperature phase change material composited on the surface of the magnetic powder. Compared with the prior art, the magnetically controlled guidewire provided by the present invention can be magnetically oriented after the guidewire is prepared, and does not require magnetic field orientation during the guidewire forming process, thereby simplifying the difficulty of guidewire preparation from a process perspective; at the same time, the magnetic orientation treatment can be re-performed as needed. The magnetically controlled guidewire of the present invention has a simple production process, repeatable magnetic orientation, excellent magnetic response performance and operational flexibility, and is suitable for various minimally invasive surgeries and interventional treatments. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] Figure 1 This is a schematic diagram of the structure of a magnetically controlled guidewire for interventional surgery prepared in Example 1 of the present invention;

[0035] Figure 2 This is a schematic diagram of the structure of a magnetically controlled guidewire for interventional surgery prepared in Example 2 of the present invention;

[0036] Figure 3 This is an example of the steering of the magnetically controlled guide wire for interventional surgery in a magnetic field prepared in Example 2 of the present invention;

[0037] Figure 4 A schematic diagram of a magnetic control guide wire comprising magnetic composite particles coated with a low-temperature phase change medium to achieve repeatable magnetic orientation through a high-temperature heat treatment process;

[0038] Figure 5The deformation shape editing of the magnetically controlled guide wire in the magnetic field and the schematic diagram of the principle;

[0039] Figure 6 This is a schematic diagram of the deformation shape editing and principle of the magnetically controlled guide wire in the magnetic field. DETAILED DESCRIPTION

[0040] The following will be combined with 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 making creative work are within the scope of protection of the present invention.

[0041] The present invention provides an interventional surgery magnetically controlled guide wire with repeatable magnetic orientation, comprising: a core wire and a coating layer; the coating layer is coated on the outside of the core wire; the coating layer comprises magnetic composite particles and a first high molecular polymer; the magnetic composite particles comprise magnetic powder and a low-temperature phase change material composited on the surface of the magnetic powder.

[0042] The interventional surgery magnetically controlled guidewire provided by the present invention comprises a core wire, which provides mechanical support function for the guidewire and maintains the flexibility of the guidewire; preferably, the core wire is concentrically arranged with the interventional surgery magnetically controlled guidewire, that is, the central axis of the core wire is also the central axis of the interventional surgery magnetically controlled guidewire; the material of the core wire is preferably metal and / or a second high molecular polymer; the hardness of the second high molecular polymer is greater than that of the first high molecular polymer; specifically, the material of the core wire can be stainless steel, nickel-titanium alloy, platinum-nickel alloy, platinum-rhenium alloy or polytetrafluoroethylene material; the diameter of the core wire is preferably Select 0.01-0.3mm; In the present invention, the diameter of the core wire can be constant or variable. When the diameter of the core wire changes, the change can be decreasing, increasing, linear, nonlinear, a mixture of increasing and decreasing, or a mixture of linear and nonlinear; In a specific embodiment provided by the present invention, the distal end of the core wire (the free end entering the body is the distal end, and the end outside the body is the proximal end) is conical, and more specifically, the diameter of the core wire gradually changes from 0.1mm at the proximal end to 0.05mm at the distal end. The present invention uses a core wire with a variable diameter, which can better balance the mechanical properties and magnetic properties of the guide wire, and give the magnetically controlled guide wire a more delicate and precise control and guidance capability.

[0043] According to the present invention, the core wire is coated with a coating layer; the coating layer includes magnetic composite particles and a first high molecular polymer; the magnetic composite particles include magnetic powder and a low-temperature phase change material composited on the surface of the magnetic powder; the magnetic powder is preferably samarium iron nitrogen magnetic powder; samarium iron nitrogen magnetic particles have the advantages of fine and uniform particles, smooth surface, high residual magnetization, high coercive force and high Curie temperature, and can provide higher magnetic response ability and more flexible magnetic control ability; and, compared with neodymium iron boron magnetic powder with larger particle size and irregular surface morphology, the magnetic composite particles prepared by the present invention have a smoother surface and better uniformity, and the magnetic powder particles are not easy to fall off, and will not cause damage to the human body. The particle size of the magnetic powder is preferably 0.1-100 μm; the mass percentage of the magnetic powder in the coating layer is preferably 1%-99%, which can be selected as needed; the low-temperature phase change material can be a low-temperature phase change material well known to those skilled in the art, and there is no special limitation. In the present invention, polyethylene glycol or paraffin is preferred; the mass ratio of the magnetic powder to the low-temperature phase change material is preferably 1:5-5:1; the particle size of the magnetic composite particles is preferably 0.15-120 μm; in a specific embodiment provided by the present invention, the coating layer includes a magnetic coating layer segment and a non-magnetic coating layer segment along the length direction of the interventional surgery magnetic control guide wire, and the magnetic coating layer is located at the distal end of the interventional surgery magnetic control guide wire; the magnetic coating layer segment includes magnetic composite particles and a second high molecular polymer; the second high molecular polymer is preferably one or more of polydimethylsiloxane, thermoplastic polyurethane elastomer rubber, silicone, polyolefin elastomer, ethylene propylene diene monomer rubber and ethylene-vinyl acetate copolymer.

[0044] In a specific embodiment provided by the present invention, a protective coating is further provided outside the coating layer; the protective coating is a biocompatible material; and the biocompatibility of the magnetically controlled guidewire for interventional surgery can be improved by providing the biocompatible material.

[0045] In a specific embodiment provided by the present invention, a protective coating and a hydrophilic coating are sequentially disposed outside the coating layer; the protective coating and the hydrophilic coating are the same as described above and will not be described again here.

[0046] In a specific embodiment provided by the present invention, the diameter of the interventional surgery magnetically controlled guide wire is preferably 0.25-1 mm; the length of the interventional surgery magnetically controlled guide wire is preferably 500-3000 mm.

[0047] The magnetically controlled guide wire for interventional surgery provided by the present invention is mainly composed of a core wire and a coating layer based on a magnetic composite material. Among them, the core wire provides a mechanical support function for the guide wire to maintain the flexibility of the guide wire, and the coating layer is composed of magnetic powder and a thermally stable polymer material wrapped by a temperature-controlled solid-liquid phase change polymer material. The temperature-controlled solid-liquid phase change polymer material is wrapped on the surface of the magnetic powder, solid at room temperature, liquid when it is higher than the phase change temperature, and solid when it is lower than the phase change temperature. The magnetic composite particles are mixed with the thermally stable polymer material and coated on the surface of the core wire. After the thermally stable polymer material is solidified and formed on the surface of the core wire, the phase change polymer material can undergo a solid-liquid phase change under thermally assisted conditions, so that the magnetic powder can be magnetically oriented and multiple magnetically oriented under a magnetic field, and complex magnetic orientation can be performed according to the patient's condition. After the magnetic orientation is completed, the temperature drops to room temperature, the phase change material is solidified, and the magnetic orientation is completed. At room temperature, the magnetic composite coating layer generates a magnetic torque under the action of an external magnetic field, causing the guide wire head to bend.

[0048] In addition, the magnetically controlled guidewire provided by the present invention can be magnetically oriented after the guidewire is prepared, thereby simplifying the difficulty of guidewire preparation from a process perspective; at the same time, the magnetic orientation process can be re-performed as required. The magnetically controlled guidewire of the present invention has a simple production process, can be magnetically oriented repeatedly, has excellent magnetic response performance and operational flexibility, and is suitable for various minimally invasive surgeries and interventional treatments.

[0049] The present invention also provides a method for preparing the above-mentioned interventional surgery magnetically controlled guidewire with repeatable magnetic orientation, comprising the following steps: S1) mixing magnetic composite particles with a first high molecular polymer to obtain a magnetic composite slurry; the magnetic composite particles include magnetic powder and a low-temperature phase change material composited on the surface of the magnetic powder; S2) injecting the magnetic composite slurry into a molding mold, and at the same time placing a core wire in the molding mold, allowing it to stand and solidify, to obtain an interventional surgery magnetically controlled guidewire with repeatable magnetic orientation.

[0050] The present invention has no special restrictions on the sources of all raw materials, and any raw materials available on the market can be used; the magnetic composite particles, the first high molecular polymer and the core wire are the same as described above, and will not be described in detail here.

[0051] According to the present invention, the magnetic composite particles are preferably prepared according to the following steps: mixing magnetic powder with a low-temperature phase change material, heating to the melting temperature of the low-temperature phase change material to obtain a mixed slurry; cooling, solidifying, crushing, and grinding the mixed slurry to obtain magnetic composite particles. Among them, the magnetic powder is preferably samarium iron nitrogen magnetic powder; the particle size of the magnetic powder is preferably 0.1 to 100 μm; the mass ratio of the magnetic powder to the low-temperature phase change material is preferably 1:5 to 5:1; the particle size of the magnetic composite particles is preferably 0.15 to 120 μm. The present invention can pre-treat the magnetic powder and coat the surface of the magnetic powder with a low-temperature phase change dielectric material, so that after the magnetic control wire is solidified and formed, it still has the ability to re-orient the magnetic field, and the magnetic field re-orientation will not destroy the shape and structure of the magnetic control wire, and will not change the chemical and physical properties of the magnetic control wire.

[0052] The magnetic composite particles are mixed with the first high molecular polymer, stirred evenly and preferably subjected to vacuum defoaming to obtain a magnetic composite slurry; the mass of the magnetic composite particles is 1% to 99% of the mass of the magnetic composite slurry; and more specifically, depending on the location of the interventional magnetically controlled guide wire prepared by the magnetic composite slurry, the content of the magnetic composite particles in the magnetic composite slurry may be the same or different.

[0053] The magnetic composite slurry is injected into a molding mold, and the core wire is placed in the molding mold in a concentric manner, and allowed to stand and solidify to obtain an interventional surgery magnetically controlled guide wire with repeatable magnetic orientation; the standing and solidifying time is determined according to the properties of the selected polymer according to actual utility; more specifically, the magnetic composite particles in the magnetic composite slurry are oriented in a magnetic field before solidification.

[0054] More specifically, after being allowed to stand and solidify, the coating layer formed by the magnetic composite slurry is subjected to a magnetization treatment to obtain a magnetically controlled guide wire for interventional surgery with repeatable magnetic orientation.

[0055] In another specific embodiment provided by the present invention, during the magnetization treatment, the bending shape of the interventional surgery magnetic control guide wire in the magnetic field can be pre-designed according to the patient's condition, and the distal end of the interventional surgery magnetic control guide wire is pre-bent into the designed specific shape, and then the magnetization treatment is performed. In the applied magnetic field, the distal end of the interventional surgery magnetic control guide wire can be deformed into the pre-designed specific shape.

[0056] In another specific embodiment provided by the present invention, after the magnetic composite slurry is solidified, the interventional surgery magnetic control guide wire is subjected to high-temperature magnetic field heat treatment, the interventional surgery magnetic control guide wire is heated to above the melting temperature of the low-temperature phase change medium and below the denaturation temperature of the first high molecular polymer, and a customized magnetic field is applied to the interventional surgery magnetic control guide wire to perform customized magnetic orientation and magnetization on the magnetic powder.

[0057] In another specific embodiment provided by the present invention, when the interventional surgery magnetically controlled guide wire is subjected to magnetic field heat treatment to achieve magnetic orientation and magnetization, the bending shape of the interventional surgery magnetically controlled guide wire in the magnetic field can be pre-designed according to the patient's condition, and the interventional surgery magnetically controlled guide wire can be pre-bent into the designed specific shape, and then subjected to magnetic field heat treatment.

[0058] The interventional surgery magnetically controlled guide wire provided by the present invention can predefine the deformation shape of the distal end of the magnetically controlled guide wire in the magnetic field according to the patient's characteristics, and can better adapt to the patient's characteristics.

[0059] In order to further illustrate the present invention, a magnetically controlled guide wire for interventional surgery with repeatable magnetic orientation and a preparation method thereof provided by the present invention are described in detail below in conjunction with embodiments.

[0060] The reagents used in the following examples are all commercially available; the particle size of the samarium iron nitrogen magnetic powder used in the examples is 1 μm.

[0061] Example 1

[0062] See also Figure 1 , Figure 1 This is a schematic diagram of the structure of the magnetically controlled guide wire for interventional surgery prepared in Example 1.

[0063] 1.1 SmFeN magnetic powder and paraffin are mixed in a ratio of 1:1 (mass ratio), heated and mixed evenly, cooled to room temperature for solidification, crushed and ground to obtain magnetic composite particles.

[0064] 1.2 Mix the magnetic composite particles and silica gel in a mass ratio of 4:3 to obtain a magnetic composite slurry.

[0065] 1.3 The magnetic composite slurry is injected into the molding mold, and the core wire is placed in the molding mold in a concentric manner, and oriented in the magnetic field, left to solidify for 8 hours, and then magnetized to obtain an interventional surgery magnetically controlled guide wire with repeatable magnetic orientation.

[0066] The magnetic coating layer is prepared by the steps of the present invention with a mass ratio of samarium iron nitrogen magnetic powder and silica gel of 4:3, and the non-magnetic coating layer is formed only by curing silica gel. The core wire has a diameter of 0.1 mm, and the magnetic coating layer and other functional coatings completely cover the core wire. The guide wire has a diameter of 0.8 mm. The distance L from the core wire end to the guide wire end can be changed according to the use requirements.

[0067] Example 2

[0068] See also Figure 2 , Figure 2 This is a schematic diagram of the structure of the magnetically controlled guidewire for interventional surgery prepared in Example 2, wherein the core wire head is conical, and its diameter gradually changes from 0.1 mm to 0.05 mm, and the rest is the same as Example 1.

[0069] Figure 3 This is an example of the steering of the magnetically controlled guide wire for interventional surgery prepared in Example 2 of the present invention in a magnetic field.

[0070] Figure 4 The schematic diagram shows the principle of achieving repeatable magnetic orientation of a magnetically controlled guide wire comprising magnetic composite particles coated with a low-temperature phase change medium through a high-temperature heat treatment process.

[0071] Figure 5 This is a schematic diagram of the deformation shape editing and principle of the magnetically controlled guide wire in the magnetic field.

[0072] Figure 6 This is a schematic diagram of the deformation shape editing and principle of the magnetically controlled guide wire in the magnetic field.

[0073] The above is only a preferred embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principle of the present invention. These improvements and modifications should also be regarded as the scope of protection of the present invention.

Claims

1. A magnetically controlled guidewire for interventional surgery with repeatable magnetic orientation, characterized in that: include: Core wire and cladding; The coating layer is coated on the outside of the core wire; The coating layer includes magnetic composite particles and a first high molecular polymer; The magnetic composite particles include magnetic powder and a low-temperature phase change material composited on the surface of the magnetic powder.

2. The magnetically controlled guidewire for interventional surgery according to claim 1, characterized in that: The coating layer includes a magnetic coating layer segment and a non-magnetic coating layer segment along the length direction of the interventional surgery magnetic control guide wire, and the magnetic coating layer is located at the distal end of the interventional surgery magnetic control guide wire.

3. The magnetically controlled guidewire for interventional surgery according to claim 1, characterized in that: The material of the core wire is selected from metal and / or a second high molecular polymer; The first high molecular polymer is selected from one or more of polydimethylsiloxane, thermoplastic polyurethane elastomer rubber, silica gel, polyolefin elastomer, ethylene propylene diene monomer rubber and ethylene-vinyl acetate copolymer; The magnetic powder is samarium iron nitrogen magnetic powder; The low-temperature phase change material is polyethylene glycol or paraffin.

4. The magnetically controlled guidewire for interventional surgery according to claim 1, characterized in that: The diameter of the core wire is 0.01 to 0.3 mm; The particle size of the magnetic powder is 0.1 to 100 μm; The diameter of the interventional surgery magnetically controlled guide wire is 0.25 to 1 mm; The length of the interventional surgery magnetically controlled guide wire is 500 to 3000 mm.

5. The magnetically controlled guidewire for interventional surgery according to claim 1, characterized in that: The mass ratio of the magnetic powder to the low-temperature phase change material is 1:5 to 5:1; The particle size of the magnetic composite particles is 0.15 to 120 μm.

6. The magnetically controlled guidewire for interventional surgery according to claim 1, characterized in that: A protective coating is also arranged outside the coating layer; the protective coating is made of biocompatible material.

7. The magnetically controlled guidewire for interventional surgery according to claim 1, characterized in that: A hydrophilic coating is also arranged outside the coating layer.

8. A method for preparing a magnetically controlled guide wire for interventional surgery with repeatable magnetic orientation, characterized in that: The following steps are involved: S1) mixing magnetic composite particles with a first high molecular polymer to obtain a magnetic composite slurry; the magnetic composite particles include magnetic powder and a low temperature phase change material composited on the surface of the magnetic powder; S2) injecting the magnetic composite slurry into a molding mold, placing a core wire in the molding mold, and allowing it to solidify, thereby obtaining an interventional surgery magnetically controlled guide wire with repeatable magnetic orientation.

9. The preparation method according to claim 8, characterized in that: The magnetic composite particles are prepared according to the following method: Mixing magnetic powder and low-temperature phase change material, and heating to the melting temperature of the low-temperature phase change material to obtain a mixed slurry; The mixed slurry is cooled, solidified, crushed and ground to obtain magnetic composite particles.

10. The preparation method according to claim 8, characterized in that: The step S2) further comprises: before solidification, orienting the magnetic composite particles in the magnetic composite slurry with a magnetic field.

Images