CN115624682A

CN115624682A - TAVR guide wire with improved toughness and manufacturing method thereof

Info

Publication number: CN115624682A
Application number: CN202211321867.8A
Authority: CN
Inventors: 刘奕彤; 李子圆
Original assignee: Guangdong Hiscal Medical Technology Co ltd
Current assignee: Guangdong Hiscal Medical Technology Co ltd
Priority date: 2022-10-26
Filing date: 2022-10-26
Publication date: 2023-01-20

Abstract

The invention provides a TAVR guide wire with improved toughness and a manufacturing method thereof, and relates to the technical field of medical instruments. This TAVR seal wire that toughness is improved, including the head end, one side fixedly connected with core silk of head end is complied with the section, the inside of core silk is complied with the section is provided with sheath, developing spring, the inside of sheath is provided with developing spring, one side of developing spring is fixed in one side of head end, core silk is complied with the section and is included core silk gradual change section, core silk soft section, one side fixedly connected with support section of core silk is complied with the section, the inside of support section is provided with the core silk, the surface of support section is provided with support section PTFE coating, the surface of core silk is complied with the section and is provided with sheath PTFE coating. The sheath made of the amorphous stainless steel material improves the performance (toughness enhancement) of the guide wire sheath, and improves the support and operability of the TAVR guide wire.

Description

TAVR guide wire with improved toughness and manufacturing method thereof

Technical Field

The invention relates to the technical field of medical instruments, in particular to a TAVR guide wire with improved toughness and a manufacturing method thereof.

Background

In coronary intervention, the guide wire plays an important role in establishing an operation passage and supporting the placement of instruments. In the implementation process of Transcatheter Aortic Valve Replacement (TAVR) or transcatheter aortic valve placement (TAVI), a guide wire and a catheter need to be fed through the femoral artery, and the prosthetic heart valve is conveyed to the aortic valve area to be opened, so that the prosthetic valve placement is completed, and the valve function is recovered. In the process of operation implementation, the TAVR guide wire is used for assisting in the implantation of a large vascular access sheath, an expansion balloon and a valve system, the instruments are high in strength and hardness and large in size, and meanwhile, the heart is in a beating state in the process of operation implementation, so that the TAVR guide wire is required to have high support, stability and toughness to a certain degree, meanwhile, the safety is ensured, the vascular wall cannot be scratched or stabbed, and the extremely high requirement is provided for the performance of the guide wire.

The applicant finds that a Chinese patent discloses a TAVR guide wire through retrieval when applying the invention, and the publication number of the TAVR guide wire is CN113827846A, the TAVR guide wire mainly comprises a pushing rod section, one end of which is provided with a soft section, one end of the soft section is installed with the pushing rod section, the other end of the soft section is provided with a soft tip section, one end of the soft tip section is in bolted connection with the soft section, guide wire sheaths are wrapped and wound on the surfaces of the pushing rod section, the soft section and the soft tip section, and medicine channels are arranged inside the pushing rod section, the soft section and the soft tip section. Above-mentioned patent all strengthens the support section of TAVR seal wire with prior art, but increased the compliance that the support nature has influenced the seal wire distal end, harder head end flexibility is not enough, be unfavorable for developing of operation, and taken the solution of "two segmentations", link together soft material and hard material through the mode of "bolt", with solving this problem, but the mode of bolt leads to the fact the potential safety hazard easily, in case the bolt is insecure, fracture or drop will produce serious consequence in the blood vessel. The diameter change usually occurs at the bolted joint in the "bolting" process, which is known as stepped diameter change, the diameter-changed part is easy to break and fall off, the developing effect is not strong, and the operation is inconvenient for the operator.

Therefore, according to the applicant's invention, a TAVR guidewire with improved toughness and a manufacturing method thereof are invented, solving the following problems:

1. the bolting process has insufficient firmness and is easy to generate potential safety hazards;

2. a stepped reducing part is arranged between the supporting section and the soft section, so that the supporting section is easy to break;

3. the toughness of the soft segment is insufficient, and the support property and the compliance property cannot be considered at the same time;

4. the existing guide wire sheath is usually a flat wire wound by stainless steel, and the material is hard, so that the far-end compliance of the guide wire is influenced;

5. the existing TAVR guide wire has poor distal developing effect and inconvenient operation for operators.

Disclosure of Invention

Technical problem to be solved

Aiming at the defects of the prior art, the invention provides a TAVR guide wire with improved toughness and a manufacturing method thereof, and solves the problems that the firmness of a bolting process is insufficient, potential safety hazards are easy to generate, stepped variable diameter parts exist between a support section and a soft section, breakage is easy to occur, the toughness of the soft section is insufficient, the support and the compliance cannot be considered, the conventional guide wire sheath is usually a flat wire wound by stainless steel, the material is hard, the compliance of the far end of the guide wire is influenced, the developing effect of the far end of the conventional TAVR guide wire is poor, and the operation of a surgeon is inconvenient.

(II) technical scheme

In order to achieve the purpose, the invention is realized by the following technical scheme: the TAVR guide wire with improved toughness comprises a head end, wherein a core wire compliant section is fixedly connected to one side of the head end, a sheath and a developing spring are arranged inside the core wire compliant section, the developing spring is arranged inside the sheath, one side of the developing spring is fixed to one side of the head end, the core wire compliant section comprises a core wire gradual change section and a core wire soft section, a supporting section is fixedly connected to one side of the core wire compliant section, a core wire is arranged inside the supporting section, a supporting section PTFE coating is arranged on the outer surface of the supporting section, and a PTFE sheath coating is arranged on the outer surface of the core wire compliant section.

Preferably, the material of the support section is 304 stainless steel.

Preferably, the material of the guide wire core wire compliant section is 316 stainless steel.

Preferably, the developing spring is a wire winding made of gold or platinum.

Preferably, the material of the sheath is amorphous stainless steel alloy.

A method of making a TAVR guidewire with improved toughness, comprising the steps of: welding the developing spring and the sheath by a seamless non-variable diameter welding process; welding the developing spring, the sheath and the head end by a seamless non-variable diameter welding process; welding the support section and the core wire compliant section by a butt welding technology; the surface of the support section is coated with a support section PTFE coating; the surface of the core wire compliant section is coated with a sheath PTFE coating.

(III) advantageous effects

The invention provides a TAVR guide wire with improved toughness and a manufacturing method thereof. The method has the following beneficial effects:

1. the sheath made of amorphous stainless steel material improves the performance (toughness enhancement) of the guide wire sheath, and improves the support and operability of the TAVR guide wire.

2. The visualization of the guide wire is enhanced through the developing spring, so that a doctor can more accurately master the position of the guide wire in the operation process.

3. The seamless non-reducing welding technology of different materials connects two sections of materials with different properties together, so that the near end has required support performance and the far end has required flexibility on the premise of not influencing torsion control performance and not generating reducing.

Drawings

FIG. 1 is a schematic structural view of a TAVR guidewire with improved toughness;

FIG. 2 is a schematic diagram of the pre-plasticity of a TAVR guidewire with improved toughness;

fig. 3 is a surface microscopic imaging contrast diagram of the amorphous stainless steel alloy and the traditional medical stainless steel material.

Wherein, 1, core wire; 2. a sheath; 3. a developing spring; 4. a head end; 11. a support section; 12. a core wire compliant segment; 13. a core filament transition; 14. a core filament soft segment; 15. a support segment PTFE coating; 21. and (4) coating PTFE on the sheath.

Detailed Description

The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.

The first embodiment is as follows: TAVR guide wire with improved toughness and manufacturing method thereof

As shown in fig. 1-2, embodiments of the present invention provide a TAVR guidewire with improved toughness and a manufacturing method thereof, including a tip 4, wherein: one side of the head end 4 is fixedly connected with a core wire compliant section 12, the inside of the core wire compliant section 12 is provided with a sheath 2 and a developing spring 3, the sheath 2 is used for improving the controllability and the trackability of a TAVR guide wire, and amorphous stainless steel alloy material is selected, so that the amorphous stainless steel alloy material has better toughness compared with the traditional material, thereby improving the operability and the compliance of the guide wire and reducing the difficulty of the operation, the inside of the sheath 2 is provided with the developing spring 3 which is used for enhancing the visual effect of the guide wire under imaging equipment, one side of the developing spring 3 is fixed on one side of the head end 4, the head end 4 is used for protecting the vascular wall and preventing the guide wire from scratching the blood vessel, the core wire compliant section 12 comprises a core wire gradual change section 13 and a core wire soft section 14, the core wire gradual change section 13 is a multi-taper diameter gradual change section, flexibility and the blood vessel trafficability characteristic through diameter change reinforcing seal wire, core silk soft section 14 is the thin section, the grinding is to less diameter, further strengthen the flexibility and the compliance of seal wire, protect the blood vessel, improve the operation security, core silk gradual change section 13, core silk soft section 14 can be according to clinical needs moulding in advance, in order to improve operation efficiency and success rate, one side fixedly connected with support section 11 of core silk compliance section 12, the inside of support section 11 is provided with core silk 1, the surface of support section 11 is provided with support section PTFE coating 15, be used for increasing seal wire near-end frictional force, strengthen the support nature, the surface of core silk compliance section 12 is provided with sheath PTFE coating 21, be used for increasing seal wire far-end frictional force, promote controllability and support nature.

The support section 11 is made of 304 stainless steel, the support performance is strong, the support force of an operator to the guide wire in the left ventricle in the TAVR operation process can be met, the core wire compliant section 12 is made of 316 stainless steel, the toughness is strong, when a TAVR passage is established, the passing performance of the guide wire in a blood vessel can be guaranteed, the controllability and the safety can be guaranteed, the support section 11 is tightly connected with the core wire compliant section 12 through a butt welding technology, the diameter of the far end of the support section 11 is consistent with that of the near end of the core wire compliant section 12, stepped reducing does not exist, the safety of the TAVR guide wire in the operation implementation process is guaranteed, the developing spring 3 is a winding wire made of gold or platinum, and the sheath 2 is made of amorphous stainless steel alloy.

A method of making a TAVR guidewire with improved toughness, comprising the steps of: welding the developing spring 3 and the sheath 2 by a seamless non-reducing welding process; welding the developing spring 3, the sheath 2 and the head end 4 by a seamless non-reducing welding process; welding the support section 11 and the core wire compliant section 12 by a butt welding technique; a support section PTFE coating 15 is coated on the surface of the support section 11; the surface of the core wire compliant section 12 is coated with a sheath PTFE coating 21.

Example two: performance comparison of amorphous material with 304 stainless steel and 316 stainless steel materials

The tensile strength is a key physical property of the toughness of the reaction material, and in order to compare the tensile properties of the amorphous stainless steel alloy, 304 stainless steel and 316 stainless steel materials, a material tensile testing machine is adopted to test the peak tensile strength of the sheath flat wire consisting of the three materials. The test results are shown in the following table, and the results show that the tensile strength of the amorphous stainless steel material is significantly better than that of the traditional 304 stainless steel and 316 stainless steel materials for medical use.

Sheath flat filament material	Amorphous stainless steel	304 stainless steel	316 stainless steel
				Peak tensile Strength (MPa)	2636±31	2110±14	2225±12

Surface defects are a significant cause of adverse events such as thrombosis in medical devices and are also a significant factor affecting the trafficability of devices. The surface of the amorphous alloy is usually flocculent due to the compactness of the microstructure, and the average particle size of the particles is several to dozens of nanometers, so that the surface defects are not easily formed. In order to compare the surface properties of the amorphous stainless steel alloy and the conventional medical stainless steel material, the surfaces of the two materials were microscopically imaged using a scanning electron microscope. The test results are shown in fig. 3, and the results indicate that the surface smoothness of the amorphous stainless steel material (a) is significantly superior to the surface properties of the conventional medical stainless steel material (B).

Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that changes, modifications, substitutions and alterations can be made in these embodiments without departing from the principles and spirit of the invention, the scope of which is defined in the appended claims and their equivalents.

Claims

1. A TAVR guidewire with improved toughness, comprising a tip (4), characterized in that: one side fixedly connected with core silk of head end (4) is complied section (12), the inside of core silk is complied section (12) is provided with sheath (2), development spring (3), the inside of sheath (2) is provided with development spring (3), one side of development spring (3) is fixed in one side of head end (4), core silk is complied section (12) including core silk gradual change section (13), core silk soft section (14), one side fixedly connected with support section (11) of core silk is complied section (12), the inside of support section (11) is provided with core silk (1), the surface of support section (11) is provided with support section PTFE coating (15), the surface of core silk is complied section (12) is provided with sheath PTFE coating (21).

2. The TAVR guidewire with improved toughness of claim 1, wherein: the material of the support section (11) is 304 stainless steel.

3. The TAVR guidewire with improved flexibility of claim 1, wherein: the material of the guide wire core wire compliant section (12) is 316 stainless steel.

4. The TAVR guidewire with improved toughness of claim 1, wherein: the developing spring (3) is a winding wire made of gold or platinum.

5. The TAVR guidewire with improved toughness of claim 1, wherein: the sheath (2) is made of amorphous stainless steel alloy.

6. The method of manufacturing an improved toughness TAVR guidewire as claimed in claims 1-5, comprising the steps of: welding the developing spring (3) and the sheath (2) by a seamless non-reducing welding process; welding the developing spring (3), the sheath (2) and the head end (4) by a seamless non-reducing welding process; welding the support section (11) and the core wire compliant section (12) by a butt welding technique; a support section PTFE coating (15) is coated on the surface of the support section (11); the surface of the core wire compliant section (12) is coated with a sheath PTFE coating (21).