WO2014090076A1

WO2014090076A1 - Transradial intervention imaging guidewire

Info

Publication number: WO2014090076A1
Application number: PCT/CN2013/087678
Authority: WO
Inventors: 窦克非; 仪克晶; 刘智勇; 张久礼; 吕冬; 沈辉; 郝升旗
Original assignee: 上海微创医疗器械（集团）有限公司
Priority date: 2012-12-14
Filing date: 2013-11-22
Publication date: 2014-06-19
Also published as: CN203154553U

Abstract

A transradial intervention imaging guidewire comprising a core wire (1) and a winding wire (2). The winding wire (2) covers the entire core wire (1). The proximal end of the core wire (1) is connected to the proximal end of the winding wire (2). The distal end of the core wire (1) is in a free state. The distal end of the winding wire (2) is tapered. The guidewire solves the problem that, during transradial intervention diagnoses and surgeries, a guidewire with an overly hardened headend encounters a great push resistance and thus is difficult to pass through a blood vessel with a great curvature and is prone to cause vasospasm. 1

Description

Transradial accessory angiography

The present invention relates to the field of single-use medical devices, and in particular to a coronary interventional diagnosis and treatment operation, in particular, for guiding and locating a catheter in a human body through a radial artery approach. Guide wire. Background technique

Percutaneous coronary intervention refers to the diagnosis and treatment of transcatheter coronary artery stenosis and corresponding treatment. Currently, the interventional pathway for coronary interventional interventional and therapeutic procedures is mainly divided into the femoral artery and the radial artery. In 1989, Canadian doctor Campeau pioneered percutaneous transluminal angiography for coronary angiography. In 1992, Dutch physician Kiemenij reported the results of treatment with this route. With the worldwide promotion and popularization of coronary interventional diagnosis and treatment, coronary artery intervention through the radial artery has been widely used in the clinical diagnosis and treatment of coronary heart disease, with small damage, few local complications, before and after surgery. The advantages of anti-coagulation, anti-platelet drug restriction, immediate extubation after surgery, and no need to force bed for 24 hours are more "minimally invasive" and are favored by patients and interventionalists. At present, there are more than 500,000 cases of coronary intervention diagnosis and treatment through the radial artery pathway in China every year.

In the diagnosis and treatment of percutaneous coronary intervention, the angiographic guidewire is an important surgical instrument used to introduce the contrast catheter into the blood vessel and stay in the designated position. The most common angiographic guidewires on the market today include ultra-smooth guidewires (commonly known as loach guidewires) and conventional stainless steel wire-wound angiographic guidewires. The ultra-slip guide wire uses a polymer sheath and a special hydrophilic coating on its surface to reduce friction and enhance push performance. In recent years, more and more doctors have chosen such guidewires in the interventional diagnosis and treatment of radial artery. However, the superslip guide wire is too smooth, and the operator feels poor in the interventional diagnosis and treatment of the transradial artery. The high smoothness causes the loss of tactile feedback, which may cause vascular damage during the intervention. Lighter causes hemorrhagic complications such as local hematoma, and severe cases lead to compartment syndrome that endangers the life of the patient. According to statistics, there are currently 5% to 8% of transradial interventional diagnosis and treatment of surgical bleeding. The disease is caused directly or indirectly by the super-sliding guide wire, which increases the risk of surgery and causes unnecessary pain to the patient.

To ensure the safety of the operation, some doctors have turned to traditional stainless steel wire-wound angiographic guidewires. The guide wire is in the form of a spiral spring wound core wire, and the head end has no variable diameter, large hardness, poor flexibility, and is difficult to pass a blood vessel with a large curvature. In addition, the traditional guide wire end has no variable diameter, and the diameter of the head end is large. The friction of the guide wire with the blood vessel wall during the intervention process is large, the push is difficult, and the blood vessel is easily caused. Sometimes doctors have to choose super-smooth guidewires for better performance. In summary, there are still major improvements in the design of the main guide wires on the market.

According to the current status of traditional cardiac interventional angiography guidewires, the main shortcomings are:

1) The stainless steel wire wrapped guide wire has a large cross-sectional area at the head end, which has a large pushing resistance, which is easy to cause vasospasm, and is difficult to perform radial artery intervention diagnosis and treatment. 2) The stainless steel wire wound guide wire has no variable diameter at the head end, resulting in the head end The hardness is too large, it can not provide good flexibility, and it is difficult to pass the blood vessels with large curvature. 3) The super-smooth guide wire is too smooth, which is easy to cause vascular damage, which may cause bleeding, which may endanger the life of the patient. Summary of the invention

The present invention is directed to solving one or more of the problems mentioned above, providing a device that is capable of having good compliance, pushability, torsion control and less likelihood of vasospasm during transradial interventional diagnosis and treatment procedures. Guide wire.

According to the present invention, there is provided a guide wire comprising a core wire and a wound wire, the wire wrapped around the entire core wire, the proximal end of the core wire being connected to the proximal end of the wire, and the distal end of the core wire being in a free state, Among them, the distal end of the wire is tapered.

Preferably, the guidewire further comprises a safety wire, the safety wire being covered by the wire, and the proximal and distal ends of the safety wire being respectively connected to the proximal and distal ends of the wire.

Preferably, the guide wire further comprises a coating applied to the surface of the wound wire.

Preferably, the distal end of the guide wire is designed to be J-shaped that can be straightened by pulling the wire. Preferably, the distal end of the core wire tapers.

Preferably, the wrap wire is a coil spring coil. Preferably, the core wire is made of Nitinol, stainless steel, Ti-Nb alloy, Ti-Ni-X alloy, Cu-Zn alloy, Cu-Zn-Ni alloy, Fe-Ni alloy or Fe-Mn alloy.

Preferably, the coating is Teflon, PVP, polyethylene, polypropylene, polyvinyl chloride, polyester, polyamide, polyimide, polyaminophthalate, polystyrene, polycarbonate, Silicone, fluororesin coating or composite coating comprising any combination of the materials.

Compared with the prior art, the invention solves the problems that the tip end of the guide wire is too hard, the pushing resistance is large, the blood vessel having a large curvature is difficult to pass, and the vasospasm is easily caused during the transradial interventional diagnosis and treatment. The specific technical effects are as follows: 1) The head end is subjected to the variable diameter treatment to gradually reduce the hardness of the head end, improve the flexibility of the tip end of the guide wire, thereby improving the ability of the guide wire to bend the blood vessel; 2) the diameter of the head end gradually becomes smaller and decreases. The friction between the guide wire and the vessel wall reduces the probability of vasospasm; 3) The coil spring design can help the operator to obtain good tactile feedback; 4) The distal end of the guide wire adopts the J-type design, which effectively reduces the puncture vessel risks of. DRAWINGS

1 is a longitudinal cross-sectional view of a guide wire according to an embodiment of the present invention; FIG. 2 is a partially enlarged view of a distal end of the guide wire of FIG. 1;

3 is a schematic view of a J-shaped distal end of a guidewire in accordance with another embodiment of the present invention. detailed description

In the present specification, the same reference numerals are used to denote the same components.

1 is a schematic longitudinal cross-sectional view of a guide wire in accordance with an embodiment of the present invention. Referring to Figure 1, the guide wire mainly comprises a core wire 1 and a wire 2 . These two sections are explained in detail below.

The core wire 1 is located in the inner layer of the guide wire to provide a supporting force for the entire guide wire. The core wire 1 has a circular cross section or any other suitable shape. The distal end of the core wire 1 may be subjected to a variable diameter treatment, preferably tapered. The core wire 1 can be made of a material such as a nickel-titanium alloy, a stainless steel, a Ti-Nb alloy, a Ti-Ni-X alloy, a Cu-Zn alloy, a Cu-Zn-Ni alloy, a Fe-Ni alloy or a Fe-Mn alloy. The wire 2 is located on the outer layer of the guide wire and is preferably a coil spring. The wire 2 covers the entire core wire 1, the proximal end of the core wire 1 is joined to the proximal end of the wire 2, and the distal end of the core wire 1 is in a free state, wrapped by the wire 2 but not joined together. Preferably, the proximal end of the core wire 1 is welded to the proximal end of the wire 2, although other material connections such as bonding, snap fit, etc., may of course be employed. According to the embodiment shown in Figures 1 and 2, the distal end of the wire 2 is of a tapered design, preferably tapered (i.e., tapered). As the distal end of the wire 2 tapers, the hardness of the distal end of the guide wire also gradually decreases, which improves the flexibility of the guide wire and the ability to bend the blood vessel while reducing the friction between the guide wire and the blood vessel wall. And the probability of occurrence of vasospasm.

Referring next to Figure 1, in addition to the two portions mentioned above, the guide wire may further comprise a safety wire 3 which is covered by a wire 2 . The proximal end and the distal end of the safety wire 3 are respectively connected to the proximal end and the distal end of the wire 2, preferably welded together, and of course other bonding means such as bonding, snap fit or the like may be employed. The safety thread 3 is able to increase the flexibility of the tip end of the guide wire while ensuring safety. The safety thread 3 is made of 304 stainless steel, and of course any other suitable material can be used.

The guide wire may also include a coating applied to the surface of the wound wire 2, preferably a Teflon coating. The coating may also be PVP, polyethylene, polypropylene, polyvinyl chloride, polyester, polyamide, polyimide, polyaminophthalate, polystyrene, polycarbonate, silicone, fluororesin coated A layer or a composite coating comprising any combination of the materials. The coating material has good biocompatibility and does not cause rejection of the body, and has no side effects on the human body. At the same time, it has the smallest coefficient of friction in plastics and is an ideal oil-free lubricant that can greatly improve the pushability and handling of the product.

Referring now to another embodiment of the invention illustrated in Figure 3, the distal shaping effect of the guidewire is illustrated. The distal end of the guide wire is designed in a J shape, which effectively reduces the risk of puncture blood vessels. When in use, the doctor can straighten the J-shaped end by pulling the wire around the surface, which is more conducive to the guide wire repeatedly entering the blood vessel through the catheter.

It will be apparent to those skilled in the art that various modifications and variations can be made in the disclosed embodiments without departing from the scope of the invention. Other embodiments will also occur to those skilled in the art based on this description and the practice of the disclosure herein. This manual and examples should The true scope of the invention is indicated by the appended claims and their equivalents.

Claims

Claim

1. A guide wire comprising:

Core wire; and

Winding, the wire wraps the entire core wire, the proximal end of the core wire is connected to the proximal end of the wire, and the distal end of the core wire is in a free state.

It is characterized in that the distal end of the wire is tapered.

2. The guidewire according to claim 1, wherein the guide wire further comprises a safety wire, the safety wire is covered by a wire, and the proximal end and the distal end of the safety wire are respectively wrapped with a wire The proximal and distal connections.

3. The guidewire according to claim 1, wherein the guide wire further comprises a coating applied to the surface of the wound wire.

The guide wire according to any one of claims 1 to 3, characterized in that the distal end of the guide wire is designed to be J-shaped which can be straightened by pulling the wire.

The guide wire according to claim 1, wherein the distal end of the core wire is tapered.

The guide wire according to claim 1, wherein the winding wire is a coil spring coil.

The guide wire according to claim 1, wherein the core wire is made of Nitinol, stainless steel, Ti-Nb alloy, Ti-Ni-X alloy, Cu-Zn alloy, Cu-Zn-Ni alloy. , Fe-Ni alloy or Fe-Mn alloy.

The guide wire according to claim 3, wherein the coating is Teflon, PVP, polyethylene, polypropylene, polyvinyl chloride, polyester, polyamide, polyimide, Polyaminophthalate, polystyrene, polycarbonate, silicone, fluororesin coating or composite coating comprising any combination of the materials.