JPS6118464B2 - - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION The present invention relates to a flow guide wire made of synthetic resin that is inserted into a blood vessel for intravascular catheterization or treatment, and its main purpose is sometimes to improve its operability. It is something to do.

Catheters used to examine the condition of diseased areas within blood vessels of the human body and to transport medicinal fluids to the affected areas are made by feeding a guide wire into the blood vessel in advance and introducing it into the affected area along the outer wall of the catheter. The guide wires used for this purpose are coiled metal wires manufactured and sold by COOK, UMI, USCI, etc. in the United States, and these are made of stainless steel wire and stainless steel wire coils. There is. This guidewire has irregularities on its surface that are unique to coiled wires, making it easy for blood clots to adhere to it.The wire is also made of metal and is hard, so when feeding the guidewire into the affected area within the blood vessel, it is difficult to push, pull, or push left or right. It requires extremely complicated operating procedures and advanced techniques, such as turning the wire around, and requires a long time to operate.Since it is a metal wire, it easily passes through the intima of the blood vessel, and it cannot be delivered to the affected area in the terminal blood vessel. It has drawbacks such as the absence of As described above, when using a metal wire guide wire, it is extremely difficult to make the guide wire reach the target affected area within the blood vessel, and the pain or burden placed on the patient during treatment is large.

Therefore, the inventors improved the above-mentioned conventional drawbacks and created a safe medical flow guide wire that has a smooth surface, is difficult to adhere to blood clots, is flexible and easy to operate, and does not cause pain to patients. Provided earlier. Patent Application No. 1984-137558 (Japanese Patent Application No. 56-63364)
The following patent application has been filed.

A ball part, a flexible part, a tapered part, and an operating part (hand part) are formed from the tip to the rear end of a hollow monofilament made of synthetic resin, and at least the hollow part of the bulb part and the operating part is filled with an X-ray opaque metal. A medical flow guide wire made of synthetic resin, characterized in that an X-ray opaque metal built into the operation part or from the operation part to the tapered part is tapered at the end in the distal direction. .

This flow guide wire has been confirmed to be highly effective in many clinical cases.
It is commercially available under the product name ``Super Selector YK.'' However, as clinical cases become more diverse, more superselective catheterization is required, and the flow guide wire described above is required to be further improved in terms of operability. . The background to this is the super-selective insertion of flow guide wires into sentinel vessels and catheter exchange techniques that are reaching the realm of higher precision.

In order to meet such demands, the inventors conducted further studies. As a result, it was discovered that superselectivity could be significantly increased if the metal wire inserted from the flexible part to the operating part was made movable to increase or decrease its insertion depth, and the present invention was hereby completed.

Therefore, in the present invention, the wire main body is constituted by a synthetic resin monofilament having a hollow structure over the entire length, and the main body distal end is constituted in order from the end to a spherical part, a flexible part, and a tapered part. The subsequent main body portion is configured as an operating section, and an X-ray opaque metal chip is enclosed in the tip sphere, and an X-ray opaque metal wire is enclosed in the flexible section, the tapered section, and the hollow section extending to the operating section. The gist of the present invention is a medical flow guide wire that is inserted in a state that allows movement in the axial direction.
This will be described in detail below with examples.

FIG. 1 is a side sectional view of a flow guide wire according to the present invention, and FIG. 2 is a sectional view taken along line AA in FIG. The wire body 1 is made of a synthetic resin monofilament having a hollow structure over its entire length. The distal end of the wire body 1 is comprised of a spherical part 2, a flexible part 3, and a tapered part 4 in this order from the end, and the portion of the wire body 1 after the tapered part 4 is constructed as an operating part 5. The tip bulb part 2 has
An X-ray opaque metal chip 6 is enclosed, and an X-ray opaque metal wire 7 is inserted into the hollow part between the flexible part 3, the tapered part 4, and the operating part 5 in a state that allows movement in the axial direction. ing. The rear end of the metal wire 7 is exposed from the wire body 1, and a knob 8 made of a synthetic resin cylinder is fixed to this exposed end with an adhesive 9. As shown in the figure, the tip of the metal wire 7 is tapered along the hollow shape of the wire body 1.

A more specific explanation of the structure of each part is as follows.

The ball part 2 located at the tip has a hollow structure, and an X-ray opaque metal chip 6 is placed in the hollow part.
is built-in. The flexible portion 3 is a hollow, extremely thin and soft portion, and has sufficient strength so that the bulbous portion 2 and the tapered portion 4 will not be separated within the blood vessel. The diameter of the tapered part 4 adjacent to the flexible part 3 and the operating part 5 increases gradually from the flexible part 3, and when it reaches the operating part 5, it becomes tapered so that it has the same diameter as the operating part 5. It has been designed and processed, and a tapered end portion 10 of an X-ray opaque metal wire 7 is placed in the hollow portion. By operating a knob 8 provided at the end of the operating section 5, the tapered X-ray opaque metal wire 7 is inserted into the hollow section from the flexible section of the hollow synthetic resin monofilament to the operating section. Move forward and backward. The dimensions of each of these parts depend on various conditions such as the age, body shape, and condition of the affected area of the patient to be treated, and are not particularly limited.

The most distinctive feature of the flow guide wire having the above basic structure is that the insertion depth of the X-ray opaque metal wire can be freely changed. In other words, this makes it possible to freely select the flexibility and elasticity of the guide wire over a wide range depending on the purpose, greatly improving maneuverability within blood vessels, which was previously impossible. This makes it possible to introduce it into the terminal sentinel vessels, broadening the therapeutic range and significantly improving the therapeutic effect.

The medical flow guide wire of the present invention having the above-mentioned configuration is inserted into a blood vessel and selectively reaches the target affected area under contrast using X-ray projection, and then a catheter is inserted along this. It is introduced to inspect the condition of the affected area in the blood vessel or to transport a therapeutic drug solution to the affected area. That is, it is used as a so-called catheter auxiliary device, and when used, it exhibits the following effects. Ball part 2 at the tip
can move freely within the blood vessel and do not penetrate into the vascular intima. Therefore, insertion into the blood vessel is a natural and natural operation, passing through the first branch, second branch, third branch, and each branch point to reach the target affected area in the terminal blood vessel. Even in extremely difficult operations, super-selective operations can be performed by moving the knob 8 at the end of the operating section back and forth to delicately adjust the flexibility and elasticity of the flexible section 3 and tapered section 4 inside the blood vessel. This makes it possible to perform operations almost at will.

When the tip of the wire reaches the terminal blood vessel near the affected area, the catheter is inserted along the outer wall surface of the wire. During this operation, the tip of the X-ray opaque metal wire 7 is inserted into the innermost end, that is, the flexible part. Push it all the way to 3. This allows the catheter to be inserted more smoothly into the blood vessel along the wire, and the tip of the wire does not come off (return to its original shape) due to this operation, allowing the catheter end to be introduced into the desired treatment area. be.

The operating section 5 is made of synthetic resin monofilament, so it has a smooth surface that prevents thrombus from accumulating, and is highly elastic, making it easy to operate.Moreover, it has a built-in metal wire 7 that is opaque to X-rays along its entire length. Because of this, the images projected through the monitor are extremely clear. In this manner, the flow guide wire of the present invention can be introduced into a blood vessel with free movement while sufficiently following delicate manipulations, and can be easily inserted into, for example, a meandering portion of a blood vessel.

The synthetic resin material constituting the guide wire of this invention may be any material that can be melt-extruded.
Although not particularly limited, polyamide, polyester, polyolefin, etc. can be preferably used. In addition, tungsten is a typical X-ray opaque metal, and there are no restrictions on the shape of the ball, which can be inserted into a sphere, powder, or wire.
A linear body is preferable for the operation part.

In order to manufacture the flow guide wire of the present invention, for example, first, a hollow monofilament is spun by a conventional melt spinning method using a hollow spinneret, and if desired, the monofilament is appropriately stretched and cut into a suitable length. Next, the tip of the monofilament is subjected to local high-magnification stretching, leaving the part where the tip bulb is formed, to create the flexible part and the tapered part all at once, and then inserting an X-ray opaque metal chip into the bulb forming part. Melt and seal to form a sphere. On the other hand, the tip of the X-ray opaque metal wire is previously processed into a tapered shape, and this is inserted into the hollow part of the monofilament from the operating part end toward the flexible part, and is stopped at the flexible part end. Insert a knob (same as the monofilament used in the main body) into the X-ray opaque metal wire remaining at the end of the operation part, and connect the inner surface of the hollow hole and the outer surface of the X-ray opaque metal wire appropriately. Secure with adhesive.

It is further preferable that the surface of the wire be subjected to antithrombotic treatment such as silicone coating.

As explained above, the medical flow guide wire of the present invention is extremely easy to operate, does not cause pain to patients, and has excellent imaging effects when exposed to X-rays, so it can be used in clinical examinations using catheters. It is extremely useful for treatment, etc.

Next, examples will be described.

Example 1 A flow guide wire was produced using a hollow monofilament made of polyethylene terephthalate having a diameter of 0.80 mm and a hollow hole diameter of 0.33 mm. That is,
This hollow monofilament was cut into a length of 1.3 m, and one end was cut into a length of approximately 3 m, leaving the part that would become the ball.
A flexible part and a tapered part with a diameter of 0.3 mm and a length of 30 mm were produced at once by steam stretching. Next, insert a tungsten wire with a diameter of 0.3 mm and a length of 1.5 mm from the tip of the sphere fabrication side, and spray the tip to make the diameter
A rectangular sphere with a length of 0.8 mm and a length of 2.5 mm, a so-called tip sphere, was fabricated.

Next, from the other end of the monofilament, measure the diameter
A tungsten wire of 0.25 mm and 1.5 mm length with one end tapered was inserted with the tapered side first, and the tapered part was inserted all the way to the flexible part to completely fill the operating part. The part protruding from the end of the operating part has a diameter of 0.80mm and a hollow hole diameter of 0.33mm.
A hollow monofilament made of polyethylene terephthalate with a length of 20 cm and a length of 20 cm was covered, and a very small amount of Aronhilfa, an instant adhesive manufactured by Toagosei Co., Ltd., was poured between the hollow hole and the tungsten wire, and the wire was fixed with adhesive to form a knob.

When the knob of the flow guide wire produced in this way is brought to the innermost side, that is, in a state where it is in almost contact with the end surface of the operating section, the tip of the tapered tungsten wire is inserted into the flexible part. In this state, the flexibility of the tapered portion of the flexible portion is relatively hard and highly elastic. As the knob is removed from the end of the operating section, the softness gradually increases and the elasticity decreases.

It has been confirmed that by adopting such a structure, the degree of clinical freedom is increased and treatment can be performed on a case-by-case basis.

A test was conducted in which the guide wire described above was inserted from point B to point C of a blood vessel 11 bent at an acute angle as shown in FIG.

First, an attempt was made to insert the tapered tungsten wire 7 in the wire main body 1 from point B to point C while pushing it to the innermost part, that is, to the flexible part 3. In this case, once a few minutes somehow C
I was able to send it to the point [Figure 3 a]. Next, the tip of the tapered tungsten wire 7 in the wire body 1 was pulled out to the boundary between the operating section 5 and the tapered section 4, and then inserted from point B to point C.
In this case, it was able to be delivered to point C extremely smoothly on the blood flow [Fig. 3b]. However, if the catheter is inserted along the wire in this state, B
When I tried to insert the wire from point C to point C, the ball tip 2 of the wire that had been inserted so far flowed backwards from point C and returned to point D. This means that without the built-in tungsten wire 7, the catheter was too flexible and had little elasticity, so the elasticity of the catheter prevailed and the force was not sufficient to reach point C. Therefore, this time, after inserting the tip without the tungsten wire 7 to point C, operate the knob to advance the tapered tungsten wire 7 from the tapered part 4 to the flexible part 3, and then insert the catheter. When the wire was inserted along the wire and the distal end was advanced from point B to point C within the blood vessel 11, unlike before, it was successfully delivered to point C.

As described above, the flow guide wire of the present invention has greatly improved operability, and thus it has become possible to treat affected areas, which was previously considered to be extremely difficult.

Example 2 As shown in Fig. 4, the flow guide wire of the present invention, which had been processed so that its tip bent at a sharp angle when the tungsten wire (core) 7 was pulled out, was percutaneously inserted into the liver from the aorta. It was inserted into an artery and subjected to a clinical trial of superselective angiography of the liver.

With the tungsten wire (core) 7 deeply pushed into the wire body 1 as shown in FIG. 5, this wire was percutaneously inserted into the aorta from the saphenous artery using the Seldinger method. Furthermore, this wire was pushed to the vicinity of the celiac artery branch of the aorta.

Since the core 7 is pushed in, the wire maintains its straightness and has a suitable degree of rigidity, making insertion very easy.

Next, in order to advance this wire into the celiac artery, the core 7 was pulled out a little and the tip was bent at an angle as shown in FIG. The wire was manipulated while monitoring the bulb 2 containing the X-ray opaque material 6 at the tip using an X-ray television, and the tip could be inserted from the aorta into the celiac artery by utilizing the bending of the tip. .
Furthermore, while changing the actual length of the flexible part by slightly pushing in or pulling out the core 7,
The wire was advanced from the celiac artery through the common hepatic artery to the proper hepatic artery. After confirming by X-ray that the tip had reached the target blood vessel, the core 7 was pushed into the wire body 1 again. When the state shown in Fig. 5 is reached, the vascular catheter (manufactured by Kutsuku Co., Ltd.) that has been previously processed and placed over the main wire.
PERT-6.5) was inserted until it reached the target blood vessel. The core of this wire extends to the tip and maintains sufficient rigidity, so even when the vascular catheter was advanced, it did not fall out unlike conventional guide wires. Furthermore, when the core is pushed in, the wire exhibits relatively straightness, making insertion of the vascular catheter easier than with conventional products.

When the tip of the vascular catheter entered the target proper hepatic artery, the wire was pulled out, a contrast agent was injected, and conventional superselective contrast imaging was performed.

The flow guide wire of the present invention was easier to operate than conventional metal guide wires, and moreover, it was easier to insert into the terminal end of a blood vessel, so the time required was about 1/5 or less. Also, because of the blunt bulb at the tip and the flexible plastic structure, it did not damage the intima of blood vessels.

[Brief explanation of the drawing]

FIG. 1 is a side sectional view of a medical flow guide wire according to the present invention, and FIG. 2 is an enlarged sectional view taken along line AA in FIG. FIGS. 3a and 3b are explanatory diagrams showing how the flow guide wire of the present invention is inserted into a bent part within a blood vessel. 4 and 5 are explanatory views of the flow guide wire according to the present invention. DESCRIPTION OF SYMBOLS 1... Wire main body, 2... Ball part, 3... Flexible part, 4... Taper part, 5... Operation part, 6...
...X-ray opaque metal chip, 7...X-ray opaque metal wire, 8...Knob.

Claims (1)

[Claims] 1. The wire body is composed of a synthetic resin monofilament having a hollow structure over its entire length,
The distal end of the main body is composed of a spherical section, a flexible section and a tapered section in order from the end, and the main body section after the tapered section is an operating section, and an X-ray opaque metal chip is enclosed in the distal spherical section. A medical flow guide wire, characterized in that an X-ray opaque metal wire is inserted into a hollow portion extending to the flexible portion, the tapered portion, and the operating portion in a state that allows movement in the axial direction.