JPH06277293A - Flow guide wire for medical treatment - Google Patents

Abstract

PURPOSE:To provide the flow guide wire for medical treatment which has excellent softness and operability, is extremely easy in antithrombotic finishing treatment, has an excellent antithrombotic property and has good opacity. CONSTITUTION:A hollow monofilament 2 of the flow guide wire for medical treatment formed by building and sealing a metallic wire 3 into the hollow part of the hollow monofilament 2 made of a synthetic resin is formed of a compsn. consisting of (a) 25 to 40wt.% polyether block amide copolymer, (b) 25 to 40wt.% polyurethane and (c) 50 to 20wt.% X-ray contrast medium.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a medical flow guide wire for use in inspecting the condition of a diseased part in a blood vessel and treating the catheter. More specifically, the present invention relates to a medical flow guide wire which has extremely excellent operability and can reach the tip of a blood vessel, for example, an affected area in an artery, without causing pain or burden on the patient.

[0002]

2. Description of the Related Art As a conventional catheter used for inspecting the condition of a diseased part in a human body and delivering a drug solution to the affected part, a guide wire is previously fed into the blood vessel and the affected part is extended along the outer wall surface. The type that is introduced into is the mainstream.

As this type of guide wire, for example, those manufactured and sold by COOK, UMI, USCI, etc. in the United States, for example, stainless steel wire, piano wire, etc. are used as the raw material, and the main body part to the tip end. A coiled metal wire whose cross-sectional area is gradually reduced over the entire area is generally used, and a catheter used in combination with this guide wire is, for example, UMI Co.
Synthetic resin tubes manufactured and sold by CC Company, USCI Company, etc. were common.

When catheter treatment is performed using the metal guide wire and the synthetic resin catheter, the guide wire is first inserted into the blood vessel to reach the affected area, and then the guide wire is used as a core. As a result, a series of steps is required to introduce the catheter in such a way as to cover it, and after reaching the affected area, pull out the guide wire, inject the therapeutic drug solution from the end of the catheter, and introduce it into the affected area. It

However, in the above-mentioned treatment operation, since the surface of the metal guide wire itself has irregularities peculiar to the coil wire, thrombus is apt to adhere, and since it is made of metal, it is a complicated procedure for insertion into a blood vessel. However, there is a problem that the operation requires a long time and requires advanced techniques, and that the intima of the blood vessel is damaged during operation, and it is easy to get under the endovascular membrane. In addition to the great pain and burden on the patient, it was extremely difficult to selectively reach the affected part in the peripheral blood vessel such as the coronary vein with the tip of the guide wire.

Therefore, recently, a synthetic resin hollow monofilament in which a metal material is enclosed and enclosed is developed. However, since the synthetic resin itself is hard in this guide wire, the metal material is plastically deformed. There was a problem.

That is, as a material for the synthetic resin hollow monofilament, a melt-spinnable resin such as polyamide, polyethylene terephthalate, polyolefin and fluororesin is generally used. Among them, JP-A-55-148568. Gazette and Japanese Patent Publication No. 57-5
As disclosed in Japanese Patent No. 5426 and the like, polyethylene terephthalate is considered to be advantageous because it has a certain degree of flexibility, is easy to melt-spin, and is low in cost. Nevertheless, kink is generated. Is extremely poor in operability, anti-thrombogenic processing is difficult, and sliding properties are still not sufficiently satisfactory, so the tip of the guide wire introduced into the blood vessel is guided to the target affected area, for example, a branched blood vessel. In this case, a method that does not have a metal inner core in order to increase the pain and burden on the patient, the difficulty of superselective introduction into peripheral blood vessels, and the improvement of the guideability of the distal end. Since the tip is flexible, there is no contrast at the tip, and when an X-ray is projected from outside the body, only the tip is imaged on the X-ray TV monitor. Raz, the position of the distal end portion inserted into the body and remains a problem such as inability to confirm from outside the body, was not obtained sufficiently exhibit the function as a flow guide wire.

[0008]

SUMMARY OF THE INVENTION The present invention has been achieved as a result of studies for solving the problems of the above-described conventional medical flow guide wires.

Therefore, an object of the present invention is to provide a medical flow guide wire which is excellent in flexibility and operability, is extremely easy to be processed for antithrombotic property, has excellent antithrombotic property, and has good contrast property. To do.

According to the studies by the present inventors, it has been found that the above-mentioned object of the present invention can be effectively achieved by using a specific resin composition as a raw material of a synthetic resin hollow monofilament.

[0011]

That is, a medical flow guide wire of the present invention is a medical flow guide wire in which a metal wire is enclosed in a hollow portion of a synthetic resin hollow monofilament. a) Polyether block amide copolymer 25
˜40% by weight, (b) 25 to 40% by weight of polyurethane, and (c) 50 to 20% by weight of X-ray contrast agent.

As the metal wire used in the medical flow guide wire of the present invention, a filament made of an X-ray opaque metal body such as a tungsten wire, a stainless steel wire and a piano wire, and a Ti-Ni alloy wire, Cu- Zn
Examples of the filament include filaments made of alloy wires and various superelastic alloys such as Ni-Al alloys. Among them, tungsten wires having excellent radiopacity and relatively inexpensive tungsten wire and Ti-having good workability and stable quality The use of Ni superelastic alloy wire is preferred and recommended.

The diameter of these metal wires is 0.1 to 1.0 m.
m, particularly a range of 0.2 to 0.5 mm is preferable, and further, one having a tapered end portion in the front end direction is preferable.

On the other hand, as a material constituting the synthetic resin hollow monofilament of the medical flow guide wire of the present invention, (a) polyether block amide copolymer 2 is used.
5-40% by weight, (b) polyurethane 25-40% by weight
And (c) it is important to use a resin composition consisting of 50 to 20% by weight of an X-ray contrast agent.

By using (a) the polyether block amide copolymer as the base resin, the hollow monofilament itself can have excellent flexibility, dimensional stability and tenacity retention.

Further, the polyether block amide copolymer has excellent compatibility with other thermoplastic resins and is characterized by having various hardnesses, and therefore has excellent compatibility with the component (b) described below. Not only can it be ensured, but also the flexibility of the guide wire itself can be set arbitrarily.

Specific examples of the polyether block amide copolymer used in the present invention include "Pebax" manufactured by Toray Industries, Inc.

By blending the component (a) with a specific amount of the component (b) polyurethane, the antithrombotic processability can be remarkably improved without impairing the flexibility and biocompatibility of the guide wire itself.

As the polyurethane used in the present invention, those used particularly for medical purposes are preferable, and specifically, "Tecoflex" manufactured by Thermedix Co., Ltd.
And "Persen" and the like.

Further, by adding a specific amount of (c) the X-ray contrast agent to the resin components of (a) and (b), the contrast property of the guide wire itself can be extremely enhanced. This makes it possible to monitor and monitor the entire position including the distal end portion of the guide wire being introduced into the blood vessel from the outside.

Specific examples of the X-ray contrast agent used in the present invention include a fine powdery substance composed of a simple metal or a compound such as barium, tungsten, bismuth and lead. The range of 0.20 to 1.00 μ is preferable.

The blending ratio of the above resin composition is (a) 25-40% by weight of polyether block amide copolymer, especially 30-35% by weight, and (b) 25-40 of polyurethane.
%, In particular 30 to 35% by weight, and (c) an X-ray contrast agent 50 to 20% by weight, in particular 30 to 40% by weight.

Here, when the content of the component (a) is 25% by weight or less, the pressure resistance and strength of the hollow monofilament tend to decrease, and when it is 40% by weight or more, the dimensional stability of the hollow monofilament is improved. Though
There is no choice but to reduce the amount of component (c) above,
It is not preferable because sufficient contrast cannot be secured.

Further, if the content of the component (b) is 25% by weight or less, the antithrombotic treatment of the hollow monofilament cannot be sufficiently improved, and if it is 40% by weight or more, the antithrombogenic treatment of the hollow monofilament is performed. Although the property is improved, the amount of the above-mentioned component (c) to be blended is reduced, and sufficient contrast cannot be ensured, which is not preferable.

Further, if the content of the above-mentioned component (b) is 20% by weight or less, sufficient contrast property cannot be expected for the hollow monofilament, and if it is 50% by weight or more, not only the melt spinning property of the hollow monofilament deteriorates. However, it is not preferable because the strength is significantly reduced.

The medical flow guide wire of the present invention comprises:
Since the hollow monofilament contains the above-mentioned component (a), it has excellent flexibility, the occurrence of kinks during operation is eliminated, and the operability is remarkably improved.

Further, in the medical flow guide wire of the present invention, the entire length or at least a part of the hollow monofilament is subjected to an antithrombotic treatment to improve the sliding property when guiding it into the blood vessel, and The guideability is excellent, and the effect of being able to perform a natural and natural operation can be obtained. However, since the component (b) is contained, the processability of the antithrombotic processing in this case is excellent,
The processed guide wire exhibits excellent antithrombotic properties.

Examples of the antithrombogenic agent used for the antithrombotic treatment include "Anthuron" manufactured by Toray Industries, Inc., "Thrombolite" manufactured by Sherwood Japan, and "Bioline" manufactured by Nipro Medical Co., Ltd. A treatment using "Anthuron" made of heparinized hydrophilic material ion-bonded with heparin manufactured by K.K. is preferable because it has a high antithrombotic effect and good workability.

As mentioned above, the hollow monofilament is
By containing the polyurethane, the polyurethane exhibits an excellent binder effect on the antithrombogenic treatment agent, and the adhesion of the antithrombotic treatment agent to the surface of the hollow monofilament is improved, which is far superior to the conventional one. Since the antithrombogenicity can be secured, the operability of the flow guide wire itself is significantly improved.

Further, since the hollow monofilament is mixed with the above-mentioned component (c), it is possible to sufficiently monitor the flexible portion at the tip where the image is not displayed on the X-ray TV monitor when the X-ray is projected. The overall contrast is improved, and not only is the running stability to a prescribed site excellent when inserted into a blood vessel, but also when introducing a catheter, the catheter can be smoothly introduced along the flow guide wire. be able to.

Next, an embodiment of the medical flow guide wire of the present invention will be described with reference to the drawings.

FIG. 1 is a sectional view showing an embodiment of the medical flow guide wire of the present invention.

In the embodiment shown in FIG. 1, the medical flow guide wire 1 is a hollow monofilament 2 in which a metal wire 3 such as a tungsten wire or a Ti--Ni superelastic alloy wire is enclosed and enclosed. is there.

In the medical flow guidewire 1 shown in FIG. 1, a distal end guide portion including a spherical portion 21, a flexible portion 22 and a taper portion 23 and an operating portion 24 are provided from the front end to the rear end of the hollow monofilament 2. Further, the tip spherical portion 21 has a chip 4 made of an X-ray impermeable metal built therein.

By processing the tip 31 of the metal wire 3 into a tapered shape as shown in the drawing, the guideability of the tip is further improved, and the operability as a whole is further improved.

Further, the tip tapered portion 31 of the metal wire 3
Does not necessarily have to reach the position of the tip spherical portion 21 of the hollow monofilament 2. For example, the tip position is set to the position of the flexible portion 22 or the tapered portion 23, and the tip spherical portion 21 does not have an X-ray line such as gold or tungsten. By inserting the tip 7 made of a transparent metal, the X-ray monitorability of the tip can be further improved.

In this way, by forming the outer shape of the tip guide portion composed of the sphere portion 21, the flexible portion 22, and the taper portion 23 and the operating portion 24 in the hollow monofilament 2, the flow to the target intravascular affected portion is performed. The operability of guiding the tip of the guide wire is further improved.

That is, the spherical portion 21 at the tip has a hollow structure, and the tip of the metal wire 3 or, if necessary, the tip 4 of a radiopaque metal such as gold or tungsten is enclosed in the hollow portion. Since this sphere 21 can freely move on the bloodstream in the blood vessel and does not damage the intima of the blood vessel or dig under the intima, the conventional metal flow guide wire is pushed in. It is a natural operation that is easier than operation and does not cause patient pain,
Reach the desired affected area.

In addition, the tip sphere 21 has a very clear image on the X-ray television monitor when an X-ray is projected, and the position of the tip inserted into the body can be easily confirmed from outside the body. .

The flexible portion 22 is a thin and supple portion and has sufficient waist strength, and is designed to be thin and flexible, so that the free movement of the spherical portion in the blood vessel is made more effective. To do. Moreover, even in this thin flexible portion, since the X-ray contrast agent is contained within the wall thickness, it has excellent contrast and can be sufficiently monitored and monitored from the outside.

The diameter of the taper portion 23 is the operating portion 24.
The taper shape is gradually increased toward the operation portion 24 and has the same diameter as the operation portion 24 when it reaches the operation portion 24. Promote and bring out the full potential. Therefore, abnormal retention of blood can be prevented, and delicate operations such as forward movement and backward movement can be easily performed in the process of introducing the bulb portion 21 into the intended inlet of the blood vessel.

The operating portion 24 has a metal inner core portion 3 built in a hollow portion extending over substantially its entire length and contains an X-ray contrast agent in its thickness, so that the operating portion 24 is appropriately hard and appropriately flexible. Therefore, since it has a strong waist, the operability of making the ball portion 21 at the tip reach the target intravascular affected area,
For example, an introduction operation for allowing the distal ball portion 21 of the flow guide wire introduced into the artery from the thigh to reach the affected area from the peripheral blood vessel via the branch from the aorta and the hepatic artery is performed at the entrance of the flow guide wire, that is, the thigh. In the above, the workability in performing the operation while operating the operating portion 24 is significantly improved, and not only the operation of the ball portion can be performed from outside the body, but also monitor monitoring from the outside of the body is excellent.

In producing the medical flow guide wire 1 of the present invention, the above resin composition is first subjected to a usual melt extrusion or spinning method using a hollow spinneret to form a hollow monofilament 2, and then, if desired. This is appropriately stretched and cut into an appropriate length.

Next, the tip portion of the cut hollow monofilament 2 is subjected to local high-magnification drawing,
Tip spherical portion 21, flexible portion 22 and tapered portion 2
3 are made all at once, and if necessary, a tip 4 of an X-ray-ray-impermeable metal such as gold or tungsten is provided in the hollow portion of the tip sphere portion 21 forming portion, and a metal wire 3 is provided in the hollow portion of the hollow monofilament 2. After inserting each, seal both ends.

Further, the surface of the hollow monofilament 2 is subjected to antithrombogenic treatment to complete the medical flow guide wire 1 of this embodiment.

The outer diameter and the total length of the medical flow guide wire of the present invention can be arbitrarily selected according to the kind of the affected area to be used and the age of the patient, but usually the outer diameter is 0.5 to.
3.0 mm, total length 120 cm or more, especially 130-250
It is preferably in the cm range.

The medical flow guide wire of the present invention having the above-mentioned constitution is inserted into a blood vessel, and the tip is selectively made to reach the target affected area on the basis of contrast enhancement by X-ray projection. Then it is used as a so-called catheter auxiliary tool for introducing a catheter along this and inspecting the state of the intravascular affected area or delivering the therapeutic drug solution to the affected area, but at that time there is no risk of causing thrombus adhesion or kink, The guideability of the tip and the operability of the whole, especially the operation part, are excellent.

Therefore, the medical flow guide wire of the present invention can be inserted into, for example, a meandering portion of a blood vessel or a peripheral blood vessel in a superselective manner. Since it is particularly easy to operate, it can be inserted into a peripheral blood vessel or a meandering blood vessel. Can be introduced very easily.

[0049]

[Test Example] The structure and effects of the present invention will be further described below with reference to test examples.

Test Example 1 As a polyether block amide copolymer, 30% by weight of "Pebax" (3533SA00, Shore hardness: A83) manufactured by Toray Industries, Inc. and "Tecoflex" manufactured by Thermedix Co., Ltd. as polyurethane were used. A resin composition containing 30% by weight and 40% by weight of barium sulfate as an X-ray contrast agent is subjected to a melt spinning method using a hollow spinneret to spin a hollow monofilament having a diameter of 0.8 mm and a hollow diameter of 0.4 mm. Then, it was cut into a length of 1.5 m.

The hollow monofilament is selectively stretched about 3 times in steam, leaving a sphere forming portion of about 3 mm at one end, and the diameter is 0.25 mm and the length is 50 mm.
The flexible part and the taper part having a length of 90 mm were prepared all at once.

Next, in the hollow portion of the tip spherical portion, the diameter = 0.3
8mm, length = 2.5mm, insert a gold chip, and heat-seal the tip, diameter = 0.8mm, length =
A 2.5 mm rectangular tip sphere was formed.

On the other hand, from the hollow portion at the other end of the operating portion, the diameter = 0.
Insert a straight metal wire made of Ti-Ni alloy with a length of 3 mm and a length of 1.54 m and tapering one end into the inside diameter of the hollow monofilament with the taper side facing the tip. Then, after filling a part of the tapered portion and the inside diameter of the entire operating portion, the rear end of the operating portion was sealed.

Next, the heparinized hydrophilic material "Anthlon" from Toray Industries, Inc. was applied to the surface of the hollow monofilament.
The anti-thrombotic treatment according to 1. was completed to complete the flow guide wire having the shape of FIG.

The flow guide wire obtained above was percutaneously inserted into the femoral artery and introduced into a coronary artery via the aorta. As a result, it was applied to a clinical test, and as a result, it had excellent antithrombotic properties and friction when contacting the blood vessel wall. Not only the resistance is small, but also the sliding characteristics are improved, and the tip is supple and has excellent flexibility, so the guideability and operability of the tip are extremely good. It was possible to easily reach the affected area, and the X-ray monitorability (imaging property) of the entire flow guide wire was very good.

[0056]

As described in detail above, the medical flow guide wire of the present invention has excellent X-ray monitorability (contrast property) as a whole, the operation part has a waist, and the tip is supple and moderately flexible. In addition to its excellent running stability to a predetermined site during insertion into a blood vessel, the catheter can be smoothly introduced along the flow guide wire when the catheter is introduced.

Further, the medical flow guide wire of the present invention can be easily subjected to antithrombotic treatment, the antithrombotic treatment agent has good adhesiveness, and the thrombus hardly adheres to form a smooth surface. As a result, it has good sliding characteristics, does not cause kinks during operation, has excellent guideability into the blood vessel, and can reduce the pain and burden on the patient.

Therefore, the medical flow guide wire of the present invention is
The overall operability is further improved, and it exhibits a useful effect in a wide range of clinical situations such as catheter exchange surgery mainly for arteries.

[Brief description of drawings]

FIG. 1 is a sectional explanatory view showing an example of a medical flow guide wire of the present invention.

[Explanation of symbols]

 1 ... Medical flow guide wire 2 ... Hollow monofilament 21 ... Sphere portion 22 ... Flexible portion 23 ... Tapered portion 24 ... Operation portion 3 ... Metal wire 31 ... Tapered portion 4 ... Roentgen ray impermeable metal tip body

Claims (2)

[Claims] 1. A medical flow guide wire comprising a synthetic resin hollow monofilament in which a metal wire is enclosed in a hollow portion, wherein the hollow monofilament comprises (a)
25-40% by weight of polyether block amide copolymer, 25-40% by weight of (b) polyurethane and (c)
A medical flow guide wire comprising a composition containing 50 to 20% by weight of an X-ray contrast agent. 2. The hollow monofilament made of synthetic resin has an outer shape consisting of a sphere portion, a flexible portion, a tip portion composed of a taper portion, and an operation portion extending from the tip portion to the rear end portion. The described medical flow guide wire.