JPH05309137A - Guide wire for medical care - Google Patents

Abstract

PURPOSE:To enable precise temperature control in heating medicine applied to lesion while improving properties required for a guide wire. CONSTITUTION:A metal thinnest wire 8, heater 9, thermo couple lead wire 10 and dummy wire 11 as one-wires are wound wrapped in a mutual condition of electric insulation and formed into a composite wire 6 with self elasticity. The outer surface of the composite wire 6 is covered with a resin layer 7 to form a guide wire 3. Low carbon microduplex structure steel wires having a tensile strength of 300Kg/mm<2> or more are adopted for the metal thinnest wire 8 and the dummy wire 11.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a medical guide wire used for inserting a diagnostic / treatment catheter, a blood circulation tube or the like into the body, and for holding the catheter or the like in a substantially straight line shape. While improving the characteristics required for the guide wire, it is a completely new type developed to accurately control the temperature when heating the affected area or heating the blood or drugs to be administered to the affected area. Regarding the structure of the guide wire.

[0002]

2. Description of the Related Art In recent years, a method of diagnosing and treating an affected area by inserting a catheter into the body and administering a drug from the tip portion of the catheter has attracted attention. When inserting this catheter into the body, a guide wire is inserted into the catheter so that the guide wire can advance and retreat, and the guide wire guides the catheter to the affected area. When this type of catheter is used for treating obstructive jaundice due to liver cancer, for example, there is hyperthermia therapy in which a drug such as an anti-cancer drug is directly injected into the affected area in a hot state to relieve symptoms. In this case, in order to reduce the pain to the patient and improve the therapeutic effect,
It is necessary to keep the temperature of the drug within a predetermined range, which requires high temperature accuracy. As a method for supplying the drug with heat, conventionally, the drug is separately heated using a warmer coil or the like, and the warmed drug is injected into the affected area with a catheter.

[0003]

However, in the above-mentioned conventional method of preheating a drug, since the temperature of the drug is lowered by the time it reaches the affected area through the catheter, a high temperature is set in advance. Moreover, the actual temperature at the affected area is unknown. As described above, the conventional method has a problem that the temperature cannot be controlled accurately. In addition, since the guide wire has to be inserted along a complicatedly bent body due to its application, it is flexible and has high pushability when pushed, and the catheter is straight. There is a demand for improvement in properties such as strength that can be retained.

The present invention has been made in view of the above-mentioned conventional circumstances, and warms the affected area or injects warmed blood or a drug into the affected area while improving each characteristic required for the guide wire. An object of the present invention is to provide a medical guide wire having a completely new structure capable of accurately controlling the temperature in the case.

[0005]

Therefore, in the invention of claim 1, a metal fine wire made of a single wire or a stranded wire, a heater wire, and a temperature sensor lead wire are wound in an electrically insulated state from each other. A medical guide wire characterized in that an outer surface of a composite wire having self-elasticity is coated with a resin. Further, the invention of claim 2 is characterized in that a dummy wire is added to the composite wire, and the invention of claim 3 is the low carbon dual phase steel having a tensile strength of 300 Kg / mm ² or more on the ultrafine metal wire. Characterized by the use of lines.

Here, as the structure of the composite wire, for example, a metal ultrafine wire is used as a core material, and a heater wire, a lead wire or the like is spirally wound around the outer peripheral surface thereof, or the metal ultrafine wire or heater. Wires and lead wires that are bundled and twisted together can be used. And in the present invention, self-elasticity means
For example, when a linear compound wire is bent with a constant force, the original linear state is restored when this force is removed.
Also, for example, the tip connection part of the thermocouple becomes a temperature sensor,
The part other than the sensor becomes a lead wire.

In addition, a dummy wire is added to the composite wire in order to improve the roundness of the guide wire and to smooth the outer surface of the wire, which allows a space between the guide wire and the catheter. This is because it is possible to reduce the resistance of flowing blood, medicines, etc., and improve the flowability.

Further, as the metal ultrafine wire, stainless wire, piano wire, low carbon dual phase steel wire or the like can be adopted. In particular, when low carbon dual phase steel wire is adopted,
Compared with stainless steel wire, etc., the flexibility, pushability, and strength can be further improved, and the diameter can be reduced. This low carbon dual-phase steel wire is produced by subjecting a wire containing Fe as a main component and adding C, Si, and Mn in predetermined amounts to a strong work by cold drawing. It has a fibrous fine metal structure by processing, which results in a wire diameter of 100 μm or less and a tensile strength of 300 Kg / mm ² or more (see JP-A-62-20824).

[0009]

According to the medical guide wire of the first aspect of the present invention, since the composite wire formed by winding the metal ultrafine wire, the heater wire and the temperature detecting lead wire is resin-coated, the guide wire itself. The drug injected into the catheter is heated as it flows through the guide wire because it heats up, and the temperature sensor can detect the temperature of the distal end of the catheter, that is, the affected part. The temperature can be controlled accurately and easily. As a result, it is possible to solve the problem of over-cooling and over-heating when a conventional drug is separately heated and injected, and it is possible to improve reliability in performing diagnosis and treatment. Further, in the present invention, since the composite wire is configured such that the metal ultrafine wire, the heater wire, and the lead wire have self-elasticity, the flexibility to bend freely and the pushability to surely advance in the pushing direction, and The strength for holding the catheter in a straight line can be secured, and the above-mentioned demand can be met. The self-elasticity of the guide wire can be adjusted by adjusting the angle of the winding wire with respect to the axis. In this case, the flexibility can be improved as the angle is closer to the axis right angle, and the pushability can be improved as the angle is closer to the axis.

Further, according to the invention of claim 2, since the dummy wire is added to the composite wire, the roundness of the guide wire can be improved and the surface can be smoothed to that extent. The resistance can be reduced, and the flowability can be improved.

Further, in the invention of claim 3, since the low carbon dual phase steel wire is adopted as the metal ultrafine wire, the tensile strength of 300 to 600 kg / mm ² can be obtained at the wire diameter of 100 μm or less. The strength of the wire can be further improved compared to wires and piano wires, and the diameter of the guide wire can be reduced.

[0012]

Embodiments of the present invention will be described below with reference to the drawings. 1 to 4 are views for explaining a medical guide wire according to an embodiment of the present invention. In the figure, 1
Is a tubular catheter, the tip 1 of which
There is a jet hole for administering the drug in a, and a rear end portion 1b.
A drug injecting section 2 is formed in a branched manner.
An infusion pump (not shown) is connected to.

A guide wire 3 is inserted in the catheter 1. The guide wire 3 includes an insertion portion 3a having an outer diameter of about 0.8 mm to be inserted into the body, and an operation portion 3b formed on the rear end of the insertion portion 3a having an outer diameter of about 1.5 mm.
The operating portion 3b projects outward from the rear end portion 1b of the catheter 1. A control device 5 is connected to the operation part 3b via an adapter 4, and the control device 5 has a heating power supply part 5a and a temperature display part 5b built therein.

The guide wire 3 is made of Teflon (registered trademark) on the outer surface of the composite wire 6 which characterizes the present embodiment.
Is formed by coating. The core of this composite wire 6 has a diameter of 0.2 mm and is a single fine metal wire 8
Are arranged in a straight line, and the ultrafine wire 8 is covered with an insulating resin film 8a. This ultrafine metal wire 8 is made of a low-carbon dual-phase steel wire, which has a fibrous fine metallographic structure in which the processing cells produced by the strong working are arranged in one direction in the form of fibers, Tensile strength of 300-600Kg / m
m ² . A Ni plating film 8b is formed on the surface of the low carbon dual phase steel wire, and the plating film 8b has a working strain due to plastic working during wire drawing work. Has improved adhesion.

A pair of heater wires 9 and a lead wire 10 of a thermocouple are arranged alternately on the outer peripheral surface of the metal ultrafine wire 8, and each heater wire 9 and lead wire 10 are arranged. Dummy lines 11 are arranged between the two. The above-mentioned low carbon dual phase steel wire is adopted for each dummy wire 11. A resin wire or a copper wire may be used as the dummy wire. The heater wire 9, lead wire 10 and dummy wire 11 all have a wire diameter of 0.1 mm.
φ, and these are wound around the metal ultrafine wire 8 in a coil shape. In this way, the composite wire 6 having a self-elasticity and a perfect circle is formed. In addition, an insulating film 9 is formed on the surfaces of the heater wire 9, the lead wire 10 and each dummy wire 11.
a, 10a, 11a are formed so that the wires are insulated from each other.

Further, the tip portion 9c of the heater wire 9 is located at the tip portion of the ultrafine metal wire 8, and the rear end portion 9b of the heater wire 9 is connected via the connector 12 to the heating power source portion 5a of the controller 5. It is connected to the. Further, the tip portion 10c of the lead wire 10 is located in front of the tip portion 9c of the heater wire, and the connecting portion of the tip portion 10c is the temperature sensor 1.
It is 3. The temperature of the heater wire 9 itself is avoided by keeping a distance between the temperature sensor 13 and the heater tip 9c. The rear end portion 10b of the lead wire 10 is connected to the temperature display portion 5b via the terminal 14.

Next, the function and effect of this embodiment will be described. The catheter 1 of the present embodiment is used for treating obstructive jaundice due to liver cancer, for example. The guide wire 3 is inserted into the catheter 1 and is inserted into an artery while being held in a substantially straight line, and the distal end portion 1a of the guide wire 3 reaches the affected area while pushing the guide wire 3 forward. In this state, the catheter 1
By injecting blood, physiological saline, or an anti-cancer agent from the injection part 2 of the above, the blood vessel of the affected area is embolized and ischemized, or the affected area is directly heated and heated with heated blood and drug. To treat. When the anticancer agent is administered, the heater wire 9 is energized by the heating power supply unit 5a of the control device 5 to heat the guide wire 3 to heat the anticancer agent, and the temperature of the anticancer agent is adjusted to the tip of the thermocouple. The temperature is detected by the temperature sensor 13 of the unit and the temperature is adjusted by operating the power supply unit 5a while confirming the detected value on the temperature display unit 5b. This sets the anti-cancer agent to the desired temperature, for example 43 ° C.
In this case, the temperature setting may be feedback controlled by a computer.

As described above, according to the guide wire 3 of this embodiment, the metal fine wire 8 is used as the core, and the heater wire 9, the lead wire 10 and the demi wire 11 are wound around the outer peripheral surface of the core in a coil shape to form a composite wire. 6 is formed and the outer surface of the composite wire 6 is covered with the resin layer 7, the guide wire 3 is formed by the heater wire 9.
Since the temperature of the tip portion of the guide wire 3 can be detected by the temperature sensor 13, the temperature of the anticancer agent can be accurately controlled, and only the affected area can be heated. As a result, it is possible to alleviate the pain to the patient, improve the therapeutic effect, and improve the reliability when performing diagnosis and treatment. Further, in the present embodiment, since the guide wire 3 is made of a metal wire, the position of the guide wire 3 can be clearly seen on, for example, an X-ray image, and the reliability of diagnosis and treatment can be improved also from this point.

Further, in this embodiment, since the low carbon dual phase steel wire is adopted as the metal fine wire 8 and the dummy wire 11 constituting the composite wire 6, the tensile strength and toughness of the wire itself can be improved, and The wire diameter can be made extremely small. As a result, the outer diameter of the guide wire 3 can be further reduced while the flexibility and pushability of the guide wire 3 are secured, and the outer diameter of the catheter itself can be reduced, so that the guide wire 3 can be inserted into a narrower affected area.

Further, since the roundness of the guide wire 3 can be improved and the surface can be smoothed by adding the dummy wire 11 to the composite wire 6, the resistance at the time of injecting the drug can be reduced and the distribution can be improved. It is possible to improve the property.

In the above embodiment, the case of treating liver cancer has been described as an example, but the use of the guide wire of the present invention is not limited to this. For example, when a large amount of blood is transfused, it can be adopted even when the refrigerated blood is heated and injected into the body.

Further, in the above-mentioned embodiment, the single wire metallic ultrafine wire 8 is adopted, and the heater wire 9, the thermocouple 10, and the dummy wire 11 which are circular in shape are wound around the ultrafine wire 8 to form the composite wire 6. Although the case has been described as an example, the present invention is not limited to this, each wire may be bundled and wound,
Alternatively, the wires may be meshed. FIG. 5 is a diagram for explaining a guide wire according to another example of the above embodiment. This guide wire 26 is formed by twisting seven low carbon dual phase steel wires together to form a stranded wire 20, and a resin layer 21 is formed on the outer surface of the stranded wire 20 to form a metal ultrafine wire 2.
Make up 2. Further, the heater wire 23, the lead wire 24, and each dummy wire 25 are formed into an elliptical shape so that the cross section thereof has a flat shape, and the wire materials 23 to 25 are wound around the metal ultrafine wire 22 to form a composite wire 27. In this example, the composite wire 27 is covered with the resin layer 28. Also in this guide wire 26, the same effect as that of the above-described embodiment can be obtained, and the elliptical shape can improve the spring property and the self-elasticity of the entire guide wire.

[0023]

As described above, according to the medical guide wire of the first aspect of the present invention, the extra fine metal wire consisting of a single wire or a stranded wire, the heater wire, and the temperature sensor lead wire are wound. Since the composite wire having self-elasticity is formed and coated with resin, it is possible to heat the affected area directly by the heat generation of the guide wire itself, to heat blood and medicines, and to perform temperature control accurately. It has the effect of improving the reliability when performing diagnosis and treatment. It also has the flexibility to bend freely, the pushability to reliably advance in the pushing direction, and the strength to hold the catheter in a straight line. There is an effect that can be done. Further, in the invention of claim 2, since the dummy wire is added to the composite wire, there is an effect that the surface of the guide wire can be smoothed and the resistance at the time of injecting the drug can be reduced. Further, in the invention of claim 3, since the low carbon dual-phase steel wire is used as the ultrafine metal wire, the tensile strength of 300 to 600 Kg / mm ² can be obtained at a wire diameter of 100 μm or less, so that the strength can be further improved. The effect is that it can contribute to the reduction of the diameter of the guide wire.

[Brief description of drawings]

FIG. 1 is a schematic configuration diagram of a catheter system for explaining a medical guide wire according to an embodiment of the present invention.

FIG. 2 is a cross-sectional view of the guide wire of the above embodiment.

FIG. 3 is a side view of the guide wire of the above embodiment.

FIG. 4 is a cross-sectional view showing the distal end portion of the guide wire of the above embodiment.

FIG. 5 is a cross-sectional view showing a guide wire according to another example of the above embodiment.

[Explanation of symbols]

 3,26 Guide wire 6,27 Composite wire 7,28 Resin layer 8,22 Metal ultrafine wire 9,23 Heater wire 10,24 Thermocouple lead wire 11,25 Dummy wire

 ─────────────────────────────────────────────────── ─── Continuation of front page (72) Inventor Masahiko Uchimura 2 Nadahamahigashi-cho, Nada-ku, Kobe-shi, Hyogo Stock Company Kobe Steel Works, Kobe Steel Works (72) Inventor Shigenobu Otsu 1-8-2 Marunouchi, Chiyoda-ku, Tokyo No. Co., Ltd.Kobe Steel Works Tokyo Head Office

Claims (3)

[Claims] 1. A resin coating on the outer surface of a composite wire having self-elasticity in which a metal ultrafine wire made of a single wire or a stranded wire, a heater wire, and a temperature sensor lead wire are wound in an electrically insulating state from each other. A medical guide wire characterized by the above. 2. The medical guide wire according to claim 1, wherein a dummy wire is located between each of the metal ultrafine wire, the heater wire, and the lead wire. 3. The medical guide wire according to claim 1 or 2, wherein a low carbon dual phase steel wire having a tensile strength of 300 Kg / mm ² or more is adopted as the metal ultrafine wire.