JPH06277294A - Self-guide type catheter - Google Patents

Abstract

PURPOSE:To improve operability and to relieve a patient's pain by subjecting a hollow monofilament having a specific hollow rate to at least two stages of local stretching, thereby successively increasing the outside diameter and hollow diameter from the front end to the rear end thereof. CONSTITUTION:The hollow monofilament 1 made of a synthetic resin having a hollow part 2 communicating with the entire part and having 50 to 80% hollow rate is used as a basic structure. A two-stage locally stretched part 4 and a one-stage locally stretched part 3 are successively formed from the front end to the rear end thereof. A liquid drug leading-out port 5 is opened on the front end side of the two-stage locally stretched part 4 and a liquid drug injection port 6 is opened on the rear end side of the hollow monofilament 1. Further, an X-ray impermeable metallic wire 9 having the diameter smaller than the bore of the hollow part 2 is built in the hollow part 2. A gap 8 between the inside wall of the hollow monofilament 1 and the surface of the metallic wire 9 is utilized as a liquid drug transporting path. As a result, the traveling stability to a prescribed part at the time of insertion into the blood vessel is improved.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a self-guided catheter which serves both as a guide wire and a catheter used for inspecting the condition of a diseased part in a blood vessel and for catheter treatment. More specifically, it has excellent operability,
The present invention relates to a self-guided catheter capable of reducing pain to a patient and capable of superselective treatment of an intravascular affected area.

[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 Co., UMI Co., USCI Co., etc. in the US, for example, a coiled metal wire made of stainless steel wire, piano wire or the like is used. In general, a catheter is used in combination with the guide wire, and examples of catheters used in combination with the guide wire include UMI in the United States.
Synthetic resin tubes manufactured and sold by the company, ECC, USCI, 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 the catheter is introduced in such a manner as to cover it, and after reaching the affected area, the guide wire is withdrawn, or, as it is, a therapeutic drug solution is injected from the end of the catheter and introduced into the affected area. Steps are required.

However, in the above-mentioned treatment operation, thrombus is apt to adhere due to the unevenness peculiar to the coil wire on the surface of the metal guide wire itself, and since the guide wire is made of metal and hard, insertion operation into a blood vessel is performed. Requires complicated procedures and advanced techniques, and it takes a long time to operate.Because of the metal filaments, it is easy to damage the intima of the blood vessel during operation or to dig under the endovascular membrane. However, in addition to causing a great deal of pain and burden to the patient being treated, it is extremely difficult to selectively reach the affected portion in the peripheral blood vessel such as coronary vein with the tip of the guide wire. It was

On the other hand, when the catheter is introduced, the catheter itself is thicker than the guide wire, so that the burden on the patient is further increased, and the tip of the catheter can reach the position reached by the guide wire in advance. Difficult and this tendency is more pronounced in peripheral blood vessels.

Therefore, the conventional treatment system using both the guide wire and the catheter requires not only many procedures such as guide wire insertion, catheter insertion, guide wire withdrawal, and drug solution injection. In many cases, a plurality of guide wires or catheters having various shapes are used in combination, so that the operation takes a long time, and the burden on the patient is large, which requires a great deal of cost. there were.

[0008]

The present invention has been achieved as a result of investigations for solving the above-mentioned problems in the conventional catheter treatment.

Therefore, an object of the present invention is to combine the functions of a guide wire and a catheter with excellent operability,
It is an object of the present invention to provide a self-guided catheter which can reduce the pain to the patient and can perform superselective treatment of an intravascular affected area.

[0010]

In order to achieve the above object, the self-guided catheter of the present invention has a hollowness of 5%.
The basic structure is a hollow monofilament made of 0 to 80% synthetic resin, the leading end thereof is a chemical solution outlet, and the rear end thereof is a chemical solution inlet, and the hollow portion communicating the chemical solution outlet and the chemical solution inlet, In a self-guided catheter in which a radiographic ray impermeable metal filament having a wire diameter capable of ensuring a void communicating with the inner wall of the hollow portion is incorporated, and the void serves as a drug solution transport path, at least with respect to the hollow monofilament. It is characterized in that the outer diameter and the hollow diameter from the front end to the rear end are successively increased by performing two-stage local stretching.

In the self-guided catheter of the present invention, the material of the hollow monofilament made of synthetic resin, which is the basic structure of the self-guided catheter, is not particularly limited as long as it is a material that can be melt-extruded and stretched, but polyamide, polyester, polyolefin, Polyether block amide copolymer, polyurethane, polyvinyl chloride and fluororesin are preferably used.

The hollow monofilament made of synthetic resin is produced by subjecting the above resin to a usual melt extrusion or spinning method using a hollow spinneret, and if necessary, appropriately stretching and cutting it into a suitable length. The hollow ratio of this hollow monofilament is set in the range of 50 to 80%.

That is, if the hollow ratio of the synthetic resin hollow monofilament is 50% or less, the function as a chemical solution transporting path is deteriorated, and if it is 80% or more, the hollow monofilament tends to be damaged by the pressure at the time of chemical solution injection, which is not preferable.

The X-ray non-transmissive metal wire (hereinafter simply referred to as metal wire) to be incorporated in the hollow part of the synthetic resin hollow monofilament has a diameter smaller than the inner diameter of the hollow part. These X-ray non-transparent metal filaments function to impart appropriate flexibility and elasticity to the hollow monofilament and enhance its operability.

Specific examples of these metal filaments include tungsten wire, stainless steel wire, piano wire and various superelastic alloy wires such as Ti--Ni alloy wire, Cu--Zn alloy wire and Ni--Al alloy. However, among them, it is preferable to use a tungsten wire which is excellent in radiopaque property and relatively inexpensive, and a Ti-Ni superelastic alloy wire which has good workability and stable quality.

Next, an embodiment of the self-guided catheter of the present invention will be described with reference to the drawings.

FIG. 1 is an explanatory sectional view showing an example of the self-guided catheter of the present invention, FIG. 2 is an enlarged sectional view of a portion A in FIG. 1, and FIG.

In the embodiment shown in FIG. 1, the self-guided catheter of the present invention has a synthetic resin hollow monofilament 1 having a hollow portion 2 communicating with the whole as a basic structure, and a main body portion (from the tip to the rear end) It is constituted by sequentially forming the two-stage local extension part 4 and the one-stage local extension part 3 to 1).

The two-stage locally extended portion 4 is the thinnest and most flexible portion, and preferably has a metal wire 9 built in a part of the hollow portion 2.

The first-stage locally extending portion 3 is a portion having a larger outer diameter than the second-stage locally extending portion 4 and a smaller outer diameter than the main body portion (1), and is a hollow portion over the entire length thereof. 2 has a metal wire 9 built therein.

A chemical solution outlet 5 is formed on the tip side of the two-stage locally extended portion 4, and a chemical solution inlet 6 is formed on the rear side of the hollow monofilament 1. In the drawings, the chemical solution outlet port 5 is open at the tip of the two-stage local extension part 4, but it may be provided on the side part of the two-stage local extension part 4 in some cases.

As shown in FIG. 3, a hollow tip 7 made of an X-ray impermeable metal is tightly fitted in the tip chemical solution outlet 5, and the hollow portion 7 of the tip 7 is tightly fitted.
′ And the hollow part of the two-stage local extension part 4 communicate with the chemical liquid outlet 4. The material of the tip 7 used here is gold, platinum, platinum, tungsten, stainless steel, T
Examples thereof include i-Ni alloy and Cu-Zn alloy.

Further, a connector 10 for connecting with a syringe or the like is connected to the rear end side drug solution introducing port 6 side,
The chemical injection port 12 is formed.

On the other hand, the hollow portion 2 of the hollow monofilament 1
Contains a metal filament 9 having a diameter smaller than the inner diameter of the hollow portion 2, and uses the void 8 between the inner wall of the hollow monofilament 1 and the surface of the metal filament 9 as a chemical liquid transport path. It has a structure.

Here, the diameter of the metal filament 9 is in the range of 30 to 80% of the inner diameter of the hollow portion 2 of the hollow monofilament 1, specifically 0.1 to 1.0 mm, especially 0.2 to 0.5 mm. The range is preferable, and in order to improve the operability and the supply of the chemical liquid, it is preferable that the end portion in the front end direction is processed into a tapered shape.

These metal filaments are usually coated with a resin such as polyamide, polyester, polyolefin, polyurethane, polyvinyl chloride and fluororesin in consideration of the reactivity with the chemical solution used. preferable.

The rear end of the metal filament 4 is passed through the ring packing 11 of the connector 10 and pulled out from the rear end of the hollow monofilament 1 to be supported. If the support of the metal wire 9 is incomplete, it will leak from the ring packing when the chemical solution is injected, and therefore the rear end of the connector 10 may be covered with a cap. In addition, in this case, the flexibility of the two-stage local extension part 4 can be improved by making it possible to perform operations such as pulling and pushing with respect to the rear end side of the metal filament 4 that is drawn from the rear end of the hollow monofilament 1 to the outside. And the elasticity can be finely adjusted, and it becomes easy to achieve superselective treatment at will.

In the above structure, a space 8 is formed between the liquid medicine inlet 12 and the liquid medicine inlet 6 of the connector 10, and the body portion (1) of the catheter, the first-stage locally extending portion 3, and the second-stage locally extending portion 4 are communicated with each other. The part is a chemical liquid transportation route,
The drug solution injected from the drug solution inlet 12 is led out to the affected area from the drug solution outlet 5. Therefore, the void (chemical solution transport path) 8 is usually sterilized.

The size of each part of the catheter of the present invention is not particularly limited because it depends on conditions such as the age and constitution of the patient to be treated or the condition of the affected part, but typical typical sizes of each part are exemplified. It is as follows.

Diameter (mm) Hollow diameter (mm) Length (mm) Main body (1) 0.60-2.0 0.30-1.9 200 <One-stage local extension 3 0.55-1.5 0.27-1.2 50-700 Two-stage local extension 4 0.40-1.0 0.25-0.8 10-300 In the self-guided catheter of the present invention, the tip is inserted into a blood vessel, the tip is allowed to reach the affected part while being monitored and monitored from the outside, and then the drug solution inlet 12 at the rear end is used. By injecting the drug solution, the drug solution is discharged from the drug solution outlet 5 at the tip to the affected part through the drug solution transport path (8).
By only inserting the self-guided catheter into the blood vessel once, the required drug solution can be administered, and the conventional catheter treatment means can be simplified to reduce the pain to the patient.

That is, since the two-stage locally extended portion 4 at the tip has a thin and flexible hollow structure, it can freely move on the bloodstream in the blood vessel, and is different from the conventional pushing operation. It reaches the target affected area without causing pain to the patient by a natural and natural operation.

In addition, the two-stage local extension part 4 has a metal wire built therein or preferably has a tip 7 made of a radiopaque metal impermeable to the tip thereof, so that when the radiograph is projected. The image on the X-ray TV monitor is clear, and the position of the tip inserted into the body can be easily confirmed from outside the body.

Since the first-stage locally extending portion 3 is the thinnest and supple portion next to the second-stage locally extending portion 4 and has sufficient waist strength, abnormal retention of blood can be prevented and
Delicate operations such as forward and backward movements can be easily performed in the process of introducing the two-stage local extension part 4 into the intended inlet of the blood vessel. Moreover, even in the one-stage locally extended portion 3, since the metal wire 9 is built in the hollow portion 2, it has excellent contrast and can be sufficiently monitored and monitored from the outside.

Since the main body (1) has the metal wire 9 built in the hollow portion 2 extending over its entire length, it is moderately hard, moderately flexible, and has a strong waist. Operability to make the stretched portion 3 and the two-stage local stretched portion 4 reach the target intravascular affected area, for example, the distal end portion of the catheter introduced into the artery from the femoral region, through the branch from the aorta and the hepatic artery, to the peripheral blood vessel. From the outside of the body, the workability when performing the introduction operation to further reach the affected area from the catheter entrance, that is, the thigh while operating the main body (1) is significantly improved. In addition to being able to do so, the monitorability from the outside of the body is also excellent.

In producing the self-guided catheter of the present invention, a resin material is first subjected to a usual melt extrusion or spinning method using a hollow spinneret to form a hollow monofilament 1 and then, if desired, it is appropriately stretched. And cut it to an appropriate length.

Next, the cut tip of the hollow monofilament 2 is subjected to local high-magnification drawing to form a one-step local drawing section 3 and a two-step local drawing section 4 at once, and then, if necessary. Accordingly, a tip 7 of a radiopaque metal such as gold or tungsten is provided around the tip chemical solution outlet 5, and a metal wire strip 9 having a diameter smaller than the inner diameter of the hollow portion is provided in the hollow portion 2 of the hollow monofilament 1. After inserting each of them, the rear end of the metal wire 9 is fixed to the vicinity of the chemical liquid inlet 6 with a ring packing 11, and the main body (1)
The connector 10 is connected to the rear end side.

Further, if necessary, the surface of the hollow monofilament 1 is subjected to an antithrombotic treatment,
The self-guided catheter of this example is completed.

In the above embodiment, the example in which the one-stage local stretching portion 3 and the two-stage local stretching portion 4, that is, two local stretching portions are provided, is described. However, the hollow monofilament 1 has three or more stages. It is also possible to further improve the operability of the catheter by providing more local stretched portions by performing local stretch. The self-guided catheter of the present invention having the above-described configuration is inserted into a blood vessel, and the tip is selectively made to reach the target affected area based on the imaging by X-ray projection, and then the drug solution injection port. 1
It is used as a so-called catheter for injecting a drug solution from 2 and for inspecting the condition of an intravascular affected area or delivering a therapeutic drug solution to the affected area. In comparison with a conventional treatment procedure using a guide wire, a catheter is introduced into the blood vessel. Since it only needs to be inserted once, the procedure is simplified and the pain on the patient can be reduced, and the guideability and operability of the tip are extremely excellent.

Therefore, the self-guided catheter of the present invention can be inserted into, for example, a tortuous portion of a blood vessel or a peripheral blood vessel in a superselective manner, and is particularly easy to operate. Installation can be done very easily.

[0040]

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

Test Example 1 Polyethylene terephthalate ("Type 9" manufactured by Toray Industries, Inc.)
00 "was subjected to a melt spinning method using a hollow spinneret, and a diameter =
A hollow monofilament having a diameter of 1.0 mm and a hollow diameter of 0.80 mm was spun and cut into a length of 1.3 m.

Then, by locally stretching the hollow monofilament from the tip of the hollow monofilament by about 2.78 times and then about 1.56 times using a local stretching device, the diameter = 0.
65mm, length = 150mm two-stage local extension and diameter =
A single-stage locally stretched part having a length of 0.80 mm and a length of 350 mm was prepared all at once, and the rear end side was cut so that the total length from the front end was 1.3 m.

Next, in the hollow portion at the tip of the two-stage locally extended portion, diameter = 0.52 mm, hollow diameter = 0.42 mm, length =
By inserting a 2.0 mm gold hollow tip, heating and half-sealing, and tightly fitting, a chemical solution outlet having an opening diameter of 0.45 mm was secured.

On the other hand, a Y-shaped connector made of acrylic PET was attached to the other end of the hollow monofilament with an adhesive (Sankyo Co., Ltd.).
Manufactured by Acrylic Hard Rock E510K), and fixed from the rear end of the Y connector to the tip diameter = 0.
04mm, rear end diameter = 0.255mm, length = 1.4m,
After inserting stainless steel wire 304 with a taper into the inside diameter of the hollow monofilament, with the taper side facing toward the tip, the metal wire protruding from the rear end has an outer diameter of 4.0 mm and an inner diameter. A self-guided catheter of the present invention was completed by inserting a silicon rubber ring packing having a length of = 0.253 mm and a length of 6.0 mm and fixing it in the groove of the Y connector.

The catheter obtained above was percutaneously inserted into the femoral artery, introduced into the coronary artery via the aorta, and applied to a clinical test in which the desired drug solution was injected into the affected area. Because it has excellent flexibility,
The tip has excellent guideability and operability, and the tip can easily reach the target affected area, and the whole catheter can be monitored by X-ray (contrast).
Was also very good.

[0046]

As described in detail above, the self-guided catheter of the present invention has an excellent X-ray monitoring property (imaging property) as a whole, the operation part (main body part) has a waist, and the tip part is supple. Since it has appropriate flexibility, it has excellent running stability to a predetermined site when it is inserted into a blood vessel.

Therefore, in the self-guided catheter of the present invention, compared with the conventional treatment procedure using a guide wire, the drug solution can be injected by only inserting it once into the blood vessel, so that the operation procedure is simplified. Since the pain to the patient is reduced and the operability is excellent, it exhibits a useful effect in a wide range of clinical situations such as catheter exchange surgery mainly on arteries.

[Brief description of drawings]

FIG. 1 is a sectional view showing an embodiment of the self-guided catheter of the present invention.

FIG. 2 is an enlarged cross-sectional view of a portion A in FIG.

FIG. 3 is a perspective explanatory view of a tip portion of the same.

[Explanation of symbols]

 1 ... Hollow monofilament (main body part) 2 ... Hollow part 3 ... One-step local extension part 4 ... Two-step local extension part 5 ... Chemical solution outlet port 6 ... Chemical solution inlet port 7 ... Chip 8 ... Void ( Chemical liquid transport route) 9 …… Roent-ray impermeable metal wire strip 10 …… Connector 11 …… Ring packing 12 …… Chemical liquid inlet

Claims (3)

[Claims] 1. A synthetic resin hollow monofilament having a hollowness of 50 to 80% as a basic structure, the front end of which is a chemical solution outlet and the rear end of which is a chemical solution inlet, and the chemical solution outlet and the chemical solution are introduced. A self-guided catheter in which a roentgen ray impermeable metal filament having a wire diameter capable of ensuring a void communicating with the hollow inner wall is built in the hollow portion communicating the mouth, and the void serves as a drug solution transport path. In the self-guided catheter, the hollow monofilament is locally expanded in at least two stages so that the outer diameter and the hollow diameter from the front end to the rear end are sequentially increased. 2. The self-guided catheter according to claim 1, wherein a tip made of a radiopaque metal is tightly fitted to the drug solution outlet. 3. The X-ray non-transmissive metal filament has a taper shape on the front end side.
Or the self-guided catheter according to item 2.