JPH03141958A - Catheter - Google Patents

Abstract

PURPOSE:To make press-in force, given in the base end part of a catheter, surely transmittable to its tip end by providing a rigidity imparting unit, formed in mesh shape by a linear unit, and a reinforcing unit provided in parallel to a lumen and formed by the linear unit extended in the axial direction. CONSTITUTION:A main unit part 4, in almost linear shape, has a rigidity imparting unit 15 extended in the axial direction and a reinforcing unit 16 extended in the axial direction of the main unit part 4. The rigidity imparting unit 15, which is formed in mesh shape by a plurality of linear units, is buried in an external surface or in large thickness of resin in which an internal layer 11 is formed. The reinforcing unit 16, which is formed by a linear unit, is extended in parallel to a lumen 10 in a direction of the tip end from the base end of a catheter main unit 2. By providing the rigidity giving unit 15, folding in a main unit part of a catheter 1 is prevented further with transmissivity improvable of torque in the catheter main unit. Also, by providing the reinforcing unit 16, the catheter main unit 2 is prevented from meandering in a blood vessel, and press-in force, given to the base end part of the catheter main unit 2, can be surely transmitted to the tip end of the catheter.

Description

DETAILED DESCRIPTION OF THE INVENTION [Industrial Application Field] The present invention relates to catheters inserted into blood vessels, such as angiography catheters and vasodilator catheters.

[Prior Art] Coronary angiography has conventionally been performed to examine the state of blood vessels in the heart, and various angiography catheters have been used for this coronary angiography.

Furthermore, in recent years, vasodilation catheters have been used to dilate intravascular stenoses of the heart and improve blood flow.

In recent years, angiography catheters and vasodilator catheters are made of somewhat soft thermoplastic resin, and the outer periphery of the catheter is made of metal wire (with stainless steel wire inside the membrane). It has become possible to create a catheter that maintains a high degree of flexibility by providing an applicator, suppresses bending and crushing, and further improves torque transmittance.

[Problems to be solved by the invention] However, by providing the above-mentioned stiffening body,
Although bending and crushing of the catheter is suppressed and torque transmittance is improved, it is not possible to prevent the catheter from meandering within the blood vessel. For this reason,
The pushing force applied at the proximal end of the catheter was damped at the meandering portion, and could not be reliably transmitted to the distal end of the catheter. This problem becomes particularly noticeable when the entire catheter is made flexible in order to improve torque transmission. For this reason, the operability of the catheter is poor, and in particular, it is sometimes difficult to suppress the distal end of the catheter into the Ifll canal.

SUMMARY OF THE INVENTION Therefore, an object of the present invention is to solve the above-mentioned problems of the prior art, and to ensure that the pushing force applied at the proximal end of the catheter is less likely to be buffered at the meandering portion and is reliably transmitted to the tip of the catheter. and the operability of the catheter, especially
The present invention provides a catheter whose tip part can be easily inserted into a blood vessel.

[Means for solving the problem] What achieves the above object is a lumen formed inside, a stiffening body formed in a mesh shape of linear bodies, and a stiffening body provided in parallel with the lumen in the axial direction. This catheter has a reinforcing body formed by a linear body extending from the inside.

The catheter has, for example, a distal end, a main body, and a curved flexible section provided between the distal end and the main body. Further, it is preferable that the tip portion and the flexible portion do not have a rigidity imparting body. Furthermore, it is preferable that the stiffening body and/or the reinforcing body are made of an amorphous alloy wire. Furthermore, it is preferable that the stiffening body and reinforcing body are embedded in the outer surface or inside of the catheter.

Therefore, the present invention will be explained using examples shown in the drawings.

The catheter 1 of the present invention has a lumen 1 formed inside.
0, and a rigidity imparting body 15 formed in a mesh shape by linear bodies.
and a reinforcing body 16 formed of a linear body provided parallel to the lumen lO and extending in the axial direction.

An embodiment in which the catheter of the present invention is applied to an angiography catheter will be described with reference to FIGS. 1 to 4.

As shown in FIG. 1, the catheter 1 of this embodiment has a catheter body having a distal end portion 5, a main body portion 4, and a curved flexible portion 3 provided between the distal end portion 2 and the main body portion 5. 2 and a knob 7 provided at the proximal end of the catheter body 2.

The tip portion 5 has an outer diameter smaller than other portions and is a bent portion.

A possible method for reducing the diameter of the tip 3 is to form the tip and then heat and stretch it. Further, it is preferable that the distal end of the catheter l forming the distal opening 6 has a rounded outer and inner surface, as shown in FIG. By doing this, the tip of the catheter can be
Damage to the inner walls of blood vessels can be suppressed.

As shown in FIG. 1, the main body 4 has a substantially linear shape, and extends in the axial direction of the main body 4, as shown in FIG. 2, which is a partially cutaway cross-sectional view of the main body 4. Rigidity imparting body 1
5 and a reinforcing body 16 extending in the axial direction of the main body portion 4.

By providing the rigidity imparting body 15, it is possible to prevent bending in the main body of the catheter 1, further improve the torque transmittance of the catheter main body, prevent bending of the catheter main body 2 at the bending part, and further, When the catheter body 2 is rotated at its proximal end, the rotation can be reliably transmitted to the distal end.

Further, by providing the reinforcing body 16, the catheter main body 2 is prevented from meandering within the blood vessel, and the pushing force applied at the proximal end of the catheter main body 2 is reliably transmitted to the distal end of the catheter. Can be done.

The hub 7 provided at the proximal end of the main body 4 is made of synthetic resin (e.g., polycarbonate, polypropylene), and a contrast agent injector (e.g., syringe) can be attached to the rear end. ing.

In the catheter 1 of this embodiment, the catheter body 2 includes an inner layer 11 forming a lumen 10 penetrating from the proximal end to the distal end, an intermediate layer 13 covering the inner layer 11, and a ? ! It is formed by an overlying outer layer I2. The inner layer 1.1 of the main body 4 has a stiffening body 15.

The material for forming the inner layer II is preferably one having a certain degree of flexibility, such as polyolefin elastomers using polyethylene, polypropylene, ethylene-propylene copolymers, polyvinyl chloride, ethylene-propylene copolymers, etc.
Vinyl acetate copolymer 1, polyamide elastomer Thermoplastic resins such as polyurethane, silicone rubber, latex rubber, etc. can be used, and preferably polyamide elastomer or polyurethane made flexible with a plasticizer such as paraoxybenzoic ethylhexyl (POBO). Furthermore, an X-ray opaque substance (for example, barium sulfate, bismuth subcarbonate), etc. may be mixed into these materials.

Furthermore, the inner layer 11 is provided with the stiffening body 15 extending from its base end to the vicinity of the flexible portion, as described above.

As shown in FIG. 4, the flexible portion 3 and the tip portion 5 are not provided with a rigidity imparting body or a reinforcing body.

As shown in FIG. 2, the rigidity imparting body 15 is formed into a mesh shape by a plurality of linear bodies.

The rigidity imparting body 15 is embedded in the outer surface or thickness of the resin forming the inner layer 11. In particular, in the case shown in FIG. 2, the inner layer 11 is formed of a thermoplastic resin, and After wrapping the stiffening body, the stiffening body (5) is embedded in the outer wall of the inner layer 11 by heating the inner layer 11 from the outside (for example, pushing the inner layer 11 through a heating die).

As the linear body used to form the stiffening body 15, a metal wire is preferable, and a stainless steel wire, an amorphous alloy wire, etc. are particularly preferable. For stainless steel wire, wire diameter is 30
~ 100 μl, more preferably 50 to 70 μl, and more preferably 4 to 25 μl of wire diameter 3 to 30 μl are twisted together, for example, 2 to 20 wires, and the wire diameter is 50 to 80 μl.
It may be one linear body of R.

Further, as the amorphous alloy wire, an amorphous alloy wire formed using an iron-silicon-boron alloy, a cobalt-silicon-boron alloy, an iron-cobalt-chromium-molybdenum-silicon-boron alloy, etc. is preferably used. Can be used. Amorphous alloy wire has an amorphous structure formed by extruding the above-mentioned metal into a linear shape and rapidly cooling it. The diameter is reduced by passing it through a Mondo die. Amorphous alloy wire has high tensile strength, wide elastic deformation range, and excellent heat resistance, corrosion resistance, and fatigue resistance. The amorphous alloy wire has a wire diameter of 5 to 30 μl, more preferably,
1O~20μ11 Furthermore, it is preferable to twist a plurality of wires, for example, 3 to 7 pieces, each having a wire diameter of 1~10μ, more preferably 2~5μ, to form a single linear body with a diameter of 10~20μ.

The thickness of the inner layer 11 is 0.05 to 0.2 mm, preferably 0.1 to 0.15 mm.

The reinforcing body 16 is provided between the inner layer 11 provided with the stiffening body 15 and the intermediate layer 13, as shown in FIGS. 2 and 3. The reinforcing body 16 prevents the catheter body 2 from being bent excessively at the bent portion without significantly reducing the flexibility of the catheter, and also facilitates pushing of the tip of the catheter.

The reinforcing body 16 is formed of a linear body and extends from the proximal end of the catheter main body 2 in the distal direction in parallel with the lumen lO. The linear body used to form the reinforcing body 16 is preferably a metal wire, and has a wire diameter of 20 to 10
0μ shoulder, preferably 50 to 7071* elastic metal such as stainless steel, superelastic alloy, etc., particularly preferably,
High tensile strength stainless steel, copper or Ni/T for springs
It is an i-alloy wire. Further, an amorphous alloy wire having a wire diameter of 5 to 30 μm, preferably 10 to 20 μm, can also be suitably used. As the amorphous alloy wire, an amorphous alloy wire formed using an iron-silicon-boron alloy, a cobalt-silicon-boron alloy, an iron-cobalt-chromium-molybdenum-silicon-boron alloy, etc. can be suitably used. Furthermore, although the reinforcing body 16 may be formed of a single linear body, it is preferably formed of a plurality of metal wires as shown in FIGS. 2 and 3. The number of metal wires is 2 to 16, preferably 4 to 8, arranged at approximately equal intervals.

Providing such a reinforcing body 16 prevents the catheter main body 2 from meandering within the blood vessel. Therefore, the pushing force applied at the proximal end of the catheter body 2 is not buffered at the meandering portion, and the catheter body 2
The pushing force applied at the proximal end of the catheter can be reliably transmitted to the distal end of the catheter. Therefore, the operability of the catheter, particularly the operation of pushing the distal end of the catheter into the blood vessel, becomes easier.

This reinforcing body 16 may also be provided in the flexible portion 3.

Moreover, the rigidity imparting body 15 is provided only in the main body portion.

Further, the reinforcing body 16 is similar to the above-mentioned rigidity imparting body 5,
The stiffening body 15 may be buried in the outer surface of the inner layer l (in which the stiffening body 15 is buried).Also, the positions where the stiffening body 15 and the reinforcing body 16 are provided may be reversed, and the reinforcing body 16 is provided in the inner layer 11, The stiffening body 15 may be provided thereon.Furthermore, the linear body forming the reinforcing body i6 may be woven together with the linear body forming the stiffening body 15.

Further, the reinforcing body 16 may be provided between the intermediate layer 13 and the outer layer 12 described below, and in this case, the reinforcing body 16 may be buried in the outer surface of the intermediate layer 13. As a method for burying the reinforcing body 16, the method for burying the above-mentioned stiffening body can be suitably used.

The intermediate layer 13 covers the inner layer 11, as shown in FIGS. 2-4. The forming material 4 of the intermediate layer 13 is preferably one that has adhesive properties with the inner layer 11;
Preferably, the resin is the same as or similar to the resin used to form the resin. For example, polyolefin elastomers using polyethylene, polypropylene, ethylene-propylene copolymers, polyvinyl chloride, ethylene-vinyl acetate copolymers 1, polyamide elastomers, thermoplastic resins such as polyurethane, silicone rubber, latex rubber, etc. can be used. Preferably, polyamide elastomer or polyurethane is made flexible with a plasticizer such as ethylhexyl barium oxybenzoin (POBO), and in addition, an X-ray opaque substance (e.g., barium sulfate, bismuth subcarbonate), etc. is added to these materials. May be mixed. Also,
The above-mentioned stiffening body may be provided in this intermediate layer 13 or between the inner layer 11 and the intermediate layer 13 as described above.

Preferably, it is provided in the intermediate layer 13, so that the position of the reinforcing layer can be easily fixed. The thickness of the intermediate layer 13 is
0.07-0.15xx, preferably 0.1-0, L3
It is xx.

Outer layer 12 covers intermediate layer 13 and forms the outer surface of catheter 1, as shown in FIGS. 2-4. The material for forming the outer layer 12 is preferably one that has adhesive properties with the intermediate layer 13, and is preferably the same as or similar to the resin used to form the intermediate layer 13. For example, polyolefins using polyethylene, polypropylene, ethylene-propylene copolymers, polyvinyl chloride, ethylene-propylene copolymers, etc.
[Vinyl copolymer, polyamide elastomer, thermoplastic resin such as polyurethane, silicone rubber, latex rubber, etc. can be used, preferably polyamide elastomer or polyurethane made flexible with a plasticizer such as paraoxybenzoic ethylhexyl (POBO), Furthermore, an X-ray opaque substance (for example, barium sulfate, bismuth subcarbonate), etc. may be incorporated into these materials, but in order to make the outer surface of the catheter smooth, the outer layer I2 requires Inner layer 11 without mixing X-ray opaque material
It is preferable that the X-ray opaque substance is mixed only in the intermediate layer 13. Furthermore, the outside of the outer layer 12 may be coated with a resin having biocompatibility, particularly antithrombotic properties, such as polyhydroxyethyl methacrylate, a copolymer of hydroquine ethyl methacrylate and styrene (for example, HEM ASt-1 (EMA bronc copolymer) etc. can be used.In particular, when material 0 mixed with an X-ray opaque substance is used for the outer layer 12, in order to eliminate the roughness of the outer surface caused by the X-ray opaque substance. The above-mentioned coating is preferably applied to the outer layer 12, preferably a biocompatible resin, but a clear coating of the material used to form the outer layer 12 may also be used.

The outer diameter of the main body 4 of the catheter is 1.0
~4.0*x, more preferably 1.3 to 3.5 layers m.

The outer diameter of the tip 3 is preferably 0.9 to 3.6 mm, more preferably 1.2 to 3 mm. It is Oxx.

The flexible portion 3 is preferably more flexible,
For this reason, after forming the catheter body 2, the flexible part 3 is immersed in a plasticizer solution acid for the resin used to form the flexible part, and a plasticizer is added to make it more flexible. It is preferable to do so.

In addition, in the above description, the catheter body has been explained using an example in which the catheter body is formed of three layers: an inner layer, an intermediate layer, and an outer layer. However, the present invention is not limited to this. may be formed. Furthermore, although the above description has been made using an angiography catheter, the catheter of the present invention is not limited to this, and can be used as a catheter for intravascular insertion such as a vasodilation catheter or a thermodilution catheter.

[Effects of the Invention] The catheter of the present invention has a lumen formed inside;
It has a stiffening body formed in a mesh shape of linear bodies, and a reinforcing body formed of linear bodies provided parallel to the lumen and extending in the axial direction. In particular, it has a stiffening body. This prevents the catheter from bending or breaking, and improves torque transmission.Furthermore, the reinforcing body prevents the catheter from meandering inside the blood vessel, and prevents the proximal end of the catheter from twisting. The pushing force applied is not buffered by the meandering portion and is reliably transmitted to the tip of the catheter. Therefore, the operability of the catheter, particularly the operation of inserting the distal end of the catheter into the blood vessel, becomes easier.

[Brief explanation of the drawing]

FIG. 1 is a side view of an embodiment of the catheter of the present invention, FIG. 2 is a partially cutaway sectional view of the main body of the catheter of the present invention, and FIG. 3 is a cross-sectional view of the main body of the catheter of the present invention. The perspective view, FIG. 4, is a partially cutaway sectional view of the tip of the force element-tel of the present invention. 1...Catheter 3...Flexible part 5...Tip part 7/Flash hub 11...Inner layer 13...Intermediate layer 16...Reinforcement body 2...Catheter body 4...Main body Part 6...Tip opening 10...Rumes 12...Outer layer 15...Rigidity imparting body

Claims (5)

[Claims] (1) It has a lumen formed inside, a stiffening body formed in a mesh shape of linear bodies, and a reinforcing body formed of linear bodies provided parallel to the lumen and extending in the axial direction. A catheter characterized by: (2) The catheter has a distal end, a main body, and a flexible section provided between the distal end and the main body.
Catheter described in. (3) The catheter according to claim 2, wherein the tip portion and the flexible portion do not have a stiffening member. (4) The catheter according to any one of claims 1 to 3, wherein the stiffening body and/or the reinforcing body are made of an amorphous alloy wire. (5) Claims 1 to 4, wherein the stiffening body and the reinforcing body are embedded in the outer surface or inside of the catheter.
The catheter described in any of the above.