JPH02102666A - Catheter for right cornary artery radiography - Google Patents

Abstract

PURPOSE:To allow the radiography of the right coronary artery with one kind by using the catheter having a catheter body of a specific outside diameter and constituting this body, successively from its root end side, of a 1st straight part, a curved S-shaped part, a 2nd straight part in succession thereto, and a front end part which is curved in the angle formed with the 2nd straight part toward the inner side at a specific angle. CONSTITUTION:The outside diameter of the catheter body 2 is <=2.1mm in 800 to 950mm of the entire length. The catheter body 2 is constituted, successively from its root end side, of the 1st straight part 21, the curved S-shaped part 22, the 2nd straight part in succession thereto and the front end part 24 in succession thereto. The 1st straight part 21 is substantially straight in the state of not exerting external force thereto and the length L1 thereof is not particularly limited. The S-shaped part 22 exhibits the smoothly curved S shape in the state of not exerting external force thereto and while the length L2 thereof is not particularly limited, L1+L2 is preferably <=120mm. The 2nd straight part 23 is substantially straight in the state of not exerting external force thereto and is preferably specified to the length L3=20 to 60mm. The front end 24 is curved to the inner and the angle alpha formed with the 2nd straight part is 90 to 115 deg..

Description

DETAILED DESCRIPTION OF THE INVENTION <Industrial Fields> The present invention relates to a catheter for right coronary angiography that is introduced from the right brachial artery using a sheath.

<Conventional technology> As a conventional catheter for coronary angiography, Judkins (
Judkins type, Amplatz
These catheters are usually introduced through the femoral artery using the Seldinger method or the sheath method to selectively image the coronary arteries.

In addition, in recent years, as a less invasive method than the femoral artery puncture method, a sheath is placed in the brachial artery, and a sheath with a relatively small diameter (5 to 6
(Grade F) Percutaneous insertion of Judkins-type and Amblatz-type catheters is also used.

The catheter for this brachial artery approach is inserted into the ascending aorta via the left subclavian artery or brachiocephalic artery,
Insert the tip of the catheter into the entrance of the right coronary artery by rotating the catheter and moving it forward and backward as appropriate.
A contrast medium is injected in this state.

In the case of a brachial approach, there are two approaches: the right or left brachial artery, but the right arm is usually more convenient in terms of equipment and technique due to the operator's strong arm.

By the way, the above-mentioned catheters, especially the Jutkins type catheter for right coronary angiography, have a structure and design assuming an approach from the femoral artery, so they are bent at the aortic arch.
The repulsive force causes the catheter tip to be pressed against the right coronary artery.

However, in the right brachial approach (via the brachiocephalic artery), the repulsive force due to this bending does not work, and there is a drawback that the tip of the catheter is easily dislodged from the right coronary artery due to injection of angiographic agent during right coronary angiography.

Additionally, Angratz-type catheters are more dangerous than Jutkins-type catheters because they usually insert too deeply into the coronary arteries, and are generally used only when Jutkins-type catheters cannot be inserted into the coronary arteries.

Furthermore, since the conventional brachial approach catheter described above is introduced from the brachial artery using a sheath, its diameter is small, and satisfactory torque transmission performance cannot be obtained. It had the disadvantage of poor responsiveness.

Furthermore, since the shape and dimensions of the ascending aorta vary depending on the patient's age, sex, and individual differences, it has been necessary to use several types of catheters depending on the case. Therefore, if the inserted catheter is inappropriate, it must be replaced with a catheter of a shape that matches the case, which has the drawback of requiring a great deal of effort and time and increasing the burden on the patient. .

<Problems to be Solved by the Invention> The purpose of the present invention is to eliminate the above-mentioned drawbacks of the prior art, provide excellent torque transmission performance in operation, and provide a
An object of the present invention is to provide a right coronary angiography catheter capable of performing contrast imaging of the right coronary artery using a different type of catheter.

Means to solve problems〉 Such objects are achieved by the present invention as described below.

That is, the present invention has a catheter main body having an outer diameter of 2.1 mm or less over its entire length, and from the proximal end thereof, a substantially straight first straight part, followed by an S-shaped curved part. S
A tip portion that is bent inward at an angle of 90° to 115° between the character portion, a substantially straight second straight portion having a length of 20 to 60 mm, and the second straight portion that follows this. A catheter for right coronary angiography, characterized in that the first straight section and the second straight section are substantially parallel.

Further, the catheter body has a reinforcing material embedded inside the catheter body over almost the entire length excluding a predetermined length from the tip thereof, and the length without the reinforcing material is within a range of 5 to 25 mm from the tip of the catheter body. It is preferable to have one.

Preferably, the angle formed by the first straight part and the second straight part is in the range of -5@ to +10' in the direction in which the tip end is bent.

Further, it is preferable that the catheter main body is composed of a laminate of a plurality of layers.

Further, it is preferable that the reinforcing material is a metal mesh.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Hereinafter, a right coronary angiography catheter (hereinafter simply referred to as a catheter) of the present invention will be described in detail with reference to preferred embodiments shown in the accompanying drawings.

FIG. 1 is a plan view showing an example of the configuration of the catheter of the present invention;
FIG. 2 is a sectional view taken along the line ■-■ in FIG. 1. As shown in these figures, the catheter 1 has a catheter body 2 that is flexible.

The outer diameter of this catheter body 2 is 2.1 mm or less (preferably 2.0 mm or less, more preferably 1.67 mm or less) over the entire length of the catheter.

It would be preferable to introduce the catheter into the blood vessel using a sheath through the brachial artery, since this would reduce the burden on the patient. could not. In contrast, since the catheter of the present invention has an outer diameter of 2.1 mm or less, it becomes possible to introduce the catheter 1 into the blood vessel using a sheath, thereby reducing the burden on the patient.

FIG. 2 shows a cross-sectional structure of the catheter body 2. The catheter body 2 has a structure in which an inner layer 6, a middle layer 7, and an outer layer 8 are laminated concentrically from the inside. With such a configuration, a reinforcing member, which will be described later, can be easily embedded in the catheter main body 2.

The constituent materials of the inner layer 6, middle M7i3, and outer layer 8 include polyamide resin (for example, nylon 11), polyester polyamide resin (for example, polyester polynylon), polyether polyamide resin (for example, polyether polynylon), Any suitable material can be used, such as polyurethane. In particular, it is preferable to use a polyamide resin, a polyether polyamide resin, or a polyether polyamide resin because high shape memory properties and flexibility of the tip portion can be obtained.

In order to insert the catheter 1 while confirming its position under X-ray fluoroscopy, the material constituting the tube body 2 is mixed with an X-ray contrast agent such as barium sulfate, bismuth oxide, or tungsten. It is preferable to keep it.

In particular, the middle layer 7 and the inner layer 6 are blended with the X-ray contrast agent to give the catheter X-ray contrast properties, and the outer layer 8 is not blended with an X-ray contrast agent, leaving the outer surface of the catheter body smooth. is preferable.

Further, the thickness of each layer 6, 7, 8 is not particularly limited, but the outer layer 8 is relatively thinner than the inner layer 6 and the middle layer 7.

Further, each layer 6, 7, 8 is adhered or fused with a suitable adhesive, or integrally formed by covering molding or the like.

At the boundary between the inner layer 6 and the middle layer 7, a metal mesh 9 serving as a reinforcing material is buried all around. This metal mesh 9 has the following characteristics in the longitudinal direction of the catheter body 2:
It is buried over almost the entire length of the catheter body 2 except for a predetermined length from the tip. The length of the part where the metal mesh 9 is not provided is 5 to 50 mm from the tip of the catheter body 2.
It is set in the range of 25 mm (preferably 10 to 20 mm).

By embedding such a metal mesh 9, it is possible to improve torque transmission when the catheter main body is rotated.

In addition, the length from the tip of the catheter body 2 is 5 to 25 mm.
The reason why the metal mesh 9 is not provided in the portion is that if the portion where the metal mesh 9 is not provided is less than 5 mm from the tip, the tip of the catheter becomes hard and there is a risk of damaging the blood vessel wall.

Also, the part where the metal mesh 9 is not provided is 25m from the tip.
This is because, if it exceeds m, the torque transmittance becomes insufficient.

The length of the part without the metal mesh 9 depends on the material, inner and outer diameters (total thickness of the inner, middle and outer layers) of the catheter body 2.
etc. will be determined as appropriate.

A specific example of the metal mesh 9 is one made of metal wire such as stainless steel, and the wire diameter is, for example, about 0.01 to 0.2 mm.

A lumen 10 is formed approximately at the center of the tube body 2. This lumen 10 is open to the distal end of the tube body 2 and also communicates with a side hole 4 formed on the outer periphery of the distal end portion 24 at an arbitrary position.

When the catheter 1 is inserted into the target site, a guide wire is inserted into the lumen 10.
Furthermore, when injecting a contrast medium, the contrast medium is injected into the target site through the lumen 10 through the opening at the distal end of the lumen.

Note that two or more side holes 4 may be formed along the longitudinal direction of the catheter body (or, there may be no side holes formed at all).

Such a catheter main body 2, as shown in FIG.
From the base end side (right side in FIG. 1), it is composed of a first straight section 21, an S-shaped section 22 following this, a second straight section following this, and a distal end section 24 following this.

The first straight portion 21 is substantially straight when no external force is applied thereto. The length of this first straight portion 21 is not particularly limited, but since the total length of a coronary artery catheter for brachial approach is usually about 800 to 950 mm, the length of this first straight section 21 is about 800 to 950 mm. Become. S
The shaped portion 22 exhibits a smoothly curved S-shape when no external force is applied. Although the length L2 of this S-shaped portion 22 is not particularly limited, it is preferable that Ll+L2 is 120 mm or less.

The second straight portion 23 is substantially straight when no external force is applied thereto, and preferably has a length of 20 to 60 mm. The reason why the length of the second straight portion 23 is set in the above range is that if L exceeds 60 mm, the S-shaped portion 22 will bend too steeply, which is undesirable for operation.
This is because if it is less than m, when the catheter tip is inserted into the right coronary artery, the second straight portion 23 will not hit the wall of the ascending aorta and will easily come off.

The first straight portion 21 and the second straight portion 23 form an angle θ in the range of -5° to +10° in the direction in which the tip portion 24 is bent when no external force is applied, that is, as shown in FIG. θ=-5 shown in
° to θ=10° shown in FIG. 4, preferably substantially parallel. This angle θ = -5° ~ 10
The range of 10° is suitable for insertion and placement of the catheter according to the shape of the ascending aorta.

As shown in FIG. 1, the tip portion 24 is bent inward, and the angle α with the second straight portion 23 is between 90@ and 115@. This is because if the angle α is outside the range of 90° to 115°, it becomes difficult to secure the right coronary artery.

Although the length of the distal end 24 is not particularly limited, the distal end 24 should be inserted and placed near the entrance of the right coronary artery, and before and after ejecting the contrast medium, the distal end 24 should be deep (not too deep into the coronary artery and The length is preferably about 7 to 15 mm so that it does not separate from the entrance.

Note that a hub 5 is formed at the proximal end of the catheter body 2 via a reinforcing tube.

This hub 5 is used for contrast agent injection or for connecting to other instruments when measuring blood pressure or the like.

For Kusaku Next, a method of using the catheter of the present invention will be explained.

As shown in FIG. 5, the catheter introducer 12 is punctured into the right brachial artery 15 by the Seldinger method.
Within the sheath 13 of the catheter introducer 12,
The catheter 1 of the present invention with the guide wire 14 inserted therein is inserted into the lumen 10, and the distal end of the catheter body 2 is made to protrude into the brachial artery 15 through the distal opening 130 of the sheath.

Next, the catheter 1 is gradually advanced in the direction of the arrow in the figure with the guide wire in front, and inserted toward the right coronary artery 19, which is the target site. At this time, in order for the tip of the catheter body 2 to pass through a bend in the blood vessel or to select a branch of the blood vessel, an appropriate combination of insertion and removal of the guide wire, forward/backward movement, and rotation of the catheter 1 is performed.

As shown in FIG. 6, when the tip of the catheter 1 reaches the vicinity of the right coronary artery orifice, the catheter 1 is rotated or moved back and forth, and the catheter tip is inserted into the entrance 191 of the right coronary artery 19.

After the tip of the catheter 1 is inserted into the right coronary artery 19 by such an operation, the guide wire may be removed from the lumen 10 (or may be removed after the catheter is introduced into the ascending aorta 17). Attach a connector to the proximal end of the tube and inject the contrast medium. The injected contrast medium passes through the lumen IO and is ejected from the opening at its tip into the right coronary artery 19, which is the target site. This makes it possible to contrast the right coronary artery 19.

In addition, since the catheter of the present invention has the above-mentioned shape and dimensions, the catheter main body 2
The distal end 24 of the right coronary artery 19 will not come off the entrance 191 of the right coronary artery 19.

<Example> Hereinafter, specific examples of the present invention will be described.

(Example 1) A catheter with the following specifications was produced and used in clinical practice.

Total length: 850mm Outer diameter: 1. 67mm Inner diameter (lumen diameter): 1.1mm Cross-sectional structure: Inner layer, middle layer, outer layer laminate material Material: Inner layer, middle layer/polyether polynylon (product name, PEBAX, B1-0s blend) Outer layer/polyester polynylon (product) 1st straight line length: approx. 750mm 5-shape length: 55mm 2nd straight line length: 47mm Tip length: 11mm Angle between the 1st straight line and 2nd straight line θ: 0° 1st straight line Angle between the part and the S-shaped part: Approximately 26'' Angle α between the second straight part and the tip: 95° Side holes: 2 (opening area 1.5 mm)
7) Reinforcement material: A metal mesh made of stainless steel wire braid (diameter 50 μm) is embedded at the boundary between the inner layer and middle layer over the entire length of the catheter body, excluding 15 mm from the tip.

Using the above catheter, 7 patients aged 53 to 76 years (
5F (F) in the right brachial artery (4 men, 3 women)
= approximately 1/3 mm) The sheath was placed percutaneously and the right coronary artery was imaged using the above procedure, and it was possible to image the right coronary artery in all patients using one type of catheter. It should be noted that during this catheter operation, there was no need to use a guide wire, stylet, etc. <Effects of the Invention> According to the catheter of the present invention, torque transmission during operation is improved! This improves the responsiveness of the distal end to operations at the proximal end of the catheter, and the shape of the distal end of the catheter makes it possible to image the right coronary artery with one type of catheter, regardless of the case.

As a result, the burden on the patient associated with contrast imaging is significantly reduced, the operation becomes easier, and the effort and time associated with contrast imaging of the right coronary artery from the right upper arm are also reduced.

[Brief explanation of the drawing]

FIG. 1 is a plan view showing an example of the configuration of the catheter of the present invention. FIG. 2 is a sectional view taken along the line ■-■ in FIG. 1. FIG. 3 and FIG. 4 are explanatory diagrams for explaining the shape of the catheter of the present invention, respectively. FIG. 5 is an explanatory diagram showing a method of introducing the catheter of the present invention into a blood vessel. FIG. 6 is an explanatory diagram showing a state in which the catheter of the present invention is inserted and left in the right coronary artery. Explanation of symbols 1 Catheter 2 Catheter body 3 Tip 4 Side hole 5 Pro Inner layer 7 Middle layer 8 Outer layer 9 ... Metal mesh 10 ... Lumen 12 ... Catheter introducer 13 ... Sheath 130 ... Tip opening 14 ... Guide wire 15 ... Brachial artery 16 ... Brachiocephalic artery 17 ...・Ascending aorta 19...Right coronary artery 1, 91...Entrance FIG, 2 FIG, "3 FIG, 4 2s

Claims (5)

[Claims] (1) It has a catheter body with an outer diameter of 2.1 mm or less over its entire length, and from the proximal end thereof, there is a substantially straight first straight section, followed by an S-shaped section that is curved into an S-shape. , a substantially linear second linear portion having a length of 20 to 60 mm, and the second linear portion that follows this, and the angle formed by the second linear portion is 90°.
A catheter for right coronary angiography, comprising a distal end portion bent inward at an angle of ~115°, and wherein the first straight portion and the second straight portion are substantially parallel. (2) The catheter main body has a reinforcing material embedded inside the catheter main body over almost the entire length excluding a predetermined length from the distal end thereof, and the length without the reinforcing material is within a range of 5 to 25 mm from the distal end of the catheter main body. The right coronary angiography catheter according to claim 1. (3) The angle formed by the first straight line portion and the second straight line portion is
The right coronary angiography catheter according to claim 1 or 2, wherein the distal end portion is bent at an angle of −5° to +10°. (4) The catheter for right coronary angiography according to any one of claims 1 to 3, wherein the catheter main body is composed of a laminate of a plurality of layers. (5) The right coronary angiography catheter according to any one of claims 1 to 4, wherein the reinforcing material is a metal mesh.