JP2736901B2 - Right coronary angiography catheter - Google Patents

Description

Description: TECHNICAL FIELD The present invention relates to a catheter for angiography of the right coronary artery introduced from the right upper arm artery using a sheath.

<Conventional technology> Conventional catheters for coronary angiography include Judkins-type and Ampplatz-type catheters. Usually, these catheters are introduced from the femoral artery by the Seldinger method or the sheath method, and the coronary artery is introduced. Was selectively imaged.

In recent years, as a less invasive technique than the femoral artery puncture method, a sheath is placed in the brachial artery and a relatively small diameter (5 to 5 mm) is used.
A method of percutaneously inserting a Judkins-type or Amplats-type catheter is also used.

Such a brachial artery catheter is inserted into the ascending aorta via the left subclavian artery or brachiocephalic artery, and the catheter is rotated or advanced or retracted as needed, and the tip of the catheter is inserted into the right coronary artery. And the contrast agent is injected in this state.

In the case of the brachial approach, the right or left brachial artery
Although there are two approaches, the approach from the right arm is usually convenient for equipment and procedural purposes because of the working arm of the operator.

By the way, the above catheter, especially the Jatkins-type right coronary angiography catheter, has a structure and a design assuming an approach from the femoral artery. Therefore, the catheter is bent at the aortic arch, and the catheter tip is pressed against the right coronary artery by the repulsive force. Becomes

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

Also, amplats-type catheters are usually more dangerous than Jatkins-type catheters because they are too deep in coronary arteries, and are generally used only when they cannot be inserted into Jatkins-type coronary arteries.

Furthermore, since the catheter of the above-mentioned conventional brachial approach is introduced from the brachial artery using a sheath, its diameter is small, satisfactory torque transmission cannot be obtained, and the distal end of the catheter for operation at the proximal end of the catheter is not obtained. There was a drawback that response was poor.

In addition, since the shape and dimensions of the ascending aorta differ depending on the age, gender and individual differences of patients, it is necessary to use several types of catheters in the above-mentioned Judkins-type and Amplats-type catheters depending on the case. For this reason, when the inserted catheter is inappropriate, it must be replaced with a catheter having a shape that matches the case, which requires a great deal of labor and time, and has the drawback that the burden on the patient increases. .

<Problem to be Solved by the Invention> An object of the present invention is to solve the above-mentioned disadvantages of the prior art,
Excellent torque transmission in operation, and regardless of the case,
An object of the present invention is to provide a right coronary angiography catheter capable of imaging the right coronary artery with one kind of catheter.

<Means for Solving the Problems> Such an object is achieved by the present invention described below.

That is, the present invention has a catheter main body having an outer diameter of 2.1 mm or less over the entire length, and from the base end side, a substantially linear first linear portion, and a subsequent S-shaped curved S portion. Character, followed by a substantially linear second 20 to 60 mm long
An angle between the straight portion and the subsequent second straight portion is formed by a tip portion bent inward at 90 ° to 115 °, and the first straight portion and the second straight portion are substantially formed. A right coronary angiography catheter, which is parallel.

Further, the catheter body has a reinforcing material embedded in the inside of the catheter body over substantially the entire length excluding a predetermined length portion from the distal end thereof, and the length without the reinforcing material is in a range of 5 to 25 mm from the distal end of the catheter main body. Preferably it is.

It is preferable that an angle between the first straight portion and the second straight portion is in a range of −5 ° to + 10 ° in a direction in which the distal end portion is bent.

Further, it is preferable that the catheter body is constituted by a laminate of a plurality of layers.

Preferably, the reinforcing material is a metal mesh.

BEST MODE FOR CARRYING OUT THE INVENTION 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 a configuration example of the catheter of the present invention, and FIG. 2 is a cross-sectional view taken along line II-II in FIG.
As shown in these drawings, the catheter 1 has a catheter body 2 having flexibility.

The outer diameter of the 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 is preferable to introduce a catheter into a blood vessel using a sheath from the brachial artery because it is less burdensome for the patient.However, since a conventional catheter has a relatively large diameter, it can be inserted into the sheath. could not. On the other hand, by setting the outer diameter of the catheter of the present invention to 2.1 mm or less, the catheter 1 can be introduced into the blood vessel using the sheath, and the burden on the patient is reduced.

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 concentrically stacked from the inside. With such a configuration, a reinforcing member described below can be easily embedded in the catheter body 2.

The constituent materials of the inner layer 6, the middle layer 7, and the outer layer 8 include polyamide resin (for example, nylon 11), polyester polyamide resin (for example, polyester polynylon), polyether polyamide resin (for example, polyether polynylon), An appropriate material can be used from polyurethane and the like. In particular, it is preferable to use a polyamide-based resin, a polyether polyamide-based resin, or a polyether polyamide-based resin because high shape memory properties and flexibility at the tip can be obtained.

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

In particular, the above-mentioned X-ray contrast agent is blended in the middle layer 7 and the inner layer 6,
Preferably, the catheter is provided with X-ray contrast, the outer layer 8 is not mixed with an X-ray contrast agent, and the outer surface of the catheter body is smooth.

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

Each of the layers 6, 7, 8 is bonded or fused with an appropriate adhesive, or is integrally formed by coating or the like.

At the boundary between the inner layer 6 and the middle layer 7, a metal mesh 9 as a reinforcing material is embedded all around. This metal mesh 9 is provided in the longitudinal direction of the catheter body 2.
The catheter body 2 is buried over substantially the entire length excluding a predetermined length from the distal end. The length of the portion where the metal mesh 9 is not provided is 5 to 25 from the tip of the catheter body 2.
mm (preferably 10 to 20 mm).

By embedding such a metal mesh 9, the torque transmission when the catheter body is rotated can be improved.

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

Also, the part without the metal mesh 9 is 25 mm from the tip.
This is because, if it exceeds, the torque transmission becomes insufficient.

The length of the portion where the metal mesh 9 is not provided is appropriately determined depending on the material of the catheter main body 2 and the inner and outer diameters (total thickness of the inner, middle and outer layers).

Specific examples of the metal mesh 9 include a metal wire made of a 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 substantially at the center of the tube body 2. The 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 a target site, a guide wire is inserted into the lumen 10.
Further, at the time of injection of the contrast agent, the contrast agent is injected through the lumen 10 from the distal end opening of the lumen to the target site.

In addition, the side hole 4 is 2 along the longitudinal direction of the catheter body.
It may be formed as described above, and the side hole may not be formed at all.

As shown in FIG. 1, such a catheter main body 2 includes a first linear portion 21 from a base end side (right side in FIG. 1),
An S-shaped portion 22 follows, a second straight portion follows, and a leading end portion 24 follows.

The first straight portion 21 is substantially straight when no external force is applied. The length L ₁ of the first straight portion 21 is not particularly limited, since the total length of the coronary catheters usually brachial approach is about 800～950Mm, a length of about minus L ₂ and L ₃ to be described later than this Becomes The S-shaped portion 22 has a smoothly curved S-shape when no external force is applied. This S
The length L ₂ of the character portion 22 is not particularly limited, but L ₁ + L ₂ is 120 mm
It is preferred that:

The second linear portion 23 is substantially linear when no external force is applied, and preferably has a length L ₃ = 20 to 60 mm. Reason for the length L ₃ of the second linear part 23 in the above range is, L ₃
If it is more than 60 mm, the bending of the S-shaped portion 22 becomes steep, which is not preferable in operation, and if it is less than 20 mm, the second linear portion 23 does not hit the wall of the ascending aorta when the catheter tip is inserted into the right coronary artery. It is easy to come off.

The angle θ between the first straight portion 21 and the second straight portion 23 when no external force is applied is −5 in the direction in which the tip portion 24 is bent.
It is in the range of ゜ to + 10 °, that is, in the range from θ = −5 ° shown in FIG. 3 to θ = 10 ° shown in FIG. 4, and is preferably substantially parallel. The range of this angle θ = −5 ° to 10 ° is
This range is suitable for insertion and placement of a catheter according to the shape of the ascending aorta.

As shown in FIG. 1, the distal end portion 24 is bent inward, and an angle α formed with the second linear portion 23 is 90 ° to 115 °.
If the angle α is out of the range of 90 ° to 115 °, it becomes difficult to secure the right coronary artery.

The length of the distal end portion 24 is not particularly limited.
Insert and place 24 near the entrance of the right coronary artery, before and after ejecting the contrast agent, the tip 24 does not enter the coronary artery too deeply,
The length is preferably such that it does not separate from the entrance, and is preferably about 7 to 15 mm.

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

The hub 5 is used to inject a contrast agent, or to connect to another device when measuring blood pressure or the like.

<Operation> Next, a method of using the catheter of the present invention will be described.

As shown in FIG. 5, the catheter introducer 12 is punctured into the right upper arm artery 15 by the Seldinger method, and the book is inserted into the sheath 13 of the catheter introducer 12 and the guide wire 14 is inserted through the lumen 10. The catheter 1 of the present invention is inserted, and the distal end of the catheter main body 2 is projected into the brachial artery 15 from the distal opening 130 of the sheath.

Next, the catheter 1 is gradually fed in the direction of the arrow in the figure with the guide wire preceding it, and inserted toward the right coronary artery 19, which is the target site. At this time, in order to allow the distal end of the catheter body 2 to pass through the bent portion of the blood vessel or to select a branch of the blood vessel, an operation is performed in which the insertion and removal of the guide wire and the advance / retreat and rotation of the catheter 1 are appropriately combined.

As shown in FIG. 6, when the distal end of the catheter 1 has reached the vicinity of the right coronary artery, the catheter 1 is rotated or moved back and forth to insert the distal end of the catheter into the entrance 191 of the right coronary artery 19.

After the distal end of the catheter 1 is inserted into the right coronary artery 19 by such an operation, the guide wire is removed from the lumen 10 (the catheter may be removed after the catheter is introduced into the ascending aorta 17). Connect the connector to the base end of 10 and inject the contrast agent. The injected contrast medium passes through the lumen 10 and the right coronary artery
It is gushing inside 19. Thereby, the right coronary artery 19 can be imaged.

Since the catheter of the present invention has the above-described shape and dimensions, the distal end portion 24 of the catheter main body 2 does not come off from the entrance 191 of the right coronary artery 19 before and after the ejection of the contrast agent.

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

(Example 1) A catheter having the following specifications was prepared and clinically performed using the catheter.

All Length: 850 mm Outer diameter: 1.67 mm inner diameter (Memen diameter): 1.1 mm cross-sectional structure: inner layer, middle layer, the outer layer laminate Material of: an inner layer, middle layer / polyether nylon (trade name, PEBAX, Bi ₂ O ₃ formulation Outer layer / Polyester poly nylon (Greax) 1st straight section length: about 750mm S-shaped section length: 55mm 2nd straight section length: 47mm Tip length: 11mm Make the 1st straight section and 2nd straight section Angle θ: 0 ゜ Angle between the first straight part and the S-shaped part: about 26 ゜ Angle α between the second straight part and the tip part: 95 ゜ Side holes: 2 (opening area 1.5mm ² / piece) Reinforcing material: A metal mesh with a stainless wire braid (diameter: 50 μm) is buried at the boundary between the inner layer and the middle layer within the entire length excluding 15 mm from the tip of the catheter body.

Using the above catheter, 5F (F = about 1 / F) was placed in the right upper brachial artery for 7 patients (four men and three women) aged 53 to 76 years.
3 mm) When the sheath was percutaneously placed and the right coronary artery was imaged by the above operation, the right coronary artery could be imaged with one kind of catheter for all patients. During the operation of the catheter, there was no need to use a guide wire, a stylet, or the like.

<Effect of the Invention> According to the catheter of the present invention, since the torque transmission in operation is excellent, the responsiveness of the distal end portion to the operation at the proximal end portion of the catheter is improved, and the shape of the distal end portion of the catheter is suitable for cases. Regardless, the right coronary artery can be imaged with one type of catheter.

As a result, the burden on the patient involved in the imaging is significantly reduced, the operation is facilitated, and the labor and time required for imaging the right coronary artery from the right upper arm are reduced.

[Brief description of the drawings]

FIG. 1 is a plan view showing a configuration example of the catheter of the present invention. FIG. 2 is a sectional view taken along line II-II in FIG. FIG. 3 and FIG. 4 are explanatory views for explaining the shape of the catheter of the present invention. FIG. 5 is an explanatory view showing a method for introducing a catheter of the present invention into a blood vessel. FIG. 6 is an explanatory view showing a state in which the catheter of the present invention has been inserted into and indwelled in the right coronary artery. DESCRIPTION OF SYMBOLS 1… catheter 2… catheter body 3… tip 4… side hole 5… hub 6… 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 191 ... Entrance

Claims (5)

(57) [Claims] 1. A catheter body having an outer diameter of 2.1 mm or less over its entire length, a substantially straight first straight portion, and an S-shaped curved S-shape following the first straight portion from its proximal end. Department and
The angle between the subsequent substantially straight second linear portion having a length of 20 to 60 mm and the subsequent second straight portion is 90 ° to 115 °.
A right coronary angiography catheter, comprising a tip portion bent inwardly, and wherein the first linear portion and the second linear portion are substantially parallel. 2. The catheter body has a reinforcing material embedded in the inside of the catheter body over substantially the entire length excluding a predetermined length portion from the distal end thereof, and the length without the reinforcing material is 5 to 25 mm from the distal end of the catheter main body. Claim 1.
The catheter for angiography of right coronary artery according to the above. 3. The angle according to claim 1, wherein an angle between the first straight portion and the second straight portion is in a range of −5 ° to + 10 ° in a direction in which the tip portion is bent. Right coronary angiography catheter. 4. The catheter for angiography of a right coronary artery according to claim 1, wherein the catheter body is composed of a laminate of a plurality of layers. 5. The right coronary angiography catheter according to claim 1, wherein the reinforcing member is a metal mesh.