JPH0724060A - Baloon catheter - Google Patents

Abstract

PURPOSE:To provide a baloon catheter for measurement of blood pressure, wherein a catheter withstands the force-back action by blood flow and a catheter does not cause the body kink after insertion into blood vessel. CONSTITUTION:A baloon catheter 20 of the disclosure is composed of a baloon 22 having the auxiliary activity for cardiac function in aorta by expanding and contracting action, a catheter tube 24 through which a pressurized fluid can be introduced and discharged for the baloon action, a flexible inner tube 30 which is extending along longitudinal direction passing through a catheter tube 24 and a baloon end 22 where a tube 30 is connected to a blood liaison unit 23. At the other tip of a catheter tube 24, a connecter 26 is installed, where a gateway 28 for the pressurized fluid and a measurement unit 32 are devised. A metallic stylet 42 is passed through a flexible inner tube 30 from a unit 32 towards a blood liaison unit 23 after insertion of a catheter into blood vessel.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a balloon catheter used for intra-aortic balloon pumping, which is a method for treating acute heart failure and the like.

[0002]

2. Description of the Related Art Aortic balloon pumping method (Intra-
aortic balloon pumping (hereinafter, abbreviated as “IABP method”) is used for treatment when the cardiac function is deteriorated such as heart failure.
As shown in FIG. 2, a balloon catheter 2 made of a synthetic polymer material is inserted into the aorta, and a pump device 8 introduces or draws out a pressure fluid from the catheter tube 6 to the balloon portion 4 in accordance with the pulsation of the heart 1. This is an auxiliary circulation method of expanding and contracting the portion 4 to assist the heart function.

As balloon catheters used in the IABP method, balloon catheters as disclosed in JP-A-63-206255 and JP-A-62-114565 are known. In such a balloon catheter, it is necessary to detect the pulsation of the patient's heart in order to expand and contract the balloon portion according to the pulsation of the heart. As a means for detecting the pulsation of the heart of a patient, there is a means for mounting an electrode on the body surface or inside the patient and detecting the pulsation of the heart as an electric signal.

As a means for detecting the heartbeat from the patient's blood pressure using a balloon catheter, a blood communication hole is provided in the tip portion 12 of the balloon portion 4 shown in FIG. There is a method of detecting the pulsation of the heart by inserting the communicating inner tube 10 into the balloon portion 4 and the catheter tube 6 in the axial direction and measuring the blood pressure fluctuation from the blood communicating hole.

When inserting the balloon portion 4 and the catheter tube 6 into the arterial blood vessel of a patient, a guide wire is inserted into the inner tube 10 and a balloon catheter is inserted along the guide wire. The inner tube 10 also has a function as a guide rod at the time of insertion together with the guide wire. Therefore, the inner tube 10 needs to have a certain degree of rigidity. Further, since the balloon catheter is inserted into the blood vessel of a tortuous patient, the inner tube 10 needs to have some flexibility.

If the rigidity of the inner tube 10 is too high, the blood vessel of the patient may be damaged while the balloon catheter is being inserted into the blood vessel of the patient, which is not preferable. On the contrary, when the flexibility of the inner tube 10 is too high, when the balloon portion 4 is positioned in the artery near the heart 1 to assist the heart, it is pushed back by the blood flow and becomes a normal one. It is not preferable because the balloon portion 4 cannot be pumped at the position, the assisting action of the heart may be reduced, and the renal artery branching from the abdominal aorta may be occluded. It is important that the balloon portion 4 is located in an arterial blood vessel as close to the heart as possible to perform a pumping action.

From this point of view, as the conventional inner tube 10, a resin tube reinforced with a mesh or a stainless thin tube is used.

[0008]

However, in such a conventional balloon catheter using the inner tube 10,
There has been a demand for a balloon catheter that has advantages and disadvantages, and has both insertability into a tortuous blood vessel and rigidity that does not push back against blood flow and does not cause kinking (breakage).

The present invention has been made in view of such circumstances, and it is possible to measure the blood pressure in the blood vessel into which the balloon catheter is inserted, and moreover, it is easy to insert the blood vessel into a tortuous blood vessel, and It is an object of the present invention to provide a balloon catheter that is not pushed back by blood flow or the like and does not cause kinking (breakage) or the like.

[0010]

In order to achieve the above object, a balloon catheter of the present invention is inserted into an aorta, and expands and contracts so as to assist the function of the heart. A catheter tube connected to the rear end of the balloon section for introducing and discharging a pressure fluid into the balloon section, and a blood communication hole provided at the tip section of the balloon section for communicating the balloon section and the inside of the catheter tube with pressure. A flexible inner tube extending in the axial direction so as not to communicate with a fluid flow path, a pressure fluid introducing / extracting port connected to a rear end of the catheter tube for introducing and discharging a pressure fluid into the catheter, A connector formed with a measurement port that communicates with the inside of the flexible inner tube, and a metallic stylet that is inserted into the inside of the flexible inner tube from the measurement port to the front of the blood communication port. With the door.

A balloon catheter according to another aspect of the present invention is inserted into the aorta and is connected to a balloon portion which is inflated and deflated so as to perform an auxiliary action of a cardiac function, and a rear end of the balloon portion. , Communicating with a catheter tube for introducing and discharging a pressure fluid into the balloon section and a blood communication hole provided at a distal end of the balloon section, and not communicating the inside of the balloon section and the catheter tube with a flow path of the pressure fluid An axially extending flexible inner tube, a pressure fluid inlet / outlet connected to the rear end of the catheter tube for introducing and discharging a pressure fluid into the catheter, and an inner portion of the flexible inner tube. A connector having a measuring port communicating with the inside of the flexible inner tube, and a blood pressure measuring wire having a pressure sensor at the tip inserted from the measuring port to the front of the blood communicating port. To.

[0012]

When inserting the balloon catheter of the present invention into a blood vessel, the balloon catheter is inserted into the blood vessel without inserting the metal stylet tube or the blood pressure measuring wire into the flexible inner tube. Therefore, the balloon catheter has excellent flexibility,
It can be inserted well without damaging the inner wall of the blood vessel.

After inserting the balloon catheter, the stylet tube or the blood pressure measuring wire is inserted along the flexible inner tube through the measuring port formed in the connector. The tip of the stylet tube or the blood pressure measuring wire reaches the tip portion of the balloon along the inside of the flexible inner tube.
Therefore, the blood of the patient can be drawn out of the body through the inside of the stylet tube and the blood pressure fluctuation can be measured. Further, since the pressure sensor is attached to the tip of the blood pressure measuring wire, the blood pressure fluctuation of the patient can be directly measured by the pressure sensor.

Since the metal stylet tube and the blood pressure measuring wire have higher rigidity than the flexible inner tube, by inserting any one of them into the flexible inner tube,
The rigidity of the balloon catheter is improved, the risk of the balloon catheter being pushed back by blood flow is reduced, and kinking (breakage) can be effectively prevented.

[0015]

The balloon catheter according to the present invention will be described in detail below with reference to the embodiments shown in the drawings. Figure 1
Is a schematic cross-sectional view of a balloon catheter according to an embodiment of the present invention, FIG. 2 is a partial cross-sectional view showing a main part of the balloon catheter of the same embodiment, and FIG. 3 is a partial cross-sectional view showing another main part of the same embodiment. FIG. 4 is a partially cutaway perspective view of a blood pressure measuring wire used in a balloon catheter according to another embodiment of the present invention, and FIG. 5 is a schematic view of a blood pressure measuring wire used in a balloon catheter according to another embodiment of the present invention. FIG.

As shown in FIG. 1, a balloon catheter 20 according to an embodiment of the present invention has a balloon portion 22 that expands and contracts in accordance with the pulsation of the heart. The balloon portion 22 is composed of a thin film having a film thickness of about 100 to 150 μm. The material of the thin film is not particularly limited, but is preferably a material having excellent bending fatigue resistance, and is composed of, for example, polyurethane. The outer diameter and the length of the balloon portion 20 are determined according to the inner volume of the balloon portion 20 that greatly affects the assisting effect of the cardiac function, the inner diameter of the arterial blood vessel, and the like. The inner volume of the balloon portion 20 is not particularly limited, but is 30 to 50 cc, and the outer diameter of the balloon portion 20 is
14 to 16 mm is preferable, and the length is 210 to 270 m
m is preferred.

A tip portion 25 having a blood communication hole 23 formed therein is attached to the tip portion of the balloon portion 22 by means such as heat fusion or adhesion. The tip portion of the inner tube 30 is attached to the inner peripheral side of the tip portion 25 by means such as heat fusion or adhesion. In the present embodiment, as will be described later, the inner tube 30 is made of a flexible synthetic resin or the like, so that the tip of the inner tube 30 is the tip portion 2 of the tip.
A structure that doubles as 5 may be used.

The inner tube 30 extends in the axial direction inside the balloon portion 22 and the catheter tube 24 and communicates with a measurement port 32 of a connector 26, which will be described later. It does not communicate with.

The inner tube 30 located in the balloon portion 22 is
When the balloon catheter 20 is inserted into an artery, it also acts as a guide rod when the deflated balloon portion 22 is rolled and the balloon portion 22 is conveniently inserted into the artery.

The distal end of the catheter tube 24 is connected to the rear end of the balloon portion 22 on the outer peripheral side of the metallic connecting tube 27. Through this catheter tube 24, a fluid pressure is introduced into or drawn out from the balloon portion 22, and the balloon portion 22 is inflated or deflated. The balloon portion 22 and the catheter tube 24 are connected by heat fusion or adhesion with an adhesive such as an ultraviolet curable resin.

The material forming the catheter tube 24 is not particularly limited, but polyurethane, polyvinyl chloride, polyethylene, nylon and the like are used. The inner diameter and wall thickness of the catheter tube 24 are not particularly limited, but the inner diameter is preferably 1.5 to 4.0 mm and the wall thickness is preferably 0.05 to 0.4 mm.

A connector 26, which is installed outside the patient's body, is connected to the rear end of the catheter tube 24. The connector 26 may be molded separately from the catheter tube 24 and fixed by means such as heat fusion or adhesion, or may be molded integrally with the catheter tube 24. The connector 26 has a pressure fluid inlet / outlet 28 for introducing or discharging the pressure fluid into the catheter tube 24 and the balloon portion 22.
And a measurement port 32 communicating with the inside of the inner tube 30.

The pressure fluid inlet / outlet 28 is connected to a pump device 8 as shown in FIG.
The fluid pressure is introduced or discharged into the balloon portion 22. The fluid to be introduced is not particularly limited, but helium gas or the like having a low viscosity is used so that the balloon portion quickly expands or contracts in response to the driving of the pump device 8. The pump device 8 is not particularly limited, and for example, a device disclosed in Japanese Patent Publication No. 2-39265 can be used.

In this embodiment, the inner tube 30 is made of a flexible material. Examples of the flexible tube forming the inner tube 30 include a synthetic resin tube such as polyurethane, a synthetic resin tube reinforced with a metal mesh, and a tube in which a synthetic resin is attached to the outer circumference of a metal spring.

The measuring port 32 formed in the connector 26 to which the rear end portion of the inner tube 30 is connected is conventionally directly connected to the blood pressure measuring device and is formed in the tip portion 25 of the balloon portion 22. The blood pressure fluctuation of blood in the artery taken from a certain blood communication hole 23 was measured.

In the present embodiment, as shown in FIGS. 1 and 2, an auxiliary connector 40 having a metallic stylet tube 42 inserted along the inner tube 30 is screw-connected to the measuring port 32. This auxiliary connector 40 is connected by means such as
A blood pressure measuring device is connected to the blood pressure measuring port 44.
The blood pressure measurement port 44 of the auxiliary connector 40 communicates with the inside of the stylet tube 42. As shown in FIG. 3, the tip of the stylet tube 42 is located in the tip portion 25 of the balloon portion 22 so that the blood taken from the blood communication hole 23 is introduced to the blood pressure measurement port 44 shown in FIG. Has become.

Based on the change in blood pressure measured by the blood pressure measuring device connected to the blood pressure measuring port 44, the heart beat is detected,
The pump device 8 as shown in FIG. 6 is controlled according to the pulsation of the heart to inflate or deflate the balloon portion 22.

The metal forming the stylet tube 42 is not particularly limited, and examples thereof include stainless steel and tungsten, but stainless steel is preferably used. As shown in FIG. 3, the length of the stylet tube 42 is such that the tip of the stylet tube 42 is the tip end portion 25 when the auxiliary connector 40 is screwed and connected to the measurement port of the connector 26.
Is designed to have a margin distance a that does not protrude from the tip of the. The allowance distance a is preferably about 3 to 30 mm, for example. The blood communication hole 23 formed in the tip portion 25
It is also possible to prevent the stylet tube 42 from sticking out by forming it in a lateral hole type so as to close the tip of the tip part 25. The reason for preventing the protrusion is to prevent the tip portion of the stylet tube 42 from damaging the inner wall of the blood vessel or the like.

The outer diameter of the stylet tube 42 is not particularly limited, but is preferably 0.5 to 0.9 mm, and the inner diameter thereof is preferably 0.3 to 0.75 mm. Also, the inner pipe 3
The outer diameter dimension of 0 is not particularly limited, but is 1.0 to 1.7.
mm is preferable, and the inner diameter is preferably 0.7 to 1.1 mm.

A gap is formed between the stylet tube 42 and the inner tube 30, and blood is likely to coagulate at that portion. When blood coagulates, bacteria are likely to propagate and cause infections and the like. As a means for preventing such a situation, FIGS.
As shown in FIG. 5, the auxiliary connector 40 is provided with an injection port 46 communicating with the gap, and the tube 4 is inserted into the injection port 46.
It is preferable to connect 8 and the three-way valve 50, and to flow the anticoagulant solution from the three-way valve 50 into the gap. As the anticoagulant, heparinized saline is used.
The flow rate is not particularly limited, but is, for example, 1 cc / min. Flowing the anticoagulant solution into the gap to prevent blood is called flushing.

As shown in FIG. 7 (A), a communication hole 70 for communicating the blood pressure measurement port 44 and the measurement port 32 may be provided in the auxiliary connector 40a, or as shown in FIG. 7 (B). By providing the communication hole 72 at the end portion of the stylet tube 42 on the side of the auxiliary connector, the flush three-way valve 50 and the tube 48 shown in FIGS. In general, a blood pressure measuring circuit connected to the blood pressure measuring port 44 has a flash mechanism incorporated therein, which is also convenient to use. However, in the example shown in FIG. 7 (A), it is preferable that the communication hole 70 be a fine hole, and in the example shown in FIG. 7 (B), the communication hole 72 that does not weaken the watertight pipe 42 is preferable. .

When inserting the balloon catheter 20 of this embodiment into a blood vessel, the balloon catheter 20 is folded and the catheter tube 24 is inserted without inserting the metallic stylet tube 42 into the flexible inner tube 30. Along with that, it is inserted into the blood vessel. In the state where the staple tube 42 is not inserted,
The balloon catheter 20 is excellent in flexibility and can be properly inserted into a tortuous blood vessel without damaging the inner wall of the blood vessel.

After the balloon catheter 20 is inserted, the stylet tube 42 is inserted along the flexible inner tube 30 from the measurement port 32 formed in the connector 26 installed outside the body. As shown in FIG. 3, the tip of the stylet tube 42 extends along the inside of the flexible inner tube 30 to form the balloon portion 22.
The tip of the tip 25 is reached, and the auxiliary connector 40 is screw-connected to the connector 26 in this state. Auxiliary connector 4
If a blood pressure measuring device is connected to the blood pressure measuring port 44 of 0, the blood of the patient can be led out of the body through the inside of the stylet tube 42 and the blood pressure fluctuation can be measured.

The metal stylet tube 42 is
Since the rigidity is higher than that of the flexible inner tube 30, the rigidity of the balloon catheter 20 is improved by inserting the stylet tube 42 into the flexible inner tube 30, and the balloon catheter 20 is pushed by the blood flow. The risk of being returned is reduced, and kinks (breaks) can be effectively prevented.

As a secondary action, the balloon portion 2
Since the metallic stylet tube 42 is present over the entire length of the catheter 2 and the catheter tube 24, it is possible to image the balloon catheter 20 over the entire length by taking a radiograph of the patient.

The present invention is not limited to the above-mentioned embodiments, but can be variously modified within the scope of the present invention. For example, instead of the auxiliary connector 40 with the stylet tube 42 used in the above-described embodiment, an auxiliary connector 60 having a blood pressure measurement wire rod 52 as shown in FIG. 4 can be used. A pressure sensor 54 is attached to the tip of the blood pressure measurement wire 52, and blood pressure can be directly sensed. The blood pressure signal detected by the pressure sensor 54 is sent to the auxiliary connector 60 side through a lead wire (not shown), and then sent to the cord 62 and the plug 64. The plug 64 is electrically connected to the blood pressure measurement device.

Since the lead wire alone generally has low rigidity, it is preferable to incorporate the reinforcing wire 58 in the blood pressure measuring wire 52 in parallel with the lead wire. Then, the periphery of the reinforcing wire 58 and the lead wire is preferably covered with the resin tube 56. The outer diameter and length of the resin tube 56 are similar to those of the stylet tube 42 of the above-described embodiment. The reinforcing wire 58 is not particularly limited, but a Ni—Ti alloy wire or the like is used. The rigidity of the blood pressure measurement wire 52 as a whole is preferably about the same as that of the stylet tube 42.

Like the auxiliary connector 40 having the stylet tube of the above-mentioned embodiment, the auxiliary connector 60 having the blood pressure measuring wire 52 is used for measuring blood pressure in the inner tube 30 after inserting the balloon catheter into the blood vessel. The wire 52 is inserted and screwed into the measurement port 32 of the connector 26. Other configurations are the same as those in the above-mentioned embodiment, and it is preferable to pour the anticoagulant solution into the gap between the blood pressure measurement wire and the flexible inner tube. This embodiment has the same operation as that of the above-described embodiment, and since the pressure sensor 54 directly measures the blood pressure change inside the blood vessel of the patient, the measurement accuracy is improved.

FIG. 5 shows a modified example of the embodiment shown in FIG. 4, in which a tightly wound spring 66 is arranged around a lead wire 65 connected to the pressure sensor 54, and a blood pressure measuring wire 67 is provided. Are configured. Resin is attached to the outer periphery of the spring 66 to seal the inside. By the spring 66, it is possible to obtain the same degree of rigidity and elasticity as the blood pressure measurement wire 52 shown in FIG.

[0040]

As described above, according to the present invention, insertion into a tortuous blood vessel is facilitated, and after insertion, it is not pushed back by the blood flow or the like, and the balloon portion is in a normal position. It is able to expand and contract, increasing the effectiveness of IABP treatment. Also, the risk of kinking (breaking) of the balloon catheter is reduced.

[Brief description of drawings]

FIG. 1 is a schematic cross-sectional view of a balloon catheter according to an embodiment of the present invention.

FIG. 2 is a partial cross-sectional view showing the main parts of the balloon catheter of the same embodiment.

FIG. 3 is a partial cross-sectional view showing another main part of the same embodiment.

FIG. 4 is a partially cutaway perspective view of a blood pressure measuring wire used in a balloon catheter according to another embodiment of the present invention.

FIG. 5 is a perspective view of a main part of a blood pressure measuring wire used in a balloon catheter according to another embodiment of the present invention.

FIG. 6 is a schematic view illustrating a method of using a balloon catheter.

FIG. 7 is a sectional view of an essential part of an auxiliary connector used in another embodiment of the present invention.

[Explanation of symbols]

 20 ... Balloon catheter 22 ... Balloon part 23 ... Blood communication hole 24 ... Catheter tube 25 ... Tip part 26 ... Connector 28 ... Pressure fluid introducing port 30 ... Flexible inner tube 32 ... Measuring port 40, 60 ... Auxiliary connector 42 ... Stylet tube 44 ... Blood pressure measurement port 52, 67 ... Blood pressure measurement wire 54 ... Pressure sensor

Claims (6)

[Claims] 1. A balloon part that is inserted into an aorta and expands and contracts so as to assist the function of a heart function; and a balloon part that is connected to a rear end of the balloon part and introduces and draws a pressure fluid into the balloon part. The catheter tube communicates with a blood communication hole provided at the distal end of the balloon section, and the balloon section and the inside of the catheter tube are extended in the axial direction so as not to communicate with the flow path of the pressure fluid. A connector formed with an inner tube, a pressure fluid inlet / outlet connected to the rear end of the catheter tube for introducing and discharging a pressure fluid into / from the catheter, and a measurement port communicating with the inside of the flexible inner tube. And a metal stylet tube inserted into the flexible inner tube from the measurement port to the front of the blood communication port. 2. The stylet tube is inserted into the flexible inner tube from the measurement port to the front of the blood communication port after the balloon portion and the catheter tube are inserted into the blood vessel. The balloon catheter according to claim 1, wherein the balloon catheter is a balloon catheter. 3. The balloon catheter according to claim 1, further comprising flushing means for supplying a liquid for preventing coagulation of blood flow into a gap between the stylet tube and the flexible inner tube. 4. A balloon part which is inserted into the aorta and expands and contracts so as to perform an auxiliary action of a cardiac function, and a balloon part which is connected to a rear end of the balloon part and introduces and draws a pressure fluid into the balloon part. The catheter tube communicates with a blood communication hole provided at the distal end of the balloon section, and the balloon section and the inside of the catheter tube are extended in the axial direction so as not to communicate with the flow path of the pressure fluid. A connector formed with an inner tube, a pressure fluid inlet / outlet connected to the rear end of the catheter tube for introducing and discharging a pressure fluid into / from the catheter, and a measurement port communicating with the inside of the flexible inner tube. And a wire catheter for blood pressure measurement having a pressure sensor at the tip inserted into the flexible inner tube from the measurement port to the front of the blood communication port. 5. The blood pressure measuring wire, after the balloon portion and the catheter tube are inserted into a blood vessel, is inserted into the flexible inner tube from the measurement port to the front of the blood communication port. The balloon catheter according to claim 4, wherein 6. The balloon catheter according to claim 4, further comprising flushing means for supplying a liquid for preventing coagulation of blood flow into a gap between the blood pressure measuring wire and the flexible inner tube.