JPH11164891A - Double balloon catheter - Google Patents

Abstract

PROBLEM TO BE SOLVED: To prevent occurrence of a peripheral embolus due to liberation of thrombus or the like when carrying out an expansion treatment of a lesion part, where a blood vessel is stenosed or blocked. SOLUTION: At the front end 2a of a catheter body 2 having a plurality of lumens 3-6, a balloon 7 for blood vessel expansion with low expansion- contractibility and a balloon 8 for blood vessel blockage with greater expansion- contractibility than the blood vessel expansion balloon 7 are disposed orderly forward from the front end of the catheter body. An outlet 9 for discharging chemicals on the outer peripheral surfaced 2b of the catheter body between the blood vessel expansion balloon 7 and the blood vessel blockage balloon 8, and both balloons 7, 8 as well as the outlet 9 are respectively communicated with different one of the lumens 3, 4 and 5.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a double-balloon catheter, and more particularly, to a double-balloon catheter capable of performing dilatation treatment of a vascular stenosis or an occluded lesion without generating a peripheral embolus due to release of a thrombus or the like. About.

[0002]

2. Description of the Related Art Percutaneous angioplasty (PTA) for stenotic lesions is performed in cerebral blood vessels, peripheral blood vessels, dialysis shunts and the like. In this angioplasty, a balloon of a balloon catheter is introduced into a stenotic lesion in a blood vessel, where the balloon is inflated to expand the stenotic blood vessel.

However, when the stenotic lesion is expanded and expanded with a balloon as described above, a thrombus or a dendritic substance attached to the stenotic lesion is released when the balloon is deflated, for example.
There is a problem that it gets on the bloodstream to reach peripheral blood vessels and causes peripheral embolism, and the peripheral occlusion may cause serious complications. The frequency of occurrence of this complication is reported to be about 8%, and in severe cases, peripheral amputation of the lower limbs and the like may be necessary. In addition, when performing angioplasty in the internal carotid artery, peripheral embolism may lead to complications of central nervous system disorders such as paralysis and aphasia. The outbreak was a major obstacle to the spread of this treatment.

[0004]

SUMMARY OF THE INVENTION An object of the present invention is to provide a double balloon catheter capable of preventing the occurrence of peripheral emboli due to release of thrombus or the like when performing dilation treatment of a vascular stenosis or an obstructed lesion. Is to do.

[0005]

SUMMARY OF THE INVENTION In order to achieve the above object, the present invention provides a catheter body having a plurality of lumens,
A balloon for inflation and contraction and a balloon for inflation and contraction having a lower inflation and contraction property than the balloon for vessel occlusion are arranged in order from the distal end to the near side, and An opening for discharging a drug solution is provided on the outer peripheral surface of the catheter body between the two, and the balloon and the opening are respectively connected to different ones of the lumens.

[0006] As described above, the vascular occlusion balloon is disposed at the distal end of the catheter body at the distal end, the vascular dilatation balloon is disposed at the near side, and an opening for discharging a drug solution is disposed between both balloons. After inflating the vaso-occlusive balloon to make the vessel occluded, the vasodilator balloon is inflated to expand and expand the occluded or stenotic lesion, and then the vasodilator balloon is deflated. By discharging the drug solution from the opening through the opening, the thrombus or denatured substance released from the lesion can be dissolved while being retained. As a result, the released thrombus and the like are prevented from flowing into peripheral blood vessels by the vaso-occlusive balloon, and the thrombus and the like can be dissolved by a high-concentration drug solution, thereby avoiding flowing into peripheral blood vessels and causing peripheral embolism. be able to.

[0007]

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS The configuration of the present invention will be described below in detail with reference to the accompanying drawings. FIG. 1 shows an example of the double balloon catheter of the present invention. The catheter 1 includes a flexible catheter body 2 and a plurality of (four in the figure) lumens 3, 4, 5, and 5 shown in FIG. 6 extend independently of each other. The distal end portion 2a of the catheter main body 2 has a vascular occlusion balloon 7 on the distal end side and a vascular dilatation balloon 8 on the proximal side in series in the longitudinal direction.

The distal-side vascular occlusion balloon 7 communicates with a lumen 3 having a substantially fan-shaped cross section in the catheter body 2.
A fluid such as carbon dioxide or a diluted contrast agent from the balloon 7
It is made to expand and contract by being supplied and discharged inside.
The vascular occlusion balloon 7 is made of a highly extensible material having a higher inflation / contraction property than the vasodilation balloon 8, and when inflated, forms a spherical shape as shown in FIG. 1 and closely adheres to the inner wall of the blood vessel to serve as a plug. It has become.

A lumen 4 having a circular cross section in the catheter body 2 communicates with the vascular dilatation balloon 8 on the near side.
By supplying and discharging a liquid such as a contrast medium diluted from the inside of the balloon 8, the balloon 8 is inflated and contracted. The vascular dilatation balloon 8 is made of a low-elongation material having a lower inflation / contraction property than the vaso-occlusive balloon 7 and is formed in a slender shape whose longitudinal length is larger than that of the vaso-occlusive balloon 7. Performs the task of expanding the department.

An opening 9 for discharging a chemical is formed on the outer peripheral surface 2b of the catheter body 2 between the balloons 7, 8. The number of the openings 9 may be two or more.
Communicates with the inner cavity 5 having a substantially fan-shaped cross section. The distal end 2c of the catheter body 2 is provided with an opening through which a lumen 6 having a large diameter and a circular cross section communicates. The lumen 6 is used for inserting a guide wire when introducing a catheter into a lesion in a blood vessel.

An X-ray opaque marker 10 is provided on the central surface of the catheter body 2 in the vaso-occlusive balloon 7 so that X-rays can be seen during treatment. In addition, the front and rear 2 of the surface of the catheter body 2 in the vascular dilatation balloon 8
An X-ray opaque marker 11 is provided in some places. The distal end of the catheter body 2 is formed in a tapered shape with a tapered end to facilitate introduction of the catheter 1 into a blood vessel.

A rear end of the catheter body 2 is connected to a connector 12 made of a hard plastic or the like, and an extension tube 13 communicating with the lumen 6 is connected to the rear end of the connector 12. In addition, lumens 3, 4, 5, and 5 are provided in each of the branch portions 12a, 12b, and 12c protruding from the outer peripheral surface of the connector 12.
Are connected to extension tubes 14, 15, and 16, respectively. Connection ports 17 to 20 are attached to the rear ends of the tubes 13 to 16, respectively.

A case where an arterial stenosis is treated by the catheter 1 of the present invention will be described as an example. First, as shown in FIG. 3A, an upstream of blood flowing as shown by an arrow is shown using a guide wire (not shown). The vascular dilatation balloon 8 in a contracted state is introduced into the stenosis lesion 22 of the blood vessel 21 from the side. Next, a fluid such as a carbon dioxide gas or a diluted contrast agent is supplied from the connection port 18, the fluid is filled into the vascular occlusion balloon 7 through the extension tube 14 and the lumen 3, and the vascular occlusion balloon 7 is connected to the blood vessel 21. Inflate to close (Fig. 3
(B)).

After the vessel is occluded, a thrombus-dissolving drug such as urokinase is discharged from the opening 9 through the extension tube 16 and the lumen 5 (FIG. 3 (c)), and the thrombus adhering to the stenosis lesion 22 is discharged. Dissolve. Next, by supplying a diluted liquid such as a contrast agent from the connection port 19, the liquid is supplied through the extension tube 15 and the lumen 4 to the vascular dilatation balloon 8.
And inflates the vasodilator balloon 8 (FIG. 3).
(D)). As a result, the stenotic lesion 22 is pressed and expanded by the vascular dilation balloon 8.

After the expansion, the filled liquid is discharged to contract the vascular dilatation balloon 8 (FIG. 3 (e)).
6. Discharge from the opening 9 through the lumen 5 (FIG. 3)
(F)). Since the inflated vascular occlusion balloon 7 blocks the downstream side of the blood vessel 21, thrombus and the like released from the stenotic lesion 21 during expansion and contraction of the balloon 8 stay in the vicinity of the lesion and dissolve and disappear by the drug solution. Therefore, even if the thrombus or the like is released, the thrombus dissolves and disappears, so that the occurrence of peripheral embolus can be prevented.

After dissolution and disappearance, the filled fluid is drained and the vascular occlusion balloon 7 is deflated to make blood flow (FIG. 3 (g)). By repeating the above-described operations of FIGS. 3B to 3G two to three times, the stenotic lesion 2
2 is expanded. In the present invention, as the flexible material constituting the catheter body 2, for example, polyethylene or nylon can be preferably used.

As a material constituting the vaso-occlusive balloon 7, latex or silicone, which easily expands and deforms when a pressure is applied, can be preferably used.
When the vascular dilatation balloon 8 is formed by combining these materials and thicknesses, it is preferable that the vascular dilatation balloon 8 has such a property that it is destroyed at less than 2 atmospheres, and has high extensibility that cannot expand the lesion. Preferably, it has a property of breaking at a pressure of 1.2 atm or less.

Examples of the material constituting the vascular dilatation balloon 8 include polyurethane, polyester, polyethylene, and nylon. Among them, polyester is preferable. When the vascular occlusion balloon 7 is formed by combining these materials and thicknesses, it is preferable that the material has a property of withstanding 2 atm. Preferably, it is made non-extensible with little stretching or deformation when pressure is applied.

It is preferable that the outer peripheral surface of the catheter body 2, the inner peripheral surfaces of the lumens 5, 6 and the outer surfaces of the balloons 7, 8 are coated with a biocompatible substance, particularly an antithrombotic substance. As this antithrombotic substance, for example, heparin, urokinase and the like are suitable. The above lumens 3,4
5 has a substantially fan-shaped or circular cross-sectional shape in the above-described embodiment, but is not limited thereto.

The present invention can also be preferably used in cases of stenosis and occlusion due to thrombus. Further, the thrombolytic agent is injected into the blood vessel from the opening 9 in a state where the blood vessel occlusion balloon 7 is used without using the blood vessel dilatation balloon and the blood vessel occlusion balloon 7 is inflated to close the blood vessel. There is an advantage that it can be used also for thrombolytic therapy administered to the resulting thrombus.

[0021]

As described above, according to the present invention, a vascular occlusion balloon and a vascular dilatation balloon are arranged at the distal end of a catheter body having a plurality of lumens in this order from the distal end to the near side. An opening for discharging a drug solution was provided on the outer peripheral surface of the catheter body between the occlusion balloon and the vascular dilatation balloon, and both balloons and the opening were respectively connected to different ones of the lumens. The balloon is expanded to block the blood vessel, and then the lesion is expanded using a vascular dilatation balloon.Then, by discharging the drug solution from the opening, the thrombus released from the vicinity of the lesion is dissolved and retained. Since it can be eliminated, it is possible to prevent the occurrence of peripheral emboli due to release of thrombus and the like in dilation treatment of a vascular stenosis or a closed lesion.

[Brief description of the drawings]

FIG. 1 is a front view showing an example of a double balloon catheter of the present invention with a part thereof omitted.

FIG. 2 is an enlarged sectional view taken along the line AA of FIG.

FIGS. 3A to 3G are explanatory views showing the operation of the double balloon catheter of the present invention.

[Explanation of symbols]

Reference Signs List 1 double balloon catheter 2 catheter main body 2a distal end portion 2b outer peripheral surface 3, 4, 5, 6 lumen 7 vascular occlusion balloon 8 vascular dilation balloon 9 opening 21 blood vessel 22 stenosis lesion

Claims (2)

[Claims] 1. A balloon for inflating and contracting a vascular occlusion in order from the distal end to a front side of a catheter body having a plurality of lumens, and a vasodilating balloon having a lower inflation and contracting property than the balloon for vascular occlusion. And an opening for discharging a drug solution is provided on the outer peripheral surface of the catheter body between the vascular occlusion balloon and the vascular dilatation balloon, and the two balloons and the opening are respectively different from one of the lumens. Double balloon catheter connected to. 2. The material of the vaso-occlusive balloon is latex or silicone, and the material of the vasodilator balloon is at least one selected from the group consisting of polyester, polyethylene, nylon and polyurethane. Double balloon catheter.