JP2003265631A - Conduit tube, balloon catheter using the same, therapeutic apparatus for arteriosclerosis, and therapeutic system - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a balloon catheter of a small diameter which is safe, is good in workability and makes therapy of the arteriosclerosis possible. <P>SOLUTION: The conduit tube consists of a lumen for a guide wire for conducting the guide wire for guiding a transparent or translucent balloon to be expanded by injection of a liquid body therein to a desired position, a lumen for feeding and discharging the liquid body for expanding/contracting the balloon and a lumen for light guiding fiber for irradiating the desired position with light. <P>COPYRIGHT: (C)2003,JPO

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a device and a treatment apparatus for photodynamically treating an affected area by administering a photosensitizer to the affected area and irradiating the affected area with laser light.

[0002]

2. Description of the Related Art Vasodilatory surgery using a balloon catheter is the mainstream of arteriosclerosis treatment. However, there is a very high probability of 40% that the proliferative reaction of vascular constituent cells is induced due to vascular disorder due to mechanical stress at the time of expansion and relapse to restenosis is 40%. In recent years, as a countermeasure against this, stent therapy has been adopted to prevent restenosis accidents due to cell proliferation by placing a metal mesh in the expanded portion.

However, since the restenosis of 15 to 20% is seen even in the stent therapy, the development of a new therapeutic method is urgently needed. As one of them, photodynamic therapy using a photosensitizer and laser light has been developed and has attracted attention.

In this therapy, a photosensitizer is administered to an affected area where a blood vessel dilatation operation is performed with a balloon, and the photosensitizer is excited by irradiating the affected area to which the photosensitizer is administered with a laser beam. As a result, It is intended to prevent restenosis accidents by killing the growth factors existing in the blood vessel wall by the action of active oxygen produced, and expansion of blood vessels, drug administration and laser light irradiation are clinically required technologies. is there.

There are two methods of administering the drug, a systemic administration method by intravenous injection and a local administration method using a sustained-release balloon.

As a conventional technique, means for irradiating a laser beam to a blood vessel after vasodilation and drug administration is described in JP-A-11-188099.

A conventional technique will be described below with reference to the drawings.

FIG. 12 is a schematic view showing the tip of a conventional balloon catheter. In the figure, 2 is a conducting tube, 3 is a balloon, 5 is a light guide fiber tip, and 21 is a side hole.

In the figure, when the distal end of the conducting tube 2 reaches the affected site in the blood vessel, a liquid is injected into the balloon 3 from the balloon expanding lumen attached to the lumen of the conducting tube 2, and the balloon 3 is expanded. To do. In this state, when the laser light is guided from the incident end of the light guide fiber 5, the laser light leaks from the clad peeling part at the tip of the light guide fiber 5 wound around the conducting tube, and the laser light is irradiated to the lumen of the blood vessel through the balloon to treat the treatment. Is done. Reference numeral 21 is a side hole, and since the blood flow is blocked when the balloon 3 is expanded, a flow path is provided in the conducting tube 2 so that blood flows from the side hole.
This function ensures a certain amount of blood flow even when the balloon is expanded.

[0010]

However, in the above-mentioned conventional technique, the optical fiber is wound around the outer circumference of the conduit tube, and the thin finish required for coronary artery treatment is impossible due to the structure and size of each member. there were.

Further, since it is a function only for laser light irradiation, it is necessary to replace the balloon catheter for each treatment such as vasodilation, administration of photosensitizer, laser light irradiation, etc., which is performed in the treatment, which is a safety aspect, The content was not satisfactory in terms of work and cost.

The present invention solves the above-mentioned problems of the prior art, and provides a balloon catheter of small diameter which is safe, has good workability, and enables coronary artery treatment.

[0013]

In order to achieve this object, the present invention is for a guide wire for conducting a guide wire for guiding a transparent or translucent balloon that expands by injecting a liquid material to a target position. Provided is a conduit tube including a lumen, a liquid material supply / discharge lumen for expanding / contracting the balloon, and a light guide fiber lumen for irradiating light to a target position.

According to this structure, it is possible to achieve a fine finish required for coronary artery treatment.

In order to achieve the above object, the present invention provides a guide wire for conducting a transparent or translucent balloon which expands by injecting a liquid material and a guide wire for guiding the balloon to a target position. Lumen for
The balloon comprises a liquid supply / discharge lumen for expanding / contracting the balloon, and a conduit tube including a light guide fiber lumen for irradiating light to a target position. The balloon has a plurality of holes. Provided is a balloon catheter capable of gradually releasing a liquid material.

According to this structure, after the drug is gradually released, the laser light irradiation work can be performed at the same position, and the replacement work of the balloon catheter is unnecessary. As a result, it is possible to eliminate the balloon catheter withdrawal / insertion actions and shorten the time required for safe treatment, and to ensure accurate treatment by matching the drug administration position with the laser irradiation position.
A great clinical advantage can be obtained.

[0017]

BEST MODE FOR CARRYING OUT THE INVENTION Embodiments of the present invention will be described below with reference to FIGS.

FIG. 1 is a schematic view showing the tip of a balloon catheter according to a first embodiment of the present invention. In the figure, 2 is a conducting tube made of a transparent or translucent material, 3 is a transparent or expandable / contractible transparent tube. A balloon made of a translucent material plays a role of expanding a blood vessel. Reference numeral 4 is a guide wire, 5 is a light guide fiber tip portion, 6 is a liquid body supplying / discharging lumen for supplying or discharging a liquid material into the balloon 3, 7 is a guide wire lumen for passing the guide wire, and 8 is When the balloon 3 reaches a target position with the lumen for the light guide fiber for passing the light guide fiber, the liquid material 10 is supplied and discharged to expand or contract the balloon.

The lumen 6 for supplying and discharging the liquid, the lumen 7 for the guide wire, the lumen for the light guide fiber, and the conduit 2 constitute a conduit for the balloon catheter.
With such a structure, it is possible to achieve a thin finish required for coronary artery treatment.

FIG. 2 is a sectional view taken along the line AA 'of the tip portion of the balloon catheter shown in FIG. In the figure, reference numeral 12 is an irradiation laser beam which is transmitted through the conduit and the balloon.

When performing a treatment for preventing restenosis of a blood vessel after a dilatation operation using the balloon catheter having the above structure, first, the guide wire 4 is inserted up to the affected part, and the distal end of the balloon catheter 1 is guided along the guide wire 4. Part is guided to the affected part. Since the position of the balloon 3 is required to be accurate, the position is confirmed by seeing through a metal marker, which is not shown in the drawing and is attached near the balloon 3. At this stage, lumen 8 for light guide fiber
When the laser light is guided from the incident end of the light guide fiber 5 inserted in the, the laser light is emitted in the circumferential direction of the conducting tube 2 from the front end of the light guide fiber 5 whose side end is laterally processed. Since the conducting tube 2 and the balloon 3 are made of a transparent or translucent material, the laser light reaches the blood vessel lumen outside the balloon while transmitting or diffusing the respective constituent materials.

When the restenosis prevention treatment is performed on the affected area after vasodilation using the balloon catheter according to the present invention,
Since the diameter of the balloon catheter is within 1 to 1.5 mm, it can be sufficiently utilized for the treatment of restenosis prevention of thin coronary vessels.

FIG. 3 is a schematic view of the distal end portion of the balloon catheter according to the second embodiment of the present invention. According to the figure, by providing the common lumen 9 that shares the liquid supply / discharge lumen and the light guide fiber lumen, the number of lumens in the conduit can be reduced, and the diameter of the conduit can be further reduced.

FIG. 4 is a schematic view showing the tip of a balloon catheter according to a third embodiment of the present invention. According to the drawing, the balloon 3 is provided with a sustained release hole indicated by 11. As the liquid material 10, an aqueous solution of a photosensitizer is used. The aqueous solution of the photosensitizer injected into the liquid supply / exhaust lumen 6 is gradually released into the blood vessel lumen through the large number of sustained release holes 11 provided on the surface of the balloon after the balloon is expanded. When laser light irradiation is performed at a stage where the photosensitizer has been sufficiently taken into the blood vessel wall by sustained release, the laser light 12 is applied to the lumen of the blood vessel through the conduit tube 2, the aqueous solution of the photosensitizer and the balloon 3.

At this time, the laser light 12 from the photosensitizer is used.
However, in an aqueous solution containing no impurities, the peak of the absorption band wavelength is 643.5 nm and the half-value width is 20 nm. Furthermore, when it is bound to proteins and the like when it is taken up by the living body, the absorption band wavelength is 664.
Shift to 5 nm. Therefore, the absorption band wavelength of the photosensitive substance remaining in the balloon is at least 643.5n.
m is absorptive to the laser light having an irradiation wavelength of 664 nm and the transmittance of the laser light 3 is not significantly impaired. The sustained release hole 11 may be provided in the embodiment in which the shared lumen 9 is provided.

There is also a method of shifting the laser light wavelength to the long wavelength side as a means for further reducing the wavelength.

FIG. 5 is a schematic diagram showing the fourth embodiment of the present invention. According to the figure, in the conduit tube 2, the light guide fiber lumen 8 is in communication with the balloon lumen. In this conduit tube, after the aqueous solution of the photosensitizer is gradually released, if the presence of the photosensitizer becomes an obstacle due to the thickness of the balloon 3 or the like, the lumen 8 for the light guide fiber is used to clear the physiological saline or the like. The above liquid is injected from the liquid supply / drainage lumen to move and replace the photosensitizer in the balloon 3 from the light guide fiber lumen to the outside of the balloon. This eliminates anxiety about laser irradiation.

FIG. 6 is a schematic view showing a fifth embodiment of the present invention in which a hemispherical projection 14 is attached to the surface of the balloon 3, and as shown in FIG. 6B, the hemispherical projection 14 is a blood vessel. Since the outer surface of the balloon and the inner wall surface of the blood vessel are not in close contact with each other by making contact with the inner wall of the vessel, it is possible to prevent deterioration of the sustained release of the aqueous solution of the photosensitizer and prevent the photosensitizer from entering the lumen of the blood vessel. Permeates everywhere.

FIG. 7 shows leak preventive walls 15 on both sides of the balloon in order to prevent the aqueous solution from leaking from the front and back of the balloon when the aqueous solution of the photosensitizer is gradually released in the balloon shown in FIG. 4 or 6. It is provided.

The conducting tube 2 in FIG. 8 monitors the laser beam 12 emitted from the tip of the light guide fiber 5. A part of the emitted laser beam 12 passes through the conducting tube 2 and is inserted into the lumen 17 for the monitor fiber. The tip of the monitored fiber 18 is irradiated. A part of the emitted laser light becomes light in the axial direction of the monitoring fiber 18, is guided to the connector side of the monitoring fiber, and is read to the reading sensor arranged at the end of the fiber of the arteriosclerosis treatment device 22. Is incident. With this information, the irradiation state of the laser light is monitored, and stable laser irradiation can be performed.

FIG. 9 shows a means for securing blood flow using a guide wire lumen. A side hole communicating with the lumen of a blood vessel is provided on the front side of the balloon of the guide wire lumen to expand the balloon. The flow path of blood at that time is secured. In this case, a more effective flow path is secured by moving the guide wire once to the introduction port side before the side hole.

FIG. 10 is a schematic view of a balloon catheter 1 according to the present invention, which includes a balloon 3 attached to the distal end of a conduit tube 2 and a monitor fiber inlet 19 at the other end, a liquid material inlet 20, and a guide wire. It is composed of an inlet 21 and a light guide fiber inlet 22.

FIG. 11 shows a balloon catheter 1 according to the present invention.
3 is a schematic view of a treatment system including an arteriosclerosis treatment device 23 and a balloon 3 attached to the distal end portion of the conduit tube 2. FIG.
The laser light 12 oscillated by the arteriosclerosis treatment device 23 is configured by the arteriosclerosis treatment device 23 in which the monitor fiber 18, the light guide fiber 5, the laser light source, the monitor light reading sensor, and the like are incorporated. The light is guided to the distal end portion of the balloon catheter 1 and becomes side-emitted light inside the balloon 3 to illuminate the lumen of the blood vessel. Further, a part of the irradiation light is guided as monitor light into the arteriosclerosis treatment device by the monitor fiber and read by the reading sensor, and the oscillation state of the laser light source and the abnormality of the light guide path are detected.

FIG. 12 shows a treatment system including a balloon catheter according to the present invention, a laser light source, and an optical sensor for reading laser light from a monitor fiber.

[0035]

As described above, according to the present invention, the laser light irradiation by the light guide fiber is performed from the inside of the conducting tube, or
The diameter of the balloon catheter was reduced by sharing the liquid supply / exhaust lumen and the light guide fiber lumen, and it became possible to prevent restenosis of thin coronary arteries.

Further, by providing a sustained-release hole on the surface of the balloon, administration of the photosensitizer and laser light irradiation can be performed with one balloon catheter, which makes it possible to reduce the safety and time of the treatment and reduce the cost. It can be reduced.

[Brief description of drawings]

FIG. 1 is a schematic diagram showing a balloon catheter tip portion according to a first embodiment of the present invention.

FIG. 2 is a schematic diagram of a catheter according to the first embodiment of the present invention.

FIG. 3 is a schematic diagram showing a balloon catheter tip portion according to a second embodiment of the present invention.

FIG. 4 is a schematic diagram showing a distal end portion of a balloon catheter having a liquid material sustained-release function according to a third embodiment of the present invention.

FIG. 5 is a schematic diagram showing a balloon catheter distal end portion having a communication hole according to a fourth embodiment of the present invention.

FIG. 6 is a schematic diagram showing a situation in which a hemispherical protrusion is provided on the surface of a balloon according to a fifth embodiment of the present invention.

FIG. 7 is a schematic diagram showing a balloon according to a sixth embodiment of the present invention.

FIG. 8 is a schematic diagram showing a laser fiber power monitor fiber structure according to a seventh embodiment of the present invention.

FIG. 9 is a schematic diagram showing a conduit tube having a blood channel according to an eighth embodiment of the present invention.

FIG. 10 is a front view showing a balloon catheter according to an embodiment of the present invention.

FIG. 11 is an explanatory diagram showing a treatment system according to an embodiment of the present invention.

FIG. 12 is a schematic view of a conventional balloon catheter tip section.

[Explanation of symbols]

2 Conduction tube 3 balloons 4 guide wire 5 Light guide fiber Lumen for liquid supply and discharge Lumen for 7 guide wires 8 Lumens for light guide fiber 10 Liquid 11 Sustained release hole

   ─────────────────────────────────────────────────── ─── Continued front page    (72) Inventor Yoshiteru Ino             1006 Kadoma, Kadoma-shi, Osaka Matsushita Electric             Sangyo Co., Ltd. (72) Inventor Katsuo Aizawa             6-26-20 Tomioka Nishi, Kanazawa-ku, Yokohama-shi (72) Inventor Tsuneyuki Nagae             2-6-6-401 Fukasawa, Setagaya-ku, Tokyo F term (reference) 4C082 PA10 PC10 PG13 PJ30 PL03                 4C167 AA06 AA09 AA28 BB28 BB47                       CC19 DD01 EE07 EE11 FF01

Claims (13)

[Claims] 1. A guide wire lumen for conducting a guide wire for guiding a transparent or translucent balloon, which expands when a liquid is injected, to a target position, and a liquid supply for expanding / contracting the balloon. A conducting tube composed of a discharge lumen and a light guide fiber lumen for irradiating light to a target position. 2. A guide wire lumen for conducting a guide wire for guiding a transparent or translucent balloon which is inflated by injecting a liquid material to a target position, and a liquid material for expanding / contracting the balloon. A conducting tube consisting of a common lumen for feeding and discharging and guiding a fiber that irradiates light to a target position. 3. The conductive tube itself is transparent or semi-transparent.
Or the conduit tube according to any one of 2. 4. A transparent or translucent balloon which expands when a liquid is injected, a guide wire lumen for conducting a guide wire for guiding the balloon to a target position, and for expanding / contracting the balloon. Of the liquid material supply and discharge lumen, and a conducting tube consisting of a light guide fiber lumen for irradiating light to a target position,
A balloon catheter in which a plurality of holes are formed in the balloon so that a liquid material can be gradually released. 5. A transparent or translucent balloon which expands when a liquid is injected, a guide wire lumen for conducting a guide wire for guiding the balloon to a target position, and for expanding / contracting the balloon. A conducting tube consisting of a common lumen for feeding and discharging the liquid material and guiding a fiber for irradiating light to a target position,
A balloon catheter in which a plurality of holes are formed in the balloon so that a liquid material can be gradually released. 6. The conductive tube itself is transparent or semi-transparent.
Alternatively, the balloon catheter according to any one of 5 above. 7. The balloon catheter of claim 4, wherein the light guide fiber lumen is in communication with the balloon lumen. 8. The balloon catheter according to claim 4, wherein the balloon surface has a large number of protrusions. 9. The balloon catheter according to claim 4, which has band-shaped projections in the circumferential direction at both ends of the balloon. 10. The balloon catheter according to claim 4, which has a lumen for a monitor fiber for conducting an optical fiber for monitoring the light emitted from the tip portion of the light guide fiber. 11. A side hole for ensuring blood flow is provided on the front side of the balloon of the lumen for a guide wire, 1, 2.
The balloon catheter according to any one of 4 and 5. 12. A transparent or translucent balloon which expands when a liquid is injected, a guide wire lumen for conducting a guide wire for guiding the balloon to a target position, and a balloon front side of the guide wire lumen. A side hole provided on the side, a liquid material supply / discharge lumen for expanding / contracting the balloon, a light guide fiber lumen for irradiating light to a target position, and a monitor fiber lumen for monitoring the irradiation status, A balloon catheter comprising a connector having an inlet for the guide wire, an inlet for the light guide fiber, an inlet for the monitor fiber, and an inlet for the liquid material. 13. A transparent or translucent balloon which expands when a liquid is injected, a guide wire lumen for conducting a guide wire for guiding the balloon to a target position, and the balloon front side of the guide wire lumen. A side hole provided in the body, a lumen for supplying / discharging a liquid material for expanding / contracting the balloon when the balloon reaches a target position, and a lumen for a light guide fiber for irradiating light to the target position, A lumen catheter for a monitor fiber for monitoring the situation, an inlet for the guide wire, an inlet for the light guiding fiber, an inlet for the monitor fiber, and a balloon catheter comprising a connector having an inlet for the liquid material. , A treatment system comprising a treatment device connected to the light guide fiber and the monitor fiber. Stem.