JPH06233823A - Balloon catheter - Google Patents

Abstract

PURPOSE:To prevent a balloon inserted into a blood vessel and inflated from completely cutting off the bloodstream, secure the minimum bloodstream quantity, and prevent ischema by providing a groove-like recess linearly in parallel with the catheter axis or spirally on the surface of the balloon. CONSTITUTION:This balloon catheter for an endoscope is constituted of a soft synthetic resin tube 2 and a balloon 1 fitted around the tip section of the tube 2, and image fibers 4 made of a bundle of fibers for lighting and for image transmission are slidably inserted into the tube 2. A balloon inflating fluid can be fed into the tube 2 by a branch pipe 7 provided on a connector 6. A recessed groove 9 in parallel with the catheter axis (or spiral recessed groove) is formed on the surface of the balloon 1 of the catheter. The balloon inserted into a blood vessel and inflated does not completely cut off the bloodstream, the minimum required bloodstream quantity can be secured, and ischema is prevented.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention is used for expanding blood vessels by inserting it into a living organ, particularly a blood vessel, in medical or animal experiments, and further using an image fiber or a combination of an image fiber and a laser light fiber or forceps. In particular, it relates to a balloon catheter used for observation and diagnosis or observation and treatment.

[0002]

2. Description of the Related Art Angiography, DSA, X-ray CT are used as a clinical method for knowing the state of a stenotic or occluded blood vessel.
Alternatively, there is an ultrasonic examination (intravascular echo method) and the like, but it is not possible to obtain information as much as direct observation as in an angioscope.

It has already been put into practical use to send an endoscope into a living body for observation, and in particular, the digestive system and respiratory system are clinically used in combination with various therapeutic devices. However, observation of the inside of blood vessels cannot be performed because the observation field of view is filled with opaque blood, and there are few technologies that have been put to practical use, such as the digestive system and respiratory system.

At present, there are the following two methods using a balloon as a method of observing the inner wall of a blood vessel with an image fiber inserted into the blood vessel.

The first method is to inflate balloons inserted at both ends of the intravascular observation site to occlude the blood vessel to stop the blood flow and replace stagnant blood with transparent physiological saline, or By occluding the blood vessel with an inflated balloon placed on the upstream side and then flushing the retained blood with transparent saline to the downstream side, the blood is eliminated by any method, and a transparent observation field of view is secured. The inside of the blood vessel is observed by sending the tip of the image fiber into the normal saline.

The second method is an image in which a balloon is placed at a site to be observed in a blood vessel, expanded with a transparent liquid to remove blood, and a blood vessel wall and an object to be observed which are in contact with the outer surface thereof are inserted into the inner space of the balloon. Observe through the membrane of the balloon with the fiber.

Many examples of use of the above two methods have been introduced, but none of them has come into widespread use.

[0008] The method of observing the inside of a blood vessel using these balloons requires that the blood vessel be occluded by the inflated balloon to obstruct the blood vessel at the time of observation, and a serious after-effect due to the blood obstruction is predicted, so that the observation time is shortened. Therefore, attention must be paid to the occurrence of sequelae due to ischemia, and there is no doubt that insufficient observation cannot be one of the factors hindering its spread.

A scheme has been proposed in which an inflated balloon occludes a blood vessel to prevent blood flow. A hemostasis balloon that prevents the bleeding by blocking the entrance of the branch blood vessel leading to the damaged blood vessel wall and the organ causing bleeding by making the cross section of the balloon's inflation axis a donut shape so that blood flow passes through the hollow of the balloon body. A catheter has been proposed in JP-A-63-161974. Similarly, an endoscopic balloon having an inflatable ring or protrusion provided in an appropriate position on the inflated balloon and having a protrusion-attached balloon in which a protrusion is applied to the blood vessel wall to create a gap between the inflated balloon and the blood vessel wall The catheter is disclosed in Japanese Patent Laid-Open No. 1-232294, and a blood flow bypass pipe penetrating the front and rear of the balloon is installed inside the catheter shaft so that the blood flow is not completely stopped even when the balloon is inflated to come into contact with the inner wall of the blood vessel. Balloon Catheter for Vasodilation Surgery Prepared for Opening to the Public
165 etc. are disclosed. In addition, the hollow of the catheter for guide wire insertion also serves as a bypass for blood flow.
NORAIL-BONGEL "and" HIGH FL
Schneid under the product name of OW CPC MAINZ "
It is clinically provided as a balloon catheter for coronary artery dilatation by er (US).

[0010]

The above-mentioned method of utilizing the hollow guide wire provided to the clinic is effective with a simple mechanism, but in general, a catheter is thin in order to reduce the damage of the insertion part. Therefore, the hollow hole for the guide wire is inevitably small, and the bypass amount of blood is small, so that the use thereof is limited to the peripheral blood vessel having a small blood flow amount.
The doughnut-shaped balloon having a cross-sectional shape has a free blood flow obtained depending on the size of the through hole, but it is difficult to manufacture. Similarly, it is difficult to manufacture a balloon in which an annular shape or a protrusion is provided at an appropriate position of the balloon, and in both cases, there is a problem in use that the expanded balloon becomes large when the balloon is incorporated as a balloon for an endoscope.

Therefore, the present invention prevents the inflated balloon of the balloon catheter inserted into the blood vessel from completely obstructing the blood vessel and causing sequelae when observation, observation and diagnosis, and treatment are performed in parallel. The mechanism of attaching a balloon with a structure that allows the required amount of blood to pass is simple,
The present invention provides a balloon catheter that is easy to manufacture.

[0012]

The inventor of the present invention provides a balloon catheter for an endoscope in which a balloon that is inserted into a blood vessel and inflated does not completely block the blood flow, and a minimum necessary blood flow is secured. As a result of intensive studies, the inventors have found that prevention of ischemia is solved by providing a groove with a groove in the balloon and flowing blood through the groove.

That is, the present invention provides a balloon catheter characterized in that a groove-shaped recess is provided on the surface of the balloon in a linear or spiral shape parallel to the catheter axis.

The structure of the balloon catheter of the present invention will be described with reference to the drawings by taking an endoscopic balloon catheter as an example. FIG. 1 shows an embodiment of the basic form of the balloon catheter for an endoscope of the present invention in which the balloon 1 in which the inflated balloon of the present invention forms a groove-shaped recess parallel to the catheter axis is attached to the tip of the catheter tube 2. As shown in Figure 2,
3A shows a sectional structure of the inflated balloon 1 mounted portion, FIG. 3A shows a sectional surface of the balloon 1 portion AA ', and FIG. 3B shows a sectional structure of the tube 2 BB' portion. showed that.

A balloon catheter for an endoscope, which is an example of the present invention, comprises a flexible synthetic resin tube 2, a hollow 3 extending over the entire length thereof, and a balloon 1 mounted around the distal end of the tube 2. An image fiber 4 composed of a bundle of fibers for illumination and image transmission is slidably arranged, and the tip of the image fiber 4 reaches the inside of the balloon 1. The hollow 3 containing the image fiber 4 communicates with a branch pipe 7 attached to the base end of the hollow 3 as a fluid passage 5 for balloon inflation, which is open to the inner space of the balloon. The branched balloon inflow fluid inflow port 7 is usually provided with a connector to which a syringe or the like for press-fitting / suctioning the inflation fluid can be connected, or an extension tube connectable to them. The insertion opening 8 of the image guide 4 is provided with a variable sealing device such as an O-ring.

The surface of the balloon has a groove 9 (recessed) or a groove (not shown) recessed in parallel with the catheter axis as shown in FIG. 1 or as shown in FIG. 3 (A). ing.

Next, the operation of the endoscope balloon catheter which is an example of the present invention will be described. Balloon 1
Made of non-stretchable latex, silicone or urethane material, or thin film made of polymer such as vinyl chloride or polyester that has no stretchability but excellent pressure resistance There is. And
These are materials having a transparency necessary for observing a lesion portion contacting the outer surface of the thin film with the image fiber 4 through the thin film. These materials are used for the purpose of fixing the balloon to the inner wall of the blood vessel with gentle pressure to diagnose the state of the lesion, or performing vasodilation to expand the narrowed blood vessel by the expansion force of the balloon 1 while observing. Used properly.
When the balloon 1 is inflated by changing the thickness of the thin film, suppressing the expansion of a part of the balloon 1 by adhering or embedding a thread or cloth, and adhering it to the outer surface of the tube 2, the tip of the balloon 1 is expanded. Continuous recessed groove 9 between the
Is formed in a linear shape or a spiral shape. Blood flow can be secured if at least one groove 9 is provided for the balloon,
In order to place the tip of the image fiber 4 in the center of the blood vessel, it is preferable to provide two as shown in FIG. This groove creates a space between the blood vessel walls that are in contact with the balloon 1, and the blood flow flows through this space to prevent the occurrence of sequelae due to ischemia.

The catheter is made of a flexible synthetic resin such as polyurethane, polyethylene, Teflon, or vinyl chloride, and is usually a tube 2 containing an in-wall roentgen ray impermeable substance. Have one or more hollows. One of the hollows has a distal end opened to the inside of the balloon 1 and a proximal end opened to a balloon inflation fluid injection port 7 provided in a connector 6 at the rear end of the tube to connect the two together. In order to observe the inner wall of the blood vessel in contact with the outer surface of the balloon from the inside of the balloon 1, the image fiber 4 in which the illuminating fiber and the observing fiber are bundled is built in, and the gap formed by the hollow inner wall and the bundle of image fibers is expanded by the balloon. It is a passage 5 through which the working fluid passes. Image fiber 4
The arrangement of the bundles in the balloon inflating fluid passageway 5 allows the diameter of the tube 1 to be smaller than providing a dedicated hollow for each. The balloon inflation fluid present in the hollow becomes lubricating oil that improves the slidability of the fiber bundle.

In the case of a tube having two hollows, a bundle of image fibers as described above is arranged in one of the hollows, and the gap is used as a passage for a balloon inflation fluid, and the remaining hollow has a balloon at its tip. When it is opened to the outside of the balloon on the more distal side, a guide wire for guiding the catheter inserted into the blood vessel is inserted into the hollow, or a lesion is taken for examination from the lesion part of the blood vessel wall observed with an image fiber in the balloon. It is used as a passage for a diagnostic or therapeutic tool for inserting a biopsy needle or forceps for collecting foreign matter.
In addition, when this hollow tip is opened inside the balloon,
Angioplasty, which irradiates and treats a lesion such as a stenosis of a blood vessel from within the balloon, can be performed while observing with an image fiber, and the lesion irradiated by the laser is constantly monitored and irradiated. This is preferable because it can prevent perforation that tends to occur when a laser beam is inadvertently applied to the blood vessel wall, which is not necessary.

The balloon catheter of the present invention can be used not only as the above-mentioned balloon catheter for endoscopes but also, for example, for dilating blood vessels. When used for vasodilation, it is preferable to treat while observing by arranging an image fiber.

[0021]

【Example】

Example 1 A polyurethane tube having a hollow diameter of 1.3 mm and an outer diameter of 2.5 mm and containing barium sulfate was cut into an appropriate length, and a side hole was provided in a tube wall proximal to the tip, and a hollow tip was provided. Epoxy resin was injected into the side holes to close them. Apart from
A mold of a glass rod having a diameter of 5 mm was dipped in a urethane solution and then dried in an air stream at 50 ° C. to form a thin film having a thickness of 80 μm. The thin film was dipped in an acetone solution to swell and peeled from the mold to obtain a balloon base material. . Next, three holes each having a diameter of 1 mm, parallel to the expansion axis and facing the control, were narrowed on the side surface of the urethane membrane balloon substrate. The urethane tube was inserted into the thus-prepared balloon substrate from the tip, the side holes were covered with the balloon substrate, and both ends were bound with 70 μm tetron thread and fixed so as to be hermetically sealed. Next, the balloon base material was pressed against the side surface of the tube, and the instant adhesive was allowed to penetrate through the hole narrowed on the side surface of the balloon base material to be fixed by adhesion. And
Epoxy resin was applied to the surface of the thread in which the ends of the balloon base material and the holes in which the adhesive had been impregnated were coated to make a smooth surface. Finally, the urethane tube was swollen with acetone into a stainless steel pipe having an inner diameter of 1.1 mm and a length of 30 mm and having a needle base at one end at the base of the tube, and after drying,
The balloon catheter for an endoscope of the present invention was completed by reinforcing and fixing with a shrink tube.

Example 2 The balloon catheter for endoscope manufactured in Example 1 was sterilized with ethylene oxide gas with a Y-type connector attached to the needle base. Insert a separately sterilized 6,000 image guides and 40 light guides, and insert an image fiber with a diameter of 1.0 mm from the straight part of the Y-type connector to the lumen of the balloon and into the femoral artery of the rabbit. 7 Fr.
The blood vessel was retrogradely sent into the thoracic artery via the sheath introducer, and physiological saline was injected through the side hole of the Y-shaped connector to observe the lumen of the blood vessel. The lumen of the blood vessel illuminated from the light source of the Xe lamp through the ride guide is bright, and the bypass state of blood flow and arteriosclerotic lesions on the wall of the blood vessel lumen are displayed on the monitor TV via the CCD camera connected to the image guide. It was beautifully projected.

[0023]

EFFECT OF THE INVENTION The balloon of the balloon catheter for endoscope of the present invention has a structure in which a part of the balloon is incomplete even when it is inflated in the blood vessel and pressed against the wall of the blood vessel to be fixed, and complete blood flow is prevented. However, some of the blood flow is structured to flow. As a result, when observing with an image fiber from the inside of the balloon inscribed in the blood vessel wall, the observation can be performed without worrying about the aftereffects due to ischemia, and sufficient information can be obtained during diagnosis and treatment.

[Brief description of drawings]

FIG. 1 is an external view showing one aspect of a basic form of a balloon catheter for an endoscope of the present invention, which represents one of the features of the inflated balloon of the present invention.

FIG. 2 shows a fractured cross-sectional structure of an inflated balloon mounting portion.

FIG. 3A is a sectional view of a balloon portion AA ′ portion, and FIG. 3B is a sectional structure of a tube BB ′ portion.

[Explanation of symbols]

 1: Balloon 2: Tube 3: Hollow 4: Image Fiber 5: Expansion Fluid Passage 6: Connector 7: Expansion Fluid Inlet 8: Image Guide Insertion Port 9: Recessed Groove

Claims (1)

[Claims] 1. A balloon catheter, wherein a groove-shaped recess is provided on the surface of the balloon in a linear or spiral shape parallel to the catheter axis.