JP2001079093A - Protector for balloon catheter - Google Patents

Abstract

PROBLEM TO BE SOLVED: To flush a guide wire lumen without accompanying a complicated work, and also, without generating a damage and a deformation on the tip end of a balloon catheter by providing a protective tubular section, which covers and protects the tip end section including the balloon of the balloon catheter for medical treatment, and a connecting adapter, which detachably connects to a fluid feeding utensil for flushing. SOLUTION: When this protector for balloon catheter is used, a core for protection is removed from an inner shaft, and a fluid feeding utensil (syringe 20) is connected to a connecting adapter 3. The cylinder tip 21 of the syringe 20 has a tapered shape outer peripheral surface, and by meeting and closely joining to the tapered shape inner peripheral surface 7a of a connection port 7, the cylinder tip 21 is detachably fitted in the connection port 7. Under this state, a fluid for flushing in the syringe 20 is injected in the connection port 7, and the fluid is made to flow into the tip end opening 22a of a guide wire lumen 22 of a balloon catheter through a channel 9, and the guide wire lumen 22 is flushed.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a protective device for protecting the distal end of a medical balloon catheter used for treating or diagnosing blood vessels, blood vessels and other tubular tissues in the body.

[0002]

2. Description of the Related Art Conventionally, balloon catheters have been widely used in percutaneous angioplasty for dilated treatment of a stenosis or occlusion of a blood vessel lumen. A general balloon catheter is formed by joining a balloon that expands or contracts by adjusting the internal pressure to the distal end of a catheter shaft. Inside the catheter shaft, a lumen (a guidewire lumen) through which a guidewire is inserted is inserted. ) And a lumen (inflation lumen) through which the pressure fluid supplied to the balloon passes is formed along the axial direction. Angioplasty using such a balloon catheter is performed in the following procedure. First, a guidewire inserted through the guidewire lumen is passed through a lesion such as a stenosis, and a balloon is inserted into the body along the guidewire to match the lesion, and a suitably diluted pressure fluid such as a contrast medium is diluted. Is supplied to the inflation lumen to expand the balloon, and the lesion site is subjected to dilation treatment. After the dilatation treatment is performed on the lesion site, the balloon is decompressed and deflated and folded, then pulled out of the body, and the angioplasty is completed.

[0003] The distal end of such a balloon catheter is generally covered with a protective device in advance and protected, and the balloon catheter is used by removing the protective device during a procedure. One reason for using this protection is to prevent damage to the balloon portion before use. When the balloon is broken or otherwise damaged, it easily damages the inner wall of the blood vessel when the balloon passes through the lumen of the blood vessel, and the guide wire lumen also breaks, increasing the resistance to pushing the balloon. It is difficult to accurately guide the person. There is also a high risk that the balloon will rupture or leak pressurized fluid when expanding the damaged balloon, which can lead to serious medical accidents.

[0004] The second reason for using the protective equipment is to make the outer diameter of the balloon as small as possible just before performing the procedure. This means that the smaller the outer diameter of the balloon relative to the vessel lumen, the smaller the contact area between the vessel wall and the balloon,
And since the resistance when pushing the balloon is reduced,
This is because it is easy to guide the balloon to the lesion site.However, in a lesion site having a high degree of difficulty or bending, or a site with a high surface resistance such as the inside of a stent, etc. This is because the passage property of the site is improved.

Prior to performing the procedure, the protective device is removed from the balloon catheter, and then a saline solution or the like is supplied to the guide wire lumen to prevent thrombus formation. Further, the outer surface of the balloon catheter may be immersed in physiological saline. In particular, when flushing, in a balloon catheter of a type in which a guide wire lumen communicates from the proximal end to the distal end of the catheter (generally referred to as “over the wire type”), a saline solution or the like for flushing is used. Flushing is easy because the guidewire lumen can be supplied through the hub port at the end. However, the situation is different in the monorail balloon catheter 40 illustrated in FIG. 5 from the over-the-wire type. The illustrated monorail balloon catheter 40 is formed by joining a distal shaft 41 and a proximal shaft 42 to each other.
A proximal end of the proximal shaft 42 has a hub 44 with a port 44 a for supplying pressure fluid to the balloon 43, and a distal end of the distal shaft 41. It is configured by forming a guide wire lumen 45 along the long axis direction inside. Since the rear end opening 45a of the guide wire lumen 45 is provided in the middle of the shaft, a flushing fluid is supplied from the hub 44 provided on the proximal end side of the catheter to the guide wire lumen 4.
5 cannot be supplied. Therefore, conventionally, an injection needle having an outer diameter substantially equal to or slightly smaller than the inner diameter of the distal end opening 45b is inserted into the distal end opening 45b of the guide wire lumen, and an injection needle holding member for holding the injection needle is further injected. The flushing fluid is supplied to the guide wire lumen 45 by inserting the fluid into the tube and performing the flushing.

[0006]

However, the outer diameter of the distal end portion of the balloon catheter is about 0.5 mm to 3.0 m.
m, which is extremely small.
When the injection needle is inserted into the guide wire lumen 45 for flushing, the operation becomes complicated, and at the same time, the tip is bent or deformed into a trumpet shape,
Trouble such as damage is likely to occur. In such a case, it is extremely difficult to guide the balloon to the lesion site during the procedure.

In view of the above problems, an object of the present invention is to flush a guide wire lumen of a balloon catheter without complicated work and without causing damage and deformation of the distal end portion of the balloon catheter. The object of the present invention is to provide a protective device for a balloon catheter that can be used.

[0008]

In order to solve the above-mentioned problems,
The present inventors have focused on a protective device for covering the distal end portion of the balloon catheter, and as a result of earnest research, have reached the present invention. That is, the balloon catheter protective device according to the present invention includes a protective tube portion that covers and protects a distal end portion including a balloon of a medical balloon catheter, and a connection adapter that is detachably connected to a flushing fluid supply device. It is characterized by the following. With this, the flushing fluid supply device is connected to the connection adapter in a state where the balloon catheter tip is inserted into the inside of the protection tube portion and the sheath is protected, and the balloon catheter guide wire lumen is connected through the flushing fluid supply device. Flushing can be performed by supplying a flushing fluid. During this flushing operation, the distal end portion of the balloon catheter is covered and protected inside the protective tube portion, so that the distal end portion is prevented from being bent, deformed into a trumpet shape, damaged, and the like. You.

When a relatively small syringe is used when using a syringe as the flushing fluid supply device, the connection adapter may be provided with a connection port into which the tip of the syringe is removably inserted. When a very large syringe is used, it is preferable that the connection adapter is provided with a Luer lock connection portion connected to the flushing fluid supply device. Further, the connection adapter may include a connection port into which the injection needle holding member is removably inserted.

[0010]

DESCRIPTION OF THE PREFERRED EMBODIMENTS Hereinafter, various embodiments according to the present invention will be described with reference to the drawings. FIG. 1 is a schematic view showing one embodiment of a balloon catheter protector according to the present invention. FIG. 1A is a cross-sectional view showing a balloon catheter protector of the present embodiment, and FIG. 1B is a right side view of the balloon catheter protector. The protective device 1 for a balloon catheter according to the present embodiment has a cylindrical protective tube portion 2 for inserting and protecting the distal end portion of a balloon catheter, and coaxially fitted to a proximal end portion 4 of the protective tube portion 2 for injection. The connection adapter 3 is connected to a flushing fluid supply device such as a cylinder. In addition, the said protection tube part 2
The connection adapter 3 may be adhered using an adhesive, or may be heat-welded. Further, in the present embodiment, the protection tube 2 and the connection adapter 3 are fitted, but the present invention is not limited to this, and the protection tube 2 and the connection adapter 3 may be integrally formed.

The protective tube 2 is made of a resin such as polyolefin or fluorinated polyolefin, and is preferably polyethylene, polypropylene, fluorinated polyethylene, or the like.
It is made of a fluorinated polypropylene and a fluorinated ethylene propylene copolymer, particularly preferably a fluorinated ethylene propylene copolymer, has a length at least capable of covering and protecting the balloon, and is generally 5.0 mm to 100.0 mm.
mm, preferably 7.0 mm to 80.0 mm in the axial direction. Further, the distal end portion lumen 5a of the protective tube portion 2 is formed in a tapered shape that gradually increases in diameter toward the distal end so that the balloon can be easily inserted. It is selected according to the outer diameter of the balloon, but generally ranges from 0.1 mm to 4.
0 mm, preferably 0.3 mm to 2.0 mm, and more preferably 0.5 mm to 1.2 mm. In order to facilitate the removal of the balloon catheter from the protective tube 2, the lumen 5b of the protective tube 2 may have a tapered shape that gradually and gradually expands in diameter from the base end 4 to the distal end. Absent.

The connecting adapter 3 is mainly made of a polyolefin resin such as polyethylene or polypropylene, preferably a polypropylene resin, and has a cylindrical fitting portion 6 fitted to the base end 4 of the protective tube portion 2. A connection port 7 which can be connected to a flushing fluid supply device such as a syringe, and an annular flange 8 at the rear end outer peripheral portion.
Are formed. In addition, a flow passage 9 through which the flushing fluid supplied from the connection port 7 flows and communicates with the lumen 5 b of the protection tube 2 is formed inside the connection adapter 3. Further, as shown in FIG. 1 (b), the flange 8 is
Luer lock tabs 8a and 8b are formed at positions facing each other at 0 degrees.

Before use, the balloon catheter protector 1 having the above structure is covered with a balloon catheter distal end 11 having a folded balloon 10 by applying a negative pressure, as shown in FIG. Protected. Also,
In order to protect the inner shaft constituting the guide wire lumen, a steel protection core 1 is attached to the inner shaft.
2 has been inserted. The protection core 12 is fixed to the front end face of the resin core holding portion 13.
3 is detachably fitted into the connection port 7, and a pin 14 is fixed to the rear end face of the core material holding portion 13 so that the protection core material 12 can be easily removed from the inner shaft. ing.

When the protective device of this embodiment is actually used, the protective core material 12 is removed from the inner shaft, and a fluiding device for flushing is connected to the connecting adapter 3. The term "connection" as used herein refers to a state in which the protective device of the present embodiment and the flushing fluid supply device are fixed so as not to come off when flushing the guide wire lumen of the balloon catheter with physiological saline or the like. In FIG.
The state where the cylinder tip 21 of the syringe 20 having a relatively small capacity is connected to the connection adapter 3 is shown. The cylinder tip 21 of the syringe 20, which is a flushing fluid supply device, has a tapered outer peripheral surface, and is fitted and adhered to the tapered inner peripheral surface 7a of the connection port 7, so that it can be detachably attached to the connection port 7. It is inserted. In this state, the flushing fluid in the syringe 20 is injected into the connection port 7, flows into the distal opening 22 a of the guide wire lumen 22 of the balloon catheter through the flow passage 9, and flushes the guide wire lumen 22. Then, the balloon catheter protector 1 is removed from the balloon catheter after the flushing, and a procedure such as PTCA is performed.

In the above-described embodiment, the barrel 21 of the syringe barrel and the connection port 7 are fitted. However, as another embodiment, a syringe needle holding member (not shown) for holding a syringe needle is provided. May be employed. in this case,
The inner peripheral surface of the connection port is formed so as to have a tapered shape that matches and closely adheres to the outer peripheral surface of the injection needle holding member.

FIG. 4 shows a state in which the barrel 31 of the syringe 30 having a relatively large capacity is connected to the connection adapter 3 by a so-called Luer lock connection. The cylindrical tip 31 of the syringe 30 has a structure in which an outer cylindrical part 32 and an inner cylindrical part 33 are coaxially arranged, and the inner peripheral surface of the outer cylindrical part 32 has a double spiral convex part 32a, 32b is formed, and the hollow portion 33a of the inner cylindrical portion 33 is
a. Then, these spiral convex portions 32
The luer lock tabs 8a and 8b of the connection adapter 3 are rotated and fitted along the groove between the inner cylindrical portion 3a and the inner cylindrical portion 3b.
The connection port 7 having a tapered shape on the outer peripheral surface of the connection port 7
And closely contact with the inner peripheral surface 7a. Thereby, the barrel 31 of the syringe 30 is connected to the connection adapter 3. In this state, the flushing fluid in the internal space 30a of the syringe 30 is injected into the connection port 7 and flows into the distal opening 22a of the guide wire lumen 22 of the balloon catheter through the flow passage 9 to flush the guide wire lumen 22. be able to.

[0017]

As described above, the protective device for a balloon catheter according to the present invention is detachably connected to a protective tube portion for covering and protecting a distal end portion including a balloon of a medical balloon catheter, and a flushing fluid supply device. Since a connection adapter is provided, a flushing fluid supply device is connected to the connection adapter in a state where the tip of the balloon catheter is inserted into the protective tube to cover and protect the balloon catheter, and a flushing fluid is supplied to the guide wire lumen of the balloon catheter. Flushing can be performed by flowing fluid. Therefore,
The guide wire lumen of the balloon catheter can be flushed without a complicated operation and without causing damage and deformation of the balloon catheter tip.

[Brief description of the drawings]

FIG. 1A is a schematic cross-sectional view showing one embodiment of a balloon catheter protective device according to the present invention, and FIG.
It is a right view of the protective device for a balloon catheter.

FIG. 2 is a schematic cross-sectional view showing one embodiment of a balloon catheter protector that covers and protects a balloon catheter tip.

FIG. 3 is a schematic cross-sectional view showing a state where a syringe is connected to a connection adapter.

FIG. 4 is a schematic cross-sectional view showing a state in which the syringe is connected to a connection adapter with a Luer lock.

FIG. 5 is a schematic view showing a general monorail balloon catheter.

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 1 Protective equipment for balloon catheters 2 Protective tube part 3 Connection adapter 4 Base end part of protective tube part 5a End part lumen of protective tube part 5b Lumen of protective tube part 6 Fitting part 7 Connection port 8 Flange 8a, 8b Luer Lock tab 9 Flow path 10 Balloon 11 Balloon catheter tip 12 Protection core 13 Core holding 14 Pin 20 Syringe 21 Syringe tip 22 Guide wire lumen 22a Guide wire lumen tip opening 30 Syringe 30a Syringe internal space 31 Syringe barrel 32 Outer barrel 32a, 32b Helical projection 33 Inner barrel 40 Monorail balloon catheter 41 Distal shaft 42 Proximal shaft 43 Balloon 44 Hub 44a Pressure fluid supply port 45 Guide wire lumen 45a Guide wire Lumen rear end opening 4 Tip opening of b guidewire lumen

Claims (4)

[Claims] 1. A balloon catheter, comprising: a protective tube portion for covering and protecting a distal end portion including a balloon of a medical balloon catheter; and a connection adapter detachably connected to a flushing fluid supply device. Protective equipment. 2. The balloon catheter protector according to claim 1, wherein the connection adapter is provided with a connection port through which a barrel of a syringe as a flushing fluid supply device is detachably inserted. 3. The balloon catheter protector according to claim 1, wherein the connection adapter includes a Luer lock connection portion connected to a flushing fluid supply device. 4. The balloon catheter protector according to claim 1, wherein the connection adapter is provided with a connection port through which the injection needle holding member is removably inserted.