JP3654355B2 - Catheter tube set - Google Patents

Description

[0001]
[Industrial application fields]
The present invention is used when a catheter tube is inserted into a blood vessel of a patient, prevents bleeding from the blood vessel insertion port as much as possible, reduces the number of attachment sites, and the catheter tube is easily fixed to an indwelling sheath and handled. The present invention relates to a novel catheter tube set excellent in workability.
[0002]
[Prior art]
Intra-aortic balloon pumping (IABP) used for the treatment of heart failure such as heart failure, percutaneous coronary angioplasty (PTCA) used for the treatment of expanding blood vessels around the heart, heart blood In treatment methods such as thermodilution catheterization (TDC) used to measure flow, a catheter tube is inserted into a patient's arterial blood vessel. In order to insert a catheter tube into a patient's blood vessel, a catheter tube set including a puncture needle, a sheath, a positioning plug and the like is required in addition to the catheter tube. For example, first, an insertion port is first formed in a blood vessel of a patient using a puncture needle and a sheath, the puncture needle is removed, and the catheter tube is passed through the sheath, thereby feeding the catheter tube into the blood vessel.
[0003]
As the sheath, a split sheath of a type in which the catheter tube is inserted into a patient's blood vessel and then split in the axial direction (for example, see Japanese Patent Application Laid-Open No. 63-252168), and the sheath is removed even after insertion of the catheter tube. There is no indwelling type indwelling sheath.
[0004]
Each of these types of sheaths has advantages and disadvantages. For example, the former split sheath has a problem in handling workability due to bleeding at the time of splitting the sheath. Since the indwelling sheath has a hemostasis valve formed of a rubber film or the like at the outer end portion of the body, the indwelling sheath does not have the problems of the split sheath, but has the following problems.
[0005]
[Problems to be solved by the invention]
Since bleeding occurs when the indwelling sheath comes out of the patient's blood vessel, it has been necessary to fix the rear end of the indwelling sheath to the patient's skin by means such as sewing. In addition, since the tip of the catheter tube needs to be placed at a predetermined position in the blood vessel, it is necessary to fix the outer end of the catheter tube to the patient after the catheter tube is inserted into the blood vessel. It was. Therefore, conventionally, a positioning plug is attached to the outer end of the catheter tube so as to be movable in the axial direction of the catheter tube, and the catheter tube is attached to the catheter tube at a predetermined axial position of the catheter tube protruding from the indwelling sheath to the outside of the body. On the other hand, it has been necessary to fix the positioning plug to the patient's skin by fixing the positioning plug. Furthermore, it is necessary to fix the connector attached to the outside rear end of the catheter tube by means such as sewing on the patient's skin.
[0006]
That is, conventionally, the indwelling sheath and the positioning plug need to be separately fixed to the patient's skin, the fixing work is complicated, and there are many parts to be sterilized.
[0007]
The present invention has been made in view of such circumstances, and an object of the present invention is to provide a novel catheter tube set that prevents bleeding from a blood vessel insertion port as much as possible, reduces the burden on the patient, and excels in handling workability. And
[0008]
[Means for Solving the Problems]
In order to achieve the above object, the catheter tube set of the present invention has a distal end portion inserted into a blood vessel, an indwelling sheath having a hemostasis valve at the outer end of the body, and inserted from the hemostasis valve side of the indwelling sheath, A catheter tube set having at least a catheter tube to be inserted into a blood vessel, wherein the indwelling sheath is compressed in the axial direction so as to come into pressure contact with the outer periphery of the catheter tube and position the catheter tube a ring, Ri screwed cap and is mounted tare the body-side end portion of the indwelling sheath to allow compression of the locking ring in the axial direction by screwing, that hemostasis valve is attached to the cap Features.
[0009]
[Action]
In the catheter tube set of the present invention, first, an indwelling sheath is inserted into a blood vessel, and the catheter tube is inserted through the indwelling sheath into a predetermined position in the blood vessel. At that time, since a hemostasis valve is attached to the rear end of the indwelling sheath, the patient can be prevented from bleeding as much as possible. Thereafter, the indwelling sheath is operated to compress the fixing ring in the axial direction. As a result, the outer periphery of the catheter tube is fixed with respect to the sheath, and the catheter tube is positioned with respect to the indwelling sheath. Then, if the indwelling sheath is fixed to the patient's skin, the indwelling sheath can be fixed to the patient and the catheter tube can be positioned simultaneously. Therefore, in the present invention, the number of parts to be fixed to the patient's skin is reduced, the burden on the patient can be reduced, the number of parts to be disinfected is reduced, and the handling workability is improved.
[0010]
【Example】
Hereinafter, a catheter tube set according to an embodiment of the present invention will be described in detail with reference to the drawings. 1 is a cross-sectional view of a balloon catheter used in a balloon catheter tube set according to an embodiment of the present invention, FIG. 2 is a schematic view showing an example of use of a balloon catheter, and FIG. 3 is an aspect of a hemostasis valve used in an indwelling sheath. FIG. 4 and FIG. 5 are cross-sectional views showing how to use the balloon catheter set, and FIG. 6 is a cross-sectional view showing an example of using the balloon catheter set according to the embodiment of the present invention.
[0011]
The use of the catheter tube set according to the present invention is not particularly limited, but for example, it is used for treatment such as IABP method, PTCA method, TDC method and the like. In the following description, an embodiment in which a catheter tube set is used for the IABP method will be described.
[0012]
In the IABP method, the balloon catheter 20 shown in FIGS. 1 and 2 is used. The balloon catheter 20 has a balloon portion 22 that expands and contracts in accordance with the heartbeat. The balloon portion 22 is formed of a thin film having a thickness of about 100 to 150 μm. The material of the thin film is not particularly limited, but is preferably a material excellent in bending fatigue resistance, and is made of, for example, polyurethane. The outer diameter and length of the balloon portion 22 are determined according to the inner volume of the balloon portion 22 that greatly influences the assisting effect on the cardiac function, the inner diameter of the arterial blood vessel, and the like. The inner volume of the balloon part 22 is not particularly limited, but is 30 to 50 cc. The outer diameter of the balloon part 22 is preferably 14 to 16 mm, and the length is preferably 210 to 270 mm.
[0013]
A distal tip portion 25 having a blood communication hole 23 is attached to the distal end portion of the balloon portion 22 by means such as heat fusion or adhesion. On the inner peripheral side of the tip portion 25, the tip portion of the inner tube 30 is attached by means such as heat fusion or adhesion.
[0014]
The inner tube 30 is made of, for example, a stainless tube or a spring-reinforced resin tube, and extends in the balloon portion 22 and the catheter tube 24 in the axial direction and communicates with the blood pressure measurement port 32 of the connector 26. . The inside of the inner tube 30 does not communicate with the inside of the balloon portion 22. When the balloon catheter 20 is inserted into the artery, the inner tube 30 positioned in the balloon portion 22 is used as a guide rod when the deflated balloon portion 22 is wound and the balloon portion 22 is conveniently inserted into the artery. It also has an effect.
[0015]
The distal end portion of the catheter tube 24 is connected to the rear end portion of the balloon portion 22 on the outer peripheral side of the metal connection tube 27. Through the catheter tube 24, fluid pressure is introduced or led out into 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.
[0016]
The material constituting the catheter tube 24 is not particularly limited, and polyurethane, polyvinyl chloride, polyethylene, nylon and the like are used. The inner diameter of the catheter tube 24 is preferably 1.5 to 4.0 mm. The wall thickness of the catheter tube 24 is preferably about 0.05 to 0.4 mm.
[0017]
A connector 26 installed outside the patient's body is connected to the rear end of the catheter tube 24. The connector 26 may be formed separately from the catheter tube 24 and may be fixed by means such as heat fusion or adhesion, but may be formed integrally with the catheter tube 24. The connector 26 is formed with a pressure fluid introduction outlet 28 for introducing or deriving pressure fluid into the catheter tube 24 and the balloon portion 22 and a blood pressure measurement port 32 communicating with the inner tube 30.
[0018]
The pressure fluid introduction outlet 28 is connected to a pump device 10 as shown in FIG. 2, and fluid pressure is introduced into or led out from the balloon portion 22 by the pump device 10. The fluid to be introduced is not particularly limited, but helium gas having a low viscosity or the like is used so that the balloon portion can be inflated or deflated quickly according to the driving of the pump device 10. Moreover, it does not specifically limit as the pump apparatus 10, For example, an apparatus as shown to Japanese Patent Publication No. 2-39265 is used.
[0019]
The blood pressure measurement port 32 is connected to, for example, a blood pressure measurement device, and can measure the blood pressure fluctuation in the artery taken from the blood communication hole 23 of the balloon unit 22. Based on fluctuations in blood pressure measured by the blood pressure measuring device, the heart beat is detected, and the pump device 10 as shown in FIG. 2 is controlled according to the heart beat so as to inflate or deflate the balloon portion 22. It has become.
[0020]
In the present embodiment, a catheter tube set described in detail below is used to insert the balloon portion 22 and the catheter tube 24 in the balloon catheter 20 having such a configuration into a patient's blood vessel. The catheter tube set of the present embodiment includes an indwelling sheath 102 shown in FIG. 6, a puncture needle 60 shown in FIG. 4, a guide wire (not shown), a dilator and the like in addition to the balloon catheter 20 described above.
[0021]
Next, an embodiment of the present invention will be described with reference to FIG. In the set of the balloon catheter 100 according to the embodiment shown in FIG. 6, the fixing ring 47 is attached to the rear end portion of the indwelling sheath 102 together with the hemostasis valve 54.
[0022]
That is, in the indwelling sheath 102 of the present embodiment, the sheath body 53 is joined to the sheath base 90 by means such as adhesion, heat fusion, or integral molding, and the body surface of the patient is placed on the outer periphery of the sheath base 90. A handle 56 for fixing with a surgical thread or the like is formed. An outer cylinder 92 and an inner cylinder 94 project from the rear end portion of the sheath base 90 so as to be substantially concentric, and a cap 96 is screwed onto the outer periphery of the outer cylinder 92. A fixing ring 47 is disposed on the inner peripheral side of the outer cylinder 92, and the fixing ring 47 is compressed in the axial direction by screwing the cap 96 into the outer cylinder 92, so that the outer periphery of the catheter tube 24 is It is pressed and fixed. A hemostasis valve 54 is attached to the rear end portion of the cap 96 via an adapter 98. The adapter 98 is connected to the cap 96 by means such as adhesion, heat fusion, or screwing.
[0023]
The fixing ring 47 is made of a material having elasticity, and is made of, for example, silicone rubber, fluorine rubber, natural rubber, polyurethane, or the like. In the present embodiment, the JIS hardness of the fixing ring 47 is not particularly limited, but is preferably set to 52 or more, more preferably 55 to 70. The inner diameter of the fixing ring 47 is not particularly limited, but is preferably 50 to 300 μm larger than the same diameter or the outer diameter of the catheter tube 24. The outer diameter of the fixing ring 47 is preferably about 50 to 300 μm smaller than the inner diameter of the second outer cylinder 45 located on the outer periphery of the fixing ring 47. The radial thickness of the fixing ring 47 is preferably about 0.25 to 1.5 times the outer diameter of the catheter tube 24.
[0024]
The length of the sheath main body 53 in the indwelling sheath 102 is, for example, 50 to 200 mm, preferably around 100 mm, and the inner diameter thereof is about 0.8 to 3.0 mm because the catheter tube 24 shown in FIG. Is preferred. The thickness of the sheath body 53 is preferably as thin as possible from the viewpoint of reducing the burden on the patient, but is preferably about 0.05 to 0.4 mm because a predetermined rigidity is also required. The sheath body 53 is made of, for example, polyfluoroethylene, polyurethane, polyethylene, or the like.
[0025]
For example, as shown in FIG. 3A, the hemostasis valve 54 is formed of a disk-shaped rubber body, and a cut 57 is formed in the center. The balloon portion 22 and the catheter tube 24 shown in FIG. 1 are inserted into the sheath body 53 through the cuts 57 and guided to the blood vessel 70. The blood in the blood vessel is sealed by the hemostasis valve 54 and does not flow out. The film thickness of the hemostatic valve 54 is, for example, about 0.05 to 2 mm.
[0026]
The hemostasis valve is not limited to the rubber body having the shape shown in FIG. 3A, and as shown in FIG. 3B, the disc-shaped rubber body 54a having an insertion hole 57a at the center, As shown in (C), it is composed of a disc-shaped rubber body 54b in which cuts 57b are formed on both sides of the insertion hole 57a, or a conical cylinder-shaped rubber body 54c as shown in FIG. be able to.
[0027]
Next, a method for inserting the balloon catheter 20 using the catheter tube set of the present embodiment will be described. First, as shown in FIG. 4, the puncture needle 60 is pierced from above the patient's skin 82, and the tip thereof is positioned in the blood vessel 70. Next, the stylet 84 inserted inside the puncture needle is extracted, and a guide wire (not shown) is inserted into the blood vessel 70 through the hole from which the stylet 84 has been extracted.
[0028]
Next, the puncture needle 60 is withdrawn along the inserted guide wire, and then a tip-shaped small-diameter dilator (not shown) is first inserted into the insertion port 85 of the blood vessel 70 along the guide wire. Spread 85. Next, a small-diameter dilator was extracted along the guide wire, and then a relatively large-diameter, distal-tapered indwelling sheath dilator (not shown) was inserted into the indwelling sheath 102 along the guide wire. It inserts in the blood vessel 70 in a state.
[0029]
Next, with the distal end of the indwelling sheath 102 inserted into the blood vessel 70, the indwelling sheath dilator is extracted. Next, along the guide wire, the balloon portion 22 and the catheter tube 24 of the balloon catheter 20 shown in FIG. 1 are inserted into the blood vessel 70 through the indwelling sheath 102 shown in FIG. At the time of insertion, the balloon portion 22 is folded to an outer diameter equal to or smaller than the inner diameter of the indwelling sheath 102. At the time of insertion, the guide wire is passed through the inner tube 30 of the balloon catheter 20. When the balloon catheter 20 is inserted, bleeding from the blood vessel 70 is prevented by the action of the hemostasis valve 54 of the indwelling sheath 102.
[0030]
Thereafter, the guide wire is removed from the blood vessel 70, the pump device 10 shown in FIG. 2 is connected to the connector 26 of the balloon catheter 20, and IABP treatment by the balloon catheter 20 is performed.
[0031]
In the present embodiment, the distal end portion 53 a of the sheath body 53 in the indwelling sheath 102 is inserted into the blood vessel 70. Thereafter, the balloon portion and the catheter tube 24 are inserted into a predetermined position in the blood vessel through the indwelling sheath 102. At that time, since the hemostasis valve 54 is attached to the rear end portion of the indwelling sheath 102, bleeding of the patient can be prevented as much as possible. Thereafter, the cap 96 attached to the rear end portion of the indwelling sheath 102 is operated to compress the fixing ring 47 in the axial direction and press the outer periphery of the catheter tube 24. As a result, the outer periphery of the catheter tube 24 is fixed to the indwelling sheath 102, and the catheter tube 24 is positioned with respect to the indwelling sheath 102. Thereafter, if the indwelling sheath 102 is fixed to the patient's skin, the indwelling sheath 102 can be fixed to the patient and the catheter tube 24 can be positioned simultaneously.
[0032]
Therefore, in this embodiment, the portion to be fixed to the patient's skin is reduced, the burden on the patient can be reduced, and the portion to be sterilized is reduced, the handling workability is improved, Contributes to reducing the number of parts.
[0033]
The reason why it is important to position the catheter tube 24 with respect to the patient's skin is to prevent the insertion positions of the catheter tube 24 and the balloon portion 22 from being shifted in the longitudinal direction of the blood vessel with respect to the blood vessel 70. . As shown in FIG. 2, the balloon portion 22 is positioned at a predetermined position in the arterial blood vessel close to the heart 1 and is inflated and contracted to assist the cardiac function. Therefore, the catheter tube 24 is displaced in the blood vessel 70. It is important not to do so.
[0034]
In addition, this invention is not limited to the Example mentioned above, A various change is possible within the scope of the present invention.
[0035]
【The invention's effect】
As described above, according to the present invention, it is possible to prevent the patient from bleeding as much as possible, and to reduce the portion to be fixed to the patient's skin, thereby reducing the burden on the patient. Moreover, according to the present invention, the number of parts to be sterilized is reduced, and the handling workability of the person who inserts the catheter tube is improved.
[Brief description of the drawings]
FIG. 1 is a cross-sectional view of a balloon catheter used in a balloon catheter tube set according to an embodiment of the present invention.
FIG. 2 is a schematic view showing an example of use of a balloon catheter.
FIG. 3 is a perspective view showing an embodiment of a hemostasis valve used for an indwelling sheath.
FIG. 4 is a cross-sectional view showing a method of using a balloon catheter set.
FIG. 5 is a cross-sectional view showing a method of using a balloon catheter set.
FIG. 6 is a cross-sectional view showing a usage example of a balloon catheter set according to an embodiment of the present invention.
[Explanation of symbols]
20, 100 ... Balloon catheter 22 ... Balloon portion 24 ... Catheter tube 26 ... Connector 30 ... Inner tube 47 ... Fixing ring 102 ... Indwelling sheath 53 ... Sheath body 54, 54a, 54b, 54c ... Hemostasis valve 56 ... Handle 60 ... Puncture Needle 70 ... Blood vessel

Claims (3)

A catheter tube set having at least an indwelling sheath having a distal end inserted into a blood vessel and having a hemostasis valve at the outer end of the body, and a catheter tube inserted from the hemostasis valve side of the indwelling sheath and inserted into the blood vessel The indwelling sheath is compressed in the axial direction so as to be pressed against the outer circumference of the catheter tube, and the fixing ring for positioning the catheter tube can be compressed in the axial direction by screwing. a screwed cap from the body side end portion of the indwelling sheath is attached to the tare is, the catheter tube set hemostasis valve is attached to the cap.   The catheter tube set according to claim 1, wherein the fixing ring is made of an elastic material.   The catheter tube set according to claim 1 or 2, wherein a handle for fixing the indwelling sheath is formed in the indwelling sheath.

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