JP6741421B2 - Catheter assembly - Google Patents

Description

The present invention relates to a catheter assembly having an outer catheter and an inner catheter inserted into the inner lumen of the outer catheter.

There are several types of catheters used for ventriculography and coronary angiography. For example, a PIGTAIL catheter is a catheter for ventricular angiography with a rounded tip, and a contrast agent can be discharged from a tip hole formed at the tip and a plurality of side holes formed on the side surface (see, for example, Patent Document 1). reference). The NIH catheter is a catheter for ventricular angiography, has no opening at the tip, and can discharge a large amount of contrast agent from a plurality of side holes formed on the side surface. The SONS catheter is a catheter that can be used for both ventriculography and coronary angiography, and has holes formed on both the tip and the side. The SONES catheter is capable of performing ventriculography by using a lateral hole, and is also capable of performing coronary venography by inserting the distal end portion into a coronary artery and discharging a contrast agent from the distal hole.

JP, 10-212186, A

The pigtail catheter described above cannot be used for coronary angiography because the tip is rounded. Also, the NIH catheter cannot be used for coronary angiography because a hole is not formed at the tip. Further, although the SONES catheter can be used for both ventriculography and coronary angiography, since the tip hole is formed, the tip part becomes sharp and there is a possibility that intramyocardial injection of the contrast agent or perforation may occur.

The present invention has been made to solve the above-described problems, and an object of the present invention is to provide a catheter assembly having high safety and capable of ejecting a contrast agent from two locations .

A catheter assembly according to the present invention that achieves the above object has an outer catheter in which a first lumen is formed and a second lumen, and is insertable into the first lumen from the proximal side. A catheter assembly for ejecting a contrast medium, comprising: an inner catheter, wherein the outer catheter has a distal outer opening formed at a distal end thereof, into which the first lumen is opened, and a side surface of the outer catheter. 1 side lumen outer side opening is formed, and the inner catheter is formed with an inner catheter hub opening that opens at the proximal end and connects to the second lumen, and the second lumen is formed at the distal end. Is formed, and a side inner opening in which the second lumen is opened is formed on the side surface, and the tip outer opening and the inner tip opening are in a positional relationship of communicating with each other. In the state, the space between the side outer opening and the side inner opening is closed, and the side outer opening and the side inner opening are in a positional relationship of communicating with each other. during is closed, a relatively rotating to Rukoto said catheter relative to said outer catheter, the tip opening state or can der switched to the side opening state is, relative to the outer catheter and the inner catheter When the distal outer opening and the distal inner opening are in a positional relationship in which the distal outer opening and the distal inner opening overlap in the axial direction of the catheter assembly, the distal opening state is achieved, and the outer catheter and the inner catheter are relatively rotated to tip the side opening state and ing by a positional relationship to overlap in the axial direction and a different position from the outer opening the front inner opening.

In the catheter assembly configured as described above, the contrast medium can be discharged from the tip portion by opening the tip portion, and coronary angiography can be performed, and at the same time, the side opening portion is closed to discharge the contrast agent. By limiting the above, it is possible to minimize the amount of contrast medium to be ejected, and it is possible to improve safety. In addition, the contrast medium can be ejected from the side by opening the side face, and ventriculography can be performed, and the opening of the tip is blocked, and intramyocardial injection and perforation of the contrast medium are suppressed to improve safety. You can

Here, the tip end open state means a state where the tip outer side opening and the tip inner side opening communicate with each other, and the side surface open state means a state where the side surface outer side opening and the side surface inner side opening communicate with each other. In the state where the distal end is open, the lateral outer opening and the lateral inner opening do not communicate with each other, and the lateral opening of the catheter assembly is closed. In the side opening state, the tip outer opening and the tip inner opening do not communicate with each other, and the side opening of the catheter assembly is closed.

In the catheter assembly, the outer catheter and the inner catheter are relatively rotated so that the distal outer opening and the distal inner opening are in a positional relationship of overlapping in the axial direction of the catheter assembly. next, the side open state and ing by the distal outer opening said outer catheter and the inner catheter are relatively rotated is a position overlapping relationship at different positions axially from said distal inner opening. As a result, in the catheter assembly, the distal outer opening and the distal inner opening overlap in the axial direction when the distal end is open, and the guide wire can be inserted therethrough to easily guide the catheter assembly to a desired position such as a coronary artery.

In the catheter assembly, at least one of the proximal ends of the outer catheter and the inner catheter may be provided with a display section indicating that the distal end is open and/or the side is open. As a result, the open state of the tip and/or the open state of the side surface can be reliably grasped by the operator's hand, and the operability is improved.

The display unit may indicate a relative position in the circumferential direction of the outer catheter and the inner catheter. This makes it possible to easily switch to the tip open state or the side face open state by the operation of relatively rotating the outer catheter and the inner catheter.

The display unit may indicate relative positions in the axial direction of the outer catheter and the inner catheter. Thus, the distal end open state or the side open state can be easily switched by the operation of relatively moving the outer catheter and the inner catheter in the axial direction.

The inner catheter may have a projecting portion projecting in the distal direction at a position of the distal end portion different from the distal inner opening portion, and the projecting portion may be insertable into the distal outer opening portion. With this, by inserting the protrusion into the distal outer opening, the positional relationship between the outer catheter and the inner catheter is less likely to shift, and the side surface open state can be favorably maintained. In addition, when the side surface is opened, the distal outer opening is closed and the edge of the opening is not sharp, so that intramyocardial injection and perforation of a contrast agent can be suppressed and safety can be improved.

The distal inner opening and the distal outer opening may be formed in a semicircular shape that can overlap in the axial direction of the catheter assembly by relatively rotating the outer catheter and the inner catheter. Thereby, the distal inner opening and the distal outer opening can be formed as large as possible, and the passability of the contrast agent and the guide wire can be improved.

It is a top view which shows the catheter assembly which concerns on 1st Embodiment. It is a top view which shows the outer catheter and inner catheter of 1st Embodiment. It is a perspective view which shows the front-end|tip part of an outer catheter and an inner catheter. It is a longitudinal cross-sectional view which shows the front-end|tip part of the catheter assembly which concerns on 1st Embodiment, (A) shows a front end open state, (B) shows a side open state. It is a longitudinal cross-sectional view which shows the base end part of the catheter assembly which concerns on 1st Embodiment. It is a top view of the base end part in the state of a side opening of the catheter assembly concerning a 1st embodiment. It is sectional drawing which shows the state which inserted the catheter assembly which concerns on 1st Embodiment in the blood vessel. It is sectional drawing which shows the state at the time of discharging a contrast agent from the catheter assembly which concerns on 1st Embodiment, (A) shows a front end open state, (B) shows a side open state. FIG. 6 is a cross-sectional view showing a state in which a contrast agent is discharged from the distal end portion of the catheter assembly that has reached the blood vessel bifurcation. FIG. 8 is a cross-sectional view showing a state in which a contrast agent is discharged from the side surface of the catheter assembly that has reached the bifurcation of the blood vessel. It is a top view which shows the catheter assembly which concerns on 2nd Embodiment. It is a perspective view which shows the front-end|tip part of an outer catheter and an inner catheter. It is a longitudinal cross-sectional view which shows the front-end|tip part of the catheter assembly which concerns on 2nd Embodiment, (A) shows a front end open state, (B) shows a side open state. It is a top view which shows the base end part of the catheter assembly which concerns on 2nd Embodiment, (A) shows a front end open state, (B) shows a side open state. It is sectional drawing which shows the state which inserted the catheter assembly which concerns on 2nd Embodiment in the blood vessel. It is sectional drawing which shows the state at the time of discharging a contrast agent from the catheter assembly which concerns on 2nd Embodiment, (A) shows a front end open state, (B) shows a side open state. It is sectional drawing which shows the front-end|tip part of the catheter assembly which concerns on 2nd Embodiment, (A) shows a front end open state, (B) shows the state which pulled out the inner catheter from the outer catheter. It is a perspective view which shows the modification of the catheter assembly which concerns on 1st Embodiment. It is a perspective view which shows the modification of the catheter assembly which concerns on 2nd Embodiment.

An embodiment of the present invention will be described below with reference to the drawings. Note that the dimensional ratios in the drawings may be exaggerated and different from the actual ratios for convenience of description. In the following description, the proximal side of the catheter assembly will be referred to as the “proximal side”, and the side inserted into the living body will be referred to as the “distal side”.
<First Embodiment>

As shown in FIGS. 1 and 2, a catheter assembly 10 according to a first embodiment of the present invention has a double structure including an outer catheter 20 and an inner catheter 30 to transfer a contrast agent to both ventricles and coronary arteries. Can be discharged.

The outer catheter 20 includes a tubular outer catheter body 40, an outer catheter hub 50 fixed to the proximal end of the outer catheter body 40, and a kink protector 60. The inner catheter 30 includes an inner catheter body 70 that can be inserted into the outer catheter body 40, and an inner catheter hub 90 that is arranged at the proximal end of the inner catheter body 70.

The distal end side of the inner catheter main body 70 is inserted from the proximal end side of the outer catheter hub 50 into the first lumen 41 described below, and the outer catheter hub 50 and the inner catheter hub 90 are brought into contact with each other to be connected to each other. When fixed, the outer catheter 20 and the inner catheter 30 are assembled as shown in FIG. The lock mechanism does not necessarily have to be provided.

First, the outer catheter 20 will be described. As shown in FIGS. 2 to 4, the outer catheter body 40 of the outer catheter 20 is formed of a flexible tubular body, and has a first lumen 41 formed therein.

The outer catheter body 40 has a distal end formed with a distal outer opening 42 communicating with the first lumen 41. The front end outside opening 42 is formed in a semicircular shape with a bias toward the one side surface. A side surface outer opening 43 communicating with the first lumen 41 is formed on a side surface of the outer catheter body 40 on the base end side of a predetermined length from the tip portion. The side surface outside opening portion 43 is formed on the opposite side of the one side surface side where the tip end outside opening portion 42 is biased.

The constituent material of the outer catheter body 40 is preferably flexible, and examples thereof include polyolefins such as polyethylene and polypropylene, polyesters such as polyamide and polyethylene terephthalate, and fluorine-based materials such as ETFE (tetrafluoroethylene/ethylene copolymer). Polymers, PEEK (polyether ether ketone), polyimide, etc. can be used. Further, the outer catheter body 40 may be formed of a plurality of layers, and a reinforcing layer formed by braiding wire rods may be provided. A flexible material may be applied to the distal end of the outer catheter body 40 in order to reduce damage to the blood vessel as much as possible. Examples of the flexible material include various rubber materials such as natural rubber, isoprene rubber, butadiene rubber, chloroprene rubber, silicone rubber, fluororubber, and styrene-butadiene rubber, and styrene-based, polyolefin-based, polyurethane-based, polyester-based, polyamide-based materials. , Various types of thermoplastic elastomers such as polybutadiene, trans polyisoprene, fluororubber, and chlorinated polyethylene.

The outer diameter of the outer catheter body 40 is not particularly limited, but is preferably 1.37 to 2.04 mm, for example. The inner diameter of the outer catheter body 40 is not particularly limited, but is preferably 0.98 to 1.35 mm, for example. The length of the outer catheter body 40 is not particularly limited, but is preferably 500 to 1800 mm, for example.

The outer catheter hub 50 is fixed to the proximal end of the outer catheter body 40, as shown in FIGS. The outer catheter hub 50 includes a hollow outer catheter body portion 51, a plurality (two in the present embodiment) of outer catheter blade portions 52 protruding from an outer surface of the outer catheter body portion 51, and an outer catheter body portion 51. The spiral convex portion 53 is formed on the outer surface of the base end portion of the. A first display portion 80 formed in a color or shape different from the surroundings is formed on one of the outer catheter blade portions 52. The position where the first display portion is provided may not be the outer catheter blade portion 52.

The outer catheter body 51 has an outer catheter hub inner cavity 54 communicating with the first lumen 41, and an outer catheter hub opening 55 opening at the proximal end of the outer catheter hub inner cavity 54. The spiral convex portion 53 can be screwed into a spiral groove 99 formed in a screwing portion 93, which will be described later, provided in the inner catheter hub 90. The outer catheter hub opening 55 can be inserted with the tubular portion 97 formed at the tip of the inner catheter hub 90. The spiral convex portion 53 and the screwing portion 93 form a lock mechanism that holds the outer catheter hub 50 and the inner catheter hub 90 in a connected state.

The outer catheter hub inner cavity 54 is formed with a tapered portion 56 whose inner diameter decreases from the outer catheter hub opening 55 toward the distal end. The tapered portion 56 is configured as a female luer taper to which a male luer taper formed on the outer surface of the tubular portion 97 of the inner catheter hub 90 can be fitted. Further, the tapered portion 56 plays a role of guiding the medical instrument such as a guide wire from the outer catheter hub opening 55 into the first lumen 41 by the inner surface whose inner diameter decreases toward the distal direction. Fulfill

The constituent material of the outer catheter hub 50 is, for example, various thermoplastic elastomers such as styrene type, polyolefin type, polyurethane type, polyester type, polyamide type, polybutadiene type, trans polyisoprene type, fluororubber type, chlorinated polyethylene type, etc. is there.

The anti-kink protector 60 is attached so as to cover a portion connecting the outer catheter body 40 and the outer catheter hub 50, and plays a role of suppressing kink of the outer catheter 20 at the relevant portion.

Next, the inner catheter 30 will be described. As shown in FIGS. 2 to 4, the inner catheter body 70 of the inner catheter 30 is made of a flexible tubular body, and has a second lumen 71 formed therein. A distal inner opening 72 communicating with the second lumen 71 is formed at the distal end of the inner catheter body 70. The front end inside opening 72 is formed in a semicircular shape with a bias toward the one side surface. A side surface inner opening portion 73 communicating with the second lumen 71 is formed on a side surface of the inner catheter body 70 on the base end side of a predetermined length from the distal end portion. The side surface inside opening portion 73 is formed on the same side as the one side surface side on which the tip inside opening portion 72 is biased.

The constituent material of the inner catheter body 70 is preferably flexible, and examples thereof include polyolefin such as polyethylene and polypropylene, polyester such as polyamide and polyethylene terephthalate, and fluorine-based material such as ETFE (tetrafluoroethylene/ethylene copolymer). Polymers, PEEK (polyether ether ketone), polyimide, etc. can be used. Moreover, the inner catheter body 70 may be formed of a plurality of layers, and a reinforcing layer in which wire rods are braided may be provided. A flexible material may be applied to the distal end portion of the inner catheter body 70 in order to reduce the damage of blood vessels as much as possible. Examples of the flexible material include various rubber materials such as natural rubber, isoprene rubber, butadiene rubber, chloroprene rubber, silicone rubber, fluororubber, and styrene-butadiene rubber, and styrene-based, polyolefin-based, polyurethane-based, polyester-based, polyamide-based materials. , Polybutadiene-based, trans-polyisoprene-based, fluororubber-based, chlorinated polyethylene-based thermoplastic elastomers and the like.

The outer diameter of the inner catheter body 70 is preferably slightly smaller than the inner diameter of the outer catheter body 40 so that the inner catheter body 70 can be inserted into the outer catheter body 40. The inner diameter of the inner catheter body 70 is not particularly limited, but is preferably 0.6 to 1.0 mm, for example. The length of the inner catheter body 70 is preferably slightly shorter than the outer catheter body 40.

As shown in FIGS. 2 and 5, the inner catheter hub 90 includes a hollow inner catheter body portion 91 and a plurality (two in the present embodiment) of inner catheter blades protruding from the outer surface of the inner catheter body portion 91. A portion 92 and a screwing portion 93 that is rotatably arranged on the outer surface of the inner catheter body portion 91 are provided. A second display portion 81 formed in a color or shape different from the surroundings is formed on one side of the inner catheter blade portion 92. The position where the second display portion is provided may not be the inner catheter blade portion 92.

The inner catheter body 91 is formed with an inner catheter hub lumen 94 penetrating from the proximal end to the distal end, and the inner catheter hub lumen 94 is opened at the inner catheter hub opening 95 at the proximal end of the inner catheter body 91. ing. On the outer surface of the inner catheter body portion 91, a groove portion 96 with which the screwing portion 93 is rotatably engaged is formed in the circumferential direction.

A tubular portion 97 that can be inserted into the outer catheter hub opening 55 of the outer catheter hub 50 is formed at the tip of the inner catheter body portion 91. The outer surface of the cylindrical portion 97 is configured as a male luer taper whose outer diameter decreases in the distal direction. By inserting the tubular portion 97 into the outer catheter hub opening 55, the outer surface (male luer taper) of the tubular portion 97 is brought into close contact with the taper portion 56 (female luer taper) of the outer catheter hub inner cavity 54 to ensure liquid tightness. The outer catheter hub 50 and the inner catheter hub 90 can be connected while securing the state.

The screwing portion 93 is formed in a tubular shape, and an engaging convex portion 98 that rotatably engages with the groove portion 96 of the inner catheter body portion 91 is formed on the inner surface of the proximal end in the circumferential direction. Further, on the inner surface of the screwing portion 93, a spiral groove 99 that can be screwed with the spiral convex portion 53 of the outer catheter hub 50 is formed. By inserting the tubular portion 97 into the outer catheter hub opening 55 and rotating the screwing portion 93, the spiral convex portion 53 is screwed into the spiral groove 99, and the tubular portion 97 is inserted into the outer catheter hub inner cavity 54. By being pushed toward the distal end, the outer surface of the tubular portion 97 is brought into close contact with the taper portion 56 of the inner lumen 54 of the outer catheter hub, and the outer catheter hub 50 and the inner catheter hub 90 can be maintained in a connected state.

The constituent material of the inner catheter hub 90 is, for example, various thermoplastic elastomers such as styrene series, polyolefin series, polyurethane series, polyester series, polyamide series, polybutadiene series, trans polyisoprene series, fluororubber series, chlorinated polyethylene series, etc. is there.

Then, as shown in FIG. 1, when the inner catheter body 70 is inserted into the outer catheter body 40 and the positions of the first display portion 80 and the second display portion 81 in the circumferential direction are aligned, the result is shown in FIG. 4(A). As described above, the tip outer opening 42 and the tip inner opening 72 are axially overlapped and communicate with each other. In the front end open state having such a positional relationship, the side surface outside opening portion 43 and the side surface inside opening portion 73 are located on the opposite sides in the circumferential direction and do not communicate with each other. In this tip open state, the guide wire 200 can be led out or the contrast agent can be discharged through the tip outer opening 42 and the tip inner opening 72.

Further, as shown in FIG. 6, when the inner catheter body 70 is inserted into the outer catheter body 40 and the circumferential positions of the first display portion 80 and the second display portion 81 are set to opposite directions, FIG. As shown, the side outer opening 43 and the side inner opening 73 overlap and communicate with each other. In the side opening state having such a positional relationship, the tip outer opening 42 and the tip inner opening 72 do not overlap in the axial direction and do not communicate with each other. In this side surface open state, the contrast agent can be ejected through the side surface outside opening portion 43 and the side surface inside opening portion 73.

Next, the operation of the catheter assembly 10 according to this embodiment will be described.

First, before introducing the catheter assembly 10 into the blood vessel, as shown in FIG. 1, FIG. 4(A), and FIG. 5, the distal outer opening 42 and the distal inner opening 72 are in communication with each other in a distal open state. The outer catheter 20 and the inner catheter 30 are assembled. When assembling, the inner catheter 30 is inserted into the outer catheter hub opening 55, and while the positions of the first display portion 80 and the second display portion 81 in the circumferential direction are aligned with each other, the tubular portion 97 is moved to the outer catheter hub opening portion 55. The inner catheter 30 is pushed until it is inserted into After the tubular portion 97 is inserted into the outer catheter hub opening 55, when the screwing portion 93 is rotated, the spiral convex portion 53 is screwed into the spiral groove 99 and the tubular portion 97 is inserted into the outer catheter hub inner cavity 54. On the other hand, it is pushed in the distal direction, and the outer surface of the tubular portion 97 comes into close contact with the tapered portion 56 of the outer catheter hub inner cavity 54. As a result, the outer catheter hub 50 and the inner catheter hub 90 are connected in a liquid-tight state, and this state can be reliably maintained. Therefore, when the catheter assembly 10 is inserted into a blood vessel, the outer catheter 20 and the inner catheter 30 can be integrally operated, which facilitates the operation and allows the outer catheter 20 and the inner catheter 30 to unexpectedly operate. It is highly safe by preventing it from coming off.

In this state, since the positions of the first display section 80 and the second display section 81 in the circumferential direction are aligned with each other, it is possible to easily grasp that the front end is open.

Next, the guide wire 200 is percutaneously inserted into the blood vessel by a known method. Subsequently, the guide wire 200 is inserted into the second lumen 71 from the distal outer opening 42 and the distal inner opening 72, and the catheter assembly 10 is moved forward while the guide wire 200 is advanced as shown in FIG. 7. Push it into the blood vessel. Since the catheter assembly 10 can guide the guide wire 200 through the distal outer opening 42 and the distal inner opening 72, the distal end of the catheter assembly 10 can be guided not only to the ventricles but also to the coronary arteries. For example, when the distal end portion of the catheter assembly 10 is guided to the coronary artery using the guide wire 200, the guide wire 200 is removed from the second lumen 71, and the contrast agent is kept in the open state at the inner catheter hub. Supply from the opening 95. The contrast agent passes through the second lumen 71 from the inner catheter hub opening 95, and is discharged into the blood vessel from the distal outer opening 42 and the distal inner opening 72 as shown in FIG. 8(A). Thereby, the coronary artery can be imaged. At this time, since the contrast agent is not discharged from the side surface, the discharged contrast agent can be minimized and safety can be improved.

Further, when the distal end portion of the catheter assembly 10 is guided to the ventricle, the guide wire 200 is removed from the second lumen 71, and as shown in FIG. The connection of the inner catheter 30 is released, and the positions of the first display unit 80 and the second display unit 81 in the circumferential direction are set in opposite directions. As a result, as shown in FIG. 8(B), the side surface outside opening portion 43 and the side surface inside opening portion 73 are in a side surface open state in which they are in communication with each other. Next, when the contrast agent is supplied from the inner catheter hub opening portion 95, the contrast agent passes through the second lumen 71 from the inner catheter hub opening portion 95 and into the blood vessel from the side outer opening portion 43 and the side inner opening portion 73. Is ejected. This makes it possible to image the ventricles. Further, in the side open state, the outer tip end opening 42 and the inner tip end opening 72 do not overlap with each other in the axial direction and do not communicate with each other, so that the edges are not sharp and the contrast agent is not ejected. Therefore, it is possible to suppress intramyocardial injection of the contrast agent and the occurrence of perforation. Further, since the contrast agent is not ejected from the tip portion, the amount of the contrast agent ejected can be minimized and safety can be improved.

Further, the catheter assembly 10 may be introduced into a site other than the ventricle or the coronary artery. For example, as shown in FIG. 9, it may be inserted into the blood vessel from the radial artery and introduced into one side of the branched blood vessel of the lower limb through the aorta. The side outer opening 43 is located near the branch portion. Then, when the distal end is opened and the contrast agent is supplied from the inner catheter hub opening section 95, the contrast agent passes through the second lumen 71 from the inner catheter hub opening section 95, and the outer tip opening section 42 and the inner tip opening section 72. Is discharged to one side of the branched blood vessel. Further, when the side surface is opened and the contrast agent is supplied from the inner catheter hub opening portion 95, as shown in FIG. 10, the contrast agent passes from the inner catheter hub opening portion 95 through the second lumen 71 to the side surface outer side opening portion. It is discharged to the other side of the branched blood vessel from 43 and the side inner opening 73. In this way, the contrast agent can be selectively ejected from two locations without replacing the long catheter assembly 10 with another catheter, so that the operability is high.

As described above, in the catheter assembly 10 according to the first embodiment, the outer catheter 20 in which the first lumen 41 is formed and the second lumen 71 are formed and the proximal end is inside the first lumen 41. A catheter assembly (10) having an inner catheter (30) insertable from the side, wherein an outer catheter (20) has a distal outer opening (42) for opening a first lumen (41) at the distal end, and a side surface. A side outer opening 43 is formed in which the first lumen 41 is opened, and a distal inner side opening 72 in which the second lumen 71 is opened is formed in the distal end of the inner catheter 30 and a second lumen is formed in the side surface. A side inner opening 73 is formed to open 71, and the side outer opening 43 and the side inner opening 73 are closed in a tip open state in which the tip outer opening 42 and the tip inner opening 72 communicate with each other. The side outer opening 43 and the side inner opening 73 are in a positional relationship in which the side outer opening 43 and the side inner opening 73 communicate with each other, and the tip outer opening 42 and the tip inner opening 72 are closed and do not communicate with each other. In the catheter assembly 10 configured as described above, the contrast agent can be ejected from the side surface when the side surface is opened, and ventricular imaging can be performed, and the contrast agent can be ejected from the tip portion when the distal end is opened. Therefore, coronary angiography is possible. Further, by opening the side surface, the opening at the tip is closed, and intramyocardial injection of the contrast medium and perforation can be suppressed, and safety can be improved. Further, the catheter assembly 10 has high operability because the position where the contrast agent is discharged can be selected without replacing the catheter. Further, since the catheter assembly 10 can select the position at which the contrast agent is ejected, the amount of the contrast agent ejected can be suppressed to the necessary minimum, and the safety is high.

Further, in the catheter assembly 10, the outer catheter 20 and the inner catheter 30 are relatively rotated, and the distal outer opening 42 and the distal inner opening 72 are in a positional relationship of overlapping in the axial direction of the catheter assembly 10. In the open state, the outer catheter 20 and the inner catheter 30 are relatively rotated, and the distal outer opening 42 and the distal inner opening 72 have a positional relationship in which they are axially overlapped with a position different from the distal inner opening 72, and a side open state is achieved. As a result, in the catheter assembly 10, the distal outer opening 42 and the distal inner opening 72 overlap each other in the axial direction when the distal end is open, and the guide wire 200 can be inserted therethrough, for example, at a desired position such as a coronary artery. You can easily lead to.

In addition, the catheter assembly 10 is provided with a first display portion 80 and a second display portion 81 at the proximal end portions of the outer catheter 20 and the inner catheter 30, respectively, which indicate a tip open state or a side open state. As a result, it is possible to surely grasp the tip open state and the side face open state at the hand of operation, and the operability is improved.

The first display section 80 and the second display section 81 show the relative positions of the outer catheter 20 and the inner catheter 30 in the circumferential direction. Accordingly, the outer catheter 20 and the inner catheter 30 can be easily switched to the tip open state or the side open state by an operation of relatively rotating the outer catheter 20 and the inner catheter 30.

The distal inner opening 72 and the distal outer opening 42 are formed in a semicircular shape that can overlap in the axial direction of the catheter assembly 10 by relatively rotating the outer catheter 20 and the inner catheter 30. .. Accordingly, the distal inner opening 72 and the distal outer opening 42 can be formed as large as possible, and the passability of the contrast agent and the guide wire 200 can be improved.
<Second Embodiment>

The catheter assembly 100 according to the second embodiment of the present invention differs from the first embodiment only in the configuration of the inner catheter 110. The parts having the same functions as those in the first embodiment are designated by the same reference numerals, and the description thereof will be omitted to avoid duplication.

As shown in FIGS. 11 and 12, the inner catheter body 120 of the inner catheter 110 according to the second embodiment is formed of a flexible tubular body, and has a second lumen 121 formed therein. .. At the distal end portion of the inner catheter body 120, a protrusion 124 having a semicircular cross-section in the axial direction and protruding in the distal direction, and at a position deviated by 180 degrees in the circumferential direction from the semicircular portion of the protrusion 124, are disposed in the proximal direction. An inclined portion 125 that is formed to be inclined is formed, and a distal end inside opening portion 122 that communicates with the second lumen 121 is formed in this inclined portion 125. The tip inside opening 122 is formed in a semicircular shape. A side surface inner opening 123 communicating with the second lumen 121 is formed on a side surface of the inner catheter body 120 on the base end side of a predetermined length from the distal end. The side inner opening 123 is formed on the same side as the one side where the front inner opening 122 is located.

At the base end of the inner catheter body 120, a third display portion 82 that displays the position in the axial direction relative to the outer catheter 20 is formed. The third display unit 82 is composed of, for example, a line whose color is different from that of the surrounding area.

Then, as shown in FIG. 14(A), the inner catheter body 120 is inserted into the outer catheter body 40 so that the positions of the first display portion 80 and the second display portion 81 in the circumferential direction coincide with each other, and the third display portion. When 82 is aligned with the proximal end of the outer catheter hub 50, the distal outer opening 42 and the distal inner opening 122 are axially overlapped and communicate with each other, as shown in FIG. In the front end open state having such a positional relationship, the side surface outside opening portion 43 and the side surface inside opening portion 123 are located on the opposite sides in the circumferential direction and do not communicate with each other. In this tip open state, the guide wire 200 can be led out or the contrast agent can be ejected through the tip outer opening 42 and the tip inner opening 122.

Further, as shown in FIG. 14B, the inner catheter body 120 is inserted into the outer catheter body 40, the positions of the first display portion 80 and the second display portion 81 in the circumferential direction are opposite, and the screwing portion 93 is provided. When the outer catheter 20 and the inner catheter 110 are connected by rotating, the side surface outside opening portion 43 and the side surface inside opening portion 123 overlap and communicate with each other, as shown in FIG. 13(B). In the side opening state having such a positional relationship, the protruding portion 124 is fitted into the tip outer opening 42, and the tip outer opening 42 and the tip inner opening 122 do not overlap in the axial direction and do not communicate with each other. In this side surface open state, the contrast agent can be ejected through the side surface outside opening portion 43 and the side surface inside opening portion 123.

Next, the operation of the catheter assembly 100 according to the second embodiment will be described.

First, before introducing the catheter assembly 100 into the blood vessel, the outer catheter 20 and the inner catheter 110 are assembled as shown in FIGS. 13(A) and 14(A). When assembling, the inner catheter body 120 is inserted into the outer catheter hub opening 55, the circumferential positions of the first display portion 80 and the second display portion 81 are made to coincide, and the third display portion 82 is arranged at the outer catheter hub 50. The distal end outside opening 42 and the distal end inside opening 122 are made to communicate with each other so as to correspond to the base end of the above, and the distal end open state is established. By providing the first display section 80, the second display section 81, and the third display section 82, it is possible to easily understand that the tip end is open.

Next, the guide wire 200 is percutaneously inserted into the blood vessel by a known method. Subsequently, the guide wire 200 is inserted into the second lumen 121 from the distal outer opening 42 and the distal inner opening 122, and the guide wire 200 is advanced, and as shown in FIG. Push it into the blood vessel. Since the catheter assembly 100 can guide the guide wire 200 through the distal outer opening 42 and the distal inner opening 122, the distal end of the catheter assembly 100 can be guided not only to the ventricles but also to the coronary arteries. For example, when the distal end portion of the catheter assembly 100 is guided to the coronary artery using the guide wire 200, the guide wire 200 is removed from the second lumen 121 as shown in FIG. In that state, the contrast agent is supplied from the inner catheter hub opening 95. The contrast agent passes through the second lumen 121 from the inner catheter hub opening 95, and is discharged into the blood vessel from the distal outer opening 42 and the distal inner opening 122. Thereby, the coronary artery can be imaged.

Further, when the distal end portion of the catheter assembly 100 is guided to the ventricle, the guide wire 200 is removed from the second lumen 121, and the first display portion 80 and the second display portion 80 are displayed as shown in FIG. 14B. The circumferential position of the portion 81 is opposite. Next, when the inner catheter 110 is pushed into the outer catheter 20 and the screwing portion 93 is rotated to connect the outer catheter 20 and the inner catheter 110, as shown in FIG. The side surface inside opening portion 123 overlaps and is in communication with the side surface inside opening portion 123. Next, when the contrast agent is supplied from the inner catheter hub opening 95, the contrast agent passes through the second lumen 121 from the inner catheter hub opening 95, and enters the blood vessel from the side outer opening 43 and the side inner opening 123. Is ejected. This makes it possible to image the ventricles. Further, in the side surface open state, the protruding portion 124 is fitted in the tip outer side opening portion 42, and the tip outer side opening portion 42 and the tip inner side opening portion 122 do not communicate with each other, so that it is not sharp and the contrast agent is not discharged. Therefore, it is possible to suppress intramyocardial injection of the contrast agent and the occurrence of perforation.

In addition, the catheter assembly 100 is moved to the proximal end side without rotating the inner catheter 110 with respect to the outer catheter 20 from the side face open state shown in FIG. 16(B), and is shown in FIG. 17(A). As described above, the tip can be opened. In this state, the tip of the protrusion 124 is located closer to the base end than the tip outer opening 42. Therefore, the distal outer opening 42 and the distal inner opening 122 do not overlap each other in the axial direction, but can communicate with each other through the first lumen 41 to discharge the contrast agent.

In addition, as shown in FIG. 17B, the catheter assembly 100 ejects the contrast agent from both the distal outer opening 42 and the lateral outer opening 43 by removing the inner catheter 110 from the outer catheter 20. can do.

As described above, in the catheter assembly 100 according to the second embodiment, the third display portion 82 (display portion) shows the relative positions of the outer catheter 20 and the inner catheter 110 in the axial direction. Accordingly, the outer catheter 20 and the inner catheter 110 can be easily switched to the distal end open state or the side open state by an operation of relatively moving them in the axial direction.

Further, the inner catheter 110 has a protruding portion 124 protruding in the distal direction at a position different from the distal inner opening 122 of the distal end, and the protruding portion 124 can be inserted into the distal outer opening 42. Accordingly, by inserting the protruding portion 124 into the distal outer opening portion 42, the positional relationship between the outer catheter 20 and the inner catheter 110 is less likely to shift, and the side opening state can be favorably maintained.

The present invention is not limited to the above-described embodiments, and various modifications can be made by those skilled in the art within the technical idea of the present invention. For example, as in the modified example of the first embodiment shown in FIG. 18, the distal outer opening 131 of the outer catheter 130 and the distal inner opening 141 of the inner catheter 140 do not have to be semicircular, and are circular. It may be.

Further, as in the modified example of the second embodiment shown in FIG. 19, the portion of the inner catheter 150 where the distal inner opening 151 is formed may not be inclined, and the inner catheter 150 does not have to be inclined with respect to the axial direction of the inner catheter 150. It may be vertical.

Further, at least one of the outer catheter body and the inner catheter body may be curved. Further, a plurality of side surface outside openings and side surface inside openings may be provided.

10, 100 catheter assembly,
20, 130 outer catheter,
30, 110, 140, 150 inner catheter,
40 outer catheter body,
41 First lumen,
42, 131 tip outer opening,
43 side outer opening,
70, 120 inner catheter body,
71,121 Second lumen,
72, 122, 141, 151 tip inside opening,
71, 123 Side inner opening,
80 first display section (display section),
81 second display section (display section),
82 third display section (display section),
124 protrusion,
200 guide wire.

Claims (6)

Catheter for ejecting a contrast agent having an outer catheter having a first lumen formed therein and an inner catheter having a second lumen formed therein and insertable into the first lumen from a proximal end side An assembly,
In the outer catheter, a distal outer opening in which the first lumen is opened is formed at a distal end, and a side outer opening in which the first lumen is opened is formed on a side surface,
The inner catheter is formed with an inner catheter hub opening that opens at the proximal end and connects to the second lumen, and a distal inner side opening where the second lumen opens is formed at the distal end, and a side surface. An inner side surface opening is formed in which the second lumen is opened,
In a tip opening state in which the tip outside opening and the tip inside opening are in a positional relationship of communicating with each other, a gap between the side outside opening and the side inside opening is closed,
In a side opening state in which the side outer opening and the side inner opening are in a positional relationship of communicating with each other, a space between the tip outer opening and the tip inner opening is closed,
Relatively rotating to Rukoto said catheter relative to said outer catheter, Ri can der switched to the front end opening state or the side opening state,
By rotating the outer catheter and the inner catheter relatively, the distal outer opening and the distal inner opening are in a positional relationship of overlapping in the axial direction of the catheter assembly, whereby the distal open state is achieved,
Said outer catheter and the inner catheter by relatively rotating the tip the side opening state and name Ru said catheter set by a positional relationship to overlap in the axial direction and a different position from the outer opening the front inner opening Three-dimensional. Said outer catheter and an inner one of the base end portion less of the catheter, the tip opening state and / or the side catheter assembly of claim 1, the display unit is provided which indicates that the open state. The catheter assembly according to claim 2 , wherein the display portion indicates relative positions in the circumferential direction of the outer catheter and the inner catheter. The catheter assembly according to claim 2 or 3 , wherein the display portion indicates a relative axial position of the outer catheter and the inner catheter. The catheter has a protrusion protruding to the distal tip inwardly opening different from the position of the tip, claim 1-4 the protrusion is insertable into said distal outer opening The catheter assembly according to item 1. The tip inner opening and the tip outer opening are formed in a semicircular shape capable of overlapping in the axial direction of the catheter assembly by relatively rotating the outer catheter and the inner catheter. The catheter assembly according to claim 5 .

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