WO2015146408A1

WO2015146408A1 - Catheter assembly and inner catheter

Info

Publication number: WO2015146408A1
Application number: PCT/JP2015/054969
Authority: WO
Inventors: 丸山真理子; 福岡徹也
Original assignee: テルモ株式会社
Priority date: 2014-03-28
Filing date: 2015-02-23
Publication date: 2015-10-01
Also published as: JPWO2015146408A1

Abstract

Provided are a catheter assembly and inner catheter with which: burden on a body during insertion into a bodily lumen is reduced by disposing an inner catheter inside an outer catheter; a guide wire does not have to be made longer than necessary; and high operability is exhibited. This catheter assembly (10) is provided with an outer catheter (20) and an inner catheter (30). Therein, an inner catheter body (31) has a shaft (70) that extends from an inner catheter hub (90) toward the tip, and a tube body (80) which is provided at the tip of the shaft (70) and in which an inner catheter lumen (83), which opens to the outside at a tip portion and a base end portion and can have a guide wire inserted into the inner catheter lumen, is formed. When an outer catheter hub (50) and the inner catheter hub (90) are connected, the tip of the tube body (80) of the inner catheter body (31) is disposed more to the tip side than the tip of an outer catheter body (40), and the base end of the tube body (80) is disposed more to the base-end side than the tip of the outer catheter body (40).

Description

Catheter assembly and internal catheter

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

A guiding catheter for guiding a treatment catheter to insert a treatment catheter (such as an expansion catheter or a stent placement catheter) into a body lumen such as a blood vessel to perform treatment or diagnosis to a target site is provided. Used.

The guiding catheter is required to have a smaller outer diameter in order to reduce the incision in the blood vessel insertion portion in order to reduce the burden on the patient and to reduce friction with the blood vessel. On the other hand, a treatment catheter inserted into a guiding catheter is required to have a larger outer diameter in order to exert a sufficient effect at a target site such as a treatment site. Therefore, the guiding catheter into which the treatment catheter is inserted is required to have a larger inner diameter.

However, in a guiding catheter having a large inner diameter and a small outer diameter, a gap is formed between the inner surface of the guiding catheter and the outer surface of the guide wire when the guiding catheter is advanced along the guide wire. there is a possibility. In that case, the tip of the guiding catheter is formed with a large step between the inner surface of the guiding catheter and the outer surface of the guide wire. Therefore, when the guiding catheter is delivered to the target site by following the guide wire, the tip of the guiding catheter may damage the blood vessel due to the step.

Therefore, in recent years, other catheters have been inserted inside the guiding catheter for the purpose of reducing the gap between the guiding catheter and the guide wire and improving the kink resistance and operability of the guiding catheter. A double catheter has been proposed (see, for example, Patent Document 1). The double catheter is composed of an outer catheter corresponding to a guiding catheter and an inner catheter that is inserted into the lumen of the outer catheter and supports the guiding catheter. The inner catheter is inserted into the lumen of the outer catheter, and the guide wire is inserted into the lumen of the inner catheter, so that the gap between the outer catheter and the guide wire is compensated by the inner catheter. In addition to improving operability, it is possible to reduce blood vessel damage by suppressing the occurrence of a step between the distal end of the outer catheter and the guide wire.

However, the inner catheter constituting the double catheter described in Patent Document 1 is an over-the-wire type in which a guide wire lumen is formed over the entire axial direction. For this reason, when removing the inner catheter while leaving the outer catheter and guide wire in the living body lumen, the operator maintains a state where the guide wire is exposed without being completely hidden in the inner catheter at the hand of operation. There is a need to. Therefore, the surgeon must use a guide wire that is longer than the length of the inner catheter because the length of the guide wire protruding from the proximal end of the outer catheter to the proximal side is longer than necessary. It was necessary to operate and extend the guide wire during the procedure.

In recent years, a technique for treating a coronary artery by inserting a catheter from a wrist artery using TRI (Trans Radial Intervention) has been widely performed. Such a procedure using TRI has been spreading because the patient's postoperative burden is small. However, if the same procedure is applied to the lower limb artery, the procedure from the insertion site into the living body lumen to the lesion site is performed. Since the distance is long, it is necessary to use a long guiding catheter and guide wire. That is, when an over-the-wire inner catheter is inserted into a guiding catheter (outer catheter), when the inner catheter is removed while leaving the guiding catheter and guide wire in the living body lumen, a long guide wire is used. I need it.

As a result of intensive efforts to solve the problems of the double catheter (catheter assembly) described above, the inventors have invented an optimal structure.

JP 2010-029559 A

The present invention reduces the burden on the living body when the inner catheter is placed inside the outer catheter and inserted into the living body lumen, and the high operability can be obtained without making the guiding wire longer than necessary. It is an object to provide a catheter assembly and an inner catheter.

A catheter assembly according to the present invention that achieves the above object includes an outer catheter including a tubular outer catheter main body and an outer catheter hub provided at a proximal end of the outer catheter main body, and an inner catheter that can be inserted into the outer catheter main body. A catheter assembly comprising a catheter body and an inner catheter provided at a proximal end of the inner catheter body and connectable to the outer catheter hub and having an inner catheter hub lumen formed therein. The inner catheter body is provided at the distal end of the shaft extending from the inner catheter hub in the distal direction, and is open to the outside at the distal end portion and the proximal end portion so that a guide wire can be inserted. A tube body in which an inner catheter lumen is formed, and the outer catheter hub and the inner catheter hub are connected to each other. In this case, the inner catheter body has the distal end of the tubular body disposed closer to the distal side than the distal end of the outer catheter body, and the proximal end of the tubular body is proximal to the distal end of the outer catheter body. The catheter assembly is characterized in that a proximal end of the tube body is located in an outer catheter lumen of the outer catheter body.

In the catheter assembly configured as described above, when the outer catheter hub and the inner catheter hub are connected, the tube of the inner catheter extends from the distal side of the outer catheter to the proximal side of the outer catheter. Arranged in a predetermined area. Therefore, when the guide wire is projected to the distal end of the inner catheter through the inner catheter hub lumen and the inner catheter lumen in a state where the outer catheter hub and the inner catheter hub are connected, the tube body is formed at the distal end of the outer catheter. The step formed between the outer surface of the guide wire and the inner surface of the outer catheter is smoothed. Therefore, the catheter assembly of the present invention can reduce the burden on the living body due to the distal end of the outer catheter when inserted into the living body lumen.

Furthermore, the catheter assembly is configured such that the proximal end of the tube is located in the outer catheter lumen of the outer catheter body. Further, the guide wire inserted into the inner catheter hub lumen is configured to be inserted into the proximal end portion of the inner catheter lumen of the tubular body. That is, since the guide wire is disposed between the outer peripheral surface of the shaft and the inner peripheral surface of the outer catheter body, the guide wire extends from the proximal end side of the tube body to the distal end side of the inner catheter hub. Located outside. Therefore, in the state where the guide wire is inserted into the catheter assembly of the present invention, when removing the inner catheter while leaving the guide wire and the outer catheter, the guide wire inserted into the inner catheter passes through the lumen of the inner catheter. Since the distance is shortened, it is not necessary to use a long guide wire or to extend the guide wire, and it can be easily removed from the living body lumen.

When the outer catheter hub and the inner catheter hub are connected, in the cross section orthogonal to the axis of the outer catheter body at the distal end of the outer catheter body, the radial thickness of the tubular body is the same as that of the outer catheter body. It is preferable that the thickness be larger than the radial thickness. With this configuration, the catheter assembly can reduce the step formed between the outer surface of the outer catheter body and the outer surface of the tube while keeping the tip of the outer catheter along the outer surface of the tube. can do. Therefore, damage to living tissue can be reduced as much as possible. Further, when the catheter assembly is inserted into the living body lumen, the thickness of the inner catheter reduces the impact on the distal end of the outer catheter, so that the operator can increase the inner diameter without kinking the distal end of the outer catheter. In addition, an outer catheter having a small outer diameter (an outer catheter having a small radial thickness) can be inserted up to the lesion site.

When the outer catheter hub and the inner catheter hub are connected, the length in the axial direction between the distal end of the tubular body and the distal end of the outer catheter body is such that the distal end of the outer catheter body and the tubular body If the length is smaller than the length in the axial direction between the proximal end and the tube, the length in which the tube is accommodated inside the outer catheter is sufficiently secured, and bending at the distal end region of the outer catheter can be suppressed. For this reason, during the operation of inserting the catheter assembly into the living body lumen, it is possible to insert the catheter assembly more safely into the living body lumen while ensuring sufficient pushability and torque transmission to the distal end side.

The outer catheter body has a stiffness transition portion in which the stiffness decreases in the distal direction, and a stiffness uniform portion provided on the proximal end side of the stiffness transition portion and having a uniform stiffness in the axial direction. If the proximal end of the tubular body is positioned closer to the proximal end side than the distal end of the rigid uniform portion when the catheter hub and the inner catheter hub are connected, the proximal end of the tubular body is the rigid transition portion. The rigidity transition of the outer catheter main body can be favorably maintained without being located in the middle. For this reason, during the operation of inserting the catheter assembly into the living body lumen, it is possible to insert the catheter assembly more safely into the living body lumen while ensuring sufficient pushability and torque transmission to the distal end side.

When the tube body is formed with a second inner catheter lumen that opens to the outside at the distal end portion and the proximal end portion, the contrast medium passes through the second inner catheter lumen from the outer catheter lumen. And a liquid such as physiological saline can be discharged from the distal end of the inner catheter. At this time, liquid such as contrast medium and physiological saline injected from the inner catheter hub is supplied using the lumen of the outer catheter having a relatively large inner diameter until the liquid reaches the second inner catheter lumen. Therefore, the pressure loss is reduced, and for example, even a contrast agent having a high viscosity can be easily pushed out with a small force. In the state where the guide wire is inserted into the catheter assembly, the tube cannot form a sufficient gap between the inner peripheral surface of the inner catheter lumen of the tube and the outer peripheral surface of the guide wire. Therefore, the catheter assembly can discharge the liquid such as the contrast medium injected from the inner catheter hub from the distal end of the tube body by providing the tube body with the second inner catheter lumen.

The shaft is formed with a shaft lumen penetrating in the axial direction, and the tubular body is formed with a second inner catheter lumen that communicates with the shaft lumen and opens to the outside at a distal end portion. When the hub is formed with a second inner catheter hub lumen that communicates with the shaft lumen and opens to the outside, a contrast medium and a physiological saline are provided via the shaft lumen and the second catheter lumen. Etc. can be discharged from the tip of the inner catheter. At this time, the liquid does not come into contact with the guide wire, and the liquid can be effectively delivered without being obstructed by the guide wire.

If the shaft is connected to the inner catheter hub at a position different from the inner catheter hub lumen, the outer catheter hub and the inner catheter hub are connected to each other through the inner catheter hub lumen. It becomes easier to supply liquid into the lumen of the catheter.

An inner catheter that can be inserted into the outer catheter body of the outer catheter including a tubular outer catheter body, and an inner catheter hub lumen that opens to the outside at the distal end and the proximal end is formed; A shaft connected to the inner catheter hub and extending from the inner catheter hub in the distal direction, and an inner shaft provided at the distal end of the shaft and open to the outside at the distal end portion and the proximal end portion to which a guide wire can be inserted. In the case of an inner catheter having a tube body in which a catheter lumen is formed, liquid is supplied into the lumen of the outer catheter via the inner catheter hub lumen in a state where the inner catheter is inserted into the outer catheter body. be able to.

If the inner catheter hub can be connected to the outer catheter hub provided at the proximal end of the outer catheter body, the state in which the inner catheter is inserted into the outer catheter body can be satisfactorily maintained, so that the operability is improved. In addition, the liquid can be supplied into the lumen of the outer catheter through the inner catheter hub lumen.

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 longitudinal cross-sectional view which shows the base end part of the catheter assembly which concerns on 1st Embodiment. It is a longitudinal cross-sectional view which shows the front-end | tip part of the catheter assembly which concerns on 1st Embodiment. It is a schematic sectional drawing which shows the state at the time of inserting the catheter assembly which concerns on 1st Embodiment in the blood vessel. It is a schematic sectional drawing which shows the state at the time of pushing forward the catheter assembly which concerns on 1st Embodiment within the blood vessel. It is a schematic sectional drawing which shows the state at the time of pulling out the inner catheter of 1st Embodiment from an outer catheter. It is a schematic sectional drawing which shows the state at the time of pulling out the inner catheter of 1st Embodiment from an outer catheter. It is a schematic sectional drawing which shows the state at the time of inserting a balloon catheter into the blood vessel through the outer catheter of 1st Embodiment. It is a schematic sectional drawing which shows the state at the time of inserting a balloon catheter into the blood vessel through the outer catheter of 1st Embodiment. It is a schematic sectional drawing which shows the state at the time of expanding the balloon catheter inserted in the blood vessel through the outer catheter of 1st Embodiment. It is a longitudinal cross-sectional view which shows the front-end | tip part of the catheter assembly which concerns on 2nd Embodiment. FIG. 13 is a transverse sectional view taken along line AA in FIG. 12. It is a longitudinal cross-sectional view which shows the base end part of the catheter assembly which concerns on 2nd Embodiment. It is a longitudinal cross-sectional view which shows the front-end | tip part of the catheter assembly which concerns on 3rd Embodiment. FIG. 16 is a transverse sectional view taken along line BB in FIG. 15. It is a longitudinal cross-sectional view which shows the base end part of the catheter assembly which concerns on 3rd Embodiment. It is a top view which shows the modification of the catheter assembly which concerns on 1st Embodiment.

Embodiments of the present invention will be described below with reference to the drawings. In addition, the dimension ratio of drawing is exaggerated on account of description, and may differ from an actual ratio. In the following description, the proximal side of the catheter assembly is referred to as “proximal end side”, and the side inserted into the living body is referred to as “distal end side”.
<First Embodiment>

As shown in FIGS. 1 and 2, the catheter assembly 10 according to the first embodiment of the present invention has a double structure including an outer catheter 20 and an inner catheter 30 and is percutaneously percutaneous and brachial artery. Or to insert into the femoral artery, etc., to reach the target site through the blood vessel, and to introduce treatment catheters such as balloon catheters and various liquids such as contrast media, drug solutions, and physiological saline into the target site Used.

The outer catheter 20 includes a tubular outer catheter main body 40, an outer catheter hub 50 fixed to the proximal end of the outer catheter main body 40, and a kink protector 60.

The inner catheter 30 includes an inner catheter body 31 that can be inserted into the outer catheter body 40, and an inner catheter hub 90 disposed at the proximal end of the inner catheter body 31. The inner catheter main body 31 includes a linear shaft 70 that can be inserted into the outer catheter main body 40, and a tube body 80 provided at the tip of the shaft 70.

When the distal end side of the tube body 80 is inserted into the proximal end side of the outer catheter hub 50, the outer catheter hub 50 and the inner catheter hub 90 are brought into contact with each other, and fixed by a lock mechanism described later, as shown in FIG. The outer catheter 20 and the inner catheter 30 are assembled (assembled state). Note that the lock mechanism is not necessarily provided as long as the outer catheter hub 50 and the inner catheter hub 90 can be connected. The inner catheter hub 90 may have a slit through which a guide wire can be taken in and out from the distal end to the proximal end of the inner catheter hub 90. Thereby, in a state where the guide wire is inserted into the catheter assembly 10, the operator can easily remove the inner catheter while leaving the guide wire and the outer catheter 20 in the living body lumen.

First, the outer catheter 20 will be described. As shown in FIGS. 2 to 4, the outer catheter body 40 is formed of a flexible tubular body, and an outer catheter lumen 41 is formed at almost the center of the outer catheter body 40 over the entire length of the outer catheter body 40. Has been.

The outer catheter body 40 includes an inner layer 42 that forms an inner surface within the outer catheter lumen 41, an outer layer 43 that forms the outer surface, a reinforcing layer 44 positioned between the inner layer 42 and the outer layer 43, an inner layer 42, And a soft tip 45 having high flexibility provided on the front end side of the reinforcing layer 44 and the outer layer 43.

The outer layer 43 includes a first region 431 located on the proximal side of the soft chip 45, a second region 432 located on the proximal side of the first region 431, and a proximal side of the second region 432. It has a third region 433 that is located and a fourth region 434 that is located on the proximal side of the third region 433. The fourth region 434 is secured to the outer catheter hub 50 at the proximal end. The third region 433 is more flexible than the fourth region 434, the second region 432 is more flexible than the third region 433, and the first region 431 is the second region 433. More flexible than region 432.

The range of the outer catheter body 40 that includes the distal end portion of the fourth region 434 to the soft tip 45 constitutes the stiffness transition portion 401 in which the stiffness decreases in the distal direction, and the range that includes the fourth region 434 is The rigidity uniform portion 402 having a uniform rigidity in the axial direction is formed. With such a configuration, when the catheter assembly 10 is inserted into a blood vessel, it can be more safely inserted into the blood vessel while sufficiently securing pushability and torque transmission to the distal end side.

Constituent materials of the first region 431, the second region 432, the third region 433, and the fourth region 434 are, for example, styrene, polyolefin, polyurethane, polyester, polyamide, polybutadiene, transpoly Examples include various types of thermoplastic elastomers such as isoprene-based, fluororubber-based, and chlorinated polyethylene, and combinations of one or more of these (polymer alloys, polymer blends, laminates, etc.) Can do.

The constituent material of the inner layer 42 is made of a material that causes at least a portion in contact with the medical instrument to have low friction when a medical instrument such as a treatment catheter or a guide wire is inserted into the outer catheter lumen 41. It is preferable. Thereby, the medical instrument inserted with respect to the outer catheter main body 40 can be moved to an axial direction with smaller sliding resistance, and operativity improves. Of course, the entire inner layer 42 may be made of a low friction material. Examples of the low friction material include fluorine resin materials such as polytetrafluoroethylene (PTFE).

In addition, since insertion of the catheter assembly 10 into the body is performed while confirming the position under X-ray fluoroscopy, a radiopaque material (X-ray contrast agent) is included in the constituent material of the outer catheter body 40. It is preferable that it is blended. As the radiopaque material, for example, barium sulfate, bismuth oxide, tungsten, or the like can be used. Such a radiopaque material is not limited to being present over the entire length of the outer catheter body 40, but may be present in a part of the outer catheter body 40.

The reinforcing layer 44 is for reinforcing the outer catheter main body 40 and has a reinforcing material composed of a plurality of reinforcing wires 441. The material of the outer layer 43 or the inner layer 42 enters the gaps between the plurality of reinforcing wires 441 in the reinforcing layer 44. Examples of the reinforcing material include those in which the reinforcing wire 441 is formed in a spiral shape or a net shape. The reinforcing wire 441 is made of a metal such as stainless steel or NiTi. As a specific example of the linear body, there may be mentioned a flat plate shape obtained by crushing a stainless steel wire into a flat plate shape so that the radial thickness of the catheter body 2 is reduced. In addition, examples of the reinforcing material include those formed by using a plurality of 8 to 32 spirals, knitted materials (braided bodies), and the like. The number of reinforcing wires 441 is preferably a multiple of 8 in order to reinforce the tube in a well-balanced manner. The reinforcing wire 441 is not limited to the above-described flat wire, and may be a round wire or an elliptic wire, for example. Further, one reinforcing wire 441 may be a bundle of two or more reinforcing wires.

By having such a reinforcing layer 44, sufficient rigidity and strength can be ensured without increasing the wall thickness of the outer catheter body 40, that is, while relatively increasing the inner diameter of the outer catheter body 40. As a result, it is possible to obtain the outer catheter 20 in which a medical device having a relatively large outer diameter can be inserted, is excellent in pushability and torque transmission, and is unlikely to be kinked or crushed.

The soft tip 45 is formed more flexibly than the three-layered tube 80 constituted by the inner layer 42, the reinforcing layer 44 and the outer layer 43. As a result, when the assembled catheter assembly 10 is inserted into the body, damage to the blood vessel due to the distal end of the outer catheter body 40 can be reduced as much as possible.

The constituent material of the soft chip 45 is, for example, various rubber materials such as natural rubber, isoprene rubber, butadiene rubber, chloroprene rubber, silicone rubber, fluorine rubber, styrene-butadiene rubber, styrene, polyolefin, polyurethane, and polyester. And various thermoplastic elastomers such as polyamide, polybutadiene, trans polyisoprene, fluororubber, and chlorinated polyethylene.

The outer diameter of the outer catheter body 40 is preferably 1.35 mm or more and 3 mm or less. If the outer diameter is too large, the operability when the outer catheter main body 40 is inserted into the artery and traveled is lowered, and the burden on the patient may be increased.

Also, the inner diameter of the outer catheter body 40 is preferably 1.2 mm or more and 2.85 mm or less. If the inner diameter is too small, the treatment catheter or the like that can be inserted into the outer catheter main body 40 has a smaller outer diameter, which is not preferable because the range of selection of medical instruments to be inserted is limited.

The length of the outer catheter body 40 can be appropriately set according to the use of the outer catheter 20, and is, for example, 500 mm to 2500 mm.

The outer catheter hub 50 is fixed to the proximal end of the outer catheter main body 40. As shown in FIGS. 2 and 3, the outer catheter hub 50 includes a hollow outer catheter body 51 and a plurality (two in this embodiment) of outer catheter blades protruding from the outer surface of the outer catheter body 51. A portion 52 and a spiral convex portion 53 formed on the outer surface of the proximal end portion of the outer catheter body portion 51 are configured. The outer catheter body 51 is formed with an outer catheter hub lumen 54 that communicates with the outer catheter lumen 41 and an outer catheter hub opening 55 that opens at the proximal end of the outer catheter hub lumen 54. The spiral convex portion 53 can be screwed into a spiral groove 99 formed in a later-described screwing portion 93 provided in the inner catheter hub 90. The outer catheter hub opening 55 can be inserted with a cylindrical portion 97 formed at the distal end of the inner catheter hub 90. The spiral convex portion 53 and the screwing portion 93 constitute a lock mechanism that maintains a state where the outer catheter hub 50 and the inner catheter hub 90 are connected.

The outer catheter hub lumen 54 is formed with a tapered portion 56 whose inner diameter decreases from the outer catheter hub opening 55 toward the distal end. The taper portion 56 is configured as a female luer taper into 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 taper portion 56 has a role of guiding into the outer catheter lumen 41 by the inner surface whose inner diameter decreases toward the distal end when inserting a medical instrument such as a balloon catheter from the outer catheter hub opening 55. Fulfill.

Examples of the constituent material of the outer catheter hub 50 include various thermoplastic elastomers such as styrene, polyolefin, polyurethane, polyester, polyamide, polybutadiene, transpolyisoprene, fluororubber, and chlorinated polyethylene. And combinations of one or more of these (polymer alloys, polymer blends, laminates, etc.).

In such an outer catheter hub 50, the inner catheter 30 is inserted from the proximal end side in the assembled state. After the inner catheter 30 is removed, for example, a guide wire, catheters (for example, a PTCA balloon catheter) ), Insert or remove long objects (linear bodies) such as endoscopes, ultrasonic probes, temperature sensors, or inject various liquids such as contrast media (X-ray contrast media), chemicals, and physiological saline. Can be.

The 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 kinking of the outer catheter 20 at the site.

Next, the inner catheter 30 will be described. As shown in FIGS. 2 and 4, the tube body 80 provided in the inner catheter 30 has a tube body base end portion 81 whose outer diameter is constant along the axial direction, and an outer diameter that tapers in the distal direction along the axial direction. And a tubular body tip portion 82 that decreases in a shape. An inner catheter lumen 83 penetrating from the distal end to the proximal end along the axis is formed in the central portion of the tube body 80. The outer diameter of the tubular body base end portion 81 substantially matches the inner diameter of the outer catheter main body 40. As long as the tube body 80 can be inserted into the outer catheter body 40 and can be pulled out, the outer diameter of the tube base end portion 81 may not match the inner diameter of the outer catheter body 40. Then, the tube base end portion 81 is disposed in the outer catheter main body 40, so that the outer surface of the tube base end portion 81 is in contact with the inner surface of the outer catheter main body 40 without a gap, or a minute gap is formed. Adjacent through.

The inner diameter of the tube body 80 may be configured to be substantially the same as the outer diameter of the guide wire used. As long as the guide wire can be inserted into and pulled out from the tube body 80, the inner diameter of the tube body 80 may not match the outer diameter of the guide wire. For example, when inserting the guide wire into the catheter assembly before insertion into the living body lumen, the operator may insert the guide wire from the inner catheter hub opening 95 toward the distal end of the tube body 80. In such a case, the inner diameter of the tube body 80 is preferably larger than the inner diameter of the opening at the distal end of the tube body 80. Further, at the distal end portion of the tube body 80, the guide wire is disposed in the inner catheter lumen 83, so that the outer surface of the guide wire is in contact with the inner surface of the tube body 80 without a gap, or a minute gap is formed. Adjacent through.

The length of the tube 80 is not particularly limited, but is, for example, 200 mm to 600 mm.

In the assembled state, the length L1 in the axial direction between the distal end of the tube body 80 and the distal end of the outer catheter body 40 is the axial direction length between the distal end of the outer catheter body 40 and the proximal end of the tube body 80. The length L2 that is smaller than the length L2 and the tube body 80 is accommodated in the outer catheter 20 is sufficiently secured. The length L1 is not particularly limited, but is, for example, 30 to 50 mm.

Further, in the assembled state, the proximal end of the tube body 80 is located closer to the proximal end side than the distal end of the rigid uniform portion 402 of the outer catheter main body 40. In the assembled state, the tube distal end portion 82 is located on the distal end side with respect to the distal end of the outer catheter main body 40.

Examples of the constituent material of the pipe body 80 include various thermoplastic elastomers such as styrene, polyolefin, polyurethane, polyester, polyamide, polybutadiene, transpolyisoprene, fluororubber, and chlorinated polyethylene. And combinations of one or more of these (polymer alloys, polymer blends, laminates, etc.).

As shown in FIGS. 2 and 3, the inner catheter hub 90 includes a hollow inner catheter body 91 and a plurality (two in this embodiment) of inner catheter blades protruding from the outer surface of the inner catheter body 91. And a threaded portion 93 that is rotatably disposed on the outer surface of the inner catheter body portion 91.

The inner catheter body 91 is formed with an inner catheter hub lumen 94 penetrating from the proximal end to the distal end. The inner catheter hub lumen 94 opens at an inner catheter hub opening 95 at the proximal end of the inner catheter body 91. ing. The inner diameter of the inner catheter hub lumen 94 is preferably larger than the outer diameter of the guide wire used. With this configuration, the contact area between the outer surface of the guide wire and the inner peripheral surface of the inner catheter hub lumen is reduced, so that the operator can easily operate the guide wire on the hand side. Further, when the catheter assembly is inserted into the living body lumen, an operation of inserting the guide wire from the distal end portion of the tube body 80 to the inner catheter hub opening 95 can be easily performed. As long as the guide wire can be inserted into and pulled out from the inner catheter hub lumen 94, the inner diameter of the inner catheter hub lumen 94 may substantially match the outer diameter of the guide wire to be used.

On the outer surface of the inner catheter body portion 91, a groove portion 96 is formed over the circumferential direction so that the screwing portion 93 is rotatably engaged.

A cylindrical portion 97 that can be inserted into the outer catheter hub opening 55 of the outer catheter hub 50 is formed at the distal end 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 toward 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 tapered portion 56 (female / luer taper) of the outer catheter hub lumen 54, thereby being liquid-tight. The outer catheter hub lumen 54 and the inner catheter lumen 83 can be communicated with each other while securing the state.

The threaded portion 93 is formed in a tubular shape, and an engaging convex portion 98 that is rotatably engaged with the groove portion 96 of the inner catheter body 91 is formed on the inner surface of the proximal end in the circumferential direction. Further, a spiral groove 99 that can be screwed with the spiral convex portion 53 of the outer catheter hub 50 is formed on the inner surface of the threaded portion 93. By inserting the tubular portion 97 into the outer catheter hub opening 55 and rotating the screwing portion 93, the helical convex portion 53 is screwed into the spiral groove 99, so that the tubular portion 97 enters the outer catheter hub lumen 54. On the other hand, it is pushed in the distal direction, and the outer surface of the cylindrical portion 97 is brought into close contact with the tapered portion 56 of the outer catheter hub lumen 54, and the state where the outer catheter hub 50 and the inner catheter hub 90 are connected can be maintained.

Examples of the constituent material of the inner catheter hub 90 include various thermoplastic elastomers such as styrene, polyolefin, polyurethane, polyester, polyamide, polybutadiene, transpolyisoprene, fluororubber, chlorinated polyethylene, and the like. And combinations of one or more of these (polymer alloys, polymer blends, laminates, etc.).

The shaft 70 is a member that is flexible and extends linearly as shown in FIGS. 2 to 4, and the distal end portion is radially outward from the inner catheter lumen 83 of the proximal end surface of the tube body 80. The proximal end portion is fixed at a position shifted radially outward from the inner catheter hub lumen 94 on the distal end surface of the tubular portion 97 of the inner catheter hub 90. In the shaft 70, when the inner catheter hub 90 is operated, the tube body 80 moves in the axial direction in conjunction with the inner catheter hub 90, and the tube body 80 that receives a force from the living tissue at the time of insertion into the living body. In order not to be pushed back into the outer catheter main body 40, it has an appropriate rigidity while being flexibly bent.

In the assembled state, the length of the shaft 70 in the axial direction is such that the distal end of the tube body 80 is located on the distal end side of the distal end of the outer catheter body 40, and the proximal end of the tube body 80 is closer to the proximal end of the outer catheter body 40. It is preferable that the length is appropriately set according to the length of the outer catheter main body 40 so as to be positioned on the proximal end side.

The outer diameter of the shaft 70 is preferably not less than 0.3 mm and not more than 1.5 mm, but is not limited thereto. The outer diameter of the shaft 70 is designed to be smaller than the inner diameter of the outer catheter body. If the outer diameter of the shaft 70 is too large, the movement of the guide wire in the outer catheter lumen 41 in the assembled state is hindered. If the outer diameter of the shaft 70 is too small, the tube body 80 is interlocked with the inner catheter hub 90. It becomes difficult to move.

The constituent material of the shaft 70 is not particularly limited as long as the necessary rigidity is obtained. For example, metals such as stainless steel and NiTi, styrene, polyolefin, polyurethane, polyester, polyamide, polybutadiene, transpoly Various thermoplastic elastomers such as isoprene, fluororubber and chlorinated polyethylene, or thermosetting resins such as unsaturated polyester, urea resin, melamine resin, silicone resin, phenol resin, epoxy resin, etc. Among them, one (a polymer alloy, a polymer blend, a laminate, or the like) may be used. The shaft 70 may be made of a plurality of materials.

In the assembled state, as shown in FIG. 4, the distal end of the tube body 80 is disposed on the distal end side with respect to the distal end of the outer catheter body 40, and the proximal end of the tube body 80 is disposed more than the distal end of the outer catheter body 40. It is arranged on the base end side. Therefore, when the guide wire 120 is inserted into the inner catheter lumen 83, the tubular body 80 is positioned in the gap between the outer surface of the guide wire 120 and the inner surface of the outer catheter body 40 (see FIG. 6).

Further, in the assembled state, the radial thickness of the tubular body 80 is larger than the radial thickness of the outer catheter main body 40 in a cross section orthogonal to the axis of the outer catheter main body 40 at the distal end of the outer catheter main body 40. . Therefore, the distal end of the outer catheter body 40 can be prevented from projecting as far as possible radially outward from the outer surface of the tube body 80 along the outer surface of the tube body 80.

Next, a method of using the catheter assembly 10 according to this embodiment will be described. In the following description, an example will be described in which the external catheter 20 is a guiding catheter, and an operator introduces the balloon catheter 100 into a blood vessel via the guiding catheter to treat a stenosis in the blood vessel. The balloon catheter 100 is a rapid exchange type, and a guide wire lumen 102 into which a guide wire 120 can be inserted is formed only at the distal end portion where the balloon 101 is provided, as shown in FIGS. Has been. The balloon catheter 100 supplies the expansion fluid into the balloon 101 at the distal end portion from the balloon catheter hub 103 through the expansion lumen formed in the balloon catheter shaft 104, so that the balloon 101 is diametrically deformed by fluid force. It can be expanded outward in the direction.

First, before introducing the catheter assembly 10 into the blood vessel, the outer catheter 20 and the inner catheter 30 are assembled as shown in FIGS. When assembling, the inner catheter 30 is inserted into the outer catheter hub opening 55 from the tube body 80 side, and the inner catheter 30 is pushed forward until the tubular portion 97 is inserted into the outer catheter hub opening 55. When the threaded portion 93 is rotated after the tubular portion 97 is inserted into the outer catheter hub opening 55, the spiral convex portion 53 is threadedly engaged with the spiral groove 99 as shown in FIG. It is pushed toward the outer catheter hub lumen 54 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 lumen 54. Thereby, the outer catheter hub lumen 54 and the inner catheter lumen 83 communicate with each other in a liquid-tight state, and this state can be reliably maintained. For this reason, when the catheter assembly 10 is inserted into the blood vessel, the outer catheter 20 and the inner catheter 30 can be integrally operated. Therefore, the operation is facilitated, and the outer catheter 20 and the inner catheter 30 are unexpectedly operated. The safety is improved by suppressing the disconnection.

Next, as shown in FIG. 5, the surgeon punctures the radial artery and inserts a mini guide wire by a known method such as the Seldinger method. Thereafter, a catheter introducer 110 having a dilator inserted into the lumen of the sheath 111 is inserted along the mini guide wire into the puncture site of the radial artery. Then, after the distal end of the catheter introducer 110 is advanced by a predetermined amount toward the central side, the operator removes the mini guide wire and the dilator from the catheter introducer 110 and places them in the sheath 111 in the radial artery. Thereby, the surgeon can secure an introduction part for introducing the catheter assembly 10 into the radial artery. In the following description, a case where the operator introduces the catheter assembly 10 from the radial artery and treats a stenosis in the blood vessel of the lower limb such as the femoral artery will be described in detail. The method is not particularly limited. For example, the operator may introduce the catheter assembly 10 from the brachial artery or femoral artery. Further, the position of the treatment site such as the stenosis is not particularly limited.

Next, the surgeon moves the catheter assembly 10 with the guide wire 120 inserted into the inner catheter lumen 83, the outer catheter lumen 41, the outer catheter hub lumen 54, and the inner catheter hub lumen 94 into the sheath 111. Insert from the tip opening. Then, the operator introduces the distal end of the catheter assembly 10 into the radial artery along the guide wire 120.

Next, as shown in FIG. 6, while the guide wire 120 is advanced, the catheter assembly 10 is gradually pushed forward to the stenosis (target site) in the assembled state. For example, when the catheter assembly 10 is introduced from the radial artery to the femoral artery, the operator confirms the position of the distal end portion of the guide wire 120 by X-ray imaging or the like, while the radial artery, brachial artery, subclavian artery, arm The catheter assembly 10 is introduced into the femoral artery, which is the target site, through the head artery, thoracic aorta, abdominal aorta, common iliac artery, and external iliac artery. At this time, in the catheter assembly 10, the tube body 80 is disposed inside the outer catheter main body 40, and the outer surface of the guide wire 120 inserted into the inner catheter lumen 83 and the inner surface of the outer catheter main body 40 are arranged. The tubular body 80 is located in the gap therebetween, and the outer diameter of the distal end portion of the tubular body 80 is smaller than the outer diameter of the proximal end portion. For this reason, the catheter assembly 10 has a step formed between the outer surface of the outer catheter body 40 and the outer surface of the guide wire 120 with the distal end of the outer catheter body 40 being along the outer surface of the tube body 80. Can be reduced. Therefore, the damage of the blood vessel can be reduced as much as possible, and the turning of the outer catheter main body 40 caused by the resistance of the distal end of the outer catheter main body 40 from the blood vessel can be suppressed. In addition, since the tube distal end portion 82 whose outer diameter decreases toward the distal end is located on the distal end side with respect to the distal end of the outer catheter main body 40, the tube distal end portion 82 smoothly contacts the blood vessel. In addition, damage to blood vessels can be reduced as much as possible.

In the assembled state, the radial thickness of the tube body 80 is larger than the radial thickness of the outer catheter body 40 in a cross section orthogonal to the axis of the outer catheter body 40 at the distal end of the outer catheter body 40. . Therefore, the catheter assembly 10 can reduce the level difference formed between the outer surface of the outer catheter main body 40 and the outer surface of the tube body 80, and can further reduce blood vessel damage.

In the assembled state, the axial length L1 between the distal end of the tube body 80 and the distal end of the outer catheter body 40 is the axial direction between the distal end of the outer catheter body 40 and the proximal end of the tube body 80. Therefore, the length L2 in which the tube body 80 is accommodated inside the outer catheter 20 is sufficiently secured, and bending at the distal end region of the outer catheter body 40 can be suppressed. For this reason, in the operation of inserting the catheter assembly 10 into the blood vessel, it is possible to insert the catheter assembly 10 more safely into the blood vessel while ensuring sufficient pushability and torque transmission to the distal end side.

Furthermore, in the assembled state, the proximal end of the tube body 80 is located on the proximal end side with respect to the distal end of the uniform rigidity portion 402 of the outer catheter main body 40. Therefore, the proximal end of the tube body 80 has rigidity in the distal direction. The rigidity transition of the outer catheter main body 40 can be favorably maintained without being positioned in the middle of the rigidity transition portion 401 that decreases toward the bottom. For this reason, in the operation of inserting the catheter assembly 10 into the blood vessel, it is possible to insert the catheter assembly 10 more safely into the blood vessel while ensuring sufficient pushability and torque transmission to the distal end side.

After the distal end of the catheter assembly 10 reaches the target site, the threaded portion 93 is rotated to release the connection between the spiral groove 99 and the spiral convex portion 53, and as shown in FIGS. The inner catheter 30 is removed from the outer catheter 20 while the guide wire 120 remains in the blood vessel. At this time, the inner catheter lumen 83 into which the guide wire 120 can be inserted into the tube body 80 provided on the distal end side of the shaft 70 of the inner catheter 30 by opening to the outside at the distal end portion and the proximal end portion of the tube body 80. In the proximal end side of the tube body 80, the guide wire 120 is located outside the inner catheter 30, not inside. For this reason, when the inner catheter hub 90 moves to the proximal end side with respect to the proximal end of the guide wire 120, the guide wire 120 is pulled out from the inner catheter hub lumen 94 to the distal end side. Therefore, since the guide wire 120 is located outside the inner catheter 30 at a portion other than the inner catheter lumen 83 of the tube body 80, the guide wire 120 is formed along the guide wire 120 without making the guide wire 120 longer than necessary. The catheter 30 can be removed. Specifically, the catheter assembly 10 can maintain a state where the guide wire 120 is exposed without being hidden in the inner catheter 30 at the time of performing the operation when the inner catheter 30 is removed. Operability is obtained.

After completely pulling out the inner catheter 30 from the outer catheter 20, as shown in FIG. 9, using the spiral convex portion 53 of the outer catheter hub 50, the threaded portion 93 and the tube of the inner catheter hub 90 described above are used. A general Y connector 130 having a connecting portion 133 having a structure similar to that of the portion 97 (see FIG. 3) is connected to the outer catheter hub 50. The Y connector 130 includes a first port 131 having a hemostasis valve and a second port 132 for injecting a contrast medium and the like. By connecting the connecting portion 133 to the outer catheter hub 50, the outer catheter The hub lumen 54 communicates with the first port 131 and the second port 132. When connecting the Y connector 130 to the outer catheter hub 50, the guide wire 120 protruding from the outer catheter hub opening 55 toward the proximal end is led out from the first port 131 through the hemostasis valve. A syringe or the like containing a contrast medium can be connected to the second port 132. By pushing the contrast medium from the syringe or the like, the outer catheter main body 40 is passed from the outer catheter hub lumen 54 via the outer catheter lumen 41. The contrast agent can be released from the tip of each. In addition, the liquid accommodated in a syringe etc. is not limited to a contrast agent, For example, a chemical | medical agent and physiological saline may be sufficient.

Next, the proximal end of the guide wire 120 is inserted from the distal end side of the guide wire lumen 102 of the balloon catheter 100, and the balloon catheter 100 is inserted into the first port 131 along the guide wire 120 as shown in FIG. . Thereafter, the balloon catheter 100 is moved in the distal direction within the outer catheter lumen 41, and the balloon 101 is projected from the outer catheter main body 40 toward the distal end side. Thereafter, a syringe or the like containing an expansion fluid is connected to the balloon catheter hub 103, the expansion fluid is supplied to the balloon 101 through the expansion lumen, and the balloon 101 is expanded as shown in FIG. Thereby, the balloon 101 is expanded, and for example, a treatment for expanding the stenosis (target site) of the blood vessel by the balloon 101 can be performed.

Next, the expansion fluid is discharged from the balloon 101 through the expansion lumen, and the balloon 101 is deflated. Thereafter, the balloon catheter 100 and the guide wire 120 are removed from the outer catheter 20.

The treatment performed via the outer catheter 20 is not limited to the treatment using the balloon catheter 100. For example, a stent may be disposed on the outer surface of the balloon 101. When the stent is disposed on the outer surface of the balloon 101, the stent is expanded while being plastically deformed when the balloon 101 is expanded. When the balloon 101 is contracted, the plastically deformed stent is not contracted. In addition, the stent can be satisfactorily maintained by the stent by being placed on the inner wall surface of the blood vessel and pushing the blood vessel. In addition, a long object such as a catheter other than the balloon catheter 100, an endoscope, an ultrasonic probe, and a temperature sensor is inserted or removed via the outer catheter 20, or a contrast medium (X-ray contrast medium), a drug solution, a physiological Various liquids such as saline can be injected.

Thereafter, the outer catheter 20 is withdrawn from the sheath 111, the sheath 111 is withdrawn from the radial artery, and the puncture site by the sheath 111 is hemostatic, thereby completing the procedure.

As described above, in particular, when treating the blood vessel of the lower limbs such as the femoral artery from the blood vessel of the arm such as the radial artery using the TRI technique, the operator has a distance from the insertion site of the catheter assembly to the treatment site. Due to the length, a long catheter assembly and guide wire must be used. Therefore, when an operator uses an over-the-wire type inner catheter, it takes time to remove the inner catheter. In the catheter assembly 10 according to the present invention, since the inner catheter 30 is a rapid exchange type, the inner catheter 30 can be easily removed while leaving the outer catheter 20 and the guide wire in the living body lumen. Therefore, the catheter assembly 10 according to the present invention is suitable for treating the blood vessel of the lower limb such as the femoral artery from the blood vessel of the arm such as the radial artery.
Second Embodiment

The catheter assembly 140 according to the second embodiment of the present invention differs from the first embodiment only in the configuration of the inner catheter 150. In addition, the part which has the same function as 1st Embodiment attaches | subjects the same code | symbol, and abbreviate | omits description in order to avoid duplication.

As shown in FIGS. 12 and 13, the tube body 160 of the inner catheter 150 in the second embodiment penetrates from the distal end to the proximal end of the tube body 160 in addition to the inner catheter lumen 83 into which the guide wire can be inserted. A two-inner catheter lumen 161 is formed. The shaft 70 is fixed to a position different from the site where the inner catheter lumen 83 and the second inner catheter lumen 161 of the tube body 160 are formed. The second inner catheter lumen 161 can function as a flow path for circulating a liquid such as a contrast medium or physiological saline. The inner diameter of the inner catheter lumen 83 is preferably larger than the inner diameter of the second inner catheter lumen 161. With this configuration, when the guide wire is inserted into the inner catheter lumen 83 of the tube body 160, the inner diameter of the second inner catheter lumen 161 is equal to the outer diameter of the guide wire. By making it smaller than the cavity 83, it is possible to reduce the risk that the surgeon erroneously inserts the guide wire into the second inner catheter lumen 161. In the assembled state in which the inner catheter hub 170 and the outer catheter hub 50 are connected, the tube body 150 has an outer diameter from the distal end of the tube body 160 toward the proximal end side in a region closer to the distal end side than the distal end of the outer catheter 20. It is preferable to have a taper part where becomes large. At this time, the tube body 160 has an inner catheter lumen 83 penetrating from the distal end of the tube body 160 to the proximal end, and a second inner catheter lumen 161 penetrating from the tapered portion of the tube body 160 to the proximal end. More preferably, it is configured. The opening at the tip of the inner catheter lumen 83 is located on the tip side of the opening at the tip of the second inner catheter lumen 161. With such a configuration, when inserting a guide wire into the inner catheter lumen 83 of the tube body 160, the risk of an operator erroneously inserting the guide wire into the second inner catheter lumen 161 can be reduced. Further, since the catheter assembly 140 can form the inner catheter lumen 83 through which the guide wire can be inserted near the center of the tube body 160, the operability of the guide wire can be improved.

Further, as shown in FIG. 14, the inner catheter hub 170 of the inner catheter 150 is formed with a port 171 for injecting a liquid such as a contrast medium or physiological saline, and the inner catheter 150 is formed in the port 171. A second inner catheter hub lumen 172 extending to the distal end surface of the cylindrical portion 97 is formed. Therefore, the inner catheter hub 170 is formed with an inner catheter hub lumen 94 into which a guide wire can be inserted and a second inner catheter hub lumen 172. The second inner catheter hub lumen 172 can function as a flow path for circulating a liquid such as a contrast medium or physiological saline.

Next, the operation of the catheter assembly 140 according to the second embodiment will be described.

As shown in FIGS. 12 and 13, the catheter assembly 140 according to the second embodiment has a second inner catheter lumen 161 formed in the tube body 160 of the inner catheter 150, and as shown in FIG. A second inner catheter hub lumen 172 is formed in the catheter hub 170. Therefore, with the guide wire inserted into the inner catheter lumen 83 and the inner catheter hub lumen 94, a syringe containing a liquid such as a contrast medium, physiological saline, or a medicine is connected to the port 171 to inject the liquid. Thus, after the liquid flowing into the outer catheter 40 through the second inner catheter hub lumen 172 is circulated in the distal direction through the outer catheter lumen 41, the inside of the second inner catheter of the tube body 160 is It can be discharged to the distal end side of the catheter assembly 140 through the cavity 161. At this time, until the liquid reaches the second inner catheter lumen 161, the liquid is delivered in the distal direction using the outer catheter lumen 41 having a relatively large inner diameter located outside the inner catheter 150. Loss is reduced and the liquid can be easily pushed out with a small force. Therefore, it is particularly effective when injecting a liquid having a high viscosity such as a contrast agent.
<Third Embodiment>

The catheter assembly 180 according to the third embodiment of the present invention is different from the first embodiment only in the configuration of the inner catheter 190. Note that parts having the same functions as those in the first embodiment or the second embodiment are denoted by the same reference numerals, and description thereof is omitted to avoid duplication.

As shown in FIGS. 15 and 16, the tube body 200 of the inner catheter 190 in the third embodiment penetrates from the distal end of the tube body 200 to the proximal end in addition to the inner catheter lumen 83 into which the guide wire 120 can be inserted. A second inner catheter lumen 201 is formed.

As shown in FIG. 17, the inner catheter hub 210 of the inner catheter 190 is formed with a port 211 for injecting a liquid such as a contrast medium or physiological saline. In the port 211, a tube of the inner catheter 190 is formed. A second inner catheter hub lumen 212 extending to the distal end surface of the portion 97 is formed.

The shaft 220 of the inner catheter 190 is a tubular body in which a shaft lumen 221 penetrating in the axial direction is formed. 15 and 16, the distal end portion of the shaft 220 is fixed to the tube body 200 so that the shaft lumen 221 communicates with the second inner catheter lumen 201, and the proximal end portion of the shaft 220 is As shown in FIG. 17, the shaft lumen 221 is fixed to the tubular portion 97 of the inner catheter hub 210 so as to communicate with the second inner catheter hub lumen 212. The second inner catheter hub lumen 212, the shaft lumen 221 and the second inner catheter lumen 201 can function as a flow path for flowing a liquid such as a contrast medium, physiological saline, or a medicine.

Next, the operation of the catheter assembly 180 according to the third embodiment will be described.

As shown in FIGS. 15 and 16, the catheter assembly 180 according to the third embodiment has a second inner catheter lumen 201 formed in the tube body 200 of the inner catheter 190, and as shown in FIG. A shaft lumen 221 is formed, and a second inner catheter hub lumen 212 is formed in the inner catheter hub 210. The second inner catheter lumen 201, the shaft lumen 221 and the second inner catheter hub lumen 212 communicate with each other. Therefore, with the guide wire inserted into the inner catheter lumen 83 and the inner catheter hub lumen 94, a syringe containing a liquid such as a contrast medium, physiological saline, or medicine is connected to the port 211 to inject the liquid. Thus, the liquid can be discharged to the distal end side of the catheter assembly 180 via the second inner catheter hub lumen 212, the shaft lumen 221 and the second inner catheter lumen 201. At this time, since the liquid does not flow through the outer catheter lumen 41 into which the guide wire is inserted, the liquid can be effectively discharged to the distal end side of the catheter assembly 180 without being blocked by the guide wire. .

Note that the present invention is not limited to the above-described embodiment, 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 modification shown in FIG. 18, the outer catheter main body 230 may be provided with a reinforcing member in which a spiral slit 231 is formed between the inner layer and the outer layer. Then, slits 231 are formed at a fixed pitch at the proximal end portion of the outer catheter main body 230 to form a uniform rigidity portion 232, and the pitch of the slits 231 toward the distal end is formed at the distal end portion of the outer catheter main body 230. As a result, a rigid transition portion 233 is formed in which gradually decreases. The rigidity uniform portion 232 thus formed has a uniform rigidity along the axial direction, and the rigidity transition portion 233 has a rigidity that decreases in the distal direction. The proximal end of the tube body 80 provided in the inner catheter 30 is located on the proximal end side with respect to the distal end of the rigid uniform portion 232. By adopting such a configuration, the proximal end of the tube body 80 is not positioned in the middle of the rigid transition portion 233, and the transition of the rigidity of the outer catheter body 230 can be favorably maintained, and the catheter to the living body lumen can be maintained. During the insertion operation of the assembly, it is possible to insert the assembly more safely into the living body lumen while ensuring sufficient pushability and torque transmission to the distal end side.

Further, at least one of the outer catheter body and the inner catheter body may be curved.

The use of the catheter assembly is not particularly limited as long as it is inserted into a living body lumen and used. Therefore, for example, it may be a catheter introducer in which the outer catheter is a sheath and the inner catheter (shaft) is a dilator. The living body lumen is not limited to a blood vessel, and may be, for example, a blood vessel, a ureter, a bile duct, a fallopian tube, a hepatic tube, or the like. In particular, in recent years, there is a demand that an operator wants to deliver a catheter assembly to a blood vessel of a lower limb via a radial artery, a subclavian artery or the like using a TRI technique. When using the blood vessel of the lower limb as a treatment site, the blood vessels to be treated are, for example, the iliac artery and the femoral artery. In such a case, since the distance from the insertion site of the catheter assembly into the blood vessel to the treatment site in the blood vessel is long, the operator needs to use a long guide wire, an inner catheter, and an outer catheter. Therefore, when treating a blood vessel in the lower limb in the TRI procedure, the catheter assembly according to the present invention that can prevent the guide wire from becoming longer than necessary is preferable.

The number of overlapping catheters in the catheter assembly is not particularly limited as long as it is two or more. Thus, for example, the catheter assembly may include other catheters on the outer side of the outer catheter, or may include other catheters between the outer and inner catheters.
Furthermore, this application is based on Japanese Patent Application No. 2014-67600 filed on March 28, 2014, the disclosures of which are incorporated by reference in their entirety.

10, 140, 180 catheter assembly,
20 external catheter,
30, 150, 190 Intracatheter,
31 Internal catheter body,
40,230 outer catheter body,
41 outer catheter lumen,
50 outer catheter hub,
54 lumen of the outer catheter hub,
70,220 shaft,
80, 160, 200 tube,
81 tubular body proximal end,
82, tube tip,
83 inner catheter lumen,
90,170,210 intracatheter hub,
94 inner catheter hub lumen,
100 balloon catheter,
120 guide wire,
161, 201 second inner catheter lumen,
172,212 second inner catheter hub lumen,
221 shaft lumen,
230 outer catheter body,
232, 402 rigid uniform part,
233,401 Rigid transition part.

Claims

An outer catheter having a tubular outer catheter body and an outer catheter hub provided at the proximal end of the outer catheter body, an inner catheter body that can be inserted into the outer catheter body, and a proximal end of the inner catheter body A catheter assembly comprising an inner catheter hub that is connectable to the outer catheter hub and has an inner catheter hub lumen formed therein,
The inner catheter body includes a shaft extending in the distal direction from the inner catheter hub, and an inner catheter provided at the distal end of the shaft and open to the outside at a distal end portion and a proximal end portion to which a guide wire can be inserted. A tube in which a cavity is formed,
When the outer catheter hub and the inner catheter hub are connected, the inner catheter body has the distal end of the tubular body disposed closer to the distal end side than the distal end of the outer catheter body, and the proximal end of the tubular body is A catheter assembly, wherein the catheter assembly is disposed on a proximal end side with respect to a distal end of the outer catheter body, and a proximal end of the tubular body is located in an outer catheter lumen of the outer catheter body.
When the outer catheter hub and the inner catheter hub are connected, in the cross section orthogonal to the axis of the outer catheter body at the distal end of the outer catheter body, the radial thickness of the tubular body is the same as that of the outer catheter body. The catheter assembly of claim 1, wherein the catheter assembly is greater than a radial thickness.
When the outer catheter hub and the inner catheter hub are connected, the length in the axial direction between the distal end of the tubular body and the distal end of the outer catheter body is such that the distal end of the outer catheter body and the tubular body The catheter body according to claim 1 or 2, wherein the catheter body is smaller than the length in the axial direction between the proximal end and the proximal end.
The outer catheter body has a stiffness transition portion in which the stiffness decreases in the distal direction, and a stiffness uniform portion that is provided on the proximal end side of the stiffness transition portion and the stiffness is uniform in the axial direction.
The proximal end of the tubular body is located on the proximal end side with respect to the distal end of the rigid uniform portion when the outer catheter hub and the inner catheter hub are connected to each other. Catheter assembly.
The catheter assembly according to any one of claims 1 to 4, wherein the tube body is formed with a second inner catheter lumen that opens to the outside at a distal end portion and a proximal end portion.
The shaft is formed with a shaft lumen penetrating in the axial direction,
The tube is formed with a second inner catheter lumen that communicates with the shaft lumen and opens to the outside at a distal end portion thereof.
The catheter assembly according to any one of claims 1 to 4, wherein the inner catheter hub is formed with a second inner catheter hub lumen that communicates with the shaft lumen and opens to the outside.
The catheter assembly according to any one of claims 1 to 6, wherein the shaft is connected to the inner catheter hub at a position different from a lumen of the inner catheter hub.
An inner catheter that can be inserted into the outer catheter body of an outer catheter comprising a tubular outer catheter body,
An inner catheter hub in which an inner catheter hub lumen that opens to the outside at the distal end and the proximal end is formed;
A shaft connected to the inner catheter hub and extending distally from the inner catheter hub;
An inner catheter provided at a distal end of the shaft and having an inner catheter lumen that is open to the outside at a distal end portion and a proximal end portion and into which a guide wire can be inserted.
The inner catheter according to claim 8, wherein the inner catheter hub is connectable to an outer catheter hub provided at a proximal end of the outer catheter main body.