WO2006126642A1

WO2006126642A1 - Catheter

Info

Publication number: WO2006126642A1
Application number: PCT/JP2006/310466
Authority: WO
Inventors: Masayuki Takatera
Original assignee: Kaneka Corporation
Priority date: 2005-05-26
Filing date: 2006-05-25
Publication date: 2006-11-30
Also published as: TW200706199A; JPWO2006126642A1

Abstract

A medical catheter having a resin shaft composed of two sections that are a distal shaft and a proximal shaft, a metal core wire, and a resin hub. The distal shaft is constructed such that its rigidity increases from its distal end to its proximal end, and is formed in a dual lumen structure having a first lumen from the distal end to the proximal end of the distal shaft and a second lumen from a position more on the proximal end side than the distal end of the first lumen to the proximal end of the proximal end of the distal shaft. The proximal shaft is formed in a coaxial dual tube structure having, from the distal end to the proximal end of the proximal shaft, an inner tube and an outer tube. The proximal end of the second lumen of the distal shaft and the distal end of the inner tube of the proximal shaft are connected such that a guide wire can be inserted through them, and the proximal end of the outer tube of and the proximal end of the inner tube of the proximal shaft are connected to the resin hub such that the guide wire can be inserted through them. The metal core wire is placed between the inner tube and the outer tube, across the overall length of the proximal shaft, and is fixed to a resin material of the proximal end of the distal shaft and to a resin material of the distal end of the proximal shaft.

Description

Specification

Catheter technology

[0001] The present invention introduces or moves other vascular treatment catheters or medical devices accompanying the body, particularly peripheral blood vessels, branches in the coronary vasculature, or obstructed lesions. The present invention relates to a medical catheter that can be suitably used for various functions such as introduction of a guide wire for injection, injection of a drug into a lesioned part, and use during blood pressure measurement.

Background art

[0002] A treatment method for expanding a stenosis or occlusion in a body passage using a medical dilatation catheter is widely known. According to this treatment method, an expanded body portion of a catheter is inserted into a stenotic site via a patient's internal passage, and then a site where the stenosis or occlusion is caused by the expanded body is introduced by introducing pressure fluid therein. .

[0003] Among the treatment targets using such medical dilatation catheters, in particular, when performing coronary intervention (percutaneous coronary interventi on: PCI) for bifurcation lesions of coronary vessels, only the main vessel is expanded As a result, high stenosis may occur again at the start of the blood vessel branch, or the branch may be blocked at the start. Therefore, for bifurcation lesions with large branches in the perfusion region, guide wires can be inserted not only into the main trunk but also into the branches to protect the branches, or against branches. However, it is necessary to expand with balloon force tails. The method of dilating the main trunk and branch of a bifurcation lesion with a balloon catheter is called the kissing balloon technique (KBT). In general, two balloon catheters are used to connect the main trunk and the side branch to the bifurcation lesion. This refers to the technique of simultaneous expansion using

[0004] When performing this procedure, a high-speed exchange type (RX type, monorail type) in which the proximal opening of the guide wire lumen is provided in the middle of the shaft in the balloon catheter is extremely difficult when the none catheter is exchanged. It is often used because it has the merit that it can be replaced quickly and easily (the item of the background art of Patent Document 1), but there are also demerits that the guide wire is tangled and it is difficult to select blood vessels. In this case, especially in cases where blood vessel selection is difficult, When operating the wire, the guide wire lumen is provided over the entire length of the catheter. If the over-the-wire type (OTW type) is advanced near the tip of the guide wire, the wire will not be entangled! (Background item in Reference 2). Using a special catheter with both lumen configurations described above instead of an over-the-wire balloon can make vessel selection very easy and prevent guide wire entanglement.

[0005] The catheter is a dual lumen catheter having two lumens, a monorail and an over-the-the-wire, and the mono-rail lumen opens at the tip of the catheter, and the over-the-the-wire lumen is about 5 mm from the tip. It opens on the side of the position. The catheter can be introduced to the periphery beyond the lesion in the coronary artery using a monorail lumen, and on top of that, it is possible to perform some operation using an over-the-the-wire lumen. It is a function. As described above, the guide wire is introduced into the branch through the over-the-wire device, the drug is reliably injected into the periphery from the lesion, and the peripheral pressure is measured from the lesion. Can be used over a wide range (Background Art Item of Patent Document 3).

[0006] Recently, in bifurcation lesions, stents are frequently placed after arch I after balloon catheter dilation, and this catheter is extremely useful for selecting side branches among struts on the stent surface. It is possible to repeat the procedure reliably until the guide wire is guided to the route that contacts the side branch with the over-the-wire lumen of this catheter, and the deformation of the strut due to the guide wire is minimized. be able to. For such bifurcation lesions, an over-the-wire type medical dilatation catheter can be used only as a guide wire passing catheter, or a simple tube-shaped catheter with no dilator (for example, to the cerebral blood vessel) It is costly to use two angiographic micro force tapes used for injecting drug solutions for the main trunk and branch of the blood vessel branch.

[0007] However, there have been four problems with a catheter having two lumens, such as a catheter for penetrating a coronary artery stenosis, which has been commercially available. First, conventional catheters have poor single-pipe force and flexible material force, so that the ability to push the kink immediately is poor. Second, the conventional one has a bending rigidity at the tip. Therefore, the catheter distal end member has high bending rigidity and excellent pushing characteristics, but the guide wire is difficult to back up and the followability to curved blood vessels is poor.

. Third, because the material used for the inner surface of the lumen of the tip member is a material with high surface friction resistance, the operability of the guide wire is poor, and fourth, when inserting the catheter into the body. In order to increase the rigidity of the rear end side member and improve the push-in characteristics, a metal stylet separated from the catheter must be inserted into the catheter separately, and the catheter was positioned near the bifurcation lesion Later, when the guide wire is inserted into the over-the-wire lumen, it must be removed and the operation becomes complicated.

[0008] As a characteristic required for a medical catheter generally used for guide wire backup, the operability of the guide wire and the pushing force applied to the proximal end are efficiently transmitted to the distal end. Pushability, flexibility of 20-30cm at the tip, that is, track ability that allows smooth progress along curved blood vessels, and pushes into narrow blood vessels. In order to make it possible, a small diameter is mentioned. However, indentation force transmission and curved path followability are contradictory properties that are difficult to achieve at the same time, and that the frictional resistance between the inner surface of the lumen and the outer surface of the guide wire is greatly related to these characteristics. .

Patent Document 1: Japanese Unexamined Patent Application Publication No. 2004-154195

Patent Document 2: Japanese Translation of Special Publication 2002-508987

Patent Document 3: Japanese Translation of Special Publication 2004-522525

Disclosure of the invention

Problems to be solved by the invention

[0009] In view of the above, the problem to be solved by the present invention is to provide a medical catheter that has excellent kink resistance, excellent track following ability, pushing force transmission ability, and guide wire operability.

Means for solving the problem

[0010] Thus, the present invention provides the following:

(a) A shaft made of resin that also has two section forces, a distal shaft and (b) a proximal shaft. (c) a metal core wire;

(d) a resin hub;

A medical catheter comprising:

The distal shaft (a) is

The distal end of the distal shaft is configured to increase in rigidity continuously or intermittently toward the proximal end,

At least a part of the tip side shaft (a)

(a-1) A first portion having a distal end side opening and a proximal end side opening, which extends from the distal end portion of the distal end side shaft (a) to the proximal end portion of the distal end side shaft (a). (A-2) a position force that is proximal to the distal end of the first lumen (a-1) and extends to the proximal end of the distal shaft (a), and a distal opening A second lumen having a proximal opening;

Has a dual lumen structure with

The proximal shaft (b) is

At least part of the proximal shaft (b)

(b-1) The distal end force of the proximal end side shaft (b) The inner tube extending to the proximal end,

(b-2) The distal end force of the proximal end side shaft (b) also extends to the proximal end, and the inner tube

(b-1) an outer pipe having a different diameter,

It has a coaxial double pipe structure with

Here, the proximal end portion of the second lumen (a-2) of the distal end side shaft (a) and the distal end portion of the inner tube (b-1) of the proximal end side shaft (b) are connected to the guide wire. Can be inserted, and the proximal end of the outer tube (b-2) and the proximal end of the inner tube (b-1) of the proximal shaft (b) can be inserted into the guide wire. Connected to the hub (d) made of resin,

The metal core wire (c)

In order to adjust the flexibility of the medical catheter, the inner tube (b-1) and the outer tube (b-2) of the proximal shaft (b) at least over the entire length of the proximal shaft (b) Between the base material of the distal end side shaft (a) and the proximal end side shaft (b). Is fixed to the grease material at the tip of the

A medical catheter characterized by.

(1 ') A medical catheter comprising a resin shaft that also has two section forces on the distal side and proximal side, a metal core layer, and a resin knob,

The tip side shaft has a dual lumen structure having a first lumen and a second lumen at least at a part thereof,

The first lumen extends to the proximal end side of the distal end force of the distal end shaft, and the first lumen includes a distal end opening and a proximal end opening at the distal end and the proximal end. Have

The second lumen has a proximal force at the distal end of the distal shaft over the proximal end of the distal shaft, and the second lumen has a distal opening and a proximal end at the distal end and the proximal end. Having side openings,

The distal shaft is configured to increase in rigidity continuously or intermittently toward the proximal end,

The base end side shaft is coaxial with at least a portion having an inner tube and an outer tube having different diameters.

It has a double tube structure, the inner tube is over the proximal end of the proximal shaft, and the outer tube is over the proximal force of the proximal shaft,

Here, a proximal end portion of the second lumen of the distal end side shaft and a distal end portion of the inner tube of the proximal end side shaft are connected so that a guide wire can be inserted therethrough. The proximal end of the outer tube and the proximal end of the inner tube are connected to the resin hub so that a guide wire can be inserted therethrough,

The core wire is disposed between the outer tube and the inner tube of the proximal shaft at least over the entire length of the proximal shaft to adjust the flexibility of the catheter,

Here, the medical catheter is characterized in that the core wire is fixed to a proximal end portion of the distal end side shaft and a grease material of the distal end portion of the proximal end side shaft.

[0011] (2) The medical catheter according to (1), wherein the distal shaft is composed of at least two layers of an inner layer having a lumen and an outer layer.

[0012] (3) The material of the outer layer of the tip side shaft is low density polyethylene, polyamide elast The medical catheter according to (2), wherein the medical catheter is formed of at least one material selected from the group consisting of mer and polyamide.

[0013] (4) The material of the inner layer of the tip side shaft is at least one selected from the group consisting of high density polyethylene, polytetrafluoroethylene, and tetrafluoroethylene perfluoroalkyl vinyl ether copolymer force. The medical catheter according to (2), which is formed of a material.

(5) The material of the outer layer of the tip of the tip side shaft is a flexural modulus (ASTM D790,

(23) The medical catheter according to (3), characterized in that it is 150 kgZcm ² or more and 2000 kgZcm ² or less.

[0015] (6) Flexural modulus of material of outer layer other than the tip of the tip side shaft (ASTM D7

90, 23 ° C) is 2000 kg / cm ² or more and lOOOOkg / cm ² or less.

(3) The medical catheter according to the above.

[0016] (7) The material of the outer layer of the tip portion of the tip side shaft is a polyamide elastomer, the polyamide elastomer force S, a block copolymer including a hard segment and a soft segment, and the polyamide elastomer The medical catheter according to (3), wherein the proportion of the soft segment is 10% by weight or more and 30% by weight or less.

(8) The material of the outer layer other than the tip of the shaft on the tip side is a polyamide elastomer, and the polyamide elastomer also has a block copolymer force including a hard segment and a soft segment, and the polyamide elastomer The medical catheter according to (3), wherein the proportion of the soft segment is 10% by weight or less.

[0018] (9) The bending elastic modulus (ASTM D790, 23 ° C) of the material of the inner layer of the tip side shaft is 5

The medical catheter according to (4), wherein the medical catheter is 000 kg / cm ² or more and 15000 kg / cm ² or less.

[0019] (10) The medical catheter according to (4), wherein the entire surface of the lumen of the inner layer of the distal shaft has a rough surface with fine irregularities.

[0020] (11) The medical catheter according to (2), wherein at least one radiopaque marker is disposed at a distal end portion of the distal shaft.

(12) The central axis of the distal end portion of the second lumen is the second lumen in the radial direction of the first lumen. The medical catheter according to (1), wherein the medical catheter is curved so as to separate from a central axis of one lumen.

[0022] (13) The outer tube of the proximal end shaft is composed of a distal end portion and a proximal end portion, and the material of the distal end portion of the outer tube is lower in hardness than the material of the inner tube. The medical catheter according to any one of (2) to (12), wherein the medical catheter is characterized.

[0023] (14) The material according to (13), wherein the material of the distal end portion of the outer tube is formed of one or more materials selected from the group consisting of low density polyethylene, polyamide elastomer and polyamide. Medical catheter.

[0024] (15) The medical catheter according to (13), wherein the material of the distal end portion of the outer tube is made of polyimide resin.

[0025] (16) The bending elastic modulus (ASTM D790, 23 ° C) of the material of the distal end portion of the outer tube is 3

The medical catheter according to (13), wherein the medical catheter is 500 kgZcm ² or more and 12000 kgZcm ² or less.

[0026] (17) The outer tube is at least partially reinforced with metal (

13) The medical catheter according to the above.

[0027] (18) The medical catheter according to (13), wherein the inner tube is made of polyethylene.

(19) The outer layer of the distal shaft, the outer tube of the proximal shaft, and the inner tube of the proximal shaft are heat-welded, so that the core wire is interposed between them. The catheter according to (13), wherein is fixed.

[0029] (20) The outer diameter force of the core wire, wherein at least a part of the core wire has a tapered shape that increases toward the proximal end of the core wire. catheter.

[0030] (21) The distal end force of the catheter is provided with a hydrophilic coating on the proximal end side.

V. The medical catheter according to any one of (1) to (20), characterized in that it is V.

[0031] (22) The medical catheter according to (21), wherein the range of the hydrophilic coating extends to the entire distal shaft portion.

The invention's effect As described above, according to the present invention (1), the proximal shaft has a coaxial double tube structure having an inner tube and an outer tube having different diameters at least in part, and the core wire is at least By being arranged between the outer tube and the inner tube with the proximal shaft over the entire length of the proximal shaft, it has excellent kink resistance, curved path followability, pushing force transmission performance, and guide wire operability. An excellent medical catheter is provided.

[0033] Further, as in the present invention (2), the tip side shaft is configured to have at least two or more layers of force, so that the guide wire operability and the curve followability are further improved according to the purpose of use. be able to.

[0034] Further, as in the present inventions (3), (5), (6), (7) and (8), by adjusting the material of the outer layer of the distal shaft, the flexibility of the distal shaft can be improved. A medical force tape that is excellent and has excellent track following ability is provided.

[0035] Further, the operability of the guide wire can be further improved by selecting the material of the inner layer of the distal shaft as in the present invention (4).

[0036] Further, according to the present invention (10), since the entire lumen surface of the inner layer of the tip side shaft has a rough surface with irregularities, the guide wire is further slippery.

[0037] Further, according to the present invention (11), a medical catheter with good X-ray visibility is provided.

[0038] Further, according to the present invention (12), the central axis of the distal end portion of the second lumen is curved in the radial direction of the first lumen so as to be separated from the central axial force of the first lumen. The guide wire can be easily inserted into the branched blood vessel.

[0039] According to the present invention (13) to (18), the hardness of the proximal shaft is adjusted, so that the kink resistance is excellent, the curve following ability, the pushing force transmission ability, In addition, the operability of the guide wire is further improved.

Further, according to the present invention (19), since the core wire is easily fixed to the inner tube, the outer tube and the second lumen, the kink resistance is excellent, the curve following property, the pushing force transmitting property, and the guide Wire The operability is further improved.

Further, according to the present invention (20), by adjusting the hardness of the core wire, the followability, pushing force transmission property, curved track followability, and guide wire operability are further improved. Further, according to the present invention (21) and (22), the insertion into the blood vessel is further facilitated. Brief Description of Drawings

FIG. 1 is a schematic cross-sectional view showing the overall structure of a medical catheter according to the present invention (hereinafter also simply referred to as a catheter).

FIG. 2 is a schematic cross-sectional view showing the distal end side shaft structure of the catheter according to the present invention. FIG. 2 (b) is a cross-sectional view taken along the line II in FIG. 2 (a).

FIG. 3 is a schematic cross-sectional view showing the structure of the connecting portion between the distal shaft and the proximal shaft of the catheter according to the present invention. Fig. 3 (b) is a cross-sectional view taken along line II-II in Fig. 3 (a), and Fig. 3 (c) is a cross-sectional view taken along line III-III in Fig. 3 (a).

FIG. 4 is a schematic cross-sectional view showing a proximal-end shaft structure of a catheter according to the present invention. Fig. 4 (c) is a sectional view taken along the line IV-IV in Fig. 4 (b).

FIG. 5 is a schematic cross-sectional view showing the structure of the connecting portion between the proximal end shaft of the catheter according to the present invention and the resin-made nodule and bush.

FIG. 6 is a schematic cross-sectional view showing another example of the distal shaft structure of the catheter according to the present invention. FIG. 6 (b) is a cross-sectional view taken along the line V-V in FIG. 6 (a).

FIG. 7 is a schematic cross-sectional view showing a state in which a guide wire protrudes from the lumen of a conventional catheter.

FIG. 8 is a schematic sectional view showing a state in which a guide wire protrudes from the lumen of the catheter according to the present invention.

FIG. 9 is a continuous diagram showing the curve following ability when the guide wire is placed in the first lumen of the medical catheter obtained in the examples and comparative examples, and the catheter is caused to follow the bent circuit. It is a graph which shows the data of a load value.

[Fig. 10] Proximal force when the guide wire is placed in the first lumen of the medical catheter obtained in the examples and comparative examples when the catheter follows the bent circuit. It is a graph which shows the result of a load transmissibility.

Explanation of symbols

[0041] 1 Front shaft

2 Proximal shaft

3 Metal core wire Plastic hub

First lumen

Second lumen

Cutting edge

Tip side opening

Proximal opening

Tip side opening

12 inner layers

Outer layer

Tip side shaft tip Tip side shaft intermediate part Tip shaft base end, 18 X-ray opaque marker outer tube

Inner pipe

Proximal end

Tip

Proximal end

Tip

Proximal end

Tip

Wire port part

Proximal shaft (outer tube) distal end Proximal shaft (outer tube) proximal end Proximal side

Tip side

Metal body 34 space

35 Tip

36 Curved part

37 Guide wire

38 Tip

BEST MODE FOR CARRYING OUT THE INVENTION

[0042] In the configuration as described above, the tip side shaft may be formed by using a plastic tube having two or more layers of different structural forces between the inner surface of the two lumens and the outer surface of the shaft. From the viewpoint of improving the slipperiness of the guide wire by arranging a flexible material in the outer layer part of the structure to improve the curve followability and further arranging a material with low surface friction resistance in the material of the inner layer part. ,preferable. In this case, it is possible to obtain a higher track followability.

[0043] Further, the proximal shaft is formed by an outer tube arranged in a coaxial double tube and an inner tube forming a lumen through which the guide wire passes, thereby improving the operability of the guide wire. Further, when at least the base end portion of the outer tube is made of polyimide resin, particularly when a part of the polyimide resin is reinforced with metal, it is possible to obtain high indentation force transmission.

[0044] In addition, a taper-shaped metal core wire having an outer diameter that increases from the distal end side to the proximal end side is disposed between the outer tube and the inner tube on the proximal end shaft over the entire length of the proximal end shaft. In this case, further kink resistance and pushing force transmission can be improved. In this way, by incorporating the metal core wire into the shaft, it is possible to eliminate the trouble of attaching and detaching a metal stylet that has been used in the past, and to prevent the troublesome operation of a conventional commercial product.

[0045] Further, in these configurations, the entire catheter is configured so that the rigidity increases continuously or intermittently from the distal end side toward the proximal end side. Backing up the guide wire can be facilitated by balancing the contradictory properties of the guide wire.

As another usefulness of this catheter, a central axial force at the distal end of the second lumen is provided with a curved portion in the radial direction of the first lumen so that the central axial force of the first lumen is also separated. In this case, a guide wire is inserted into the lumen in the distal direction from the proximal end of the catheter proximal end opening and advanced, and when the distal end of the guide wire protrudes from the distal opening, it is inclined by the curved portion. Deflection and protruding. The structure provided with the curved portion makes it easy to introduce a guide wire into the branch as well as the main force of the branch lesion.

[0047] In addition, when two or more X-ray opaque markers are disposed within the range of the distal end portion of the catheter, in particular, the vicinity of the distal end opening portion of the first lumen and the distal end opening portion of the second lumen are not transparent. When a marker is placed, the positional relationship can be easily confirmed when a guide wire is introduced into the main force branch of the bifurcation lesion at the time of surgery.

Furthermore, a hydrophilic coating is applied to the polyimide tube portion of the proximal end portion of the proximal end shaft of the catheter to reduce contact with the inner surface of the blood vessel, thereby further improving the curve following ability.

Next, embodiments of the present invention will be described with reference to the drawings. An example of the present invention is shown in FIG. 1. The catheter body is composed of a resin shaft having two section forces, a distal shaft 1 and a proximal shaft 2, a metal core wire 3, and a proximal shaft 2. It consists of a resin hub 4 connected to the base end of

First, the front end side shaft will be described. Here, the proximal side means the direction in which the hub is attached to the catheter, and the distal direction means the direction opposite to the proximal direction.

[0050] The distal shaft 1 has a dual lumen structure having a first lumen 5 and a second lumen 6 as shown in FIGS. The first lumen 5 is provided with a distal end opening 8 at the most distal end 7 of the distal shaft 1 and extends to the proximal opening 9 formed in the middle of the distal shaft 1 toward the proximal end. The second lumen 6 includes a distal end opening 10 at a position closer to the proximal end than the distal opening 8 of the first lumen 5, and extends from there to the proximal end of the distal shaft 1.

As shown in FIG. 2, the distal end side shaft has at least part of the first lumen and the second lumen when the distal end opening 8 of the first lumen 5 and the distal opening 10 of the second lumen 6 are A configuration in which the shaft does not have the same cross-sectional shape, in particular, the distal end opening 8 of the first lumen 5 is disposed on the distal end side of the shaft, and the distal end opening 10 of the second lumen 5 is first in cross section. Shows a configuration that is formed in a slanted shape facing the end direction, and it is possible to prevent the guide wire from becoming trapped and to improve the followability when inserting the catheter (preventing scratching). There is an advantage that can be made.

Moreover, the cross section of the tip opening part of the first lumen and the second lumen may be on the same plane.

The first lumen is a lumen for introducing a catheter, and the second lumen is for introducing a guide wire, or for introducing a device used for various purposes such as drug injection, a removable coil, or pressure measurement. This is a so-called lumen for multi-function catheters. Therefore, the diameters of these lumens may be within a known range depending on the respective use. The purpose of use of these lumens can be changed based on technical matters well known to those skilled in the art.

[0051] Further, the front shaft 1 is composed of inner layers 11 and 12 that form the inner surfaces of the two lumens of the first lumen 5 and the second lumen 6, and the outer layer 13 of the shaft, and these layers also have different plastic material forces. . The outer layer 13 should be made of a material that is more flexible than the material that forms the inner layers 11 and 12! /, Characterized by that!

[0052] The material of the outer layer 13 portion of the distal shaft is not particularly limited as long as it is a resin. Specifically, nylon, polyamide elastomer, polyester, polyester elastomer, polyurethane elastomer, polyolefin, polyimide, polyimide Examples thereof include amide and polyetherimide resin materials. Among these, it is preferable that the material is formed of at least one material selected from the group consisting of low density polyethylene, polyamide elastomer and polyamide.

[0053] In order to improve the curve following ability, the distal shaft 1 is intermittently rigid with the distal end 14, the intermediate portion 15, and the proximal end 16 from the distal end toward the proximal end (hand side). (Figures 2 and 3). Further, the distal end shaft may be manufactured by means of switching extrusion molding well known to those skilled in the art, and the distal end force may be continuously increased in rigidity toward the proximal end side. The rigidity of the distal shaft indicates the rigidity of the outer layer portion of the distal shaft, and is evaluated by, for example, the flexural modulus.

The flexural modulus (ASTM D790, 23 ° C, the same shall apply hereinafter) of the outer layer material of the tip 14 of the tip side shaft 1 is preferably 150 kgZcm ² or more and 2000 kgZcm ² or less. Ri preferably about lOOOkgZcm ^2. Further, the flexural modulus of the outer layer portion material other than the tip portion 14 from the intermediate portion 15 to the base end portion 16 is preferably 2000 kgZcm ² or more and 10 OOOkg / cm ² or less, more preferably 2000 to It is 5000 kg / cm ² , and the base end 16 is about lOOOOkgZcm ² . Furthermore, when the material forming the outer layer 13 portion of the shaft is a polyamide elastomer, the polyamide elastomer preferably has a block copolymer power including a hard segment and a soft segment. More preferably, the proportion of the soft segment in the polyamide elastomer at the distal end portion 14 is 10 wt% or more and 30 wt% or less, and the intermediate portion 15 and the base end portion 16 are 10 wt% or less. In a particularly preferred embodiment, according to the NMR spectrum analysis of the polyamide elastomer used for the distal end portion 14 and the proximal end portion 16, the hard / soft segment ratio was calculated. The weight ratio of part 16 was 83Z17.

[0054] The material of the tip side shaft inner layers 11 and 12 is not particularly limited. The force is preferably a high-strength polyethylene, polytetrafluoroethylene, and tetrafluoroethylene perfluoroalkyl butyl ether. One or more materials selected from polymers, more preferably a flexural modulus of 5000 kgZcm ² or more and 15000 kgZcm ² or less, most preferably a material having a flexural modulus higher than the outer layer 13 of the shaft, for example, , the scope of 11000~14000kg / cm ^2, preferably ί or, 12500kg / cm ² force ^ good!ヽ. In addition, when the distal shaft inner layer or the proximal shaft inner tube is made of a resin material with a high degree of lubrication with respect to a guide wire having a surface energy of 50 dynZcm or less, specifically, a polyolefin-based bottle containing polyethylene is used. It is preferable that the oil material or the fluorine-based resin material is manufactured.

[0055] Furthermore, it is possible to improve the slipperiness of the guide wire by having a rough surface with fine irregularities on the whole lumen side surface of the two lumens of the distal end side shaft or the proximal end side shaft inner tube, Further, it is possible to obtain a high track following ability.

As described above, the rough surface with fine unevenness means a state in which the frictional resistance is lowered and the slip property is improved, and in this way, making the “rough surface with fine unevenness” This can be achieved by a lumen manufacturing method well known to those skilled in the art.

[0056] In the present invention, the tip side shaft is composed of an inner layer and an outer layer having a lumen as described above. It is also preferred that the force is composed of 2 or 3 layers or more. For example, the inner layer is made of polyamide elastomer (product name: PEBAX (manufactured by ARKEMA)), the intermediate layer between the inner layer and the outer tank is low density polyethylene, and the outer layer is high density polyethylene. Can be adopted.

[0057] X-ray opaque marker of gold or platinum for the purpose of confirming the position of the tip of the catheter by X-ray contrast in the form of covering the outer layer 13 on the inner layer 11 at the position of the most advanced portion 7. 17 may be fixed. In addition, as shown in FIG. 6, in order to confirm the position of the opening 10 on the tip side of the second lumen 6, the outer layer 13 covers the outer periphery of the shaft on the inner layer 12 and is semi-circular X-ray opaque. It is preferable that the marker 18 is fixed. This is to easily confirm the positional relationship when a guide wire is introduced into the main force branch of the bifurcation lesion during surgery. The number of radiopaque markers is not particularly limited, and may be 1 or 2 or more.

Further, as shown in FIG. 7, in the conventional structure, when the guide wire 37 slidable in the axial direction moves in the distal direction through the second lumen 6 and protrudes from the distal end side opening 10, There was a possibility that it could get entangled with the guide wire from the first lumen 5 in some cases along the axial direction.

On the other hand, in the present invention, the guide shaft is operated by curving the central axis of the distal end portion of the second lumen so as to be separated from the central axis of the first lumen in the radial direction of the first lumen. It can be made more excellent in properties. Specifically, as shown in FIG. 8 (a), by providing a curved portion 36 at the distal end of the distal end opening 10 of the second lumen 6, the center line force at the distal end opening 10 of the first lumen 5 When the guide wire 37, which is arranged with its axis tilted obliquely with respect to the center line and is slidable in the axial direction, moves in the distal direction through the second lumen 6, the distal end portion 38 of the guide wire becomes the distal end. It is deflected and protrudes obliquely from the opening 10 (Figs. 8 (b) and (c)). It is a great utility of this catheter that it is possible to easily introduce a guide wire into the main force branch of the bifurcation lesion by the structure provided with the curved portion.

[0059] Next, the proximal shaft is described. As shown in FIG. 3, the proximal shaft 2 has an outer tube 19 and an inner tube 20 having different diameters at least partially, and these are coaxial double tube structures. I'm stuck. The inner tube 20 and the outer tube 19 extend from the distal end of the proximal shaft 2 to the proximal end, and in the example of this figure, the inner tube 20 is disposed in the outer tube 19 longer than the entire length of the outer tube 19. . The total length of the inner tube and the total length of the outer tube may be set to be substantially the same length. The distal end 22 of the proximal shaft 2 is connected to the proximal end 21 of the distal shaft 1, where the proximal end 23 of the inner layer 12 of the second lumen 6 of the distal shaft 1 and the inner tube are connected. It is also connected to the tip 24 of the 20. On the other hand, as shown in Fig. 5, the base end 25 of the outer pipe 19 and the base end 26 of the inner pipe 20 are connected to the front end 27 of the resin hub 4 so that the inner pipe 20 protrudes to the base end side. It communicates with the wire port 28 of the resin knob 4. Therefore, the guide wire can be passed through the inner tube 20 from the wire port portion 28 of the resin knob 4.

As shown in FIG. 4, the outer tube 19 includes a distal end portion 29 that is a distal end portion and a proximal end portion 30 that is a proximal end portion. The inner diameter is expanded from the tip side 32 reduced in diameter from the outer diameter, and they are fixed in an overlapping manner. Examples of the material of the distal end portion 29 of the outer tube 19 include nylon, polyamide elastomer, polyester, polyester elastomer, polyurethane elastomer, polyolefin, and the like. Among them, low density polyethylene, polyamide elastomer and It is preferably made of a material selected from polyamides or made of polyimide resin. More preferably, the flexural modulus of the material of the tip portion 29 is 3500 kgZcm ² or more and 1200 OkgZcm ² or less. More preferably, the material strength at the distal end portion 29 of the outer tube 19 should be lower than the material of the inner tube 20. In addition, the base end 30 of the outer tube 19 is made of polyimide resin! /, In which case the length may be set to about 1000 to 1200 mm! /.

[0061] Further, in the present invention, at least a part of the outer tube is reinforced with metal in order to obtain a higher indentation force transmission ability by applying a larger load in the direction toward the distal end. May be. In particular, when the polyimide resin is partially reinforced by a metal body 33 such as a cache or a coil, it is possible to obtain higher push force transmission and torque transmission (Fig. 4 ( b), (c)).

[0062] The material of the inner tube 20 can be formed of polyethylene. For example, the inner tube 20 and the outer tube 19 can be heat-welded in a state where a material compatible with both materials is disposed at the position of the distal end portion 22 of the proximal end side shaft 2. Or glue between them It is preferable that the heat-welded with the modified polyethylene.

In the proximal shaft 2, the metal core wire 3 is disposed over the entire length of the proximal shaft in the space 34 between the outer tube 19 and the inner tube 20 disposed concentrically. By having such a configuration, the flexibility of the catheter can be adjusted. Examples of the metal component constituting the metal core wire include stainless steel, nickel titanium, cobalt chrome, and the like. The metal core wire 3 is located from the proximal end portion 30 of the proximal end side shaft 2 to the proximal end portion 21 of the distal end side shaft 1. The outer diameter of the metal core wire 3 can have a tapered shape that increases from the distal end 35 toward the proximal end. In a preferred embodiment, the metal core wire 3 is made of a shaft grease material (base end and base end of the distal shaft) at the position of the proximal end 21 of the distal shaft 1 and the distal end 22 of the proximal shaft 2. It is fixed in the form of embedding in the grease material at the tip of the side shaft. By arranging the metal core wire inside the shaft in this way, kink resistance and indentation force transmission are improved, and the trouble of attaching and detaching and the troublesome operation of conventional commercially available products are prevented. Furthermore, the entire catheter is configured so that the rigidity is intermittently increased toward the proximal end side from the distal end side force by these configurations, thereby satisfying the contradictory properties of pushing force transmission and curved path followability. The guide wire can be easily backed up.

[0064] In the present invention, the specific configuration, size, and appearance of the distal shaft, proximal shaft, metal core wire, and resin knob depend on the use of the catheter. Set as appropriate.

[0065] It is preferable that the medical catheter of the present invention has at least a hydrophilic coating on the distal end portion of the catheter. The hydrophilic coating is composed of polyacrylamide copolymer and polybutyropyrrolidone copolymer having photoreactive functional groups, photoreactive quaternary ammonium salt as a cross-linking material, and polyvinylpyrrolidone, and contains the above coating agent. More preferably, the coating is applied by dipping the catheter into the solution, air drying, and curing by UV irradiation. In terms of efficacy, it exhibits wettability with the catheter inserted into the blood vessel, and plays a role in improving the operability and passage of the catheter. The scope of coating extends to the polyimide part of the proximal shaft 2, which is the proximal side of the catheter, especially when it is used in the blood vessels of the coronary arteries. To show its effect. In particular, it is preferable that the coating range extends to the entire tip side shaft portion.

Example

[0066] Hereinafter, the present invention will be described in detail based on examples, but the present invention is not limited to these examples.

In the embodiment shown in FIG. 1 of the present invention, the tip shaft is divided into three portions in the length direction, and polyamide elastomers having different hardnesses are arranged in the outer layer, and high-density polyethylene is arranged in the inner layer. . The length, inner / outer diameter, and outer layer hardness of each part are as shown in Table 1. The comparative example is a configuration in which the shaft tip has only a single hardness of a polyamide elastomer, and the outer diameter is changed in each part. For other configurations included in the tip shaft, the examples and comparative examples are The same.

[0068] Items for confirming the effects of the invention include a curved path following ability and a pushing force transmitting ability. The measurement methods for each performance are described below. These performances are evaluated by our evaluation device, which is a model that simulates the aortic arch and coronary vascular runway in the body, placed in a water tank section and a simulation circuit so that it is kept at 37 ° C in water. It consists of a control unit that combines a slider with a load meter to perform a certain fixed operation, a control box that activates the input program, and a personal computer that records the load transmitted to the hand side. As an example of measuring the track following ability, a guide wire is placed in a simulated circuit of a coronary artery blood vessel (here, L CX: Left CircumflexArtery), and the guide wire is passed through the wire lumen of the catheter to be constant. The load received on the hand side when it was pushed in at a speed of was recorded. For pushing force transmission, set the catheter in the aortic arch model of the same evaluation device, connect it to the load meter at the catheter tip and hand part, and apply it at the tip and hand when pushed for a certain length from the hand direction. The load was measured, and the load transfer rate at that time was shown as Load transfer rate = (Load on the tip side) Z (Load on the hand side).

[0069] Table 1 shows the results of comparing the load value in the three-point bending test and the outer diameter and length of each part of the tip end shaft as a contrast between the change in outer diameter and the continuity of bending rigidity. In addition, inside the LCX simulation circuit where the catheter is bent when the guide wire is placed in the first lumen. Figures 9 and 10 show the data of continuous load values indicating the track following ability when following, and the data of load transfer rate from the base end to the tip.

[table 1]

Figure [] 90071

However, because the bending rigidity at the tip and the outer diameter are large, the load value when following the inside of a bent circuit with poor tracking ability was high.

Thus, by considering the material of the resin material used and the dimensions such as the shaft outer diameter so that the bending elasticity of each part of the outer layer constituting the tip shaft is in an appropriate range, the object of the present invention is good. A catheter that achieves the purpose of knock-up of the guide wire with both push force transmission and curved path follow-up characteristics has been realized.

Claims

Claims (a) Medical shaft comprising a shaft made of resin that also has two section forces of a distal shaft and (b) a proximal shaft, (c) a metal core wire, and (d) a resin hub. The distal-side shaft (a) is configured to increase in rigidity continuously or intermittently toward the proximal end of the distal-side shaft of the distal-side shaft, and at least the distal-side shaft ( (a-1) extends from the distal end of the distal shaft (a) to the proximal end of the distal shaft (a), and includes a distal opening and a proximal end. A first lumen having an opening; and (a-2) a positional force on a proximal side of the distal end of the first lumen (a-1) to a proximal end portion of the distal shaft (a). And a dual lumen structure having a second lumen having a distal end side opening and a proximal end side opening. The base end side shaft (b) has at least a part of the base end side shaft (b), and (b-1) a distal end force of the base end side shaft (b) extends to the base end portion. (B-2) The distal end force of the proximal end shaft (b) also extends over the proximal end, and the inner tube

(b-1) an outer pipe having a different diameter,

It has a coaxial double pipe structure with

The metal core wire (c)

In order to adjust the flexibility of the medical catheter, at least the proximal shaft (b) It is disposed between the inner tube (b-1) and the outer tube (b-2) of the proximal shaft (b) over the entire length, and the proximal portion of the distal shaft (a). The resin material and the resin material at the tip of the proximal shaft (b),

A medical catheter characterized by.

[2] The medical catheter according to [1], wherein the distal side shaft is configured to have a force of at least two layers of an inner layer having a lumen and an outer layer.

[3] The medical use according to claim 2, wherein the material of the outer layer of the distal shaft is formed of one or more materials selected from the group consisting of low density polyethylene, polyamide elastomer and polyamide. catheter.

[4] The material of the inner layer of the tip side shaft is at least one selected from the group consisting of high density polyethylene, polytetrafluoroethylene, and tetrafluoroethylene perfluoroalkyl butyl ether copolymer. The medical catheter according to claim 2, wherein the medical catheter is formed of the material.

[5] The material of the outer layer at the tip of the tip side shaft is flexural modulus (ASTM D790, 23 ° C

) Is 150 kg / cm ² or more and 2000 kg / cm ² or less, The medical catheter according to claim 3.

[6] Flexural modulus of the material of the outer layer other than the tip of the tip side shaft (ASTM D790, 2

The medical catheter according to claim 3, wherein 3 ° C) is 2000 kgZcm ² or more and lOOOOkgZcm ² or less.

[7] The material of the outer layer of the tip portion of the tip side shaft is a polyamide elastomer, the polyamide elastomer S, a block copolymer including a hard segment and a soft segment, and the soft segment in the polyamide elastomer 4. The medical catheter according to claim 3, wherein the ratio is 10% by weight or more and 30% by weight or less.

[8] The material of the outer layer other than the tip of the tip side shaft is a polyamide elastomer, and the polyamide elastomer is made of a block copolymer including a hard segment and a soft segment, and the soft segment in the polyamide elastomer 4. The medical catheter according to claim 3, wherein the ratio is 10% by weight or less.

[9] The flexural modulus (ASTM D790, 23 ° C) of the material of the inner layer of the tip side shaft is 5000. kg / cm ² or more, and medical Ryoyo catheter according to claim 4, characterized in that 15,000 kg / cm ² or less.

10. The medical catheter according to claim 4, wherein the entire surface of the lumen of the inner layer of the distal shaft has a rough surface with fine irregularities.

11. The medical catheter according to claim 2, wherein at least one radiopaque marker is disposed at the distal end portion of the distal shaft.

[12] The central axis of the tip of the second lumen is curved so as to be separated from the central axis of the first lumen in the radial direction of the first lumen. The medical catheter according to 1.

[13] The outer tube of the proximal end shaft is composed of a distal end portion and a proximal end portion, and the material of the distal end portion of the outer tube is lower in hardness than the material of the inner tube. Item 14. The medical catheter according to any one of Items 2 to 12.

[14] The medical use according to claim 13, wherein the material of the distal end portion of the outer tube is formed of one or more materials selected from the group consisting of low density polyethylene, polyamide elastomer, and polyamide. catheter.

15. The medical catheter according to claim 13, wherein the material of the distal end portion of the outer tube is made of polyimide resin.

[16] The bending elastic modulus (ASTM D790, 23 ° C) of the material of the distal end portion of the outer tube is 3500 kg

14. The medical catheter according to claim 13, wherein the medical catheter is / cm ² or more and 12000 kg / cm ² or less.

17. The outer tube according to claim 1, wherein at least a part of the outer tube is reinforced with metal.

3. The medical catheter according to 3.

18. The medical force tester according to claim 13, wherein the inner tube is made of polyethylene.

[19] The outer layer of the distal shaft, the outer tube of the proximal shaft, and the inner tube of the proximal shaft are heat-welded to each other, thereby fixing the core wire therebetween. The catheter according to claim 13.

[20] Outer diameter force of the core wire 20. The medical catheter according to claim 19, wherein the distal end force of the wire exhibits a tapered shape that increases toward the proximal end.

21. The medical catheter according to any one of claims 1 to 20, wherein a hydrophilic coating is applied from a distal end portion to a proximal end side of the catheter.

[22] The medical catheter according to [21], wherein the hydrophilic coating extends to the entire distal shaft portion.