JP2009082566A - Catheter - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To more quickly and safely measure a lesion length for determining the appropriate length of a stent than the conventional one in a bifurcation constricted lesion or blocked lesion in a body, especially in a peripheral blood vessel and a coronary blood vessel. <P>SOLUTION: This catheter is provided with a first lumen and a second lumen and for inserting a wire into the bifurcation constricted lesion, wherein at least the second lumen consists of an inner layer, a reinforcing layer and an outer layer, the first lumen has a first X-ray impermeable marker section capable of specifying the position at the distal end of the constricted lesion, and a second X-ray impermeable marker section capable of specifying the position at a proximal end of the constricted lesion, and the second lumen has a third X-ray impermeable marker section capable of specifying the position of a collateral opening portion for determining a distance from the distal end of the constricted lesion specified by the first X-ray impermeable marker to the collateral opening portion of the constricted lesion. <P>COPYRIGHT: (C)2009,JPO&INPIT

Description

  The present invention relates to a catheter capable of introducing a guide wire, measuring the length of a lesion, injecting a drug into a lesion, and the like in a branch stenosis lesion in the body, particularly peripheral blood vessels and coronary blood vessels.

  A medical dilatation catheter is widely used as a method for treating a stenosis or blockage in a body passage. In this treatment method, after an expanded body portion of a catheter is inserted into a stenotic site through a body passage of a patient, the site of stenosis or occlusion is expanded by introducing and expanding a pressure fluid into the expanded body.

  In such treatment using a medical dilatation catheter, when only coronary intervention (PCI) is performed for bifurcated stenosis of a coronary artery, when only the main vessel is expanded, In some cases, severe stenosis or occlusion of the side branch at the origin may occur. Therefore, for branching stenosis lesions with large side branches in the perfusion region, a guide wire is inserted not only into the main trunk but also into the side branch, or the side branch is simultaneously expanded with a balloon catheter. Need to be protected. A method in which two balloon catheters are inserted into the parent catheter and simultaneously expanded is called a kissing balloon technique (KBT). A technique of simultaneous expansion using a balloon catheter is also one of KBTs.

  When treating branch stenosis lesions with a single lumen (for example, using an over-the-wire medical dilatation catheter only as a guide wire passing catheter) for such branch stenosis lesions In general, the procedure takes time. In addition, it is economical to use two simple tube-shaped catheters (for example, angiographic microcatheter used for injecting medicinal solution into cerebral blood vessels) for the main and side branches of bifurcated stenosis. Not right. Therefore, a dual lumen catheter having two lumens is preferably used for the treatment of the branch stenosis lesion.

  Some of these dual lumen catheters have both high-speed exchange type (RX type, monorail type) and over-the-wire type (OTW type) lumens (see Patent Document 1). In the dual lumen catheter disclosed herein, a part or all of each lumen is composed of two layers, an inner layer and an outer layer. In branch stenosis lesions in the body, particularly peripheral blood vessels, coronary blood vessels, or obstructed lesions, the blood vessels are often bent, and the catheter having the tip composed of two layers is used for such lesions. When used, not only can the tip of the lumen become kinked and the procedure is delayed, but there is also a significant risk that the guidewire will penetrate the inner and outer layers of the lumen and damage the blood vessels.

  In addition, in a branch stenosis lesion as described above, it is also common to place a stent after balloon catheter expansion. When placing a stent, it is often the case that the stent is too short or too long for the lesion, despite the importance of selecting an appropriately sized stent for the lesion. If the stent is too short, an additional stent is required, which is not economical and requires extra procedure time. If too long, there is a significant risk of restenosis in the stent in the future. The reason for selecting an inappropriately sized stent was that it was determined by the operator's experience or visual observation with reference to a contrasted photograph of the lesion.

  As a technique for solving this problem, there is a major function catheter (see Patent Document 2). When using a conventional major function catheter, first measure the length of the lesion with a major function catheter through a wire through the trunk of the bifurcated stenosis, and then use another backup catheter that is different from the major function catheter. Then, the wire is passed through the side branch, and after the major function catheter and the backup catheter for the side branch are removed, the stent is placed.

However, in such a catheter having only the major function, when the stent is placed and then passed through the strut to treat the side branch, a new backup catheter must be used, which takes time. Furthermore, since it is a high-speed exchange type, there is a problem that the guide wire is entangled or a sufficient backup force cannot be obtained and it is difficult to select a blood vessel.
: International Publication Gazette WO2006-126642 : Registered Utility Model No. 3100671

  In view of the above, the problem to be solved by the present invention is to determine an appropriate stent length more quickly and more easily than before in a branch stenotic lesion or an obstructed lesion in the body, particularly in peripheral blood vessels and coronary blood vessels. It is possible to measure the length of the lesion, and to easily and safely pass two wires through the trunk and the side branch of the branch stenosis, and to guide the lumen through the guide wire during operation. The object is to provide a highly safe catheter with reduced risk.

Thus, the present invention provides the following:
(1) It has a first lumen and a second lumen, and at least the second lumen is composed of an inner layer, a reinforcing layer, and an outer layer, and X-rays are respectively formed at the tip portions of the first lumen and the second lumen. A catheter characterized in that one or more impermeable markers are arranged,
The first lumen has a distal end side opening and a proximal end side opening at its distal end and proximal end,
The distal end side opening of the first lumen is located at the tip of the second lumen at the most distal end, or is projected to the tip side from the most distal portion,
The proximal end opening of the first lumen is located at the proximal end of the second lumen or at the distal end;
The catheter is characterized in that at least the second lumen is configured to increase in rigidity continuously or stepwise toward the proximal side.

(2) The first lumen has a first X-ray opaque marker portion capable of identifying the first lumen tip portion at a tip portion thereof, and a second X-ray at a proximal end side with respect to the tip portion of the first lumen. An impermeable marker part,
The second lumen has a third X-ray opaque marker part capable of specifying the position of the tip side opening at the tip part,
The second X-ray opaque marker part forms a second scale part by the X-ray opaque marker by providing a plurality of X-ray opaque markers,
The third X-ray opacity marker portion forms a third scale portion by the X-ray opacity marker by providing a plurality of X-ray opacity markers,
Each graduation included in the second graduation portion and each graduation included in the third graduation portion are formed at positions that are not side by side at least partially in the axial direction of the catheter. (1) Catheter.

(3) The first lumen has a first X-ray opaque marker portion capable of specifying the first lumen tip portion at a tip portion thereof, and a second X-ray closer to the proximal end side than the tip portion of the first lumen. An opaque marker part, and a third X-ray opaque marker part capable of identifying the second lumen tip,
The second X-ray opaque marker part forms a second scale part by the X-ray opaque marker by providing a plurality of X-ray opaque markers,
The catheter according to (1), wherein the third X-ray opaque marker portion includes a plurality of X-ray opaque markers to form a third scale portion by the X-ray opaque marker.

  (4) The central axis of the tip of the second lumen is curved in the radial direction of the first lumen so as to be away from the central axis of the first lumen (1) to ( 3) The catheter as described.

  (5) The catheter according to any one of (1) to (4), wherein the material of the outer layer of the first lumen and the second lumen is formed of a material selected from low density polyethylene, polyamide elastomer and polyamide.

  (6) The material of the inner layer of the first lumen and the second lumen is formed of a material selected from high-density polyethylene, polytetrafluoroethylene, and a tetrafluoroethylene-perfluoroalkyl vinyl ether copolymer. The catheter according to (1) to (5).

  (7) The catheter according to any one of (1) to (6), wherein inner diameters of distal ends of the first lumen and the second lumen are 50 to 100% of a proximal end inner diameter.

  (8) The catheter according to any one of (1) to (7), wherein a hydrophilic coating is applied from the distal end portion to the proximal end side of the catheter.

  By using the catheter of the present invention, it is possible to easily and quickly measure the lesion length for determining an appropriate stent size as compared with the conventional major function catheter, and the main trunk and the side branch of the branch stenosis can be measured. It is possible to pass two wires easily and quickly. In addition, the reinforcement layer is strong against kinks and can suppress penetration of the lumen by the guide wire, so that it is possible to treat the lesion quickly and safely.

  The catheter of this invention is demonstrated in detail based on embodiment shown to an accompanying drawing. Hereinafter, although the catheter which introduces the guide wire for inserting a medical device into a lesioned part is illustrated, the present invention is not limited to this. The catheter of the present invention includes any catheter known to those skilled in the art, such as a vascular treatment catheter (including a balloon catheter) having a balloon, a stent, or the like, or a catheter for injecting a drug.

1. Catheter Structure (1) Overall Catheter Structure The catheter 1 is composed of a first lumen 2 and a second lumen 3 that are adjacent to each other, and a resin hub connected to the proximal end of the second lumen. Here, the proximal end side means a direction in which the hub is attached in the catheter, and the distal end side means a direction opposite to the proximal end side. The first lumen 2 is a first base located closer to the proximal end than the second distal end opening 6 from the first distal end opening 4 located closer to the distal end than the second distal end opening 6 of the second lumen 3. The second lumen 3 extends from the second distal end opening 6 to the proximal direction of the catheter 1.

It is preferable that the first lumen 2 and the second lumen 3 are seamlessly connected from the distal end portion to the proximal end portion, and the rigidity changes continuously or stepwise. As a result, the pushing force transmission is further improved, and the procedure can be performed quickly and easily.
At least the second lumen 3 has a reinforcing layer 12 made of resin or metal between the inner layer 9 and the outer layer 11, and the first lumen 2 also has a reinforcing layer 12 made of resin or metal between the inner layer 8 and the outer layer 10. It is preferable to have. Thereby, the rigidity and kink resistance of the catheter 1 are improved, the risk of lumen penetration by the guide wire during lesion treatment is significantly suppressed, and the safety is further enhanced. In addition, it is possible to continuously change the rigidity around the first X-ray opaque marker portion 21, the second X-ray opaque marker portion 22, and the third X-ray opaque marker portion 23 including a plurality of markers. This makes it possible to advantageously increase the transmission force of the pushing force during insertion.

  The first radiopaque marker portion 21 is disposed at the distal end portion of the first lumen 2. The material of the marker included in the first X-ray opaque marker portion 22 is not particularly limited as long as it is substantially X-ray opaque, and the type of metal or resin material is not limited. The first X-ray opaque marker portion 21 may include only one marker, or may include two or more markers. The markers may be on the inner layer 8 or the reinforcing layer 12, respectively, and may be covered and fixed by the outer layer 10. This is preferable because the manufacturing process becomes easier. Moreover, although the shape of the marker contained in the 1st X-ray opaque marker part 21 is not ask | required, it is preferable that it is a hollow ring shape. Since the hollow ring-shaped shape looks the same when viewed from any radial direction of the catheter 1 under X-ray contrast, visualization is easy. Moreover, it can be manufactured easily. Furthermore, the first radiopaque marker portion 21 is arranged at the distal end portion of the first lumen 2 so that the leading edge of the catheter 1 can be specified, and the safety is further enhanced.

  The second X-ray opaque marker part 22 is arranged on the proximal end side with respect to the first X-ray opaque marker part 21 on the distal end side of the first lumen 2. The second radiopaque marker portion 22 may include only one marker, or may include two or more markers. The material of each marker included in the second radiopaque marker portion 22 is not particularly limited as long as it is substantially radiopaque, and the type of metal or resin material is not limited. Each marker included in the second radiopaque marker portion 22 is on the inner layer 8 or the reinforcing layer 12 and may be covered and fixed by the outer layer 10. This is preferable because the manufacturing process becomes easier. In addition, the shape of each marker included in the second X-ray opaque marker portion 22 is not limited, but is preferably a hollow ring shape. Since the hollow ring-shaped shape looks the same when viewed from any radial direction of the catheter 1 under X-ray contrast, visualization is easy. Moreover, it can be manufactured easily.

  The third radiopaque marker portion 23 is disposed around the distal end portion of the second lumen 3. The third radiopaque marker portion 23 may include only one marker, or may include two or more markers. The material of each marker included in the third X-ray opaque marker portion 23 is not particularly limited as long as it is substantially X-ray opaque, and the type of metal or resin material is not limited. Each marker included in the third radiopaque marker portion 23 is on the inner layer 8, the inner layer 9, or the reinforcing layer 12, and may be covered and fixed by the outer layer 10 or the outer layer 11. This is preferable because the manufacturing process becomes easier. The shape of each marker included in the third X-ray opaque marker portion 23 is not limited, but is preferably a hollow ring shape. Since the hollow ring-shaped shape looks the same when viewed from any radial direction of the catheter 1 under X-ray contrast, visualization is easy. Moreover, it can be manufactured easily. Furthermore, the positional relationship between the injection port and the affected part can be specified by arranging the third radiopaque marker part 23 around the distal end of the second lumen. Accordingly, the guide wire can be accurately inserted into the side branch from the second distal end side opening 6, and a medicine or the like can be accurately injected into the affected area from the second distal end side opening 6.

The distal end portion of the second lumen 3 may be curved so that its central axis is away from the central axis of the first lumen in the radial direction of the first lumen 2. When such a structure is adopted, when the guide wire 32 slidable in the axial direction moves in the distal direction through the second lumen 3, the distal end portion of the guide wire comes from the second distal end side opening 6. It is preferable because the guide wire can be easily introduced from the main trunk of the branch lesion to the side branch because it is deflected obliquely and protruded.
The outer diameter of the distal end side opening 4 of the first lumen 2 is smaller than the outer diameter of the catheter 1 at the position of the second distal end side opening 6 of the second lumen 3. Thereby, the passability to the lesioned part can be improved, and the first X-ray opaque marker part 21 can be easily arranged at the distal end of the lesioned part.
The inner diameter of the distal end side opening 4 of the first lumen 2 may be smaller than the inner diameter of the first proximal end opening 5 of the first lumen. Thereby, since the outer diameter of the first lumen 2 can be reduced, the passage to the lesioned part is improved, and the first X-ray opaque marker part 21 can be easily arranged at the distal end of the lesioned part. In addition, the gap between the distal end portion of the guide wire and the inner layer 8 is preferably reduced, so that the backup force of the guide wire is increased and the guide wire operation can be facilitated.
The inner diameter of the distal end side opening 6 of the second lumen 3 may be smaller than the inner diameter of the proximal end side of the second lumen 3. Thereby, since the outer diameter around the second tip opening 6 can be reduced, the passage through the lesion is improved, and the first radiopaque marker portion 21 can be easily disposed at the distal end of the lesion. In addition, the gap between the distal end portion of the guide wire and the inner layer 9 is reduced, so that the backup force of the guide wire is increased and the guide wire operation can be facilitated.

(2) Inner layer The inner layer 8 and the inner layer 9 form a first lumen 2 and a second lumen 3 as well as a core for arranging a reinforcing layer and / or an outer layer. The inner layer is preferably made of a low friction material. Thereby, sliding resistance with the guide wire inserted through the first lumen 2 and the second lumen 3 is reduced, and the operation of placing the guide wire on the trunk and the side branch and the catheter 1 along the preceding guide wire are reduced. The operation of inserting into the stenotic lesion and the operation of removing the guide wire from the catheter 1 can be performed more easily and smoothly.
The material of the inner layer 8 and the inner layer 9 may be any material that can reduce the frictional resistance of the inner surface from the viewpoint of the operability of the guide wire. For example, fluorine resin, nylon 66, polyether ether ketone, high density polyethylene Etc. Among these, a fluororesin having low friction and excellent heat resistance is preferable because guide wire operation is facilitated and deformation of the inner layer at the time of heat welding in the manufacturing process can be suppressed. Examples of the fluorine-based resin include polytetrafluoroethylene, polyvinylidene fluoride, ethylenetetrafluoroethylene, perfluoroalkoxy resin, and the like. Among these, polytetrafluoroethylene is more preferable.
Although it does not specifically limit as thickness of the inner layer 8 and the inner layer 9, For example, it is preferable that it is 50 micrometers or less, and it is more preferable that it is 30 micrometers or less. Thereby, the diameter of the lumen can be reduced and the peripheral reachability can be improved. If the thicknesses of the inner layer 8 and the inner layer 9 exceed the aforementioned upper limit value, it is disadvantageous for reducing the diameter of the first lumen 2 and the second lumen 3.
Further, in order to make it possible to visually recognize the position and state of the catheter 1 during use, the constituent material of the inner layer 8 and the inner layer 9 includes, for example, platinum, gold, silver, tungsten or a metal powder of these alloys, barium sulfate, bismuth oxide, You may knead | mix the X-ray contrast agents like those coupling compounds.

(3) Reinforcing layer The reinforcing layer 12 is made of a linear body, and the constituent material of the linear body constituting the reinforcing layer 12 may be any material as long as it has sufficient rigidity to obtain a sufficient reinforcing effect. , For example, stainless steel, copper, tungsten, nickel, titanium, piano wire, Ni—Ti alloy, Ni—Ti—Co alloy, Ni—Al alloy, Cu—Zn alloy, Cu—Zn—X alloy (for example, X = Various metal materials such as superelastic alloys such as Be, Si, Sn, Al, and Ga), amorphous alloys, and polyesters such as polyethylene terephthalate, polyethylene naphthalate, and polybutylene terephthalate, and polyolefins such as polyethylene and polypropylene , Rigid polyvinyl chloride, polyamide, polyimide, polystyrene, thermoplastic polyurethane, polycarbonate Bonate, ABS resin, acrylic resin, polymethyl methacrylate, polyacetal, polyarylate, polyoxymethylene, high tensile polyvinyl alcohol, fluororesin, polyvinylidene fluoride, polytetrafluoroethylene, ethylene-vinyl acetate saponified product, polysulfone, polyethersulfone, Examples thereof include polyether ketone, polyphenylene oxide, polyphenylene sulfide, polymer alloy containing any of these, carbon fiber, glass fiber, or a combination of two or more thereof. Of these materials, stainless steel is preferred for reasons such as workability, economy, and lack of toxicity.
The cross-sectional shape of the linear body constituting the reinforcing layer 12 is not particularly limited, but is not limited to a circular shape, and may be a flat shape, that is, a ribbon shape (band shape). The thickness of the linear body only needs to be such that a necessary and sufficient reinforcing effect can be obtained in relation to the constituent material. For example, when the cross-sectional shape is circular, the diameter is about 10 to 100 μm. Is preferable, and 20-50 micrometers is more preferable. In the case of a ribbon, a width of about 50 to 500 μm and a thickness of about 10 to 100 μm are preferable.
The linear body may be either a single fiber or an aggregate of fibers (for example, a bundle of single fibers) made of the above materials, etc., and may be used alone or in a state where a plurality of fibers are bundled. Good.

(4) Outer layer The outer layer 10 and the outer layer 11 are provided outside the inner layer and / or the reinforcing layer, and cover the inner layer and / or the reinforcing layer. Further, in the present embodiment, the outer layer 10 and the outer layer 11 are made of outer layers having different hardnesses, the outer layer of the hand portion is formed of a resin having a high shore hardness (hard), and the shore hardness gradually increases from the hand portion to the tip portion. By forming with a low (soft) resin and changing the length of each hardness, the rigidity balance of the first lumen 2 and the second lumen 3 can be set in various ways. Ease is improved.
Examples of the constituent material of the outer layer 10 and the outer layer 11 include polyolefins such as polypropylene, polyethylene, and ethylene-vinyl acetate copolymer, polyesters such as polyamide, polyethylene terephthalate, and polybutylene terephthalate, polyurethane, polyvinyl chloride, and polystyrene. Various flexible resins such as resin, fluorine-based resin such as ethylene-tetrafluoroethylene copolymer, polyimide, polyamide elastomer, polyester elastomer, polyurethane elastomer, polystyrene elastomer, fluorine-based elastomer, silicone rubber, latex rubber, etc. Various elastomers or a combination of two or more of these can be used.

Here, the polyamide elastomer is, for example, nylon 6, nylon 64, nylon 66, nylon 610, nylon 612, nylon 46, nylon 9, nylon 11, nylon 12, N-alkoxymethyl modified nylon, hexamethylenediamine-isophthalic acid. Typical block copolymers include polycondensates, various aliphatic or aromatic polyamides such as metaxyloxydiamine-adipic acid polycondensate as hard segments, and polymers such as polyester and polyether as soft segments. In addition, a polymer alloy (polymer blend, graft polymerization, random polymerization, etc.) of the polyamide and a flexible resin, a softened polyamide with a plasticizer or the like, and a concept including a mixture thereof It is.
The polyester elastomer is typically a block copolymer of a saturated polyester such as polyethylene terephthalate or polybutylene terephthalate and a polyether or polyester. In addition, the polymer alloy or the saturated polyester may be used as a plasticizer. It is a concept that includes a softened material and a mixture thereof. The constituent materials of the outer layer 10 and the outer layer 11 may be the same as or different from those of the inner layer 8 and / or the inner layer 9, and the outer layer 10 and the outer layer 10 and the inner layer 9 may be visually recognized in X-ray fluoroscopy at the time of use. In the constituent material of the outer layer 11, for example, an X-ray contrast agent such as metal powder of platinum, gold, silver, tungsten or an alloy thereof, barium sulfate, bismuth oxide or a coupling compound thereof may be kneaded. Good.

(5) Radiopaque marker The catheter 1 is disposed on the proximal side of the first radiopaque marker part 21 disposed at the distal end of the first lumen 2 and the first radiopaque marker part 21. The second X-ray opaque marker part 22 and the third X-ray opaque marker part 23 arranged around the distal end of the second lumen 3 are each provided with one or more markers. As a result, the position and state of the first lumen, the position of the tip opening of the second lumen 3 and the direction thereof can be visually recognized, and the safety is further enhanced. Furthermore, the length of the lesion can be measured by a plurality of markers, and the procedure can be performed quickly and easily.

The radiopaque marker constituting each marker portion is a metal tube made of a metal having radiopacity, and is fixed by caulking on the inner layer 8, the inner layer 9, or the reinforcing layer 12. The thickness of the metal is preferably about 5 to 60 μm, and may be cut in order not to reduce the flexibility of the tip portions of the first lumen 2 and the second lumen 3.
Further, as the radiopaque marker, a radiopaque metal element wire may be wound on the inner layer 8, the inner layer 9 or the reinforcing layer 12 in a coil shape. The cross-sectional shape of the radiopaque metal wire is not particularly limited, but is not limited to a circle, and may be a flat shape, that is, a ribbon shape (band shape). When the cross-sectional shape is circular, the diameter is preferably about 5 to 60 μm. In the case of a ribbon, it is preferable that the width is about 10 to 120 μm and the thickness is about 5 to 60 μm.
In addition, as a radiopaque marker, a radiopaque metal thin plate having a cut from both sides of a square may be wound around the inner layer 8, the inner layer 9, or the reinforcing layer 12. When using a metal thin plate, it is preferable that the thickness shall be about 5-60 micrometers. The metal thin plate is provided with suitable flexibility by making a cut.
As the material of the radiopaque metal tube, the wire, and the thin plate, tungsten metal, platinum metal, and gold metal can be used. Tungsten metal is pure tungsten, W-45Mo alloy, W-5Mo-5Ni (Co, Fe) alloy, W-Re alloy, W-ThO ₂ alloy, and alloys of tungsten, copper, carbon, etc. Represents this. The platinum-based metal represents platinum or an alloy of platinum and tungsten, rhodium, iridium, osmium, palladium, ruthenium, or the like. The gold-based metal represents pure gold or an alloy of gold and copper, silver, rhodium, iridium, osmium, palladium, ruthenium, or the like.

  In addition, as a radiopaque marker, a resin tube kneaded with radiopaque metal powder such as barium sulfate, bismuth oxide, bismuth subcarbonate, bismuth tungstate, bismuth-oxychloride, tungsten, gold, platinum, etc. You may arrange | position on the inner layer 8, the inner layer 9, or the reinforcement layer 12. FIG. The resin used here is preferably the same as that used for the outer layer 10 and the outer layer 11 described above. In this arrangement, the resin tube kneaded with the radiopaque metal powder may be cut and arranged. The thickness of the resin tube kneaded with the radiopaque metal powder is preferably about 5 to 60 μm.

(6) Hydrophilic coating In this embodiment, it is preferable that the outer surface of the catheter 1 is covered with a hydrophilic (or water-soluble) polymer substance. Thereby, when the outer surface of the catheter 1 comes into contact with blood, physiological saline, or the like, the friction coefficient is reduced and lubricity is imparted, and the slidability of the catheter 1 is further improved. Followability, kink resistance and safety are further enhanced.
Examples of the hydrophilic polymer substance include the following natural or synthetic polymer substances or derivatives thereof. In particular, cellulosic polymer materials (eg, hydroxypropyl cellulose), polyethylene oxide polymer materials (polyethylene glycol), maleic anhydride polymer materials (eg, maleic anhydride such as methyl vinyl ether maleic anhydride copolymer) Copolymers), acrylamide polymer substances (for example, polyacrylamide), and water-soluble nylon are preferable because a low coefficient of friction can be stably obtained.

2. The marker placement catheter 1 can identify the most advanced position of the catheter 1 under fluoroscopy by arranging the first radiopaque marker portion 21 as shown in FIG.
FIG. 2 shows an example in which a plurality of markers are arranged in the second radiopaque marker portion 22 as an embodiment. By arranging a plurality of markers, it becomes easy to measure the lesion length. In addition, it is preferable to arrange a plurality of markers at equal intervals because the length of the lesion can be accurately measured like a ruler.
The distance between the markers included in the second X-ray opaque marker part 22 and / or the third X-ray opaque marker part 23 is visually easy for the size range of the measurement target and / or the operator. It may be set appropriately in advance according to the thickness, number, interval, etc. of the markers that can be identified. Specifically, each marker is generally provided at intervals of 3 mm, 5 mm, 10 mm, and the like.

2-1. Marker part placement variation 1
FIGS. 3 and 4 are uniaxial cross-sectional schematic views showing the overall structure of catheters of other embodiments, respectively. As shown in FIG. 3, it is possible to arrange a plurality of markers in the third radiopaque marker portion 23, and it becomes easy to measure the lesion length by arranging a plurality of markers. ,preferable. In addition, it is preferable to arrange a plurality of markers at equal intervals because the length of the lesion can be accurately measured like a ruler.

2-2. Marker part placement variation 2
As shown in FIG. 4, each marker included in the second X-ray opaque marker portion 22 is coaxially arranged from the first X-ray opaque marker portion 21 in the longitudinal direction of the catheter, and the first X-ray opaque marker portion 21 is arranged on a different axis. By disposing each marker included in the three X-ray opaque marker part 23, the position and direction of the first tip side opening 4 can be specified. Further, in the embodiment shown in FIG. 4, each marker included in the second X-ray opaque marker portion 22 and each marker included in the third X-ray opaque marker portion 23 are arranged in parallel in the catheter axial direction. Since they are not arranged, the marker is included in the second X-ray opaque marker part 22 or the third X-ray opaque marker part 23 as compared with the case where both are arranged in parallel in the catheter axial direction. Can be easily identified. As a result, not only the position of the second lumen 3 in the axial direction but also the position of the second lumen 3 on the rotation axis of the catheter can be identified. Specifically, for example, as shown in FIG. 5, when the guide wire 32 is passed through the first lumen 2 and disposed from the second distal end side opening 6 to the lesioned side branch, the second distal end side opening 6 is It is possible to confirm at which angle the position is relative to the catheter axial direction, for example, whether or not the second distal end side opening 6 faces the side branch.

2-3. Marker part placement variation 3
The second X-ray opaque marker part 22 and the third X-ray opaque marker part 23 may be arranged in any way with respect to the axial direction of the catheter, but as shown in FIG. By arranging each marker included in the X-ray opaque marker portion 22 and each marker included in the third X-ray opaque marker portion 23 alternately with respect to the axial direction, the scale becomes easy to read and measurement is performed. This is preferable because mistakes can be prevented. For example, by increasing the visibility of the scale, it becomes easier to determine the position of the marker corresponding to the position of the measuring object from the distal end side of the catheter.
In the concept that “the scales included in the scale part are formed in a predetermined order with respect to the axial direction of the catheter”, as shown in FIG. The case where it arrange | positions in the order of the marker contained in the marker part 22, the marker contained in the 3rd X-ray opaque marker part 23, and the marker contained in the 2nd X-ray opaque marker part 22 is included. In addition, the order of X markers included in the second X-ray opaque marker portion 22 and Y markers included in the third X-ray opaque marker portion 23 in the catheter axial direction (X and Y are, for example, 1 Also, the above concept is included in the case of arranging with an integer of 2, 3, etc.).

2-4. Marker part placement variation 4
As another embodiment, as shown in FIG. 6, the length (or the length and thickness of the marker) of each marker included in the second X-ray opaque marker portion 22 in the catheter axial direction and the third X-ray opaque By making the length of each marker included in the transparent marker portion 23 in the catheter axial direction (or the length and thickness of the marker) different, it is possible to prevent erroneous reading of the scale. Specifically, it becomes possible to more easily determine which marker position the target position corresponds to from the tip. Furthermore, not only the position of the second lumen 3 in the axial direction but also the position of the second lumen 3 on the rotation axis of the catheter can be easily identified, and the second distal end side opening 6 is positioned in the catheter axial direction. Since it is possible to confirm at which angle the position is, the guide wire can be accurately inserted into the side branch, for example.

2-5. Marker part placement variation 5
As another embodiment, as shown in FIG. 7, two or more markers are arranged as the second X-ray opaque marker part 22 between the markers at both ends included in the third X-ray opaque marker part 23. Also good. Alternatively, two or more markers may be arranged as the third X-ray opaque marker portion 23 between the markers at both ends included in the second X-ray opaque marker portion 22.
In this case, the third X-ray opaque marker part 23 (or the second X-ray opaque marker part 22) shows a large scale (large scale), and the second X-ray opaque marker part 22 (or the third X-ray opaque part). Since the transparent marker portion 13) shows a more detailed scale (small scale), accurate measurement is possible. For example, a marker is provided every 5 mm as a large scale, and a marker is provided every 2.5 mm as a small scale.

2-6. Marker part placement variation 6
As shown in FIG. 8 as another embodiment, the first X-ray opaque marker part 21, the second X-ray opaque marker part 22, and the third X-ray opaque marker part 23 may be arranged on the same axis. Is possible. This makes it possible to reduce the rigidity of the catheter shaft. Furthermore, compared with the case where a marker is arrange | positioned to several lumen | bore, manufacture of a catheter becomes easy.

  Specific examples of the present invention will be described in detail below, but the present invention is not limited to the following examples.

(Catheter manufacturing method)
Polytetrafluoroethylene was extrusion-coated on a silver-plated annealed copper wire metal core having a diameter of 0.42 mm to form an inner layer 8 and an inner layer 9 having a thickness of 20 μm on the outer periphery of the metal core. The outer surface of the inner layer 9 was defluorinated with a solution composed of sodium naphthalene and dimethyl ether. Next, a reinforcing layer 12 was formed by braiding the inner layer 9 and a linear body of stainless steel (SUS304) having a diameter of 20 μm on the outer peripheral portion of the inner layer 9 and a structure having two ends and 16 strokes using a braider.

  A first X-ray opaque marker portion is formed by fixing a first X-ray opaque marker made of a platinum-iridium alloy (iridium content of 10 wt%) at a position 3 mm from one end of the inner layer 8 provided with the reinforcing layer 12. At the same time, a second X-ray opaque marker made of a platinum-iridium alloy (iridium content 10 wt%) was fixed at the positions of 8 mm, 13 mm, 18 mm, and 23 mm (the second X-ray opaque marker portion was formed by fixing the outside). Further, the reinforcing layer 12 on the tip side from the first X-ray opaque marker was removed to expose the inner layer 9. Next, hollow tubes having various hardnesses forming the outer layer 11 were formed by a hollow extrusion method. The outer layer hardness was increased from the distal end side to the proximal end side, and a heat shrinkable tube was further covered on the inner layer 9 provided with the reinforcing layer 12 and then covered with a heater at 200 ° C. It was heated for 2 minutes, and at the same time to melt adhesion of the adjacent regions to each other, are integrated inner layer 9 and the reinforcing layer 12 and the outer layer 11 to form a first lumen 2.

A third X-ray opaque marker made of a platinum-iridium alloy (iridium content: 10 wt%) is fixed at a position 0.5 mm from one end of the inner layer 9 provided with the reinforcing layer 12, and the tip side is closer to the X-ray opaque marker. The reinforcing layer 12 was removed, and the inner layer 9 was exposed. Next, hollow tubes having various hardnesses for forming the outer layer 11 are formed by the hollow extrusion molding method, and the outer layer hardness is formed on the inner layer 9 including the reinforcing layer 12 from the distal end side to the proximal end side. It was covered so that it would be higher. Further, a heat shrinkable tube was placed thereon. And it heated at 200 degreeC for 2 minute (s) with the heater, the adjacent area | region was melt | dissolved and adhered, and the inner layer 9, the reinforcement layer 12, and the outer layer 11 were integrated, and the 2nd lumen | rumen 3 was formed.
A heat-shrinkable tube was placed over the first lumen 2 and the second lumen 3, and these were integrated to create a catheter.

(Catheter safety)
According to the catheter of the above embodiment, Conquest Pro 8-20 (manufactured by Getz Brothers), which is a guide wire often used in the treatment of stenotic lesions, is inserted with the catheter bent, and the tip of the guide wire is inserted into the catheter. It was confirmed that it could be used safely and easily without penetrating the lumen.

  On the other hand, in the catheter manufactured by the same method as the catheter of the above example without forming the reinforcing layer 12 on the inner layer 8 and the inner layer 9, the distal end of the guide wire penetrated the lumen with a curvature radius of 20 mm.

(Catheter function)
According to the catheter of the above embodiment, the drug and / or contrast agent can be accurately injected into the affected area from the distal end side opening of the first lumen. That is, the positional relationship between the injection port and the affected part can be specified by the third X-ray opaque marker part (corresponding to the marker part 23 in FIG. 2).

  According to the catheter of the embodiment, it becomes possible to measure the distance between the bifurcation and the distal end lesion of the main trunk, and as a result, the size selection of the Y-type stent placed in the bifurcation stenosis lesion becomes easy. .

FIG. 1 is a schematic diagram showing the overall structure of a catheter according to an embodiment of the present invention. FIG. 2 is a uniaxial cross-sectional schematic diagram showing the overall structure of the catheter of the embodiment of the present invention. FIG. 3 is a uniaxial cross-sectional schematic diagram showing the overall structure of a catheter according to another embodiment. FIG. 4 is a uniaxial cross-sectional schematic diagram showing the overall structure of a catheter according to another embodiment. FIG. 5 is a schematic view showing an example of use of a catheter according to another embodiment. FIG. 6 is a uniaxial cross-sectional schematic diagram showing the overall structure of a catheter according to another embodiment. FIG. 7 is a uniaxial cross-sectional schematic diagram showing the overall structure of a catheter according to another embodiment. FIG. 8 is a uniaxial cross-sectional schematic diagram showing the overall structure of a catheter according to another embodiment. FIG. 9 is a cross-sectional view of a portion including the first radiopaque marker of the catheter of the embodiment. FIG. 10 is a cross-sectional view of a portion including the second radiopaque marker of the catheter of the embodiment. FIG. 11 is a cross-sectional view of a portion including the third radiopaque marker of the catheter of the embodiment.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Catheter 2 1st lumen 3 2nd lumen 4 1st front end side opening part 5 1st base end side opening part 6 2nd front end side opening part 7 1st lumen front end part 8 1st lumen inner layer 9 2nd lumen inner layer 10 1st One lumen outer layer 11 Second lumen outer layer 12 Reinforcing layer 21 First X-ray opaque marker portion 22 Second X-ray opaque marker portion 23 Third X-ray opaque marker portion 31, 32 Guide wire

Claims (8)

A first lumen and a second lumen, wherein at least the second lumen is composed of an inner layer, a reinforcing layer, and an outer layer, and an X-ray opaque marker is provided at each of the distal end portions of the first lumen and the second lumen. Is a catheter characterized in that one or more are arranged,
The first lumen has a distal end side opening and a proximal end side opening at its distal end and proximal end,
The distal end side opening of the first lumen is located at the tip of the second lumen at the most distal end, or is projected to the tip side from the most distal portion,
The proximal end opening of the first lumen is located at the proximal end end of the second lumen or at the distal end;
The catheter is characterized in that at least the second lumen is configured to increase in rigidity continuously or stepwise toward the proximal side. The first lumen has a first X-ray opaque marker portion capable of specifying the first lumen distal end at a distal end portion thereof, and a second X-ray opaque marker at a proximal end side with respect to the distal end portion of the first lumen. And
The second lumen has a third X-ray opaque marker part capable of specifying the position of the tip side opening at the tip part,
The second X-ray opaque marker part forms a second scale part by the X-ray opaque marker by providing a plurality of X-ray opaque markers,
The third X-ray opaque marker part includes a plurality of X-ray opaque markers to form a third scale part by the X-ray opaque marker,
2. Each of the scales included in the second scale part and each of the scales included in the third scale part is formed at a position that is not side by side at least partially in the axial direction of the catheter. The catheter described. The first lumen has a first X-ray opaque marker portion capable of specifying the first lumen distal end at a distal end portion thereof, and a second X-ray opaque marker at a proximal end side with respect to the distal end portion of the first lumen. And a third X-ray opaque marker part capable of specifying the second lumen tip,
The second X-ray opaque marker part forms a second scale part by the X-ray opaque marker by providing a plurality of X-ray opaque markers,
2. The catheter according to claim 1, wherein the third X-ray opaque marker portion includes a plurality of X-ray opaque markers to form a third scale portion by the X-ray opaque marker.   The catheter according to claim 1, wherein the central axis of the distal end portion of the second lumen is curved away from the central axis of the first lumen in the radial direction of the first lumen. .   The catheter according to any one of claims 1 to 4, wherein the material of the outer layer of the first lumen and the second lumen is formed of a material selected from low-density polyethylene, polyamide elastomer, and polyamide. The material for the inner layer of the first lumen and the two lumen is formed of a material selected from high density polyethylene, polytetrafluoroethylene, and a tetrafluoroethylene-perfluoroalkyl vinyl ether copolymer. ~ 5 catheter.   The catheter according to claim 1, wherein the first lumen and the second lumen have a distal inner diameter of 50 to 100% of a proximal inner diameter.   The catheter according to each of claims 1 to 7, wherein a hydrophilic coating is applied from the distal end portion to the proximal end side of the catheter.

Images