JP2006122551A - Catheter - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a catheter improved in pushability, particularly kink resistance, while maintaining crossability and trackability, and dispensing with a complicated process. <P>SOLUTION: This catheter to be inserted into an organism lumen has a rear end side shaft 501 having a distal section and a proximal section, and a tip side shaft 502 having a distal section and a proximal section, wherein the proximal section of the shaft 502 is joined to the distal section of the rear end side shaft 501. The tip side shaft 502 has a guide wire lumen 503 having a proximal side aperture part 504 and a distal side aperture part on the distal side rather than the distal end of the rear end side shaft 501 to follow a guide wire, and an intermediate part 505 between the proximal side aperture part 504 of the guide wire lumen and the distal end of the rear end side shaft. At least a part of the intermediate part 505 is formed of a double tube structure comprising an outer tube 506 formed of a polymeric material, and an inner tube 507 formed of a polymeric material and existing in the inner void of the outer tube. <P>COPYRIGHT: (C)2006,JPO&NCIPI

Description

  The present invention relates to a catheter that is percutaneously transluminally introduced into a body to treat or diagnose a lumen in the body.

  In recent years, surgery that treats a lesion by inserting a catheter into a body lumen percutaneously and transluminally without performing a surgical operation has come to be used. Here, an example is an angioplasty (PTCA: Percutaneous Transluminal Coronary Angioplasty) performed to improve blood flow on the peripheral side of the coronary artery. A balloon catheter used for PTCA is used in a set of a guide catheter and a guide wire mainly for dilating a stenosis site or an occlusion site of a blood vessel. In this angioplasty using a balloon catheter, a guide catheter is first inserted from the femoral artery, the tip is positioned at the entrance of the coronary artery via the aorta, and then the guide wire penetrating the balloon catheter is connected to the stenosis site of the blood vessel or Advancing beyond the occlusion site, then advancing the balloon catheter along the guide wire, inflating the balloon with the balloon positioned at the stenosis site or occlusion site, and expanding the stenosis site or occlusion site; and The balloon is deflated and removed from the body. This balloon catheter is not limited to treatment of a stenosis or occlusion site of a blood vessel, but is useful for many medical applications including insertion into a blood vessel and insertion into various body cavities and tubular tissues.

  As another example, in order to prevent the peripheral blood vessel from being blocked, the peripheral blood vessel of the blood vessel that becomes the lesion is temporarily blocked, and the angioplasty of the lesion is performed in that state. Examples include balloon catheters. As an embodiment of the temporary occlusion balloon catheter, the shaft of the temporary occlusion balloon catheter is used as a guide wire, and other treatment catheters, for example, a balloon catheter for vasodilation, etc., travel along the shaft of the temporary occlusion balloon catheter and the lesioned part Until inserted. Thereafter, the temporary occlusion balloon catheter is expanded at the periphery of the lesion, and the lesion is treated with the blood flow blocked.

  These catheters are roughly classified into two types according to the shaft structure. One is an over-the-guide wire lumen that is provided from the proximal end side to the distal end side of the catheter, that is, the entire length of the catheter, and a proximal opening of the guide wire lumen is provided at the proximal end of the catheter. A wire type (OTW type), and another is a high-speed exchange type in which a guide wire lumen is provided only on the distal end side of the catheter, and a proximal opening of the guide wire lumen is provided in the middle of the catheter shaft ( RX type).

  The catheter is not limited to the balloon catheter used for these PTCA and the balloon catheter for temporary occlusion, and the catheter is required to have an operability capable of being inserted into a very fine and complex blood vessel diameter with quick and reliable selectivity. The main performance required for such a catheter is that it can pass through a stenosis site, that is, crossability, followability to a bent blood vessel, that is, trackability, and insert a medical balloon catheter into the blood vessel. It can be roughly divided into three types of force transmission, that is, pushability. Also, kink-resistance can be cited as a performance related to pushability.

  Although the crossability is improved by reducing the profile (thickness) of the catheter shaft, the pushability and kink resistance tend to decrease. In addition, pushability and kink resistance are improved by increasing the rigidity of the catheter shaft, but trackability tends to decrease. That is, the above performances are closely related to each other, and it is not easy to improve all the performances.

  Generally, the rear end side shaft of the catheter is composed of a resin tube or metal tube having high rigidity in order to improve pushability. The distal shaft of the catheter is composed of a resin tube with low rigidity in order to improve trackability to a highly bent body lumen. Therefore, the rigidity of the intermediate portion corresponding to the joint between the rear end side shaft and the front end side shaft is very important for the performance of the catheter. In particular, the above-mentioned RX type catheter has a guide wire lumen only on the distal end side of the catheter, unlike the OTW type catheter. For this reason, it is difficult to adjust the rigidity of the distal end side where the guide wire exists, the intermediate portion where the guide wire does not exist, and the rigid rear end side shaft during treatment. Various techniques have been disclosed for adjusting the rigidity and the like of the intermediate portion to improve the crossability, the pushability, the trackability, and the kink resistance.

  In Patent Document 1, a transition portion extending from the distal side of the proximal lumen opening of the guide wire lumen to the vicinity of the distal end of the first shaft portion (the rear end side shaft in the present invention) is the first shaft portion. A balloon dilatation catheter having a rigidity between the rigidity and the rigidity of the second shaft portion (the distal shaft in the present invention) is disclosed.

  In this prior art, a catheter shaft having improved kink resistance is provided, and the improvement of kink resistance is realized by providing a coil-shaped member as a deformation preventing structure on the second shaft. By providing the coil-shaped member, the man-hours for manufacturing the catheter are extremely increased, and at the same time, the assembling method is complicated, resulting in an increase in manufacturing cost. In addition, there is a problem that the transition portion exists to the distal side of the proximal lumen opening of the guide wire lumen, the vicinity of the proximal lumen opening becomes very hard, and the trackability is lowered.

  Further, in Patent Document 2, a main shaft (rear end side shaft in the present invention), a balloon, a plastic shaft portion between the main shaft and the balloon (front end side shaft in the present invention), a plastic attached to the main shaft in a proximal direction. An intravascular catheter is disclosed that includes an intermediate member that extends into the shaft portion and is less stiff than the main shaft portion and a guide wire lumen, the guide wire inlet being spaced proximally from the proximal end of the main shaft portion. ing.

  In this prior art, an intravascular catheter having improved pushability and trackability and at the same time improved kink resistance is provided. However, kink resistance when an intravascular catheter is inserted into a guide catheter along a guide wire is provided. Is hard to say. To further improve kink resistance, it is necessary to increase the diameter of the core wire used as a non-rigid intermediate member, but to ensure an effective inflation lumen, the catheter shaft profile must be increased. This is necessary, and there is concern about the loss of crossability and trackability. Further, when the kink resistance is improved by the core wire, the difference between the outer diameter of the core wire and the inner diameter of the plastic shaft portion is large, and only the plastic shaft portion may be kinked. In this case, the catheter may be directional depending on the position of the core wire in the radial direction of the catheter. That is, the kink resistance in a certain direction of the catheter is different from the kink resistance in the opposite direction.

  Moreover, in patent document 3, the catheter with an expansion body which has a rigidity provision body which provides rigidity while giving an axial direction to an outer tube, and has a part which does not have a rigidity provision body at the front-end | tip of this outer tube is provided. It is disclosed.

  In this prior art, the outer tube having high trackability has a rigidity imparting body to improve kink resistance. However, when the outer tube itself has high kink resistance, or a metal wire is provided in the lumen of the outer tube. In the case of having high kink resistance by providing a reinforcing member such as the above, the rigidity of the outer tube is partially improved, and it is difficult to improve the kink resistance of the entire catheter shaft. In addition, in the prior art, an example in which a wire blade is embedded in a resin outer tube is presented, and there are problems such as an increase in manufacturing steps and an increase in manufacturing cost.

  Patent Document 4 discloses a catheter having a double tube structure in which an outer tube and an inner tube are in close contact with each other, and an outer diameter gradually decreasing toward the distal end of the catheter.

In this prior art, the bending elastic modulus of the inner tube is larger than the bending elastic modulus of the outer tube, and the distal end portion of the catheter has only the outer tube, thereby improving the trackability and kink resistance. There has been a problem of increased manufacturing costs due to complicated processes such as close contact of the outer tube and gradual reduction of the outer diameter.
Japanese Patent No. 2933389 Special table hei 6-507105 Japanese Patent Publication No.4-44553 JP-A-5-253304

  In view of these circumstances, the present invention aims to provide a catheter that improves pushability and particularly kink resistance while maintaining crossability and trackability, and does not require a complicated process. It is in.

  The present invention is a catheter for insertion into a living body lumen, comprising a rear end side shaft having a distal portion and a proximal portion, a distal portion and a proximal portion, and the proximal portion being A distal end shaft that is joined to a distal portion of the rear end side shaft, and the distal end shaft has a proximal side opening and a distal side distal to the distal end of the rear end side shaft; A guide wire lumen having a distal opening for following the guide wire; and an intermediate portion between the proximal opening of the guide wire lumen and the distal end of the rear shaft. And at least a part of the intermediate portion has a double tube structure including an outer tube made of a polymer material and an inner tube made of a polymer material present in the lumen of the outer tube. preferable. According to such a structure, by adjusting the rigidity of the intermediate part and making the distribution of the rigidity of the catheter continuous, the pushability and especially the kink resistance are improved while maintaining the crossability and the trackability. In addition, since the rigidity can be controlled by a combination of the inner tube and the outer tube, a catheter that does not require a complicated process can be manufactured. Further, it is preferable that a balloon for expanding or closing a living body lumen is provided outside the distal end side shaft, and the balloon is located more distally than the proximal opening of the guide wire lumen. Preferably there is. With these structures, the guide wire penetrates the balloon, and the crossability can be improved. Furthermore, the balloon is preferably located proximal to the proximal opening of the guidewire lumen. In the case of a temporary occlusion balloon catheter or the like, the blood flow can be completely occluded by such a structure. It becomes possible.

  The outer tube and the inner tube are preferably not directly joined, and the outer tube and the inner tube are preferably made of different polymer materials. According to such a structure, it is possible to select a desired rigidity and profile, and it is possible to reduce an increase in the profile of the catheter at each joint.

  Moreover, it is preferable that the outer tube and a part of the inner tube are joined, and it is more preferable that the proximal portion of the outer tube and the proximal portion of the inner tube are joined. The outer tube and the inner tube are preferably made of the same polymer material. According to these structures, when joining the outer tube and the inner tube, it is possible to easily join by a method such as welding, it is possible to reduce the profile, and further, the rigidity at the joint between the outer tube and the inner tube is reduced. Since the improvement is performed on the proximal side of the distal shaft, the rigidity distribution of the catheter can be made more continuous.

  The inner pipe is preferably joined to the rear end side shaft. With this structure, the distribution of the rigidity of the catheter can be made more continuous.

  The polymer material may be one or more selected from the group consisting of polyimide, polyamide, polyurethane, polyester, polyolefin, polytetrafluoroethylene, silicon rubber, polyamide elastomer, polyester elastomer, polyolefin elastomer or polyurethane elastomer. Preferably, the polymer material is made of a polyamide-based elastomer.

  Moreover, it is preferable to have a part in which the said inner tube does not exist in the distal part of the said intermediate part. With this structure, the distribution of the rigidity of the catheter can be made more continuous.

  Further, it is preferable to have a metal core wire over the entire length of the intermediate portion, and at least a part of the metal core wire has a tapered shape such that the outer diameter decreases toward the distal side. Is more preferable. Furthermore, it is preferable that a proximal portion of the metal core wire is joined to the rear end side shaft. With these structures, it becomes possible to make the distribution of rigidity of the catheter more continuous.

  Further, the rear end side shaft is preferably made of metal, and the rear end side shaft is one or more selected from the group consisting of stainless steel, Ni—Ti alloy, Co—Cr alloy, or a composite thereof. It is more preferable. With these structures, it is possible to make the distribution of rigidity throughout the catheter more continuous.

  Moreover, it is preferable that the said rear end side shaft is 1 or more types chosen from the group which consists of a polyimide, polyetheretherketone, polyamide, and a polyamide-type elastomer, or those composites.

  As described above, in the catheter of the present invention, at least a part of the intermediate portion existing between the distal end portion of the rear end side shaft and the proximal opening portion of the guide wire lumen is formed by the lumen of the outer tube and the outer tube. By providing a double-tube structure consisting of the inner tube existing in the catheter, pushability and particularly kink resistance are improved while maintaining the crushability and trackability, and a catheter that does not require complicated processes is provided. It becomes possible to do.

  The catheter according to the present invention will be described below. The catheter according to the present invention relates to an RX type in which a guide wire lumen is provided only on the distal end side of the catheter, and a proximal opening of the guide wire lumen is provided in the middle of the catheter shaft. The present invention is a catheter for insertion into a living body lumen, comprising a rear end side shaft having a distal portion and a proximal portion, a distal portion and a proximal portion, and the proximal portion being A distal end shaft that is joined to a distal portion of the rear end side shaft, and the distal end shaft has a proximal side opening and a distal side distal to the distal end of the rear end side shaft; A guide wire lumen having a distal opening for following the guide wire; and an intermediate portion between the proximal opening of the guide wire lumen and the distal end of the rear shaft. And at least a part of the intermediate portion has a double tube structure including an outer tube made of a polymer material and an inner tube made of a polymer material existing in the lumen of the outer tube. A catheter is provided. According to these structures, by adjusting the rigidity of the middle part and making the distribution of the rigidity of the catheter continuous, the pushability and particularly the kink resistance are improved while maintaining the crossability and the trackability, In addition, since the rigidity can be controlled by a combination of the inner tube and the outer tube, a catheter that does not require a complicated process can be manufactured. Also, until the outer tube and the inner tube are in contact, the rigidity of the catheter is only that of the outer tube, and when the outer tube and the inner tube are in contact, the rigidity of the catheter is that of a double tube. By setting the positional relationship and dimensions, it is possible to easily adjust the point at which the rigidity changes with respect to the bending of the shaft. Furthermore, unlike the case of securing rigidity with a core wire, the difference between the inner diameter of the outer tube and the outer diameter of the inner tube can be made relatively small, and there is little possibility that only the outer tube will be kinked. It is possible to have the same kink resistance in any direction. The present invention relates to a catheter for insertion into a living body lumen, and particularly relates to an RX type in which a guide wire lumen is provided only on the distal end side of the catheter, and a proximal end opening of the guide wire lumen is provided in the middle of the catheter shaft. However, its structure is not limited. That is, as shown in FIGS. 1 and 2, the inner tubes 105 and 205 and the outer tubes 106 and 206 exist in a coaxial double tube, and the guide wire lumens 101 and 201 inside the inner tubes 105 and 205 and the outer tube 106, The other lumens 102 and 202 inside 206 may have a coaxial structure, and the guide wire lumens 301 and 401 and the other lumens 302 and 402 are arranged as shown in FIGS. 3 and 4. A bi-axial structure arranged in parallel may be used. Further, the catheter may or may not have the balloons 103 and 303 for expanding or closing the living body lumen. When the catheter has the balloons 103 and 303, the balloons 103 and 303 are guides. The wire lumen may be located more distally than the proximal openings 104, 304, or may be present proximally. When the catheter has a balloon, the outer diameter of the balloon portion is generally larger than the outer diameter of the distal shaft, so that the catheter has a higher pushability and resistance than a catheter without a balloon when inserted into a lesion. Kink properties are required. Therefore, in a catheter having a balloon, these structures are more effective. Such catheters with or without balloons include PTCA catheters, PTA catheters, temporary occlusion balloon catheters, drug infusion catheters, etc., but their structures are not limited at all.

  One embodiment of the intermediate portion of the catheter according to the present invention is shown in FIG. The catheter shown in FIG. 5 has a rear end side shaft 501, a front end side shaft 502, and a guide wire lumen 503. Between the distal end of the rear end side shaft 501 and the proximal opening 504 of the guide wire lumen. The intermediate portion 505 has a double tube structure in which a portion of the intermediate portion 505 includes an outer tube 506 and an inner tube 507. The guide wire lumen 503 is formed inside the guide wire lumen tube 512. The outer tube 506 is a part of the front end side shaft 502, and the outer tube 506 and the rear end side shaft 501 are joined by a method well known to those skilled in the art (for example, adhesion). The distal end of the outer tube 506 may be near the proximal opening 504 of the guidewire lumen and may be as far as the distal side of the distal shaft 502. The outer tube 506 and the inner tube 507 in the intermediate portion 505 may be made of different polymer materials. By using different polymer materials, it is possible to select a desired rigidity and profile. Further, the outer tube 506 and the inner tube 507 in the intermediate portion 505 may not be directly joined, and each may be joined to the rear end side shaft 501 by an individual method. According to such a structure, particularly when the outer tube 506 and the inner tube 507 are made of different polymer materials, it is possible to reduce an increase in the catheter profile at each joint. The distal portion of the intermediate portion 505 may have a portion that does not have the inner tube 507 and is not a double tube structure in order to make the distribution of the rigidity of the catheter continuous. The polymer material forming the outer tube 506 and the inner tube 507 is made of polyimide, polyamide, polyurethane, polyester, polyolefin, polytetrafluoroethylene, silicon rubber, polyamide elastomer, polyester elastomer, polyolefin elastomer or polyurethane elastomer. May be. Further, the inner tube 507 may have a thickness that decreases toward the distal side in order to continuously distribute the rigidity distribution of the catheter.

  Another embodiment of the intermediate portion of the catheter according to the present invention is shown in FIG. The catheter shown in FIG. 6 has a rear end side shaft 601, a front end side shaft 602, a guide wire lumen 603, and a core wire 608, and a part of the intermediate portion 605 is the outer tube 606 as in the catheter shown in FIG. And a double pipe structure having an inner pipe 607. The guide wire lumen 603 is formed inside the guide wire lumen tube 612. By having the metal core wire 608 in the intermediate portion 605, it becomes possible to make the distribution of the rigidity of the catheter more continuous. The core wire 608 is tapered so that a part of the core wire 608 has a smaller outer diameter toward the distal side, so that it is possible to further select a desired stiffness distribution. The core wire 608 is preferably joined to the rear end side shaft 601, and the joining method in this case is not limited (for example, welding, adhesion, etc.). Also, the distal portion of the core wire 608 extends to the proximal opening 604 of the guide wire lumen, which can make the stiffness distribution between the intermediate portion 605 and the guide wire lumen 603 more continuous. It becomes possible. At this time, the core wire 608 may be joined to the guide wire lumen 603 and the distal end side shaft 602 in the vicinity of the proximal opening 604 of the guide wire lumen by a method known to those skilled in the art (for example, adhesion, pressure bonding, etc.). . The material of the core wire 608 is preferably made of stainless steel, Ni—Ti alloy, or Co—Cr alloy in order to make the distribution of the rigidity of the catheter more continuous. It does not matter. The outer tube 606 and the inner tube 607 may be made of the same polymer material. By using the same polymer material, when the outer tube 606 and the inner tube 607 are joined, they can be easily joined by a method such as welding, and the profile can be reduced. In this case, the outer tube 606 and the inner tube 607 may be joined to the distal portion or the proximal portion, and any portion of the intermediate portion thereof, but the proximal portion of the outer tube 606 and the proximal portion of the inner tube 607 may be joined. Are preferably joined, and more preferably joined on the rear end side shaft 601. According to this structure, the rigidity of the joint between the outer tube 606 and the inner tube 607 is improved on the rear end side shaft 601 with high rigidity, so that the distribution of the rigidity of the catheter can be made more continuous. It becomes possible. Considering the rigidity necessary for the catheter and the ease of joining, the polymer material forming the outer tube 606 and the inner tube 607 is preferably made of a polyamide-based elastomer. In the present embodiment, in the case of a structure that improves the continuity of the stiffness distribution using only the core wire 608 without the inner tube 607, it is necessary to further increase the outer diameter of the core wire 608. In the case of a general temporary occlusion balloon catheter, the rear end side shaft 601 is thin (outer diameter is about 0.35 mm), and it is extremely difficult to arrange the core wire 608 coaxially with the rear end side shaft 601. The end shaft 601 and the core wire 608 must be arranged in parallel. Therefore, if the outer diameter of the core wire 608 is increased, the profile of the catheter becomes very large, which causes a decrease in crossability and trackability. Further, by arranging the rear end side shaft 601 and the core wire 608 in parallel, the directivity in the radial direction of the catheter is more strongly generated.

  Another embodiment of the intermediate portion of the catheter according to the present invention is shown in FIG. The catheter shown in FIG. 7 includes a rear end side shaft 701, a front end side shaft 702, a balloon 709, a ring marker 710, a guide wire lumen 703, and a core wire 708, and the intermediate portion 705 is similar to the catheter shown in FIG. A part of the tube has a double tube structure having an outer tube 706 and an inner tube 707. The guide wire lumen 703 is formed inside the guide wire lumen tube 712. The balloon 709 is located more proximal than the proximal opening 704 of the guide wire lumen, and the temporary occlusion balloon catheter can completely occlude blood flow by such a structure. In the case of the balloon catheter for temporary occlusion, since it is generally inserted to the periphery rather than a normal catheter, especially the pushability and kink resistance improvement by such a structure are needed. The ring marker 710 is a marker made of a radiopaque material, is generally made of metal, and is placed inside the balloon 709 to confirm the position of the balloon 709 under fluoroscopy. A side hole 711 for expanding or contracting the balloon 709 exists inside the balloon 709. The outer tube 706 is joined to the guide wire lumen tube 712 at the guide wire lumen proximal opening 704 and the distal end of the outer tube 706 is near the guide wire lumen proximal opening 704. Thus, the absence of the outer tube 706 at the distal portion of the catheter makes it possible to reduce the rigidity of the distal portion of the catheter and improve crossability and trackability. In general, the rear end side shaft 701 of the catheter is composed of a resin tube or a metal tube having high rigidity. Therefore, the rigidity is distributed in a portion between the distal end of the rear end side shaft 701 and the metal ring marker 710. Tends to be discontinuous. This portion has a double tube structure composed of an outer tube 706 and an inner tube 707, and the distal end of the inner tube 707 is present in the ring marker 710 or on the distal end side of the ring marker 710, so that the distribution of rigidity is achieved. Can be made more continuous. The core wire 708 may have a tapered shape such that the outer diameter decreases toward the distal end side. The core wire 708 also extends to the proximal opening 704 of the guide wire lumen and is secured in a manner well known to those skilled in the art at the distal portion of the rear shaft 701 and the proximal opening 704 of the guide wire lumen. It is preferred that In this manner, the core wire 708 can be prevented from falling off by being fixed at a plurality of locations.

  Another embodiment of the intermediate portion of the catheter according to the present invention is shown in FIG. The catheter shown in FIG. 8 has a rear end side shaft 801, a front end side shaft 802, a balloon 809, a ring marker 810, and a guide wire lumen 803, and an intermediate portion 805 connects the outer tube 806 and the inner tube 807 over the entire length. It has a double tube structure. The guide wire lumen 803 is formed inside the guide wire lumen tube 812. The inner tube 807 is preferably secured in a manner well known to those skilled in the art at the distal portion of the rear shaft 801 and the proximal opening 804 of the guidewire lumen. Thus, the inner tube 807 exists up to the proximal opening 804 of the guide wire lumen, so that the rigidity of the intermediate portion 805 can be easily adjusted. As with the catheter shown in FIG. 7, the ring marker 810 is disposed inside the balloon and has a side hole 811 for expanding or deflating the balloon.

  The material of the rear end side shaft is not particularly limited. For example, polyimide, polyetheretherketone, polyamide, polyurethane, polyester, polyolefin, polytetrafluoroethylene, silicon rubber, polyamide elastomer, polyester elastomer, polyolefin Polymer materials such as elastomers or polyurethane elastomers, various metals, etc., or composites thereof can be used. However, in consideration of the balance of rigidity distribution in the whole catheter, pushability, trackability, etc., it is preferable that the metal tube is a stainless steel, Ni-Ti alloy, Ni-Ti- Fe alloy, Ni-Ti-Cu alloy, Ni-Ti-Cr alloy, Ni-Ti-V alloy, Ni-Ti-Co alloy, Ni-Ti-Nb alloy, Ni-Ti-Pd alloy, Ni-Ti-Cu More preferably, it is composed of one or more selected from the group consisting of a -Cr alloy, a Fe-Mn-Si alloy, and a Co-Cr alloy, or a composite thereof. In consideration of the rigidity and cost of the rear end side shaft itself, it is more preferably made of a composite of stainless steel and a Ni—Ti alloy. In addition, when using the above resin material as the rear end side shaft, taking into consideration the continuity of rigidity distribution in the entire catheter, a tube in which a core wire is arranged inside the rear end side shaft or a metal wire is embedded May be used to adjust the stiffness. The rear end side shaft and the front end side shaft may be coated, and the coating may be hydrophilic or hydrophobic such as silicone oil.

  Examples of the catheter according to the present invention will be described below in detail with reference to examples and comparative examples using a temporary occlusion balloon catheter, but the following examples do not limit the present invention.

(Example 1)
FIG. 9 shows the distal portion of the catheter in this embodiment. A metal tube made of stainless steel (SUS316L) having an outer diameter of 0.33 mm and an inner diameter of 0.25 mm was used as the rear end side shaft 901. A metal tube having a total length of 1800 mm was used, with one end as the proximal end and the other end as the distal end. A polyimide tube having an outer diameter of 0.44 mm, an inner diameter of 0.36 mm and a length of 15 mm was used as the inner tube 907 with one end as the proximal end and the other end as the distal end. A tube having an outer diameter of 0.78 mm, an inner diameter of 0.60 mm, and a length of 55 mm (Atokemi polyamide elastomer Pebax 7233) was used as an outer tube 906 with one end as a proximal end and the other end as a distal end. . A platinum ring marker 910 having an outer diameter of 0.85 mm, an inner diameter of 0.80 mm, and a length of 1 mm is placed at a position 10 mm from the distal end of the outer tube 906 (trade name “UR0531”; H And B. Fuller). The proximal portion of the inner tube 907 is covered with 5 mm on the distal portion of the rear end side shaft 901 and bonded using a two-component urethane adhesive, and further on the outer tube from the distal end of the rear end side shaft 901 to 13 mm. 906 was applied, and a 5 mm proximal portion of the outer tube 906 was adhered using a two-component urethane adhesive. A tube having an outer diameter of 0.56 mm, an inner diameter of 0.42 mm, and a length of 25 mm (Atokemi polyamide elastomer Pebax 7233) is used as a guide wire lumen tube 912 with one end as a proximal end and the other end as a distal end. used. A side hole is opened with a razor at a position about 35 mm from the proximal end of the outer tube 906, and heat welding is performed with the guide wire lumen tube 912 exposed on the outer surface of the outer tube 906 from there. After the distal opening 904 was produced, the distal end of the outer tube 906 and the distal portion of the guide wire lumen tube 912 were joined by thermal welding to obtain a front end shaft-rear end shaft assembly. Using a tube with an outer diameter of 1.20 mm, an inner diameter of 1.00 mm and a length of 15 mm (Thermoplastics thermoplastic polyurethane TecothaneTT-1085A) as a balloon 909, a ring on the front shaft-rear shaft assembly The balloon 909 was covered so that the marker 910 was at the center, and each side was adhered by 5 mm using a two-component urethane adhesive. In the evaluation, since the balloon 909 is not expanded, the side hole 911 for balloon expansion is not formed.

(Example 2)
A catheter including the embodiment shown in FIG. The rear end side shaft 701, the outer tube 706, the guide wire lumen tube 712, the ring marker 710, and the balloon 709 were produced in the same manner as in Example 1. However, the length of the outer tube 706 is 48 mm, and the ring marker 710 is used at a position 25 mm from the proximal end of the outer tube 706 using a two-component urethane adhesive (trade name “UR0531”; manufactured by HB Fuller). And glued. A tube (Atochemi polyamide elastomer Pebax 7233) having an outer diameter of 0.44 mm, an inner diameter of 0.36 mm, and a length of 27.5 mm is used as an inner tube 707 with one end as a proximal end and the other end as a distal end. used. The proximal portion of the inner tube 707 is covered with a distal portion of the rear end side shaft 701 by 15 mm and bonded using a two-component urethane adhesive, and further, a core wire 708 (outer diameter: 0.13 mm, length: 35 mm, SUS304) to 5 mm from the distal end of the rear end shaft 701, and the outer tube 706 so that the distal end of the inner tube 707 fits within the ring marker 710. The proximal portion of the outer tube 706, the proximal portion of the inner tube 707, and the proximal portion of the core wire 708 were joined by heat welding and pressure bonding. The balloon 709 was covered so that the ring marker 710 on the outer tube 706 was at the center, and bonded on each side by 5 mm each using a two-component urethane adhesive. In the evaluation, since the balloon 709 is not expanded, the side hole 711 for balloon expansion is not formed. A side hole is opened with a razor at a position about 5 mm distal from the distal end of the balloon 709 on the outer tube 706, and the guide wire lumen tube 712 is exposed from the outer surface of the outer tube 706 to the outer tube 706. 706, the guide wire lumen tube 712, and the core wire 708 distal portion are thermally welded to form a proximal opening 704 of the guide wire lumen, and then the distal portion of the outer tube 706 and the guide wire lumen tube 712 are thermally welded. It joined by.

(Example 3)
A catheter including the embodiment shown in FIG. The rear end side shaft 801, the outer tube 806, the guide wire lumen tube 812, the ring marker 810, and the balloon 809 were produced in the same manner as in Example 2. The ring marker 810 was adhered to a position 25 mm from the proximal end of the outer tube 806 using a two-component urethane adhesive (trade name “UR0531”; manufactured by HB Fuller). A polyimide tube having an outer diameter of 0.44 mm, an inner diameter of 0.36 mm, and a length of 45 mm was used as the inner tube 807 with one end as the proximal end and the other end as the distal end. The proximal portion of the inner tube 807 is covered with a distal portion of the rear end side shaft 801 by 15 mm and adhered using a two-component urethane adhesive, and the outer tube 806 is further formed on the outer tube 806 from the distal end of the rear end side shaft 801. It was covered to a position of 13 mm and adhered to the proximal portion of the inner tube 807 using a two-component urethane adhesive. The balloon 809 was covered so that the ring marker 810 on the outer tube 806 was at the center, and bonded on each side by 5 mm each using a two-component urethane adhesive. In the evaluation, since the balloon 809 is not expanded, the side hole 811 for balloon expansion is not formed. A side hole is made with a razor at a position about 5 mm distal from the distal end of the balloon 809 on the outer tube 806, and a guide wire lumen tube 812 is exposed through the outside of the inner tube 807 from the outer surface of the outer tube 806. In this state, the distal portion of the outer tube 806 and the guide wire lumen tube 812 and the inner tube 807 are thermally welded to form the proximal opening 804 of the guide wire lumen, and then the distal portion of the outer tube 806 and the guide wire The lumen tube 812 was joined by heat welding.

(Comparative Example 1)
FIG. 10 shows a catheter in this comparative example. It was produced in the same manner as in Example 1 except that the inner tube was not present.

(Comparative Example 2)
FIG. 11 shows an intermediate portion of the catheter in this comparative example. The rear end side shaft 1101, the outer tube 1106, the guide wire lumen tube 1112, the ring marker 1110, the balloon 1109, and the core wire 1108 were produced in the same manner as in Example 2. The ring marker 1110 was adhered to a position 25 mm from the proximal end of the outer tube 1106 using a two-component urethane adhesive (trade name “UR0531”; manufactured by HB Fuller). The core wire 1110 is covered to 5 mm from the distal end of the rear end side shaft 1101 and the outer tube 1106 is covered to 13 mm from the distal end of the rear end side shaft 1101, and joined to the rear end side shaft 1101 with a two-component urethane adhesive. . The balloon 1109 was covered so that the ring marker 1110 on the outer tube 1106 was at the center, and each side was adhered 5 mm at a time using a two-component urethane adhesive. In the evaluation, since the balloon 1109 is not expanded, the side hole 1111 for balloon expansion is not formed. A side hole is made with a razor at a position about 5 mm distal from the distal end of the balloon 1109 on the outer tube 1106, and heat welding is performed with the guide wire lumen tube 1112 exposed from the outer surface of the outer tube 1106. After producing the proximal opening 1104 of the guide wire lumen, the distal portion of the outer tube 1106 and the guide wire lumen tube 1112 were joined by heat welding.

(Evaluation)
The simulated aorta 12 and the guiding catheter 14 were placed in the water tank 11 filled with 37 ° C. physiological saline, and the hemostack valve 15 was fixed to the guiding catheter 14. The distal end of the guiding catheter 14 is connected to a bending plate 16 simulating a coronary artery, and a 0.014 "guide wire 13 is inserted in the guiding catheter 14 in advance. A polyethylene tube 17 is disposed on the bending plate 16. The polyethylene pipe 17 is composed of a straight part 19 and a bent part 18, the length of the straight part 19 is 60 mm, the curvature radius of the bent part 18 is 10 mm, the outer diameter 20 of the polyethylene pipe 17 is 5 mm, and the inner diameter 21 is The end of the guide wire 13 was placed at a position protruding 50 mm from the end of the bent plate 16. When the catheter was inserted from the outside of the water tank 11 through the hemostack valve 15 along the guide wire 13 in the guiding catheter 14. The proximal end of the catheter was fixed to a digital force gauge. The digital force gauge was pushed at 10 mm / sec on the slide table, and the maximum load generated when the digital force gauge was advanced to the end of the bending plate 16 was measured, and the kink of the catheter at the time of measurement was also evaluated. The results are shown in Table 1.

この評価により、体外から体内へのカテーテル挿入時の耐キンク性及びトラッカビリティを評価することができる。

By this evaluation, kink resistance and trackability at the time of catheter insertion from outside the body into the body can be evaluated.

  In Examples 1 to 3, the catheter kink did not occur when passing through the bending plate 16, and the generated maximum load value was about 0.71 N to 0.94 N, indicating good trackability.

  On the other hand, in Comparative Example 1, kinks occurred at the boundary between the distal end side shaft and the rear end side shaft distal end when the bent portion 18 was passed. In Comparative Example 1, such a kink seems to have occurred because there is a sudden stiffness change point in this portion. In Comparative Example 2, kinks occurred between the rear end side shaft distal end of the front end side shaft and the ring marker when the bent portion 18 was passed. In Comparative Example 2, the core wire was not kinked, but the difference between the outer diameter of the core wire and the inner diameter of the tip side shaft was large, and the tip side shaft was kinked between the metal rear end side shaft and the ring marker. It seems to be. Since the comparative examples 1 and 2 generated such a kink when passing through the bent portion 18, a sudden increase in load occurred, and it was difficult to insert the catheter further distally at a constant speed by the slide table. there were. Therefore, it is judged that the kink resistance and the trackability in Comparative Examples 1 and 2 are extremely low.

FIG. 5 is a schematic side view showing a cross section of a shaft on the distal end side of a coaxial structure in a general PTCA balloon catheter among high-speed exchange types. It is A-A 'sectional drawing of FIG. FIG. 5 is a schematic side view showing a cross section of a tip side shaft of a biaxial structure in a general PTCA balloon catheter among high-speed exchange types. FIG. 4 is a B-B ′ sectional view of FIG. 3. 1 is a schematic view of one embodiment of an intermediate portion of a catheter according to the present invention. FIG. 6 is a schematic view of another embodiment of an intermediate portion of a catheter according to the present invention. FIG. 6 is a schematic view of another embodiment of an intermediate portion of a catheter according to the present invention. FIG. 6 is a schematic view of another embodiment of an intermediate portion of a catheter according to the present invention. 1 is a schematic view of one embodiment of a distal portion of a catheter according to the present invention. It is drawing for description of a comparative example. It is another explanatory drawing of a comparative example. It is the schematic which shows the evaluation system of a catheter. It is an enlarged view of the bending plate of FIG.

Explanation of symbols

DESCRIPTION OF SYMBOLS 11 Water tank 12 Simulated aorta 13 Guide wire 14 Guiding catheter 15 Hemo stack valve 16 Bending plate 17 Polyethylene pipe 18 Bending part 19 Straight part 20 Polyethylene pipe outer diameter 21 Polyethylene pipe inner diameter 101 Guide wire lumen 102 Other lumen 103 Balloon 104 Proximal opening of guide wire lumen 105 Inner tube 106 Outer tube 201 Guide wire lumen 202 Other lumen 205 Inner tube 206 Outer tube 301 Guide wire lumen 302 Other lumen 303 Balloon 304 Proximal opening of guide wire lumen 401 Guide wire lumen 402 Other lumen 501 Rear end side shaft 502 Front end side shaft 503 Guide wire lumen 04 Guide wire lumen proximal side opening 505 Intermediate portion 506 Outer tube 507 Inner tube 512 Guide wire lumen tube 601 Rear end side shaft 602 Front end side shaft 603 Guide wire lumen 604 Proximal side opening portion of guide wire lumen 605 Intermediate portion 606 Outer tube 607 Inner tube 608 Core wire 612 Guide wire lumen tube 701 Rear end side shaft 702 Front end side shaft 703 Guide wire lumen 704 Proximal opening 705 guide wire lumen 705 Middle portion 706 Outer tube 707 Inner tube 708 Core wire 709 Balloon 710 Ring marker 711 Side hole 712 Guide wire lumen tube 801 Rear end side shaft 802 Front end side shaft 803 Guide wire lumen 804 Ga Id wire lumen proximal opening 805 Middle portion 806 Outer tube 807 Inner tube 809 Balloon 810 Ring marker 811 Side hole 812 Guide wire lumen tube 901 Rear end side shaft 902 Front end side shaft 903 Guide wire lumen 904 Near guide wire lumen Position side opening 905 Middle portion 906 Outer tube 907 Inner tube 909 Balloon 910 Ring marker 911 Side hole 912 Guide wire lumen tube 1001 Rear end side shaft 1002 Front end side shaft 1003 Guide wire lumen 1004 Proximal opening portion of guide wire lumen 1005 Intermediate portion 1006 Outer tube 1009 Balloon 1010 Ring marker 1011 Side hole 1012 Guide wire lumen tube 1101 Rear end side shaft 1102 Tip side shaft 1103 Guide wire lumen 1104 Proximal opening of guide wire lumen 1105 Intermediate portion 1106 Outer tube 1108 Core wire 1109 Balloon 1110 Ring marker 1111 Side hole 1112 Guide wire lumen tube

Claims (19)

  A catheter for insertion into a body lumen, comprising a rear end side shaft having a distal portion and a proximal portion, and a distal portion and a proximal portion, wherein the proximal portion is on the rear end side A distal shaft joined to a distal portion of the shaft, wherein the distal shaft is located more proximally and distally than the distal end of the rear shaft. A guide wire lumen for following the guide wire, and an intermediate portion between the proximal opening of the guide wire lumen and the distal end of the rear shaft, At least a part of the intermediate portion has a double tube structure including an outer tube made of a polymer material and an inner tube made of a polymer material existing in the lumen of the outer tube. .   The catheter according to claim 1, further comprising a balloon for expanding or closing a living body lumen outside the distal shaft.   The catheter of claim 2, wherein the balloon is distal to the proximal opening of the guidewire lumen.   The catheter according to claim 2 or 3, wherein the balloon is located more proximal than the proximal opening of the guidewire lumen.   The catheter according to any one of claims 1 to 4, wherein the outer tube and the inner tube are not directly joined.   The catheter according to any one of claims 1 to 4, wherein a part of the outer tube and the inner tube are joined.   The catheter according to any one of claims 1 to 6, wherein a proximal portion of the outer tube and a proximal portion of the inner tube are joined.   The catheter according to any one of claims 1 to 7, wherein the inner tube is joined to the rear end side shaft.   The catheter according to any one of claims 1 to 8, further comprising a portion where the inner tube does not exist at a distal portion of the intermediate portion.   The catheter according to any one of claims 1 to 9, wherein the outer tube and the inner tube are made of the same polymer material.   The catheter according to any one of claims 1 to 10, wherein the outer tube and the inner tube are made of different polymer materials.   The polymer material is at least one selected from the group consisting of polyimide, polyamide, polyurethane, polyester, polyolefin, polytetrafluoroethylene, silicon rubber, polyamide elastomer, polyester elastomer, polyolefin elastomer or polyurethane elastomer. Item 12. The catheter according to any one of Items 1 to 11.   The catheter according to claim 12, wherein the polymer material is made of a polyamide-based elastomer.   The catheter according to any one of claims 1 to 13, further comprising a metal core wire over the entire length of the intermediate portion.   The catheter according to claim 14, wherein at least a part of the metal core wire has a tapered shape such that an outer diameter decreases toward a distal side.   The catheter according to claim 14 or 15, wherein a proximal portion of the metal core wire is joined to the rear end side shaft.   The catheter according to any one of claims 1 to 16, wherein the rear end side shaft is made of metal.   The catheter according to claim 17, wherein the rear end side shaft is one or more selected from the group consisting of stainless steel, Ni-Ti alloy, and Co-Cr alloy, or a composite thereof.   The catheter according to any one of claims 1 to 16, wherein the rear end side shaft is one or more selected from the group consisting of polyimide, polyetheretherketone, polyamide, and polyamide-based elastomer, or a composite thereof.

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