JP5243155B2 - Aspiration catheter - Google Patents

Description

  The present invention introduces percutaneously transluminally into the body, and removes debris (foreign matter) such as thrombus generated in blood vessels in the body and atheromas released in the blood vessel by negative pressure applied from the proximal end of the catheter. The present invention relates to a suction catheter.

  In recent years, it has become clear that a treatment method that sucks and removes a thrombus is effective as a treatment method when a stenosis or occlusion occurs in a blood vessel such as a blood vessel, or when a blood vessel is occluded by a thrombus. It is coming. Catheters used for such treatments are called suction catheters, and these catheters are used to reach the lesion site where the foreign object to be sucked exists and to suck as much foreign matter as possible. Suction performance is required at the same time. As an aspiration catheter, there is an over-the-wire OTW type catheter mainly using a single lumen tube and a rapid exchange type RX type catheter having a guide wire lumen for inserting a guide wire into the distal end portion of the catheter.

  In the OTW type catheter, there is no guide wire lumen other than the suction lumen, so the suction lumen can be enlarged as much as possible, and the suction performance is excellent, but the followability to the guide wire is poor and the target lesion site is reached. There was a problem that could not be. In the suction catheter, it is important to remove the foreign substance at the lesion site, so that the catheter that cannot reach the lesion site is not useful at all.

On the other hand, RX type catheters as shown in Patent Document 1 and Patent Document 2 are generally known to have excellent reachability to a lesion site by having a guide wire lumen at the tip. However, in recent years, there has been a demand for insertion into a highly bent blood vessel. When the guide wire lumen is short in the RX type catheter as in Patent Document 1, the force applied to the shaft is applied to the guide wire lumen. There is room for improvement in that the axial direction of the guide wire to be held is displaced and it becomes impossible to follow the guide wire. In order to solve such a problem, it is necessary to lengthen the guide wire lumen in the RX type catheter as in Patent Document 2, but it is difficult to manufacture a long guide wire lumen because of the manufacturing difficulty. The catheter shaft in the portion including the lumen becomes hard, and there is a problem that the insertion property into the bent blood vessel is poor. Further, in the RX type catheter, there is a risk that the guide wire lumen is torn during the procedure because the guide wire is exposed to the outside from the middle of the catheter. Further, on the proximal side of the RX type catheter, the guide wire is arranged outside the catheter, so that the suction lumen is small and the suction performance is inferior, and there is no guide wire inside the proximal side shaft. There was a problem that it was necessary to improve the rigidity of the shaft on the distal side.
JP 2004-65326 A JP 2006-297063 A

  In view of these situations, the problem to be solved by the present invention is to provide an aspiration catheter that is excellent in both reachability to a lesion site and aspiration performance.

The present invention is a result of extensive studies, and Aspirate lumen, a suction catheter having a guide wire lumen for sliding the guide wire, the suction lumen opening at the distal end and the opening in the proximal end The guide wire lumen communicates with the suction lumen by disposing the opening of the proximal end inside the suction lumen. An aspiration catheter is provided that is in communication.

  In addition, the suction catheter is characterized in that the proximal end of the guide wire lumen is in fluid-tight communication with the suction lumen.

  In addition, the suction catheter is characterized in that the proximal end of the guide wire lumen communicates with the suction lumen on the proximal side of the distal end of the suction lumen.

  According to these structures, reachability to a lesion site can be improved, suction performance can be improved, and a large amount of foreign matters such as a thrombus present in a highly bent blood vessel can be removed. It becomes possible.

  In addition, the distal portion of the suction lumen has a cross-sectional shape having a flat portion on the guide wire lumen side at least at a part thereof, or the direction connecting the central axis of the guide wire lumen and the central axis of the suction lumen is on the short axis side An aspiration catheter having a substantially elliptical cross-sectional shape is provided.

  According to these structures, the suction lumen lumen in the proximal shaft is enlarged to have excellent suction performance, and the outer diameter of the distal shaft is reduced to have excellent reachability to the lesion site. Thus, it is possible to remove a large amount of foreign matter such as a thrombus existing in a highly bent blood vessel.

  Further, the suction catheter is characterized in that a main shaft defining a suction lumen is integrally formed in the axial direction.

  In addition, the suction catheter is characterized in that the main shaft defining the suction lumen is formed by connecting two or more shafts in the axial direction.

  Also provided is the aspiration catheter in which a guide wire lumen shaft is disposed in the distal portion of the aspiration lumen, or a distal shaft that defines the distal portion of the aspiration lumen is disposed in the guide wire lumen.

  The suction catheter is characterized in that the distal portion of the suction lumen and the guide wire lumen are formed of a multi-lumen tube.

  In addition, the suction catheter is provided in which the distal shaft and the guide wire lumen shaft that define the distal portion of the suction lumen are at least partially in parallel.

  As described above, the suction catheter of the present invention has both the reachability to the lesion site and the suction performance because the proximal end of the guide wire lumen is fluid-tightly connected to the suction lumen, and is more flexible. It is possible to remove foreign substances such as a large amount of thrombus present in the blood vessel.

  The suction catheter according to the present invention will be described below. The present invention relates to a suction catheter having a suction lumen communicating from a distal portion to a proximal portion, and a guide wire lumen in a distal portion, wherein the proximal end of the guide wire lumen is in communication with the suction lumen. The present invention relates to an aspiration catheter. In particular, the communication between the proximal end of the guide wire lumen and the suction lumen is preferably fluid-tight communication. In addition, it is preferable that the proximal end of the guide wire lumen communicates with the suction lumen on the proximal side of the distal end of the suction lumen. According to these structures, reachability to a lesion site can be improved, suction performance can be improved, and a large amount of foreign matters such as a thrombus present in a highly bent blood vessel can be removed. It becomes possible. In particular, unlike the OTW type catheter, it has a guide wire lumen so that it can be easily guided and guided, and the proximal end of the guide wire lumen communicates with the suction lumen. Is inserted into the proximal part of the suction lumen, so that the force applied to the shaft, which occurs when the guidewire lumen is short with an RX type catheter, causes a deviation from the axial direction of the guidewire. It is possible to prevent it from becoming difficult to follow (so that a long guide wire lumen is not provided and the insertion property is not reduced), and the risk of the guide wire lumen tearing during the procedure is low, and it has recently been rapidly Therefore, it is excellent in insertability and reachability into a highly bent blood vessel. Moreover, in the RX type catheter, the suction side becomes small and the suction performance is inferior because the guide wire is arranged outside the catheter, and the suction performance is inferior. The suction lumen can be provided as large as possible, and the suction performance is excellent. Furthermore, since the suction catheter of the present invention has a structure in which the guide wire is inserted into the proximal portion of the suction lumen, it is not necessary to particularly improve the rigidity of the proximal portion, which is advantageous in terms of cost.

  Note that the liquid-tight communication is communication in which there is no gap through which gas or liquid leaks at the communication portion. That is, due to the fluid-tight communication between the guide wire lumen and the suction lumen, the opening of the suction lumen is only the distal end and the proximal end, and the opening of the guide wire lumen exists in the distal end and the suction lumen. Therefore, the suction force can be transmitted to the distal end of the suction lumen without leakage.

  The shape of the opening provided at the distal end of the suction lumen is not particularly limited, and the opening may be perpendicular to the longitudinal axis of the catheter, or may be obliquely opened. Moreover, you may open so that an arc may be drawn. Here, the distal end of the suction lumen refers to the most proximal portion of the opening when the opening provided at the distal end opens obliquely. In the present invention, particularly when the proximal end of the guide wire lumen is communicated with the suction lumen on the proximal side of the distal end of the suction lumen, it becomes easy to continuously change the rigidity of the catheter to the distal end. It is possible to further improve the reachability to the lesion site (for example, when the tip of the shaft defining the suction lumen is cut obliquely to form an opening, particularly in the vicinity of the guide wire lumen. When the end is communicated to the obliquely cut area as the axial position of the catheter (ie, the proximal end of the guidewire lumen communicates with the suction lumen distal to the distal end of the suction lumen) In other words, there are parts where guide wire shafts are installed side by side and parts that are not provided side by side within the range that is cut diagonally, and parts that are installed side by side and have increased rigidity. From being disposed distal from the portion not to be, in order to continuously change the stiffness to the distal end, and further requires the other device.).

  In addition, the inner diameter of the suction lumen at the proximal portion is larger than the inner diameter of the suction lumen at the distal portion from the viewpoint that the distal portion needs to be inserted into a blood vessel that is bent more narrowly and further maximizes the suction performance. It is preferable that they are formed as described above. In addition, as a method of making the inner diameters of the suction lumens different, a method in which two or more tubes having different inner diameters are joined in the axial direction (the control of the inner diameter during manufacture is easy), or a tube in which the inner diameter gradually changes. Can be used (a method in which the rigidity is easily changed continuously) can be used. According to these structures, the catheter has excellent suction performance by increasing the suction lumen lumen in the proximal shaft, and has excellent reachability to the lesion site by reducing the outer diameter of the distal shaft. Can be easily manufactured.

  In addition, the outer diameter of the distal portion of the suction catheter is suppressed and has excellent reachability to the lesioned part, and the suction lumen has an excellent suction performance by securing a larger lumen of the suction lumen. The distal portion has a cross-sectional shape having a flat portion on the guide wire lumen side at least at a part thereof, or a substantially elliptical shape in which the direction connecting the central axis of the guide wire lumen and the central axis of the suction lumen is the short axis side It is preferable to have a cross-sectional shape.

  Further, the suction catheter of the present invention may be formed by integrally forming the main shaft defining the suction lumen in the axial direction for various purposes, or by forming two or more shafts in the axial direction. May be.

  Hereinafter, a suction catheter according to the present invention will be described using a first embodiment. Other embodiments will also be described.

1. First Embodiment (1) Structure FIG. 1 shows a first embodiment (one example) of a suction catheter according to the present invention. In the first embodiment, a guide wire lumen shaft is disposed in the distal portion of the suction lumen, or a distal shaft that defines the distal portion of the suction lumen is disposed in the guide wire lumen (FIG. 1). Is described as the former). That is, the suction catheter 101 of FIG. 1 includes a suction lumen 102, a guide wire lumen 103, a main shaft 104 (distal shaft 104A and proximal shaft 104B; in this application, the expression “main shaft” is integrated in the axial direction). In addition, in the case of being integrally formed, the distal portion thereof is referred to as a distal shaft, for the sake of convenience. The proximal portion may be referred to as a proximal shaft.), A guide wire lumen shaft 105 is provided, and the guide wire lumen shaft 105 is joined and formed in the suction lumen 102 of the distal shaft 104A. In the suction catheter 101, the distal shaft 104A and the proximal shaft 104B are integrally formed. In order to improve reachability to the lesion site, the distal shaft 104A is used as the proximal shaft 104B. It is preferable that it is flexible compared with. Moreover, as a method for making the distal shaft 104A flexible, for example, the thickness of the tube forming the distal shaft 104A can be reduced.

  The aspiration catheter 101 also has a guide wire lumen proximal end 107 communicating with the aspiration lumen, particularly at a location proximal to the aspiration lumen distal end 106, with the guide wire lumen proximal end 107 being connected to the aspiration lumen 102. It is in fluid-tight communication. In the present invention, having such a structure makes it possible to remarkably improve the reachability to the lesion site while having the suction performance equivalent to that of the conventional OTW type catheter. Further, the guide wire is inserted from the guide wire lumen 103 through the suction lumen 102 to the catheter proximal end, so that the guide wire does not come out of the catheter. Therefore, it is possible to reduce the risk that the guide wire and the catheter are separated and the guide wire lumen is torn during the procedure, which has been a problem with the conventional RX catheter.

  Various methods can be used for joining the distal shaft 104A and the guide wire lumen shaft 105. For example, welding (such as hot air or laser as a heat source) or adhesion may be used. From the viewpoint of ensuring the flexibility of the portion (the portion where the distal shaft 104A and the guide wire lumen shaft 105 are present) and from the viewpoint of ease of manufacture, welding by welding is preferable, and laser bonding is more preferable. is there. Further, in order to join the distal shaft 104A and the guide wire lumen shaft 105 by welding, it is preferable to use the same material for the surfaces of the shafts to be joined. Further, the distal shaft 104 </ b> A and the guide wire lumen shaft 105 may be joined at only two locations, the distal portion and the proximal portion of the guide wire lumen shaft 105, and are joined over the entire length of the guide wire lumen 103. However, in order to reduce the risk of breakage of the guide wire lumen when the catheter is used, it is preferable to join the entire length. The distal end of the guidewire lumen shaft 105 can be in any position, but to improve reachability to the lesion site, the same position as the distal end 108 of the distal shaft, or the distal shaft It is preferable to be located on the distal side with respect to the distal end 108.

  The length of the main shaft 104 joined to the guide wire lumen shaft 105 (or the length of the distal shaft 104A) and the length of the proximal shaft 104B are not particularly limited. By setting a shorter length, it becomes possible to further improve the suction performance and the insertion property even in a state where the guide wire is inserted, and the particularly preferable length of the distal shaft 104A is 30 mm or less (these characteristics are the other It is possible to apply to the embodiment.) In the conventional RX type catheter, when the guide wire lumen (the distal shaft portion in the present embodiment) is short as described above, there is a problem that the catheter and the guide wire are displaced in the axial direction. In this case, since the proximal portion of the guide wire is also present inside the catheter, even if the distal shaft 104A is short, there is no deviation in the axial direction of the catheter and the guide wire, and good followability to the guide wire is achieved. It can be secured.

  In order to ensure good slidability with the guide wire, the inner surface of the guide wire lumen 103 is preferably made of a material such as fluororesin or polyethylene. In order to further improve the slidability, it is preferable to perform coating with silicone oil on the inner surface of the guide wire lumen 103.

(2) Usage method The basic usage method of the suction catheter according to the present invention is the same as that of a general suction catheter. The guide wire is passed through the guide wire lumen, and the catheter is allowed to reach the lesion site along the guide wire. Thereafter, a negative pressure device (not shown) such as a syringe or a negative pressure pump is connected to the proximal end of the proximal shaft 104B, and a negative pressure is generated to remove foreign substances from the body.

  In order to connect the negative pressure device to the proximal shaft 104B, a hub 109 may be provided at the proximal end of the proximal shaft 104B, and a detachable connector is attached to the proximal shaft 104B. You may provide in the tip vicinity. Further, suction may be performed with the guide wire inserted into the guide wire lumen 103 being inserted, or suction may be performed by removing the guide wire (when suction is performed with the guide wire inserted). Can be suctioned by connecting a Y connector to the proximal end of the proximal shaft 104B or the hub 109). With conventional RX catheters, the suction performance did not change even when the guide wire was removed when performing suction. However, in the suction catheter according to the present invention, the guide wire is partially inserted into the suction lumen. Therefore, it is preferable to perform suction by removing the guide wire from the viewpoint of exhibiting excellent suction performance.

  In addition, after aspiration with the guide wire removed, when the catheter is advanced again to the blood vessel distal side, the guide wire can be inserted and advanced from the proximal end opening to the distal opening of the suction lumen 102. Is possible.

  When the hub 109 is provided at the proximal end of the proximal shaft 104B, in order to reduce the rigidity discontinuity at the boundary between the proximal shaft 104B and the hub 109, a resin tube (strain relief 110) is provided at the boundary portion. It is preferable to have.

2. Second Embodiment Hereinafter, a second embodiment will be described, but a part of the points common to the first embodiment will be omitted. FIG. 2 shows a second embodiment (one example) of the suction catheter according to the present invention. The second embodiment, like the first embodiment, arranges the guide wire lumen shaft in the distal portion of the suction lumen, or arranges the distal shaft defining the distal portion of the suction lumen in the guide wire lumen. However, in particular, the main shaft that defines the suction lumen is formed by connecting two or more shafts in the axial direction. Similar to the suction catheter 101 shown in FIG. 1, the suction catheter 201 includes a suction lumen 202, a guide wire lumen 203, a main shaft 204 (distal shaft 204 </ b> A and proximal shaft 204 </ b> B), and a guide wire lumen shaft 205. Catheter. In the suction catheter 201, the distal shaft 204A and the proximal shaft 204B are constituted by different members and joined. In this way, by configuring the distal shaft 204A and the proximal shaft 204B from separate members, the distal shaft 204A can be easily softened by using a flexible material, and the lesion site can be obtained. It becomes possible to improve the reachability. The suction catheter 201 has a proximal end portion of the distal shaft 204A and a distal end portion of the proximal shaft 204B joined together, and a guide wire lumen on the proximal side of the distal end 206 of the suction lumen. The proximal end 207 is in fluid-tight communication with the suction lumen 202, so that the reachability to the lesion site can be remarkably improved while having excellent suction performance. In addition, as a joining method of 204 A of distal side shafts, and the proximal side shaft 204B, it can carry out with various methods, for example, welding or adhesion | attachment etc. are mentioned.

  In the present embodiment, the distal shaft 204A and the proximal shaft 204B are joined to form the main shaft. However, each shaft may be composed of a plurality of members and joined. . In particular, it is preferable that the distal end portion of the distal shaft 204A has a very flexible tip 211, and a tube made of a flexible material is disposed, or the distal end opening is formed obliquely. (Note that these features can also be applied to other embodiments.) According to these structures, it is possible to reduce damages such as blood vessels at the most distal portion of the catheter, and it is possible to more efficiently and reliably remove foreign matters such as thrombus.

  The distal shaft 204A and the guide wire lumen shaft 205 may have a cross section as shown in FIG. 3 made of different members and joined together, but have a cross section as shown in FIG. 4 by integral molding. (In other words, the distal portion of the suction lumen and the guide wire lumen are formed by a multi-lumen tube.) Various methods can be used for joining the distal shaft 204A and the guide wire lumen shaft 205. For example, welding (hot air or laser as a heat source) or adhesion can be used. In particular, bonding by welding is preferable from the viewpoint of ensuring flexibility of the distal portion of the catheter and ease of manufacturing, and more preferably bonding using a laser.

  In order to confirm the position of the catheter distal portion in the body, the catheter distal portion preferably contains a radiopaque material. The kind of X-ray opaque material is not particularly limited, and barium, bismuth, tungsten, platinum, gold, and the like can be used. As in this embodiment, a platinum ring marker 212 may be provided near the distal end of the guidewire lumen shaft 205 or near the distal end of the distal shaft 204A, and barium sulfate or tungsten may be provided distally. It may be kneaded into the resin of the side shaft 204A. These features can be applied to other embodiments.

3. Third Embodiment FIG. 5 shows a third embodiment (one example) of a suction catheter according to the present invention. In the suction catheter 301, a distal shaft that defines the distal portion of the suction lumen and a guide wire lumen shaft are at least partially in parallel, and in particular, two or more main shafts that define the suction lumen are arranged in the axial direction. It is formed by joining the shaft. In addition, the distal shaft and guidewire lumen shaft that define the distal portion of the suction lumen are each positioned in proximity to the distal end of the proximal shaft that defines the proximal portion of the suction lumen. It is connected to communicate with the position. In addition, the suction catheter 301 is similar to the suction catheter 201 shown in FIG. 2, the suction lumen 302, the guide wire lumen 303, the main shaft 304 (the distal side shaft 304 </ b> A and the proximal side shaft 304 </ b> B), and the guide wire lumen shaft 305. , A catheter provided with a distal tip 311 and a ring marker 312.

  In the suction catheter 301, the distal shaft 304A and the guide wire lumen shaft 305 exist in parallel over the entire length of the distal shaft 304A. Here, the term "parallel" means that the member constituting the suction lumen 302 of the distal shaft 304A and the member constituting the guide wire lumen 303 of the guide wire lumen shaft 305 are composed of different members, respectively. This refers to a structure having a cross section as shown in FIG. 6 in which the outer surfaces of the members are joined or face each other. . The distal shaft 304A and the guide wire lumen shaft 305 are thus arranged in parallel, so that the outer diameter of the distal shaft 304A having a large influence on the rigidity of the distal portion of the catheter can be easily controlled. Can be small and flexible. According to such a structure, the flexibility of the distal portion of the catheter can be easily ensured, and the reachability to the lesion site can be improved. As a method for joining the distal shaft 304A and the guide wire lumen shaft 305, various methods (laser welding, adhesion, etc.) can be used as described above. In this case, since the distal shaft 304A and the guide wire lumen shaft 305 exist in parallel, the joint surfaces of the shafts can be confirmed from the outside and joined, and can be joined very easily. Become.

  The lengths of the distal shaft 304A and the proximal shaft 304B are not particularly limited. However, by setting the distal shaft 304A to be shorter, it is possible to have excellent suction performance, and a more preferable distal side. The length of the shaft 304A is 30 mm or less (these features can be applied to other embodiments). As described above, with this structure, while having excellent suction performance, there is no deviation in the axial direction of the catheter and the guide wire, and good followability to the guide wire can be ensured.

  A composite tube having a reinforcing layer and an outer layer can be used for the distal shaft 304A and the proximal shaft 304B. The reinforcing layer of the composite tube is preferably a braided structure or a coil structure using various metals such as stainless steel, Ni-Ti alloy, and tungsten. When using a composite tube for the distal shaft 304A, it is preferable to use a material that is as flexible as possible for the outer layer. By using a composite tube for the distal shaft 304A, the distal shaft 304A can be made to be flexible and not easily broken, and reachability to a lesion site can be improved. When a composite tube is used for the distal shaft 304A in this way, the influence of the rigidity of the composite tube on the rigidity of the distal shaft 304A increases, and therefore the distal shaft 304A and the guide wire lumen shaft 305 exist in parallel. This makes it possible to further soften the distal shaft 304A. The composite tube may have an inner layer on the inner surface of the reinforcing layer.

  Further, since the distal shaft 304A and the guide wire lumen shaft 305 exist in parallel, the short diameter (D in FIG. 6) of the distal portion of the catheter can be reduced, and the reachability to the lesion site is further improved. Can be improved.

4). Fourth Embodiment FIG. 7 shows a fourth embodiment (one example) of a suction catheter according to the present invention. In the suction catheter 401, a distal shaft that defines the distal portion of the suction lumen and a guide wire lumen shaft are present in parallel at least partially, and in particular, the main shaft that defines the suction lumen is integrally formed. ing. Similar to the suction catheter 201 shown in FIG. 2, the suction catheter 401 includes a suction lumen 402, a guide wire lumen 403, a main shaft 404 (distal shaft 404A and proximal shaft 404B), a guide wire lumen shaft 405, and a tip. The catheter includes a tip 411 and a ring marker 412. A part of the guide wire lumen shaft 405 in the suction catheter 401 is parallel to the distal shaft 404A.

  The distal shaft 404 </ b> A and the proximal shaft 404 </ b> B of the suction catheter 401 are formed integrally and are preferably composed of a composite tube having a reinforcing layer 413 and an outer layer 414. By using the composite tube, the main shaft 404 can be easily formed by integral molding from the proximal end to the distal end, and the rigidity can be freely set. Further, it is preferable that the proximal portion of the distal shaft 404A has a lumen taper structure in which the suction lumen lumen gradually decreases. With such a structure, the suction lumen 402 in the proximal shaft 404B is enlarged to have an excellent suction performance, and the outer diameter of the distal shaft 404A is reduced to achieve an excellent reach to a lesion site. It becomes possible to produce the catheter which has it simply by integral molding. The reinforcing layer 413 of the composite tube preferably has a braided structure or a coil structure using various metals such as stainless steel, Ni—Ti alloy, and tungsten.

  The guide wire lumen shaft 405 is joined to the outer layer 414 of the main shaft 404 constituted by the composite tube, and the proximal end 407 of the guide wire lumen shaft communicates with the suction lumen 402 through a hole formed in the side surface of the composite tube. It is fixed like. In particular, the fixing is preferably performed in a liquid-tight manner, and various methods can be used as the method. Further, when the composite tube is molded, the guide wire lumen shaft 405 is disposed on the distal shaft 404A portion of the inner layer 415 of the composite tube so as to contact the outer surface, and the reinforcing layer 413 and the outer layer 414 are disposed thereon. This makes it possible to produce a catheter in which the guide wire lumen shaft 405 and the main shaft 404 are joined more simply (FIG. 8).

5. Fifth Embodiment FIG. 9 shows a fifth embodiment (one example) of a suction catheter according to the present invention. As in the fourth embodiment, the suction catheter 501 has a distal shaft that defines the distal portion of the suction lumen and a guide wire lumen shaft at least partially in parallel, and particularly defines the suction lumen. The main shaft is integrally formed. Similar to the suction catheter 201 shown in FIG. 2, the suction catheter 501 includes a suction lumen 502, a guide wire lumen 503, a main shaft 504 (distal shaft 504A and proximal shaft 504B), a guide wire lumen shaft 505, and a tip. The catheter includes a tip 511 and a ring marker 512. The guide wire lumen shaft 505 in the suction catheter 501 exists in parallel with the distal shaft 504A over substantially the entire length thereof.

  The distal shaft 504A and the proximal shaft 504B of the suction catheter 501 are preferably integrally formed and formed of a composite tube having a reinforcing layer 513 and an outer layer 514. Furthermore, the lumen of the suction lumen 502 in the distal shaft 504A is at least partially in a cross-sectional shape that is substantially elliptical (see FIG. 10, in particular, the direction connecting the central axis of the guide wire lumen and the central axis of the suction lumen). It is preferable to have a cross-sectional shape having a flat portion on the guide wire lumen side (FIG. 11). The proximal portion of the distal shaft 504A preferably has a transition portion in which the lumen of the suction lumen 502 is deformed into such a shape. With such a structure, even when the distal shaft 504A and the proximal shaft 504B are integrally formed, the distal portion of the catheter is not particularly required to perform the diameter reduction operation of the shaft. It is possible to easily produce a catheter having excellent suction performance by suppressing the outer diameter, having excellent reachability to the lesioned part, and enlarging the lumen of the suction lumen 502 in the proximal shaft 504B. .

  Hereinafter, examples and comparative examples of the suction catheter according to the present invention will be described in detail, but the following examples do not limit the present invention. In addition, all the following examples and comparative examples have a structure that can be inserted into a 6Fr guiding catheter having an inner diameter of 1.78 mm along a guide wire of 0.014 inch (0.36 mm).

Example 1
The total length of the proximal shaft was 1390 mm, and the total length of the distal shaft was 10 mm. The proximal shaft proximal side 1000 mm is a polyimide tube having an outer diameter of 1.70 mm and an inner diameter of 1.45 mm. The proximal shaft tip side 390 mm to the distal shaft 10 mm is 400 mm, the outer diameter is 1.70 mm, the inner diameter 1 A 40 mm low density polyethylene tube was used. The distal end of the polyimide tube was heated and stretched to reduce the diameter, and the reduced diameter portion was covered with a proximal end of a low density polyethylene tube and joined with a urethane adhesive. As the guide wire lumen shaft, a high density polyethylene tube having an outer diameter of 0.56 mm, an inner diameter of 0.43 mm, and a length of 12 mm was used. The distal end of the distal shaft was cut obliquely with a razor so that the cut portion had an axial length of 2 mm. Insert the guide wire lumen shaft from the distal end of the distal shaft and place it at a position 2mm beyond the distal end of the diagonally cut part, and join the distal shaft and guide wire lumen shaft by thermal welding . A polycarbonate hub was joined to the proximal end of the proximal shaft with urethane adhesive.

(Example 2)
Similar to Example 1, the total length of the proximal shaft was 1390 mm, and the total length of the distal shaft was 10 mm. For the proximal shaft proximal side 1000 mm, a polyimide tube having an outer diameter of 1.70 mm and an inner diameter of 1.45 mm was used. As the proximal shaft tip side 390 mm, a low density polyethylene tube having an outer diameter of 1.70 mm and an inner diameter of 1.40 mm was used. The distal shaft uses a low density polyethylene tube with an outer diameter of 1.30 mm, an inner diameter of 1.00 mm, and a length of 10 mm. The guide wire lumen shaft has an outer diameter of 0.56 mm, an inner diameter of 0.43 mm, and a length of 12 mm. High density polyethylene tubes were used. The distal end of the distal shaft was cut obliquely with a razor so that the cut portion had an axial length of 2 mm. The guide wire lumen shaft was placed in parallel with the distal shaft at a position 2 mm beyond the distally cut end of the distal shaft, and joined by thermal welding. A polycarbonate hub was joined to the proximal end of the proximal shaft with urethane adhesive to produce a distal portion of the catheter. The proximal end of the distal portion was brought into contact with the distal end of the proximal shaft and joined by heat welding. A polycarbonate hub was joined to the proximal end of the proximal shaft with urethane adhesive.

(Example 3)
Tetrafluoroethylene perfluoro with a thickness of 0.03 mm on a silver-plated annealed copper wire with an outer diameter of 1.45 mm at the hand side, an outer diameter of the tip side of 1.00 mm, and a transition portion from the hand side to the tip side of 10 mm An alkyl vinyl ether copolymer (PFA, inner layer) was coated and cut so that the length on the hand side was 1380 mm and the length on the tip side was 10 mm. A stainless steel round wire (SUS304WPB, reinforcing layer) having an outer diameter of 0.03 mm was braided on this PFA in a 16-punch configuration using a braiding machine. This braid was covered with a polyamide elastomer tube (outer layer) and coated by heat welding so that the outer diameter on the hand side was 1.70 mm and the outer diameter on the tip side was 1.30 mm. The Shore hardness of the tube made of polyamide elastomer was set so that the proximal side 1000 mm was 72 D, the distal end side 100 mm was 35 D, and the middle portion 300 mm was 55 D, and a composite tube having a length of 1400 mm was produced. A polyamide elastomer tube (Shore hardness 35D) with an outer diameter of 1.30 mm and an inner diameter of 1.00 mm is abutted against the tip of this composite tube, and the tip is joined by thermal welding so that the axial length of the tip is 2 mm. In addition, it was cut obliquely with a razor from the tip to the tip tip weld. Using an excimer laser, a hole having a diameter of 0.50 mm was formed in the outer layer and the inner layer in the transition portion, and the reinforcing layer in the hole portion was removed with a YAG laser.

  The guide wire lumen shaft was a polyamide elastomer tube (shore hardness 55D) having an outer diameter of 0.56 mm, an inner diameter of 0.43 mm, and a length of 24 mm. The guide wire lumen shaft was inserted into a hole provided in the transition portion, and the tip end side was arranged in parallel with the distal shaft at a position 2 mm beyond the tip of the tip tip cut obliquely. The guide wire lumen shaft was joined to the outer layer by thermal welding over the entire length, and the transition portion was also joined in a liquid-tight manner by thermal welding. A polycarbonate hub was joined to the proximal end of the proximal shaft with urethane adhesive.

(Comparative Example 1)
The same polyimide tube and low-density polyethylene tube as in Example 1 were used, and these tubes were joined by the same method as in Example 1. The distal end of the distal shaft was cut obliquely with a razor so that the cut portion had an axial length of 2 mm. A polycarbonate hub was joined to the proximal end of the proximal shaft with urethane adhesive to produce a conventional OTW suction catheter.

(Comparative Example 2)
Similar to Example 1, the total length of the proximal shaft was 1390 mm, and the total length of the distal shaft was 10 mm. The proximal shaft proximal side 1000 mm is a polyimide tube having an outer diameter of 1.30 mm and an inner diameter of 1.10 mm, and the proximal shaft distal end side of 390 mm to the distal shaft 10 mm is 400 mm, an outer diameter of 1.30 mm and an inner diameter of 1 mm. A 0.000 mm low density polyethylene tube was used. The distal end portion of the proximal shaft was heated and stretched to reduce the diameter, and the reduced diameter portion was covered with the proximal end on the proximal shaft distal end side and joined with a urethane adhesive. As the guide wire lumen shaft, a high density polyethylene tube having an outer diameter of 0.56 mm, an inner diameter of 0.43 mm, and a length of 12 mm was used. The distal end of the distal shaft was cut obliquely with a razor so that the cut portion had an axial length of 2 mm. The guide wire lumen shaft was placed in parallel with the distal end of the distal shaft, and the distal shaft and the guide wire lumen shaft were joined by thermal welding at a position 2 mm beyond the distal end of the obliquely cut portion. A polycarbonate hub was joined to the proximal end of the proximal shaft with urethane adhesive to produce a conventional RX suction catheter.

(Comparative Example 3)
A conventional RX suction catheter was prepared in the same manner as Comparative Example 2 except that the length of the guide wire lumen shaft was set to 102 mm.

(Evaluation)
Two types of evaluation were performed: “reachability evaluation” inserted into a simulated plate in physiological saline at 37 ° C., and “aspiration evaluation” for suctioning 37 ° C. physiological saline.

(Reachability evaluation)
The simulated aorta 12 and the guiding catheter 13 were placed in the water tank 11 filled with 37 ° C. physiological saline, and the hemostack valve 14 was fixed to the 6Fr guiding catheter 13 (inner diameter 1.78 mm) (FIG. 12). The distal end of the guiding catheter 13 was connected to the simulation plate 15, and a 0.014 inch (0.36 mm) guide wire was inserted through the guiding catheter 13 in advance. The simulated plate 15 is made of polyethylene, and the base end portion 16 has a length of 30 mm, the inner diameter is 5 mm, the intermediate portion 17 has a length of 20 mm, the inner diameter is 3 mm, the distal portion 18 has a length of 30 mm, and the inner diameter is 3 mm. (FIG. 13). The end of the guide wire was arranged in accordance with the end of the peripheral portion 18. The operability when the catheter was inserted from the outside of the water tank 11 through the hemostack valve 14 along the guide wire in the guiding catheter 13 was evaluated. When the catheter is inserted with the proximal end of the catheter held by hand and can be advanced to the end of the distal portion 18, Δ when it can be advanced to the end of the intermediate portion 17, When it was only possible to proceed to the end, the reachability was evaluated as x.

(Suction performance evaluation)
The simulated plate was removed from the evaluation system used for reachability evaluation, and the catheter tip was placed 100 mm from the guiding catheter tip. A 30 mL syringe was connected to the hub at the proximal end of the catheter, and the amount of physiological saline that could be aspirated when the syringe was fully pulled and held for 5 seconds was measured with a graduated cylinder to evaluate the suction performance. It can be determined that the greater the amount of physiological saline that can be aspirated, the better the aspiration performance. Measurements were made three times with each catheter, and the average value was evaluated. In this evaluation, no guide wire was used, and all catheters were evaluated without a guide wire.

  Table 1 shows the results of reachability evaluation and suction performance evaluation.

  About reachability evaluation, although Examples 1-3 felt the difference in the resistance at the time of passage, all can be advanced to the termination | terminus of the peripheral part 18, and the favorable reachability was shown. On the other hand, in Comparative Example 1, the distal end portion of the catheter was caught at the end of the base end portion 16, and it was impossible to proceed further. When pushed further, the tip of the catheter was damaged. In Comparative Example 2, although the terminal end of the proximal end portion 16 has passed, the catheter shaft near the proximal end portion 16 bends when the distal end portion of the catheter reaches the end of the intermediate portion 17 and cannot be advanced any further. there were. When pushed further, the catheter shaft near the proximal end 16 was damaged. In Comparative Example 3, although resistance was slightly felt when passing, it was possible to proceed to the end of the peripheral portion 18 and showed good reachability.

  Regarding the suction performance evaluation, Examples 1 to 3 had a suction amount of 20 mL or more, and showed a good suction performance. On the other hand, it was confirmed that Comparative Examples 2 and 3 had an extremely small suction amount of about 7 mL and were inferior in suction performance.

  From these evaluations, it can be determined that Examples 1 to 3 have both excellent reachability to the lesion site and suction performance.

1 is a side view of an embodiment of a suction catheter according to the present invention. 1 is a side view of an embodiment of a suction catheter according to the present invention. It is sectional drawing in the catheter distal side part of one Embodiment of the suction catheter which concerns on this invention. It is sectional drawing in the catheter distal side part of one Embodiment of the suction catheter which concerns on this invention. 1 is a side view of an embodiment of a suction catheter according to the present invention. It is sectional drawing in the catheter distal side part of one Embodiment of the suction catheter which concerns on this invention. 1 is a side view of an embodiment of a suction catheter according to the present invention. It is sectional drawing in the catheter distal side part of one Embodiment of the suction catheter which concerns on this invention. 1 is a side view of an embodiment of a suction catheter according to the present invention. It is sectional drawing in the catheter distal side part of one Embodiment of the suction catheter which concerns on this invention. It is sectional drawing in the catheter distal side part of one Embodiment of the suction catheter which concerns on this invention. It is the schematic which shows the evaluation system of a catheter. It is an enlarged view of the simulation plate of FIG.

Explanation of symbols

DESCRIPTION OF SYMBOLS 11 Water tank 12 Simulated aorta 13 Guiding catheter 14 Hemo stack valve 15 Simulated plate 16 Base end part 17 Middle part 18 Peripheral part 101 Suction catheter 102 Suction lumen 103 Guide wire lumen 104 Main shaft 104A Distal side shaft 104B Proximal side shaft 105 Guidewire lumen shaft 106 Distal end of suction lumen 107 Proximal end of guidewire lumen 108 Distal end of distal shaft 109 Hub 110 Strain relief 201 Aspiration catheter 202 Aspiration lumen 203 Guidewire lumen 204 Main shaft 204A Distal side Shaft 204B Proximal shaft 205 Guide wire lumen shaft 206 Suction lumen distal end 207 Guide wire lumen Distal end 208 Distal end of distal shaft 209 Hub 210 Strain relief 211 Tip tip 212 Ring marker 301 Suction catheter 302 Suction lumen 303 Guide wire lumen 304 Main shaft 304A Distal shaft 304B Proximal shaft 305 Guide wire lumen shaft 306 Distal end of suction lumen 307 Proximal end of guide wire lumen 308 Distal end of distal shaft 309 Hub 310 Strain relief 311 Tip tip 312 Ring marker 401 Suction catheter 402 Suction lumen 403 Guide wire lumen 404 Main shaft 404A Distant Distal shaft 404B Proximal shaft 405 Guidewire lumen shaft 406 Distal end of suction lumen 407 Ga Id wire lumen proximal end 408 Distal shaft distal end 409 Hub 410 Strain relief 411 Tip tip 412 Ring marker 413 Reinforcement layer 414 Outer layer 415 Inner layer 501 Suction catheter 502 Suction lumen 503 Guide wire lumen 504 Main shaft 504A Distal Side shaft 504B Proximal shaft 505 Guide wire lumen shaft 506 Suction lumen distal end 507 Guide wire lumen proximal end 508 Distal shaft distal end 509 Hub 510 Strain relief 511 Tip tip 512 Ring marker 513 Reinforcement layer 514 Outer layer 515 Inner layer

Claims (13)

And Aspirate lumen, a suction catheter having a guide wire lumen for sliding the guide wire, a,
The suction lumen communicates from the distal portion to the proximal portion of the suction catheter by having a distal end opening and a proximal end opening,
Guide wire lumen, the opening of the proximal end, by disposed within the aspiration lumen, the suction catheter, characterized in that communicates to the aspiration lumen.   2. A suction catheter according to claim 1, wherein the proximal end of the guidewire lumen is in fluid tight communication with the suction lumen.   The suction catheter according to claim 1, wherein the proximal end of the guide wire lumen communicates with the suction lumen at a position proximal to the distal end of the suction lumen.   The suction catheter according to claim 1, wherein an inner diameter of the suction lumen in the proximal portion is larger than an inner diameter of the suction lumen in the distal portion.   The suction catheter according to any one of claims 1 to 4, wherein the suction lumen has at least a part of which the inner diameter gradually changes.   The distal portion of the suction lumen has a cross-sectional shape having a flat portion on the guide wire lumen side at least at a part thereof, or the direction connecting the central axis of the guide wire lumen and the central axis of the suction lumen is the short axis side The suction catheter according to any one of claims 1 to 5, wherein the suction catheter has a substantially elliptical cross-sectional shape.   The suction catheter according to claim 1, wherein a main shaft that defines a suction lumen is integrally formed in an axial direction.   The suction catheter according to any one of claims 1 to 6, wherein a main shaft defining the suction lumen is formed by connecting two or more shafts in the axial direction.   The guide wire lumen shaft is disposed in the distal portion of the suction lumen, or the distal shaft that defines the distal portion of the suction lumen is disposed in the guide wire lumen. Suction catheter.   The suction catheter according to claim 8, wherein the distal portion of the suction lumen and the guide wire lumen are formed by a multi-lumen tube.   9. The suction catheter according to claim 7, wherein the distal shaft and the guide wire lumen shaft that define the distal portion of the suction lumen are at least partially in parallel. .   The distal shaft defining the distal portion of the suction lumen and the guidewire lumen shaft are relative to the distal end of the proximal shaft defining the proximal portion of the suction lumen, each lumen being a proximal portion of the suction lumen The suction catheter according to claim 8, wherein the suction catheter is connected to communicate with the suction catheter.   The suction catheter according to claim 7 or 8, wherein a proximal end of the guide wire lumen shaft is fixed to a hole formed in a side surface of the main shaft.