WO2005092426A1 - Catheter - Google Patents

Abstract

Provided are a catheter with which a member for sealing can be operated with a small force and which can be easily produced without requiring a strict tolerance in production processes, and an adaptor enabling stable operation of the catheter. A catheter having a balloon, a tubular body (205) having an inflation lumen (201), and a fluid sealing section (202) for sealing fluid, wherein the structure of the fluid sealing section is constituted of a movable tightly sealing member (203) having a tapered section (203A) whose outer diameter reduces gradually and of a tightly sealing section (204) fitted on the tapered section. A catheter system for operating the catheter is also provided.

Description

 Catheter

 Technical field

 The present invention relates to a catheter having a balloon that is introduced percutaneously transluminally into a body and expands or closes a lumen in the body, and a catheter system including an adapter that operates the catheter.

 Background art

 [0002] Conventionally, when stenosis or occlusion occurs in a blood vessel such as a blood vessel, angioplasty (PTA: Percutaneous surgery) performed to improve the blood flow on the peripheral side of the blood vessel by expanding the stenotic or occluded part of the blood vessel. Transluminal Angioplasty ^ PTCA (Percutaneous Transluminal Coronary Angioplasty etc.) has a large number of surgical cases in many medical institutions, and it has become a common operation in this type of case. In addition, stents for maintaining the state of an expanded stenosis have been widely used in recent years.

 [0003] Balloon catheters used for PTA and PTCA are mainly used as a set of a guide catheter and a guide wire to expand a stenosis site or an occlusion site of a blood vessel. In angioplasty using this balloon catheter, a guide catheter is first inserted from the femoral artery, the distal end is positioned at the entrance of the coronary artery via the aorta, and then a guide wire penetrated through the balloon catheter is inserted into the blood vessel. Advance over the stenosis or occlusion, then advance the balloon catheter over the guidewire to inflate the balloon while positioned at the stenosis or occlusion to expand the stenosis or occlusion. The procedure is followed, and the balloon is deflated and removed from the body. This balloon catheter is useful not only for treating stenotic or occluded sites in blood vessels but also for many medical applications including insertion into blood vessels and into various body cavities and tubular tissues.

[0004] If the occlusion in the blood vessel is caused by a thrombus while the force is applied, when the occlusion site is expanded with a balloon catheter, the thrombus may be released from the inner wall of the blood vessel and occlude a peripheral blood vessel on the downstream side. Also, when dilating a stenosis site in a blood vessel, the lesion contains many plaque-like plaques. In some cases, plaque (atheroma) may be scattered from the lesion due to dilatation with a balloon catheter, and may block peripheral blood vessels. When the peripheral blood vessels are occluded in this way, even if the occluded part or the stenotic part is expanded, blood flow does not flow to the periphery, resulting in a slow flow or no reflow situation.

 [0005] In such a situation, in a coronary artery or the like, it is common to see the state until the blood flow is restored, but there is a problem that time is required until the blood flow is restored. Also, depending on the situation, a vasodilator may be administered to restore blood flow, or a drug such as a thrombolytic agent may be locally administered to dissolve obstructions. It takes time, there is a problem. If peripheral obstruction is severe and hemodynamics are poor, auxiliary measures such as IABP are also used.

 [0006] In particular, in the case of vascular occlusion or stenosis in the carotid or cerebral arteries, if peripheral angioplasty occurs by performing angioplasty with a balloon force stent, the blood flow to the brain stops. As a result, the peripheral brain cells at the site of the occlusion become ischemic. A prolonged ischemic state of the brain can lead to the death of brain cells, which can be very dangerous, leaving injury, and such cerebral or carotid angioplasty compared to other blood vessels Care must be taken to ensure that peripheral vessels are not blocked.

 [0007] In order to prevent the peripheral blood vessels from being occluded in this way, it has been attempted to temporarily occlude the peripheral blood vessels of the diseased blood vessels and perform angioplasty on the affected area in that state. You. Conventionally, a temporary occlusion nore catheter has been used as a means for temporarily obstructing a blood vessel. As one mode of the temporary occlusion balloon catheter, the shaft of the temporary occlusion balloon catheter is used as a guide wire, and another therapeutic catheter, for example, a vasodilation balloon catheter, travels along the shaft of the temporary occlusion balloon catheter. It is inserted up to the lesion. Thereafter, a temporary occlusion drain catheter is dilated at the periphery of the lesion, and the lesion is treated while the blood flow is blocked.

[0008] At this time, the shaft of the balloon catheter for temporary occlusion may be located inside the guide wire lumen of another treatment catheter, and is generally thinner than the inner diameter of the guide wire lumen over the entire length of the shaft. Must have the same diameter as the guide wire. The temporary occlusion balloon is inflated by an inflation device connected to the proximal end of the catheter. When a dilatation device is connected, other treatment catheters cannot be operated along the shaft of the temporary occlusion balloon catheter. Therefore, a seal portion is provided at the proximal end of the catheter so that the nolane can be expanded even when the dilatation device is removed, and the outer diameter of the seal portion is smaller than that of the guide wire lumen of the treatment catheter. It must be thin. As a prior art, in Patent Document 1, as the sealing portion of such a balloon catheter for temporary occlusion, an outer diameter smaller than 0.014 inch, which is the outer diameter of the most common guide wire used in ordinary PTCA or the like, is described. The invention discloses a catheter valve having a very small cross section. In the prior art, a fluid-tight seal is formed between the surface of a tubular body of a catheter and the surface of a seal portion present inside or outside thereof. Control the flow. However, since the surfaces form a liquid-tight seal as described above, it is not possible to easily operate the seal portion where the frictional resistance between the surface of the tubular body and the surface of the seal portion is large. For this reason, there is a risk that the extended part that extends the seal force during operation may be damaged. In addition, such a valve having a liquid-tight seal between its surfaces needs to be manufactured with extremely tight tolerances, which poses a problem in the manufacturing process.

[0009] Similarly, Patent Document 2 discloses a system for maintaining the inflation of a temporary occlusion balloon. In this prior art, the expansion member is inserted at the proximal end of the inflation conduit for inflating the balloon to maintain the inflation of the balloon. The surface of the inner surface and the outer surface of the extension member are connected or screwed together. In the case of coupling between surfaces, there are problems such as high frictional resistance as in Patent Document 1.In the case of a screw type, it is necessary to tighten the screws between thin members to form a seal. There is a problem that it is very difficult to operate at the procedure site.

[0010] As described above, some of the temporary occlusion drainage catheters have a knob mechanism on the proximal side for sealing the lumen of the catheter. This valve mechanism has a movable portion according to the present invention and is often operated with an adapter attached.However, since the shaft of the temporary closing balloon catheter is generally very thin, the adapter force cannot be applied. There is a problem if it is easily destroyed. [0011] Patent Document 3 discloses a catheter that blocks blood flow using a single inflation balloon and an adapter for inflating or deflating the inflation balloon. It is stated only that the adapter in the prior art is detachable from the proximal end portion of the catheter, and the adapter is also provided with the function of operating the elongate member (movable part in the present invention) in the prior art. Not been. In such a case, it is considered that the extension member is directly operated by the operator's hand, but it is considerably difficult to directly operate the thin shaft by hand. The fitting between the extension member and the catheter body and the fluid seal are performed by threading or friction.In the case of threading, inserting a thin extension member into a thin shaft with a screw in a real clinical setting is very operation. There is a problem that a smooth procedure cannot be performed. In addition, in the case of fitting by friction, it is necessary to manufacture with very close tolerances in order to demonstrate the performance of the fluid seal, and at the same time, to demonstrate the performance of the fluid seal There was a problem when the extension member and the catheter shaft were destroyed when operating an extension member with extremely high frictional resistance.

[0012] Patent Document 4 discloses a catheter having a valve of a rope opening file and an inflation adapter for operating the valve. The adapter in the prior art is a housing having a first portion and a second portion, which secures the catheter within the housing, and the first and second portions are brought together and housed with a lock'clip. However, the catheter cannot be easily fixed by one operation, and there is a problem that a smooth operation cannot be performed in an actual clinical site. Further, in order to inject a fluid into the connected catheter, it is necessary to attach an external pressurized fluid source (the inflation mechanism in the present invention), and it has been necessary to take a large space on a procedure table in a clinical setting. The prior art adapter is configured so that the movement distance of the valve increases with an increase in the operation amount of the actuator (the operation part in the present invention), and furthermore, the distance between the panel for fixing the catheter and the catheter is increased. Since the valve is configured to maximize frictional force, if the valve setting is misaligned, the valve will not move anymore. There was a problem of doing it. A similar problem is caused by the valve striking structure. In such cases, if the moving distance of the knob is small, the fluid cannot be sealed, and if the moving distance of the valve is large, the catheter will be broken.

 Patent Document 1: Japanese Patent Publication No. 2000-511082

 Patent Document 2: JP 2001-190686 A

 Patent Document 3: JP 2002-126093 A

 Patent Document 4: Japanese Translation of PCT International Publication No. 2001-523535

 Disclosure of the invention

 Problems to be solved by the invention

[0013] In view of these circumstances, what the present invention seeks to solve is that the sealing member can be operated with a small force and can be easily manufactured without requiring strict tolerances in the manufacturing process. Provide a catheter that can be used, and furthermore, the catheter can be fixed easily and securely, does not cause destruction of the catheter or damage to blood vessels, even if the operator's skill is insufficient and there is a concern about operation errors. Another object of the present invention is to provide an adapter that enables stable operation.

 Means for solving the problem

 [0014] The present invention provides a catheter having a balloon, a tubular body having an inflation lumen through which a fluid for expanding or deflating the balloon is movable, and a fluid seal portion for sealing the fluid. A catheter characterized in that the structure of the sealing portion comprises a movable sealing member having a tapered portion whose outer diameter gradually decreases, and a sealing portion force fitted to the tapered portion. It is preferable that a maximum outer diameter of the tapering portion of the sealing member is larger than a minimum inner diameter of the sealing portion. According to such a configuration, the sealing member can be operated with a small force without using a specific expansion adapter, and can be easily manufactured without requiring strict tolerances in a manufacturing process.

It is preferable that the center line average roughness Ra of the sealed portion is 0.80 m or less, more preferably, the center line average roughness Ra of the sealed portion is 0.40 / zm or less. And more preferably, the center line average roughness Ra of the sealed portion is 0.20 / zm or less. According to these configurations, it is easy to exhibit high sealing properties. [0016] It is preferable to have a structure for preventing the sealing member from falling off from the proximal end of the tubular body.

 [0017] Further, it is preferable that a substance for improving the sealing property is disposed at a contact portion between the sealing member and the sealing portion, and a seal is provided at a contact portion between the sealing member and the sealing portion. More preferably, the substance for improving the properties is silicone oil.

 [0018] It is preferable that the fluid seal portion exists on the proximal side of a maximum outer diameter portion of the sealing member.

 [0019] Further, it is preferable that one fluid seal portion is present on each of a distal side and a proximal side of a maximum outer diameter portion of the sealing member. According to these structures, it becomes possible to prevent the sealing member, which does not have a special drop-prevention mechanism, from falling off the proximal end force of the tubular body.

 [0020] Furthermore, since the fluid seal portion is present at one position on the distal side and one position on the proximal side of the maximum outer diameter portion of the sealing portion, respectively, when the seal on the distal side is released, This makes it possible to prevent the fluid from flowing out of the tubular body from the opening at the proximal end of the tubular body.

 [0021] It is preferable that a fluid passage for expanding or deflating the balloon passes through a side surface of the tubular body closer to the sealing portion than the sealing portion. According to this structure, it is possible to reliably secure a fluid path.

[0022] The present invention is also a force catheter system including a catheter and an adapter for operating the catheter, wherein the catheter is capable of moving a balloon and a fluid for expanding or deflating the balloon. A tubular body having an inflation lumen; and a catheter having a fluid seal portion for sealing the fluid, wherein the structure of the fluid seal portion is a movable sealing member having a tapered portion whose outer diameter gradually decreases. A sealing portion force fitted with the tapered portion, wherein the adapter is adapted to insert a movable or detachable movable portion including the proximal portion of the catheter including the sealing portion and the sealing member. A fixed portion for sandwiching a proximal portion of the catheter inserted in the groove, the movable portion of the catheter inserted in the groove. A driving part for sandwiching and fixing the part and moving the movable part, and operating the driving part. It is preferable that a control mechanism be provided that has an operating portion that does not generate a load equal to or more than a predetermined value in the axial direction of the movable portion when the operating portion is operated. According to such a configuration, the catheter can be fixed easily and securely, and does not cause breakage of the catheter, and a stable operation can be performed without depending on the skill of the operator or operation error. In addition, since the control mechanism includes an elastic body, the control mechanism can be easily realized.

 [0023] Further, it is preferable that the operation portion, which preferably includes an inflation mechanism for injecting a fluid into the medical device from the vicinity of the movable portion, is operated by rotation. According to these configurations, it is possible to make the device itself compact, which does not require a large space for the procedure table.

 [0024] Further, since the fixing of the movable portion in the driving portion and the fixing of the proximal end portion of the medical device in the fixed portion are performed almost simultaneously, the operator can fix the catheter and the movable portion in one operation. It is possible to operate smoothly and reliably in clinical practice!

 [0025] It is more preferable that the port portion of the medical device be sealed and sealed by fixing the proximal portion of the medical device at the fixing portion. According to these configurations, smooth and reliable operation of the force catheter at the clinical site is possible.

 The invention's effect

 [0026] As described above, the catheter of the present invention has a fluid seal portion inside a tubular body having an inflation lumen of the catheter, and has a movable portion having a tapered portion whose outer diameter gradually decreases as a result of the structural force of the fluid seal portion. Since the sealing member and the sealing part force that fits into the tapered portion are also configured, the sealing member can be operated with a small force, and it can be easily performed without requiring tight tolerances in the manufacturing process. It is possible to provide a catheter that can be manufactured.

 BEST MODE FOR CARRYING OUT THE INVENTION

Hereinafter, the catheter according to the present invention will be described. The present invention relates to a catheter having a balloon, a tubular body having an inflation lumen through which a fluid for expanding or deflating the balloon is movable, and a fluid seal portion for sealing the fluid, wherein the structure of the fluid seal portion is provided. Has a tapered portion where the outer diameter gradually decreases A catheter comprising: a movable sealing member; and a sealing partial force fitted to the tapered portion. More preferably, the maximum outer diameter of the tapered portion of the sealing member is larger than the minimum inner diameter of the sealing portion. According to these structures, it is possible to form a fluid seal with a small force. In this state, a seal is formed in the fluid seal portion, and in a state in which the fluid is not moved between the outside of the tubular body and the inflation lumen, in a state where the seal in the fluid seal portion is released, Fluid movement between the outside of the tubular body and the inflation lumen is possible. The present invention relates to various catheters having a balloon, for example, PTCA catheters, PTA catheters, balloon catheters for temporary occlusion, and the like.

FIG. 1 shows an overall view of a balloon catheter for temporary occlusion which is one embodiment of the catheter according to the present invention. In each of the drawings from FIG. 1 to FIG. 9, the left side shows the proximal side and the right side shows the far side. 2 (a) and 2 (b) are enlarged views (cross-sectional views) of the vicinity of the proximal end of the catheter including the fluid seal portion in one embodiment of the catheter according to the present invention. One embodiment of the catheter according to the present invention, shown in FIG. 1, has an elongated, flexible tubular body 101 and a balloon 102 at the distal end of the catheter for expanding or occluding a body lumen. . FIGS. 2A and 2B show an inflation lumen 201 in which a fluid for expanding or contracting a balloon formed inside a tubular body 205 is movable, and a fluid sealing portion 202. In addition, the sealing member 204 is in close contact with the tapered portion 203A where the outer diameter is reduced due to the force on the proximal side of the sealing member 203 whose fluid sealing portion is movable toward the distal side. At this time, it is preferable that the maximum outer diameter (the outer diameter at 203B) of the tapered portion 203A be larger than the minimum inner diameter of the sealing portion 204. The sealing member 203 has a tapered portion 203A, and the outer diameter force of the tapered portion 203A at 203B is larger than the minimum inner diameter of the sealing portion 204. be able to. Further, since the taper portion 203A is provided, an appropriate seal can be formed by the amount of the sealing member 203 pushed into the sealing portion 204. Therefore, if the outer diameter of 203B is smaller than the inner diameter of the tubular body 205 which is larger than the minimum inner diameter of the sealed portion 204, no particularly tight tolerance is required. . Therefore, the sealing member 203 can be easily manufactured. A sealing member having no tapered portion (for example, a stepped sealing member) should form a seal with the inner surface of the sealing portion 204 as in the prior art disclosed in JP-A-2001-190686. In this case, a strict tolerance is required for the outer diameter of the sealing member, and it cannot be easily manufactured. Further, since a seal is formed between the inner surface of the sealing portion 204 and the outer surface of the sealing member, the sealing member may be damaged during an operation in which the fitting is tight. On the other hand, the catheter according to the present invention forms a seal by fitting the tapered portion 203A and the sealing portion 204, so that the formation and release of the seal can be performed with a small force. Further, the elevation angle の of the tapered portion 203A is preferably 0.10 degrees or more, and more preferably 0.40 degrees or more. If the elevation angle Θ is less than 0.10 degrees, the tight contact between the tapered portion 203A and the sealing portion 204 is so strong that the sealing member 203 may be damaged during operation. The elevation angle の of the tapered portion 203A is preferably not more than 60.00 degrees.

 [0029] The proximal portion 203C of the sealing member 203 is necessarily formed of a tapered portion and a cylindrical portion, and need not necessarily be formed of only a tapered portion or a cylindrical portion. Such a shape is also possible. The distal portion 203D of the sealing member can be cylindrical or any other shape. The most important portion of the sealing member 203 is the tapered portion 203A, and the shapes of 203C and 203D can be any shape.

 FIG. 2 (a) shows a state in which a seal is formed in the fluid seal portion 202, and in this state, the movement of fluid between the outside of the tubular body 205 and the inflation lumen 201. Is impossible. FIG. 2B shows a state in which the seal is released at the fluid seal portion 202.In this state, the fluid can move between the outside of the tubular body 205 and the inflation lumen 201, and the balloon 102 expands. And shrinkage can be performed. The proximal opening force of the tubular body 205 can also inflate and deflate the balloon 102 by injecting fluid. Further, it is preferable to have a side hole on the tubular body through which a fluid for expanding or deflating the balloon passes.

[0031] The center line average roughness Ra on the surface of the sealed portion 204 is preferably 0.80 m or less. When the center line average roughness Ra on the surface of the sealed portion 204 is greater than 0.80 m In this case, high sealing performance cannot be achieved, and the sealing member 203 needs to be pressed with a large force against the sealing portion 204, so that the sealing member 203 may be damaged. Further, when a high pressure is generated from the inflation lumen, the seal may be released, or fluid may leak out of the tubular body 205 from a gap in the seal. Perspective of operability at actual treatment sites It is required that sealing can be performed with as small a force as possible.Therefore, the center line average roughness Ra is preferably 0.40 / zm or less, and more preferably the center line average roughness. Ra is less than 0.20 / zm. According to the present invention, the center line average roughness Ra and ίo IS Β0601-1982. As the measuring device, for example, there is a three-dimensional interference measuring microscope (manufactured by zygo).

 [0032] The sealing portion 204 can be made of any material. In order to exhibit high sealing performance in the fluid sealing portion 202, it is preferable that the sealing portion 204 also has a high polymer material force. Considering the easiness of production, it is more preferable that the group force is selected from the group consisting of polyimide, polyamide, polyurethane, Teflon (registered trademark), silicone rubber, polyamide-based elastomer and polyurethane-based elastomer. ,. In order to achieve high sealing performance when the thickness of the sealed portion 204 is thin and when repeated sealing operations are performed, polyimide is also used in view of ease of tube formation and resin hardness. Is more preferable. When the sealing portion 204 is made of metal, the above-mentioned surface roughness is particularly important.

 [0033] In order to achieve even higher sealing performance in the fluid sealing portion 202, it is preferable that a substance that improves the sealing property is arranged at the contact portion between the sealing member 203 and the sealing portion 204. From the viewpoint of the operability and the performance of improving the sealability, it is more preferable that the substance that improves the sealability is silicone oil in consideration of the fluidity.

 As shown in FIG. 2A, by joining the sealing portion 204 to the tubular body 205, the material of the sealing portion 204 can be freely selected regardless of the material of the tubular body 205. The sealing portion 204 can be joined to the inside of the tubular body 205 by a method known to those skilled in the art (for example, adhesion or welding)

Since the sealing member 203 has a certain degree of rigidity and is easy to operate, at least a part thereof, for example, 203A and 203C is made of stainless steel, Ni—Ti, Ni—Ti Fe, Ni— Ti—Cu, Ni—Ti—Cr, Ni—Ti—V, Ni—Ti—Co, Ni—Ti—Nb, Ni—Ti—Pd, Ni—Ti—Cu—Cr, Fe Mn—Si, Co— It is preferable that one or more selected from the group force composed of Cr or a composite thereof is also formed. In addition, in order to exhibit high sealing performance in the fluid seal portion 202, considering the ease of manufacture when manufacturing a catheter in which at least a part of the sealing member 203 preferably has a high polymer material strength, Polyimide, polyamide, polyurethane, Teflon (registered trademark), silicone rubber, polyamide-based elastomer or polyurethane-based elastomer are preferred. In particular, when the sealing portion 204 is made of metal, it is preferable that at least a portion of the sealing member 203 involved in the adhesion with the sealing portion 204 also has the above-mentioned polymer material strength.

FIGS. 3 (a) and 3 (b) are cross-sectional views showing the vicinity of the proximal end of the catheter in another embodiment. As in the embodiment of FIG. 2 (a), the inflation lumen 301 and the sealing member 303, It has sealing components 304A, 304B, and tubular bodies 305, 305A, 305B. The sealing portion 304A in 03 (a) is a part of the tubular body 305, and the sealing member 303 includes a tapered portion 303A, a proximal portion 303C, and a distal portion 303D. The sealing portion 304B in FIG. 3 (b) is a part of the tubular body 305A, and is disposed inside the tubular body 305B. Since the sealing portion is a part of the tubular body, the number of constituent members is reduced, and the manufacturing is easy.

FIG. 4 is a cross-sectional view near the proximal end of the catheter according to another embodiment, and includes an inflation lumen 401, a sealing member 403, and a sealing portion 404, similarly to the embodiment of FIG. As shown in FIG. 4, the tubular body force at the proximal end portion of the catheter may be constituted by tubular bodies 405A, 405B, and 405C, or may be made of different materials. When the tubular body is used as a very small diameter catheter such as a balloon catheter for temporary occlusion, the thickness of the tubular body needs to be extremely thin, so that the kink resistance and the delivery property of the catheter are important. To polyimide, stainless steel, Ni—Ti, Ni—Ti Fe, Ni—Ti—Cu, Ni—Ti—Cr, Ni—Ti—V, Ni—Ti—Co, Ni—Ti—Nb, Ni—Ti—Pd , Ni—Ti—Cu—Cr, Fe Mn Si, and Co—Cr It is preferable to be made of one or more selected from or a composite thereof. The respective tubular joints 406A and 406B can be joined by methods well known to those skilled in the art (eg, gluing or welding). Joining multiple tubular bodies Thus, such a structure near the proximal end of the catheter can be easily manufactured. Further, it is preferable to have a side hole 407 on the tubular body through which a fluid for expanding or contracting the nore passes. When the sealing member 403 is moved proximally to release the seal and expand or contract the balloon, only the proximal end opening 408 of the tubular body and the outside of the tubular body 405A-405B and the inflation lumen 401 are used. When the fluid is moved between the balloon and the balloon, it may take time to inflate or deflate the balloon, which narrows the passage of the fluid. The time required to inflate or deflate the balloon is also associated with the time required for the entire procedure, and may increase the burden on the patient. In the case of a balloon catheter for temporary occlusion, when an abnormality is found in a patient during occlusion of a blood vessel, it may be necessary to deflate the balloon immediately to restore blood flow. At this time, if it takes time to deflate the balloon, the recovery of blood flow may be delayed and the burden on the patient may increase. Therefore, it is preferable that the side hole 407 be provided to ensure the path of the fluid. The location of the side hole 407 may be any location as long as it is on the tubular body proximal to the sealing portion 404, and the number and shape of the side holes are not limited.

By having a structure to prevent the sealing member 403 from falling off from the proximal end opening 408 of the tubular body, when the seal is once released and the seal is to be formed again, the sealing member is lost or damaged. Can be prevented. Further, in the case of a balloon catheter for temporary occlusion, it is difficult to reconnect the sealing member that has fallen off from the proximal end cap of the tubular body and the outer diameter of the sealing member to be reduced at the treatment site. It will be. Therefore, it is preferable to have a structure that prevents the sealing member 403 from falling off from the proximal end opening 408 of the tubular body. As a method of preventing the sealing member 403 from falling off, a method of fixing a portion of the sealing member 403 to the tubular body is considered, but the maximum outer diameter of a portion of the sealing member 403 that can be inserted into the tubular body is considered. Is preferably larger than the minimum inner diameter at the proximal end 409 of the tubular body, so that the sealing member 403 is prevented from falling off to prevent the sealing member 403 from falling off. In order to have such a structure for preventing the sealing member from falling off, it is preferable that the sealing portion is disposed inside the tubular body. Although the method of manufacturing the proximal end 409 of the tubular body is not limited, as shown in FIG. 4, the proximal end portion of the tubular body 405C constituting the proximal end is subjected to drawing processing to form the proximal end of the tubular body. 409 to It can be easily manufactured, and the strength of the proximal end 409 of the tubular body can be increased. It is also possible to adopt a structure in which another member is joined to the proximal end of the tubular body to prevent the sealing member from falling off from the proximal end of the tubular body. For example, by joining a member having a ring portion having an inner diameter smaller than the maximum outer diameter portion of the sealing member to the proximal end of the tubular body, it is possible to provide a mechanism for preventing the sealing member from falling off. Such a mechanism for preventing the sealing member from falling off can be applied to any embodiment.

 FIG. 5 is a cross-sectional view near the proximal end of the catheter according to still another embodiment. As in the embodiment shown in FIG. 4, the inflation lumen 501, the sealing member 503, the sealing portion 504, and the side hole 507 are provided. It has. The portion near the proximal end of the catheter is formed by the tubular body 505A and the tubular body 505B. The proximal end portion of the tubular body 505A is drawn, covered with the tubular body 505B, and formed at the joint 506 by a method well known to those skilled in the art. Bonding at a distance makes it possible to reduce the profile near the catheter proximal end. The tubular body 505B is drawn at the proximal end to prevent the sealing member 503 from falling off. However, the method of preventing the sealing member 503 from falling off is not limited to this, and a tubular body having an inner diameter smaller than the outer diameter of the tubular body 503B may be joined to the proximal end portion of the tubular body 505B. Further, by joining the reinforcing member 510 to the proximal end portion of the sealing member 503 at the joint 511 by a method known to those skilled in the art, the operation of the sealing member 503 becomes easy. Further, since the tubular body 505B or the tubular body 510 always exists outside the proximal cylindrical portion 503C of the sealing member 503, the strength of the catheter can be increased. Further, the sealing member 503 and the reinforcing member 510 can be integrally formed. Such a structure of the reinforcing member or the like can be applied to any embodiment.

FIG. 6 is a cross-sectional view near the proximal end of a catheter according to yet another embodiment, which is the same as the embodiment shown in FIG. 5 except for the sealing portion 604 and the panel 612. The sealing portion 604 is a portion obtained by drawing the proximal end portion of the tubular body 605A. The sealing portion 604 is joined to the tubular body 605B at the joining portion 606, and at the same time, a seal is formed by being in close contact with the sealing member 603. are doing. The panel 612 disposed between the largest outer diameter portion 603B that can be inserted into the inside of the tubular body of the sealing member 603 and the proximal end drawing portion of the tubular body 605B releases the seal once, and re-opens the seal. When forming the seal, the seal can be formed by the force of the panel 612 without applying a force toward the distal end to the sealing member 603 from outside. The spring 612 may or may not be joined to the sealing member 603 and the tubular body 605B. When joining, it is joined by a method well known to those skilled in the art. Further, the position where the panel 612 is arranged is not limited to the above-mentioned portion, and may be any other position that may be arranged outside the tubular body 605B or inside the reinforcing member 610. Such panels can be used in any embodiment.

 FIGS. 7 and 8 are cross-sectional views of a catheter proximal end according to still another embodiment, in which a fluid seal portion 702 is present on a proximal side of a maximum outer diameter portion 703B of a sealing member 703. The fluid seal portions 802A and 802B may be located one each on the distal side and the proximal side of the largest outer diameter portion 803B of the sealing portion 803. Since the fluid seal portion is located on the proximal side of the maximum outer diameter portion of the sealing member, it is necessary to prevent the sealing member from falling off the proximal end force of the tubular body without providing a special drop-out prevention mechanism. Becomes possible. In addition, since the fluid seal portion is present at one position on the distal side and one position on the proximal side of the largest outer diameter portion of the sealing portion, a proximal seal is formed when the distal seal is released. It is possible to prevent a fluid other than the side hole 807 from flowing out of the tubular body.

[0042] The tubular body 101 of the temporary occlusion balloon catheter as shown in Fig. 1 may be located inside the guide wire lumen of another therapeutic force table. The temporary occlusion balloon catheter is expanded by a dilatation device connected to the proximal end of the catheter or to the normal expansion port, but when the dilatation device is connected, another treatment catheter can be temporarily occluded by the balloon. Unable to operate along the tubular body 101 of the catheter. The force catheter according to the present invention has a fluid seal portion 202 and can be used as such a temporary occlusion balloon catheter because the balloon can be maintained in an inflated state even when the inflation device is removed. preferable. Further, when another treatment catheter is used along the tubular body 101 of the balloon catheter for temporary occlusion, the type of the treatment catheter that can be used as the outer diameter of the tubular body 101 and the portion 103 near the proximal end of the catheter is smaller is used. The outer diameter of the tubular body 101 and the portion 103 near the proximal end of the catheter should be less than 0.018 inches. More preferably, it is 0.014 inches or less, which is the most common guide wire outer diameter that is preferred. The temporary occlusion balloon catheter may have a guidewire lumen, and the guidewire lumen may be located anywhere on the catheter. For example, the proximal entrance of the guidewire lumen may be proximal to the temporary occlusion balloon or distal to the temporary occlusion balloon. FIG. 10 is a plan view and FIG. 11 is a side view of an embodiment of the included adapter. The adapters 100 1 and 1101 according to the present invention shown in FIGS. 10 and 11 have grooves 1002 and 1102 for inserting a catheter, a fixing portion 1003, a driving portion 1004, a fixing knob 1005, and an abutting portion 1006. . FIG. 12 shows a balloon catheter for temporary occlusion used as one embodiment of the catheter. FIG. 12 (a) is an external view of a balloon catheter for temporary occlusion, and FIG. 12 (b) is an inner view of the balloon catheter for temporary occlusion. The temporary occlusion balloon catheter 1201 includes a tubular body 1202, a nolan 1203, an inflation lumen 1204 through which a fluid for expanding or deflating the balloon 1203 can move, a port portion 1205 through which fluid flows to the side surface of the proximal portion, It has a movable portion 1206 including a sealing member movable relative to the tubular body 1202, and a fluid seal portion 1207 for sealing a fluid by a sealing portion 1208 fitted with the movable portion 1206. After introducing the catheter 1201 into the patient and placing the force catheter so that the balloon 1203 comes to the periphery of the lesion, insert the proximal portion of the catheter 1201 into the groove 1002 of the adapter 1001 and rotate the fixation knob 1005. With this, the catheter 1201 can be fixed to the adapter 1001. At this time, it is preferable to fix the catheter 1201 by dropping it into the groove 1002 to determine the circumferential position of the catheter 1201.The proximal end of the catheter 1201 is abutted against the abutting portion 1006, which is preferable. It is preferable to determine By dropping the catheter 1201 to the bottom of the groove 1002, it is possible to determine the circumferential position of the catheter 1201 simply and reliably, and it is not necessary to use a marker or the like by abutting the proximal end of the catheter 1201. Furthermore, the axial position of the catheter 1201 can be easily and reliably determined. For example, if a lateral hole for positioning is provided in the adapter and the lateral hole is positioned in the circumferential direction through a catheter, The proximal end force of a thin catheter must also be passed through the side hole. In an actual clinical setting, it is necessary to check the position of the lateral force lateral hole in order to pass the catheter through the lateral hole even further in the dark, which is extremely troublesome. In addition, the catheter may be kinked when the catheter is passed through the side hole. When the catheter 1201 is positioned in the circumferential direction by a structure in which the catheter 1201 is dropped into the groove 1002 as in the adapter 1001 according to the present invention, the operator can surely drop the catheter 1201 into the adapter 1001 even in the dark clinical setting where the upper force is also dropped. The catheter 1201 is not likely to be broken by kink or the like. In addition, when positioning the catheter in the axial direction by arranging a marker on the catheter at a specified position on the adapter, it is very difficult in an actual dark clinical site, but it is very difficult as in the case of the adapter 1001 according to the present invention. In addition, by positioning the catheter 1201 in the axial direction by a structure in which the proximal end of the catheter 1201 is abutted, the positioning can be performed reliably and easily even in a dark clinical site. Further, when the fixing knob 1005 is rotated to fix the catheter 1201, the fixing of the movable portion 1206 of the catheter 1201 in the driving portion 1004 and the fixing of the proximal portion of the catheter 1201 in the fixing portion 1003 are performed almost simultaneously. For this reason, it is preferable that the operation by rotation of the fixing knob 1005 communicates with both the driving portion 1004 and the fixed portion 1003. As a result, the operator can fix the catheter 1201 and the movable portion 1206 in one operation, and the operation can be performed smoothly and reliably at the clinical site. FIG. 13 shows an inner view of the adapter of the embodiment shown in FIG. FIG. 13 (a) is a view of the adapter 1301 before fixing the force table, and FIG. 13 (b) is fixing the catheter, expanding the balloon, and closing the fluid seal portion of the catheter. It is a diagram of the adapter 1301. When the proximal side of the catheter 1201 shown in FIG. 12 is inserted into the groove 1302 and the proximal end of the catheter 1201 is abutted against the abutting portion 1306, the port 1205 of the catheter 1201 is placed in the sealed portion 1307 of the adapter 1301. You. Then, the fixing knob 1005 is rotated to fix the proximal side of the catheter 1201 and the movable portion 1206 to the adapter 1301. At the same time, the ゝ sealing of the adapter 1301 咅 盼 the 1307 force Seal tightly. As a result, as shown in FIG. 13 (b), the inflation knob 1308 is then rotated to inject fluid into the balloon 1203, and the Can be extended. The inflation knob 1308 is preferably capable of finely controlling the amount of injection into the balloon 1203. In the case of a temporary ozone catheter 1201, it is necessary to control the balloon diameter optimally according to the amount of injection. Therefore, it is preferable to control the balloon with an accuracy of 5 L or less. In addition, since the adapter 1301 has an injection volume scale, the operator can easily control the injection volume. Since the adapter 1301 has the inflation mechanism as described above, it is possible to reduce the size of the device itself, which does not require a large space on the procedure table. In order to securely seal around the port 1205 of the catheter 1201, the sealing portion 1307 of the adapter 1301 is preferably made of silicone rubber or butadiene rubber. In addition, the proximal side of the catheter 1201 and the movable part 1206 are fixed to the adapter 1301, and at the same time, the sealing part 1307 sandwiches the port 1205 of the catheter 1201 and securely seals around the port 1205. And a reliable operation becomes possible. FIG. 14 shows an enlarged view of the fixed part and the drive part of the adapter of the embodiment shown in FIG. Fig. 14 (a) shows the state before the catheter is fixed, and Fig. 14 (b) shows the state of the fixed part and the drive part after the operation to close the fluid seal part of the catheter described later is performed. is there. After the catheter fixing operation and the balloon expanding operation described above, by rotating the operating portion 1309 of the adapter, the driving portion 1404 moves to the distal side of the catheter 1201 via the shaft 1401. Since the movable part 1206 of the catheter 1201 is fixed by the drive part 1404, the movable part 1206 also moves to the distal side with the movement of the drive part 1404, and the catheter moves by moving the movable part 1206 to the distal side. The fluid seal portion existing on the proximal side of 1201 can be closed. In addition, the sealing portion of the drive portion 1404 (the portion in contact with the movable portion 1206 of the drive portion 1404) 1407 is preferably made of a polymer material. The polymer material is preferably polyamide, polyurethane, polyester, polyolefin, Teflon ( (Registered trademark), silicone rubber, butadiene rubber, polycarbonate, ABS resin, polypropylene, polystyrene, polyamide-based elastomer, polyesterenole-based elastomer, polyolefin-based elastomer or polyurethane-based elastomer or a composite thereof. In order to properly fix the movable portion 1206 by the driving portion 1404, it is preferable that the polyamide-based elastomer be used. The operation performed in operation part 1309 The shaft for transmitting and the driving portion 1404 are preferably connected by an elastic body, and more preferably the elastic body is a panel. Since the shaft 1401 and the driving portion 1404 are connected in the moving direction of the shaft 1401 by the panel 1405 and the panel 1406, the load in the moving direction of the shaft 1401 due to the operation of the operating portion 1309 is absorbed by the panel 1405 and the panel 1406. Through the portion 1404, it is possible to have a control mechanism in which a load equal to or more than a certain value is not generated in the movable portion 1206 in the axial direction. The load generated in the axial direction of the movable part 1206 can be easily determined by the spring constant, and the most suitable panel can be selected according to the catheter to be used. Panel 1405 and panel 1406 may or may not be joined to shaft 1401 and drive portion 1404. When joining, joining is performed by a method well known to those skilled in the art. In addition, by having two panels 1405 and 1406, the load in the direction of movement of the shaft 1401 is moved by the panel 1405 when moving the movable part 1206 to the distal side, and by the panel 1406 when moving it to the proximal side. Can be absorbed. By using panels with different panel constants when moving to the distal side and when moving to the proximal side, the axial load generated on the movable part 1206 can be reduced when moving the distal side and when moving proximally. It can be adjusted with. The fluid seal portion 1207 of the catheter 1201 shown in FIG. 12 is closed by pressing the distal side of the movable portion 1206 against the sealed portion 1208 inside the tubular body 1202, but the movable distance of the movable portion 1206 is too large. In such a case, the sealed portion 1208 or the movable portion 1206 may be broken. However, with the control mechanism as described above, even when the moving distance of the movable portion 1206 is too large, a load exceeding a certain value is not generated, and thus the sealing portion 1208 and the movable portion 1206 do not break. Furthermore, since the axial load that presses the distal side of the movable portion 1206 against the sealing portion 1208 can be constant regardless of the force for operating the operation portion, the fluid seal can be performed regardless of the operator's handling. A reliable seal can be achieved when the part 1207 is closed. Like the fixing knob 1005, the inflation knob 1308, and the operating portion 1309 of the adapter 1001 in this embodiment, the fixing of the catheter 1201, the inflation, and the operation of the operating portion 1309 are preferably operated by rotation. As a result, each operating part can be stored in a small part in the adapter, and the device itself can be made compact without having to take up a large space on the procedure table. FIG. 15 shows another embodiment of the fixed part and the drive part of the adapter included in the catheter system according to the present invention. FIG. 15 (a) shows a state before the catheter is fixed, and FIG. 15 (b) shows a state of the fixed part and the driving part after an operation of closing a fluid seal part of the catheter described later is performed. FIG. 16 shows a balloon catheter for temporary occlusion as another embodiment of the catheter. A temporary occlusion balloon catheter 1601 in this embodiment includes a tubular body 1602 having a distal end and a proximal end, a balloon 1603 near the distal end, and a balloon 1603 expanded or deflated between the distal and proximal ends. The inflation lumen 1604 through which the fluid can move, the port 1605 through which the fluid passes to the proximal end, the movable part 1606 detachable from the tubular body 1602, and the fluid seal part 1607 that controls the fluid by moving the movable part 1606. Have. FIG. 16A is an external view of the fluid seal portion 1607 of this embodiment in a closed state, and FIG. 16B is an inner view of the fluid seal portion 1607 in an open state. The catheter 1601 is introduced into the patient, and the catheter 1601 is arranged so that the balloon 1603 comes to the periphery of the lesion.Then, the proximal side of the catheter 1601 is inserted into the groove 1502, and the shaft 1501 is moved in the circumferential direction of the catheter 1601. Then fix the catheter 1601. At this time, the fixing of the movable portion 1606 of the catheter 1601 in the driving portion 1504 is preferably performed via a panel 1505 existing between the shaft 1501 and the driving portion 1504. This allows the panel 1505 to absorb the load in the driving portion 1504 in the circumferential direction of the catheter 1601 and to keep the load fixing the catheter 1601 constant. Thereafter, the drive portion 1504 is moved to move the movable portion 1606 of the catheter 1601 to the distal side, and the fluid seal portion 1607 of the catheter 1601 is closed. By making the load for fixing the movable portion 1606 constant, it is possible to have a control mechanism in which a load equal to or greater than a certain value is generated in the axial direction of the movable portion 1606 through the drive portion 1504. The load in the axial direction of the drive part 1504 is absorbed by sliding between the contact part 1508 of the drive part 1504 (the part in contact with the movable part of the drive part) 1508 and the movable part 1606, and a certain amount or more in the axial direction of the movable part 1606 It is possible to avoid the occurrence of the load. Since the load to fix the movable part 1606 is determined by the frictional force between the contact part 1508 and the movable part 1606, the panel constant of the panel 1505 and the force using the material of the contact part 1508 can be selected according to the catheter. , Realizes the optimal load for fixing the movable part 1606 It is possible to do.

 Example

 Hereinafter, a catheter including the embodiment of FIG. 3 (a), an adapter including the embodiment of FIG. 5, and a balloon catheter for temporary occlusion shown in the embodiment of FIG. Although described in detail, the following examples do not limit the present invention in any way. The shape of the comparative example is shown in FIG.

 [0048] The present invention relates to a catheter system including a catheter having a balloon and an adapter for operating the catheter. In Examples 1-112 and Comparative Examples 1-16, a fluid seal portion without installing a balloon at the distal end was used. Next, all evaluations were performed (Evaluation 1). In addition, in Example 13 and Comparative Example 7, the total length for evaluating the fluid seal portion and balloon portion was 100 mm, which was not used for a temporary occlusion balloon catheter having a length of 1800 mm or more used in an actual clinical site. The evaluation of the catheter system was performed using a balloon catheter for evaluation of degree (Evaluation 2).

 (Example 1)

 (Creation of tubular body)

 A stainless steel (SUS316L) metal tube with an outer diameter of 0.31 mm and an inner diameter of 0.23 mm was used as the tubular body through which the fluid could move. A tube with a total length of 110 mm was cut into 100 mm. One end of the metal tube cut to 100 mm was a proximal end, and the other end was a distal end. The residue of the tubular body was used to measure the center line average roughness Ra.

 (Evaluation of center line average roughness)

 The remainder of the tubular body, that is, the remaining 10 mm metal tube obtained by cutting the tubular body is polished until it becomes semicircular, and the center line average roughness Ra of the inner surface of the metal tube is measured with a three-dimensional interference measurement microscope (manufactured by zygo). Was measured. The center line average roughness Ra was 0.89 m.

(Creation of sealing member)

The shape of the sealing member shall be the shape shown in 303 shown in Fig. 3 (a), and the outer diameter at the proximal portion 303C of the sealing member is 0.30mm, the length is 40mm, and the distal portion of the sealing member is 30 3D outer diameter 0.10mm, length 30mm, taper section 303A length 20mm It was designed to be. The material of the sealing member was stainless steel (SUS304). The outer diameter of the 43mm part of the 303D side end force is calculated to be 0.23mm. The outer diameter of the actually obtained sealing member was measured using a laser outer diameter measuring device and found to be 0.22 mm-0.24 mm. That is, there was a difference of ± 0. Olmm between the calculated value and the actually measured value. Of these, the evaluation described later was performed using a sealing member having an outer diameter of 0.22 mm at the portion where the 303D side end force was also 43 mm.

 (Example 2)

 A tubular body was produced in the same manner as in Example 1. The center line average roughness Ra of the inner surface of the metal tube was 0.89 m. The evaluation described below was performed using a sealing member having an outer diameter of 0.23 mm at a portion where the end force at the 303D side was 43 mm among those obtained in Example 1.

 (Example 3)

 A tubular body was produced in the same manner as in Example 1. The center line average roughness Ra of the inner surface of the metal tube was 0.89 m. The evaluation described later was performed using a sealing member having an outer diameter of 0.24 mm at a portion where the 303D side end force was 43 mm among the sealing members obtained in Example 1.

 (Example 4)

 A tubular body was prepared in the same manner as in Example 1, except that a metal tube having a different center line average roughness was used. The center line average roughness Ra of the inner surface of the metal tube was 0.62 m. The evaluation described later was performed using a sealing member having an outer diameter of 0.22 mm at a portion where the end force on the 303D side was 43 mm among the sealing members obtained in Example 1.

 (Example 5)

 A tubular body was prepared in the same manner as in Example 4. The center line average roughness Ra of the inner surface of the metal tube was 0.62 m. The evaluation described below was performed using a sealing member having an outer diameter of 0.23 mm at a portion where the end force at the 303D side was 43 mm among those obtained in Example 1.

 (Example 6)

A tubular body was prepared in the same manner as in Example 4. The center line average roughness of the inner surface of the metal tube is R a was 0.62 / zm. The evaluation described later was performed using a sealing member having an outer diameter of 0.24 mm at a portion where the 303D side end force was 43 mm among the sealing members obtained in Example 1.

 (Example 7)

 A tubular body was prepared in the same manner as in Example 1, except that a metal tube having a different center line average roughness was used. The center line average roughness Ra of the inner surface of the metal tube was 0.28 m. The evaluation described later was performed using a sealing member having an outer diameter of 0.22 mm at a portion where the end force on the 303D side was 43 mm among the sealing members obtained in Example 1.

 (Example 8)

 A tubular body was produced in the same manner as in Example 7. The center line average roughness Ra of the inner surface of the metal tube was 0.28 / zm. The evaluation described below was performed using a sealing member having an outer diameter of 0.23 mm at a portion where the end force at the 303D side was 43 mm among those obtained in Example 1.

 (Example 9)

 A tubular body was produced in the same manner as in Example 7. The center line average roughness Ra of the inner surface of the metal tube was 0.28 / zm. The evaluation described later was performed using a sealing member having an outer diameter of 0.24 mm at a portion where the 303D side end force was 43 mm among the sealing members obtained in Example 1.

 (Example 10)

 A tubular body was prepared in the same manner as in Example 1, except that a metal tube having a different center line average roughness was used. The center line average roughness Ra of the inner surface of the metal tube was 0.13 m. The evaluation described later was performed using a sealing member having an outer diameter of 0.22 mm at a portion where the end force on the 303D side was 43 mm among the sealing members obtained in Example 1.

 (Example 11)

A tubular body was produced in the same manner as in Example 10. The center line average roughness Ra of the inner surface of the metal tube was 0.13 m. The sealing member obtained in Example 1 was evaluated using a sealing member having an outer diameter of 0.23 mm at a portion where the end force on the 3D side was also 43 mm, which was described later. (Example 12)

 A tubular body was produced in the same manner as in Example 10. The center line average roughness Ra of the inner surface of the metal tube was 0.13 m. For the sealing member, an evaluation described later was carried out using a sealing member having an outer diameter of 0.24 mm at a portion where the end force on the 3D side was 43 mm among those obtained in Example 1.

(Example 13)

 (Preparation of balloon catheter for evaluation)

As the tubular body, a stainless steel (SU S316L) metal tube having an outer diameter of 0.33 mm and an inner diameter of 0.25 mm was used. A metal tube with a total length of 100 mm was used, with one end being the proximal end and the other being the distal end. A tube of 0.80mm in outer diameter, 0.38mm in inner diameter, and 30mm in length (Atomie polyamide elastomer Pebax7233) is sealed by heat-sealing the distal end and near the distal end. A side hole having a major axis of about 1.5 mm and a minor axis of about 0.5 mm was opened using a razor and used as a sleeve. The proximal end side of the sleeve was placed ⁵ mm over the distal end side of the tubular body, and bonded using a two-component urethane adhesive. A tube with a diameter of 1.20 mm, an inner diameter of 1.00 mm, and a length of 15 mm (Thermedics thermoplastic polyurethane TecothaneTT-1085A) was used as the balloon, and the center of the balloon was placed over the side hole of the sleeve. Adhesion was performed using a two-component urethane adhesive, 5 mm on each side. The movable part has the shape shown in 1606 in Fig. 16, and the outer diameter at the distal part of the movable part is 0.10 mm, the length is 20 mm, and the outer diameter at the proximal part of the movable part is 0.30 mm, the length Using a stainless steel (SUS304) tapered wire having a length of 30 mm and a length of the intermediate tapered portion of 20 mm, 20 balloon catheters for evaluation of this example were produced. The two-component urethane adhesive used was Nippon Polyurethane Industry Co., Ltd., 4235 and Coronate 4403, mixed at a ratio of 2: 1 to obtain an adhesive.

(Production of evaluation adapter)

Using a polycarbonate plate as the base of the adapter, including the shaft 1401, the groove 1402, the fixed part 1403, the driving part 1404, the screws 1405 and 1406, the sealing part 1407, and the sealing part 1408 shown in FIG. The center part of the adapter was joined to produce an adapter for evaluation. The axial movement distance of the driving part was 6 mm. Adhesive part is Atochem polyamide ela Stoma Pebax4033 sheets were used. A silicone tube with an outer diameter of 5 mm and an inner diameter of 3 mm was inserted into the fluid injection hole leading to the sealed part, and an lmL syringe for balloon expansion was connected to the opposite end. The panel used was a panel constant INZmm.

 (Comparative Example 1)

 A tubular body was produced in the same manner as in Example 1. The center line average roughness Ra of the inner surface of the metal tube was 0.89 m. The sealing member is a stainless steel (SUS304) stepped without tapered portion shown in Fig. 9 and has an outer diameter of 0.30mm, a length of 40mm, and a proximal portion 903C of the sealing member. The outer diameter of the sealed portion 903E was 0.21 mm and the length was 40 mm.

 (Comparative Example 2)

 The same as Comparative Example 1 except that the outer diameter of the sealed portion 903E was 0.22 mm.

 (Comparative Example 3)

 The same as Comparative Example 1 except that the outer diameter of the sealed portion 903E was 0.23 mm.

 (Comparative Example 4)

 A tubular body was prepared in the same manner as in Example 1, except that a metal tube having a different center line average roughness was used. The center line average roughness Ra of the inner surface of the metal tube was 0.13 m. The sealing member is a stainless steel (SUS304) with a step that does not have a tapered portion as shown in Fig. 9 and has an outer diameter of 0.30 mm, a length of 4 Omm at the proximal portion 903C of the sealing member, and a length of 4 Omm. The outer diameter of the sealed part 903E was 0.21 mm and the length was 40 mm.

 (Comparative Example 5)

 The same as Comparative Example 4 except that the outer diameter of the sealed portion 903E was 0.22 mm.

(Comparative Example 6)

 The same as Comparative Example 4 except that the outer diameter of the sealed portion 903E was 0.23 mm.

(Comparative Example 7)

As in Example 13, 20 evaluation balloon catheters were produced. The evaluation adapter was the same as Example 13 except that panels 1405 and 1406 were removed, and the shaft and the driving part were directly joined by bolts. [0072] (Evaluation 1)

 A sealing member was inserted at the proximal end of the tubular body, and a connector was connected at the distal end. A three-way stopcock was connected to the connector, a pressure gauge was connected to one of them, and an inflation device filled with water was connected to the other. With a pressure of 5 atm applied by an inflation device, the sealing member is pushed into the proximal end of the tubular body to a position where the sealing member can be pushed in so that the sealing member is not broken, and a fluid seal is formed. I left it. The degree of pressure retention was evaluated 10 minutes later than immediately after the application of pressure. Table 1 shows the results.

[0073] [Table 1]

Ra Pressure retention Operability

 Example 1 0.8 9 μ τίΐ 9 2% 〇

 Example 2 0.8 9 μ μΩ. 9 2% 〇

 Example 3 0.8 9 μτη 9 2% 〇

 Example 4 0.β 2 μ η 9 5% 〇

 Example 5 0.6 2 μm 9 5% 〇

 Example 6 0.6 2 μτα 9 5% 〇

 Example 7 0.2 8 μΐα 9 8% 〇

 Example 8 0.2 8 μ ΐη 9 8% 〇

 Example 9 0.2 8 ^ m 9 8% 〇

 Example 10 0 0.16 μΐΏ. 9 9% 〇

 Example 1 1 0.16 μ τα 9 9% 〇

 Example 1 2 0.16 μτα 9 9% 〇

 X

 Comparative Example 1 0.8 9 m 0%

 Missing sealing member

 Comparative Example 2 0.8 9 μ τη 8 3% 〇

 X

 Comparative Example 3 0.8 9 m

 Do not push

 X

 Comparative Example 4 0.16 μ τ 0%

 Missing sealing member

 Comparative Example 5 0.1 6 μm 8 3% 〇

 X

 Comparative Example 6 0.1 6 μ τ

 Do not push

[0074] The pressure holding ratio is a value obtained by dividing the value of the pressure gauge after 10 minutes by the value of the pressure gauge immediately after applying pressure and multiplying by 100. The closer the value is to 100%, the higher the sealing performance is It indicates that. The operability indicates the ease of pushing the sealing member into the tubular body and the state at the time of sealing.

[0075] As is clear from Table 1, in Examples 1-112, the pressure holding ratio was 92% -99%, and the sealing could be performed almost certainly. Also, when the center line surface roughness Ra of the inner surface of the tubular body was the same, the pressure holding ratio could be maintained even if a difference occurred in the outer diameter of the tapered portion of the sealing member. If the center line surface roughness Ra of the tubular body surface is different, the smaller Ra is the pressure The higher the retention, the higher the sealing performance. On the other hand, in Comparative Examples 1 to 6, when the outer diameter is 0.21 mm as in Comparative Examples 1 and 4, the sealing member can be pushed into the tubular body with a small force. The pressure from the inflation device, which has a large gap with the sealing member, causes the sealing member to fall off from the tubular body, so that the sealing performance could not be exerted. In addition, when the outer diameter was 0.22 mm as in Comparative Examples 2 and 5, the pressure retention rate was 83%, which was a sufficient force to exhibit high sealing performance. When the outer diameter was 0.23 mm as in Comparative Examples 3 and 6, there was no gap between the tubular body and the sealing member, and the sealing member that had extremely high resistance when the sealing member was pushed into the tubular body was damaged. . As a result, it was not possible to evaluate the sealing performance.

(Evaluation 2)

 The proximal side of the balloon catheter for evaluation was inserted into the groove of the adapter for evaluation, and the port portion was arranged so as to be inside the sealed portion. The movable part was removed 3 mm from the position where it was inserted until it hit the port. In this state, the catheter was fixed, and 0.15 mL of water was also injected into the syringe for balloon expansion, thereby expanding the norain. The shaft was operated by hand until the drive part stopped moving in the axial direction. The catheter was removed from the adapter, and the state of the balloon 3 minutes later was evaluated. After that, the catheter was fixed to the adapter again, and the shaft was manually operated to move the driving portion to the opposite side until the power was removed, and the movable portion was also removed from the port portion. Further, the same operation was repeated once again, and a second evaluation was performed. Table 1 shows the results.

[0077] [Table 2]

m

11 times compared to the comparative example

 The operating part of the state operating part

 Withdrawal impossible

 Extension

 Body flow part

 Destructive

 Not extendable

 Moving part difference

 Lack

 Dish i

 Times cn o

Plate 〇

 Times 〇 〇

 〇

 Em

 〇

 Times eg 〇 〇

As is clear from Example 13, in Example 13, both the first time and the second time The balloon was maintained inflated three minutes after the adapter force was removed, and no catheter was able to remove the movable part from the port. In contrast, in Comparative Example 7, in the first evaluation, only 11 catheters maintained balloon expansion three minutes after the catheter was removed from the adapter. For the remaining nine tubes, the fluid seal was broken and the balloon could not be maintained inflated. In addition, nine of the nine fluid seals were destroyed and three of the eleven with the expansion maintained, a total of twelve that could not remove the port force from the movable part. In the case of the sample in which the fluid seal part was broken, both the tubular body and the movable part kinked, and a force that could not be removed was applied. For the other three, the axial load that the movable part was pressed against the port part was too strong, and the movable part was fitted into the port part, making it impossible to remove it. The second evaluation was performed for the remaining eight tubes, with the axial movement distance of the drive part being 3 mm so as not to destroy the fluid seal part. As is clear from Table 2, only three catheters maintained balloon expansion, and the remaining five balloons gradually contracted due to insufficient insertion of movable parts.

Brief Description of Drawings

FIG. 1 is a schematic view of one embodiment of a catheter according to the present invention.

 FIG. 2 is a schematic view showing a state where a seal is formed near a proximal end of the catheter according to an embodiment of the catheter according to the present invention (a), and a schematic view showing a state where the seal is released. (B).

 FIGS. 3A and 3B are schematic views (a) and (b) of a catheter according to another embodiment of the present invention in the vicinity of the proximal end of the catheter.

 FIG. 4 is a schematic view of a catheter according to another embodiment of the present invention in the vicinity of the proximal end of the catheter.

 FIG. 5 is a schematic view of a catheter according to another embodiment of the present invention in the vicinity of the proximal end of the catheter.

 FIG. 6 is a schematic view of another embodiment of the catheter according to the present invention in the vicinity of the proximal end of the catheter.

FIG. 7 shows a catheter according to another embodiment of the present invention in the vicinity of the proximal end of the catheter. FIG.

[8] Fig. 8 is a schematic view of a catheter according to another embodiment of the present invention in the vicinity of the proximal end of the catheter.

 FIG. 9 is an explanatory drawing of a comparative example.

 FIG. 10 is a schematic view of an embodiment of the adapter according to the present invention.

[11] FIG. 11 is a schematic side view of an embodiment of the adapter according to the present invention.

[12] Schematic diagrams (a) and (b) of one embodiment of a medical device using the adapter according to the present invention.

 FIG. 13 is schematic diagrams (a) and (b) of another embodiment of the adapter according to the present invention.

[14] Figures 14 (a) and 14 (b) are central schematic views of an embodiment of the adapter according to the present invention.

[15] FIGS. 15A and 15B are schematic diagrams (a) and (b) of central parts of another embodiment of the adapter according to the present invention. FIG. 16 is schematic views (a) and (b) of another embodiment of the medical device using the adapter according to the present invention.

Explanation of symbols

 101 tubular body

 102 balloon

 103 Near the proximal end of the catheter

 201 Inflation Noramen

 202 Fluid seal

 203 Sealing material

 203A tapered part

 203B Maximum outer diameter of the part that can be inserted inside the tubular body of the sealing member

 203C Proximal part of sealing element

 203D distal part of sealing element

 204 Sealed part

 205 tubular body

 301 Inflation Noremen

302 Fluid seal 303 Sealing material

 303A taper part

 303C Proximal part of the sealing element

 303D distal part of sealing element

 304 sealed part

 304A sealed part

 304B sealed part

 305 tubular body

 305A tubular body

 305B tubular body

 401 Inflation Noramen

 403 Sealing member

 404 Sealed part

 405A tubular body

 405B tubular body

 405C tubular body

 406A Joint between tubular body 405A and tubular body 405B 406B Joint between tubular body 405B and tubular body 405C 407 Side hole

 408 Proximal end opening of tubular body

 409 Proximal end of tubular body

 501 Inflation Noremen

 503 Sealing member

 504 Sealed part

 505A tubular body

 505B tubular body

506 Joint of tubular body 505A and tubular body 505B 507 Side hole 510 reinforcement

 511 Joint between sealing member and reinforcing material

601 Inflation Noremen

603 Sealing member

 603B Maximum outer diameter portion of portion that can be inserted inside tubular body of sealing member 604 Sealing portion

605A tubular body

605B tubular body

 606 Joint of tubular body 605A and tubular body 605B

607 Side hole

610 Reinforcement

 611 Joint between sealing member and reinforcing material

612 Panele

 701 Inflation Noremen

702 Fluid seal

703 Sealing member

 703B Maximum outer diameter portion of portion that can be inserted inside tubular body of sealing member 704 Sealing portion

705 tubular body

 801 Inflation Noremen

802A fluid seal

802B fluid seal

803 Sealing member

 803B Maximum outer diameter portion of portion that can be inserted inside tubular body of sealing member 804A Sealing portion

804B Sealed part

805A tubular body

805B tubular body 805C tubular body

807 side hole

810 Reinforcement

 901 Inflation Noremen

903 Sealing member

 903C Proximal part of sealing element

903E Sealed part

 905 tubular body

 1001 Adapter

 1002 groove

 1003 Fixed part

 1004 drive part

 1005 fixing knob

 1006 Butt

 1101 Adapter

 1102 groove

 1201 — Balloon catheter for time occlusion

1202 tubular body

 1203

 1204 Inflation Noramen

1205 port 咅

 1206 Moving parts

 1207 Fluid seal

 1208 Scenery section

 1301 Adapter

 1302 groove

 1303 Fixed part

1304 drive part 1306 Butt

 1307 Sealed part

 1308 Knob for inflation

 1309 Operation part

 1401 Adapter

 1402 groove

 1403 Fixed part

 1404 drive part

 1405 No

 1406 No

 1407 Sealed part

 1408 Close contact area

 1410 Fluid injection hole

 1501 Adapter

 1502 groove

 1503 Fixed part

 1504 drive part

 1505 No ^^

 1508 Close contact area

 1601 Temporary occlusion balloon catheter

1602 tubular body

 1603 Balloon

 1604 Inflation Noremen

1605 Port section

 1606 Moving parts

 1607 Fluid seal

Claims

 The scope of the claims

 [I] A catheter having a balloon, a tubular body having an inflation lumen through which a fluid for expanding or deflating the balloon can move, and a catheter having a fluid seal portion for sealing the fluid, The catheter according to claim 1, further comprising a movable sealing member having a tapered portion whose outer diameter gradually decreases, and a sealing portion fitted with said tapered portion.

 2. The catheter according to claim 1, wherein a maximum outer diameter of the tapered portion of the sealing member is larger than a minimum inner diameter of the sealing portion.

3. The catheter according to claim 1, wherein a center line average roughness Ra of the sealed portion is 0.80 μm or less.

[4] The catheter according to any one of [1] to [3], wherein a center line average roughness Ra of the sealed portion is 0.40 μm or less.

[5] The catheter according to any one of [1] to [4], wherein the center line average roughness Ra of the sealed portion is 0.20 μm or less.

[6] The catheter according to any one of [1] to [5], wherein the sealed portion is a part of the tubular body.

[7] The catheter according to any one of [6] to [7], wherein at least a part of the sealing portion is disposed inside the tubular body.

[8] The force according to claim 1, wherein the sealing portion is a member joined to the tubular body. The catheter according to any one of the preceding claims.

[9] The catheter according to any one of claims 1 to 8, wherein the catheter has a structure for preventing the sealing member from falling off from a proximal end of the tubular body.

[10] A maximum outer diameter of a portion of the sealing member that can be inserted into the inside of the tubular body is larger than a minimum inner diameter of a proximal end of the tubular body, so that the sealing member is a proximal end of the tubular body. 10. The catheter according to claim 9, having a structure for preventing the catheter from falling off.

[II] The structure having a structure for preventing the sealing member from falling off from the proximal end of the tubular body by joining another member to the proximal end of the tubular body. 9 Item 10. The catheter according to item 8.

 [12] The catheter according to any one of [1] to [11], wherein the sealed portion is made of a polymer material.

[13] Polymer material is polyimide, polyamide, polyurethane, Teflon (registered trademark), silicon rubber

13. The catheter according to claim 12, wherein the catheter is at least one member selected from the group consisting of a polyamide-based elastomer and a polyurethane-based elastomer.

[14] The catheter according to claim 12, wherein the polymer material comprises polyimide.

[15] The catheter according to any one of claims 1 to 11, wherein the sealed portion is made of metal.

 [16] The force according to any one of [16] to [16], wherein a substance that improves sealing properties is disposed at a contact portion between the sealing member and the sealing portion. Power of Tetenore.

 [17] The force roller according to claim 16, wherein the substance improving the sealing property is silicone oil.

 [18] At least a part of the sealing member is made of stainless steel, Ni—Ti, Ni—Ti Fe, Ni—Ti—Cu, Ni—Ti—Cr, Ni—Ti—V, Ni—Ti—Co, Ni— A group consisting of Ti—Nb, Ni—Ti—Pd, Ni—Ti—Cu—Cr, Fe Mn—Si, and Co—Cr One or more selected members, or a complex thereof. 18. The catheter according to any one of clauses 17, wherein the force is also.

 19. The catheter according to claim 1, wherein at least a part of the sealing member is made of a polymer material.

 20. The polymer material according to claim 19, wherein the polymer material is at least one selected from the group consisting of polyimide, polyamide, polyurethane, Teflon (registered trademark), silicone rubber, polyamide-based elastomer and polyurethane-based elastomer. Catheter.

 21. The catheter according to any one of claims 1 to 20, wherein the fluid seal portion is present on a distal side of a maximum outer diameter portion of the sealing member.

 22. The catheter according to claim 1, wherein the fluid seal portion is present on a proximal side of a maximum outer diameter portion of the sealing member.

[23] The fluid seal portion is located on a distal side and a proximal side of a maximum outer diameter portion of the sealing member. 23. The catheter according to any one of claims 22 to 22, wherein the catheter is present at one location each.

24. The outer diameter of the tubular body and the sealing member is 0.018 inches or less.

24. The catheter according to any one of clause 23, wherein the first term force is also one.

25. The outer diameter of the tubular body and the sealing member is 0.014 inches or less.

30. The catheter according to any one of clause 24, wherein the one-term force is also one.

[26] The catheter according to any one of claims 1 to 25, wherein the balloon is intended to temporarily occlude a blood vessel.

[27] The catheter according to any one of [1] to [27], wherein a path through which a fluid for expanding or deflating the balloon passes is provided on a side surface of the tubular body closer to the seal portion. .

 [28] The tubular body is made of polyimide, stainless steel, Ni—Ti, Ni—Ti Fe, Ni—Ti Cu, Ni-Ti-Cr, Ni-Ti-V, M—T to Co, M—T to Nbゝ M—T to Pd ゝ M to T to Cu—Cr—Fe Mn—Si, Co—Cr or at least one member selected from the group consisting thereof or a composite thereof. The catheter according to any one of claims 1 to 4.

[29] A catheter system including a catheter and an adapter for operating the catheter, wherein the catheter has a balloon, and a tubular body having an inflation lumen through which a fluid for expanding or deflating the balloon is movable. A catheter having a fluid seal portion for sealing the fluid, wherein the structure of the fluid seal portion is a movable sealing member having a tapered portion whose outer diameter gradually decreases, and a seal fitted to the tapered portion. A catheter system, characterized in that the adapter is adapted to insert a proximal or lower portion of the catheter including the sealing portion and a movable or detachable movable portion including the sealing member. Groove, a fixed portion for sandwiching the proximal portion of the catheter inserted in the groove, and a fixing portion inserted in the groove. A driving part for sandwiching and fixing the movable part of the catheter and moving the movable part; and an operating part for operating the driving part. When the operating part is operated, the movable part A catheter system as an adapter, comprising a control mechanism that does not generate a load that is equal to or more than a predetermined value in an axial direction.

30. The catheter system according to claim 29, wherein the adapter is an adapter characterized in that the control mechanism has an elastic body.

31. The catheter according to claim 29, wherein the adapter includes an inflation mechanism for injecting a fluid from the vicinity of the movable portion into the catheter. system.

[32] The catheter system according to any one of [29] to [31], wherein the adapter operates the operation portion by rotation.

[33] The adapter according to claim 29, wherein the adapter fixes the movable portion in the driving portion and the proximal portion of the catheter in the fixed portion almost simultaneously. 33. The catheter tenor system according to any one of paragraphs 32 to 43, further comprising:

 [34] The adapter seals and seals a passage on a side surface of the tubular body of the catheter or a proximal end opening of the tubular body by fixing the proximal portion of the catheter at the fixed portion. The catheter system according to any one of claims 33 to 33, wherein the adapter is an adapter.