WO2007001033A1 - Catheter - Google Patents

Abstract

A catheter for blocking a lumen in the body which has a tubular member having a distal part and a proximal part, an expansion member which closely adheres to the inner wall of the lumen in the body upon expansion, and an inflation lumen which is formed within the tubular member and connected to the inside of the expanding member for flowing a fluid for expanding by which the expansion member is expanded or contracted, characterized by having a reflux lumen for connecting the distal side of the expansion member to the proximal side thereof and a filter member provided in the reflux lumen. The above-described catheter can highly adhere to a lumen in the body and ensure a peripheral fluid flow.

Description

 Specification

 Catheter

 Technical field

 [0001] The present invention relates to a catheter having an expander or a balloon that is introduced into a body percutaneously and transluminally and temporarily blocks a lumen in the body.

 Background art

 [0002] Conventionally, when stenosis or occlusion occurs in a blood vessel such as a blood vessel, angioplasty (PTA: Percutaneous) is performed to expand the stenosis or occlusion of the blood vessel and improve blood flow in the periphery of the blood vessel. Transluminal Angioplasty ^ PTCA (Percutaneous Transluminal Coronary Angioplasty, etc.) has a large number of cases in many medical institutions, and it is a common operation for this type of case. In addition, stents and the like for maintaining the state of the expanded stenosis have recently become widely used.

 [0003] Balloon catheters used for PTA and PTCA are mainly used as a set of a guide catheter and a guide wire in order to expand a stenosis site or a blockage site of a blood vessel. In angioplasty using this balloon catheter, a guide catheter is first inserted from the femoral artery, the tip is positioned at the entrance of the coronary artery via the aorta, and then a guide wire penetrating the balloon catheter is inserted into the blood vessel. Advance beyond the stenosis or occlusion site, and then advance the balloon catheter along the guide wire to expand the stenosis or occlusion site by inflating the balloon with the balloon positioned at the stenosis or occlusion site Follow the procedure, then deflate the balloon and remove it from the body. This balloon catheter is not limited to the treatment of stenosis or occlusion sites of blood vessels, but is useful for many medical applications including insertion into blood vessels and insertion into various body cavities and tubular tissues.

However, when the occlusion in the blood vessel is caused by a thrombus, the blood clot may be released from the inner wall of the blood vessel and occlude the downstream peripheral blood vessel. In addition, when a stenotic site in a blood vessel is expanded, if the lesion contains a large number of rod-like plaques, expansion by a balloon catheter causes a plaque-like plaque (character) from the lesion. Rome) may scatter and obstruct peripheral blood vessels. In this way, when the peripheral blood vessel is occluded, even if the occluded portion or the stenosis portion is expanded, the blood flow does not flow to the periphery, resulting in a situation of slow flow or no reflow.

 [0005] In such a situation, it is common to look at the coronary artery or the like until the blood flow is recovered, but there is a problem that it takes time to recover. In addition, depending on the situation, vasodilators may be administered to restore blood flow, or drugs such as thrombolytic agents may be administered locally to dissolve obstructions. It takes time, and there are problems. If peripheral obstruction is severe and hemodynamics is poor, auxiliary means such as IABP are also used.

 [0006] Especially in the case of vascular occlusion or stenosis in the carotid artery or cerebral artery, blood flow to the brain stops when peripheral occlusion occurs due to angioplasty with a balloon force tailor stent. As a result, the peripheral brain cells at the site of obstruction become ischemic. If the ischemic state of the brain continues for a long time, brain cells may die and damage may remain, which is very dangerous. In the case of angioplasty of such cerebral artery or carotid artery, compared to other blood vessels Care must be taken to ensure that the peripheral blood vessels do not occlude.

 [0007] In order to prevent peripheral blood vessels from being occluded in this way, it has been attempted to temporarily occlude the peripheral blood vessels of the blood vessels that become lesions and perform angioplasty of the lesioned portion in that state. The As a prior art, Patent Document 1 discloses a temporary occlusion balloon catheter as a means for temporarily occlusion of a blood vessel. The temporary occlusion balloon force tail is inserted into the peripheral part of the lesion where the balloon is treated, and another therapeutic catheter, such as a balloon catheter for vasodilation, is inserted into the lesion. Thereafter, the temporary occlusion balloon catheter is expanded on the peripheral side of the lesion, and the lesion is treated with the blood flow blocked. After treatment, remove the causative agent that has occurred in the suction catheter, etc., together with the blood from the blocking part, and then deflate and remove the temporary occlusion balloon catheter.

[0008] Patent Document 2 discloses a filter device that captures an embolization-causing substance, which also includes a foldable frame connected to the tip of a guide wire and a filter. The filter device can be used with a sheath that houses the filter inside. The filter is inserted into the distal part of the lesioned part with the filter folded inside the sheath. Thereafter, the filter is deployed by removing the sheath. After the filter is deployed, the lesion is treated in the same way as a temporary occlusion balloon catheter, with the embolizing agent prevented from flowing to the periphery by the filter. After the treatment, the sheath is advanced again, and the embolizing substance is retained in the filter, stored in the sheath, and then removed.

 [0009] With the technique of Patent Document 1, the relatively flexible balloon is occluded so as to be in close contact with the body lumen, and the fluid flow can be completely stopped, so that the occlusion performance is almost perfect. However, since it is completely occluded, when treatment is performed using a contrast agent, the liquid containing the contrast agent accumulates in the vicinity of the occlusion balloon, and the target treatment is not possible. appear. In addition, when used in important arteries such as coronary arteries and carotid arteries, obstruction is performed for the purpose of protecting the periphery, but blood flow does not flow to the periphery. In the case of coronary arteries, the condition of the heart deteriorates. Side effects such as disturbance of consciousness may occur.

 [0010] In the technique of Patent Document 2, the liquid can flow because of the peripheral protection by the filter, and there is no use of a contrast agent or side effects that blood does not flow to the periphery. However, the cross-sectional shape of the inner wall of the blood vessel is often not a perfect circle, and it is difficult for the filter to perfectly match the cross-sectional shape of the inner wall of the blood vessel, especially when the bend and the inner wall of the blood vessel are elliptical. . Another problem is that the frame of the filter is made of a thin metal and its expanded state cannot be confirmed.

 Patent Document 1: Japanese Translation of Special Publication 2001-514544

 Patent Document 2: Japanese Translation of Special Publication 2002-505151

 Disclosure of the invention

 Problems to be solved by the invention

[0011] In view of these situations, the problem to be solved by the present invention is to provide a catheter that is highly intimately contacted with a living body lumen and can ensure the flow of peripheral fluid.

 Means for solving the problem

[0012] The present invention includes a tubular body having a distal portion and a proximal portion, and a portion near the distal portion of the tubular body. A catheter having an inflation lumen formed inside the tubular body, in communication with the inside of the expansion body, and through which a fluid for expansion for expanding or contracting the expansion body is passed. A catheter comprising: a first outer surface that is in close contact with the inner wall of a living body lumen during expansion; a perfusion lumen that allows communication between a distal side and a proximal side of the expansion body; and a filter element disposed in the perfusion lumen. is there. According to these structures, close contact with the body lumen is prevented, and flow between the inner wall of the living body lumen and the first outer surface is prevented, and fluid flow in the living body lumen to the periphery is ensured. It becomes possible to do.

 [0013] In addition, it is preferable that the expansion body has a second outer surface that forms the perfusion lumen. According to this structure, the number of catheter members is reduced, and the catheter can be easily manufactured.

 [0014] Preferably, the filter element is joined to the sleeve, preferably the perfusion lumen is formed by a sleeve joined to the third outer surface of the expansion body. According to these structures, the catheter can be easily manufactured, and the flow of the fluid in the living body lumen flowing through the perfusion lumen is stabilized, thereby preventing the perfusion lumen from being reduced or blocked due to thrombus adhesion or the like. It becomes possible.

 [0015] Further, it is preferable that the first outer surface of the expansion body has a substantially circular shape and is in close contact with the entire circumference of the inner wall of the living body lumen. According to this structure, it becomes possible to closely adhere to the body lumen.

 [0016] Preferably, the expansion body is formed by a tube having the first outer surface and the second outer surface or the third outer surface, the first outer surface, Preferably, it has a spiral shape having the second outer surface or the third outer surface. According to these structures, the catheter can be easily manufactured. In addition, it is preferable that the tubes forming a spiral shape are joined together by tubes adjacent in the axial direction. According to these structures, the fluid force flowing through the living body lumen does not pass through the perfusion lumen and filter element, and does not flow to the distal side of the expansion body. Can be prevented from flowing to the peripheral side of the expansion body

[0017] The expansion body has the first outer surface and the second outer surface or the third outer surface. It is preferable that the filter element preferably having a ring shape is joined to the expansion body. According to these structures, the fluid force perfusion lumen flowing through the living body lumen and the filter element do not pass through and do not flow to the distal side of the expansion body. It is possible to prevent the flow to the peripheral side of the body.

 [0018] In addition to the joint point between the tubular body and the expansion body, it is preferable that at least one joining element for joining the tubular body and the expansion body or the sleeve is present, and a proximal portion of the tubular body The perfusion lumen force when the expansion body is contracted by the contraction operation of the inflation device connected to the tube and the operation of moving the joining element in the axial direction relative to the tubular body. Preferably it is smaller than the perfusion lumen. According to these structures, it is possible to reduce the perfusion lumen when the expansion body contracts.

 [0019] In addition, it is preferable that a metal member is provided in the vicinity of the expansion body, and the metal member is preferably a super-metallic metal. Furthermore, it is preferable that the super elastic metal is a Ni—Ti alloy, and the metal member is preferably present inside the expansion body. According to these structures, the insertion property of the catheter can be improved, and the influence on the living body lumen at the time of insertion can be reduced.

 [0020] Further, only by the contraction operation of the inflation device connected to the proximal portion of the tubular body, the perfusion lumen when the expansion body is contracted becomes smaller than the perfusion lumen when the expansion body is expanded. It is preferable that when the inflation device connected to the proximal portion of the tubular body is contracted, the metal member is deformed as the expansion body contracts, so that the expansion body contracts. It is preferable that the perfusion lumen force at the time is smaller than the perfusion lumen when the expansion body is expanded. According to these structures, the perfusion lumen can be made smaller when the expansion body contracts.

[0021] Further, the contraction operation of the inflation device connected to the proximal portion of the tubular body, and the operation of moving the metal member in the axial direction relative to the tubular body, the contraction operation of the expansion body Preferably, the perfusion lumen force is smaller than the perfusion lumen when the expansion body is expanded. According to this structure, the perfusion lumen is reduced when the expansion body contracts. It is pretty easy to do.

 [0022] Further, it is preferable that a sheath is provided that houses at least a part of the expansion body and the filter element when the expansion body contracts. According to this structure, it is possible to reduce the perfusion lumen when the expansion body contracts.

 [0023] The present invention also relates to a catheter having a tubular body having a balloon and an inflation lumen through which a fluid for expanding or contracting the balloon can be moved, the proximal side and the distal side of the northern part. This is a catheter for occluding a body lumen, which has a perfusion lumen so that fluid can freely flow through the body. According to the present invention, a new structure and material arrangement of a catheter having a balloon that occludes a lumen in the body, and a high occlusion performance due to close contact of the balloon with the lumen in the body is maintained, while the proximal side of the balloon is maintained. In addition, a catheter is provided that has a drain that allows fluid to freely flow through the distal side and occludes a body lumen with reduced use restrictions and side effects.

 [0024] Further, the catheter force has a filter mechanism at a position related to the perfusion lumen! /, And the upstream side position where the fluid in the body lumen for the purpose of occlusion is preferred. It is preferable to be provided. According to these structures, since the catheter for occluding a body lumen has a filter mechanism at the relevant position of the perfusion lumen, the embolizing substance is not allowed to flow to the peripheral side by the balloon and the filter mechanism. ! By making fluids such as blood freely circulateable, if an occlusion balloon is used in an important artery such as the coronary artery or carotid artery, blood flow does not flow to the periphery, causing side effects. It becomes difficult.

 [0025] Further, it is preferable that the filter mechanism has a structure having a length along the axial direction of the catheter. The filter mechanism has a length along the axial direction of the catheter, and the length is not less than lmm. Preferably there is. According to these structures, since the filter mechanism has a length along the catheter, it is possible to provide a sufficient filter area without enlarging the cross-sectional area of the catheter for occluding a body lumen, and embolization. The causative substance makes it difficult to clog the filter.

[0026] Further, it is preferable that the opening portion of the filter mechanism is close to the balloon. According to these structures, by reducing the dead space between the nolane and the filter mechanism, The flexibility and perfusion effect of the end part can be maximized, and the restriction on the balloon expansion location can be reduced.

 [0027] In addition, it is preferable that the filter mechanism is configured by a mesh-like structure body, and the filter mechanism is also configured by a structure body force having a through hole. Better ,. Further, the minimum length of the filter opening of the filter mechanism is more preferably 50 μm to 200 μm. According to these structures, it is possible to provide a filter mechanism with a large aperture ratio, and the filter mechanism allows the liquid such as blood to freely flow while preventing the embolization-causing substance from flowing to the peripheral side. Because the filter mechanism is flexible, the catheter for occluding a body lumen can be made flexible.

[0028] It is also preferable that the filter mechanism forms a guide wire lumen at the same time.

 According to these structures, the filter mechanism forms the guide wire lumen at the same time, so that it is possible to have better operability and entry characteristics into the body passage, and the profile of the whole body lumen occlusion catheter can be obtained. It is possible to optimize and make it thinner.

 [0029] Further, the material of the filter mechanism is preferably stainless steel or Ni-Ti alloy. According to these structures, it is possible to design a filter mechanism having a good balance between flexibility and strength and a certain degree of biocompatibility.

 [0030] Further, the material of the filter mechanism is preferably a polymer material. According to these structures, since the filter mechanism becomes flexible, the body lumen occlusion catheter can be made flexible.

 [0031] Further, it is preferable that the surface of the filter mechanism is anti-thrombogenic treated! The material of the filter mechanism is preferably an anti-thrombogenic material. According to these structures, by creating a thrombus in the filter mechanism, blood flow does not flow to the periphery, and the performance of causing side effects is improved.

 The invention's effect

[0032] The catheter of the present invention as described above includes a tubular body having a distal portion and a proximal portion, an expanded body that is in close contact with the inner wall of a biological lumen when expanded, and a distal side and a proximal side of the expanded body. A perfusion lumen for communicating, a filter element disposed in the perfusion lumen, and an interior of the tubular body And an inflation lumen that communicates with the inside of the expansion body and passes an expansion fluid for expanding or contracting the expansion body. The flow of fluid can be ensured.

Brief Description of Drawings

FIG. 1 is a side view of an embodiment of a catheter according to the present invention.

FIG. 2 is a cross-sectional view of one embodiment of a catheter according to the present invention.

FIG. 3 is a side view of one embodiment of the catheter according to the present invention.

FIG. 4 is a cross-sectional view of one embodiment of a catheter according to the present invention.

FIG. 5 is a side view of one embodiment of the catheter according to the present invention.

FIG. 6 is a cross-sectional view of one embodiment of a catheter according to the present invention.

FIG. 7 is a side view of one embodiment of the catheter according to the present invention.

FIG. 8 is a cross-sectional view of one embodiment of a catheter according to the present invention.

FIG. 9 is a side view of the catheter according to the embodiment of the present invention when the expansion body is expanded.

 FIG. 10 is a cross-sectional view of the catheter according to the embodiment of the present invention when the expansion body is expanded.

 FIG. 11 is a side view when the expansion body contracts in one embodiment of the catheter according to the present invention.

 FIG. 12 is a cross-sectional view of the catheter according to the embodiment of the present invention when the expansion body contracts.

 FIG. 13 is a side view of the catheter according to the embodiment of the present invention when the expansion body is expanded.

 FIG. 14 is a cross-sectional view of the embodiment of the catheter according to the present invention when the expansion body is expanded.

 FIG. 15 is a side view at the time of contraction of the expansion body in one embodiment of the catheter according to the present invention.

FIG. 16 is a cross-sectional view of the catheter according to the embodiment of the present invention when the expansion body contracts. FIG. 17 is a schematic diagram for explaining an embodiment of the catheter according to the present invention.

 FIG. 18 is a schematic diagram showing the AA cross section of FIG.

 FIG. 19 is a schematic diagram showing a BB cross section of FIG.

 FIG. 20 is a schematic diagram showing a CC cross section of FIG.

[21] FIG. 21 is a schematic diagram of one embodiment of the catheter according to the present invention.

[22] FIG. 22 is a schematic diagram of one embodiment of the catheter according to the present invention.

 FIG. 23 is a schematic diagram of one embodiment of a catheter according to the present invention.

 FIG. 24 is a schematic diagram of one embodiment of the catheter according to the present invention in which the guide wire is passed through the guide wire inlet portion of the catheter shown in FIG.

 FIG. 25 is a schematic diagram of one embodiment of the catheter according to the present invention, in which the guide wire is removed from the guide wire inlet portion of the catheter shown in FIG.

Explanation of symbols

 101 Power Tetenor

 102 Tubular body

 103 Extension

 104 Filter elements

 105 Inflation Nomen

 106 Perfusion lumen

 107 Female Girl JW.

 108 First outer surface

 109 Second exterior

 110 Proximal part of filter element

 201 Power Tetenor

 202 Tubular body

 203 extension

204 filter elements 205 inflation nomen

206 Perfusion lumen

 207 Female

 208 First exterior

 209 Second outer surface

 210 Proximal part of filter element

 211 Extension tube

 301 Force Tetenor

 302 Tubular body

 303 extension

 304 filter elements

 305 Inflation Nomen

306 Perfusion lumen

 307

 308 First outer surface

 309 Second exterior

 310 Proximal part of filter element

 312 Joining elements

 313 Joint part between joint element and expansion body

401 force

 402 Tubular body

 403 extension

 404 filter elements

 405 Inflation Noremen

406 Perfusion Lumen

 407

 408 First outer surface

410 Proximal part of filter element 414 Third exterior

 415 sleeve

 501 Power Tetenor

 502 Tubular body

 503 extension

 504 filter elements

 505 inflation nomen

506 Perfusion lumen

 507 Kojo JW.

 508 First exterior

 509 Second exterior

 510 Proximal part of filter element

516 Metal parts

 517 Bent part of metal member

518 Body lumen

 601 Power Tetenor

 602 Tubular body

 603 extension

 604 filter elements

 605 Inflation noremen

606 perfusion lumen

 607 Female Woman JW.

 608 First outer surface

 609 Second exterior

 610 Proximal part of filter element

611 expansion body forming tube

616 Metal parts

618 biological lumen 701 occlusion balloon

 702 main shaft

 703 Guide wire lumen

704 Tip shaft

 705 Perfusion lumen

 706 Communication tube

 707 Filter mechanism

 708 materials

 709 Inflation Nomen

801 occlusion balloon

 805 perfusion lumen

 806 Communication tube

 808 materials

 901 occlusion balloon

 902 Main shaft

 905 perfusion lumen

 906 Communication tube

 907 Filter mechanism

 908 materials

 909 Inflation Nomen

1002 Main shaft

 1007 Filter mechanism

 1009 Inflation lumen

1010 Filter mechanism opening

1101 occlusion balloon

 1102 Main shaft

 1103 Guide wire lumen

1104 Tip shaft 1105 Perfusion lumen

 1106 Communication tube

 1107 Filter mechanism consisting of mesh structure

 1108 Core material

 1109 Inflation noremen

 1111 Proximal cylindrical opening lid member of filter mechanism

 1201 occlusion balloon

 1202 Main shaft

 1203 Guide wire lumen

 1204 Tip shaft

 1205 Perfusion Noremen

 1206 Communication tube

 1207 Structural force with through-holes is also filtered

1208 Core material

 1209 Inflation noremen

 1211 Proximal cylindrical opening lid member of filter mechanism

 1301 occlusion balloon

 1302 Main shaft

 1303 Guidewire lumen

 1304 chips

 1305 Perfusion Noremen

 1306 Communication tube

 1307 Filter mechanism with structural force with through holes 1308 Core material

 1309 Inflation noremen

 1311 Proximal slit for passing guide wire of filter mechanism 1312 Guide wire

1402 Main shaft 1407 Filter mechanism with structural force with through holes

 1409 Inflation noremen

 1410 Filter mechanism opening

 1411 Proximal slit for passing guide wire of filter mechanism (guide wire passing state)

 1412 Guide wire

 1502 Main shaft

 1507 Filter mechanism with structural force with through holes

 1509 Inflation noremen

 1510 Filter mechanism opening

 1511 Proximal slit portion for passage of guide wire of filter mechanism (closed state) BEST MODE FOR CARRYING OUT THE INVENTION

[0035] The catheter according to the present invention will be described below. The present invention provides a tubular body having a distal portion and a proximal portion, an expansion body joined in the vicinity of the distal portion of the tubular body, and an internal portion of the tubular body. A catheter having an inflation lumen through which a fluid for expansion is used to expand or contract the body, the expansion body being in close contact with the inner wall of the body lumen during expansion, and a distal side and a proximal side of the expansion body There is provided a catheter comprising a perfusion lumen communicating with each other and a filter element disposed in the perfusion lumen. According to these structures, it is closely attached to the body lumen and is prevented from flowing between the inner wall of the living body lumen and the first outer surface, and the fluid flow in the living body lumen to the periphery is secured. It becomes possible to do. This is particularly useful in preventing embolization-causing substances generated during treatment in important arteries such as coronary arteries and carotid arteries from flowing from the portion other than the filter element to the peripheral side. In addition, in the treatment of important arteries as described above, the blood flow to the periphery can be secured, so that the operator can calmly perform the procedure.

FIG. 1 shows a side view of a temporary occlusion catheter which is an embodiment of the catheter according to the present invention, and FIG. 2 shows a cross-sectional view thereof. In each side view, the left side is the proximal side and the right side is the distal side. The catheter 101 shown in FIGS. 1 and 2 includes a tubular body 102, an expansion body 103, It has a filter element 104, an inflation lumen 105, and a perfusion lumen 106. The tubular body 102 and the expansion body 103 are joined at a joining point 107 by a method well known to those skilled in the art (such as bonding). At this time, the inflation lumen 105 and the expansion body 103 are connected so as to communicate with each other, and an expansion fluid (such as a contrast medium) is supplied by an inflation device (not shown) connected to the proximal portion of the tubular body 102. The expansion body 103 can be expanded and contracted by flowing into or out of the expansion body 103. The expansion body 103 has a first outer surface 108 and a second outer surface 109. The first outer surface 108 is in close contact with the inner wall of the living body lumen, and the second outer surface 109 forms a perfusion lumen 106. The filter element 104 is joined at its proximal portion 110 so that there is no gap between the expansion body 103 and the filter element 104.

 [0037] By adopting such a structure, the fluid force flowing in the living body lumen does not pass through the perfusion lumen 106 and the filter element 104, and does not flow toward the peripheral side of the expansion body 103. It becomes possible to prevent an embolization-causing substance larger than the opening area of 104 from flowing to the peripheral side of the expansion body 103.

 [0038] In addition, the expansion body 103 may have any shape, but the same effect can be obtained because the expansion body 103 has a ring shape. The expansion body 103 may have a length in the axial direction, the first outer surface 108 may have a cylindrical shape, and may have a shape having a perfusion lumen 106 inside. Further, the filter element 104 may be completely contained within the perfusion lumen 106.

 [0039] The axial length of the expansion body 103 is a force that can be freely designed. It is preferable that the length of the expansion body 103 is appropriately designed in consideration of the application range of the catheter 101 described later and the degree of adhesion to the inner wall of the living body lumen. In order to closely adhere to the inner wall of the living body lumen, the first outer surface 108 preferably forms a substantially circular shape when expanded. The expansion body 103 is preferably flexible so that it can be expanded at a low pressure, and more preferably it can be expanded at a pressure of 2 atm or less. According to such a structure, even when the inner wall of the living body lumen has an elliptical shape, the expansion body 103 is expanded in a shape along the inner wall, and can be closely adhered over the entire circumference of the inner wall. . Here, the fluid includes physiological fluid injected from outside the body, contrast medium, and the like in addition to body fluids such as blood.

[0040] The main use examples of the catheter 101 will be described. Catheter 101 mainly has stenosis. It is used to prevent embolization-causing substances from flying to the periphery of the body lumen when treating the lesion. The catheter 101 is inserted into a living body lumen, particularly a coronary artery or a carotid artery with the expansion body 103 contracted. When inserting into a blood vessel, it is preferable that the outer diameters of the expansion body 103 and the filter element 104 are smaller. Further, it is preferable to have a thin and flexible guide wire on the distal side of the expansion body 103 and a guide wire lumen for following a general guide wire. By having these structures, the operator can easily operate when selecting a target blood vessel or passing through a lesion. Further, in order to reduce the outer diameter of the expansion body 103 and the filter element 104, it is possible to have an introduction sheath having a small outer diameter that can accommodate the expansion body 103 and the filter element 104 therein. In this case, the same effect as described above can be obtained by providing the sheath with a guide wire lumen.

[0041] After the expansion body 103 and the filter element 104 of the catheter 101 have passed the lesioned part, an expansion fluid is introduced into the expansion body 103 to expand the expansion body 103 and the filter element 104. The conventional filter device such as Patent Document 2 cannot be confirmed to actually expand when the filter is expanded in the blood vessel. The catheter 101 according to the present invention can confirm that the expansion body 103 is closely attached to the inner wall of the blood vessel by including a contrast medium in the expansion fluid. When the catheter 101 includes an introduction sheath, the introduction sheath is moved to the proximal side before expansion, and the expansion body 103 and the filter element 104 are exposed from the introduction sheath. Then, a general balloon catheter stent is introduced to treat the lesion. At this time, it may be introduced following a general guide wire or may be introduced following the tubular body 102 of the catheter 101. Due to this method of use, the outer diameter of the tubular body 102 should be less than 0.018 inches (about 0.46 mm), preferably 0.014 inches (about 0.36 mm) when used in coronary arteries. It is preferable that

[0042] After the lesion treatment, the expansion body 103 is contracted by removing the internal force of the expansion fluid from the expansion fluid 103, and the catheter 101 is removed from the body together with the embolization-causing substance present in the filter element 104. At this time, it is preferable that the perfusion lumen 106 is small when the expansion body 103 contracts, so that the embolization-causing substance inside the filter element 104 does not fall off in the body. In addition, with the extraction sheath introduced, the contracted expansion body 103 is retracted into the extraction sheath. The catheter 101 may be removed from the body. By retracting a part of the contracted expansion body 103 into the extraction sheath, the perfusion lumen 106 can be reduced. Alternatively, a part or all of the filter element 104 that may draw the entire expansion body 103 into the extraction sheath may be drawn into the extraction sheath. The outer diameter of the extraction sheath is preferably as thin as possible in view of insertion into the vascular apex. Aspiration catheter may be used for aspiration so that the embolizing substance present in the filter element 104 does not fall off in the body. This suction catheter may be inserted following a normal guide wire, or may be inserted following the tubular body 102.

[0043] Fig. 3 is a side view of a temporary occlusion catheter as another embodiment of the catheter according to the present invention, and Fig. 4 is a cross-sectional view thereof. Similar to the embodiment of FIG. 1, it has a tubular body 202, an expansion body 203, a filter element 204, an inflation lumen 205, and a perfusion lumen 206. The expansion body 203 has a spiral shape having a first outer surface 208 and a second outer surface 209, the first outer surface 208 is in close contact with the inner wall of the body lumen, and the second outer surface 209 forms a perfusion lumen 206.

 [0044] Since the expansion body 203 has a spiral shape, the expansion body 203 can be closely adhered to the inner wall of the living body lumen, and the expansion body 203 can be easily manufactured. In addition, it is preferable to form the expansion body 203 with a polymer material formed into a tube shape. According to these structures, the expansion body 203 can be manufactured more easily, and the dimensions of the perfusion lumen 206 and the outer diameter of the expansion body 203 can be freely designed. The expansion body 203 forming a spiral shape may be joined to each other between the adjacent tubes 211 in the axial direction by a method well known to those skilled in the art. A part may be inserted and joined. By having these structures, the fluid flowing in the living body lumen does not pass through the perfusion lumen 206 and the filter element 204 and does not flow to the peripheral side of the expansion body 203. Therefore, the fluid exceeds the opening area of the filter element 204. It is possible to prevent the embolization-causing substance from flowing to the peripheral side of the expanded body 203.

[0045] FIG. 5 shows a side view of a temporary occlusion catheter as another embodiment of the catheter according to the present invention, and FIG. 6 shows a cross-sectional view thereof. Similar to the embodiment of FIG. 1, it has a tubular body 302, an expansion body 303, a filter element 304, an inflation lumen 305, and a perfusion lumen 306. . Since the tubular body 302 has a shape bent from the joint point 307 with the expansion body 303, the tubular body 302 can be positioned near the center of the living body lumen in the vicinity of the expansion body 303. According to these structures, the expanded body 303 can be more closely attached to the inner wall of the living body lumen without being affected by the living body lumen near the lesioned part. In addition, the suction catheter that follows the tubular body 302 makes it possible to maximize the effect of the suction catheter when suctioning the embolization-causing substance existing inside the filter.

 [0046] In addition to the joint point 307 between the tubular body 302 and the expansion body 303, it is preferable that a joining element 312 for joining the tubular body 302 and the expansion body 303 is present. By having such a structure, it becomes easy to bring the expansion body 303 into the vertical direction with respect to the living body lumen, and the distance between the proximal end and the distal end of the expansion body 303 is reduced. When a temporary occlusion catheter such as the present invention is used, a space for arranging a filter and a balloon is required on the distal side of the diseased part. However, this space may not be sufficient due to peripheral branching. Therefore, by reducing the distance between the proximal end and the distal end of the expansion body 303, that is, the length of the portion that is in close contact with the inner wall of the living body lumen, the application range of these catheters can be widened. Very useful.

 [0047] The material of the joining element 312 is not particularly limited as long as the tubular body 302 and the expansion body 303 can be joined. However, from the viewpoint of catheter insertion properties, the thinner the better the safety viewpoint power, the better the strength. Therefore, the joining element 312 is preferably made of metal. Further, the number and position of at least one joining element 312 are not limited, and the force is not limited. From the viewpoint of uniformly expanding the expansion body 303 and highly adhering it to the inner wall of the living body lumen, It is preferable to distribute evenly on the extension body 303 including the junction point 307.

 [0048] The joining element 312 is joined to the tubular body 302 so as to be movable in the axial direction, and may extend to the proximal portion of the catheter 301 along the inner surface or the outer surface of the tubular body 302. By allowing the joining element 312 to move axially relative to the tubular body 302, the perfusion lumen 306 can be made smaller when the expansion body 303 contracts. By having such a structure, it becomes possible to collect the embolization-causing substance existing inside the filter element 304 outside the body without dropping out.

[0049] In order to make the perfusion lumen 306 as small as possible, the joining element 312 is near the expansion body 303 In at least a part of which it is preferable to be joined to the tubular body 302, it is preferable that the tubular body 302 moves relatively little in the radial direction. This can be achieved, for example, by introducing the joining element 312 into the tubular body 302 or by introducing at least a part of the tubular body 302 into a double tube structure and introducing the joining element 312 into one lumen. .

[0050] Fig. 7 shows a side view of a temporary occlusion catheter as another embodiment of the catheter according to the present invention, and Fig. 8 shows a cross-sectional view thereof. Similar to the embodiment of FIG. 1, it has a tubular body 402, an expansion body 403, a filter element 404, an inflation lumen 405, and a perfusion lumen 406.

[0051] In this embodiment, a sleeve 415 joined to the expansion body 403 is further provided. There is no expansion body outer surface (second outer surface) that forms the perfusion lumen, but the sleeve 415 is joined to the expansion body outer surface at a position corresponding to the second outer surface. In this embodiment, the outer surface of the expansion body forms a perfusion lumen, and therefore, the outer surface of the expansion body joined to the sleeve is hereinafter referred to as a third outer surface in order to distinguish it from the second outer surface forming the perfusion lumen.

 [0052] By forming the perfusion lumen 406 with the sleeve 415, the catheter 401 can be easily manufactured. In addition, by forming the perfusion lumen 406 with the sleeve 415, the fluid flow in the living body lumen flowing therethrough is stabilized, and it becomes possible to prevent the perfusion lumen 406 from being reduced or blocked due to adhesion of thrombus, etc. . The third outer surface 414 of the extension 403 is joined to the sleeve 415 in a manner well known to those skilled in the art, even if the proximal portion 410 of the filter element 404 is joined between the third outer surface 414 and the sleeve 415. I do not care.

 [0053] The catheter 401 can be easily manufactured by joining the proximal portion 410 of the filter element 404 to the sleeve 415. In all the embodiments shown so far, it is possible to have a sleeve 415. The catheter 401 can be easily manufactured by attaching and joining the expansion body 403 formed on the tube to the outer surface of the sleeve 415, and the perfusion lumen 406 can be more reliably secured. The material and length of the sleeve 415 are not limited, but are preferably made of a more flexible polymer material from the viewpoint of reducing the perfusion lumen 406 when the expansion body 403 contracts.

[0054] Fig. 9 shows a side view of a temporary occlusion catheter as another embodiment of the catheter according to the present invention, and Fig. 10 shows a cross-sectional view thereof. Similar to the embodiment of FIG. 1, the tubular body 502, the expanded body 5 03, filter element 504, inflation lumen 505, perfusion lumen 506. In this embodiment, a metal member 516 is further provided inside the expansion body 503. The metal member 516 is joined to at least a part of the expansion body 503 and reaches the proximal portion of the tubular body 502 through the tubular body 502. The metal member 516 is movable in the axial direction relative to the tubular body 502. By moving the metal member 516 relative to the tubular body 502 toward the proximal side of the catheter 501, FIG. As shown in FIG. 12, the perfusion lumen 506 can be reduced when the expansion body 503 contracts. By having such a structure, it becomes possible to collect the embolization-causing substance existing inside the filter outside the body without dropping out.

 [0055] The material of the metal member 516 is not particularly limited as long as it is a metal, but from the viewpoint of the insertion property of the catheter 501, it is preferable that the metal member 516 has rigidity for obtaining an effect of reducing the perfusion lumen 506 that is preferable as it is thinner. Further, in order to reduce the resistance when the catheter 501 is removed and to safely remove the embolization-causing substance from the body, it is preferable that the expansion body 503 at the time of contraction is closer to the living body lumen.

 [0056] This can be achieved, for example, by appropriately shaping the metal member 516.

 As shown in FIG. 9, by bending the bent portion 517 of the metal member 516 and drawing the bent portion 517 into the tubular body 502, the bent portion 517 becomes substantially linear as shown in FIG. The tip side of the bent portion 517 of the metal member 516 is exposed from the distal portion of the tubular body 502 and exists inside the contracted expansion body 503. Since the distal end side of the bent portion 517 is a linear metal, the contracted expansion body 503 can be made almost parallel to the living body lumen. Such a shape is preferably maintained even when the expansion / contraction operation of the expansion body 503 is repeated a plurality of times. For this purpose, it is preferable to use a superelastic metal for the metal member 516, and a Ni—Ti alloy is more preferable.

[0057] The metal member 516 has an effect of reducing the perfusion lumen 506 when the expansion body 503 is contracted. If the metal member 516 is present in the vicinity of the expansion body 503 and exhibits its effect, the shape, position, and number are particularly It doesn't matter. It may exist inside the extension body 503 or may exist outside the extension body 503. However, in consideration of the insertion property of the catheter 501 and the influence on the living body lumen at the time of insertion, it is preferable that the catheter 501 exists inside the expansion body 503. [0058] FIG. 13 shows a side view of a temporary occlusion catheter as another embodiment of the catheter according to the present invention, and FIG. 14 shows a sectional view thereof. Similar to the embodiment of FIG. 9, it has a tubular body 602, an expansion body 603, a filter element 604, an inflation lumen 605, a perfusion lumen 606, and a metal member 616. In this embodiment, the expansion body 603 has a spiral shape formed by the tubes 611, and the adjacent tubes 611 are not joined but are in close contact.

 [0059] The metal member 616 is stainless steel, preferably a superelastic metal, and is present inside the expansion body 603, and may or may not be bonded to the inner surface of the expansion body 603. The metal member 616 is shaped so as to have a small coil shape as shown in FIGS. 15 and 16 with no external force applied by appropriate heat treatment or the like. When the expansion body 603 is expanded by the inflation device connected to the proximal portion of the tubular body 602, the expansion body 603 is formed by the tube 611. Therefore, in the direction in which the tube 611 becomes a straight line, that is, in the radial direction of the spiral. It is expanded to be larger (Figure 13).

 [0060] The metal member 616 is preferably flexible to the extent that the expansion of the expansion body 603 is not hindered. Thus, the expansion body 603 can be expanded at an extremely low pressure, and the influence on the living body lumen at the time of expansion can be reduced. When the expansion body 603 is contracted after the treatment of the lesioned part, the metal member 616 is deformed into a small coil shape shown in FIG. 15 without applying an external force. Along with this, the contracted expanded body 603 is deformed so as to become smaller in the radial direction of the spiral. According to these structures, the perfusion lumen 606 can be made smaller when the expansion body 603 contracts, and the embolization-causing substance existing inside the filter can be recovered outside the body without falling off inside the body.

 [0061] In addition, when operating the catheter 601 of this embodiment, the operator operates the perfusion lumen 606 without any special operation other than the contraction operation of the inflation device connected to the proximal portion of the tubular body 602. It becomes possible to make it smaller. Therefore, the procedure is simplified, the procedure can be performed safely in a short time, and the burden on the patient can be reduced.

[0062] This metal member 616 has the effect of reducing the perfusion lumen 606 without any external force being applied when the expansion body 603 is contracted, and is present in the vicinity of the expansion body 603 so that the effect is reduced. The material, shape, position and number are not particularly limited as long as the results are exhibited. It may exist inside the extension body 603 or may exist outside the extension body 603. However, considering the ease of insertion of the catheter 601 and the influence on the living body lumen at the time of insertion, it is preferable that the catheter 601 exists inside the expansion body 603.

 [0063] The present invention also relates to a catheter for occluding a body lumen, comprising a balloon for occluding a body lumen and a tubular body having an inflation lumen through which a fluid for expanding or deflating the balloon can move. A catheter lumen occlusion catheter characterized by having a perfusion lumen that allows fluid to freely flow through the proximal and distal sides of the balloon portion.

 [0064] FIG. 17 is a schematic view of the distal end portion of a body lumen occlusion catheter according to the present invention.

 A main shaft 702 having a balloon 701, a tubular body having an inflation lumen 709 capable of moving a fluid for expanding or contracting the balloon communicated to the inside of the balloon, and a guide wire following the guide wire A tip shaft portion 704 having a guide lumen 703, a communication tube 706 that forms a perfusion lumen 705 that allows fluid to freely flow through the proximal and distal sides of the balloon portion, a filter mechanism 707, and a strength balance It shows that it has core material 708 for adjustment

FIG. 18 is a cross-sectional view corresponding to the AA cross section of FIG. FIG. 19 shows a cross-sectional view corresponding to the BB cross section of FIG. FIG. 20 shows a cross-sectional view corresponding to the CC cross section of FIG. To illustrate the use of the intended treatment site in the body, in this case for stenting of the internal carotid artery, first, the balloon part is inserted into the proximal side of the body (usually from the artery of the limb, and the aorta and common carotid artery are Via) to expand the balloon 701 by inserting it to the distal side of the site to be treated. At that point, blood enters the catheter through the opening 1010 of the filter mechanism 707, which is proximal to the balloon portion, and the perfusion lumen 705, so that the fluid in the communication tubes 706, 906, 806 can flow freely. It flows through 905, 805 to the distal side of the balloon part. In other words, the embolic material flows to the peripheral side by the balloon and the filter mechanism, and the blood flow is sent to the periphery by the filter mechanism and the communication tube, so that the contrast and side effects after the balloon dilation are obtained. Can be reduced. [0066] The material of the balloon is not particularly limited, and is relatively flexible material such as polyurethane, silicone rubber, polyethylene, polyamide, polyurethane, polyamide elastomer, polyester elastomer, latex rubber, SEBS, SIBS, etc. Can be suitably used. The balloon can be manufactured by a known method, for example, as disclosed in JP-T-9-509860.

 [0067] The material of the main shaft is not particularly limited. Polyimide, stainless steel, Ni-Ti ゝ Ni-TiFe ゝ Ni-TiCu ゝ Ni-TiCr ゝ Ni-TiV ゝ Ni-TiCo, Ni-Ti-Nb, Ni-Ti-Pd, Ni-Ti-Cu-Cr, Fe Mn-Si, Co-Cr, etc. are used alone or in combination to optimize the axial direction in consideration of the strength balance of the catheter. Can be used in any material arrangement.

 [0068] Also, the position, structure, length, and mounting position of the filter mechanism should be designed according to the body lumen used and its therapeutic characteristics. The position of the filter mechanism must be related to the perfusion lumen from the viewpoint of preventing the embolization-causing substance from flowing sufficiently to the peripheral side. The position associated with the perfusion lumen can be determined experimentally or empirically by those skilled in the art. The position of the filter mechanism is preferably provided on the upstream side where the fluid in the body lumen flows, because the filter is less likely to be clogged by the generated embolic material. In this case, the filter mechanism is placed proximally or distally of the perfusion lumen, depending on the intended use.

[0069] The perfusion lumen has a structure in which the filter mechanism has a length in the axial direction of the catheter, and the opening portion of the filter (the opening through which liquid can flow) is also distributed along the length in the axial direction of the filter ( The part where the fluid flows is distributed in the axial direction with a longer length), and the embolic material that can be generated can have a sufficient filter area without enlarging the cross-sectional area of the catheter for occluding the body lumen. This is preferable because the filter is less likely to clog. The length along the axial direction of the filter mechanism is preferably 1 mm or more, and more preferably 3 mm or more because clogging by the embolic material that occurs is almost eliminated. In addition, from the viewpoint of making the profile as thin as possible without sacrificing the flexibility of the tip portion, the length along the axial direction of the filter mechanism is preferably 15 mm or less, and more preferably 5 mm or less. Also, the dead space is smaller when the opening of the filter is closer to the balloon. It is preferable that the distance force from the closest opening to the balloon is 3 mm or less.

 The filter mechanism is not particularly limited as long as it functions as a filter. Since the structure of the filter mechanism can be designed with a balance between the size of the aperture ratio and flexibility, it is possible to create a mesh-like structure in which a wire or ribbon-like material is knitted into a tubular structure, or a tubular structure. A structure having a through hole can be suitably used. These are illustrated by 1107 in FIG. 21, which is illustrated by 1207 in FIG. The size of the opening of the filter part should also be designed according to the body lumen used for the eye and its intended therapeutic properties, but when used in blood vessels, the minimum length of the filter opening ( The length of the narrowest part of the opening part) Force S If it is too small, clogging tends to occur. Therefore, it is preferably 50 111 to 200 111, and more preferably 50 μm to 100 μm.

 [0071] The material of the filter mechanism is not particularly limited, but a polymer material such as stainless steel, Ni-Ti alloy, polyimide, polyethylene, polyamide elastomer, polytetrafluoroethylene, or the like is preferably used. The When the occlusion target portion is a blood vessel, a stable fluid flow function may be obtained by applying antithrombotic treatment to the surface of the filter mechanism. Fixing is preferred. Moreover, it is preferable because the same effect can be obtained by using an antithrombotic material such as polytetrafluoroethylene as a material of the filter mechanism.

 [0072] In addition, it is preferable that a guide wire lumen 703 is disposed in the catheter for occluding a body lumen so as to be easily inserted into the body lumen. Guide wire lumen 703 can be provided, for example, by placing tip shaft 704 distal to balloon 701. The material of the tip shaft 704 is not particularly limited, but a polyamide elastomer is preferable from the viewpoint of flexibility. Alternatively, the perfusion lumen and the filter mechanism that allow fluid to flow freely may be formed to double as a guide wire lumen as shown in FIG. 23. In that case, as shown in FIG. 23 and FIG. It is preferable that the filter mechanism has a guide wire inlet portion that is reversibly deformed so that it opens when the guide wire is passed through and closes when the guide wire is removed as shown in FIG.

[0073] It is also sufficient that the cross-sectional area of the perfusion lumen so that the liquid can freely flow is too small. Since the effect may not be exhibited, it is necessary to some extent of the cross-sectional area, the average that is favored gestures et sectional area is 0. 12 5 mm ² or more preferably be at 0. 196 mm ² or more instrument 0. 282 mm More preferably, it is ² or more.

[0074] The perfusion lumen 705 may be provided, for example, by a tubular body having openings at both ends. In this case, the tubular body can be a single layer or a structure having two or more layers. The viewpoint power to reduce the outer shape of the tubular body inside the balloon is the adhesiveness and blood compatibility of other members preferred by the single layer. When considering both of these, the outer layer may be made of polyurethane of the same material as the balloon, the polyamide elastomer of the same material as the tip tube, and the inner layer may be made of polyethylene, polytetrafluoroethylene, or the like. The material of the tubular body is not particularly limited, and examples thereof include polyurethane, polyamide elastomer, polyethylene, polytetrafluoroethylene, other fluorinated polymer materials, and polyimide. From the viewpoint of reducing the outer shape of the tubular body inside the balloon while ensuring the rigidity of the tubular body, the material of the tubular body is preferably polyimide.

 [0075] The operation for expanding and contracting the lane is preferably performed by introducing physiological saline containing a contrast medium at a suitable ratio from the proximal portion of the catheter, and the introduction portion on the catheter is used in combination. It may be designed in consideration of the dimensional compatibility and operability of other treatment tools and the adapter for introduction.

 Example

 [0076] Examples and comparative examples of the catheter according to the present invention will be described in detail below, but the following examples do not limit the present invention.

[0077] (Adhesion degree evaluation)

 The present invention is a force related to a temporary occlusion catheter having a filter element. In the following examples and comparative examples, a sheet having no holes was used in the filter element, and the degree of adhesion with the inner wall of the biological lumen was evaluated. .

[0078] (Example 1)

 As a tubular body with a lumen through which the expansion fluid can move, the outer diameter is 0.35 mm and the inner diameter is 0

A metal tube made of 27 mm stainless steel was used. The total length was 2000 mm, with one end as the proximal end and the other end as the distal end. As a metal member, the outer diameter is 0.1 A metal wire made of stainless steel with a length of 2100 mm was used, with one end as the proximal end and the other end as the distal end. It was bent at 60 ° at a position of about 15 mm from the distal end. The expanded body was made of polyurethane molded into a tube shape with an outer diameter of 1. Omm and an inner diameter of 0.8 mm by extrusion, and the length was cut to about 20 mm. The filter element used was a 0.1 mm thick polyurethane sheet without holes. The sheet was formed into a mortar shape by datebing. The distal end force of the tubular body was also inserted so that the proximal end of the metal member was inserted and the bent portion of the metal member was at the distal end of the tubular body. The expansion body was covered from the distal end of the metal member, and when the distal end of the tubular body was reached, the distal end of the tubular body and one end of the expansion body were bonded with an adhesive. At this time, bonding was performed so that there was no gap between the outer surface of the tubular body and the inner surface of the expanded body. A polyurethane tube formed by extrusion molding with an outer diameter of 2. Omm and an inner diameter of 1.9 mm was used as the sleeve. The expansion body having one end attached to the tubular body was wound around the outer diameter of the sleeve, and was fixed using an adhesive at the contact surface between the outer surface of the sleeve and the expansion body. About 1 to 2 mm of the tip of the metal member was bent at 60 °, and the bent portion and the expanded body and tubular body on the bent portion were placed in the heat-shrinkable tube. The heat shrinkable tube was heated and shrunk to fix the tip part of the metal member, the expanded body, and the distal end of the tubular body. At this time, the one end not bonded to the tubular body of the expansion body is fixed so that the lumen is completely sealed. The filter element was fixed to the outer surface of the distal side of the expansion body with an adhesive so that there was no gap over the entire circumference.

 (Example 2)

The same tubular body and filter element as in Example 1 were used. As the metal member, a metal wire having an outer diameter of 0.10 mm and a length of 7 mm and having Ni-Ti alloy force was used, with one end as the proximal end and the other end as the distal end. The entire length of the metal member was formed into a spiral shape with an inner diameter of 0.5 mm by heat treatment. A spiral-shaped polyurethane tube in which adjacent tubes are in close contact with each other by dating using a spiral core material with an inner diameter of 2 mm and an outer diameter force of mm was used as the expansion body. The expanded body was cut to a length of 15 mm, and one end was sealed with a heat seal. The one end force of the expansion body that was not sealed was also applied to the metal member. When the expansion body was completely covered, the proximal end of the metal member and the expansion body were fixed with an adhesive. One end of the expansion body to which the metal member was fixed was adhered to the distal end of the tubular body with an adhesive. At this time, Bonding was performed so that no gap was formed between the outer surface of the tubular body and the inner surface of the expansion body. At the lmm portion of the distal end of the expansion body, the adjacent expansion body tubes were bonded to each other using an adhesive. The filter element was fixed to the outer surface on the distal side of the expansion body with an adhesive so that there was no gap around the entire circumference.

[0080] (Comparative Example 1)

 A temporary occlusion catheter was prepared in the same manner as in Example 1. Example 1 was performed except that the filter element was directly fixed to the metal member without using the expansion body.

[0081] (Evaluation)

 The degree of adhesion between the inner wall of the blood vessel and the expansion body was evaluated using the carotid artery of a piglet. Since the temporary occlusion catheters of Examples 1 and 2 and Comparative Example 1 use a sheet without a hole as a filter element, the higher the degree of contact between the inner wall of the blood vessel and the expansion body, the more distal the expansion body becomes. Blood will not flow to the side. Therefore, an expansion body was placed in the porcine carotid artery, and the blood flow to the distal side of the expansion body was evaluated by performing contrast imaging with the expansion body expanded.

[0082] (Extended confirmation test)

 It was confirmed that the expanded bodies of Examples 1 and 2 and Comparative Example 1 were normally expanded by using a 4 mm inner diameter tube made of vinyl chloride as a simulated tube for a living body lumen. Example In Example 2, the expansion body was expanded by connecting a syringe containing a contrast medium 50% physiological saline to the proximal portion of the tubular body and introducing the contrast medium into the expansion body. . In Comparative Example 1, the metal member was pushed in until the proximal force of the tubular body could not be pushed in, and the expanded body was expanded. It was confirmed by visual observation from the outside of the tube that the expansion body was expanded in the tube.

 [0083] (Occlusion confirmation test)

Using the temporary occlusion catheters of Examples 1-2 and Comparative Example 1, occlusion of the left internal carotid artery of a piglet was performed. Under anesthesia, a sheath (6Fr) was inserted from the right femoral artery of the piglet, and the tip of the guiding catheter (6Fr) inserted from the sheath was placed in the left common carotid artery. From the guiding catheter, the left internal carotid artery of the piglet was imaged and the position where the blood vessel diameter was about 3.5 mm was identified. Through the guiding catheter to that position, the temporary occlusion catheter Each expansion body was expanded in the same manner as in the expansion confirmation test. While maintaining expansion of the dilator, a 50% saline contrast medium was injected from the guiding catheter and the blood flow on the distal side of the dilator was observed. Thereafter, the expansion body was contracted and contrast was performed again to confirm the blood flow on the distal side of the expansion body. These expansion and contraction operations were repeated three times in total to evaluate the degree of adhesion between the inner wall of the blood vessel and the expanded body.

As a result, in Example Example 2, the blood flow was completely blocked during expansion of the expansion body, and the contrast agent did not flow to the distal side of the expansion body. In addition, it was confirmed that the expansion body was in close contact with the inner wall of the blood vessel by contrast enhancement performed during expansion of the expansion body. It was confirmed that the contrast medium flowed to the distal side of the expansion body and blood flowed normally during the contrast expansion. These results were all the same when the expansion and contraction operations were repeated three times. In contrast, in Comparative Example 1, it was confirmed that a trace amount of contrast agent was flowing to the distal side of the expansion body by contrast enhancement during expansion of the expansion body. In addition, in the contrast enhancement performed during expansion of the expansion body, the position of the expansion body and the expansion state could not be confirmed. Contrast-enhanced contraction of the dilated body confirmed that the contrast medium flowed to the distal side of the dilated body and blood flowed normally. These results were all the same when the expansion and contraction operations were repeated three times. From these results, it was confirmed that Examples 1-2 were superior to Comparative Example 1 in the degree of adhesion between the blood vessel inner wall and the expanded body.

 [0085] (Example 3)

The main shaft has a 0.33mm outer diameter shaft (made of stainless steel coated with Teflon (registered trademark)) and a 0.33mm outer diameter shaft (surface is coated with Teflon (registered trademark)). (Ni—Ti steel) shaft. Polyurethane balloon, guide wire lumen inner surface polyethylene, main body made of polyamide elastomer Tip shaft, polyimide communication tube with an inner diameter of 0.60mm, tapered stainless steel core material, stainless steel thread After assembling the filter mechanism, the filter mechanism part is a mesh structure knitted in a mesh shape so that the minimum length of the filter opening is 100 m and the axial length is 1.5 mm. force Tete axially length along Le (a) is lmm, the opening portion of the filter and the balloon distance (b) is 2. 5 mm, in FIG. 5 is the average cross-sectional area of the perfusion lumen is 0. 283 mm ² Body as represented A lumen occlusion catheter was obtained.

 [0086] (Example 4)

The main shaft has a 0.33mm outer diameter shaft (made of stainless steel coated with Teflon (registered trademark)) and a 0.33mm outer diameter shaft (surface is coated with Teflon (registered trademark)). (Ni—Ti steel) shaft. Polyurethane balloon, polyethylene inner guide wire lumen, main body is a polyamide elastomer tip shaft, polyimide communication tube with an inner diameter of 0.50 mm, tapered stainless steel core, stainless steel tube 100 μm After assembling the filter mechanism parts with a 2.5 mm axial length with multiple circular through-holes (minimum length of the filter opening portion of 100 m) formed along the axial direction of the catheter of the filter mechanism Body lumen occlusion as shown in Figure 22 with a length (a) of 2 mm, distance between the opening of the filter and the balloon (b) of 1.5 mm, and an average cross-sectional area of the perfusion lumen of 0.196 mm ² A catheter was obtained.

 [Example 5]

The main shaft has a 0.33mm outer diameter shaft (made of stainless steel coated with Teflon (registered trademark)) and a 0.33mm outer diameter shaft (surface is coated with Teflon (registered trademark)). (Ni—Ti steel) shaft. Polyurethane balloon, guide wire lumen inner surface is polyethylene, main body is polyamide elastomer chip shaft, polyimide communication tube with an inner diameter of 0.50mm, tapered stainless steel core, polytetrafluoro After assembling a filter mechanism part with an axial length of 4 mm, which consists of an ethylene tube with multiple 50 μm circular through-holes (minimum length of the filter opening is 50 μm). The length of the catheter in the axial direction (a) is 3 mm, the distance between the filter opening and the balloon (b) is 2 mm, and the average cross-sectional area of the perfusion lumen is 0.196 mm ² . Thus, a catheter for occluding an intraluminal lumen was obtained.

 [0088] (Example 6)

The main shaft has a 0.33 mm outer diameter shaft (made of stainless steel with a Teflon (registered trademark) coating on the surface) and a 0.33 mm outer diameter shaft (Teflon (surface (Registered trademark) coated Ni-Ti steel). Balloon made of polyurethane, inner part of guide wire lumen made of polyethylene, outer part made of polyamide elastomer, chip part made of polyimide, inner diameter of 0.40mm polyimide tube, tapered stainless steel core, heparin on the surface Fixed polyamide elastomer A plurality of 70 m circular through-holes (minimum length of the filter opening is 70 m) are formed in a single tube, and the portion corresponding to the proximal side is cut diagonally and stress is applied. When not applied, the filter mechanism parts with an axial length of 5 mm that have been heat-deformed to close on the slit are assembled. After assembly, the length (a) along the axial direction of the catheter of the filter mechanism is 4 mm. The distance between the opening of the filter and the balloon (b) is 1 mm, and the average cross-sectional area of the perfusion lumen is 0.125 mm ² . An embolic catheter was obtained.

 (Evaluation)

Using the above-described catheter for occluding a body lumen, an attempt was made to occlude the porcine internal carotid artery. A 6F guide catheter was inserted from the porcine femoral artery and placed up to the common carotid artery. A guide wire with a nominal diameter of 0.014 inches was inserted through the guide catheter, and the internal carotid artery was selected and placed. Insert the catheter for occluding the body lumen of Example 1 along the guide wire into the internal carotid artery, remove the guide wire, introduce 50% physiological saline into the balloon from the proximal side of the catheter, and insert the balloon into the balloon. It was expanded to occlude the internal carotid artery. Force that injects contrast medium into blood vessel through guiding catheter after occlusion Internal carotid artery After contrast, contrast medium flows along with blood through catheter's perfusion lumen and disappears, and there is no effect on subsequent operation Was confirmed. Next, 100 mm ² of a cross-linked polyvinyl alcohol gel having a diameter of 0.3 mm as a simulated embolic material was released into the internal carotid artery using a microcatheter. After that, a diagnostic agent is injected into the blood vessel through the guiding catheter to perform internal carotid angiography, and the cross-linked polyvinyl alcohol gel is blocked by the balloon part of the intraluminal lumen occlusion catheter and does not flow to the periphery. Was confirmed. Subsequently, the main shaft of the catheter for occluding the body lumen is replaced with a guide wire, and a suction catheter is inserted and a suction operation is performed to remove the cross-linked polyvinyl alcohol gel, which is a simulated embolic material, outside the body. Cavity occlusion catheter The balloon was also deflated and removed. The recovery rate of embolic material was 100%, and there was no abnormality in pigs. It was confirmed that the intraluminal lumen occlusion catheter of Example 3 exhibited the effect of the present invention and functioned as an intraluminal lumen occlusion catheter. Similarly, evaluation was performed on the catheters for occluding the body lumens of Examples 4 to 6, and it was confirmed that the effects of the present invention were exhibited and functioned as a catheter for occluding the body lumens as in Example 3. It was done.

Claims

The scope of the claims

 [I] a tubular body having a distal portion and a proximal portion, an expanded body joined in the vicinity of the distal portion of the tubular body, formed inside the tubular body, communicated with the interior of the expanded body, A force tape with an inflation lumen through which an expansion fluid is passed to expand or contract the expansion body,

 The expansion body includes a first outer surface that is in close contact with the inner wall of a living body lumen at the time of expansion, a perfusion lumen that allows communication between a distal side and a proximal side of the expansion body, and a filter element disposed in the perfusion lumen. Catheter.

 [2] The catheter according to claim 1, wherein the expansion body has a second outer surface forming the perfusion lumen.

[3] The catheter according to claim 1 or 2, wherein the perfusion lumen is formed by a sleeve joined to a third outer surface of the expansion body.

[4] The catheter according to any one of claims 1 to 3, wherein the first outer surface of the expansion body forms a substantially circular shape and is in close contact with the entire circumference of the inner wall of the living body lumen.

[5] The catheter according to any one of [2] to [4], wherein the expansion body is formed by a tube having the first outer surface and the second outer surface or the third outer surface.

6. The catheter according to any one of claims 2 to 5, wherein the expansion body has a ring shape having the first outer surface and the second outer surface or the third outer surface.

7. The catheter according to any one of claims 2 to 5, wherein the expansion body has a spiral shape having the first outer surface and the second outer surface or the third outer surface.

[8] The catheter according to [7], wherein the tubes forming a spiral shape are joined together by tubes adjacent in the axial direction.

[9] The invention according to claim 1, wherein there is at least one joining element that joins the tubular body and the expansion body or the sleeve in addition to the joining point of the tubular body and the expansion body.

9. The catheter according to any one of 8.

[10] The catheter according to any one of [1] to [9], wherein the filter element is joined to the expansion body.

[II] The filter element is characterized in that the filter element is joined to the sleeve. The catheter according to any one of 0.

[12] The catheter according to any one of [1] to [11], further comprising a metal member in the vicinity of the expansion body.

 13. The catheter according to claim 12, wherein the metal member is a superelastic metal.

14. The force tail according to claim 13, wherein the superelastic metal is a Ni—Ti alloy.

 [15] The catheter according to any one of [12] to [14], wherein the metal member is present inside the expansion body.

 [16] The perfusion lumen force when the expansion body is contracted is smaller than the perfusion lumen when the expansion body is expanded only by the contraction operation of the inflation device connected to the proximal portion of the tubular body. The catheter according to any one of claims 1 to 15, wherein:

 [17] The perfusion during contraction of the expansion body by the contraction operation of the inflation device connected to the proximal portion of the tubular body and the operation of moving the metal member in the axial direction relative to the tubular body The catheter according to any one of claims 1 to 15, wherein a lumen is smaller than the perfusion lumen when the expansion body is expanded.

 [18] The perfusion during contraction of the expansion body by the contraction operation of the inflation device connected to the proximal portion of the tubular body and the operation of moving the joining element in the axial direction relative to the tubular body The catheter according to any one of claims 1 to 15, wherein a lumen is smaller than the perfusion lumen when the expansion body is expanded.

 [19] When the inflation device connected to the proximal portion of the tubular body is contracted, the metal member is deformed as the expansion body contracts, whereby the perfusion when the expansion body contracts. The catheter according to any one of claims 1 to 18, wherein a lumen is smaller than the perfusion lumen when the expansion body is expanded.

 [20] The catheter according to any one of [1] to [19], further comprising a sheath that accommodates at least a part of the expansion body and the filter element when the expansion body contracts.

[21] A catheter having a tubular body having a balloon and an inflation lumen through which a fluid for expanding or contracting the balloon can move. A catheter for occluding a body lumen, characterized by having a perfusion lumen that allows fluid to freely flow between the distal side and the distal side.

 22. The catheter according to claim 21, wherein the catheter force has a filter mechanism at a position associated with the perfusion lumen.

23. The catheter according to claim 22, wherein the filter mechanism is provided at an upstream position where the fluid in the body lumen intended for occlusion flows.

[24] The catheter according to [22] or [23], wherein the catheter has a structure having a length along the axial direction of the filter mechanism force catheter.

25. The catheter according to claim 24, wherein the filter mechanism has a length along the axial direction of the catheter, and the length is 1 mm or more.

[26] The opening portion of the filter mechanism is close to the balloon,

25V, slippery catheter.

[27] The filter mechanism according to any one of claims 22 to 2, wherein the filter mechanism is composed of a mesh structure.

6V, catheter with a slippage.

[28] The catheter according to any one of claims 22 to 261 /, wherein the filter mechanism is structured to have a structure force with a through hole.

[29] The catheter according to any one of claims 22 to 28, wherein the minimum length of the filter opening portion of the filter mechanism is 50 μm to 200 μm.

30. The catheter according to claim 22, wherein the filter mechanism forms a guide wire lumen at the same time.

[31] The catheter according to claims 22 to 301 /, wherein the material of the filter mechanism is stainless steel or Ni—Ti alloy.

[32] The catheter according to any one of claims 22 to 30, wherein the material of the filter mechanism is a polymer material.

[33] The catheter according to any one of claims 22 to 32, wherein the surface of the filter mechanism is antithrombogenic.

34. The catheter according to claim 32, wherein the material of the filter mechanism is an antithrombotic material. 35. The catheter according to any one of claims 21 to 34, wherein an average cross-sectional area of the perfusion lumen so that the fluid can freely flow is 0.125 mm ² or more.