WO2007001033A1 - Catheter - Google Patents

Catheter Download PDF

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Publication number
WO2007001033A1
WO2007001033A1 PCT/JP2006/312924 JP2006312924W WO2007001033A1 WO 2007001033 A1 WO2007001033 A1 WO 2007001033A1 JP 2006312924 W JP2006312924 W JP 2006312924W WO 2007001033 A1 WO2007001033 A1 WO 2007001033A1
Authority
WO
WIPO (PCT)
Prior art keywords
lumen
catheter
expansion body
catheter according
expansion
Prior art date
Application number
PCT/JP2006/312924
Other languages
English (en)
Japanese (ja)
Inventor
Hitoshi Tahara
Kohei Fukaya
Original Assignee
Kaneka Corporation
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from JP2005189439A external-priority patent/JP4940583B2/ja
Priority claimed from JP2006021760A external-priority patent/JP2007202614A/ja
Application filed by Kaneka Corporation filed Critical Kaneka Corporation
Publication of WO2007001033A1 publication Critical patent/WO2007001033A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1002—Balloon catheters characterised by balloon shape
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22051—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
    • A61B2017/22054—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation with two balloons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1052—Balloon catheters with special features or adapted for special applications for temporarily occluding a vessel for isolating a sector

Definitions

  • 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.
  • angioplasty PTA: Percutaneous
  • Transluminal Angioplasty ⁇ PTCA Percutaneous Transluminal Coronary Angioplasty, etc.
  • stents and the like for maintaining the state of the expanded stenosis have recently become widely used.
  • 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.
  • 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.
  • 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.
  • the blood clot may be released from the inner wall of the blood vessel and occlude the downstream peripheral blood vessel.
  • 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.
  • 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.
  • 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.
  • another therapeutic catheter such as a balloon catheter for vasodilation
  • the temporary occlusion balloon catheter is expanded on the peripheral side of the lesion, and the lesion is treated with the blood flow blocked.
  • 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.
  • 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.
  • 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.
  • the sheath is advanced again, and the embolizing substance is retained in the filter, stored in the sheath, and then removed.
  • 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.
  • 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
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the catheter can be easily manufactured.
  • 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
  • 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.
  • 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 is smaller than the perfusion lumen. According to these structures, it is possible to reduce the perfusion lumen when the expansion body contracts.
  • a metal member is provided in the vicinity of the expansion body, and the metal member is preferably a super-metallic metal.
  • the super elastic metal is a Ni—Ti alloy, and the metal member is preferably present inside the expansion 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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. !
  • 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.
  • 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.
  • 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.
  • the minimum length of the filter opening of the filter mechanism is more preferably 50 ⁇ m to 200 ⁇ m.
  • the filter mechanism forms a guide wire lumen at the same time.
  • 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.
  • 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.
  • 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.
  • 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 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.
  • 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.
  • 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.
  • FIG. 21 is a schematic diagram of one embodiment of the catheter according to the present invention.
  • 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.
  • the catheter according to 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
  • a catheter comprising a perfusion lumen communicating with each other and a filter element disposed in the perfusion lumen.
  • FIG. 1 shows a side view of a temporary occlusion catheter which is an embodiment of the catheter according to the present invention
  • FIG. 2 shows a cross-sectional view thereof.
  • 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).
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the fluid includes physiological fluid injected from outside the body, contrast medium, and the like in addition to body fluids such as blood.
  • 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.
  • the outer diameters of the expansion body 103 and the filter element 104 are smaller.
  • the operator can easily operate when selecting a target blood vessel or passing through a lesion.
  • 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.
  • 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.
  • 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.
  • 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
  • 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.
  • 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.
  • 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.
  • 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.
  • Fig. 3 is a side view of a temporary occlusion catheter as another embodiment of the catheter according to the present invention
  • 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.
  • 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.
  • 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.
  • FIG. 5 shows a side view of a temporary occlusion catheter as another embodiment of the catheter according to the present invention
  • 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.
  • a joining element 312 for joining the tubular body 302 and the expansion body 303 is present.
  • a temporary occlusion catheter such as the present invention
  • a space for arranging a filter and a balloon is required on the distal side of the diseased part.
  • this space may not be sufficient due to peripheral branching.
  • the application range of these catheters can be widened. Very useful.
  • 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.
  • 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.
  • the perfusion lumen 306 can be made smaller when the expansion body 303 contracts.
  • 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. .
  • FIG. 7 shows a side view of a temporary occlusion catheter as another embodiment of the catheter according to the present invention
  • 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.
  • a sleeve 415 joined to the expansion body 403 is further provided.
  • 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.
  • the catheter 401 can be easily manufactured.
  • 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.
  • 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.
  • Fig. 9 shows a side view of a temporary occlusion catheter as another embodiment of the catheter according to the present invention
  • Fig. 10 shows a cross-sectional view thereof.
  • 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.
  • the perfusion lumen 506 can be reduced when the expansion body 503 contracts.
  • 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.
  • the bent portion 517 of the metal member 516 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.
  • 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.
  • 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.
  • 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.
  • the metal member 616 is preferably flexible to the extent that the expansion of the expansion body 603 is not hindered.
  • 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.
  • the metal member 616 is deformed into a small coil shape shown in FIG. 15 without applying an external force.
  • the contracted expanded body 603 is deformed so as to become smaller in the radial direction of the spiral.
  • 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.
  • the operator 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the material of the main shaft is not particularly limited.
  • Polyimide, stainless steel, Ni-Ti ⁇ Ni-TiFe ⁇ Ni-TiCu ⁇ Ni-TiCr ⁇ Ni-TiV ⁇ 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.
  • 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.
  • 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.
  • the length along the axial direction of the filter mechanism is preferably 15 mm or less, and more preferably 5 mm or less.
  • 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 ⁇ m to 100 ⁇ m.
  • 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.
  • a polymer material such as stainless steel, Ni-Ti alloy, polyimide, polyethylene, polyamide elastomer, polytetrafluoroethylene, or the like is preferably used.
  • 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.
  • an antithrombotic material such as polytetrafluoroethylene as a material of the filter mechanism.
  • 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.
  • 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.
  • 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.
  • the perfusion lumen 705 may be provided, for example, by a tubular body having openings at both ends.
  • 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.
  • 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.
  • 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.
  • the present invention is a force related to a temporary occlusion catheter having a filter element.
  • 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. .
  • 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.
  • the same tubular body and filter element as in Example 1 were used.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Example 1 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 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. .
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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
  • 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.
  • 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 ⁇ m
  • 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 ⁇ m circular through-holes (minimum length of the filter opening is 50 ⁇ m).
  • 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
  • the average cross-sectional area of the perfusion lumen is 0.196 mm 2 .
  • 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).
  • 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.

Abstract

L’invention concerne un cathéter servant à bloquer une lumière corporelle. Le cathéter comprend un élément tubulaire présentant une partie distale et une partie proximale, un élément de dilatation adhérant fermement à la paroi intérieure de la lumière corporelle lorsqu’il se dilate, et une lumière de gonflage formée à l’intérieur de l’élément tubulaire et reliée à l’intérieur de l’élément de dilatation pour acheminer un fluide de dilatation permettant de dilater ou de contracter l’élément de dilatation. Le cathéter est caractérisé en ce qu’il comprend une lumière de reflux servant à relier le côté distal de l’élément de dilatation à son côté proximal, et un élément filtrant inséré dans la lumière de reflux. Le cathéter est capable d’adhérer fortement à une lumière corporelle et d’assurer un écoulement périphérique de fluide.
PCT/JP2006/312924 2005-06-29 2006-06-28 Catheter WO2007001033A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
JP2005-189439 2005-06-29
JP2005189439A JP4940583B2 (ja) 2005-06-29 2005-06-29 カテーテル
JP2006021760A JP2007202614A (ja) 2006-01-31 2006-01-31 カテーテル
JP2006-021760 2006-01-31

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WO2007001033A1 true WO2007001033A1 (fr) 2007-01-04

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2001520548A (ja) * 1997-04-16 2001-10-30 エンボル−エックス・インコーポレイテッド 付属フィルタを有するカニューレ
JP2002537943A (ja) * 1999-03-08 2002-11-12 マイクロベナ コーポレーション 最小侵襲型医療用装置の配置及び回収システム
JP2003500121A (ja) * 1998-09-10 2003-01-07 パーカーディア，インコーポレイティド 心室壁の人工導管用導通カテーテル
WO2004056275A1 (fr) * 2002-12-23 2004-07-08 Lithotech Medical Ltd. Dispositif chirurgical permettant d'extraire un objet etranger et procede de fabrication de ce dispositif

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2001520548A (ja) * 1997-04-16 2001-10-30 エンボル−エックス・インコーポレイテッド 付属フィルタを有するカニューレ
JP2003500121A (ja) * 1998-09-10 2003-01-07 パーカーディア，インコーポレイティド 心室壁の人工導管用導通カテーテル
JP2002537943A (ja) * 1999-03-08 2002-11-12 マイクロベナ コーポレーション 最小侵襲型医療用装置の配置及び回収システム
WO2004056275A1 (fr) * 2002-12-23 2004-07-08 Lithotech Medical Ltd. Dispositif chirurgical permettant d'extraire un objet etranger et procede de fabrication de ce dispositif

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