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WO2015141317A1 - Dispositif de retrait de corps étrangers - Google Patents

Dispositif de retrait de corps étrangers Download PDF

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Publication number
WO2015141317A1
WO2015141317A1 PCT/JP2015/053251 JP2015053251W WO2015141317A1 WO 2015141317 A1 WO2015141317 A1 WO 2015141317A1 JP 2015053251 W JP2015053251 W JP 2015053251W WO 2015141317 A1 WO2015141317 A1 WO 2015141317A1
Authority
WO
WIPO (PCT)
Prior art keywords
foreign matter
opening
flow path
foreign
rotating body
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/JP2015/053251
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English (en)
Japanese (ja)
Inventor
野崎　雄介
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Terumo Corp
Original Assignee
Terumo Corp
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
Application filed by Terumo Corp filed Critical Terumo Corp
Publication of WO2015141317A1 publication Critical patent/WO2015141317A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A61B17/320758—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions with a rotating cutting instrument, e.g. motor driven
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22038—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for with a guide wire
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/32—Surgical cutting instruments
    • A61B2017/320004—Surgical cutting instruments abrasive
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2217/00—General characteristics of surgical instruments
    • A61B2217/002—Auxiliary appliance
    • A61B2217/005—Auxiliary appliance with suction drainage system

Definitions

  • the present invention relates to a foreign matter removing device.
  • Thrombus formed in blood vessels can inhibit blood circulation in the body and cause thrombosis such as cerebral infarction and myocardial infarction. For this reason, it is generally desirable to remove such thrombus.
  • Patent Document 1 As a method for removing a thrombus, for example, a method for removing a thrombus by sucking the whole blood as described in Patent Document 1 is known.
  • the thrombus removal method by suction does not have sufficient thrombus recovery efficiency, and in some cases, a relatively large amount of blood leaks by this method. In such cases, blood transfusion may be necessary.
  • an object of the present invention is to provide a foreign substance removal device capable of efficiently removing foreign substances such as blood clots existing in a biological tube such as a blood vessel while reducing leakage of a body fluid such as blood, and a biological tube using the same. It is to provide a method for removing foreign matter.
  • the present inventors have been able to generate a local flow of body fluid containing foreign matters while crushing foreign matters by rotating a rotating body having a specific flow path in the vicinity of the foreign matters. It has been found that by contacting the body fluid with a capturing member such as a filter, foreign matter can be efficiently recovered while preventing leakage of the body fluid, and the present invention has been completed.
  • the present invention relates to the following.
  • a device for removing foreign matter in a biological tube A long body, A rotating body that is provided on the distal end side of the elongated body and is rotatable about the longitudinal direction as a rotation axis;
  • a foreign matter catching member The rotating body includes a first opening provided on the surface, a second opening provided on the surface and provided at a position further away from the rotation axis than the first opening, the first opening, and the first opening.
  • the foreign matter removing device is configured to catch foreign matter in a flow generated in the flow path.
  • the foreign matter removing device according to (1), wherein the foreign matter catching member is a filter provided in the flow path.
  • the elongated body has a lumen that penetrates from the distal end to the vicinity of the proximal end and communicates with the flow path,
  • the filter is configured to be switchable so that any one of a flow from the first opening toward the second opening or a flow from the flow path toward the lumen passes therethrough, (2) Device for removing foreign matter as described in 1.
  • the surface on the first opening side of the filter has a flow from the flow path toward the lumen.
  • the foreign matter removing device according to (3) which is a surface on the lumen side of the filter when passing through the filter.
  • the foreign object removing device according to (3) or (4), wherein the elongated body further includes a valve that controls movement of an object in the lumen.
  • the foreign matter removing device according to any one of (1) to (5), wherein the rotating body has a plurality of convex portions on a tip end side.
  • the foreign matter removing device according to any one of (1) to (6), wherein the first opening is provided on a rotation shaft of the rotating body.
  • It has a long body, a rotating body that is provided on the distal end side of the long body and is rotatable about the longitudinal direction as a rotation axis, and a foreign matter capturing member, and the rotating body is provided on the surface.
  • a method for removing foreign matter in a biological tube comprising: a capturing step of capturing the foreign matter in the flow generated in the flow path by rotating the rotating body with the foreign matter capturing member.
  • the foreign matter removing device (9) The foreign matter removing device according to (3) or (4), wherein the switching of the filter is performed using a centrifugal force generated by the rotation of the rotating body. (10) The foreign matter removing device according to (3) or (4), wherein the switching of the filter is performed by controlling a pressure in the lumen with respect to a pressure in the flow path. (11) The filter is connected to a wire passing through the elongated body, The foreign matter removing device according to (3) or (4), wherein the switching of the filter is configured to be controllable by movement of the wire in the vicinity of a proximal end of the elongated body.
  • the foreign matter capturing member includes a cylindrical body, and is arranged to store the flow generated in the flow path discharged from the second opening of the rotating body in the cylindrical body, and in the cylindrical body
  • the foreign matter removing device according to (1) configured to be able to capture foreign matter in the flow.
  • a device for removing foreign matter present in a living body tube A long body, A rotating body that is provided on the distal end side of the elongated body and is rotatable about the longitudinal direction as a rotation axis;
  • a foreign matter capturing member configured to include a cylindrical body, The rotating body includes a first opening provided on the surface, a second opening provided on the surface and provided at a position further away from the rotation axis than the first opening, the first opening, and the first opening.
  • a flow path having two openings at both ends, The foreign matter capturing member is disposed so as to accommodate the flow generated in the flow path discharged from the second opening of the rotating body in the cylindrical body, and captures the foreign matter in the flow in the cylindrical body.
  • a device for removing foreign substances that is configured to be capable of.
  • It has a plurality of pairs of the first opening and the second opening, and independent flow paths are provided for each pair of the first opening and the second opening.
  • the foreign matter removing device according to (16), wherein the protruding portion is inclined toward a distal end side.
  • a long body a rotary body that is provided on the distal end side of the long body and is rotatable about the longitudinal direction as a rotation axis, and a foreign matter capturing member including a cylindrical body, and the rotation
  • the body includes a first opening provided on the surface, a second opening provided on the surface and provided at a position further away from the rotation axis than the first opening, the first opening, and the second opening.
  • the foreign substance capturing member is disposed so as to accommodate the flow generated in the flow path discharged from the second opening in the cylindrical body, and Supplying a foreign matter removing device configured to capture foreign matter in the flow; and An arrangement step of arranging the rotating body in the vicinity of a foreign substance in a living body tube; A method for removing foreign matter existing in a biological tube, comprising: a capturing step of capturing the foreign matter in the flow generated in the flow path by rotating the rotating body with the foreign matter capturing member.
  • the foreign material removal device which can remove efficiently foreign materials, such as blood clots, which exist in biological vessels, such as blood vessels, while reducing leakage of bodily fluids, such as blood, and a foreign material in a biological tube using the same Can be provided. That is, the foreign substance removing device can collect the foreign substance while circulating the body fluid, and therefore, less body fluid leaks out of the body than the conventional suction method. In addition, since most of the crushed foreign matter is captured by the foreign matter capturing member, the crushed material is prevented from diffusing into the body.
  • FIG. 1 is a schematic diagram of a foreign matter removing device according to a first embodiment of the present invention.
  • 2A and 2B are partially enlarged vertical sectional views of the foreign matter removing device shown in FIG.
  • FIG. 3 is a partially enlarged longitudinal sectional view of a foreign matter removing device according to a modification of the first embodiment of the present invention.
  • 4 (a) and 4 (b) are partially enlarged longitudinal sectional views of the foreign matter removing device according to the modified embodiment of the first embodiment of the present invention.
  • FIGS. 5A to 5D are schematic diagrams for explaining the foreign matter removing method according to the first embodiment of the present invention.
  • FIG. 6 is a schematic view of a foreign matter removing device according to the second embodiment of the present invention.
  • 7A and 7B are partially enlarged longitudinal sectional views of the foreign matter removing device shown in FIG.
  • FIG. 8 is a partially enlarged longitudinal sectional view of a foreign matter removing device according to a modification of the second embodiment of the present invention.
  • FIG. 9 is a partially enlarged longitudinal sectional view of a foreign matter removing device according to a modification of the second embodiment of the present invention.
  • FIGS. 10A to 10C are schematic views for explaining the foreign matter removing method according to the second embodiment of the present invention.
  • FIGS. 11A to 11D are schematic views for explaining the foreign matter removing method according to the second embodiment of the present invention.
  • FIG. 1 is a schematic view of a foreign matter removing device according to a first embodiment of the present invention
  • FIGS. 2A and 2B are partially enlarged longitudinal sectional views of the foreign matter removing device shown in FIG.
  • These are the partial expanded longitudinal cross-sectional views of the foreign material removal device which concerns on the deformation
  • the size of each member is emphasized as appropriate, and the illustrated members do not indicate actual sizes.
  • the foreign substance removing device 1 is used to remove foreign substances existing in the lumen of a target biological tube.
  • the biological tube is not particularly limited, and examples thereof include blood vessels, esophagus, other gastrointestinal tract, trachea, bile duct, lymphatic vessel, urethra, ureter, and intracardiac.
  • the foreign matter is not particularly limited, but refers to a solid matter that should be removed in a living tube as necessary, and includes a mixture of a solid such as a gel and a liquid and / or gas.
  • foreign substances examples include thrombus, various stones such as gallstones, kidney stones, urinary tract stones, bladder stones, and urethral stones, sputum, granulation tissue, and calcified tissue.
  • the foreign substance removing device 1 is particularly suitable for removing a thrombus generated in a blood vessel.
  • a foreign body removing device 1 is provided on a long body 10, a rotary body 20 provided on the distal end side (distal end side) of the long body 10, and rotatable about a longitudinal direction as a rotation axis.
  • the foreign body capturing member 30 and the device main body 40 are included.
  • the long body 10 is a tubular member having a lumen 11, and the rotating body 20 is connected to the distal end side, and the device main body 40 is connected to the proximal end side (proximal end side).
  • the lumen 11 extends from the port 41 described later to the distal end of the long body 10, and penetrates the long body 10 and the device main body 40, and inserts an instrument such as a guide wire or foreign matter captured by the rotating body 20 described later. It is configured to be able to suck.
  • the elongated body 10 is provided with a valve 12 in the vicinity of the proximal end of the lumen 11 thereof.
  • a part of the end portion of the valve 12 is connected to the inner wall surface of the elongated body 10 by an elastic member (not shown).
  • the elastic member can function as a hinge, so that the position of the valve 12 can be appropriately changed from the elastic member as a starting point.
  • the valve 12 is configured not to rotate to the distal end side from the elastic member as a starting point by the protrusion 13 provided on the inner wall surface of the long body 10, but to rotate to the proximal end side.
  • the valve 12 can open with respect to the flow which goes to a base end side, and the elongate body 10 can transfer the foreign material collect
  • the valve 12 can block the lumen 11 and restrict the flow. As a result, gas such as air and unnecessary substances are prevented from leaking from the proximal end side through the lumen 11 to the distal end side.
  • the long body 10 can rotate with respect to the device body 40, and can transmit a driving force necessary for the rotation of the rotating body 20 from the device body 40.
  • the long body 10 is configured to be detachable from the device main body 40, and accordingly, the combination of the long body 10 and the rotating body 20 can be appropriately changed with respect to the device main body 40, for example, a target affected part or Can be changed according to symptoms.
  • the outer diameter of the long body 10 is not particularly limited, but can be 0.5 to 6 mm, for example. Further, the inner diameter of the long body 10 is not particularly limited, but may be 0.4 to 3 mm, for example. Further, the length (effective length) of the long body 10 is not particularly limited, but may be, for example, 500 to 2500 mm.
  • the material constituting the long body 10 is not particularly limited, but a material having appropriate flexibility is preferable.
  • examples of the material constituting the long body 10 include metals and resins.
  • the metal include pseudoelastic alloys (including superelastic alloys) such as Ni—Ti alloys, shape memory alloys, stainless steel (for example, SUS304, SUS303, SUS316, SUS316L, SUS316J1, SUS316J1L, SUS405, SUS430, SUS434, SUS444, SUS429, SUS430F, SUS302, etc.), cobalt-based alloys, noble metals such as gold and platinum, tungsten-based alloys, carbon-based materials (including Viano wires), and the like.
  • pseudoelastic alloys including superelastic alloys
  • Ni—Ti alloys such as Ni—Ti alloys, shape memory alloys, stainless steel (for example, SUS304, SUS303, SUS316, SUS316L, SUS316J1, SUS316J
  • the resin examples include polyolefin (for example, polyethylene, polypropylene, polybutene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, ionomer, or a mixture of two or more thereof), polyvinyl chloride, polyamide, Examples thereof include polymer materials such as polyamide elastomers, polyesters, polyester elastomers, polyurethanes, polyurethane elastomers, polyimides, fluororesins or mixtures thereof, or two or more of the above polymer materials.
  • the long body 10 can also apply a composite of these metals and resins (for example, a multilayer tube in which a metal and a resin are laminated).
  • the entire shape of the rotating body 20 has a substantially hemispherical shape with the apex arranged on the tip side.
  • the rotating body 20 is configured to be rotatable about the central axis 1 of the long body 10 as a rotation axis.
  • the rotating body 20 includes a first opening 21, a second opening 22, and a flow path 23.
  • the first opening 21 is provided in the vicinity of the top of the hemisphere of the rotator 20, that is, on the surface of the rotator 20 on the central axis l that is the rotation axis.
  • the second opening 22 is provided on the surface of the rotating body 20 at a position farther from the central axis 1 than the first opening 21.
  • the flow path 23 has the first opening 21 and the second opening 22 as both ends, and in the present embodiment, the first opening 21 is an end portion, and the lumen 11 of the elongated body 10 is used.
  • the first channel 231 communicated with the second channel 22 and the second channel 22 having the second opening 22 as one end and the other end connected to the first channel 231 so as to be orthogonal to the first channel 231. And have.
  • the rotating body 20 is applied with an abrasive on the front surface 24 thereof, and is provided with a plurality of convex portions. Thereby, the foreign body can be crushed and atomized on the distal surface 24 by rotating the rotating body 20 in contact with the foreign object in the living body tube.
  • polishing agent For example, a diamond powder, a metal powder, a resin powder etc. can be used.
  • a foreign matter capturing member 30 is provided between the first flow path 231 and the second flow path 232.
  • the foreign matter capturing member 30 is a filter, and can capture foreign matter in the fluid from the first flow path 231 toward the second flow path 232.
  • the foreign matter capturing member 30 is partially connected to the wall surface of the flow path 23 by an elastic member (not shown).
  • the elastic member can function as a hinge, so that the foreign substance capturing member 30 can appropriately change its position from the elastic member as a starting point.
  • the foreign material capturing member 30 is configured to be disposed between the first flow path 23 and the lumen 11 when the rotation of the rotating body 20 is stopped. .
  • FIG. 2A when the rotating body 20 rotates, the first flow path 231 and the second flow path 232 are accompanied by centrifugal force and movement of fluid in the flow path 23. Move between.
  • the surface on the first opening 21 side of the foreign material capturing member 30 flows from the flow path toward the lumen. Becomes the surface of the foreign material capturing member 30 on the side of the lumen 11 when passing through the foreign material capturing member 30.
  • the foreign matter capturing member 30 captures the foreign matter in the fluid from the first flow path 231 toward the second flow path 232 on the surface on the first opening 21 side. can do.
  • the foreign matter capturing member 30 can direct the surface carrying the captured foreign matter toward the lumen 11, so that the foreign matter is removed through the lumen 11 by suction or the like. Can be transported out of the device 1.
  • the maximum outer diameter of the cross section of the rotating body 20 is not particularly limited, but can be, for example, 0.5 to 100 mm. Further, the inner diameters of the first opening 21, the second opening 22 and the flow path 23 are not particularly limited, but may be 0.4 to 3 mm, for example.
  • the rotating body 20 as described above generates a flow in the flow path 23 by rotating. That is, as shown in FIG. 2 (a), the rotating body 20 rotates around the central axis l as a rotation axis, so that the fluid moves to a position away from the central axis l in the flow path 23, particularly near the second opening 22. Centrifugal force is generated. On the other hand, in the vicinity of the first opening 21 of the flow path 23, the first opening 21 is located closer to the central axis 1 than the second opening 22, particularly on the central axis 1, and thus the second opening 22. Only a small centrifugal force is generated as compared with the centrifugal force generated in the above.
  • the fluid existing in the flow path 23 is discharged from the second opening 22 in the direction of the arrow A.
  • the fluid is sucked from the first opening in the direction of arrow B in the figure.
  • the rotating body 20 can take in the foreign matter in the living body tube into the flow path 23 by rotating.
  • the rotator 20 atomizes the foreign matter even when the foreign matter present in the living body tube is relatively large. Thus, it can be taken into the flow path 23.
  • the foreign matter taken into the flow path 23 of the rotating body 20 is captured by the foreign matter capturing member 30. Even when the foreign matter captured by the foreign matter catching member 30 becomes relatively large, the foreign matter catching member 30 can move the foreign matter toward the lumen 11 by changing its position, and by sucking this The clogging of the foreign material capturing member 30 is also prevented.
  • the rotating body 20 may be made of any material, for example, can be made of a material that can be used in the long body 10 described above.
  • the member constituting the foreign matter capturing member 30 is not particularly limited.
  • a material having a hole that allows liquid to pass therethrough and does not allow foreign matter to pass therethrough specifically, a metal mesh, a wire net, or a woven fabric.
  • a fiber material (mesh fabric) having a predetermined mesh such as (woven fabric, knitted fabric) or non-woven fabric, a porous membrane such as a semipermeable membrane, or the like can be used alone or in combination.
  • the mesh fabric can be suitably used because the mesh opening is relatively uniform and the mesh opening can be easily selected in accordance with the recovery of the target foreign matter.
  • a material of the member it can select suitably, for example, the material which can be used in the elongate body 10 mentioned above can be used.
  • the opening of the mesh fabric or the average pore diameter of the porous membrane is not particularly limited, but is preferably 10 to 1000 ⁇ m, more preferably 50 to 200 ⁇ m.
  • the device main body 40 is connected to the proximal end side of the long body 10 and is used for operating and gripping the long body 10 and the rotating body 20, and an apparatus necessary for the operation of the long body 10 and the rotating body 20. Storing.
  • the device main body 40 includes a driving device therein, and by operating the driving device, the long body 10 and the rotating body 20 connected thereto can be rotated about the central axis l as a central axis. it can.
  • a gas turbine, an electromagnetic motor, or the like can be used as the drive device.
  • the device main body 40 includes a port 41 on the base end side.
  • the port 41 communicates with the lumen 11 of the elongated body 10.
  • the suction device is connected to the port 41, and the foreign matter captured by the foreign matter capturing member 30 can be collected by sucking the foreign matter through the lumen 11.
  • the foreign matter removing device 1A has a sheath (outer tube) 50 that covers the long body 10 to the proximal end side.
  • the long body 10 is prevented from touching the living body tube wall and other tissues of the target when the rotating body 20 is rotated, and unintentional damage to the target tissue is reliably prevented.
  • the foreign matter removing device 1B shown in FIGS. 4A and 4B includes a wire 14 disposed along the lumen 11 up to the device main body 40.
  • the wire 14 is connected to the foreign matter capturing member 30 and the valve 14. Thereby, the opening and closing of the valve 12 and the change of the direction of the foreign material capturing member 30 can be easily and reliably performed.
  • the wire 14 is accommodated in a lumen (not shown) other than the lumen 11 through the hole 15 as appropriate so that the obstruction of the passage of foreign matter and body fluid is as much as possible.
  • the wire 14 is configured along the groove 16 provided in the flow path 23. Further, the opening / closing of the valve 12 and the change of the direction of the foreign material capturing member 30 can be appropriately performed by changing the pressure in the lumen 11 from the device body 40.
  • the shape of the rotating body 20 can be changed to various shapes.
  • the shape that the rotating body can take may be a substantially spherical shape, a substantially elliptical shape, or the like.
  • the cross section of a rotary body is a substantially circular shape. Thereby, the burden of the living body tube wall at the time of rotation of a rotary body is reduced.
  • the shape of the flow path 23 can be variously changed.
  • the flow path may be a straight line connecting the first opening 21 and the second opening 22 or may be curved.
  • FIGS. 5A to 5D are schematic diagrams for explaining the foreign matter removing method according to the first embodiment of the present invention.
  • the method according to the present embodiment includes a long body, a rotating body that is provided on the distal end side of the long body and is rotatable about the longitudinal direction as a rotation axis, and a foreign matter capturing member.
  • the biological tube and foreign material applicable to this method are not particularly limited and include those described above, but the following description will be made assuming that the biological tube is a blood vessel and the foreign material is a thrombus.
  • the foreign matter removing device is not particularly limited as long as it is a foreign matter removing device of the present invention, and the foreign matter removing device according to the first embodiment described above can be used.
  • description will be made assuming that the foreign matter removing device 1 is used.
  • the provided foreign substance removal device 1 may be appropriately subjected to washing and sterilization treatment by a known method.
  • the rotating body 20 is arranged near the thrombus 101 in the blood vessel 100.
  • the foreign substance removing device 1 is delivered to the vicinity of the thrombus 101 in the blood vessel 100 using a guide catheter.
  • the guide wire 200 is inserted into the lumen 102 of the biological tube 100 using the Seldinger method or the like, and then the introducer sheath is inserted. Thereafter, the guiding catheter 200 is introduced into the vicinity of the thrombus 101 of the target blood vessel 100 along the guide wire 200. Finally, the foreign substance removing device 1 is inserted into the blood vessel 100 along the guiding catheter, and the rotating body 20 is disposed near the thrombus 101 (FIG. 5A).
  • the rotating body 20 is rotated and the foreign material 101 in the flow generated in the flow path 23 is captured by the foreign material capturing member 30 (FIG. 5B).
  • This step is preferably performed after the guide wire 100 is removed and the valve 12 is closed, for example.
  • the foreign matter capturing member 30 is disposed between the first flow path 231 and the second flow path 232 by the rotation of the rotating body 20.
  • the rotating body 20 is rotated by operating a driving device housed in the device main body 40 and rotating the long body 10 and the rotating body 20 around the central axis 1 as a rotation axis.
  • the number of rotations (rotational speed) of the rotating body 20 is not particularly limited, but may be, for example, 1,000 to 500,000 rpm, and preferably 5,000 to 200,000 rpm.
  • the flow of the thrombus 101 can be suitably taken into the flow path 23 by suitably generating a flow in the flow path 23 without imposing a burden on the inner wall of the blood vessel 100.
  • the thrombus 101 taken into the channel 23 is captured by the foreign substance capturing member 30 after passing through the first channel 231.
  • the body fluid taken into the flow path 23 together with the thrombus 101 passes through the foreign substance capturing member 30 and is discharged from the second opening 22 through the second flow path 232.
  • the rotating body 20 Since the abrasive is applied to the front surface 24 of the rotating body 20, even when the thrombus 101 is larger than the inner diameter of the first opening 21, the rotating body 20 flows. It can be taken into the path 23.
  • the foreign substance removing device 1 can collect the thrombus 101 while circulating blood (body fluid), the amount of blood leaking outside the body is less than that of the conventional suction method. Moreover, since most of the crushed thrombus 101 is captured by the foreign substance capturing member 30, the crushed material is prevented from diffusing into the body.
  • a suction step for sucking the thrombus 101 may be further performed. Specifically, the rotation of the rotating body 20 is stopped, and the side facing the first opening 21 when the rotating body 20 of the foreign body capturing member 30 rotates is directed toward the lumen 11 side of the long body 10. Then, by connecting the suction device to the port 41 and performing suction, the thrombus 101 captured by the foreign material capturing member 30 is released out of the foreign material removal device 1 (FIG. 5C). At this time, the valve 12 is opened by negative pressure.
  • the capture step for capturing the thrombus 101 again can be performed after the suction step is completed.
  • the thrombus 101 in the blood vessel 100 can be removed by repeating the step of capturing the thrombus 101 and the step of sucking the thrombus 101 (FIG. 5D). .
  • a foreign substance removing device capable of efficiently removing foreign substances such as blood clots existing in a biological tube such as a blood vessel while reducing leakage of a body fluid such as blood and a living body using the same A method for removing foreign matter in a tube can be provided.
  • FIG. 6 is a schematic diagram of a foreign matter removing device according to a second embodiment of the present invention
  • FIGS. 7A and 7B are partially enlarged longitudinal sectional views of the foreign matter removing device shown in FIG. 8 is a partially enlarged longitudinal sectional view of a foreign matter removing device according to a modified embodiment of the second embodiment of the present invention
  • FIG. 9 is a portion of the foreign matter removing device according to a modified embodiment of the second embodiment of the present invention. It is an enlarged vertical sectional view.
  • the foreign matter removing device 1 ⁇ / b> C includes a long body 10 ⁇ / b> C, a rotary body 20 ⁇ / b> C that is provided on the distal end side of the long body 10 ⁇ / b> C, and that can rotate about the longitudinal direction as a rotation axis. It has a foreign material capturing member 30C and a device main body 40C.
  • the long body 10C is a rod-shaped shaft, and the rotating body 20C is connected to the distal end side, and the device main body 40C is connected to the proximal end side.
  • the long body 10C is rotatable with respect to the device main body 40C, and can transmit a driving force necessary for the rotation of the rotating body 20C from the device main body 40C.
  • the long body 10C is configured to be detachable from the device main body 40C, and accordingly, a combination of the long body 10C, the rotating body 20C, and the foreign matter capturing member 30C is appropriately attached to the device main body 40C. For example, it can be changed according to the affected area and symptoms of the subject. Further, the foreign matter capturing member 30C as described later can be replaced.
  • the outer diameter of the long body 10C is not particularly limited, but can be, for example, 0.5 to 6 mm. Further, the length (effective length) of the long body 10C is not particularly limited, but may be, for example, 500 to 2,500 mm. In addition, although it does not specifically limit as a material which comprises the elongate body 10C, For example, the various materials enumerated in the elongate body 10 can be used.
  • the rotating body 20C includes a combination of two sets of a first opening 21C, a second opening 22C, and a flow path 23C. Further, these combinations are arranged so as to be symmetric with respect to the central axis l ′ of the long body 10C.
  • the first opening 21C is provided on the surface near the front end side of the rotating body 20C with reference to the longitudinal direction of the long body 10C.
  • the second opening 22C is located on the surface of the rotating body 20C at a position farther from the central axis l ′ of the long body 10C than the first opening 21C, and on the proximal end side of the long body 10C. It is provided for.
  • the flow path 23C has the first opening 21C and the second opening 22C as both ends, and is provided so that fluid and foreign substances can pass from the first opening 21C to the second opening 22C.
  • the rotating body 20C can generate a flow similar to that of the rotating body 20 in the first embodiment described above by rotating, sucking fluid and foreign matter from the first opening 21C, and passing through the flow path 23C.
  • the second opening 22C can be discharged toward the proximal end side of the long body 10C.
  • the angle ⁇ formed by the central axis of the flow path 23C near the second opening 22C and the central axis (rotary axis) of the elongated body 10C is not particularly limited, but is preferably 1 to 90 degrees. More preferably, it is 45 to 90 degrees. This facilitates centrifugation of the foreign substance and the liquid component as will be described later.
  • the rotating body 20C is applied with an abrasive on the tip side surface 24C, and is provided with a plurality of convex portions.
  • the foreign matter capturing member 30C has a cylindrical body with both ends opened.
  • the foreign matter catching member 30C is connected to the rotating body 20C by sandwiching the rotating body 20C at the edge on the tip side.
  • acquisition member 30C has accommodated the 2nd opening 22C of the rotary body 20C in the space 31C comprised with a cylinder. Thereby, the flow containing the foreign material and fluid discharged from the 2nd opening 22C can be accommodated in a cylinder. Note that the opening on the proximal end side of the foreign matter capturing member 30C is opened.
  • the foreign matter capturing member 30C is connected to the rotating body 20C but is not fixed by adhesion or fusion. Therefore, it is possible to remove and replace only the foreign material capturing member 30C from the rotating body 20C.
  • the outer diameter of the foreign matter capturing member 30C is not particularly limited, but can be, for example, 0.5 to 6 mm. Further, the inner diameter of the foreign matter capturing member 30C is not particularly limited, but may be, for example, 0.4 to 5.7 mm. Further, the length of the foreign material capturing member 30C is not particularly limited, but may be 3 to 150 mm, for example.
  • the device main body 40C is connected to the proximal end side of the long body 10C, and is used for the operation and gripping of the long body 10C and the rotating body 20C, and an apparatus necessary for the operation of the long body 10C and the rotating body 20C. Storing.
  • the device main body 40C includes a driving device therein, and by operating the driving device, the long body 10C and the rotating body 20C connected thereto are centered on the center line of the long body 10C. Can be rotated.
  • the foreign matter removing device 1C as described above has the following effects by operating the drive device of the device body 40C in the living body tube to rotate the long body 10C and the rotating body 20C.
  • the foreign matter removing device 1C is configured to be able to catch the foreign matter 101 in the spiral flow on the inner wall surface 32C of the foreign matter catching member 30C.
  • the foreign matter catching member 30D is configured by a transmission portion 33 that is configured by a member that allows a liquid base to pass through the cylindrical base end side and cannot pass a foreign matter.
  • the transmission part 33 can be a member similar to the foreign material capturing member 30 in the first embodiment as described above, for example.
  • a sheath 50D that covers the long body 10D to the base end side of the long body 10D is connected to the base end side of the transmission portion 33, and the sheath 50D seals the base end side opening of the foreign matter capturing member 30D. ing. Thereby, even if the foreign matter reaches the vicinity of the end of the foreign matter catching member 30D, the foreign matter can be reliably caught.
  • the foreign material capturing member 30D while the tip end side of the foreign material capturing member 30D is in contact with the rotating body 20D, the foreign material capturing member 30D and the rotating body 20D are not connected by adhesion or fusion. Thereby, it is possible to collect the foreign matter capturing member 30D together with the sheath 50D, and it is also possible to install a new foreign matter capturing member 30D. Therefore, even when there are a relatively large number of foreign substances in the living body tube, the foreign substance capturing member 30D can be appropriately replaced.
  • the opening on the proximal end side of the foreign matter catching member 30C is covered with a member through which liquid can pass and foreign matter cannot pass. Things. Thereby, even if the foreign matter reaches the vicinity of the end of the foreign matter catching member 30C, the foreign matter can be reliably caught.
  • the cylindrical body of the foreign matter catching member 30C is configured by a member that allows liquid to pass therethrough but cannot pass foreign matter. It is done. In this case, passage of the liquid foreign matter capturing member is facilitated, and foreign matter is more easily captured.
  • FIG. 9 there may be mentioned one in which a protrusion 34 is erected on the inner wall surface 32E of the foreign matter catching member 30E.
  • the protrusion 34 is inclined toward the distal end side of the foreign matter capturing member 30E.
  • the rotating body and the cylindrical body of the foreign matter catching member may be integrated by adhesion or fusion.
  • the foreign matter can be removed from the biological tube by removing the foreign matter removing device that has captured the foreign matter from the biological tube.
  • FIGS. 10A to 10C are schematic diagrams for explaining the foreign matter removing method according to the second embodiment of the present invention
  • FIGS. 11A to 11D are diagrams illustrating the second embodiment of the present invention. It is a schematic diagram explaining the foreign material removal method which concerns on an aspect.
  • the method according to this embodiment includes: A long body and a rotating body that is provided on the distal end side of the long body and is rotatable about the longitudinal direction as a rotation axis; and a foreign matter capturing member that includes a cylindrical body.
  • the foreign substance capturing member is disposed so as to accommodate the flow generated in the flow path discharged from the second opening of the rotating body in the cylindrical body, and the flow
  • a supply step for supplying a foreign matter removing device configured to capture foreign matter therein;
  • the biological tube and foreign material applicable to this method are not particularly limited and include those described above, but the following description will be made assuming that the biological tube is a blood vessel and the foreign material is a thrombus.
  • a foreign matter removing device is provided.
  • the foreign matter removing device the foreign matter removing device according to the second embodiment can be used.
  • description will be made assuming that the foreign matter removing device 1C is used.
  • the provided foreign substance removal device 1C may be appropriately subjected to washing and sterilization by a known method.
  • the rotating body 20C is arranged near the thrombus 101 in the blood vessel 100 (FIG. 10A). This step can be performed in the same manner as in the first embodiment.
  • the rotating body 20C is rotated to capture the thrombus 101 in the flow generated in the flow path 23C by the foreign material capturing member 30C (FIG. 10B).
  • the rotating body 20C is rotated by operating a driving device housed in the device main body 40C and rotating the long body 10C and the rotating body 20C around the central axis of the long body 10C as a rotation axis.
  • the thrombus 101 is taken in from the first opening 21C together with the blood (body fluid) in the blood vessel, passes through the flow path 23C, and is discharged from the second opening 22C.
  • the flow of the thrombus 101 and the body fluid discharged in the foreign matter capturing member 30C is spiral as described by the dotted line in the figure and moves to the proximal end side.
  • the thrombus 101 is relatively heavier than blood, the thrombus 101 collides with the inner wall surface of the foreign material capturing member 30C due to centrifugal force, decelerates, and remains near the inner wall surface of the foreign material capturing member 30C.
  • blood is discharged from the opening on the proximal end side of the foreign matter capturing member 30C.
  • the rotational speed (rotational speed) of the rotating body 20C is not particularly limited, but can be, for example, 1,000 to 500,000 rpm, and preferably 5,000 to 200,000 rpm. Thereby, it is possible to separate the thrombus 101 from the blood by suitably generating a spiral flow in the foreign matter capturing member 30C without imposing a burden on the inner wall of the blood vessel 100.
  • polishing agent is applied to the front end side surface of the rotary body 20C, even if the thrombus 101 is larger than the inner diameter of the first opening 21C, the flow path of the rotary body 20C is crushed. 23C can be imported.
  • the foreign substance removing device 1C can collect the thrombus 101 while circulating blood, the amount of blood leaking outside the body is smaller than that of the conventional suction method. Further, most of the crushed thrombus 101 is captured by the foreign material capturing member 30C, so that the crushed material is prevented from diffusing into the body.
  • an exchange step for exchanging the foreign substance capturing member 30C may be performed (FIGS. 11A to 11D).
  • the exchange of the foreign matter capturing member 30C can be performed using, for example, a balloon catheter.
  • the balloon catheter 400 is inserted into the blood vessel 100 along the long body 10C, and the deflated balloon 401 provided near the distal end of the balloon catheter 400 is captured. It arrange
  • the balloon 401 is expanded to press the inner wall of the foreign material capturing member 30C from the inside, and the foreign material capturing member 30C is carried by the balloon 401 (FIG. 11B).
  • the balloon catheter 400 is removed while maintaining the state in which the foreign substance capturing member 30C is carried (FIG. 11C).
  • the balloon catheter 400 carrying the new foreign substance capturing member 30C is inserted again into the blood vessel 100 (FIG. 11 (d)). Then, in a state where the foreign body capturing member 30C is in contact with the rotating body 20C, the balloon 401 is reduced, and the foreign body capturing member 30C is fixed to the rotating body 20C. After the completion of this step, the capture step can be performed again.
  • the thrombus 101 can be removed from the blood vessel 100 and collected in the foreign substance removal device 1C (FIG. 10C).
  • the removal of the foreign substance removal device 1C after capturing the thrombus 101 can be performed by collecting the foreign substance removal device 1C with a guide catheter or by removing the foreign substance removal device 1C as it is. Can do.
  • a foreign substance removing device capable of efficiently removing foreign substances such as blood clots existing in a biological tube such as a blood vessel while reducing leakage of a body fluid such as blood, and a biological tube using the same It is possible to provide a method for removing foreign matter.
  • each component can be replaced with any component that can exhibit the same function, or any component can be added.
  • This application is based on Japanese Patent Application No. 2014-057894 filed on March 20, 2014, the disclosure of which is referenced and incorporated as a whole.

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Abstract

L'objectif de la présente invention est de fournir un dispositif de retrait de corps étrangers qui est apte à retirer efficacement les corps étrangers, tels qu'un caillot de sang, présents dans un vaisseau d'un corps vivant tel qu'un vaisseau sanguin tout en réduisant la fuite d'un fluide corporel tel que le sang, et de fournir un procédé permettant de retirer un corps étranger dans un vaisseau d'un corps vivant à l'aide dudit dispositif. La présente invention concerne par conséquent un dispositif de retrait de corps étrangers (1) qui est un dispositif permettant de retirer un corps étranger dans un vaisseau d'un corps vivant, et comprend un corps long (10), un corps de rotation (20) qui est prévu sur le côté d'extrémité avant du corps long (10) et peut tourner, sa direction longitudinale lui servant axe de rotation, et un élément de piégeage de corps étranger (30). Le corps de rotation (20) est pourvu d'une première ouverture (21) prévue dans sa surface, d'une seconde ouverture (22) prévue dans la surface au niveau d'une position plus éloignée de l'axe de rotation que la première ouverture (21), et d'une voie d'écoulement ayant la première ouverture (21) et la seconde ouverture (22) au niveau des ses deux extrémités, et l'élément de piégeage de corps étrangers (30) est configuré pour être capable de piéger un corps étranger dans un écoulement généré dans la voie d'écoulement (23).
PCT/JP2015/053251 2014-03-20 2015-02-05 Dispositif de retrait de corps étrangers Ceased WO2015141317A1 (fr)

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JP2014057894 2014-03-20

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