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WO2010055875A1 - Fil-guide destiné à être inseré dans une lumière d'un corps vivant - Google Patents

Fil-guide destiné à être inseré dans une lumière d'un corps vivant Download PDF

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Publication number
WO2010055875A1
WO2010055875A1 PCT/JP2009/069254 JP2009069254W WO2010055875A1 WO 2010055875 A1 WO2010055875 A1 WO 2010055875A1 JP 2009069254 W JP2009069254 W JP 2009069254W WO 2010055875 A1 WO2010055875 A1 WO 2010055875A1
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WO
WIPO (PCT)
Prior art keywords
tube
distal end
living body
guide wire
tip
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/JP2009/069254
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English (en)
Japanese (ja)
Inventor
定夫 尾股
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Nihon University
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Nihon University
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Filing date
Publication date
Application filed by Nihon University filed Critical Nihon University
Publication of WO2010055875A1 publication Critical patent/WO2010055875A1/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
    • A61B17/22—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
    • A61B17/221—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions
    • 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
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • 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
    • A61B17/22—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
    • A61B17/221—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions
    • A61B2017/2212—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions having a closed distal end, e.g. a loop
    • 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
    • A61B17/221—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions
    • A61B2017/2215—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions having an open distal end
    • 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
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A61M2025/09175—Guide wires having specific characteristics at the distal tip
    • A61M2025/09183—Guide wires having specific characteristics at the distal tip having tools at the distal tip

Definitions

  • the present invention relates to a guide tube for inserting a living body tube portion, and more particularly, to a guide wire for inserting a living body tube portion that is inserted into an axial through hole of a catheter and is movable and rotatable in the axial direction.
  • a blood clot or plaque or the like is present in a blood vessel in a living body, blood vessel stenosis occurs. Therefore, in order to dilate the blood vessel, a balloon or a stent is placed through a catheter.
  • Patent Document 1 discloses a filter element that is mounted on a filter carrier for feeding through a patient's vasculature and has an inlet end and an outlet end, and can be folded as an embolus prevention device.
  • the filter element has one or more inlet openings whose inlet end is sized to allow blood and embolic material to enter the filter body, the outlet end of which allows blood to pass, but preferably within the filter body. It has a plurality of outlet openings that are sized to trap any material.
  • a drawer device which is a catheter or pod, engages the filament, slides on the filter to fold the filter element, and the filter element is rotatably mounted on the filter carrier.
  • a blood vessel that becomes narrowed by a thrombus or the like can be expanded.
  • a thin blood vessel of 1 mm or less such as a cerebral blood vessel
  • these can be treated using a catheter. It is almost impossible to insert.
  • it is possible to capture an embolic substance in a blood vessel and, depending on the case, to draw it out and discharge it, but in order to add a complicated filter structure, it can be applied to a thin blood vessel.
  • a guide wire for inserting a biological tube includes a root portion to which a rotation mechanism is connected, a main body portion that is inserted into an axial through hole of a catheter, is movable in the axial direction, and can be rotated around an axis.
  • the guide wire is made of a shape memory alloy material imparted with super elasticity.
  • the distal end portion is divided into a plurality of elongated portions at the end portion of the main body portion by a plurality of slits having end portions on both sides.
  • the distal end portion is divided into a plurality of elongated portions at the end portion of the main body portion by a plurality of cuts having an end portion on the root side and opening the distal end side. It is preferable.
  • the tip portion is provided with uneven portions at a plurality of cut portions.
  • the distal end portion has coupling means for integrally coupling the divided portions at the distal end side of the plurality of divided portions divided by the cuts.
  • the root portion and the main body portion originally have the same outer diameter before being divided, and the distal end portion has a predetermined axial length.
  • a portion having a length not exceeding half of the circumferential length of the sphere in contact with the inner diameter of the target biological tube portion is divided into a plurality of elongated portions by slitting along the axial direction or cutting by a cut along the axial direction. It is preferable.
  • the guide tube for inserting a biological tube has a sheet-like thin film attached over the entire circumference along the circumferential direction in a part of the longitudinal direction of the tip, When the distal end portion expands into an envelope contour shape, the distal end portion expands into an envelope contour shape.
  • the distal end portion When the distal end portion is housed in the axial through hole of the catheter, the distal end portion is folded together with the distal end portion so as to be axially penetrated through the catheter. It is preferable to be housed in
  • the sheet-like thin film is preferably a mesh-like thin film having an opening in a mesh shape.
  • the sheet-like thin film is preferably made of a shape memory alloy material imparted with superelasticity.
  • the main body portion has a tubular shape including an axial center hole, and the distal end portion is free to the distal end side among a plurality of elongated divided portions. At least one divided portion having an end, the non-expanded divided portion not provided with superelasticity so as to expand into an envelope contour shape when the distal end protrudes from the distal end of the catheter, and A heater part that is inserted into the axial center hole of the main body part, and heat-deforms the free end on the front end side of the non-expanded divided part to have a predetermined shape by heating the front end part. It is preferable to provide a part.
  • the guide tube for inserting a living body tube portion is divided into a plurality of elongated portions along the axial direction at a predetermined axial length portion at the end of the body portion inserted into the axial through hole of the catheter.
  • tip part protrudes from the front-end
  • segmentation parts each expand in the direction perpendicular
  • the tip is plastically deformed into a predetermined envelope contour shape so that it does not exceed the elastic limit even if it is inserted into the catheter and deformed, it can be used as a free shape when protruding from the tip of the catheter.
  • the thickness passing through the axial through hole of the catheter is the same for the main body portion and the distal end portion.
  • the outer diameter of the catheter depends on the outer shape of the catheter that passes through the catheter. However, if only one guide wire is passed, the outer diameter of the catheter itself can be 1 mm or less.
  • the guide wire for inserting a living body tube is made of a shape memory alloy material to which super elasticity is imparted. Since shape memory alloys with superelasticity still remain at the elastic limit even when subjected to large deformations, they do not exceed the elastic limit even if they are inserted into the catheter and greatly deformed.
  • the contour shape can be formed by fairly large plastic deformation. Therefore, since the envelope contour shape for entwining the thrombus can be increased, the ability to remove the thrombus can be enhanced.
  • the tip portion protrudes from the tip of the catheter, a plurality of elongated divided portions are perpendicular to the axial direction. Since the envelope contour shape is formed in a predetermined direction to form a predetermined envelope contour shape, it can be applied to a thinner living body tube portion as compared with the prior art. Further, since the envelope contour shape of the tip portion can be rotated around the axis, an occlusive substance such as a thrombus can be entangled and captured in this envelope contour shape.
  • the distal end portion is divided into a plurality of elongated portions by a plurality of slits having end portions on both sides at the end portion of the main body portion. That is, a living body tube insertion guide wire can be obtained only by performing a process of making a slit in the distal end portion of the guide wire.
  • the distal end portion is divided into a plurality of elongated portions at the end portion of the main body portion by a plurality of cuts having end portions on the root side and opened on the distal end side.
  • a guide wire for inserting a living body tube can be obtained more easily than the process of inserting a slit.
  • the tip portion is provided with uneven portions at a plurality of cut portions. This makes it easier to entangle and capture occlusive substances such as thrombus.
  • the distal end portion has coupling means for integrally coupling the divided portions on the distal end side of the plurality of divided portions divided by the cuts.
  • the base portion and the main body portion originally have an outer diameter of the same thickness before being divided, and a sphere in contact with the inner diameter of the target living body tube portion at the distal end portion
  • a portion having a length not exceeding half of the circumferential length is divided into a plurality of elongated portions by cutting with slits along the axial direction or cuts along the axial direction.
  • a sheet-like thin film is attached to a part of the distal end in the longitudinal direction along the entire circumference.
  • the sheet-like thin film expands together with the distal end portion into an envelope contour shape when the distal end portion expands into an envelope contour shape, and folds together with the distal end portion when the distal end portion is housed in the axial through hole of the catheter. And stored in the axial through hole of the catheter.
  • occlusion substance of a biological tube part can be capture
  • the sheet-like thin film is a mesh-like thin film having an opening in a mesh shape. Capture can be performed efficiently.
  • the sheet-like thin film is made of a shape memory alloy material to which superelasticity is imparted, so that it is easy to specify the size when expanding.
  • the main body portion has a tubular shape including an axial center hole, into which a heater portion is inserted. Then, at least one of the divided portions of the distal end portion is heated by the heater portion, so that the free end on the distal end side is thermally deformed so as to have a predetermined shape.
  • a tip-shaped divided portion that efficiently captures the occlusive substance of the biological tube portion can be obtained, so that the occlusive substance of the biological tube portion is further efficiently captured. be able to.
  • a nickel-titanium alloy will be described as a shape memory material to which a superelastic metal is applied.
  • a nickel-titanium alloy is 5 to 10 times that of a normal metal by heat treatment.
  • Any metal can be used as long as it has the elastic range and has superelastic characteristics that can return to its original shape even when a large deformation is applied.
  • it may be an alloy based on a nickel-titanium alloy and optionally added with copper, cobalt, chromium, iron or the like, or may be a nickel-aluminum alloy or the like.
  • FIG. 1 is a diagram for explaining the configuration and operation of a guide wire 20 for inserting a biological tube.
  • the catheter 10 and the blood vessel 4 as the living tube portion into which these are inserted are shown.
  • the blood vessel 4 is shown to have a blocking substance 8 attached to the tube wall of the tube portion 6 through which blood passes, and that portion being narrowed.
  • a representative example of the occlusive substance is an athenome segment formed in the carotid artery. Since the blood vessel 4 is constricted by these occluding substances and the blood flow is stopped in some cases is called a thrombus, the occluding substance is also a thrombotic substance.
  • the catheter 10 is passed from the outside into the blood vessel 4 and inserted to the affected area, where the balloon is expanded using the inner catheter or guide wire, or the stent is expanded.
  • the balloon or stent cannot be carried to the affected area by the catheter 10 in a thin blood vessel, the thrombus substance is dissolved with a drug or the like.
  • the guide wire 20 for inserting the living body tube portion is simply referred to as the guide wire 20.
  • the entire instrument that encloses an elongate wire or the like in an elongate tube and passes the inside of the blood vessel 4 as a whole is sometimes called a catheter.
  • the outer tube is made of an outer catheter or an outer catheter.
  • the elongate wires stored in the through holes are distinguished from each other as inner catheters. Therefore, the catheter 10 of FIG. 1 can also be called an outer catheter and the guide wire 20 can be called an inner catheter.
  • the catheter 10 is a tube having a function of passing the guide wire 20.
  • a catheter 10 a general one selected for medical use and having a thin outer diameter can be used.
  • the outer diameter is preferably about 2 mm or less, preferably about 1 mm or less, and about 0.80 mm which is a standard inch type.
  • the inner diameter has such a dimension that the guide wire 20 can be smoothly introduced while having a sufficient tube thickness and a gap that can be moved in the axial direction can be secured.
  • the inner diameter is preferably 0.46 mm.
  • the catheter 10 a nylon tube in which a stainless mesh is embedded can be used.
  • the guide wire 20 includes a root portion 22, a main body portion 24, and an expanded distal end portion 30 shown as an expanded state in FIG. 1.
  • the expanded distal end portion 30 is in an expanded state when protruding from the distal end of the catheter 10, but is originally a material having the same thickness as the main body portion 24.
  • the guide wire 20 is an elongated bar that is originally composed of a single material having the same thickness.
  • the outer diameter is preferably about 1 mm or less, preferably 0.5 mm or less, for example, about 0.43 mm to 0.25 mm, which is a standard numerical value for an inch system.
  • shape memory alloy material As shape memory alloy material, it has superelasticity by heat treatment in a deformed state, and has an elastic range of 5 to 10 times that of normal metal when returned to room temperature. However, a material that can return to its original shape when the deformation force is removed is used. As such a metal material, a nickel-titanium alloy can be used.
  • the nickel-titanium alloy can have a shape recovery temperature of room temperature or lower, and can be, for example, about 500 ° C. for about 30 minutes as a heat treatment for imparting superelasticity.
  • the root mechanism 22 of the guide wire 20 is connected to the rotation mechanism 12.
  • the rotation mechanism 12 is a mechanism that rotates the guide wire 20 around an axis, and can be configured with a small motor, a drive circuit, and the like. In some cases, a handle mechanism can be provided so that an operator who performs an operation of inserting the catheter 10 and the guide wire 20 into the living body can easily rotate manually.
  • the total length of the guide wire 20 is set to be sufficiently longer than the total length of the catheter 10 so that the root portion 22 of the guide wire 20 does not enter the inside of the catheter 10.
  • FIG. 2 is a diagram for explaining a state in which the distal end portion of the guide wire 20 is housed in the catheter 10 and a state of change when protruding from the distal end of the catheter 10.
  • the catheter 10 and the guide wire 20 for example, when the inner diameter of the catheter 10 is 0.46 mm and the outer diameter of the guide wire 20 is 0.43 mm, the catheter 10 is located at the body portion 24 of the guide wire 20. The gap between the inner diameter of the guide wire 20 and the outer diameter of the guide wire 20 is 0.03 mm.
  • the guide wire 20 can move in the axial direction relative to the inside of the catheter 10, and can be rotated around the axis by the rotation mechanism 12.
  • FIG. 2 is a view showing a state in which the distal end portion of the guide wire 20 is accommodated in the catheter 10, and here, the distal end portion in which the outer diameter is regulated by the inner wall of the catheter 10 and folded. 28 is shown.
  • the folded distal end portion 28 is the shape of the expanded distal end portion 30 described with reference to FIG. 1 when superelasticity is applied, but the shape of the superelasticity is applied by the inner wall of the catheter 10. A large deformation is applied so that the outer diameter is regulated. Therefore, the folded distal end portion 28 applies a force to be expanded to the inner wall of the catheter 10.
  • the lower view of FIG. 2 is compared with the upper view, and the distal end portion of the guide wire 20 protrudes from the distal end portion of the catheter 10 by moving the catheter 10 in the direction of the white arrow, and is superelastic. It is a figure which shows a mode that it returns to the shape at the time of becoming and becomes the expansion front-end
  • the shape of the expanded distal end portion 30 shown in the lower diagram of FIG. 2 is the state in which the deformation is applied when heat treatment is applied to the distal end portion of the guide wire 20 to apply superelasticity.
  • Shape That is, in the step of applying superelasticity, an appropriate deformation jig is used so that the distal end portion of the guide wire 20 has a predetermined envelope contour shape. The heat treatment is performed.
  • a metal sphere having an appropriate outer diameter can be used as the deformation jig for forming the envelope contour shape.
  • the outer diameter of the envelope contour shape can be appropriately determined according to the inner diameter of the blood vessel 4 when the guide wire 20 is inserted and expanded.
  • the outer diameter of the catheter 10 is 0.8 mm
  • the inner diameter of the blood vessel 4 is about 1 mm
  • the outer diameter of the envelope contour shape can also be about 1 mm.
  • the function of the widening tip portion 30 having the envelope contour shape is to entangle the occluding substance 8, and at this time, it is preferable to rotate the guide wire 20 around the axis.
  • the outer diameter of the envelope contour shape does not have to be so large.
  • FIG. 3 is a view showing a state of the guide wire 20 prepared before the step of applying superelasticity.
  • the guide wire 20 is an elongated rod originally composed of a single material having the same thickness.
  • the guide wire 20 is a nickel-titanium alloy thin wire having an outer diameter of 0.43 mm. is there.
  • the distal end portion of the guide wire 20 is a distal end portion 26 with a slit provided with a plurality of slits 32. That is, in the above example, a plurality of slits having end portions on both sides are carved by processing at the distal end portion of a thin wire having an outer diameter of 0.43 mm and are divided into a plurality of elongated portions.
  • two elongated slits 32 are cut along the axial direction at the distal end of the guide wire 20 so as to be orthogonal to each other in a plane perpendicular to the axis.
  • the process of cutting the slit 32 can be performed by laser processing or the like. This processing is performed in an atmosphere at room temperature or the like on a nickel-titanium alloy fine wire as a raw material. In this way, the super-elastic processing is performed on the guide wire 20 having the slit-attached tip portion 26 provided with the plurality of slits 32.
  • the manufacturing method of the guide wire 20 is performed through the following steps.
  • a thin line of shape memory material having an outer diameter corresponding to the inner diameter of the target catheter 10 is prepared (thin line preparation step).
  • a nickel-titanium alloy fine wire having an outer diameter of 0.43 mm is prepared.
  • the length is sufficiently longer than the entire length of the catheter 10.
  • a plurality of slits are processed at a predetermined slit length at the tip of the thin wire (slit processing step). Thereby, the guide wire 20 which has the front-end
  • two slits 32 perpendicular to each other in a plane perpendicular to the axial direction are formed by laser processing or the like.
  • the slit length is half of the circumferential length of the sphere in contact with the inner diameter of the target blood vessel 4. Since the distal end portion 26 with the slit is divided into four elongated portions whose both ends are connected to each other, the distal end portion 26 with the slit is formed into an arbitrary shape by utilizing the flexibility of the four elongated portions. It can be.
  • a process of giving superelasticity is performed on the guide wire 20 having the tip portion 26 with a slit (superelasticity applying step).
  • the four divided portions of the tip portion 26 with the slit are opened, and a metal sphere is disposed therein as a jig, and is held in the envelope contour shape.
  • tip part of the guide wire 20 is performed in the state hold
  • heating is performed at about 500 ° C. for 30 minutes. After heating, return to room temperature and remove the metal bulb.
  • the guide wire 20 having the expanded distal end portion 30 whose distal end portion has an envelope contour shape is obtained. Since the envelope contour portion has superelasticity, it has an elasticity range 5 to 10 times that in a state where superelasticity is not applied. Therefore, when an external force is applied to the outer shape of the envelope contour shape and plastic deformation does not occur even in a flat state and the external force is removed, the outer shape of the original envelope contour shape is restored.
  • the rotation mechanism 12 is connected to the root thereof. This completes the preparation of the guide wire 20.
  • the prepared guide wire 20 is inserted into and stored in the axial through hole of the catheter 10 separately prepared (accommodating step in the catheter). At this time, the distal end portion of the guide wire 20 becomes the folded distal end portion 28 as described with reference to the upper side of FIG. The folded tip 28 is inserted to the vicinity of the tip of the catheter 10.
  • the catheter 10 storing the guide wire 20 is inserted into the blood vessel 4 of the target living body (insertion step).
  • a marker (not shown) is attached to the distal end portion of the catheter 10, and the position of the distal end of the catheter 10 in the blood vessel 4 of the living body can be observed on a monitor or the like using, for example, X-rays.
  • the base part of the catheter 10 is operated, the front-end
  • the catheter 10 When the distal end portion of the catheter 10 reaches a desired site, the catheter 10 is moved to the front side while the position of the guide wire 20 is left as it is, as described in the lower diagram of FIG. As a result, the folded distal end portion 28 of the guide wire 20 protrudes from the distal end of the catheter 10, and a plurality of elongated divided portions are expanded by the slits 32 in the direction perpendicular to the axial direction. A shape is formed to become the expanded tip 30 (expanding step).
  • the guide wire 20 is rotated around the axis by the rotating mechanism 12 or moved back and forth in the axial direction by the operation on the hand side, and the occluding substance 8 is entangled in the envelope contour shape and removed from the vessel wall or inside of the blood vessel 4.
  • Yes occlusion substance capture step.
  • the distal end portion entangled with the occlusive substance 8 is stored in the catheter 10 again by returning the catheter 10 to the original position or pulling the guide wire 20 further forward.
  • the catheter 10 containing the guide wire 20 passes through the blood vessel 4 again, is pulled out, and is returned to the outside of the living body, whereby the occluding substance 8 can be carried out of the living body (discharge process).
  • a plurality of slits 32 are formed at the distal end portion of the guide wire 20, but a shape effective for entanglement of the occluding substance 8 may be obtained by other methods.
  • 4 to 6 are views showing examples of guide wires having different tip end shapes.
  • the guide wire 40 shown in FIG. 4 is provided with a plurality of cuts at the end portion of the main body portion 24 that have end portions on the root side and open at the tip end side, thereby forming a tip portion 42 that is divided into a plurality of elongated portions.
  • the tip end sides of the plurality of divided parts are integrally coupled.
  • the distal end portion 42 of the guide wire 40 can be formed into a plurality of elongated divided portions by a simple cutting process without using slit processing, and the distal end side thereof is integrated by, for example, a thin wire binding member 44, thereby It can be made into the same shape as what gave the slit process. Giving super-elasticity to the envelope contour shape can be realized by a process similar to that described with reference to FIGS.
  • the distal end portion of the main body portion 24 of the guide wire 40 is provided with a cut over an appropriate length, and the length of the cut at the distal end portion is adjusted later so as to correspond to the size of the desired envelope contour shape. Just cut it.
  • the guide wire 50 shown in FIG. 5 is provided with a cut 54 at the end of the main body 24 to form a plurality of elongated tip portions 52, and the tip side is integrated. They are not tied together and remain separated from each other.
  • FIG. 5 shows the outer shape after imparting superelasticity.
  • a spherical or elliptical sphere jig is used, as in the case described in relation to FIG. 2 and FIG. Since the tip portions of the plurality of divided parts are separated from each other, it is preferable to use another jig that presses each of the divided parts against the outer surface of the jig.
  • the shape of the tip portion to which superelasticity is imparted is an envelope contour shape that opens on the tip side, and it is expected that the occluding substance 8 can be easily taken from the opening.
  • the guide wire 60 shown in FIG. 6 is a diagram showing an example in which a process for attaching a locking shape is added to the tip portion 62 divided into a plurality of parts when the cut described in FIGS. 4 and 5 is made.
  • FIG. 6 shows a state before applying superelasticity, that is, a state in which a cut 66 is made in the material thin line and a process of applying the locking portion 64 is performed. The step of imparting superelasticity is performed thereafter.
  • the tip side may be bound as shown in FIG. 4, or the tip side may be left open as shown in FIG.
  • the locking portion 64 is for preventing the occluding substance 8 entangled at the tip portion divided into long and narrow portions from being peeled again and keeping it tangled. Therefore, it is preferable to have a concavo-convex shape such as a bowl-shaped one or a surface roughened like a bowl surface.
  • the guide tube for inserting a living body tube is described as being made of a shape memory alloy material to which superelasticity is imparted, but it may be a normal fine metal wire that cannot impart superelasticity. Even in this case, if the tip portion is plastically deformed to a predetermined envelope contour shape so that it does not exceed the elastic limit even if it is inserted into the catheter and deformed, the free shape can be obtained when protruding from the tip of the catheter. It is possible to return to the original envelope contour shape.
  • a general steel fine wire is preliminarily processed into an envelope contour shape so as to have an outer shape larger than the inner diameter of the catheter, if it is within the inner diameter of the catheter, the inner diameter is within the elastic limit range. Although it is deformed, when it protrudes from the distal end of the catheter, it returns to the original enveloped contour shape.
  • it is a normal thin metal wire, although it is a small external shape compared with the case where super elasticity is given, it can be expanded to an envelope outline shape when it protrudes from the tip of a catheter.
  • the locking portion 64 is provided on the divided distal end portion 62.
  • a locking portion may be provided for each element divided at the tip end portion 26.
  • Such a locking part can be formed by performing an appropriate uneven
  • the tip portion 22 and the main body portion 24 originally have the same outer diameter before being divided, and the tip portion is As a predetermined axial length, a portion having a length not exceeding half of the circumferential length of the sphere in contact with the inner diameter of the target biological tube portion is caused by a slit notch along the axial direction or a cut along the axial direction. Divided into multiple strips by cutting.
  • the slit nicks or cuts made on the front end of the main body 24 are performed with a slit width and a cut width sufficient to separate the front end into a plurality of pieces.
  • a slit width and a cut width of about several tens of ⁇ m are sufficient.
  • narrower slit width and cut width can be used. Therefore, even if the slit width and the slit width are provided to divide the tip portion, the divided portions are aligned with almost no gap, and the overall outer diameter is the outer diameter of the original root portion 22 and the main body portion 24. And no different. This is also shown in the enlarged view of FIG.
  • the sectional shape of each divided portion is a quarter circle with a radius of 0.215 mm
  • the length of the slit 32 in the axial direction is less than 1.57 mm which is a half of the circumferential length of a sphere having a diameter of 1 mm
  • the slit width is several tens of ⁇ m.
  • FIG. 7 is a diagram illustrating a state in which the thin film 70 is attached to the distal end portion 26 of the guide wire 20 having the configuration described in FIG.
  • the upper diagram shows a state in which the thin film 70 is attached to the guide wire 20 prepared before superelasticity is applied, and the lower diagram shows the state of the expanded tip 30 having an envelope contour shape.
  • FIG. 7 is a diagram illustrating a state in which the thin film 70 is attached to the distal end portion 26 of the guide wire 20 having the configuration described in FIG.
  • the upper diagram shows a state in which the thin film 70 is attached to the guide wire 20 prepared before superelasticity is applied
  • the lower diagram shows the state of the expanded tip 30 having an envelope contour shape.
  • the thin film 70 is a thin film having a sheet shape and a plurality of openings 72.
  • the thin film 70 can be made of a thin film material having appropriate elasticity and biocompatibility.
  • the plurality of openings 72 can also be configured by making a plurality of holes in the sheet, and use a net-like thin film formed by knitting fine lines into a mesh shape. it can.
  • a biocompatible plastic film having appropriate holes As the former example, it is possible to use a biocompatible plastic film having appropriate holes as the opening 72.
  • a nickel-titanium alloy fine wire knitted into a sheet shape and a stitch formed as an opening 72 can be used. In this case, it is possible to use a superelastic material like the guide wire 20.
  • the thin film 70 is attached to a part of the distal end portion 26 along the circumferential direction so as to partially cover the entire length of the slit 32 extending in the longitudinal direction at the distal end portion 26.
  • Partially covering the entire length of the slit 32 is that when the guide wire 20 is pulled in the direction of the arrow to capture the occlusive material as shown in the lower view of FIG. This is to drive in. Therefore, about 1/2 of the entire length of the slit 32 is covered from the most distal side of the guide wire 20 in the longitudinal direction of the slit 32 so as to form an umbrella shape that opens upstream with respect to the direction in which the guide wire 20 is captured and collected. It is preferable to do so.
  • the thin film 70 expands into an envelope contour shape together with the expanded distal end portion 30, and the distal end portion is accommodated in the axial through hole of the catheter 10. Sometimes it is folded together with the distal end portion 26 and stored in the axial through hole of the catheter 10. That is, the thin film 70 is in close contact with the shape of the distal end portion of the guide wire 20 in any state.
  • the sheet-like thin film 70 having a plurality of openings 72 is attached to a part of the distal end portion 26 of the guide wire 20, when the expanded distal end portion 30 having the expanded distal end portion 30 is obtained, It becomes an umbrella shape opened upstream of the blood flow, and the occluding substance can be effectively captured while passing the blood flow through the opening 72 opened in the umbrella-shaped film surface.
  • the guide wire 20 is a solid thin wire so that it can be applied to a blood vessel having an inner diameter of about 1 mm.
  • a tubular guide wire should be used. Can do.
  • a thin control material that controls the shape of the tip can be passed through the tube.
  • FIGS. 8 to 10 are diagrams illustrating an example in which the shape control of the distal end portion 86 of the guide wire 80 is performed through the ultrafine heater portion 140 through the guide wire 80 having a tubular shape.
  • FIG. 8 is a view showing a state of the guide wire 80 prepared before the step of superelasticity.
  • vertical to a longitudinal direction are shown.
  • the root portion 82 is connected to the rotation mechanism 12 in the same manner as the configuration described in FIG.
  • the main body portion 84 has a tubular shape including an axial center hole 88, and the distal end portion 86 is elongated into a plurality of divided portions by slit notching.
  • at least one of the plurality of divided portions has a free end on the distal end side, and expands to have an envelope contour shape when the distal end portion protrudes from the distal end of the catheter 10. It is a non-expanded divided part to which no elasticity is given.
  • the distal end portion 86 is formed with six elongated divided portions 90, 91, 92, 93, 100, 102 by slit notching by laser processing or the like.
  • the four divided portions 90, 91, 92, and 94 are divided portions having end portions on both sides in the same manner as described with reference to FIG. 3, and as described above, for example, an appropriate metal Using a spherical jig, super-elasticity that gives an envelope contour shape is imparted.
  • the remaining two divided portions 100 and 102 have end portions on one side, but are free ends on the other side.
  • the split portions 100 and 102 are not given superelasticity.
  • the conditions for the overall length of the slit, the slit width, and the like are the same as those described in relation to FIG.
  • FIG. 9 is a view showing a state in which the distal end portion of the guide wire 80 prepared as shown in FIG. As described with reference to FIG. 8, the four divided portions 90, 91, 92, and 93 are subjected to superelastic processing to become an envelope contour shape. As shown in the figure, the expanded divided portions 120, 121, 122, 123 are formed. On the other hand, since the remaining two divided portions 100 and 102 are not subjected to superelastic processing, they remain in a free end shape. Even in this state, when the guide wire 80 is rotated around the axis by the rotation mechanism 12, the occluding substance in the blood vessel can be captured by the expanded distal end portion 109 having the envelope contour shape.
  • the ultrathin heater part 140 is passed through the axial center hole 88 of the guide wire 80, and the two divided parts 100 and 102 that are not superelastically processed are heated by the heating part 142 at the tip.
  • FIG. 10 shows a mode that control which makes a shape the predetermined shape defined beforehand is performed. This makes it possible to capture the occluding substance more effectively than the state of FIG.
  • FIG. 10 in order to show a state in which the two divided portions 100 and 102 become bent divided portions 130 and 132 whose tip shapes have been changed by heating, respective states when they differ from each other by 90 degrees in the angle around the axial direction. It is shown.
  • the axial direction is taken as the Z axis, and the directions of the X axis and the Y axis, which are two axes perpendicular to the Z direction, are shown in FIG.
  • the extra-fine heater unit 140 needs to supply heating energy to the heating unit 142 at the tip while ensuring insulation between the guide wire 80 and the heater.
  • the two divided portions 100 and 102 that are not subjected to superelastic processing are heated according to the magnitude of the electric power, and heating is performed. Since the portion closer to the portion 142 extends more and the portion farther away has less extension, the tip portion has a bend and forms a kind of ridge shape.
  • the shape of the bend can be controlled by the magnitude of electric power controlled by the ultrafine heater unit 140. For example, it is possible to precisely control the shape of the bend by supplying electric power in pulses.
  • the two divided portions 100 and 102 that are not subjected to the superelastic treatment become the bent divided portions 130 and 132 by heating control.
  • the guide wire 80 is rotated around the axis by the rotation mechanism 12 in this state, the ridge-like shape of the distal end portions of the bent divided portions 130 and 132 together with the expanded distal end portion 109 having the envelope contour shape causes An occlusive substance can be effectively captured.
  • the guide tube for inserting a living body tube according to the present invention can be used as a guide wire for inserting into a thin blood vessel and capturing an occlusive substance such as a thrombus.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Anesthesiology (AREA)
  • Hematology (AREA)
  • Pulmonology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Vascular Medicine (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biophysics (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

L'invention concerne un fil-guide (20) possédant une section racine sur laquelle un mécanisme de rotation est relié, une section de corps (24) insérée dans un trou traversant axial dans un cathéter (10) conçue pour pouvoir se déplacer axialement et tourner de manière circonférentielle, et une section de bout (28) formée en divisant axialement une portion d'une extrémité de la section de corps (24), ladite portion ayant une longueur axiale prédéterminée, en portions allongées par des fentes. Selon l'invention, le fil-guide (20) est constitué d'un matériau en alliage à mémoire de forme extrêmement élastique. Lorsque la section de bout (28) est entraînée de manière à faire saillie depuis le bout du cathéter (10), les portions allongées divisées sont déployées perpendiculairement par rapport au sens de l'axe pour devenir une section de bout déployée (30) dont les contours ont une forme prédéterminée d'enveloppe.
PCT/JP2009/069254 2008-11-12 2009-11-12 Fil-guide destiné à être inseré dans une lumière d'un corps vivant Ceased WO2010055875A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2008289640A JP2012024111A (ja) 2008-11-12 2008-11-12 生体管部挿入用ガイドワイヤ
JP2008-289640 2008-11-12

Publications (1)

Publication Number Publication Date
WO2010055875A1 true WO2010055875A1 (fr) 2010-05-20

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PCT/JP2009/069254 Ceased WO2010055875A1 (fr) 2008-11-12 2009-11-12 Fil-guide destiné à être inseré dans une lumière d'un corps vivant

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JP (1) JP2012024111A (fr)
WO (1) WO2010055875A1 (fr)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN107898487A (zh) * 2017-11-28 2018-04-13 郑州大学第附属医院 一种具有仿生水母收缩膨胀功能的通用型血栓碎取装置
CN113819780A (zh) * 2021-09-22 2021-12-21 锘威科技(深圳)有限公司 一种5g智能手机用高性能超薄微热管
CN114469274A (zh) * 2022-01-17 2022-05-13 中国人民解放军空军军医大学 一种用于蛛网膜下腔出血模型探针

Families Citing this family (1)

* Cited by examiner, † Cited by third party
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JP2021078858A (ja) * 2019-11-20 2021-05-27 メディカル・イノベイション株式会社 ガイドワイヤー、その成形方法および成形装置

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Publication number Priority date Publication date Assignee Title
US20020183783A1 (en) * 2001-06-04 2002-12-05 Shadduck John H. Guidewire for capturing emboli in endovascular interventions
US20030015206A1 (en) * 2001-07-18 2003-01-23 Roth Noah M. Integral vascular filter system
US20070129753A1 (en) * 2005-12-01 2007-06-07 Chris Quinn Method and apparatus for recapturing an implant from the left atrial appendage

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20020183783A1 (en) * 2001-06-04 2002-12-05 Shadduck John H. Guidewire for capturing emboli in endovascular interventions
US20030015206A1 (en) * 2001-07-18 2003-01-23 Roth Noah M. Integral vascular filter system
US20070129753A1 (en) * 2005-12-01 2007-06-07 Chris Quinn Method and apparatus for recapturing an implant from the left atrial appendage

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN107898487A (zh) * 2017-11-28 2018-04-13 郑州大学第附属医院 一种具有仿生水母收缩膨胀功能的通用型血栓碎取装置
CN107898487B (zh) * 2017-11-28 2023-11-03 郑州大学第一附属医院 一种具有仿生水母收缩膨胀功能的通用型血栓碎取装置
CN113819780A (zh) * 2021-09-22 2021-12-21 锘威科技(深圳)有限公司 一种5g智能手机用高性能超薄微热管
CN113819780B (zh) * 2021-09-22 2024-05-24 锘威科技(深圳)有限公司 一种5g智能手机用高性能超薄微热管
CN114469274A (zh) * 2022-01-17 2022-05-13 中国人民解放军空军军医大学 一种用于蛛网膜下腔出血模型探针
CN114469274B (zh) * 2022-01-17 2023-07-18 中国人民解放军空军军医大学 一种用于蛛网膜下腔出血模型探针

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