WO2021075245A1 - Instrument d'expansion médicale - Google Patents

Instrument d'expansion médicale Download PDF

Info

Publication number
WO2021075245A1
WO2021075245A1 PCT/JP2020/036546 JP2020036546W WO2021075245A1 WO 2021075245 A1 WO2021075245 A1 WO 2021075245A1 JP 2020036546 W JP2020036546 W JP 2020036546W WO 2021075245 A1 WO2021075245 A1 WO 2021075245A1
Authority
WO
WIPO (PCT)
Prior art keywords
diameter
medical
expanded
enlarged diameter
axial direction
Prior art date
Application number
PCT/JP2020/036546
Other languages
English (en)
Japanese (ja)
Inventor
坂口　幸彦
Original Assignee
住友ベークライト株式会社
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 住友ベークライト株式会社 filed Critical 住友ベークライト株式会社
Publication of WO2021075245A1 publication Critical patent/WO2021075245A1/fr

Links

Images

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/958—Inflatable balloons for placing stents or stent-grafts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • 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
    • A61M29/00—Dilators with or without means for introducing media, e.g. remedies

Definitions

  • the present invention relates to a tubule or a medical dilator that expands a stent inserted into the tubule.
  • the present application claims priority based on Japanese Patent Application No. 2019-189288 filed in Japan on October 16, 2019, the contents of which are incorporated herein by reference.
  • Medical dilation device is a device used to dilate a tube such as a blood vessel that is narrowed or occluded due to a disease.
  • a balloon catheter is inserted into the stenotic area.
  • the inserted balloon is removed from the blood vessel after dilation of the blood vessel.
  • a mesh-like tubular body called a stent may be placed in the blood vessel.
  • a balloon through which blood can flow is described in Patent Document 1, for example.
  • the perfusion catheter described in Patent Document 1 is a channel recirculation catheter using a tubular array of individually inflatable balloons. According to this perfusion catheter, when treating a stenosis, the array of balloons will apply uniform radial pressure to the wall of the stenosis.
  • the tubular array of balloons is arranged around a hollow shaft and at least one lumen is formed in the shaft to supply the balloon with an expansion fluid. Balloons individually inflate through individual channels connected to allow fluid to flow through the lumens in the shaft. The channels are separated from each other by the web, and the expansion of the balloon widens the openings provided in the web, allowing blood to flow through the openings and the array.
  • the above-mentioned reflux catheter inflates the balloon with a fluid for expansion, the work of inspecting the expanded state of the balloon or contracting the expanded balloon to return it to the original state before shipping or using the balloon catheter. Is required. Further, in the case of intravascular use, it is necessary to perform a priming operation in which the air in the balloon is sucked and removed to bring it into a state close to a vacuum, or the inside of the balloon and the flow path communicating with the inside of the balloon are filled with a physiological saline solution. Such a process becomes particularly complicated in the above-mentioned reflux catheter including a plurality of balloons.
  • a medical expansion device that expands a tube body inside the body or an indwelling type medical device inserted into the tube body, and is attached to a shaft body extending in the axial direction and a side of the tip of the shaft body.
  • An enlarged diameter portion provided and expandable and contractible in an intersecting direction intersecting the axial direction, and an enlarged diameter portion provided on the side of the base end of the shaft body, and the enlarged diameter portion is expanded or contracted in the intersecting direction by a mechanical operation.
  • the enlarged diameter portion includes an operation mechanism for applying a force toward the crossing direction to the inside of the tubular body or the indwelling medical device, and a liquid flowing through the tubular body is allowed to flow.
  • a medical expansion device configured to be able to flow through the enlarged diameter portion.
  • the shaft body includes an action portion that compresses or expands the enlarged diameter portion in the axial direction.
  • the enlarged diameter portion is an elastic member in which one end is fixed to the shaft body and the other end is fixed to the working portion, and the acting portion moves in the axial direction to obtain the above-mentioned.
  • Medical dilation device that is compressed or stretched in the axial direction.
  • the length of the notch is longer than the non-cut portion, and the non-cut portion on the first straight line among the plurality of the straight lines is on the second straight line adjacent to the first straight line.
  • the medical expansion device of (6) which is formed adjacent to the notch in the circumferential direction of the insertion portion.
  • drawings used in the present embodiment exemplify the configuration and shape of the medical expansion device of the present invention and the arrangement of each member constituting the medical expansion device, and do not limit the present invention.
  • the drawings do not always accurately represent dimensional ratios such as length, width, and height of medical expansion devices.
  • an example of applying a medical dilator to a blood vessel will be described.
  • the present invention is a medical expansion device that expands a tube body or an indwelling type medical device inserted into the tube body. Such medical dilators are sometimes also referred to as balloon catheters.
  • FIG. 1 is a diagram for explaining the medical expansion device 1 of the first embodiment.
  • the medical expansion device 1 includes a shaft body 100 extending in the axial direction, a diameter-expanding portion 10 provided on the tip side of the shaft body 100 and expandable and contractible in an intersecting direction intersecting the direction of the shaft ax. It is provided on the side of the base end of the shaft body 100, and includes an operation mechanism 3 (FIG.
  • FIG. 1 shows a state in which the enlarged diameter portion 10 is expanded, and (b) shows a state in which the enlarged diameter portion 10 is reduced.
  • tubular body refers to a tubular tissue existing in the body, for example, a blood vessel, a digestive tract, or the like.
  • the “shaft body extending in the axial direction” is a rod-shaped member having a central axis extending in one direction, and a member having another shape may be attached to the shaft body.
  • the “base end” means an end portion that is on the operator side when operating the medical expansion device 1.
  • “the side of the base end of the shaft body 100” is the end portion of the shaft body 100 on the side of the member to which the shaft body 100 is fixed, and in the first embodiment, the shaft body 100 is fixed. Refers to the end on the side of the operating mechanism 3 (FIG. 5A, etc.).
  • the “tip” is the other end that is different from the base end, and means the end that becomes the leading portion when the medical expansion device 1 is inserted into the tube.
  • the “indwelling medical device” (not shown) may be any medical device indwelling in the tube, and for example, a stent or a stent graft can be considered.
  • Mechanism operation refers to a mechanism in which a plurality of parts such as a machine work in relation to each other. As a mechanism, for example, there are those that move members in at least one direction, those that engage members with each other, gears, actuators, motors, and the like.
  • the "operation mechanism” refers to a part that performs an operation for enlarging or reducing the diameter-expanded portion by a mechanical operation.
  • the "intersection direction intersecting the axial direction” means a direction substantially orthogonal to the axis ax.
  • the "force toward the crossing direction” means a force substantially orthogonal to the axis ax and toward the outer peripheral surface of the enlarged diameter portion 10 from the axis ax.
  • the medical expansion device of the present invention expands the enlarged diameter portion in the radial direction (intersection direction intersecting the axial direction) inside the tubular body and pushes the inner wall of the tubular body.
  • the medical expansion device expands the stent or stent graft to be placed in the tube after expansion from the inside and places it in the tube.
  • the medical device of the present invention is configured so that the liquid flowing through the tube can flow through the enlarged diameter portion, the expansion process in the tube or the installation process of the medical indwelling device is performed. It can also supply blood to the organs inside.
  • the medical expansion device 1 is provided with a shaft body 100 extending in the axial ax direction.
  • the shaft body 100 is composed of a first pipe 11 and a second pipe 12 having a diameter smaller than that of the first pipe 11.
  • the inner pipe 14 refers to a portion of the second pipe 12 in the enlarged diameter portion 10.
  • the pipe refers to a hollow member extending in one direction, and both the first pipe 11 and the second pipe 12 have a hollow portion.
  • the second pipe 12 is inserted into the cavity of the first pipe 11 and moves so as to slide in the cavity.
  • the axis ax is the central axis of this cavity.
  • a guide wire (not shown) for inserting the medical expansion device 1 into the blood vessel is inserted into the cavity 13aa of the second pipe 12, and the second pipe 12 has elasticity to bend in accordance with the guide wire.
  • the first pipe 11 may have an operation line (not shown) embedded in the pipe wall, and the inner pipe 14 may be bent and deflected at hand using the operation line.
  • the first pipe 11, the second pipe 12, and the inner pipe 14 are made of metal, ceramics, plastic, or the like.
  • the metal those containing stainless steel, cobalt, titanium and alloys thereof are preferable.
  • the alloy of nickel and titanium is preferably applied to the medical expansion device 1 because of its biocompatibility, elasticity, shape memory, and the like.
  • the diameter of the first pipe 11 is preferably 3 mm ⁇ or more and 5 mm ⁇ or less, and the diameter of the second pipe 12 is preferably 1 mm ⁇ or more and 2 mm ⁇ or less.
  • the tip of the first pipe 11 is fixed to the enlarged diameter portion 10 at the second fixing portion 13b.
  • packing may be further provided between the second fixing portion 13b and the first pipe 11.
  • the packing is provided at a position that does not hinder the sliding of the second pipe 12 in the first pipe 11.
  • the inner pipe 14 is a pipe that penetrates the enlarged diameter portion 10 along the axis ax.
  • the second pipe 12 is continuous with the inner pipe 14.
  • the second pipe 12 and the inner pipe 14 may be integrated or may be connected at any place.
  • the tip of the inner pipe 14 is fixed to the diameter-expanded portion 10 at the first fixing portion 13a.
  • the first fixing portion 13a may be one that bundles the end portions on the tip end side of the strip 15 and fixes them to the inner pipe 14.
  • the relationship between the second pipe 12 and the inner pipe 14 is as long as the second pipe 12 moves in the direction of the first fixed portion 13a and the inner pipe 14 also moves in the direction of the first fixed portion 13a. It may be anything.
  • the end of the first pipe 11 on the distal end side is fixed to the enlarged diameter portion 10 at the second fixing portion 13b.
  • the second fixing portion 13b may be, for example, an annular member inserted into the inner wall of the first pipe 11.
  • the second pipe 12 is inserted through the annular portion of the second fixed portion 13b and slides, and is not fixed to the base end side of the enlarged diameter portion 10. Further, the ends of the strips 15 on the base end side are bundled by the second fixing portion 13b, and the second fixing portion 13b is joined to the tip end side of the first pipe 11. In this way, the diameter-expanded portion 10 can be fixed to the first pipe 11 via the second fixing portion 13b.
  • the inner pipe 14 located in the enlarged diameter portion 10 by pushing the second pipe 12 toward the side of the first fixing portion 13a while fixing the first pipe 11.
  • the length is increased by the length d shown in the figure.
  • the first pipe 11 and the second pipe 12 can apply a force for extending the diameter-expanded portion 10 in the axial ax direction.
  • the force for pushing the second pipe 12 into the cavity of the first pipe 11 (the force from the side of the second fixing portion 13b toward the side of the first fixing portion 13a) is released or weakened, the inner pipe 14 is second-fixed. Moving (backward) to the side of the portion 13b, the diameter-expanded portion 10 expands in a direction orthogonal to or substantially orthogonal to the axis ax.
  • the first fixing portion 13a and the second fixing portion 13b are formed of a metal or the like that can be easily joined to the fragment 15 described later, and are preferably formed of a shape memory alloy such as a Ni—Ti alloy (Nitinol). To.
  • the enlarged diameter portion 10 is fixed between the first fixing portion 13a and the second fixing portion 13b.
  • the enlarged diameter portion 10 shown in FIG. 1 has a plurality of small pieces 15 whose ends are fixed to the first fixing portion 13a or the second fixing portion 13b.
  • the strip 15 is branched into strips 152 and 153 at a connection point 151 formed between the first fixing portion 13a and the second fixing portion 13b, and is reconnected at another connection point 151.
  • an opening 15a is formed between the fragment portion 152 and the fragment portion 153.
  • the strips 15 are separated from each other, and an opening 15b is formed between the plurality of strips 15.
  • the entire diameter-expanded portion 10 has a mesh shape formed of the fine pieces 15.
  • the strip 15 is formed of, for example, an elastic member (superelastic body) such as a shape memory alloy such as a Ni—Ti alloy, a Cu—Al—Ni alloy, or a Cu—Zn alloy, preferably a Ni—Ti alloy (Nitinol). ).
  • an elastic member such as a shape memory alloy such as a Ni—Ti alloy, a Cu—Al—Ni alloy, or a Cu—Zn alloy, preferably a Ni—Ti alloy (Nitinol).
  • the enlarged diameter portion 10 has a pressurizing portion that applies a force toward the crossing direction to the inside of the blood vessel or the indwelling medical device.
  • the portion of the enlarged diameter portion 10 having a diameter larger than the inner diameter of the blood vessel is the pressurized region.
  • FIG. 1 (a) shows a press section range of P 1 of the enlarged diameter portion 10. Strips 15 contained in the press section P 1, connection point 151, strips 152 and 153 is the pressing of the first embodiment. Since such an enlarged diameter portion 10 has openings 15a and 15b, a liquid such as blood flowing through a tube such as a blood vessel can flow through the enlarged diameter portion 10. As shown in FIG. 1A, in the first embodiment, the area occupied by the openings 15a and 15b is larger than the area occupied by the fragment 15, so that a liquid such as blood can sufficiently flow in the enlarged diameter portion 10. is there.
  • pressing region P 1 is a medical dilator 1 rather than the specific region, changes in the course of the enlarged diameter portion 10 is inserted into a blood vessel or the like. That is, as shown in FIG. 1A, the diameter-expanded portion 10 comes into contact with a blood vessel or the like in a wide range when it is located in a narrowed portion such as a blood vessel in the expanded state. Further, as shown in FIG. 1B, when the diameter-expanded portion 10 is inside a blood vessel or the like without stenosis in a reduced diameter state, the region in contact with the blood vessel or the like becomes smaller and the pressure applied to the blood vessel is applied. It can be made as small as possible.
  • the enlarged diameter portion 10 having an opening 15a on the fragment 15 forms a slit in the strip 15 that passes through the center in the width direction and along the length direction, and the strips 15 are placed around the inner pipe 14 with each other. It can be formed by arranging them apart. At this time, the strip 15 is fixed at both ends of the first fixing portion 13a and the second fixing portion 13b.
  • Such an enlarged diameter portion 10 has a low rigidity at the central portion in the length direction and is easily bent, and can be easily expanded and compressed by moving the second pipe 12 in and out of the first pipe 11.
  • the diameter-expanded portion 10 is not limited to being formed as described above, and can also be formed by knitting a wire to form a balloon-shaped mesh.
  • the cover film (cover tube) 2 may be provided on the enlarged diameter portion 10.
  • the cover film 2 is a thin-walled or thin-walled tube made of a resin having elasticity such as silicon, and pressure is applied to the enlarged diameter portion 10 regardless of the state of diameter expansion or contraction.
  • the thickness of the thin film or thin-walled tube is preferably, for example, about 10 to 50 ⁇ m, and more preferably about 20 to 40 ⁇ m, from the viewpoint of reducing the bulkiness at the time of non-expansion as much as possible to reduce the diameter.
  • the pressure changes according to the maximum diameter of the enlarged diameter portion 10.
  • the cover membrane 2 it is possible to reliably prevent the blood vessel or the like from being damaged when the diameter-expanded portion 10 is expanded inside the blood vessel, the stent or the stent graft (hereinafter, referred to as “blood vessel or the like”).
  • the cover film 2 may cover the outside, the outside and the inside of the enlarged diameter portion 10. In FIG. 1, it is assumed that the cover film 2 covers the outside of the enlarged diameter portion 10, and is schematically shown by a broken line.
  • the diameter-expanded portion 10 is operated by the operation mechanism (FIG. 5A, etc.) so that the first fixing portion 13a, which is the acting portion, faces the base end side in the axial ax direction (first fixing portion 13a). It is compressed (in the direction from the side toward the second fixing portion 13b side) to increase the diameter ((a) in FIG. 1), or toward the tip side (from the second fixing portion 13b side to the first fixing portion 13a side). It is stretched (in the direction toward) and reduced in diameter ((b) in FIG. 1). Expansion or contraction takes place in an intersecting direction that intersects the direction of the axis ax.
  • the crossing direction refers to a direction substantially orthogonal to the inner pipe 14, and the diameter-expanded portion 10 is expanded so that its outer shell is substantially spherical.
  • the diameter expansion and reduction of the diameter expansion portion 10 is not limited to the one performed by expanding or contracting the diameter expansion portion 10.
  • the diameter reduction can also be performed, for example, by attaching a regulating member that regulates the elastic force to the expandable elastic member.
  • the diameter increase can also be performed, for example, by removing such a regulating member from the elastic member.
  • the regulating member may be a pipe, and the elastic member may be inserted from one end of the pipe and extended from the other end.
  • the enlarged diameter portion 10 is an elastic member in which one end is fixed to the second fixing portion 13b of the shaft body 100 and the other end is fixed to the first fixing portion 13a, and the first fixing portion 13a is the shaft ax. It is compressed or decompressed in the axial direction by moving in the direction of.
  • the base end of the enlarged diameter portion 10 is fixed to the second fixing portion 13b provided at the tip end portion of the first pipe 11 in the shaft body 100.
  • the tip of the enlarged diameter portion 10 is fixed to the first fixing portion 13a provided at the tip of the second pipe 12 (inner pipe 14).
  • the diameter-expanded portion 10 has a longer portion into which the inner pipe 14 is inserted, and extends between the first fixing portion 13a and the second fixing portion 13b.
  • the diameter of the enlarged diameter portion 10 becomes smaller, and it becomes easier to insert it into the blood vessel.
  • the diameter-expanding portion 10 is reduced in diameter by moving the first fixing portion 13a toward the tip side (direction away from the second fixing portion 13b), and the diameter is expanded by its own elastic force. I have to. Therefore, the diameter-expanded portion 10 is expanded by releasing or loosening the push-in of the second pipe 12. Further, the maximum diameter of the enlarged diameter portion 10 may be further increased by pulling out the second pipe 12 to the side (base end side) of the operating mechanism 3 (FIG. 5A or the like).
  • the diameter-expanded portion 10 whose diameter is expanded by the self-elastic force can be realized, for example, by covering a mesh-shaped fragment 15 on a spherical or substantially spherical jig and heating and cooling at about 500 ° C.
  • the first embodiment is not limited to the configuration in which the diameter-expanded portion 10 is expanded by the self-elastic force, and the diameter-expanded portion 10 is naturally reduced in diameter and is first fixed from the reduced diameter state.
  • the diameter may be increased by moving the portion 13a to the base end side (the side of the second fixing portion 13b).
  • the diameter-expanded portion 10 is reduced in diameter before the medical expansion device 1 is inserted, and the second pipe 12 is connected at the timing when the diameter-expanded portion 10 reaches the affected portion in the blood vessel to be expanded. It is pulled back and the first fixing portion 13a is moved to the base end side.
  • the diameter-expanded portion 10 expands in diameter at the affected portion and pushes the inner wall of the blood vessel.
  • FIG. 2 is a schematic view for explaining the diameter-expanded portion 20 of another aspect of the first embodiment.
  • the enlarged diameter portion 20 includes mesh-shaped strips 15 arranged around the inner pipe 14.
  • the opening 15a of the fragment 15 of the diameter-expanded portion 10 is arranged in the circumferential direction of the inner pipe 14, whereas the opening 15c is arranged in the longitudinal direction as well as the circumferential direction of the inner pipe 14. ing.
  • the strips 15 of the enlarged diameter portion 20 are intermittently connected by the connection points 151, and four openings 15c are formed at each connection point 151 centering on the connection point 151.
  • a portion having a diameter larger than the inner diameter of the blood vessel becomes a pressurized region.
  • 2 shows a range of pressure area P 2 of the enlarged diameter portion 20. It strips 15 contained in the pressure area inside the P 2, part of the connection point 151 is pressing.
  • the small pieces 15 and the connection points 151 are arranged closer than the enlarged diameter portion 10, and the blood vessels and the like can be uniformly pressed and expanded from the inside than the enlarged diameter portion 10. it can.
  • FIG. 3 is a schematic view for explaining the configuration of the enlarged diameter portion 20.
  • the diameter-expanded portion 20 is, for example, an inserted portion 155 through which the inner pipe 14 is inserted.
  • the insertion portion 155 may be an annular shape having a cavity inside, and its peripheral surface may be a curved surface.
  • the insertion portion 155 is configured to have notches s11, s12, s13, s21, s22, and s23 along the axial direction on the peripheral surface. Note that FIG. 3 does not correspond to the diameter-expanded portion 20, but is simplified for explaining the structure of the diameter-expanded portion 20.
  • FIG. 3 does not correspond to the diameter-expanded portion 20, but is simplified for explaining the structure of the diameter-expanded portion 20.
  • FIG. 3 shows an example in which the cuts s11 and the like are formed on two straight lines, but when the diameter-expanded portion 20 shown in FIG. 2 is manufactured, the cuts are formed on a larger number of straight lines. Is preferable.
  • the number of straight lines is preferably, for example, between 8 and 30.
  • the cuts s11, s12, and s13 are formed on a straight line L1 on the peripheral surface of the insertion portion 155, and the portion where there is no cut between the cuts s11 and the like is referred to as a non-cut portion.
  • the space between the notch s11 and the notch s12 is referred to as the non-cut portion ns11,12
  • the space between the notch s12 and the notch s13 is referred to as the non-cut portion ns12,13.
  • the space between the cut s21 and the cut s22 is referred to as a non-cut portion ns21,22, and the space between the cut s22 and the cut s23 is described as a non-cut portion ns22,23.
  • the notch s11 or the like opens in the circumferential direction of the inner pipe 14 to form an opening 15c.
  • cuts and non-cut portions are alternately formed along a plurality of straight lines L1 and L2 along the direction of the axis ax.
  • the length from the cut s11 to the cut s23 is longer than the non-cut portions ns11, 12 to the non-cut portions ns22, 23, and the non-cut portions ns11, 12, which are on the straight line L1 (first straight line) of the plurality of straight lines,
  • the ns12 and 13 are formed so as to be adjacent to the cuts s21, s22 and s23 on the straight line L2 (second straight line) adjacent to the straight line L1 in the circumferential direction of the insertion portion 155.
  • the notch s11 to the notch s23 are arranged in a so-called "staggered" shape.
  • a force in the compression direction is applied to the inserted portion 155 having the staggered notch s11 or the like, in the case of the enlarged diameter portion 20 shown in FIG. 2, four each of the plurality of non-notched portions ns11, 12 and the like are centered.
  • the opening 15c is formed.
  • FIG. 4 is a diagram for explaining the relationship between the notch shown in FIG. 3 and the enlarged diameter portion 20 shown in FIG. 2, and a plurality of notches s formed in the insertion portion 155 are developed on a plane. It is a figure shown. As shown in FIG. 4, a plurality of cuts s are formed on a plurality of parallel straight lines, and the non-cut portion ns between the cuts s corresponds to the connection point 151 shown in FIG. When a force in the direction intersecting the axis ax shown in the figure is applied to the insertion portion 155 in which the notches s are formed in a staggered pattern, four notches s centered on the connection point 151 are applied to each connection point 151. Opens.
  • openings 15c 1 and 15c 3 are formed on the left and right of the connection point 151, and openings 15c 2 and 15c 4 are formed above and below the connection point 151.
  • the force required to expand or reduce the diameter of the enlarged diameter portion 20 is determined according to the width and length of the cut s as well as the thickness of the inserted portion 155.
  • the distance between the notch s in the axis ax direction and the direction orthogonal to the axis ax is determined in consideration of the strength and operation of the enlarged diameter portion 20.
  • the notch s can be formed, for example, by laser machining. According to the laser processing, the portion of the insertion portion 155 irradiated with the laser beam is melted, and the melt is blown off by the assist gas. Therefore, the formed notch s becomes a hole portion of the fine groove.
  • the insertion portion 155 is formed of, for example, an elastic member (superelastic body) such as a shape memory alloy such as Ni—Ti alloy, Cu—Al—Ni alloy, Cu—Zn alloy, and is preferably a Ni—Ti alloy (superelastic body). Nitinol).
  • the insertion portion 155 having the notch s is covered with a spherical or substantially spherical jig to expand the diameter, and the shape is formed into a spherical shape by heat treatment in that state.
  • the diameter-expanded portion 20 naturally becomes substantially spherical, and the diameter is expanded by the self-elastic force.
  • Such a diameter-expanded portion 20 can be reliably and as designed to expand the diameter inside the blood vessel, and the reliability of the vasodilation procedure can be enhanced.
  • FIG. 5A, 5B and 5C are schematic views for explaining the operation mechanism 3 of the medical expansion device 1.
  • the diameter-expanded portion 20 may be the diameter-expanded portion 10.
  • the operation mechanism 3 is provided on the side of the base end of the shaft body 100, and the diameter-expanded portion 20 is expanded or contracted in the radial direction by a mechanical operation.
  • FIG. 5A shows a state in which the diameter of the enlarged diameter portion 20 is the maximum.
  • FIG. 5C shows a state in which the diameter of the enlarged diameter portion 20 is the minimum
  • FIG. 5B shows an initial state in which no force is applied to the enlarged diameter portion 20 in either the stretching or compressing directions.
  • the diameter of the enlarged diameter portion 20 in the initial state is, for example, 16 mm, and the diameter of the enlarged diameter portion 20 is expanded to, for example, 32 mm by retracting the lever 33 toward the base end side of the operation mechanism 3 along the ratchet groove 32. Further, the diameter-expanded portion 20 is reduced in diameter to, for example, 3 mm by moving the lever 33 forward (on the tip end side of the operating mechanism 3) along the ratchet groove 32.
  • the enlarged diameter portion 20 is in the state of the minimum diameter shown in FIG. 5C.
  • the shaft body 100 is fixed to the grip 31 of the operation mechanism 3. More specifically, the base end portion of the enlarged diameter portion 20 is connected to the tip end portion of the first pipe 11 via the second fixing portion 13b, and the base end portion of the first pipe 11 is the tip end portion (diameter expansion portion) of the grip 31. It is connected to the side toward the part 20).
  • a rear shaft 34 communicating with the second pipe 12 projects to the rear (base end side) of the grip 31.
  • a holding groove (not shown) in which the second pipe 12 is slidably held is provided inside the grip 31.
  • the rear shaft 34 and the holding groove are coaxial and communicate with each other, and even if the second pipe 12 moves forward or backward by operating the lever 33, the second pipe 12 and the rear shaft 34 remain liquid-tight via the holding groove. Communicating.
  • the rear end of the guide wire inserted into the tube body is inserted into the cavity 13aa, it can be projected from the rear shaft 34 through the inner pipe 14 and the holding groove.
  • the grip 31 is provided with a ratchet mechanism for moving the second pipe 12 to move the first fixing portion 13a to the tip end or base end side.
  • the ratchet mechanism is composed of a ratchet groove 32 and a lever 33 that can move along the ratchet groove 32.
  • a triangular wave-shaped concave-convex engaging portion 35 is formed in the ratchet groove 32, and a triangular protrusion 36 that engages with the concave-convex engaging portion 35 is formed on the side of the lever 33.
  • a scale indicating the degree of diameter expansion of the diameter-expanded portion 20 is marked along the ratchet groove 32.
  • the operator of the medical expansion device 1 grips the grip 31 and operates the lever 33 to move the second pipe 12 and the inner pipe 14 so as to move forward or backward.
  • the operator moves the lever 33 forward from the initial state to the concave-convex engaging portion 35 at the portion marked with "S”.
  • the triangular protrusion 36 is engaged (see FIG. 5C).
  • the position of the first fixing portion 13a is fixed, and it is possible to prevent the diameter-expanding portion 20 from expanding in diameter due to self-elasticity.
  • the diameter-expanded portion 20 is reduced in diameter from the initial state, and the resistance when the diameter-expanded portion 20 is inserted into the blood vessel can be reduced.
  • a marker that does not transmit radiation is attached to the first fixing portion 13a.
  • the operator makes the enlarged diameter portion 20 reach the affected portion while visually recognizing the marker under irradiation.
  • the lever 33 is operated to increase the diameter of the enlarged diameter portion 20 to a desired size.
  • the diameter of the enlarged diameter portion 20 is determined by the type (thickness) of the blood vessel, the condition of the affected portion, and the like.
  • the operator determines the size of the diameter of the enlarged diameter portion 20 in advance according to the thickness of the blood vessel and the state of stenosis.
  • the operator engages the triangular protrusion 36 with the concave-convex engaging portion 35 of the scale corresponding to the determined diameter, and fixes the diameter of the enlarged diameter portion 20 to a desired size.
  • the diameter of the enlarged diameter portion 20 is fixed to a desired diameter in the affected area, and the blood vessel can be appropriately dilated, or a stent or a stent graft can be placed in the dilated blood vessel to maintain the dilated blood vessel. it can.
  • the medical dilation device 1 of the first embodiment since the enlarged diameter portions 10 and 20 allow blood to flow while pressurizing the inside of blood vessels and the like, blood is supplied to internal organs even during vasodilation. , It is possible to improve the reliability of the treatment by eliminating the limitation of the treatment time.
  • the first embodiment is not limited to the movement of the first fixing portion 13a by the ratchet mechanism, and may be performed by another method.
  • a dial type or a method in which the protrusion amount of the rear shaft 34 is adjusted by a screw may be used.
  • the movement of the first fixing portion 13a may be carried out by attaching a small motor to the operation mechanism 3 to move the second pipe 12 forward and backward, or by using an actuator operated by a control signal to move the second pipe 12. It may be the one that drives the twelve.
  • the first embodiment is not limited to the one in which the diameter-expanded portions 10 and 20 are expanded in the initial state.
  • the diameter-expanded portion may be, for example, reduced in diameter as shown in FIG. 5C in the initial state, and may be expanded to an arbitrary diameter by moving the first fixing portion 13a to the proximal end side.
  • the operator inserts the medical expansion instrument into a blood vessel or the like without applying force to the diameter-expanded portion, and when the operator reaches the affected portion, the first fixing portion 13a Is pulled back to the base end side to expand the diameter of the enlarged diameter portion.
  • FIG. 6A and 6B are diagrams for explaining the medical expansion device 5 of the second embodiment of the present invention.
  • FIG. 6A shows the diameter-reduced state of the diameter-expanded portion 10 in the medical expansion device 5
  • FIG. 6B shows the diameter-expanded state.
  • the medical expansion device 5 includes a shaft body 110, a diameter-expanding portion 10, and an operation mechanism (not shown), and is the same as the medical expansion device 1 of the first embodiment. The description of the configuration will be omitted.
  • the diameter-expanded portion 10 may be the diameter-expanded portion 20.
  • the shaft body 110 of the second embodiment is different from the first embodiment in that the cover film (cover tube) 2 covers the enlarged diameter portion 10 and the second pipe 12 instead of the first pipe 11.
  • the cover film 2 covers up to the tip of the enlarged diameter portion 10 and extends to the operating mechanism 3.
  • the cover film 2 is formed of, for example, a thin film or a thin-walled tube made of a resin having a low friction coefficient such as a polytetrafluoroethylene (PTFE) resin, and is preferably formed of a thin-walled tube. Further, it is also preferable to embed a braided mesh of polyamide resin or stainless steel in the thin film or thin tube from the viewpoint of ensuring the thin wall and the rigidity for the retracting operation described later.
  • the operation mechanism of the second embodiment is provided on the base end side of the shaft body 110, and has a cover film 2 that covers and extends the diameter-expanded portion 10, and the cover film 2 that is wound up and removed from the diameter-expanded portion 10. It is composed of a mechanism. That is, in the second embodiment, the diameter-expanded portion 10 whose diameter is expanded by self-elasticity is reduced in diameter by the pressure of the cover film 2 at the time of insertion, and is removed and expanded in diameter when it reaches the affected portion.
  • the cover film 2 can be removed by pulling a part of the cover film 2, for example.
  • the traction of the cover film 2 is performed, for example, by peeling a part of the tip end side of the cover film 2 from the enlarged diameter portion 20 and the second pipe 12, or by retracting the cover film 2 as a whole toward the proximal end side. This is done, but preferably by retracting the cover film 2 toward the proximal end.
  • the diameter-expanded portion 10 that was in the reduced diameter state due to the pressure of the cover film 2 is expanded to the initial state.
  • the state shown in FIG. 6B shows a state in which the cover film 2 is retracted to a range outside the range shown in the drawing.
  • the diameter-expanded portion 10 can be designed to have a desired diameter according to the blood vessel or the like to be inserted, and the diameter of the diameter-expanded portion 10 can be reliably set to a desired size in the affected portion.
  • the medical expansion device of the present invention is provided on the side of the tip of the shaft body extending in the axial direction, and has a diameter-expanding portion that can be expanded and contracted in the intersecting direction intersecting the axial direction. Force can be applied from the inside to the outside. Further, since it is provided on the base end side of the shaft body and has an operation mechanism for expanding or contracting the enlarged diameter portion in the radial direction by a mechanical operation, the expansion or contraction of the enlarged diameter portion is performed by a fluid such as a liquid or a gas. It can be done mechanically regardless.
  • the enlarged diameter part is configured to allow the liquid flowing through the tube to flow while pressurizing the inside of the tube or indwelling medical device, liquid such as blood can be applied to the internal organs during the procedure. Can be supplied.

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Hematology (AREA)
  • Anesthesiology (AREA)
  • Cardiology (AREA)
  • Transplantation (AREA)
  • Vascular Medicine (AREA)
  • Biophysics (AREA)
  • Child & Adolescent Psychology (AREA)
  • Pulmonology (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

L'invention concerne un instrument d'expansion médicale (1) qui permet la circulation de liquides dans un corps tel que le sang, qui facilite la confirmation de l'efficacité fonctionnelle avant utilisation, et qui permet l'expansion d'un dispositif médical de type à demeure inséré dans un vaisseau sanguin ou similaire présent dans le corps, formé des éléments suivants : un corps de tige (100) qui s'étend dans une direction axiale ; une partie d'extension de diamètre (20) qui est disposée sur le côté pointe du corps de tige (100) et qui est extensible et rétractable dans une direction d'intersection croisant la direction axiale ; et un mécanisme de manipulation (3) qui est disposé sur le côté d'extrémité proximale du corps de tige (100) et qui dilate ou contracte la partie d'extension de diamètre (20) par une opération mécanique dans la direction d'intersection, la partie d'extension de diamètre (20) étant configurée de telle sorte qu'une partie d'application de pression est prévue pour appliquer une force orientée dans la direction d'intersection par rapport à l'intérieur d'un vaisseau sanguin ou similaire, et de telle sorte que le liquide s'écoulant dans le vaisseau sanguin et similaire traverse la partie d'extension de diamètre (20) de manière à pouvoir s'écouler.
PCT/JP2020/036546 2019-10-16 2020-09-28 Instrument d'expansion médicale WO2021075245A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2019189288A JP2021062111A (ja) 2019-10-16 2019-10-16 医療用拡張器具
JP2019-189288 2019-10-16

Publications (1)

Publication Number Publication Date
WO2021075245A1 true WO2021075245A1 (fr) 2021-04-22

Family

ID=75486825

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/JP2020/036546 WO2021075245A1 (fr) 2019-10-16 2020-09-28 Instrument d'expansion médicale

Country Status (2)

Country Link
JP (1) JP2021062111A (fr)
WO (1) WO2021075245A1 (fr)

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2001518328A (ja) * 1997-10-01 2001-10-16 ボストン サイエンティフィック リミテッド 拡張システムおよび関連方法
JP2003325672A (ja) * 2002-05-13 2003-11-18 Atsusato Kitamura 拡張用デバイス
JP2012196294A (ja) * 2011-03-21 2012-10-18 Nipro Corp カテーテル
JP2013192566A (ja) * 2012-03-15 2013-09-30 Kaneka Corp コントローラおよびカテーテルキット

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2001518328A (ja) * 1997-10-01 2001-10-16 ボストン サイエンティフィック リミテッド 拡張システムおよび関連方法
JP2003325672A (ja) * 2002-05-13 2003-11-18 Atsusato Kitamura 拡張用デバイス
JP2012196294A (ja) * 2011-03-21 2012-10-18 Nipro Corp カテーテル
JP2013192566A (ja) * 2012-03-15 2013-09-30 Kaneka Corp コントローラおよびカテーテルキット

Also Published As

Publication number Publication date
JP2021062111A (ja) 2021-04-22

Similar Documents

Publication Publication Date Title
EP1861156B1 (fr) Cathéter d'accès aux propiétés de dilatation
CA2513368C (fr) Catheter a canal pour fil-guide amovible
JP3349151B2 (ja) 内部マンドレルを有するカテーテルと使用方法
US20070173918A1 (en) Apparatus and methods for locating an ostium of a vessel
US20120004717A1 (en) Apparatus and methods for delivering a stent into an ostium
CN110809435A (zh) 医疗器械及处置方法
US20070282302A1 (en) Stent Positioning Using Inflation Tube
JP5137846B2 (ja) モジュール構造の医療用カテーテル
US5108413A (en) Dilator for opening the lumen of a tubular organ
RU2370224C2 (ru) Внутрипросветная хирургическая система доставки
US11033712B2 (en) Intravascular catheter having an expandable portion
JP2004049583A (ja) 管状器官用治療具の挿入装置
JP2004180764A (ja) 能動細管
WO2021075245A1 (fr) Instrument d'expansion médicale
JP2005270394A (ja) 管状器官治療具の拡張補助具
JP2022064077A (ja) 留置具デリバリー装置、及び留置具付きデリバリー装置
JP2022053075A (ja) バルーンカテーテル
JP6769905B2 (ja) 医療用長尺体
JPH10165507A (ja) Ｐｔｃａによる冠状動脈拡張用器具
KR102164495B1 (ko) 조향이 가능한 주름진 튜브를 이중으로 포함하는 카테터
JP2016174828A (ja) 医療器具
JP2022123437A (ja) カテーテルシステム
JP2023004673A (ja) 大動脈補強材
JP2009233202A (ja) ピン打込装置
JPWO2018181312A1 (ja) バルーンカテーテル、および医療用長尺体の製造方法

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 20876379

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 20876379

Country of ref document: EP

Kind code of ref document: A1