WO2019188707A1 - Medical device - Google Patents

Medical device Download PDF

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Publication number
WO2019188707A1
WO2019188707A1 PCT/JP2019/011850 JP2019011850W WO2019188707A1 WO 2019188707 A1 WO2019188707 A1 WO 2019188707A1 JP 2019011850 W JP2019011850 W JP 2019011850W WO 2019188707 A1 WO2019188707 A1 WO 2019188707A1
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WO
WIPO (PCT)
Prior art keywords
balloon
expansion
medical device
lumen
hollow member
Prior art date
Application number
PCT/JP2019/011850
Other languages
French (fr)
Japanese (ja)
Inventor
内田　貴之
Original Assignee
テルモ株式会社
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 テルモ株式会社 filed Critical テルモ株式会社
Priority to JP2020510805A priority Critical patent/JP7198806B2/en
Publication of WO2019188707A1 publication Critical patent/WO2019188707A1/en

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    • 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

Definitions

  • the present invention relates to a medical instrument.
  • Some medical devices are arranged in a body lumen such as a blood vessel like a balloon in a balloon catheter, and perform a predetermined treatment by being inflated.
  • the balloon is inflated to partially occlude the aorta rather than completely, thereby reducing the blood flow to the lower limbs and increasing the blood flow to the cerebral blood vessels.
  • Patent Document 1 An instrument (see Patent Document 1).
  • the balloon When the balloon partially occludes the living body lumen as in Patent Document 1, the balloon is not fixed to the living body lumen. In such a state, for example, the balloon may inadvertently move due to an external force applied from blood flow or the like, and may collide with the inner wall surface of the living body, thereby damaging the inner wall surface of the living body.
  • an object of the present invention is to provide a medical instrument that suppresses the expansion member from inadvertently contacting the inner wall surface of the biological lumen when the biological lumen is partially occluded by an expansion member such as a balloon. .
  • a medical device that achieves the above object includes a hollow member having an elongated shape and having a lumen, an expansion member that can be expanded by a fluid supplied from the lumen of the hollow member, and the hollow An encircling member configured to be displaceable radially outwardly intersecting the longitudinal direction of the member and surrounding the expansion member in a state of being displaced radially outwardly.
  • the expansion member capable of partially closing the living body lumen is surrounded by the surrounding member from the outside in the radial direction intersecting the longitudinal direction of the hollow member. Therefore, it is possible to suppress an expansion member such as a balloon from inadvertently contacting the inner wall surface of the living body lumen during expansion.
  • the longitudinal direction of the hollow member 10 described later is referred to as a longitudinal direction d.
  • the circumferential direction or the angular direction of the hollow member 10 in the cross section perpendicular to the longitudinal direction d of the hollow member 10 is referred to as a circumferential direction ⁇ .
  • the radial direction or the radial direction in the cross section perpendicular to the axis of the hollow member 10 is referred to as a radial direction r.
  • FIG. 1 to 3 are views showing a medical device 100 according to the first embodiment of the present invention.
  • the medical instrument 100 is used for reducing blood flow in the lower limbs by partially occluding the aorta in a procedure such as cerebral infarction and increasing blood flow to the cerebral blood vessels.
  • the medical device 100 according to this embodiment will be briefly described with reference to FIGS. 1 to 3.
  • the medical device 100 includes a hollow member 10, a balloon 20 (corresponding to an expansion member), and an enclosing member 30. Details will be described below.
  • the hollow member 10 is configured as a long and substantially cylindrical tubular member. As shown in FIG. 1, the hollow member 10 includes a tubular member 11 having a lumen 12 through which an expansion fluid for expanding the balloon 20 can flow, and a lumen 14 through which the expansion fluid for displacing the surrounding member 30.
  • the tubular member 13 provided with.
  • the lumen 14 corresponds to “another lumen” in the present specification.
  • the tubular member 11 is joined to a balloon 20 having an expansion space 21.
  • the tubular member 13 is joined to the surrounding member 30. In this embodiment, the tubular member 11 and the tubular member 13 are joined to each other by adhesion or fusion.
  • the hollow member 10 is configured by the tubular members 11 and 13 in the present embodiment, but the configuration of the hollow member 10 is not limited to the above as long as the balloon 20 can be expanded and the surrounding member 30 can be displaced.
  • the tubular member 11 is configured to be connectable to an inflator (not shown) or a syringe that expands the balloon 20 in this embodiment.
  • the tubular member 13 is configured to be connectable to an indeflator or a syringe (not shown) in order to displace the surrounding member 30 in the same manner as the tubular member 11.
  • the lumen 12 of the tubular member 11 and the expansion space 21 of the balloon 20 communicate with each other through the opening 15.
  • the lumen 14 of the tubular member 13 and the expansion space 31 of the surrounding member 30 communicate with each other through the opening 16.
  • the opening 15 corresponds to a first opening in this specification
  • the opening 16 corresponds to a second opening.
  • the opening 15 is provided to supply the balloon 20 with an expansion fluid for expanding the balloon 20.
  • the opening 16 is provided to supply expansion fluid to the enclosure member 30 to displace the enclosure member 30.
  • the openings 15 and 16 are spaced apart in the circumferential direction ⁇ in the cross section perpendicular to the axis of the hollow member 10.
  • the opening 15 is configured to be arranged at least inside the radial direction r from the opening 16 when the balloon 20 is expanded when the center of the ring shape of the surrounding member 30 is considered as a reference. Further, as shown in FIG. 1, the opening 15 is spaced apart from the opening 16 by approximately 180 degrees in the circumferential direction ⁇ .
  • the opening Specific positions of the portions 15 and 16 are not limited to the above.
  • the openings 15 and 16 are configured to be provided at substantially the same position in the longitudinal direction d.
  • the surrounding member 30 can at least partially surround the balloon 20 in a state where the balloon 20 is expanded and the surrounding member 30 is displaced outward in the radial direction r, the opening 15 and the opening 16 are in the longitudinal direction d. It does not have to be exactly the same position.
  • the material of the hollow member 10 is not particularly limited as long as it can be appropriately flexibly deformed when introduced into a living body lumen.
  • a contrast marker or the like can be provided at the tip of the hollow member 10 so that the position of the medical instrument can be confirmed under radioscopy such as X-rays.
  • the balloon 20 includes an expansion space 21 that can be expanded by supplying an expansion fluid supplied from the lumen 12 of the hollow member 10.
  • the balloon 20 is configured such that the occlusion rate of the space surrounded by the surrounding member 30 can be changed with expansion when the medical device 100 is placed in the living body lumen.
  • the balloon 20 is configured to be formed in a substantially spherical shape when expanded as shown in FIG.
  • the “sphere” includes not only a perfect circle but also an ellipse in an arbitrary cross section passing through the center of a solid.
  • the balloon 20 is joined to the hollow member 10 by adhesion or fusion so that the expansion space 21 communicates with the lumen 12 of the tubular member 11 constituting the hollow member 10 through the opening 15.
  • the balloon 20 is configured to be positioned on the cylindrical side surface of the tubular member 11 constituting the hollow member 10.
  • the relative positional relationship with the hollow member 10 is not limited to the above as long as the occlusion rate of the inserted biological lumen can be adjusted when inserted into the biological lumen.
  • the material of the balloon 20 is not particularly limited as long as it has a certain degree of flexibility.
  • polyolefins such as polyethylene, polypropylene, ethylene-propylene copolymer, polyesters such as polyethylene terephthalate, polyvinyl chloride, ethylene-vinyl acetate copolymer, cross-linked ethylene-vinyl acetate copolymer, heat of polyurethane, etc.
  • plastic resin polyamide, polyamide elastomer, silicone rubber, latex rubber, and the like.
  • the surrounding member 30 is configured to be displaceable outward in the radial direction r intersecting the longitudinal direction d of the hollow member 10. As shown in FIG. 3, the surrounding member 30 surrounds the balloon 20 from the outside in the radial direction r in a state of being displaced outward in the radial direction r. As shown in FIG. 2, the surrounding member 30 has a balloon including an expansion space 31 that can be expanded by supplying an expansion fluid. The surrounding member 30 is displaced outward in the radial direction r by being expanded by supplying the expansion fluid.
  • the surrounding member 30 is joined to the hollow member 10 by adhesion or fusion so that the expansion space 31 communicates with the lumen 14 of the tubular member 13 constituting the hollow member 10 through the opening 15.
  • the surrounding member 30 is configured to include a single substantially ring-shaped balloon in this embodiment.
  • the surrounding member 30 surrounds the balloon 20 from the outside during expansion as described above by forming the opening 16 at a position opposite to the opening 15 in the circumferential direction ⁇ and forming a substantially ring shape. It deforms as follows. Note that the “opposite side” in the above description does not require the angle of the opening 15 and the opening 16 in the circumferential direction ⁇ to be strictly 180 degrees, but may be around plus or minus 2 or 3 degrees.
  • the material of the surrounding member 30 is not particularly limited, but examples thereof include the same material as that of the balloon 20.
  • the medical device 100 forms a puncture site with a puncture needle in a femoral artery or the like, and introduces a guide wire (not shown) therefrom.
  • an introducer (not shown) is inserted into the puncture site, and a guiding catheter (not shown) is introduced into the living body from the lumen of the introducer.
  • the medical instrument 100 is inserted into the lumen of the guiding catheter and introduced into the living body lumen Bl through the guiding catheter. And it moves to the target site
  • an expansion fluid is supplied to the lumen 14 of the tubular member 13 constituting the hollow member 10, and the surrounding member 30 is displaced outward in the radial direction r as shown in FIG. Expand).
  • the surrounding member 30 is brought close to the living body lumen Bl to such an extent as to contact the inner wall surface of the living body lumen Bl.
  • an expansion fluid is supplied to the lumen 12 of the tubular member 11 constituting the hollow member 10 to expand the balloon 20 as shown in FIG.
  • an expansion fluid is supplied to the lumen 12 of the tubular member 11 constituting the hollow member 10 to expand the balloon 20 as shown in FIG.
  • the living body lumen Bl in which the medical instrument 100 is disposed can be partially closed as intended by the operator.
  • positioned the medical device 100 like a cerebrovascular can be increased.
  • the surrounding member 30 surrounds the balloon 20 it is difficult for the balloon 20 to move due to an external force, and the occlusion rate of the living body lumen Bl can be prevented from being changed inadvertently.
  • the medical device 100 includes the hollow member 10, the balloon 20, and the surrounding member 30.
  • the hollow member 10 is formed in an elongated shape and includes lumens 12 and 14.
  • the balloon 20 is configured to be expandable by a fluid supplied from the lumen 12 of the tubular member 11 constituting the hollow member 10.
  • the surrounding member 30 is configured to be displaceable outward in the radial direction r intersecting the longitudinal direction d of the hollow member 10, and surrounds the balloon 20 in a state of being displaced outward in the radial direction r.
  • the biological lumen Bl such as the aorta can be partially blocked by the balloon 20. Further, since the surrounding member 30 surrounds the balloon 20, it is possible to prevent the balloon 20 from inadvertently contacting the inner wall surface of the living body lumen B1 when the balloon 20 is expanded.
  • the blockage rate of the space surrounded by the surrounding member 30 is configured to change. Therefore, the occlusion rate can be adjusted as appropriate according to the patient who uses the medical device 100 and the state of the patient.
  • the surrounding member 30 is configured by a balloon having an expansion space 31 that can be expanded by supplying a fluid.
  • the tubular member 13 constituting the hollow member 10 is configured to include a lumen 14 that supplies a fluid to the surrounding member 30. Therefore, the balloon of the surrounding member 30 can be expanded. Therefore, for example, the balloon of the surrounding member 30 can be expanded first, the balloon 20 can be expanded in a state where the balloon 20 is surrounded by the expanded surrounding member 30, and the occlusion rate of the biological lumen Bl can be adjusted.
  • the balloon of the surrounding member 30 is configured to have a substantially ring shape.
  • the balloon 20 is disposed inward of the ring-shaped radial direction r of the surrounding member 30, and the balloon 20 inadvertently contacts the inner wall surface of the living body lumen Bl when expanded. Can be suppressed.
  • the balloon 20 is configured to have a spherical shape that can be disposed inward in the radial direction r relative to the surrounding member 30 when expanded. Therefore, when the medical instrument 100 is disposed in the living body lumen Bl, the blocking rate of the living body lumen Bl can be easily adjusted according to the degree of expansion of the balloon 20. In addition, by configuring the balloon 20 in a spherical shape, it is possible to prevent the occlusion rate of the living body lumen Bl from fluctuating unexpectedly even when the balloon 20 is moved by an external force such as blood flow.
  • the hollow member 10 includes an opening 15 that communicates the lumen 12 of the tubular member 11 constituting the hollow member 10 and the expansion space 21 of the balloon 20, and the lumen 14 of the tubular member 13 constituting the hollow member 10. And an opening 16 that communicates with the expansion space 31 of the surrounding member 30.
  • the opening 15 is configured to be disposed on the side opposite to the opening 16 in the circumferential direction ⁇ of the hollow member 10 when the balloon 20 is expanded. Therefore, the balloon 20 can be disposed inward in the radial direction r from the substantially ring-shaped surrounding member 30, and the balloon 20 can be prevented from inadvertently coming into contact with the inner wall surface of the living body lumen Bl during expansion.
  • Modification of the first embodiment 4 to 6 are views for explaining a medical device 100a according to a modification of the first embodiment.
  • the balloon 20 is configured in a spherical shape arranged inward in the radial direction r with respect to the surrounding member 30 formed in a substantially ring shape when expanded.
  • it can also be configured as follows.
  • the hollow member 10 and the surrounding member 30 are common in 1st Embodiment, description is abbreviate
  • the balloon 20a is configured to be deformed into a substantially ring shape when expanded, like the surrounding member 30, as shown in FIG.
  • the balloon 20a is configured to be disposed inward in the radial direction r from the expanded portion of the surrounding member 30 during expansion.
  • the occlusion rate can be adjusted while ensuring the blood flow without completely occluding the living body lumen Bl in which the medical instrument 100 is disposed in the living body lumen Bl.
  • the usage example of the medical device 100a in this modification is the same as that of 1st Embodiment, description is abbreviate
  • (Second Embodiment) 7 to 10 are views for explaining the medical device 100b according to the second embodiment of the present invention.
  • the hollow member 10 is flexibly deformed in accordance with the shape of the living body lumen when the hollow member 10 is introduced into the living body lumen.
  • the hollow member 10 may be configured as follows.
  • the medical device 100b has a hollow member 10b, a balloon 20b, and an enclosing member 30b, as outlined with reference to FIGS.
  • the medical device 100b includes a guiding catheter 40.
  • the hollow member 10b is formed in a long and hollow tubular shape as in the first embodiment.
  • the hollow member 10b includes a tubular member 11b and a tubular member 13b.
  • the tubular member 11b is formed in a long shape having a lumen 12b as in the first embodiment.
  • the tubular member 11b is joined to the balloon 20b at the distal end so that the expansion fluid can be supplied from the lumen 12b to the expansion space 21b of the balloon 20b.
  • the tubular member 13b is formed in a long shape having a lumen 14b.
  • the tubular member 13b is joined to the surrounding member 30b at the tip so that the expansion body can be supplied from the inner cavity 14b to the expansion space 31b of the surrounding member 30b.
  • the hollow member 10 b is configured to include a bent portion 17 that can be bent outward in the radial direction r when the balloon 20 b and the surrounding member 30 b are expanded at an intermediate portion in the longitudinal direction d. .
  • the bent portion 17 bends the balloon 20b from the substantially linear shape to the outer side in the radial direction r in accordance with the supply of fluid to the inner cavity 12b of the tubular member 11b. Displace outward in the radial direction r. As the fluid is supplied to the inner cavity 14b of the tubular member 13b, the bent portion 17 is gradually bent outward in the radial direction r and displaces the surrounding member 30b outward in the radial direction r.
  • the hollow member 10b is the same as the first embodiment except that no opening is provided on the cylindrical side surface like the hollow member 10 of the first embodiment. .
  • the balloon 20b is provided at the tip of the hollow member 10b in this embodiment.
  • the balloon 20b is configured to be joined to the inner peripheral portion of the substantially ring-shaped surrounding member 30b by adhesion or fusion.
  • the balloon 20b may not be joined to the surrounding member 30b as long as the surrounding member 30b can surround the balloon 20b when the surrounding member 30b is expanded.
  • the configuration of the balloon 20b other than the above is the same as that of the balloon 20 of the first embodiment, and a description thereof will be omitted.
  • the guiding catheter 40 is disposed so as to accommodate the hollow member 10b. Similar to the hollow member 10, the guiding catheter 40 is configured in a substantially cylindrical shape and an elongated shape. The guiding catheter 40 can be moved to the target site in the state where the balloon 20b and the surrounding member 30b are accommodated in the lumen of the guiding catheter 40 until the target site such as the aorta is reached in the living body lumen B1. Moreover, the guiding catheter 40 is provided with the front-end
  • the medical device 100b may be configured as a separate part.
  • the material of the guiding catheter 40 can be configured in the same manner as the hollow member 10.
  • a puncture site is formed in the femoral artery or the like with a puncture needle or the like, and a guide wire is introduced therefrom.
  • the introducer is inserted into the puncture site, and the guiding catheter 40 is introduced into the living body from the lumen of the introducer.
  • the medical instrument 100b is inserted into the lumen of the guiding catheter 40 and introduced into the living body lumen Bl through the guiding catheter 40. And it moves to the target site
  • the balloon 20b and the surrounding member 30b are exposed from the distal end opening 41 of the guiding catheter 40. Then, an expansion fluid is supplied to the lumen 14b of the tubular member 13b constituting the hollow member 10b, and the surrounding member 30b is expanded to such an extent that it can contact the inner wall surface of the biological lumen B1 as shown in FIGS. .
  • the surrounding member 30b expands, the bent portion 17 of the hollow member 10b displaces the surrounding member 30b outward in the radial direction r as shown in FIG. 8 by supplying the expansion fluid.
  • an expansion fluid is supplied to the lumen 12b of the tubular member 11b constituting the hollow member 10b, and the balloon 20b is expanded as shown in FIG.
  • the bent portion 17 displaces the balloon 20b outward in the radial direction r with the supply of the expansion fluid.
  • the balloon 20b can be surrounded from the outside in the radial direction r, and the balloon 20b can be prevented from coming into contact with the inner wall surface of the biological lumen Bl.
  • the living body lumen Bl in which the medical instrument 100b is disposed can be partially closed as intended by the operator. In this way, the blood flow rate to the site other than the peripheral organ such as the cerebral blood vessel can be increased by the medical instrument 100b.
  • the hollow member 10b is configured to include the bent portion 17 that disposes the balloon 20b outward in the radial direction r with respect to the hollow member 10b when the balloon 20b is expanded. Therefore, the surrounding member 30b can be disposed outward in the radial direction r, and the balloon 20b can be easily positioned inward than the surrounding member 30b. Therefore, it is possible to prevent the balloon 20b from contacting the inner wall surface of the biological lumen Bl when the medical instrument 100b is disposed in the biological lumen Bl.
  • the bending portion 17 not only deforms the medical device 100b in accordance with the shape of the biological lumen Bl, but also the hollow member 10b or the guiding catheter 40 constituting the medical device 100b moves in the radial direction r. It can suppress contacting the inner wall surface.
  • FIG. 11 and 12 are cross-sectional views perpendicular to an axis showing a medical device 100c according to a third embodiment of the present invention
  • FIG. 13 is a cross-sectional view showing a modification of FIG.
  • the embodiment in which the surrounding member 30 is configured by one member that forms a substantially ring-shaped balloon has been described.
  • the structure of the hollow member 10 and the balloon 20 is the same as that of 1st Embodiment, description is abbreviate
  • the surrounding member 30c is configured to include a plurality of balloons, specifically, three balloons arranged side by side on the outer periphery of the balloon 20 as shown in FIG. 11 in this embodiment.
  • a plurality of balloons as described above, it is possible to easily form a space between the balloons as compared with the case where the balloons are formed of a single member. Therefore, it is possible to easily secure the blood flow in the biological lumen Bl together with the expansion of the balloon 20 shown in FIG. 12 while partially closing the biological lumen Bl in which the medical instrument 100c is disposed. Since the hollow member is the same as that of the first embodiment except that the tubular members are joined to the three balloons one by one, the description thereof is omitted.
  • the number of balloons constituting the surrounding member 30c is three in FIG. 11. However, if the living body lumen Bl in which the medical instrument is disposed can be partially blocked and blood flow can be secured to some extent, The number of is not limited to the above. As shown in the surrounding member 30d of the medical device 100d in FIG. 13, six balloons may be provided, or a larger number of balloons may be provided. Further, the procedure using the medical device 100c is the same as that of the first embodiment except that the expansion fluid is supplied to the three balloons, and thus the description thereof is omitted.
  • the medical device 100c according to the third embodiment is configured so that the surrounding member 30c includes a plurality of balloons arranged in the circumferential direction ⁇ outside the radial direction r of the balloon 20 when expanded. Yes. Therefore, it is possible to easily secure the blood flow while partially closing the biological lumen Bl where the medical instrument 100c is disposed.
  • (Fourth embodiment) 14 and 15 are views for explaining a medical device 100e according to the fourth embodiment of the present invention.
  • the embodiment has been described in which the balloon 20 is configured by a spherical balloon and the surrounding member 30 is configured by a substantially ring-shaped balloon that surrounds the outer side of the balloon 20 in the radial direction r when expanded.
  • the specific modes of the surrounding member and the expansion member are not limited to the above as long as the surrounding member can surround the balloon from outside in the radial direction r and the occlusion rate of the biological lumen Bl can be adjusted by the balloon.
  • the medical device 100e includes a hollow member 10e, a balloon 20e, an enclosing member 30e, and a guiding catheter 40e as shown in FIG.
  • the hollow member 10e is configured to be accommodated in the lumen of the guiding catheter 40e.
  • the balloon 20e is joined to the hollow member 10e so that a fluid for expanding the balloon 20e can be supplied at the tip of the hollow member 10e as in the second embodiment.
  • the balloon 20e has an elongated balloon shape that can be expanded along the surrounding member 30e. Since the other structure of the hollow member 10e and the balloon 20e is the same as that of 1st Embodiment, description is abbreviate
  • the surrounding member 30e is configured to be housed in the lumen of the guiding catheter 40e.
  • the surrounding member 30e is configured such that the distal end portion 33e can protrude from the opening 41e of the guiding catheter 40e.
  • the distal end portion 33e of the surrounding member 30e is formed in an arc shape as shown in FIG. 14 in a state where it is not accommodated in the lumen of the guiding catheter 40e, that is, in a natural state where no external force is applied.
  • the material of the surrounding member 30e is not particularly limited as long as the surrounding member 30e is a wire-shaped member that can be deformed in an arc shape with the distal end portion 33e exposed from the opening 41e of the guiding catheter 40e.
  • titanium-based Ti-No, Ti-Pd, Ti-Nb-Sn, etc.
  • copper-based shape memory alloys acrylic resins, transisoprene polymers, polynorbornene, styrene-butadiene copolymers, polyurethane, etc.
  • the shape memory resin, stainless steel (SUS304), ⁇ -titanium steel, Co—Cr alloy and other alloys having spring properties can be used.
  • the guiding catheter 40e is the same as the guiding catheter 40 of the second embodiment except that the opening 41e is provided on the cylindrical side surface, the description thereof is omitted.
  • a puncture site is formed in the femoral artery or the like with a puncture needle or the like, and a guide wire is introduced therefrom.
  • the introducer is inserted into the puncture site, and the guiding catheter 40e is introduced into the living body from the lumen of the introducer.
  • the medical instrument 100e is inserted into the lumen of the guiding catheter 40e and introduced into the living body lumen Bl through the guiding catheter 40e. And it moves to the target site
  • the balloon 20e and the surrounding member 30e are exposed from the opening 41e of the guiding catheter 40e.
  • the surrounding member 30e is formed in a substantially arc shape as described above, and when exposed to the outside from the opening 41e, the surrounding member 30e is deformed into a substantially arc shape along the inner wall surface of the living body lumen Bl.
  • the balloon 20e is disposed along the shape of the surrounding member 30e.
  • the balloon 20e is expanded using an inflator (not shown) or the like.
  • the balloon 20e is arranged inward in the radial direction r relative to the surrounding member 30e when expanded, as in the first embodiment. Therefore, careless contact between the balloon 20e itself and the inner wall surface of the living body lumen Bl can be suppressed.
  • the occlusion rate of the biological lumen Bl can be adjusted as intended by the operator according to the degree of expansion of the balloon 20e.
  • the surrounding member 30e is configured to include an arc-shaped wire in which the distal end portion 33e is shaped in a natural state where no external force is applied. Also with this configuration, the surrounding member 30e surrounds the balloon 20e from the outside in the radial direction r, and the balloon 20e can be prevented from inadvertently contacting the inner wall surface of the living body lumen Bl.
  • the hollow member 10 includes the tubular members 11 and 13 has been described above.
  • the configuration of the hollow member 10 is not limited to the above as long as the balloon 20 can be expanded and the surrounding member 30 can be displaced.
  • the hollow member 10 may be configured such that a lumen for supplying fluid to the balloon 20 and the surrounding member 30 is prepared by dividing the lumen of one hollow tubular member by a partition or the like.
  • the embodiment has been described in which the balloon 20a is deformed into a substantially ring shape when expanded, like the surrounding member 30a.
  • the specific configuration of the balloon 20a is not particularly limited as long as the balloon 20a can be expanded as shown in FIG.
  • a partition wall may be provided in the lumen of the balloon 20a, and when a certain pressure or more is applied, one or more partition walls may be broken to expand the balloon 20a.

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  • Heart & Thoracic Surgery (AREA)
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  • Biophysics (AREA)
  • Pulmonology (AREA)
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Abstract

[Problem] To provide a medical device which, when a lumen is partially occluded by an expanding member such as a balloon, suppresses the expanding member from unintentionally contacting the inner wall surface of the lumen. [Solution] This medical device 100 comprises: an elongate hollow member 10 having inner cavities 12, 14; a balloon 20 which can be expanded with a fluid supplied from the inner cavities of the hollow member; and a surrounding member 30 which is configured to be capable of displacement outwards in the radial direction r crossing the length direction d of the hollow member, and which, in a state displaced radially outwards, surrounds the balloon.

Description

医療器具Medical instruments
　本発明は、医療器具に関する。 The present invention relates to a medical instrument.
　医療器具では、バルーンカテーテルにおけるバルーンのように血管等の生体管腔に配置され、膨張することで所定の処置を実施するものがある。従来の技術にはバルーンを膨張させて大動脈を完全にではなく、部分的に閉塞させることで下肢等への血流を減少させ、その分、脳血管等への血流を増加させようとする器具がある（特許文献１参照）。 Some medical devices are arranged in a body lumen such as a blood vessel like a balloon in a balloon catheter, and perform a predetermined treatment by being inflated. In the prior art, the balloon is inflated to partially occlude the aorta rather than completely, thereby reducing the blood flow to the lower limbs and increasing the blood flow to the cerebral blood vessels. There is an instrument (see Patent Document 1).
特表２００２－５３７９０９号公報Special Table 2002-537909
　特許文献１のようにバルーンが生体管腔を部分閉塞させる場合、当該バルーンは生体管腔に固定されていない状態となる。そのような状態の場合、例えば血流等から付与される外力によってバルーンが不用意に動き、生体の内壁面に衝突し、生体の内壁面を傷めるおそれがある。 When the balloon partially occludes the living body lumen as in Patent Document 1, the balloon is not fixed to the living body lumen. In such a state, for example, the balloon may inadvertently move due to an external force applied from blood flow or the like, and may collide with the inner wall surface of the living body, thereby damaging the inner wall surface of the living body.
　そこで本発明は、バルーン等の拡張部材によって生体管腔を部分閉塞させる際に、拡張部材が生体管腔の内壁面に不用意に接触することを抑制する医療器具を提供することを目的とする。 SUMMARY OF THE INVENTION Accordingly, an object of the present invention is to provide a medical instrument that suppresses the expansion member from inadvertently contacting the inner wall surface of the biological lumen when the biological lumen is partially occluded by an expansion member such as a balloon. .
　上記目的を達成する本発明に係る医療器具は、長尺状に構成され内腔を備えた中空部材と、前記中空部材の前記内腔から供給される流体によって拡張可能な拡張部材と、前記中空部材の長手方向と交差する径方向外方に変位可能に構成され、前記径方向外方に変位した状態において前記拡張部材を包囲する包囲部材と、を有する。 A medical device according to the present invention that achieves the above object includes a hollow member having an elongated shape and having a lumen, an expansion member that can be expanded by a fluid supplied from the lumen of the hollow member, and the hollow An encircling member configured to be displaceable radially outwardly intersecting the longitudinal direction of the member and surrounding the expansion member in a state of being displaced radially outwardly.
　本発明に係る医療器具によれば、生体管腔を部分閉塞可能な拡張部材を包囲部材によって、中空部材の長手方向と交差する径方向における外方から包囲している。そのため、バルーン等の拡張部材が拡張時に生体管腔の内壁面に不用意に接触することを抑制できる。 According to the medical instrument of the present invention, the expansion member capable of partially closing the living body lumen is surrounded by the surrounding member from the outside in the radial direction intersecting the longitudinal direction of the hollow member. Therefore, it is possible to suppress an expansion member such as a balloon from inadvertently contacting the inner wall surface of the living body lumen during expansion.
本発明の第１実施形態に係る医療器具について説明する図である。It is a figure explaining the medical instrument which concerns on 1st Embodiment of this invention. 上記医療器具の包囲部材を変位させた状態について説明する図である。It is a figure explaining the state which displaced the surrounding member of the said medical instrument. 上記医療器具のバルーンを拡張させた状態について説明する図である。It is a figure explaining the state which expanded the balloon of the said medical device. 第１実施形態の変形例に係る医療器具であって図１に対応する図である。It is a medical device which concerns on the modification of 1st Embodiment, Comprising: It is a figure corresponding to FIG. 第１実施形態の変形例に係る医療器具であって図２に対応する図である。It is a medical device which concerns on the modification of 1st Embodiment, Comprising: It is a figure corresponding to FIG. 第１実施形態の変形例に係る医療器具であって図３に対応する図である。It is a medical instrument which concerns on the modification of 1st Embodiment, Comprising: It is a figure corresponding to FIG. 第２実施形態に係る医療器具について説明する図であって、図１に対応する図である。It is a figure explaining the medical instrument which concerns on 2nd Embodiment, Comprising: It is a figure corresponding to FIG. 第２実施形態に係る医療器具について説明する図であって、包囲部材を変位させた状態について説明する図である。It is a figure explaining the medical instrument which concerns on 2nd Embodiment, Comprising: It is a figure explaining the state which displaced the surrounding member. 図８に続いて第２実施形態に係る医療器具の包囲部材を変位させた状態を説明する図である。It is a figure explaining the state which displaced the surrounding member of the medical device which concerns on 2nd Embodiment following FIG. 図９に続いて第２実施形態に係る医療器具のバルーンを拡張させた際について説明する図である。It is a figure explaining the time of expanding the balloon of the medical device which concerns on 2nd Embodiment following FIG. 第３実施形態に係る医療器具を生体管腔に配置した際における軸直交断面を示す断面図である。It is sectional drawing which shows an axial orthogonal cross section at the time of arrange | positioning the medical device which concerns on 3rd Embodiment in the biological lumen. 図１１のバルーンを拡張させた状態を示す断面図である。It is sectional drawing which shows the state which expanded the balloon of FIG. 図１１の変形例を示す断面図である。It is sectional drawing which shows the modification of FIG. 第４実施形態に係る医療器具について説明する図である。It is a figure explaining the medical instrument which concerns on 4th Embodiment. 図１４に係る医療器具においてバルーンを拡張させた際について説明する図である。It is a figure explaining the time of expanding the balloon in the medical device which concerns on FIG.
　（第１実施形態）
　以下、添付した図面を参照しながら、本発明の実施形態を説明する。なお、以下の記載は特許請求の範囲に記載される技術的範囲や用語の意義を限定するものではない。また、図面の寸法比率は説明の都合上誇張されており、実際の比率とは異なる場合がある。なお、以下において本明細書及び図面では後述する中空部材１０の長手方向を長手方向ｄと記載する。また、中空部材１０の長手方向ｄに直交する軸直角断面において中空部材１０の周方向又は角度方向を周方向θと記載する。また、中空部材１０の軸直角断面において放射方向又は径方向を径方向ｒと記載する。 (First embodiment)
Hereinafter, embodiments of the present invention will be described with reference to the accompanying drawings. In addition, the following description does not limit the technical scope and terms used in the claims. In addition, the dimensional ratios in the drawings are exaggerated for convenience of explanation, and may differ from actual ratios. In the following description and drawings, the longitudinal direction of the hollow member 10 described later is referred to as a longitudinal direction d. In addition, the circumferential direction or the angular direction of the hollow member 10 in the cross section perpendicular to the longitudinal direction d of the hollow member 10 is referred to as a circumferential direction θ. Further, the radial direction or the radial direction in the cross section perpendicular to the axis of the hollow member 10 is referred to as a radial direction r.
　図１～図３は、本発明の第１実施形態に係る医療器具１００を示す図である。 1 to 3 are views showing a medical device 100 according to the first embodiment of the present invention.
　本実施形態に係る医療器具１００は、脳梗塞等の手技において大動脈を部分閉塞することで下肢の血流量を減らし、脳血管等への血流量を増加させる際等に用いられる。本実施形態に係る医療器具１００について図１～図３を参照して概説すれば、中空部材１０と、バルーン２０（拡張部材に相当）と、包囲部材３０と、を有する。以下、詳述する。 The medical instrument 100 according to the present embodiment is used for reducing blood flow in the lower limbs by partially occluding the aorta in a procedure such as cerebral infarction and increasing blood flow to the cerebral blood vessels. The medical device 100 according to this embodiment will be briefly described with reference to FIGS. 1 to 3. The medical device 100 includes a hollow member 10, a balloon 20 (corresponding to an expansion member), and an enclosing member 30. Details will be described below.
　（中空部材）
　中空部材１０は、長尺状かつ略円筒状の管状部材として構成している。中空部材１０は、図１に示すようにバルーン２０を拡張させる拡張用流体を流通可能な内腔１２を備えた管状部材１１と、包囲部材３０を変位させる拡張用流体を流通可能な内腔１４を備えた管状部材１３と、を備える。内腔１４は、本明細書において「他の内腔」に相当する。管状部材１１は拡張空間２１を備えたバルーン２０と接合される。管状部材１３は、包囲部材３０と接合される。管状部材１１と管状部材１３とは本実施形態において接着又は融着によって互いに接合している。 (Hollow member)
The hollow member 10 is configured as a long and substantially cylindrical tubular member. As shown in FIG. 1, the hollow member 10 includes a tubular member 11 having a lumen 12 through which an expansion fluid for expanding the balloon 20 can flow, and a lumen 14 through which the expansion fluid for displacing the surrounding member 30. The tubular member 13 provided with. The lumen 14 corresponds to “another lumen” in the present specification. The tubular member 11 is joined to a balloon 20 having an expansion space 21. The tubular member 13 is joined to the surrounding member 30. In this embodiment, the tubular member 11 and the tubular member 13 are joined to each other by adhesion or fusion.
　中空部材１０は、本実施形態において管状部材１１、１３によって構成しているが、バルーン２０を拡張でき、包囲部材３０を変位できれば、中空部材１０の構成は上記に限定されない。 The hollow member 10 is configured by the tubular members 11 and 13 in the present embodiment, but the configuration of the hollow member 10 is not limited to the above as long as the balloon 20 can be expanded and the surrounding member 30 can be displaced.
　管状部材１１は、本実施形態においてバルーン２０を拡張させる不図示のインデフレータまたはシリンジ等と接続可能に構成している。管状部材１３は、管状部材１１と同様に包囲部材３０を変位させるために不図示のインデフレータまたはシリンジ等と接続可能に構成している。 The tubular member 11 is configured to be connectable to an inflator (not shown) or a syringe that expands the balloon 20 in this embodiment. The tubular member 13 is configured to be connectable to an indeflator or a syringe (not shown) in order to displace the surrounding member 30 in the same manner as the tubular member 11.
　管状部材１１の内腔１２とバルーン２０の拡張空間２１とは開口部１５によって連通している。管状部材１３の内腔１４と包囲部材３０の拡張空間３１とは開口部１６によって連通している。なお、開口部１５は本明細書において第１開口部に相当し、開口部１６は第２開口部に相当する。 The lumen 12 of the tubular member 11 and the expansion space 21 of the balloon 20 communicate with each other through the opening 15. The lumen 14 of the tubular member 13 and the expansion space 31 of the surrounding member 30 communicate with each other through the opening 16. Note that the opening 15 corresponds to a first opening in this specification, and the opening 16 corresponds to a second opening.
　開口部１５はバルーン２０を拡張させる拡張用流体をバルーン２０に供給するために設けられる。開口部１６は包囲部材３０を変位させるために拡張用流体を包囲部材３０に供給するために設けられる。開口部１５、１６は図１に示すように中空部材１０の軸直角断面において周方向θに離間して配置している。開口部１５は、包囲部材３０のリング形状の中心を基準に考えた場合において、少なくともバルーン２０の拡張時に開口部１６よりも径方向ｒの内側に配置するように構成している。また、開口部１５は、図１に示すように開口部１６に対して周方向θにおいて略１８０度、離間して配置している。 The opening 15 is provided to supply the balloon 20 with an expansion fluid for expanding the balloon 20. The opening 16 is provided to supply expansion fluid to the enclosure member 30 to displace the enclosure member 30. As shown in FIG. 1, the openings 15 and 16 are spaced apart in the circumferential direction θ in the cross section perpendicular to the axis of the hollow member 10. The opening 15 is configured to be arranged at least inside the radial direction r from the opening 16 when the balloon 20 is expanded when the center of the ring shape of the surrounding member 30 is considered as a reference. Further, as shown in FIG. 1, the opening 15 is spaced apart from the opening 16 by approximately 180 degrees in the circumferential direction θ.
　ただし、包囲部材３０によって医療器具１００を生体管腔Ｂｌに固定でき、生体管腔Ｂｌに導入した際に包囲部材３０よりも軸直角断面における径方向ｒの内方にバルーン２０を配置できれば、開口部１５、１６の具体的な位置は上記に限定されない。また、開口部１５、１６は長手方向ｄにおいて略同位置に設けるように構成している。ただし、バルーン２０を拡張させ、包囲部材３０を径方向ｒの外方に変位させた状態において包囲部材３０が少なくとも部分的にバルーン２０を包囲できれば、開口部１５と開口部１６は長手方向ｄにおいて厳密に同位置でなくてもよい。 However, if the medical device 100 can be fixed to the living body lumen Bl by the surrounding member 30 and the balloon 20 can be disposed inward in the radial direction r in the cross section perpendicular to the surroundings when introduced into the living body lumen Bl, the opening Specific positions of the portions 15 and 16 are not limited to the above. The openings 15 and 16 are configured to be provided at substantially the same position in the longitudinal direction d. However, if the surrounding member 30 can at least partially surround the balloon 20 in a state where the balloon 20 is expanded and the surrounding member 30 is displaced outward in the radial direction r, the opening 15 and the opening 16 are in the longitudinal direction d. It does not have to be exactly the same position.
　中空部材１０の材料は、生体管腔に導入した際に適宜柔軟に変形できれば特に限定されないが、例示すれば、ポリエチレン、ポリプロピレン、ポリブテン、エチレン－プロピレン共重合体、エチレン－酢酸ビニル共重合体、アイオノマー、あるいはこれら２種以上の混合物等からなるポリオレフィン、ポリ塩化ビニル、ポリアミド、ポリアミドエラストマー、ポリエステル、ポリエステルエラストマー、ポリウレタン、ポリウレタンエラストマー、ポリイミド、フッ素樹脂等の高分子材料あるいはこれらの混合物、あるいは上記２種以上の高分子材料を挙げることができる。また、中空部材１０の先端等にはＸ線等の放射線透視下において医療器具の位置を確認できるように造影マーカー等を設けることができる。 The material of the hollow member 10 is not particularly limited as long as it can be appropriately flexibly deformed when introduced into a living body lumen. For example, polyethylene, polypropylene, polybutene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, Polymers such as ionomers, polyolefins, polyvinyl chloride, polyamides, polyamide elastomers, polyesters, polyester elastomers, polyurethanes, polyurethane elastomers, polyimides, fluororesins such as mixtures of two or more thereof, or mixtures thereof, or the above 2 Mention may be made of more than one kind of polymer material. Further, a contrast marker or the like can be provided at the tip of the hollow member 10 so that the position of the medical instrument can be confirmed under radioscopy such as X-rays.
　（バルーン）
　バルーン２０は、図１、図３に示すように中空部材１０の内腔１２から供給される拡張用流体の供給によって拡張可能な拡張空間２１を備える。バルーン２０は、医療器具１００を生体管腔に配置した際に拡張に伴って包囲部材３０によって包囲された空間の閉塞率を変化できるように構成している。バルーン２０は、本実施形態において図３に示すように拡張時に略球状に形成するように構成している。なお、本明細書において「球」とは、立体の中心を通る任意の断面が正円だけでなく、楕円となるようなものも含む。バルーン２０は、拡張空間２１が開口部１５を介して中空部材１０を構成する管状部材１１の内腔１２と連通するように中空部材１０に接着又は融着等で接合している。バルーン２０は中空部材１０を構成する管状部材１１の円筒形状の側面に位置するように構成している。ただし、生体管腔に挿入した際に挿入した生体管腔の閉塞率を調整できれば、中空部材１０との相対的な位置関係は上記に限定されない。 (balloon)
As shown in FIGS. 1 and 3, the balloon 20 includes an expansion space 21 that can be expanded by supplying an expansion fluid supplied from the lumen 12 of the hollow member 10. The balloon 20 is configured such that the occlusion rate of the space surrounded by the surrounding member 30 can be changed with expansion when the medical device 100 is placed in the living body lumen. In the present embodiment, the balloon 20 is configured to be formed in a substantially spherical shape when expanded as shown in FIG. In the present specification, the “sphere” includes not only a perfect circle but also an ellipse in an arbitrary cross section passing through the center of a solid. The balloon 20 is joined to the hollow member 10 by adhesion or fusion so that the expansion space 21 communicates with the lumen 12 of the tubular member 11 constituting the hollow member 10 through the opening 15. The balloon 20 is configured to be positioned on the cylindrical side surface of the tubular member 11 constituting the hollow member 10. However, the relative positional relationship with the hollow member 10 is not limited to the above as long as the occlusion rate of the inserted biological lumen can be adjusted when inserted into the biological lumen.
　バルーン２０の材料は、ある程度の可撓性を備えれば特に限定されない。例示すれば、ポリエチレン、ポリプロピレン、エチレン－プロピレン共重合体等のポリオレフィン、ポリエチレンテレフタレート等のポリエステル、ポリ塩化ビニル、エチレン－酢酸ビニル共重合体、架橋型エチレン－酢酸ビニル共重合体、ポリウレタン等の熱可塑性樹脂、ポリアミド、ポリアミドエラストマー、シリコーンゴム、ラテックスゴム等を挙げることができる。 The material of the balloon 20 is not particularly limited as long as it has a certain degree of flexibility. For example, polyolefins such as polyethylene, polypropylene, ethylene-propylene copolymer, polyesters such as polyethylene terephthalate, polyvinyl chloride, ethylene-vinyl acetate copolymer, cross-linked ethylene-vinyl acetate copolymer, heat of polyurethane, etc. Examples thereof include a plastic resin, polyamide, polyamide elastomer, silicone rubber, latex rubber, and the like.
　（包囲部材）
　包囲部材３０は、図３に示すように中空部材１０の長手方向ｄと交差する径方向ｒにおける外方に変位可能に構成される。包囲部材３０は、図３に示すように径方向ｒにおける外方に変位した状態においてバルーン２０を径方向ｒにおける外方から包囲する。包囲部材３０は、図２に示すように拡張用流体の供給によって拡張可能な拡張空間３１を備えたバルーンを有する。包囲部材３０は、拡張用流体の供給によって拡張することによって、径方向ｒにおける外方に変位する。 (Enclosing member)
As shown in FIG. 3, the surrounding member 30 is configured to be displaceable outward in the radial direction r intersecting the longitudinal direction d of the hollow member 10. As shown in FIG. 3, the surrounding member 30 surrounds the balloon 20 from the outside in the radial direction r in a state of being displaced outward in the radial direction r. As shown in FIG. 2, the surrounding member 30 has a balloon including an expansion space 31 that can be expanded by supplying an expansion fluid. The surrounding member 30 is displaced outward in the radial direction r by being expanded by supplying the expansion fluid.
　包囲部材３０は、拡張空間３１が開口部１５を介して中空部材１０を構成する管状部材１３の内腔１４と連通するように中空部材１０に接着又は融着等で接合している。包囲部材３０は、本実施形態において単一の略リング形状のバルーンを備えるように構成している。 The surrounding member 30 is joined to the hollow member 10 by adhesion or fusion so that the expansion space 31 communicates with the lumen 14 of the tubular member 13 constituting the hollow member 10 through the opening 15. The surrounding member 30 is configured to include a single substantially ring-shaped balloon in this embodiment.
　包囲部材３０は、開口部１６が開口部１５と周方向θにおいて反対側の位置に設けられ、かつ、略リング形状に形成することによって、上記のように拡張時にバルーン２０を外方から包囲するように変形する。なお、上記における「反対側」とは、開口部１５と開口部１６の周方向θにおける角度が厳密に１８０度でなくてもよく、プラスマイナス２、３度程度前後してもよい。 The surrounding member 30 surrounds the balloon 20 from the outside during expansion as described above by forming the opening 16 at a position opposite to the opening 15 in the circumferential direction θ and forming a substantially ring shape. It deforms as follows. Note that the “opposite side” in the above description does not require the angle of the opening 15 and the opening 16 in the circumferential direction θ to be strictly 180 degrees, but may be around plus or minus 2 or 3 degrees.
　包囲部材３０の材料についても特に限定されないが、例示すれば、バルーン２０と同様の材料を挙げることができる。 The material of the surrounding member 30 is not particularly limited, but examples thereof include the same material as that of the balloon 20.
　（使用例）
　次に本実施形態に係る医療器具１００を用いた使用例について説明する。本実施形態に係る医療器具１００は大腿動脈等に穿刺針で穿刺箇所を形成し、そこからガイドワイヤ（図示省略）を導入する。次に、イントロデューサー（図示省略）を穿刺箇所に挿入し、イントロデューサーの内腔からガイディングカテーテル（図示省略）を生体内に導入する。 (Example of use)
Next, a usage example using the medical instrument 100 according to the present embodiment will be described. The medical device 100 according to this embodiment forms a puncture site with a puncture needle in a femoral artery or the like, and introduces a guide wire (not shown) therefrom. Next, an introducer (not shown) is inserted into the puncture site, and a guiding catheter (not shown) is introduced into the living body from the lumen of the introducer.
　次に、ガイディングカテーテルの内腔に医療器具１００を挿入し、ガイディングカテーテルを通じて生体管腔Ｂｌに導入する。そして、Ｘ線画像等で確認しながら、大動脈等の目的部位まで移動させる。医療器具１００が目的部位に到達したら、中空部材１０を構成する管状部材１３の内腔１４に拡張用流体を供給し、図２に示すように包囲部材３０を径方向ｒの外方に変位（拡張）させる。そして、包囲部材３０を生体管腔Ｂｌの内壁面に当接する程度に生体管腔Ｂｌに接近させる。 Next, the medical instrument 100 is inserted into the lumen of the guiding catheter and introduced into the living body lumen Bl through the guiding catheter. And it moves to the target site | parts, such as an aorta, confirming with an X-ray image etc. When the medical instrument 100 reaches the target site, an expansion fluid is supplied to the lumen 14 of the tubular member 13 constituting the hollow member 10, and the surrounding member 30 is displaced outward in the radial direction r as shown in FIG. Expand). Then, the surrounding member 30 is brought close to the living body lumen Bl to such an extent as to contact the inner wall surface of the living body lumen Bl.
　次に、中空部材１０を構成する管状部材１１の内腔１２に拡張用流体を供給してバルーン２０を図３に示すように拡張させる。包囲部材３０がバルーン２０を包囲することによって、バルーン２０が血流等の外力によって動いた場合に、生体管腔Ｂｌの内壁面に不用意に接触することを抑制できる。 Next, an expansion fluid is supplied to the lumen 12 of the tubular member 11 constituting the hollow member 10 to expand the balloon 20 as shown in FIG. By surrounding the balloon 20 with the surrounding member 30, it is possible to suppress inadvertent contact with the inner wall surface of the living body lumen Bl when the balloon 20 is moved by an external force such as blood flow.
　また、バルーン２０を包囲部材３０よりも径方向ｒの内方において適宜拡張させることによって、医療器具１００を配置した生体管腔Ｂｌを術者の意図するように部分的に閉塞状態にできる。これにより、脳血管等のように医療器具１００を配置した抹消器官以外の部位に流通する血流量を増加させることができる。また、包囲部材３０がバルーン２０を包囲することによってバルーン２０を外力によって動きにくくでき、生体管腔Ｂｌの閉塞率が不用意に変動することを抑制しうる。 In addition, by appropriately expanding the balloon 20 in the radial direction r from the surrounding member 30, the living body lumen Bl in which the medical instrument 100 is disposed can be partially closed as intended by the operator. Thereby, the blood flow volume distribute | circulated to site | parts other than the peripheral organ which arrange | positioned the medical device 100 like a cerebrovascular can be increased. Further, since the surrounding member 30 surrounds the balloon 20, it is difficult for the balloon 20 to move due to an external force, and the occlusion rate of the living body lumen Bl can be prevented from being changed inadvertently.
　以上、説明したように本実施形態に係る医療器具１００は、中空部材１０と、バルーン２０と、包囲部材３０と、を有する。中空部材１０は長尺状に構成され、内腔１２、１４を備える。バルーン２０は、中空部材１０を構成する管状部材１１の内腔１２から供給される流体によって拡張可能に構成している。包囲部材３０は、中空部材１０の長手方向ｄと交差する径方向ｒにおける外方に変位可能に構成され、径方向ｒの外方に変位した状態においてバルーン２０を包囲する。 As described above, the medical device 100 according to this embodiment includes the hollow member 10, the balloon 20, and the surrounding member 30. The hollow member 10 is formed in an elongated shape and includes lumens 12 and 14. The balloon 20 is configured to be expandable by a fluid supplied from the lumen 12 of the tubular member 11 constituting the hollow member 10. The surrounding member 30 is configured to be displaceable outward in the radial direction r intersecting the longitudinal direction d of the hollow member 10, and surrounds the balloon 20 in a state of being displaced outward in the radial direction r.
　医療器具１００を上記のように構成することによって、大動脈等のような生体管腔Ｂｌをバルーン２０によって部分的に閉塞状態とすることができる。また、包囲部材３０がバルーン２０を包囲することによってバルーン２０の拡張時にバルーン２０が生体管腔Ｂｌの内壁面に不用意に接触することを抑制できる。 By configuring the medical instrument 100 as described above, the biological lumen Bl such as the aorta can be partially blocked by the balloon 20. Further, since the surrounding member 30 surrounds the balloon 20, it is possible to prevent the balloon 20 from inadvertently contacting the inner wall surface of the living body lumen B1 when the balloon 20 is expanded.
　また、バルーン２０の拡張に伴って、包囲部材３０によって包囲された空間の閉塞率は変化するように構成している。そのため、医療器具１００を使用する患者や患者の状態に応じて閉塞率を適宜調整することができる。 Also, as the balloon 20 is expanded, the blockage rate of the space surrounded by the surrounding member 30 is configured to change. Therefore, the occlusion rate can be adjusted as appropriate according to the patient who uses the medical device 100 and the state of the patient.
　また、包囲部材３０は、流体の供給によって拡張可能な拡張空間３１を備えるバルーンで構成される。中空部材１０を構成する管状部材１３は、包囲部材３０に流体を供給する内腔１４を備えるように構成している。そのため、包囲部材３０のバルーンを拡張できる。よって、例えば包囲部材３０のバルーンを先に拡張させ、拡張した包囲部材３０によってバルーン２０を包囲した状態でバルーン２０を拡張させ、生体管腔Ｂｌの閉塞率を調整することができる。 The surrounding member 30 is configured by a balloon having an expansion space 31 that can be expanded by supplying a fluid. The tubular member 13 constituting the hollow member 10 is configured to include a lumen 14 that supplies a fluid to the surrounding member 30. Therefore, the balloon of the surrounding member 30 can be expanded. Therefore, for example, the balloon of the surrounding member 30 can be expanded first, the balloon 20 can be expanded in a state where the balloon 20 is surrounded by the expanded surrounding member 30, and the occlusion rate of the biological lumen Bl can be adjusted.
　また、包囲部材３０のバルーンは、略リング形状を備えるように構成している。包囲部材３０を上記のように構成することによって、バルーン２０を包囲部材３０のリング形状の径方向ｒの内方に配置し、バルーン２０が拡張時に生体管腔Ｂｌの内壁面に不用意に接触することを抑制できる。 Further, the balloon of the surrounding member 30 is configured to have a substantially ring shape. By configuring the surrounding member 30 as described above, the balloon 20 is disposed inward of the ring-shaped radial direction r of the surrounding member 30, and the balloon 20 inadvertently contacts the inner wall surface of the living body lumen Bl when expanded. Can be suppressed.
　また、バルーン２０は、拡張時に包囲部材３０よりも径方向ｒの内方において配置可能な球形状を備えるように構成している。そのため、医療器具１００を生体管腔Ｂｌに配置した際にバルーン２０の拡張の程度によって生体管腔Ｂｌの閉塞率を容易に調整することができる。また、バルーン２０を球形状に構成することによって、血流等の外力によってバルーン２０が動いても生体管腔Ｂｌの閉塞率が不用意に変動することを抑制しうる。 Further, the balloon 20 is configured to have a spherical shape that can be disposed inward in the radial direction r relative to the surrounding member 30 when expanded. Therefore, when the medical instrument 100 is disposed in the living body lumen Bl, the blocking rate of the living body lumen Bl can be easily adjusted according to the degree of expansion of the balloon 20. In addition, by configuring the balloon 20 in a spherical shape, it is possible to prevent the occlusion rate of the living body lumen Bl from fluctuating unexpectedly even when the balloon 20 is moved by an external force such as blood flow.
　また、中空部材１０は、中空部材１０を構成する管状部材１１の内腔１２とバルーン２０の拡張空間２１とを連通する開口部１５と、中空部材１０を構成する管状部材１３の内腔１４と包囲部材３０の拡張空間３１とを連通する開口部１６と、を備える。開口部１５は、バルーン２０の拡張時に中空部材１０の周方向θにおいて開口部１６と反対側に配置するように構成している。そのため、バルーン２０を略リング形状の包囲部材３０よりも径方向ｒにおいて内方に配置し、バルーン２０が拡張時に生体管腔Ｂｌの内壁面と不用意に接触することを抑制できる。 The hollow member 10 includes an opening 15 that communicates the lumen 12 of the tubular member 11 constituting the hollow member 10 and the expansion space 21 of the balloon 20, and the lumen 14 of the tubular member 13 constituting the hollow member 10. And an opening 16 that communicates with the expansion space 31 of the surrounding member 30. The opening 15 is configured to be disposed on the side opposite to the opening 16 in the circumferential direction θ of the hollow member 10 when the balloon 20 is expanded. Therefore, the balloon 20 can be disposed inward in the radial direction r from the substantially ring-shaped surrounding member 30, and the balloon 20 can be prevented from inadvertently coming into contact with the inner wall surface of the living body lumen Bl during expansion.
　（第１実施形態の変形例）
　図４～図６は第１実施形態の変形例に係る医療器具１００ａを説明する図である。上記ではバルーン２０が、拡張時に略リング形状に形成された包囲部材３０に対して径方向ｒの内方に配置される球形状に構成されると説明した。しかし、以下のように構成することもできる。なお、本変形例において中空部材１０及び包囲部材３０は、第１実施形態と共通するため、説明を省略する。 (Modification of the first embodiment)
4 to 6 are views for explaining a medical device 100a according to a modification of the first embodiment. In the above description, it has been described that the balloon 20 is configured in a spherical shape arranged inward in the radial direction r with respect to the surrounding member 30 formed in a substantially ring shape when expanded. However, it can also be configured as follows. In addition, in this modification, since the hollow member 10 and the surrounding member 30 are common in 1st Embodiment, description is abbreviate | omitted.
　バルーン２０ａは、本変形例において図６に示すように包囲部材３０と同様に拡張時に略リング形状に変形するように構成している。バルーン２０ａは、拡張時に包囲部材３０の拡張部分よりも径方向ｒの内方に配置可能に構成している。バルーン２０ａを上記のように構成することにより、医療器具１００を生体管腔Ｂｌに配置した生体管腔Ｂｌを完全閉塞とせず、血流を確保しつつ、閉塞率を調整することができる。なお、本変形例における医療器具１００ａの使用例は第１実施形態と同様であるため、説明を省略する。 In the present modification, the balloon 20a is configured to be deformed into a substantially ring shape when expanded, like the surrounding member 30, as shown in FIG. The balloon 20a is configured to be disposed inward in the radial direction r from the expanded portion of the surrounding member 30 during expansion. By configuring the balloon 20a as described above, the occlusion rate can be adjusted while ensuring the blood flow without completely occluding the living body lumen Bl in which the medical instrument 100 is disposed in the living body lumen Bl. In addition, since the usage example of the medical device 100a in this modification is the same as that of 1st Embodiment, description is abbreviate | omitted.
　（第２実施形態）
　図７～図１０は本発明の第２実施形態に係る医療器具１００ｂの説明に供する図である。第１実施形態では中空部材１０が生体管腔に導入した際に生体管腔の形状に合わせて柔軟に変形すると説明したが、以下のように構成することもできる。 (Second Embodiment)
7 to 10 are views for explaining the medical device 100b according to the second embodiment of the present invention. In the first embodiment, it has been described that the hollow member 10 is flexibly deformed in accordance with the shape of the living body lumen when the hollow member 10 is introduced into the living body lumen. However, the hollow member 10 may be configured as follows.
　第２実施形態に係る医療器具１００ｂは、図７～図１０を参照して概説すれば、中空部材１０ｂと、バルーン２０ｂと、包囲部材３０ｂと、を有する。また、医療器具１００ｂは、ガイディングカテーテル４０を備える。 The medical device 100b according to the second embodiment has a hollow member 10b, a balloon 20b, and an enclosing member 30b, as outlined with reference to FIGS. The medical device 100b includes a guiding catheter 40.
　（中空部材）
　中空部材１０ｂは、第１実施形態と同様に長尺で中空の管状に形成している。中空部材１０ｂは、管状部材１１ｂと、管状部材１３ｂと、を備える。 (Hollow member)
The hollow member 10b is formed in a long and hollow tubular shape as in the first embodiment. The hollow member 10b includes a tubular member 11b and a tubular member 13b.
　管状部材１１ｂは、図７に示すように第１実施形態と同様に内腔１２ｂを備えた長尺状に構成している。管状部材１１ｂは、図１０に示すように内腔１２ｂからバルーン２０ｂの拡張空間２１ｂに拡張用流体を供給できるように先端部においてバルーン２０ｂと接合している。管状部材１３ｂは、第１実施形態と同様に内腔１４ｂを備えた長尺状に構成している。管状部材１３ｂは、内腔１４ｂから包囲部材３０ｂの拡張空間３１ｂに拡張用体を供給できるように先端部において包囲部材３０ｂと接合している。 As shown in FIG. 7, the tubular member 11b is formed in a long shape having a lumen 12b as in the first embodiment. As shown in FIG. 10, the tubular member 11b is joined to the balloon 20b at the distal end so that the expansion fluid can be supplied from the lumen 12b to the expansion space 21b of the balloon 20b. Similar to the first embodiment, the tubular member 13b is formed in a long shape having a lumen 14b. The tubular member 13b is joined to the surrounding member 30b at the tip so that the expansion body can be supplied from the inner cavity 14b to the expansion space 31b of the surrounding member 30b.
　中空部材１０ｂは、図８に示すように長手方向ｄの中間部においてバルーン２０ｂ及び包囲部材３０ｂの拡張時等に径方向ｒの外方に屈曲可能な屈曲部１７を備えるように構成している。 As shown in FIG. 8, the hollow member 10 b is configured to include a bent portion 17 that can be bent outward in the radial direction r when the balloon 20 b and the surrounding member 30 b are expanded at an intermediate portion in the longitudinal direction d. .
　屈曲部１７は、図７、図８に示すように管状部材１１ｂの内腔１２ｂへの流体の供給に伴い、バルーン２０ｂを略直線形状から次第に径方向ｒの外方に屈曲し、バルーン２０ｂを径方向ｒの外方に変位させる。屈曲部１７は、管状部材１３ｂの内腔１４ｂへの流体の供給に伴い、次第に径方向ｒの外方に屈曲し、包囲部材３０ｂを径方向ｒの外方に変位させる。なお、中空部材１０ｂは第１実施形態の中空部材１０のように円筒形状の側面に開口部を設けていない点を除き、その他の構成は第１実施形態と同様であるため、説明を省略する。 As shown in FIGS. 7 and 8, the bent portion 17 bends the balloon 20b from the substantially linear shape to the outer side in the radial direction r in accordance with the supply of fluid to the inner cavity 12b of the tubular member 11b. Displace outward in the radial direction r. As the fluid is supplied to the inner cavity 14b of the tubular member 13b, the bent portion 17 is gradually bent outward in the radial direction r and displaces the surrounding member 30b outward in the radial direction r. The hollow member 10b is the same as the first embodiment except that no opening is provided on the cylindrical side surface like the hollow member 10 of the first embodiment. .
　（バルーン）
　バルーン２０ｂは、本実施形態において中空部材１０ｂの先端部に設けている。バルーン２０ｂは、本実施形態において略リング形状の包囲部材３０ｂの内周部分に接着又は融着等で接合するように構成している。ただし、包囲部材３０ｂの拡張時に包囲部材３０ｂによってバルーン２０ｂを包囲できれば、バルーン２０ｂは包囲部材３０ｂに接合していなくてもよい。バルーン２０ｂは、上記以外の構成については第１実施形態のバルーン２０と同様であるため、説明を省略する。 (balloon)
The balloon 20b is provided at the tip of the hollow member 10b in this embodiment. In the present embodiment, the balloon 20b is configured to be joined to the inner peripheral portion of the substantially ring-shaped surrounding member 30b by adhesion or fusion. However, the balloon 20b may not be joined to the surrounding member 30b as long as the surrounding member 30b can surround the balloon 20b when the surrounding member 30b is expanded. The configuration of the balloon 20b other than the above is the same as that of the balloon 20 of the first embodiment, and a description thereof will be omitted.
　（包囲部材）
　包囲部材３０ｂは、第１実施形態の包囲部材３０と同様であるため、説明を省略する。 (Enclosing member)
Since the surrounding member 30b is the same as the surrounding member 30 of 1st Embodiment, description is abbreviate | omitted.
　（ガイディングカテーテル）
　ガイディングカテーテル４０は、中空部材１０ｂを収容するように配置される。ガイディングカテーテル４０は、中空部材１０と同様に略円筒状かつ長尺状に構成している。ガイディングカテーテル４０は、生体管腔Ｂｌにおいて大動脈等の目的部位に到達するまでバルーン２０ｂ及び包囲部材３０ｂをガイディングカテーテル４０の内腔に収容した状態で目的部位まで移動させることができる。また、ガイディングカテーテル４０は、図８等に示すようにバルーン２０ｂ及び包囲部材３０ｂを生体管腔において露出可能な先端開口部４１を備える。なお、ガイディングカテーテル４０は本実施形態において医療器具１００ｂに含むように構成している。ただし、医療器具１００ｂと別部品として構成してもよい。また、ガイディングカテーテル４０の材料は、中空部材１０と同様に構成できる。また、ガイディングカテーテルの代わりにイントロデューサーシース、ガイディングシース
等を用いてもよい。 (Guiding catheter)
The guiding catheter 40 is disposed so as to accommodate the hollow member 10b. Similar to the hollow member 10, the guiding catheter 40 is configured in a substantially cylindrical shape and an elongated shape. The guiding catheter 40 can be moved to the target site in the state where the balloon 20b and the surrounding member 30b are accommodated in the lumen of the guiding catheter 40 until the target site such as the aorta is reached in the living body lumen B1. Moreover, the guiding catheter 40 is provided with the front-end | tip opening part 41 which can expose the balloon 20b and the surrounding member 30b in a biological lumen, as shown in FIG. The guiding catheter 40 is configured to be included in the medical device 100b in the present embodiment. However, the medical device 100b may be configured as a separate part. Further, the material of the guiding catheter 40 can be configured in the same manner as the hollow member 10. Moreover, you may use an introducer sheath, a guiding sheath, etc. instead of a guiding catheter.
　（使用例）
　次に本実施形態に係る医療器具１００ｂの使用例について説明する。まず、第１実施形態と同様に穿刺針等で大腿動脈等で穿刺箇所を形成し、そこからガイドワイヤを導入する。次に、イントロデューサーを穿刺箇所に挿入し、イントロデューサーの内腔からガイディングカテーテル４０を生体内に導入する。 (Example of use)
Next, a usage example of the medical instrument 100b according to the present embodiment will be described. First, as in the first embodiment, a puncture site is formed in the femoral artery or the like with a puncture needle or the like, and a guide wire is introduced therefrom. Next, the introducer is inserted into the puncture site, and the guiding catheter 40 is introduced into the living body from the lumen of the introducer.
　次に、ガイディングカテーテル４０の内腔に医療器具１００ｂを挿入し、ガイディングカテーテル４０を通じて生体管腔Ｂｌに導入する。そして、Ｘ線画像等で確認しながら、大動脈等の目的部位まで移動させる。 Next, the medical instrument 100b is inserted into the lumen of the guiding catheter 40 and introduced into the living body lumen Bl through the guiding catheter 40. And it moves to the target site | parts, such as an aorta, confirming with an X-ray image etc.
　医療器具１００ｂが目的部位に到達したら、ガイディングカテーテル４０の先端開口部４１からバルーン２０ｂ及び包囲部材３０ｂを露出させる。そして、中空部材１０ｂを構成する管状部材１３ｂの内腔１４ｂに拡張用流体を供給して図８、図９に示すように包囲部材３０ｂを生体管腔Ｂｌの内壁面に接触できる程度に拡張させる。包囲部材３０ｂが拡張する際に中空部材１０ｂの屈曲部１７は拡張用流体の供給によって包囲部材３０ｂを図８に示すように径方向ｒの外方に変位させる。 When the medical instrument 100b reaches the target site, the balloon 20b and the surrounding member 30b are exposed from the distal end opening 41 of the guiding catheter 40. Then, an expansion fluid is supplied to the lumen 14b of the tubular member 13b constituting the hollow member 10b, and the surrounding member 30b is expanded to such an extent that it can contact the inner wall surface of the biological lumen B1 as shown in FIGS. . When the surrounding member 30b expands, the bent portion 17 of the hollow member 10b displaces the surrounding member 30b outward in the radial direction r as shown in FIG. 8 by supplying the expansion fluid.
　次に、中空部材１０ｂを構成する管状部材１１ｂの内腔１２ｂに拡張用流体を供給して、図１０に示すようにバルーン２０ｂを拡張させる。バルーン２０ｂが拡張する際に屈曲部１７は拡張用流体の供給に伴い、バルーン２０ｂを径方向ｒの外方に変位させる。 Next, an expansion fluid is supplied to the lumen 12b of the tubular member 11b constituting the hollow member 10b, and the balloon 20b is expanded as shown in FIG. When the balloon 20b is expanded, the bent portion 17 displaces the balloon 20b outward in the radial direction r with the supply of the expansion fluid.
　第１実施形態と同様に包囲部材３０ｂのバルーンを拡張させることによってバルーン２０ｂを径方向ｒの外方から包囲し、バルーン２０ｂが生体管腔Ｂｌの内壁面に接触することを抑制できる。 As in the first embodiment, by expanding the balloon of the surrounding member 30b, the balloon 20b can be surrounded from the outside in the radial direction r, and the balloon 20b can be prevented from coming into contact with the inner wall surface of the biological lumen Bl.
　また、バルーン２０ｂを包囲部材３０ｂよりも径方向ｒの内方において適宜拡張させることによって、医療器具１００ｂを配置した生体管腔Ｂｌを術者の意図するように部分的に閉塞状態にできる。このように医療器具１００ｂによって、脳血管等の抹消器官以外の部位への血流量を増加させることができる。 Further, by appropriately expanding the balloon 20b inward in the radial direction r from the surrounding member 30b, the living body lumen Bl in which the medical instrument 100b is disposed can be partially closed as intended by the operator. In this way, the blood flow rate to the site other than the peripheral organ such as the cerebral blood vessel can be increased by the medical instrument 100b.
　以上説明したように、中空部材１０ｂは、バルーン２０ｂの拡張時にバルーン２０ｂを中空部材１０ｂに対して径方向ｒの外方に配置する屈曲部１７を備えるように構成している。そのため、包囲部材３０ｂを径方向ｒにおける外方に配置してバルーン２０ｂを包囲部材３０ｂよりも内方に位置させやすくできる。よって、医療器具１００ｂを生体管腔Ｂｌに配置した際にバルーン２０ｂが生体管腔Ｂｌの内壁面に接触することを抑制できる。また、屈曲部１７によって、医療器具１００ｂを生体管腔Ｂｌの形状に合わせて単に変形させるだけでなく、医療器具１００ｂを構成する中空部材１０ｂ又はガイディングカテーテル４０が径方向ｒにおいて生体管腔Ｂｌの内壁面に接触することを抑制できる。 As described above, the hollow member 10b is configured to include the bent portion 17 that disposes the balloon 20b outward in the radial direction r with respect to the hollow member 10b when the balloon 20b is expanded. Therefore, the surrounding member 30b can be disposed outward in the radial direction r, and the balloon 20b can be easily positioned inward than the surrounding member 30b. Therefore, it is possible to prevent the balloon 20b from contacting the inner wall surface of the biological lumen Bl when the medical instrument 100b is disposed in the biological lumen Bl. In addition, the bending portion 17 not only deforms the medical device 100b in accordance with the shape of the biological lumen Bl, but also the hollow member 10b or the guiding catheter 40 constituting the medical device 100b moves in the radial direction r. It can suppress contacting the inner wall surface.
　（第３実施形態）
　図１１、図１２は本発明の第３実施形態に係る医療器具１００ｃを示す軸直角断面図、図１３は図１１の変形例を示す断面図である。第１実施形態、第２実施形態では包囲部材３０が略リング形状のバルーンを形成する一の部材によって構成する実施形態について説明したが、以下のように構成することもできる。なお、中空部材１０及びバルーン２０の構成は第１実施形態と同様であるため、説明を省略する。 (Third embodiment)
11 and 12 are cross-sectional views perpendicular to an axis showing a medical device 100c according to a third embodiment of the present invention, and FIG. 13 is a cross-sectional view showing a modification of FIG. In the first embodiment and the second embodiment, the embodiment in which the surrounding member 30 is configured by one member that forms a substantially ring-shaped balloon has been described. However, it can also be configured as follows. In addition, since the structure of the hollow member 10 and the balloon 20 is the same as that of 1st Embodiment, description is abbreviate | omitted.
　包囲部材３０ｃは、本実施形態において図１１に示すようにバルーン２０の外周に並べて配置された複数のバルーン、具体的には３つのバルーンを備えるように構成している。包囲部材３０ｃは、上記のように複数のバルーンを備えることによって、バルーンを一の部材で構成する場合と比べて、バルーンとバルーンとの間に空間を形成しやすくできる。そのため、医療器具１００ｃを配置した生体管腔Ｂｌを部分的に閉塞状態としつつ、図１２に示すバルーン２０の拡張と合わせて生体管腔Ｂｌの血流を確保しやすくできる。中空部材は、３つのバルーンに一つずつ管状部材を接合している点を除き、第１実施形態と同様であるため、説明を省略する。 The surrounding member 30c is configured to include a plurality of balloons, specifically, three balloons arranged side by side on the outer periphery of the balloon 20 as shown in FIG. 11 in this embodiment. By providing the surrounding member 30c with a plurality of balloons as described above, it is possible to easily form a space between the balloons as compared with the case where the balloons are formed of a single member. Therefore, it is possible to easily secure the blood flow in the biological lumen Bl together with the expansion of the balloon 20 shown in FIG. 12 while partially closing the biological lumen Bl in which the medical instrument 100c is disposed. Since the hollow member is the same as that of the first embodiment except that the tubular members are joined to the three balloons one by one, the description thereof is omitted.
　なお、包囲部材３０ｃを構成するバルーンの数は図１１において３つに構成しているが、医療器具を配置した生体管腔Ｂｌを部分的に閉塞でき、かつ、血流をある程度確保できれば、バルーンの数は上記に限定されない。図１３の医療器具１００ｄの包囲部材３０ｄに示すようにバルーンを６つ備えるように構成してもよいし、それ以上の個数で構成してもよい。また、医療器具１００ｃを用いた手技は３つのバルーンに各々拡張用流体を供給する点を除き、第１実施形態と同様であるため、説明を省略する。 The number of balloons constituting the surrounding member 30c is three in FIG. 11. However, if the living body lumen Bl in which the medical instrument is disposed can be partially blocked and blood flow can be secured to some extent, The number of is not limited to the above. As shown in the surrounding member 30d of the medical device 100d in FIG. 13, six balloons may be provided, or a larger number of balloons may be provided. Further, the procedure using the medical device 100c is the same as that of the first embodiment except that the expansion fluid is supplied to the three balloons, and thus the description thereof is omitted.
　以上説明したように、第３実施形態に係る医療器具１００ｃは、包囲部材３０ｃが拡張時にバルーン２０の径方向ｒの外方において周方向θに並べて配置されるバルーンを複数備えるように構成している。そのため、医療器具１００ｃを配置した生体管腔Ｂｌを部分的に閉塞しつつ、血流を確保しやすくできる。 As described above, the medical device 100c according to the third embodiment is configured so that the surrounding member 30c includes a plurality of balloons arranged in the circumferential direction θ outside the radial direction r of the balloon 20 when expanded. Yes. Therefore, it is possible to easily secure the blood flow while partially closing the biological lumen Bl where the medical instrument 100c is disposed.
　（第４実施形態）
　図１４、図１５は本発明の第４実施形態に係る医療器具１００ｅの説明に供する図である。 (Fourth embodiment)
14 and 15 are views for explaining a medical device 100e according to the fourth embodiment of the present invention.
　第１実施形態ではバルーン２０を球状のバルーンによって構成するとともに包囲部材３０を拡張時にバルーン２０よりも径方向ｒの外方において包囲する略リング状のバルーンによって構成する実施形態について説明した。しかし、包囲部材によってバルーンを径方向ｒの外方から包囲し、バルーンによって生体管腔Ｂｌの閉塞率を調整できれば、包囲部材と拡張部材の具体的態様は上記に限定されない。 In the first embodiment, the embodiment has been described in which the balloon 20 is configured by a spherical balloon and the surrounding member 30 is configured by a substantially ring-shaped balloon that surrounds the outer side of the balloon 20 in the radial direction r when expanded. However, the specific modes of the surrounding member and the expansion member are not limited to the above as long as the surrounding member can surround the balloon from outside in the radial direction r and the occlusion rate of the biological lumen Bl can be adjusted by the balloon.
　医療器具１００ｅは、図１４等に示すように中空部材１０ｅと、バルーン２０ｅと、包囲部材３０ｅと、ガイディングカテーテル４０ｅと、を有する。 The medical device 100e includes a hollow member 10e, a balloon 20e, an enclosing member 30e, and a guiding catheter 40e as shown in FIG.
　（中空部材）
　中空部材１０ｅは、ガイディングカテーテル４０ｅの内腔に収容可能に構成される。 (Hollow member)
The hollow member 10e is configured to be accommodated in the lumen of the guiding catheter 40e.
　（バルーン）
　バルーン２０ｅは、第２実施形態と同様に中空部材１０ｅの先端においてバルーン２０ｅを拡張させる流体を供給できるように中空部材１０ｅと接合される。バルーン２０ｅは、図１５に示すように包囲部材３０ｅに沿って拡張できるように拡張時のバルーンの形状を長尺状に形成している。中空部材１０ｅ及びバルーン２０ｅのその他の構成は第１実施形態と同様であるため、説明を省略する。 (balloon)
The balloon 20e is joined to the hollow member 10e so that a fluid for expanding the balloon 20e can be supplied at the tip of the hollow member 10e as in the second embodiment. As shown in FIG. 15, the balloon 20e has an elongated balloon shape that can be expanded along the surrounding member 30e. Since the other structure of the hollow member 10e and the balloon 20e is the same as that of 1st Embodiment, description is abbreviate | omitted.
　（包囲部材）
　包囲部材３０ｅは、ガイディングカテーテル４０ｅの内腔に収容可能に構成される。包囲部材３０ｅは、先端部３３ｅがガイディングカテーテル４０ｅの開口部４１ｅから突出可能に構成される。包囲部材３０ｅの先端部３３ｅは、ガイディングカテーテル４０ｅの内腔に収容しない状態、すなわち外力が付与されていない自然状態において図１４に示すように円弧状に形状づけしている。 (Enclosing member)
The surrounding member 30e is configured to be housed in the lumen of the guiding catheter 40e. The surrounding member 30e is configured such that the distal end portion 33e can protrude from the opening 41e of the guiding catheter 40e. The distal end portion 33e of the surrounding member 30e is formed in an arc shape as shown in FIG. 14 in a state where it is not accommodated in the lumen of the guiding catheter 40e, that is, in a natural state where no external force is applied.
　包囲部材３０ｅの材料は、先端部３３ｅがガイディングカテーテル４０ｅの開口部４１ｅから露出した状態で円弧状に変形可能なワイヤ状の部材である限り、特に限定されない。例示すれば、チタン系（Ｔｉ－Ｎｏ、Ｔｉ－Ｐｄ、Ｔｉ－Ｎｂ－Ｓｎ等）や銅系の形状記憶合金、アクリル系樹脂、トランスイソプレンポリマー、ポリノルボルネン、スチレン－ブタジエン共重合体、ポリウレタン等の形状記憶樹脂、ステンレス鋼（ＳＵＳ３０４）、βチタン鋼、Ｃｏ－Ｃｒ合金等のバネ性を備える合金を用いることができる。 The material of the surrounding member 30e is not particularly limited as long as the surrounding member 30e is a wire-shaped member that can be deformed in an arc shape with the distal end portion 33e exposed from the opening 41e of the guiding catheter 40e. For example, titanium-based (Ti-No, Ti-Pd, Ti-Nb-Sn, etc.), copper-based shape memory alloys, acrylic resins, transisoprene polymers, polynorbornene, styrene-butadiene copolymers, polyurethane, etc. The shape memory resin, stainless steel (SUS304), β-titanium steel, Co—Cr alloy and other alloys having spring properties can be used.
　（ガイディングカテーテル）
　ガイディングカテーテル４０ｅは、開口部４１ｅを円筒形状の側面に設けている点を除き、第２実施形態のガイディングカテーテル４０と同様であるため、説明を省略する。 (Guiding catheter)
Since the guiding catheter 40e is the same as the guiding catheter 40 of the second embodiment except that the opening 41e is provided on the cylindrical side surface, the description thereof is omitted.
　（使用例）
　次に本実施形態に係る医療器具１００ｅの使用例について説明する。まず、第１実施形態と同様に穿刺針等で大腿動脈等で穿刺箇所を形成し、そこからガイドワイヤを導入する。次に、イントロデューサーを穿刺箇所に挿入し、イントロデューサーの内腔からガイディングカテーテル４０ｅを生体内に導入する。 (Example of use)
Next, a usage example of the medical instrument 100e according to the present embodiment will be described. First, as in the first embodiment, a puncture site is formed in the femoral artery or the like with a puncture needle or the like, and a guide wire is introduced therefrom. Next, the introducer is inserted into the puncture site, and the guiding catheter 40e is introduced into the living body from the lumen of the introducer.
　次に、ガイディングカテーテル４０ｅの内腔に医療器具１００ｅを挿入し、ガイディングカテーテル４０ｅを通じて生体管腔Ｂｌに導入する。そして、Ｘ線画像等で確認しながら、大動脈等の目的部位まで移動させる。 Next, the medical instrument 100e is inserted into the lumen of the guiding catheter 40e and introduced into the living body lumen Bl through the guiding catheter 40e. And it moves to the target site | parts, such as an aorta, confirming with an X-ray image etc.
　医療器具１００ｅが目的部位に到達したら、ガイディングカテーテル４０ｅの開口部４１ｅからバルーン２０ｅ及び包囲部材３０ｅを露出させる。包囲部材３０ｅは、上記のように略円弧形状に形状づけされており、開口部４１ｅから外部に露出した際に生体管腔Ｂｌの内壁面に沿うように略円弧形状に変形する。バルーン２０ｅは包囲部材３０ｅの形状に沿って配置される。 When the medical instrument 100e reaches the target site, the balloon 20e and the surrounding member 30e are exposed from the opening 41e of the guiding catheter 40e. The surrounding member 30e is formed in a substantially arc shape as described above, and when exposed to the outside from the opening 41e, the surrounding member 30e is deformed into a substantially arc shape along the inner wall surface of the living body lumen Bl. The balloon 20e is disposed along the shape of the surrounding member 30e.
　次に、不図示のインデフレータ等を使用して、バルーン２０ｅを拡張させる。バルーン２０ｅは、第１実施形態と同様に拡張時に包囲部材３０ｅよりも径方向ｒの内方に配置される。そのため、バルーン２０ｅ自体が生体管腔Ｂｌの内壁面と不用意に接触することを抑制できる。 Next, the balloon 20e is expanded using an inflator (not shown) or the like. The balloon 20e is arranged inward in the radial direction r relative to the surrounding member 30e when expanded, as in the first embodiment. Therefore, careless contact between the balloon 20e itself and the inner wall surface of the living body lumen Bl can be suppressed.
　また、第１実施形態等と同様に、バルーン２０ｅの拡張の程度に応じて生体管腔Ｂｌの閉塞率を術者の意図通りに調整できる。 Also, similarly to the first embodiment, the occlusion rate of the biological lumen Bl can be adjusted as intended by the operator according to the degree of expansion of the balloon 20e.
　以上のように、第４実施形態に係る医療器具１００ｅでは、包囲部材３０ｅが、外力が付与されていない自然状態で先端部３３ｅが形状づけされた円弧形状のワイヤを備えるように構成している。このように構成することによっても包囲部材３０ｅによってバルーン２０ｅを径方向ｒの外方から包囲し、バルーン２０ｅが生体管腔Ｂｌの内壁面に不用意に接触することを抑制できる。 As described above, in the medical device 100e according to the fourth embodiment, the surrounding member 30e is configured to include an arc-shaped wire in which the distal end portion 33e is shaped in a natural state where no external force is applied. . Also with this configuration, the surrounding member 30e surrounds the balloon 20e from the outside in the radial direction r, and the balloon 20e can be prevented from inadvertently contacting the inner wall surface of the living body lumen Bl.
　なお、本発明は上述した実施形態にのみ限定されず、特許請求の範囲において種々の変更が可能である。上記では中空部材１０が管状部材１１、１３を備える実施形態について説明したが、バルーン２０を拡張でき、包囲部材３０を変位できれば、中空部材１０の構成は上記に限定されない。中空部材１０は、上記以外にも例えば一の中空の管状部材の内腔を仕切り等によって分割してバルーン２０と包囲部材３０に流体を供給する内腔を用意するように構成してもよい。 In addition, this invention is not limited only to embodiment mentioned above, A various change is possible in a claim. The embodiment in which the hollow member 10 includes the tubular members 11 and 13 has been described above. However, the configuration of the hollow member 10 is not limited to the above as long as the balloon 20 can be expanded and the surrounding member 30 can be displaced. In addition to the above, the hollow member 10 may be configured such that a lumen for supplying fluid to the balloon 20 and the surrounding member 30 is prepared by dividing the lumen of one hollow tubular member by a partition or the like.
　また、第１実施形態の変形例ではバルーン２０ａが包囲部材３０ａと同様に拡張時に略リング形状に変形する実施形態について説明した。バルーン２０ａは拡張用流体の供給によって図６等に示すように拡張できれば、具体的な構成は特に限定されない。例えば、バルーン２０ａの内腔に仕切り壁を設け、一定以上の圧力が付与されたら、一以上の仕切り壁が破れ、バルーン２０ａを拡張するように構成してもよい。 In the modification of the first embodiment, the embodiment has been described in which the balloon 20a is deformed into a substantially ring shape when expanded, like the surrounding member 30a. The specific configuration of the balloon 20a is not particularly limited as long as the balloon 20a can be expanded as shown in FIG. For example, a partition wall may be provided in the lumen of the balloon 20a, and when a certain pressure or more is applied, one or more partition walls may be broken to expand the balloon 20a.
　本出願は、２０１８年３月２９日に出願された日本国特許出願２０１８－０６５０６０号に基づいており、その開示内容は参照により全体として引用される。 This application is based on Japanese Patent Application No. 2018-0665060 filed on Mar. 29, 2018, the disclosure of which is incorporated by reference in its entirety.
１００、１００ａ、１００ｂ、１００ｃ　医療器具、
１０、１０ａ、１０ｂ、１０ｃ、１０ｅ　中空部材、
１２　内腔、
１４　（他の）内腔、
１５　（第１）開口部、
１６　（第２）開口部、
１６　屈曲部、
２０、２０ａ、２０ｂ、２０ｃ、２０ｅ　バルーン（拡張部材）、
２１　拡張空間、
３０、３０ｂ　包囲部材（バルーン）、
３１　拡張空間、
３３ｅ　先端部、
ｒ　径方向、
θ　周方向。
  100, 100a, 100b, 100c medical device,
10, 10a, 10b, 10c, 10e hollow member,
12 lumens,
14 (other) lumens,
15 (first) opening,
16 (second) opening,
16 bends,
20, 20a, 20b, 20c, 20e balloon (expansion member),
21 expansion space,
30, 30b Enclosing member (balloon),
31 expansion space,
33e tip,
r radial direction,
θ Circumferential direction.

Claims (10)

  1. 　長尺状に構成され内腔を備えた中空部材と、
    　前記中空部材の前記内腔から供給される流体によって拡張可能な拡張部材と、
    　前記中空部材の長手方向と交差する径方向外方に変位可能に構成され、前記径方向外方に変位した状態において前記拡張部材を包囲する包囲部材と、を有する、医療器具。     A hollow member configured in a long shape and having a lumen;
    An expansion member expandable by a fluid supplied from the lumen of the hollow member;
    And a surrounding member that is configured to be displaceable radially outward intersecting with the longitudinal direction of the hollow member and surrounds the expansion member in a state of being displaced radially outward.
  2. 　前記拡張部材の拡張にともなって、前記包囲部材によって包囲された空間の閉塞率が変化する、請求項１に記載の医療器具。 The medical device according to claim 1, wherein the expansion rate of the space surrounded by the surrounding member changes with expansion of the expansion member.
  3. 　前記包囲部材は、流体の供給によって拡張可能なバルーンで構成され、
    　前記中空部材は、前記バルーンに流体を供給可能な他の内腔を備える、請求項１又は２に記載の医療器具。     The surrounding member is composed of a balloon that can be expanded by supplying a fluid;
    The medical device according to claim 1, wherein the hollow member includes another lumen capable of supplying fluid to the balloon.
  4. 　前記バルーンは、リング形状である、請求項３に記載の医療器具。 The medical device according to claim 3, wherein the balloon has a ring shape.
  5. 　前記拡張部材は、球形状を備える、請求項１～４のいずれか一項に記載の医療器具。 The medical device according to any one of claims 1 to 4, wherein the expansion member has a spherical shape.
  6. 　前記拡張部材は、拡張した状態においてリング形状である、請求項１～４のいずれか一項に記載の医療器具。 The medical device according to any one of claims 1 to 4, wherein the expansion member has a ring shape in an expanded state.
  7. 　前記包囲部材は、外力が付与されていない自然状態で先端部が円弧形状に形状づけられたワイヤ部材である、請求項１に記載の医療器具。 The medical device according to claim 1, wherein the surrounding member is a wire member having a distal end shaped into an arc shape in a natural state where no external force is applied.
  8. 　前記中空部材は、前記中空部材の前記内腔と前記拡張部材の拡張空間とを連通する第１開口部と、前記中空部材の前記他の内腔と前記バルーンの拡張空間とを連通する第２開口部と、を備え、
    　前記第１開口部は、前記拡張部材の拡張時に前記中空部材の周方向において前記第２開口部と反対側に配置される、請求項３に記載の医療器具。     The hollow member communicates the first opening that communicates the lumen of the hollow member and the expansion space of the expansion member, and the second opening that communicates the other lumen of the hollow member and the expansion space of the balloon. An opening, and
    The medical device according to claim 3, wherein the first opening is disposed on the opposite side of the second opening in the circumferential direction of the hollow member when the expansion member is expanded.
  9. 　前記包囲部材は、拡張時に前記拡張部材の外周に並べて配置される複数の前記バルーンを備える、請求項３に記載の医療器具。 The medical device according to claim 3, wherein the surrounding member includes a plurality of the balloons arranged side by side on an outer periphery of the expansion member during expansion.
  10. 　前記中空部材は、前記バルーンの拡張時に前記バルーンを前記中空部材に対して前記径方向における外方に配置する屈曲部を備える、請求項３に記載の医療器具。
          The said hollow member is a medical device of Claim 3 provided with the bending part which arrange | positions the said balloon to the outward in the said radial direction with respect to the said hollow member at the time of expansion of the said balloon.
PCT/JP2019/011850 2018-03-29 2019-03-20 Medical device WO2019188707A1 (en)

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6471672B1 (en) * 1999-11-10 2002-10-29 Scimed Life Systems Selective high pressure dilation balloon
JP2002537909A (en) * 1999-03-01 2002-11-12 コーアクシア・インコーポレイテッド Aortic partial occlusion device and method for increasing cerebral perfusion
US20080255506A1 (en) * 2007-04-10 2008-10-16 Wilson David B Clampless anastomotic device

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2002537909A (en) * 1999-03-01 2002-11-12 コーアクシア・インコーポレイテッド Aortic partial occlusion device and method for increasing cerebral perfusion
US6471672B1 (en) * 1999-11-10 2002-10-29 Scimed Life Systems Selective high pressure dilation balloon
US20080255506A1 (en) * 2007-04-10 2008-10-16 Wilson David B Clampless anastomotic device

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JPWO2019188707A1 (en) 2021-03-18

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