WO2018062386A1 - Medical system, dilator, and treatment method - Google Patents

Medical system, dilator, and treatment method Download PDF

Info

Publication number
WO2018062386A1
WO2018062386A1 PCT/JP2017/035213 JP2017035213W WO2018062386A1 WO 2018062386 A1 WO2018062386 A1 WO 2018062386A1 JP 2017035213 W JP2017035213 W JP 2017035213W WO 2018062386 A1 WO2018062386 A1 WO 2018062386A1
Authority
WO
WIPO (PCT)
Prior art keywords
dilator
lumen
hole
guide wire
holding
Prior art date
Application number
PCT/JP2017/035213
Other languages
French (fr)
Japanese (ja)
Inventor
大坪靖一
早川浩一
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
Publication of WO2018062386A1 publication Critical patent/WO2018062386A1/en

Links

Images

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • 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

Definitions

  • the present invention relates to a medical system, a dilator, and a treatment method for inserting a plurality of linear bodies into a hole in a living tissue.
  • the heart circulates blood by repeating contraction and expansion at an appropriate timing when current flows through myocardial tissue called a stimulation conduction system.
  • a stimulation conduction system When the generation and transmission of electrical signals flowing through the stimulation conduction system become abnormal, contraction and expansion cannot be performed at appropriate timing, and arrhythmia occurs.
  • a method for the treatment of arrhythmia, a method is known in which the conduction path of a signal that causes arrhythmia is blocked by ablation by heating or cooling.
  • an ablation catheter that is inserted percutaneously into the left atrium and is capable of ablating the signal conduction path located at the pulmonary vein opening is known.
  • Such ablation catheters are actively used because they are minimally invasive and provide high effects.
  • a needle In order to perform ablation in the left atrium, a needle is inserted into a thin septum called the ovary fossa of the atrial septum from the right atrium to open a hole that leads from the right atrium to the left atrium. A procedure is required. In order to perform ablation, it is necessary to insert a plurality of devices into the hole from the right atrium and pass it through the left atrium. In order to insert a device into a small hole in a living body, a method is known in which a device is inserted along the guide wire after the guide wire is inserted into the living body (see, for example, Patent Document 1).
  • the plurality of devices that pass through the left atrium are, for example, a ring catheter that detects pulmonary vein potential, an ablation catheter that performs ablation, and the like.
  • a plurality of holes can also be formed by the atrial septal puncture. In this case, one device can be passed through each puncture hole.
  • puncturing is performed a plurality of times, the possibility of erroneous puncturing at a site different from the target position increases.
  • Patent Document 1 uses one guide wire to guide one device to a target position. For this reason, when a plurality of devices are inserted into the living body, it is necessary to introduce a plurality of guide wires corresponding to the number of the devices to a target position, which takes time and effort.
  • the present invention has been made to solve the above-described problems, and a medical system and a dilator that can easily insert a plurality of linear bodies into a hole in a living tissue of a living body lumen and can improve work efficiency.
  • An object of the present invention is to provide a treatment method.
  • a medical system that achieves the above-described object is a medical system for inserting a plurality of linear bodies into a hole of a living tissue in a living body lumen, wherein a lumen penetrating in the axial direction is formed and has a diameter larger than that of the lumen.
  • a dilator that achieves the above object is a dilator for widening a hole of a living tissue in a living body lumen, and the dilator is formed with a lumen penetrating in an axial direction, and is farther radially outward than the lumen.
  • a holding portion is provided in the position portion, and the holding portion holds the long linear body in a detachable manner.
  • a treatment method for achieving the above object is a treatment method for inserting a plurality of linear bodies into a hole of a living tissue in a living body lumen using the above medical system, wherein the second portion is inserted into the holding portion. Inserting the elongate body holding the linear body into a living body lumen, inserting the first linear body through the lumen of the elongate body and inserting into the hole of the biological tissue; Inserting a distal portion including the holding portion of the elongated body into the hole of the living tissue, and detaching the second linear body from the holding portion.
  • the long body can be inserted into the living body lumen, and the first linear body can be inserted into the hole of the living tissue through the lumen of the long body.
  • the second linear body held by the holding part can be inserted into the hole of the biological tissue by inserting the long body into the hole of the biological tissue in the living body lumen. For this reason, a some linear body can be easily inserted in the hole of a biological tissue, and work efficiency can be improved.
  • FIG. 1 It is sectional drawing which shows the state at the time of puncturing with the medical device which concerns on embodiment, (A) is the state which inserted the sheath assembly into the right atrium along the guide wire, (B) is the state which positioned the dilator, (C) shows a state where the fossa is punctured by the puncture device, and (D) shows a state where the sheath assembly is inserted into the right atrium.
  • distal side the side of the device that is inserted into the blood vessel
  • proximal side the proximal side that is operated
  • the medical system 10 is used to form a hole from the right atrium R to the oval fossa O of the atrial septum and to provide a plurality of access routes from the right atrium R to the left atrium L ( (See FIG. 5).
  • a plurality of access routes in the oval fossa O a plurality of devices percutaneously inserted into the vena cava can be easily inserted into the left atrium after being guided to the right atrium R.
  • the plurality of devices are, for example, an ablation catheter, a ring catheter, and the like.
  • the puncture device 60 is a device for making a hole in the oval fossa O.
  • the puncture device 60 includes a long wire portion 62 and a sharp puncture portion 61 provided at a distal end portion of the wire portion 62.
  • the puncture device 60 may not have the sharp puncture unit 61. Therefore, the puncture device 60 may have a puncture unit 61 that cauterizes and punctures a living tissue using high-frequency current, electromagnetic waves, laser, cooling, or the like.
  • the outer diameter of the wire portion 62 is not particularly limited, but is, for example, 0.1 to 2.0 mm.
  • the length of the wire portion 62 in the axial direction is not particularly limited, but is, for example, 510 to 1000 mm.
  • the attached guide wire 20 is a long guide wire whose distal end is held by the dilator 40.
  • the attached guide wire 20 can be detached from the state held by the dilator 40.
  • the attached guide wire 20 held by the dilator 40 does not pass through the lumen of the outer sheath 50 and is positioned outside the outer sheath 50.
  • the outer diameter of the attached guide wire 20 is appropriately set, and is, for example, 0.1 to 3 mm.
  • the length of the attached guide wire 20 in the axial direction is appropriately set, and is, for example, 550 to 4500 mm.
  • the constituent material of the attached guide wire 20 is appropriately set. For example, it is formed by coating a flexible resin material on the outside of a core material having flexibility and strength such as stainless steel and Ni—Ti alloy.
  • resin materials include polyolefins such as polyethylene and polypropylene, polyvinyl chloride, polyesters (PET, PBT, etc.), polyamides, polyimides, polyurethanes, polystyrenes, polycarbonates, silicone resins, fluororesins (PTFE, ETFE, etc.), and silicone rubber.
  • polyolefins such as polyethylene and polypropylene
  • PET polyesters
  • PBT polyBT, etc.
  • polyamides polyimides
  • polyurethanes polystyrenes
  • polycarbonates such as silicone resins, fluororesins (PTFE, ETFE, etc.)
  • silicone rubber such as silicone rubber
  • elastomers for example, thermoplastic elastomers such as polyamide and polyester or a composite material thereof.
  • the dilator 40 is used to widen the hole of the oval fossa O formed by the puncture device 60.
  • the dilator 40 includes a dilator center portion 41 having a substantially constant outer diameter, a taper portion 42 (tip portion) located on the distal side of the dilator center portion 41, and a dilator proximal portion located on the proximal side of the dilator center portion 41.
  • the dilator central portion 41 is a tubular body having a substantially constant outer diameter.
  • the taper portion 42 has an outer diameter that decreases in a tapered shape toward the distal side.
  • the dilator 40 is formed with a lumen 45 for movably accommodating the puncture device 60 and a holding portion 46 for detachably holding the attached guide wire 20.
  • the lumen 45 is located at the center of the dilator 40 in a cross section perpendicular to the central axis of the dilator 40.
  • the lumen 45 penetrates the dilator 40 in the axial direction.
  • the lumen 45 opens at the distal end of the tapered portion 42 with the most reduced diameter.
  • the lumen 45 changes in inner diameter between the distal lumen 45A on the distal side, the proximal lumen 45B having a larger inner diameter than the distal lumen 45A, and the distal lumen 45A and the proximal lumen 45B.
  • a central lumen 45C is provided.
  • the inner diameter of the proximal lumen 45 ⁇ / b> B is sufficiently larger than the outer diameter of the puncture device 60. For this reason, the puncture device 60 inserted into the proximal lumen 45B can move smoothly along the inner peripheral surface of the dilator 40.
  • the central lumen 45C smoothly guides the puncture device 60 through the distal lumen 45A to the proximal lumen 45B.
  • the dilator 40 has a dilator bending portion 48 bent at a predetermined angle at a distal portion in a natural state where no external force acts.
  • the dilator bending portion 48 plays a role of directing the puncture portion 61 of the puncture device 60 inserted into the right atrium R toward the foveal fossa O.
  • the holding part 46 is a part that holds the attached guide wire 20.
  • the holding part 46 has a holding hole 46 ⁇ / b> A (hole part) provided on the side surface of the tapered part 42 of the dilator 40.
  • the lumen of the holding hole 46 ⁇ / b> A is located away from the lumen 45 radially outward in a cross section perpendicular to the central axis of the dilator 40.
  • the holding hole 46A extends toward the distal side from the insertion port 46B that opens to the proximal side. Since the insertion port 46B is positioned on the proximal side of the holding hole 46A, the attached guide wire 20 can easily enter the holding hole 46A along the dilator 40.
  • the direction in which the holding hole 46 ⁇ / b> A extends approaches the central axis of the dilator 40 toward the distal side.
  • the holding part 46 can be smoothly formed along the tapered part 42 inclined with respect to the central axis of the dilator 40. Therefore, the holding part 46 has an angle with respect to the lumen 45.
  • the direction in which the accessory guide wire 20 is detached is different from the direction of the oval fossa O. For this reason, it becomes difficult for the attached guide wire 20 to pass through the foveal fossa O and from the left atrium L to the right atrium R.
  • the direction in which the holding hole 46 ⁇ / b> A extends may not be inclined with respect to the central axis of the dilator 40.
  • the holding hole 46A is closed on the distal side. For this reason, the attached guide wire 20 to be accommodated does not protrude distally from the holding hole 46A, and an appropriate position can be maintained.
  • the holding hole 46 ⁇ / b> A does not communicate with the lumen 45. For this reason, it is possible to suppress the attached guide wire 20 held in the holding hole 46 ⁇ / b> A from coming into contact with the puncture device 60 that passes through the lumen 45.
  • the holding hole 46 ⁇ / b> A may communicate with the lumen 45.
  • the angle with respect to the central axis of a part of the taper part 42 having the holding part 46 and the part of the taper part 42 not having the holding part 46 may be the same or different.
  • the dilator 40 provided with the holding part 46 can be inserted into the hole of the oval fossa O without resistance.
  • the outer diameter of a part of the tapered part 42 having the holding part 46 may be the same as or different from the outer diameter of a part of the tapered part 42 not having the holding part 46.
  • the outer diameter of a part of the tapered part 42 having the holding part 46 may be larger than the outer diameter of a part of the tapered part 42 not having the holding part 46.
  • the inner diameter of the holding hole 46A is a size that allows the attached guide wire 20 to be detachably fitted.
  • the inner diameter of the holding hole 46A substantially matches the outer diameter of the attached guide wire 20.
  • the inner diameter of the holding hole 46A is, for example, 0.1 to 3.2 mm, more preferably 0.3 to 2.1 mm, and still more preferably 0.4 to 1.0 mm. Note that the inner diameter of the holding hole 46A may decrease toward the distal side. Accordingly, the attached guide wire 20 can be firmly fixed by pushing the attached guide wire 20 into the holding hole 46A.
  • the inner surface of the holding hole 46A may be smooth or non-smooth as long as the attached guide wire 20 can be held.
  • the inner surface of the holding portion 46A may be embossed, for example.
  • the holding portion 46 needs to have a size that can pass through the lumen of the outer sheath 50. Therefore, it is preferable that the distance from the central axis of the dilator 40 to the farthest part of the holding portion 46 outward in the radial direction is equal to or less than the radius of the inner surface of the outer sheath 50.
  • the position where the holding part 46 of the dilator 40 is provided may not be the taper part 42 as long as it can reach the left atrium L through the ovary fossa O. However, since the width of the left atrium L is limited, the holding portion 46 is preferably located as far as possible in the dilator 40.
  • the direction in which the holding portion 46 is provided with respect to the central axis of the dilator 40 is the same as the direction in which the distal portion is bent with respect to the proximal portion of the dilator 40.
  • the direction in which the holding portion 46 is provided with respect to the central axis of the dilator 40 may not be the same as the direction in which the distal portion bends with respect to the proximal portion of the dilator 40, and may be in the opposite direction.
  • the length of the dilator 40 in the axial direction is appropriately set, and is, for example, 500 to 800 mm.
  • the outer diameter of the dilator 40 is set as appropriate, and is, for example, 1.0 to 10.0 mm.
  • the clearance between the inner peripheral surface of the site where the distal lumen 45A of the dilator 40 is provided and the outer peripheral surface of the puncture device 60 is appropriately set, and is, for example, 0.01 to 1.00 mm.
  • the angle ⁇ 1 of the dilator bending portion 48 with respect to the proximal portion of the dilator 40 is not particularly limited, and is, for example, 10 to 90 degrees.
  • the length from the distal end portion of the dilator 40 to the dilator bending portion 48 is appropriately set, and is, for example, 10 to 150 mm.
  • the constituent material of the dilator 40 is preferably flexible.
  • polyolefins such as polyethylene and polypropylene, polyesters such as polyamide and polyethylene terephthalate, fluorine-based polymers such as ETFE, PEEK (polyether ether ketone), polyimide, Metals such as shape memory alloy, stainless steel, tantalum, titanium, platinum, gold, and tungsten can be suitably used.
  • the dilator 40 may include an X-ray contrast material or an ultrasound contrast material.
  • the outer sheath 50 provides an access route for a device such as an ablation catheter.
  • the outer sheath 50 includes a sheath body 51, a hub 54 connected to the proximal portion of the sheath body 51, a port portion 56 communicating with the hub 54, and a valve body 55 inside the hub 54.
  • the sheath body 51 is a long tube body that accommodates the dilator 40 so as to be movable in the axial direction.
  • the sheath body 51 has an inner peripheral surface that slides smoothly with the dilator 40.
  • the sheath body 51 has a sheath bent portion 52 bent at a predetermined angle at the distal portion in a natural state.
  • the angle ⁇ 2 of the sheath bending portion 52 with respect to the proximal portion of the sheath body 51 is not particularly limited, and is, for example, 0 to 90 degrees.
  • the sheath bending portion 52 plays a role of directing the puncture portion 61 of the puncture device 60 inserted into the right atrium R toward the foveal fossa O.
  • the sheath main body 51 has a sheath taper portion 53 whose diameter decreases in a tapered shape toward the distal side at the distal end portion.
  • the lumen of the sheath body 51 is open at the end of the sheath taper portion 53 that has the smallest diameter.
  • the inclination angle ⁇ 2 with respect to the central axis of the sheath taper portion 53 is appropriately set, and is, for example, 1 to 15 degrees.
  • the sheath taper portion 53 can be positioned on the proximal side of the taper portion 42 of the dilator 40 and can be continuous with the taper portion 42.
  • the inner peripheral surface of the sheath body 51 preferably has a clearance between the outer peripheral surface of the dilator 40 and the outer peripheral surface of the dilator 40 so that the outer peripheral surface of the dilator 40 is slidably contacted.
  • the dilator 40 can pass through the entire length of the sheath body 51. Therefore, the axial length of the sheath body 51 is shorter than that of the dilator 40.
  • the axial length of the sheath body 51 is set as appropriate, and is, for example, 400 to 790 mm.
  • the outer diameter of the sheath body 51 is set as appropriate, and is, for example, 1.1 to 11.0 mm.
  • the inner diameter of the sheath body 51 is set as appropriate, and is, for example, 1.05 to 10.95 mm.
  • the clearance between the inner peripheral surface of the sheath body 51 and the outer peripheral surface of the dilator 40 is set as appropriate, and is, for example, 0.01 to 1.00 mm.
  • the constituent material of the sheath body 51 is preferably a flexible material.
  • polyolefin such as polyethylene or polypropylene
  • polyester such as polyamide or polyethylene terephthalate
  • fluorine-based polymer such as ETFE, PEEK (polyetheretherketone).
  • Polyimide and the like can be suitably used.
  • the hub 54 is provided at the proximal portion of the sheath body 51 and communicates with the lumen of the sheath body 51.
  • the dilator 40 passes through the hub 54.
  • the port portion 56 is connected to the hub 54 and communicates with the lumen of the sheath body 51 through the lumen of the hub 54.
  • the port portion 56 has a three-way cock 57 at the end. By connecting a syringe or the like to the three-way cock 57, the lumen of the sheath body 51 can be primed, or a contrast agent, a drug, or the like can be injected into the sheath body 51.
  • the valve body 55 is a member for sealing the lumens of the hub 54 and the sheath body 51.
  • the valve body 55 can be flexibly deformed and is disposed on the inner peripheral surface of the hub 54.
  • the valve body 55 is slidably in contact with the outer peripheral surface of the dilator 40. Further, the valve body 55 can press the dilator 40 with elastic force in a state where the dilator 40 is inserted, and can fix the dilator 40 and the outer sheath 50. Even if the valve body 55 is fixed, it can be relatively moved in the axial direction by gripping the dilator 40 and the outer sheath 50 and applying a force.
  • the valve body 55 is a member having a cut in the center of a disk-like elastic body, for example.
  • the elastic body include natural rubber, silicone rubber, and various elastomers.
  • the valve body 55 suppresses blood from leaking through the outer sheath 50 while allowing the dilator 40 to be inserted and removed, and suppresses air from entering the body.
  • the dilator 40 and the outer sheath 50 are combined to form a sheath assembly 80.
  • the positions, bending directions, and bending angles of the dilator bending portion 48 and the sheath bending portion 52 match or substantially match. Thereby, the puncture part 61 can be protruded in a desired direction.
  • a needle is punctured into the femoral vein, and a short guide wire is inserted into the needle.
  • the needle is removed and a catheter introducer is inserted into the blood vessel along the short guide wire.
  • a sheath assembly 80 in which the dilator 40 is inserted into the outer sheath 50 is prepared (see FIG. 3).
  • the holding portion 46 of the dilator 40 holds the distal portion of the attached guide wire 20.
  • the guide wire 90 is inserted into the lumen 45 of the dilator 40.
  • the sheath assembly 80 is inserted into the catheter introducer and inserted into the blood vessel (step S10).
  • the dilator 40 is pushed distally while observing the inside of the right atrium R with an intracardiac echo catheter (ICE: Intra cardiac echo catheter).
  • ICE Intra cardiac echo catheter
  • the puncture device 60 is inserted into the lumen 45 from the proximal side of the dilator 40 and protruded from the distal end of the dilator 40.
  • the puncture part 61 punctures the oval fossa O (step S12).
  • a part of the distal end portion of the dilator 40 that has pressed the foveal fossa O to the left atrium L side enters a hole opened in the foveal fossa O. .
  • a part of the dilator 40 may not enter the hole of the oval fossa O.
  • the first linear body is a puncture device 60 having a puncture portion 61 that outputs sharp or energy capable of forming a hole in the foveal fossa O.
  • a hole is formed in the oval fossa O by the puncture device 60, and the dilator 40 can be inserted into the formed hole along the puncture device 60.

Abstract

Provided are a medical system, a dilator, and a treatment method, whereby a plurality of linear bodies can easily be inserted into a hole in a biological tissue in an organismal lumen, and working efficiency can be increased. A medical system (10) for inserting a plurality of linear bodies into a hole of an oval fossa (O) in an organismal lumen, the medical system (10) having a dilator (40) in which a lumen (45) penetrating in the axial direction thereof is formed and a retaining part (46) is provided to a distal part thereof further outside in the radial direction than the lumen (45), the lumen (45) being capable of accommodating a puncture device (60), and the retaining part (46) detachably retaining the distal part of an attached guide wire (20).

Description

医療システムおよびダイレータ並びに処置方法Medical system, dilator and treatment method
　本発明は、生体組織の孔に複数の線状体を挿入するための医療システムおよびダイレータ並びに処置方法に関する。 The present invention relates to a medical system, a dilator, and a treatment method for inserting a plurality of linear bodies into a hole in a living tissue.
　心臓は、刺激伝導系と呼ばれる心筋組織に電流が流れることで、適切なタイミングで収縮および拡張を繰り返し、血液を循環させている。この刺激伝導系を流れる電気信号の発生や伝達が正常でなくなると、適切なタイミングで収縮および拡張ができなくなり、不整脈が生じる。 The heart circulates blood by repeating contraction and expansion at an appropriate timing when current flows through myocardial tissue called a stimulation conduction system. When the generation and transmission of electrical signals flowing through the stimulation conduction system become abnormal, contraction and expansion cannot be performed at appropriate timing, and arrhythmia occurs.
　不整脈の治療のために、不整脈を引き起こす信号の伝導経路を、加熱または冷却によりアブレーションして遮断する方法が知られている。この治療方法を行うために、経皮的に左心房まで挿入し、肺静脈口に位置する信号の伝導経路をアブレーション可能なアブレーションカテーテルが知られている。このようなアブレーションカテーテルは、低侵襲で高い効果が得られるとして盛んに用いられている。 For the treatment of arrhythmia, a method is known in which the conduction path of a signal that causes arrhythmia is blocked by ablation by heating or cooling. In order to perform this treatment method, an ablation catheter that is inserted percutaneously into the left atrium and is capable of ablating the signal conduction path located at the pulmonary vein opening is known. Such ablation catheters are actively used because they are minimally invasive and provide high effects.
　左心房でアブレーションを行うためには、右心房から心房中隔の卵円窩という肉薄な隔壁に針を刺して、右心房から左心房へ通じる孔を開ける、心房中隔穿刺（Ｂｒｏｃｋｅｎｂｒｏｕｇｈ法）という手技が必要となる。アブレーションを行うためには、右心房からこの孔に複数のデバイスを挿入し、左心房へ通す必要がある。生体内の小さい孔にデバイスを挿入するためには、ガイドワイヤを生体内に挿入した後、このガイドワイヤに沿ってデバイスを挿入する方法が知られている（例えば、特許文献１を参照）。左心房へ通す複数のデバイスは、例えば、肺静脈電位を検出するリングカテーテル、アブレーションを行うアブレーションカテーテルなどである。ところで、卵円窩の１つの穿刺孔に複数のデバイスを通すことは難しく、熟練を必要とする。また、前述の心房中隔穿刺により、複数の孔を形成することもできる。この場合、それぞれの穿刺孔に、デバイスを一本ずつ通すことができる。しかしながら、穿刺を複数回行うと、目標位置と異なる部位に誤穿刺する可能性が高まる。 In order to perform ablation in the left atrium, a needle is inserted into a thin septum called the ovary fossa of the atrial septum from the right atrium to open a hole that leads from the right atrium to the left atrium. A procedure is required. In order to perform ablation, it is necessary to insert a plurality of devices into the hole from the right atrium and pass it through the left atrium. In order to insert a device into a small hole in a living body, a method is known in which a device is inserted along the guide wire after the guide wire is inserted into the living body (see, for example, Patent Document 1). The plurality of devices that pass through the left atrium are, for example, a ring catheter that detects pulmonary vein potential, an ablation catheter that performs ablation, and the like. By the way, it is difficult to pass a plurality of devices through one puncture hole of the foveal fossa, and skill is required. A plurality of holes can also be formed by the atrial septal puncture. In this case, one device can be passed through each puncture hole. However, if puncturing is performed a plurality of times, the possibility of erroneous puncturing at a site different from the target position increases.
国際公開第２００５／１０７８４２号明細書International Publication No. 2005/107842 Specification
　特許文献１に記載の方法は、１つのデバイスを目的の位置へ導くために、１本のガイドワイヤを使用する。このため、複数のデバイスを生体内に挿入する場合には、その数に応じた複数のガイドワイヤを目的の位置へ導入することが必要となり、操作に手間がかかる。 The method described in Patent Document 1 uses one guide wire to guide one device to a target position. For this reason, when a plurality of devices are inserted into the living body, it is necessary to introduce a plurality of guide wires corresponding to the number of the devices to a target position, which takes time and effort.
　本発明は、上述した課題を解決するためになされたものであり、複数の線状体を生体管腔の生体組織の孔へ容易に挿入でき、作業効率を高めることが可能な医療システムおよびダイレータ並びに処置方法を提供することを目的とする。 The present invention has been made to solve the above-described problems, and a medical system and a dilator that can easily insert a plurality of linear bodies into a hole in a living tissue of a living body lumen and can improve work efficiency. An object of the present invention is to provide a treatment method.
　上記目的を達成する医療システムは、生体管腔内の生体組織の孔に複数の線状体を挿入するための医療システムであって、軸方向へ貫通するルーメンが形成され、前記ルーメンよりも径方向外側で、遠位部に保持部が設けられた長尺体と、を有し、前記ルーメンに前記第１の線状体を収容可能であり、前記保持部は、前記第２の線状体の遠位部を離脱可能に保持する。 A medical system that achieves the above-described object is a medical system for inserting a plurality of linear bodies into a hole of a living tissue in a living body lumen, wherein a lumen penetrating in the axial direction is formed and has a diameter larger than that of the lumen. An elongate body having a holding portion at a distal portion outside the direction, the first linear body can be accommodated in the lumen, and the holding portion is the second linear shape. Removably hold the distal part of the body.
　上記目的を達成するダイレータは、生体管腔内の生体組織の孔を広げるためのダイレータであって、前記ダイレータは、軸方向へ貫通するルーメンが形成され、前記ルーメンよりも径方向外側で、遠位部に保持部が設けられており、前記保持部は、長尺な線状体を離脱可能に保持する。 A dilator that achieves the above object is a dilator for widening a hole of a living tissue in a living body lumen, and the dilator is formed with a lumen penetrating in an axial direction, and is farther radially outward than the lumen. A holding portion is provided in the position portion, and the holding portion holds the long linear body in a detachable manner.
　上記目的を達成する処置方法は、上記の医療システムを使用して生体管腔内の生体組織の孔に複数の線状体を挿入するための処置方法であって、前記保持部に前記第２の線状体を保持した前記長尺体を生体管腔内に挿入するステップと、前記第１の線状体を前記長尺体のルーメンに通して前記生体組織の孔に挿入するステップと、前記長尺体の前記保持部を含む遠位部を前記生体組織の孔に挿入するステップと、前記第２の線状体を前記保持部から離脱させるステップと、を有する。 A treatment method for achieving the above object is a treatment method for inserting a plurality of linear bodies into a hole of a living tissue in a living body lumen using the above medical system, wherein the second portion is inserted into the holding portion. Inserting the elongate body holding the linear body into a living body lumen, inserting the first linear body through the lumen of the elongate body and inserting into the hole of the biological tissue; Inserting a distal portion including the holding portion of the elongated body into the hole of the living tissue, and detaching the second linear body from the holding portion.
　上記のように構成した医療システムおよびダイレータ並びに処置方法は、長尺体を生体管腔内に挿入し、長尺体のルーメンを介して、第１の線状体を生体組織の孔に挿入できる。さらに、長尺体を生体管腔内の生体組織の孔に挿入することで、保持部に保持される第２の線状体を生体組織の孔に挿入できる。このため、複数の線状体を容易に生体組織の孔に挿入でき、作業効率を高めることができる。 In the medical system, the dilator, and the treatment method configured as described above, the long body can be inserted into the living body lumen, and the first linear body can be inserted into the hole of the living tissue through the lumen of the long body. . Furthermore, the second linear body held by the holding part can be inserted into the hole of the biological tissue by inserting the long body into the hole of the biological tissue in the living body lumen. For this reason, a some linear body can be easily inserted in the hole of a biological tissue, and work efficiency can be improved.
実施形態に係る医療システムを示す平面図である。It is a top view which shows the medical system which concerns on embodiment. ダイレータおよび外シースを示す断面図である。It is sectional drawing which shows a dilator and an outer sheath. 実施形態に係る医療システムの各デバイスを組み合わせた状態を示す断面図である。It is sectional drawing which shows the state which combined each device of the medical system which concerns on embodiment. 医療システムの遠位部を示す斜視図である。It is a perspective view which shows the distal part of a medical system. 心臓の内部を示す部分断面図である。It is a fragmentary sectional view showing the inside of the heart. 実施形態に係る医療デバイスにより穿刺を行う際の状態を示す断面図であり、（Ａ）はガイドワイヤに沿ってシース組立体を右心房に挿入した状態、（Ｂ）はダイレータを位置決めした状態、（Ｃ）は穿刺デバイスにより卵円窩を穿刺した状態、（Ｄ）はシース組立体を右心房に挿入した状態を示す。It is sectional drawing which shows the state at the time of puncturing with the medical device which concerns on embodiment, (A) is the state which inserted the sheath assembly into the right atrium along the guide wire, (B) is the state which positioned the dilator, (C) shows a state where the fossa is punctured by the puncture device, and (D) shows a state where the sheath assembly is inserted into the right atrium. 実施形態に係る医療デバイスにより穿刺を行う際の状態を示す断面図であり、（Ａ）は保持部から付属ガイドワイヤを離脱させた状態、（Ｂ）は外シースからダイレータおよび穿刺デバイスを引き抜いた状態、（Ｃ）は他のシース組立体を右心房に挿入した状態、（Ｄ）は他のシース組立体の外シースからダイレータを引き抜いた状態を示す。It is sectional drawing which shows the state at the time of performing puncture with the medical device which concerns on embodiment, (A) is the state which detached | attached the guide wire from the holding | maintenance part, (B) extracted the dilator and the puncture device from the outer sheath A state, (C) shows a state in which another sheath assembly is inserted into the right atrium, and (D) shows a state in which the dilator is pulled out from the outer sheath of the other sheath assembly. 医療デバイスを用いた手技を説明するためのフローチャートである。It is a flowchart for demonstrating the procedure using a medical device. 医療システムの変形例を示す平面図であり、（Ａ）は第１の変形例、（Ｂ）は第２の変形例、（Ｃ）は第３の変形例、（Ｄ）は第４の変形例を示す。It is a top view which shows the modification of a medical system, (A) is a 1st modification, (B) is a 2nd modification, (C) is a 3rd modification, (D) is a 4th modification. An example is shown. 医療システムの第５の変形例を示す図であり、（Ａ）は平面図、（Ｂ）は（Ａ）のＡ－Ａ線に沿う断面図である。It is a figure which shows the 5th modification of a medical system, (A) is a top view, (B) is sectional drawing which follows the AA line of (A). 医療システムの第６の変形例を示す図であり、（Ａ）は平面図、（Ｂ）は（Ａ）の矢線Ｂから視た平面図である。It is a figure which shows the 6th modification of a medical system, (A) is a top view, (B) is the top view seen from the arrow B of (A). 医療システムの変形例を示す平面図であり、（Ａ）は第７の変形例、（Ｂ）は第８の変形例を示す。It is a top view which shows the modification of a medical system, (A) shows a 7th modification, (B) shows an 8th modification.
　以下、図面を参照して、本発明の実施の形態を説明する。なお、図面の寸法比率は、説明の都合上、誇張されて実際の比率とは異なる場合がある。本明細書では、デバイスの血管に挿入する側を「遠位側」、操作する手元側を「近位側」と称することとする。 Hereinafter, an embodiment of the present invention will be described with reference to the drawings. In addition, the dimension ratio of drawing is exaggerated on account of description, and may differ from an actual ratio. In this specification, the side of the device that is inserted into the blood vessel is referred to as the “distal side”, and the proximal side that is operated is referred to as the “proximal side”.
　本発明の実施形態に係る医療システム１０は、右心房Ｒから心房中隔の卵円窩Ｏに孔を形成し、右心房Ｒから左心房Ｌへ通じる複数のアクセスルートを設けるために用いられる（図５を参照）。卵円窩Ｏに複数のアクセスルートがある場合、経皮的に大静脈に挿入した複数のデバイスを右心房Ｒへ導いた後、左心房へ容易に挿入できる。複数のデバイスは、例えば、アブレーションカテーテル、リングカテーテル等である。 The medical system 10 according to the embodiment of the present invention is used to form a hole from the right atrium R to the oval fossa O of the atrial septum and to provide a plurality of access routes from the right atrium R to the left atrium L ( (See FIG. 5). When there are a plurality of access routes in the oval fossa O, a plurality of devices percutaneously inserted into the vena cava can be easily inserted into the left atrium after being guided to the right atrium R. The plurality of devices are, for example, an ablation catheter, a ring catheter, and the like.
　本実施形態に係る医療システム１０は、図１～４に示すように、穿刺デバイス６０（第１の線状体）と、ダイレータ４０（長尺体）と、外シース５０と、付属ガイドワイヤ２０（第２の線状体）とを有している。 As shown in FIGS. 1 to 4, the medical system 10 according to this embodiment includes a puncture device 60 (first linear body), a dilator 40 (long body), an outer sheath 50, and an attached guide wire 20. (Second linear body).
　穿刺デバイス６０は、卵円窩Ｏに孔を開けるためのデバイスである。穿刺デバイス６０は、長尺な線材部６２と、線材部６２の遠位側端部に設けられる鋭利な穿刺部６１とを有している。なお、穿刺デバイス６０は、鋭利な穿刺部６１を有さなくてもよい。したがって、穿刺デバイス６０は、高周波電流、電磁波、レーザ、冷却等を利用して生体組織を焼灼して穿刺する穿刺部６１を有してもよい。線材部６２の外径は、特に限定されないが、例えば０．１～２．０ｍｍである。線材部６２の軸方向の長さは、特に限定されないが、例えば５１０～１０００ｍｍである。 The puncture device 60 is a device for making a hole in the oval fossa O. The puncture device 60 includes a long wire portion 62 and a sharp puncture portion 61 provided at a distal end portion of the wire portion 62. Note that the puncture device 60 may not have the sharp puncture unit 61. Therefore, the puncture device 60 may have a puncture unit 61 that cauterizes and punctures a living tissue using high-frequency current, electromagnetic waves, laser, cooling, or the like. The outer diameter of the wire portion 62 is not particularly limited, but is, for example, 0.1 to 2.0 mm. The length of the wire portion 62 in the axial direction is not particularly limited, but is, for example, 510 to 1000 mm.
　付属ガイドワイヤ２０は、遠位側の端部がダイレータ４０に保持される長尺なガイドワイヤである。付属ガイドワイヤ２０は、ダイレータ４０に保持された状態から、離脱可能である。ダイレータ４０に保持された付属ガイドワイヤ２０は、外シース５０の内腔を通らず、外シース５０の外側に位置する。付属ガイドワイヤ２０の外径は、適宜設定されるが、例えば０．１～３ｍｍである。付属ガイドワイヤ２０の軸方向の長さは、適宜設定されるが、例えば５５０～４５００ｍｍである。付属ガイドワイヤ２０の構成材料は、適宜設定されるが、例えば、ステンレス鋼やＮｉ－Ｔｉ合金等の柔軟性および強度を備える芯材の外側に、柔軟な樹脂材料を被覆して形成される。樹脂材料は、例えば、ポリエチレン、ポリプロピレン等のポリオレフィン、ポリ塩化ビニル、ポリエステル（ＰＥＴ、ＰＢＴ等）、ポリアミド、ポリイミド、ポリウレタン、ポリスチレン、ポリカーボネート、シリコーン樹脂、フッ素系樹脂（ＰＴＦＥ、ＥＴＦＥ等）、シリコーンゴム、その他各種のエラストマー（例えば、ポリアミド系、ポリエステル系等の熱可塑性エラストマー）またはこれらの複合材料である。 The attached guide wire 20 is a long guide wire whose distal end is held by the dilator 40. The attached guide wire 20 can be detached from the state held by the dilator 40. The attached guide wire 20 held by the dilator 40 does not pass through the lumen of the outer sheath 50 and is positioned outside the outer sheath 50. The outer diameter of the attached guide wire 20 is appropriately set, and is, for example, 0.1 to 3 mm. The length of the attached guide wire 20 in the axial direction is appropriately set, and is, for example, 550 to 4500 mm. The constituent material of the attached guide wire 20 is appropriately set. For example, it is formed by coating a flexible resin material on the outside of a core material having flexibility and strength such as stainless steel and Ni—Ti alloy. Examples of resin materials include polyolefins such as polyethylene and polypropylene, polyvinyl chloride, polyesters (PET, PBT, etc.), polyamides, polyimides, polyurethanes, polystyrenes, polycarbonates, silicone resins, fluororesins (PTFE, ETFE, etc.), and silicone rubber. Other various elastomers (for example, thermoplastic elastomers such as polyamide and polyester) or a composite material thereof.
　ダイレータ４０は、穿刺デバイス６０により形成される卵円窩Ｏの孔を広げるために用いられる。ダイレータ４０は、外径が略一定のダイレータ中央部４１と、ダイレータ中央部４１の遠位側に位置するテーパ部４２（先端部）と、ダイレータ中央部４１の近位側に位置するダイレータ近位部４３とを有している。ダイレータ中央部４１は、外径が略一定の管体である。テーパ部４２は、遠位側に向かってテーパ状に減少する外径を有している。テーパ部４２の中心軸に対する傾斜角度α１は、適宜設定されるが、例えば１～８０度、より好ましくは１～３０度、さらに好ましくは１～１０度である。ダイレータ近位部４３は、外周面に、Ｙコネクタと連結可能な雄コネクタ４４を有している。 The dilator 40 is used to widen the hole of the oval fossa O formed by the puncture device 60. The dilator 40 includes a dilator center portion 41 having a substantially constant outer diameter, a taper portion 42 (tip portion) located on the distal side of the dilator center portion 41, and a dilator proximal portion located on the proximal side of the dilator center portion 41. Part 43. The dilator central portion 41 is a tubular body having a substantially constant outer diameter. The taper portion 42 has an outer diameter that decreases in a tapered shape toward the distal side. The inclination angle α1 with respect to the central axis of the taper portion 42 is appropriately set, and is, for example, 1 to 80 degrees, more preferably 1 to 30 degrees, and further preferably 1 to 10 degrees. The dilator proximal portion 43 has a male connector 44 that can be connected to the Y connector on the outer peripheral surface.
　また、ダイレータ４０は、穿刺デバイス６０を移動可能に収容するルーメン４５と、付属ガイドワイヤ２０を離脱可能に保持する保持部４６が形成されている。ルーメン４５は、ダイレータ４０の中心軸と垂直な断面において、ダイレータ４０の中心部に位置する。ルーメン４５は、ダイレータ４０を軸方向へ貫通している。ルーメン４５は、テーパ部４２の最も縮径した遠位側の端部で開口している。 Further, the dilator 40 is formed with a lumen 45 for movably accommodating the puncture device 60 and a holding portion 46 for detachably holding the attached guide wire 20. The lumen 45 is located at the center of the dilator 40 in a cross section perpendicular to the central axis of the dilator 40. The lumen 45 penetrates the dilator 40 in the axial direction. The lumen 45 opens at the distal end of the tapered portion 42 with the most reduced diameter.
　ルーメン４５は、遠位側の遠位側ルーメン４５Ａと、遠位側ルーメン４５Ａよりも内径の大きい近位側ルーメン４５Ｂと、遠位側ルーメン４５Ａと近位側ルーメン４５Ｂの間で内径が変化する中央ルーメン４５Ｃを備えている。近位側ルーメン４５Ｂの内径は、穿刺デバイス６０の外径よりも十分に大きい。このため、近位側ルーメン４５Ｂに挿入した穿刺デバイス６０は、ダイレータ４０の内周面に沿って滑らかに移動可能である。中央ルーメン４５Ｃは、遠位側ルーメン４５Ａを通る穿刺デバイス６０を、近位側ルーメン４５Ｂへ円滑に誘導する。挿入するガイドワイヤとダイレータ４０の内壁面のクリアランスは、近位側ルーメン４５Ｂよりも遠位側ルーメン４５Ａで小さい。このため、遠位側ルーメン４５Ａの内径は、ガイドワイヤと接触しつつ摺動可能な内径である。したがって、近位側ルーメン４５Ｂから遠位側ルーメン４５Ａへ、ガイドワイヤや穿刺デバイス６０を押し込みやすい。さらに、ダイレータ４０は、遠位側ルーメン４５Ａを移動する穿刺デバイス６０のダイレータ４０からの突出長を正確に規定できる。なお、ダイレータ４０の内径は、軸方向に沿って一定でもよい。 The lumen 45 changes in inner diameter between the distal lumen 45A on the distal side, the proximal lumen 45B having a larger inner diameter than the distal lumen 45A, and the distal lumen 45A and the proximal lumen 45B. A central lumen 45C is provided. The inner diameter of the proximal lumen 45 </ b> B is sufficiently larger than the outer diameter of the puncture device 60. For this reason, the puncture device 60 inserted into the proximal lumen 45B can move smoothly along the inner peripheral surface of the dilator 40. The central lumen 45C smoothly guides the puncture device 60 through the distal lumen 45A to the proximal lumen 45B. The clearance between the guide wire to be inserted and the inner wall surface of the dilator 40 is smaller in the distal lumen 45A than in the proximal lumen 45B. For this reason, the inner diameter of the distal lumen 45A is an inner diameter that can slide while being in contact with the guide wire. Therefore, it is easy to push the guide wire or the puncture device 60 from the proximal lumen 45B to the distal lumen 45A. Further, the dilator 40 can accurately define the protruding length from the dilator 40 of the puncture device 60 that moves in the distal lumen 45A. Note that the inner diameter of the dilator 40 may be constant along the axial direction.
　ダイレータ４０は、外力が作用しない自然状態において、遠位部に所定の角度で曲がったダイレータ曲げ部４８を有する。ダイレータ曲げ部４８は、右心房Ｒに挿入した穿刺デバイス６０の穿刺部６１を、卵円窩Ｏへ向ける役割を果たす。 The dilator 40 has a dilator bending portion 48 bent at a predetermined angle at a distal portion in a natural state where no external force acts. The dilator bending portion 48 plays a role of directing the puncture portion 61 of the puncture device 60 inserted into the right atrium R toward the foveal fossa O.
　保持部４６は、付属ガイドワイヤ２０を保持する部位である。保持部４６は、ダイレータ４０のテーパ部４２の側面に設けられる保持孔４６Ａ（孔部）を有する。保持孔４６Ａの内腔は、ダイレータ４０の中心軸と垂直な断面において、ルーメン４５から径方向外側へ離れて位置する。保持孔４６Ａは、近位側に開口する挿入口４６Ｂから、遠位側へ向かって延在する。挿入口４６Ｂが保持孔４６Ａの近位側に位置することで、付属ガイドワイヤ２０が、ダイレータ４０に沿いつつ、保持孔４６Ａに無理なく入り込むことができる。保持孔４６Ａが延在する方向は、遠位側へ向かうほどダイレータ４０の中心軸に近づく。これにより、ダイレータ４０の中心軸に対して傾斜するテーパ部４２に沿って、保持部４６を滑らかに形成できる。したがって、保持部４６は、ルーメン４５に対して角度を有する。これによって、付属ガイドワイヤ２０を保持部４６から離脱する際、離脱する方向が卵円窩Ｏの方向と異なっている。このため、付属ガイドワイヤ２０が卵円窩Ｏを通って、左心房Ｌから右心房Ｒに抜けにくくなる。なお、保持孔４６Ａが延在する方向は、ダイレータ４０の中心軸に対して傾斜しなくてもよい。保持孔４６Ａは、遠位側が閉じている。このため、収容する付属ガイドワイヤ２０が保持孔４６Ａから遠位側へ突出せず、適切な位置を維持できる。保持孔４６Ａは、ルーメン４５と連通しない。このため、保持孔４６Ａに保持される付属ガイドワイヤ２０が、ルーメン４５を通る穿刺デバイス６０と接触することを抑制できる。なお、保持孔４６Ａは、ルーメン４５と連通してもよい。保持孔４６Ａは、テーパ面４２Ａが構成する円錐状の外周面よりも内側まで到達している。このため、付属ガイドワイヤ２０を保持する位置がダイレータ４０のより内側に配置される。これにより、保持部４６のテーパ面４６Ａからの突出量が抑えられる。また、保持部４６の外面は、遠位側へ向かってダイレータ４０の中心軸に近づくように傾斜している。このため、保持部４６は、卵円窩Ｏに形成される孔に挿入する際の妨げ（抵抗）となり難い。保持部４６を有するテーパ部４２の一部と、保持部４６を有さないテーパ部４２の一部の中心軸に対する角度は同じでもよいが、異なってもよい。角度が同じ場合、保持部４６を設けられたダイレータ４０が卵円窩Ｏの孔に抵抗なく挿入されることができる。また、保持部４６を有するテーパ部４２の一部の外径が、保持部４６を有さないテーパ部４２の一部の外径と同じでもよいが、異なってもよい。外径が同じ場合、保持部４６を設けられたダイレータ４０が卵円窩Ｏの孔に抵抗なく挿入されることができる。また、保持部４６を有するテーパ部４２の一部の外径が、保持部４６を有さないテーパ部４２の一部の外径よりも大きくてもよい。 The holding part 46 is a part that holds the attached guide wire 20. The holding part 46 has a holding hole 46 </ b> A (hole part) provided on the side surface of the tapered part 42 of the dilator 40. The lumen of the holding hole 46 </ b> A is located away from the lumen 45 radially outward in a cross section perpendicular to the central axis of the dilator 40. The holding hole 46A extends toward the distal side from the insertion port 46B that opens to the proximal side. Since the insertion port 46B is positioned on the proximal side of the holding hole 46A, the attached guide wire 20 can easily enter the holding hole 46A along the dilator 40. The direction in which the holding hole 46 </ b> A extends approaches the central axis of the dilator 40 toward the distal side. Thereby, the holding part 46 can be smoothly formed along the tapered part 42 inclined with respect to the central axis of the dilator 40. Therefore, the holding part 46 has an angle with respect to the lumen 45. Thus, when the attached guide wire 20 is detached from the holding portion 46, the direction in which the accessory guide wire 20 is detached is different from the direction of the oval fossa O. For this reason, it becomes difficult for the attached guide wire 20 to pass through the foveal fossa O and from the left atrium L to the right atrium R. The direction in which the holding hole 46 </ b> A extends may not be inclined with respect to the central axis of the dilator 40. The holding hole 46A is closed on the distal side. For this reason, the attached guide wire 20 to be accommodated does not protrude distally from the holding hole 46A, and an appropriate position can be maintained. The holding hole 46 </ b> A does not communicate with the lumen 45. For this reason, it is possible to suppress the attached guide wire 20 held in the holding hole 46 </ b> A from coming into contact with the puncture device 60 that passes through the lumen 45. The holding hole 46 </ b> A may communicate with the lumen 45. The holding hole 46A reaches the inner side of the conical outer peripheral surface formed by the tapered surface 42A. For this reason, the position for holding the attached guide wire 20 is arranged on the inner side of the dilator 40. Thereby, the protrusion amount from 46 A of taper surfaces of the holding | maintenance part 46 is suppressed. Further, the outer surface of the holding portion 46 is inclined so as to approach the central axis of the dilator 40 toward the distal side. For this reason, the holding | maintenance part 46 becomes difficult to become an obstruction (resistance) at the time of inserting in the hole formed in the oval fossa O. The angle with respect to the central axis of a part of the taper part 42 having the holding part 46 and the part of the taper part 42 not having the holding part 46 may be the same or different. When the angles are the same, the dilator 40 provided with the holding part 46 can be inserted into the hole of the oval fossa O without resistance. Further, the outer diameter of a part of the tapered part 42 having the holding part 46 may be the same as or different from the outer diameter of a part of the tapered part 42 not having the holding part 46. When the outer diameter is the same, the dilator 40 provided with the holding part 46 can be inserted into the hole of the oval fossa O without resistance. Further, the outer diameter of a part of the tapered part 42 having the holding part 46 may be larger than the outer diameter of a part of the tapered part 42 not having the holding part 46.
　保持孔４６Ａの内径は、付属ガイドワイヤ２０を着脱可能に嵌合できる大きさである。保持孔４６Ａの内径は、付属ガイドワイヤ２０の外径と略一致する。保持孔４６Ａの内径は、例えば０．１～３．２ｍｍ、より好ましくは０．３～２．１ｍｍ、さらに好ましくは　０．４～１．０ｍｍである。なお、保持孔４６Ａの内径は、遠位側へ向かって減少してもよい。これにより、付属ガイドワイヤ２０を保持孔４６Ａの奥へ押し込むことで、付属ガイドワイヤ２０を強固に固定できる。保持孔４６Ａの内表面は、付属ガイドワイヤ２０を保持できれば、滑らかあっても、滑らかでなくてもよい。保持部４６Ａの内表面は、例えばエンボス加工が施されてもよい。これにより、保持孔４６Ａの内表面は、摩擦力が大きくなり、付属ガイドワイヤ２０を適切に保持できる。保持孔４６Ａの延在方向の長さは、適宜設定されるが、例えば１～３０ｍｍ、より好ましくは２～２０ｍｍ、さらに好ましくは３～１０ｍｍである。 The inner diameter of the holding hole 46A is a size that allows the attached guide wire 20 to be detachably fitted. The inner diameter of the holding hole 46A substantially matches the outer diameter of the attached guide wire 20. The inner diameter of the holding hole 46A is, for example, 0.1 to 3.2 mm, more preferably 0.3 to 2.1 mm, and still more preferably 0.4 to 1.0 mm. Note that the inner diameter of the holding hole 46A may decrease toward the distal side. Accordingly, the attached guide wire 20 can be firmly fixed by pushing the attached guide wire 20 into the holding hole 46A. The inner surface of the holding hole 46A may be smooth or non-smooth as long as the attached guide wire 20 can be held. The inner surface of the holding portion 46A may be embossed, for example. As a result, the friction force on the inner surface of the holding hole 46 </ b> A increases, and the attached guide wire 20 can be appropriately held. The length of the holding hole 46A in the extending direction is appropriately set, and is, for example, 1 to 30 mm, more preferably 2 to 20 mm, and further preferably 3 to 10 mm.
　保持部４６は、外シース５０の内腔を通過できる大きさである必要がある。したがって、ダイレータ４０の中心軸から、径方向の外側へ、保持部４６の最も遠い部位までの距離は、外シース５０の内表面の半径以下であることが好ましい。 The holding portion 46 needs to have a size that can pass through the lumen of the outer sheath 50. Therefore, it is preferable that the distance from the central axis of the dilator 40 to the farthest part of the holding portion 46 outward in the radial direction is equal to or less than the radius of the inner surface of the outer sheath 50.
　ダイレータ４０の保持部４６が設けられる位置は、卵円窩Ｏを貫通して左心房Ｌへ到達可能な位置であれば、テーパ部４２でなくてもよい。ただし、左心房Ｌの広さに限界があるため、保持部４６は、ダイレータ４０のできるだけ遠位部に位置することが好ましい。 The position where the holding part 46 of the dilator 40 is provided may not be the taper part 42 as long as it can reach the left atrium L through the ovary fossa O. However, since the width of the left atrium L is limited, the holding portion 46 is preferably located as far as possible in the dilator 40.
　ダイレータ４０の中心軸に対して保持部４６が設けられる方向は、ダイレータ４０の近位部に対して遠位部が曲がる方向と同じである。これにより、保持部４６に保持された付属ガイドワイヤ２０を近位側へ牽引することで、ダイレータ４０をダイレータ曲げ部４８が曲がる方向へ曲げることができる。これにより、ダイレータ４０の遠位側の端部の位置を、より高精度に操作できる。なお、ダイレータ４０の中心軸に対して保持部４６が設けられる方向は、ダイレータ４０の近位部に対して遠位部が曲がる方向と同じでなくてもよく、逆方向であってもよい。 The direction in which the holding portion 46 is provided with respect to the central axis of the dilator 40 is the same as the direction in which the distal portion is bent with respect to the proximal portion of the dilator 40. Thereby, by pulling the attached guide wire 20 held by the holding portion 46 to the proximal side, the dilator 40 can be bent in the direction in which the dilator bending portion 48 is bent. As a result, the position of the distal end of the dilator 40 can be manipulated with higher accuracy. Note that the direction in which the holding portion 46 is provided with respect to the central axis of the dilator 40 may not be the same as the direction in which the distal portion bends with respect to the proximal portion of the dilator 40, and may be in the opposite direction.
　ダイレータ４０の軸方向の長さは、適宜設定されるが、例えば５００～８００ｍｍである。ダイレータ４０の外径は、適宜設定されるが、例えば１．０～１０．０ｍｍである。ダイレータ４０の遠位側ルーメン４５Ａが設けられる部位の内周面と、穿刺デバイス６０の外周面との間のクリアランスは、適宜設定されるが、例えば０．０１～１．００ｍｍである。ダイレータ４０の近位部に対するダイレータ曲げ部４８の角度β１は、特に限定されないが、例えば１０～９０度である。ダイレータ４０の遠位側端部からダイレータ曲げ部４８までの長さは、適宜設定されるが、例えば１０～１５０ｍｍである。 The length of the dilator 40 in the axial direction is appropriately set, and is, for example, 500 to 800 mm. The outer diameter of the dilator 40 is set as appropriate, and is, for example, 1.0 to 10.0 mm. The clearance between the inner peripheral surface of the site where the distal lumen 45A of the dilator 40 is provided and the outer peripheral surface of the puncture device 60 is appropriately set, and is, for example, 0.01 to 1.00 mm. The angle β1 of the dilator bending portion 48 with respect to the proximal portion of the dilator 40 is not particularly limited, and is, for example, 10 to 90 degrees. The length from the distal end portion of the dilator 40 to the dilator bending portion 48 is appropriately set, and is, for example, 10 to 150 mm.
　ダイレータ４０の構成材料は、可撓性を有することが好ましく、例えば、ポリエチレン、ポリプロピレンなどのポリオレフィン、ポリアミド、ポリエチレンテレフタレートなどのポリエステル、ＥＴＦＥ等のフッ素系ポリマー、ＰＥＥＫ（ポリエーテルエーテルケトン）、ポリイミド、形状記憶合金、ステンレス、タンタル、チタン、プラチナ、金、タングステンなどの金属などが好適に使用できる。また、ダイレータ４０は、Ｘ線造影性材料や超音波造影性材料を含んでもよい。 The constituent material of the dilator 40 is preferably flexible. For example, polyolefins such as polyethylene and polypropylene, polyesters such as polyamide and polyethylene terephthalate, fluorine-based polymers such as ETFE, PEEK (polyether ether ketone), polyimide, Metals such as shape memory alloy, stainless steel, tantalum, titanium, platinum, gold, and tungsten can be suitably used. In addition, the dilator 40 may include an X-ray contrast material or an ultrasound contrast material.
　外シース５０は、アブレーションカテーテル等のデバイスのアクセスルートを提供する。外シース５０は、シース本体５１と、シース本体５１の近位部に連結されるハブ５４と、ハブ５４に連通するポート部５６と、ハブ５４の内部の弁体５５とを有している。 The outer sheath 50 provides an access route for a device such as an ablation catheter. The outer sheath 50 includes a sheath body 51, a hub 54 connected to the proximal portion of the sheath body 51, a port portion 56 communicating with the hub 54, and a valve body 55 inside the hub 54.
　シース本体５１は、ダイレータ４０を軸方向へ移動可能に収容する長尺な管体である。シース本体５１は、ダイレータ４０と円滑に摺動する内周面を有する。シース本体５１は、自然状態において、遠位部に所定の角度で曲がったシース曲げ部５２を有する。シース本体５１の近位部に対するシース曲げ部５２の角度β２は、特に限定されないが、例えば０～９０度である。シース曲げ部５２は、右心房Ｒに挿入した穿刺デバイス６０の穿刺部６１を、卵円窩Ｏへ向ける役割を果たす。 The sheath body 51 is a long tube body that accommodates the dilator 40 so as to be movable in the axial direction. The sheath body 51 has an inner peripheral surface that slides smoothly with the dilator 40. The sheath body 51 has a sheath bent portion 52 bent at a predetermined angle at the distal portion in a natural state. The angle β2 of the sheath bending portion 52 with respect to the proximal portion of the sheath body 51 is not particularly limited, and is, for example, 0 to 90 degrees. The sheath bending portion 52 plays a role of directing the puncture portion 61 of the puncture device 60 inserted into the right atrium R toward the foveal fossa O.
　シース本体５１は、遠位側端部に、遠位側に向かってテーパ状に縮径するシーステーパ部５３を有している。シース本体５１の内腔は、シーステーパ部５３の最も縮径した端部で開口している。シーステーパ部５３の中心軸に対する傾斜角度α２は、適宜設定されるが、例えば１～１５度である。外シース５０にダイレータ４０を挿入したシース組立体８０において、シーステーパ部５３は、ダイレータ４０のテーパ部４２の近位側に位置し、テーパ部４２と連続するように位置することができる。シース本体５１の内周面は、ダイレータ４０の外周面が摺動可能に接するように、ダイレータ４０の外周面との間にクリアランスを有することが好ましい。 The sheath main body 51 has a sheath taper portion 53 whose diameter decreases in a tapered shape toward the distal side at the distal end portion. The lumen of the sheath body 51 is open at the end of the sheath taper portion 53 that has the smallest diameter. The inclination angle α2 with respect to the central axis of the sheath taper portion 53 is appropriately set, and is, for example, 1 to 15 degrees. In the sheath assembly 80 in which the dilator 40 is inserted into the outer sheath 50, the sheath taper portion 53 can be positioned on the proximal side of the taper portion 42 of the dilator 40 and can be continuous with the taper portion 42. The inner peripheral surface of the sheath body 51 preferably has a clearance between the outer peripheral surface of the dilator 40 and the outer peripheral surface of the dilator 40 so that the outer peripheral surface of the dilator 40 is slidably contacted.
　シース本体５１は、その全長にわたってダイレータ４０が貫通可能である。したがって、シース本体５１の軸方向の長さは、ダイレータ４０よりも短い。シース本体５１の軸方向の長さは、適宜設定されるが、例えば４００～７９０ｍｍである。シース本体５１の外径は、適宜設定されるが、例えば１．１～１１．０ｍｍである。シース本体５１の内径は、適宜設定されるが、例えば１．０５～１０．９５ｍｍである。シース本体５１の内周面と、ダイレータ４０の外周面との間のクリアランスは、適宜設定されるが、例えば０．０１～１．００ｍｍである。 The dilator 40 can pass through the entire length of the sheath body 51. Therefore, the axial length of the sheath body 51 is shorter than that of the dilator 40. The axial length of the sheath body 51 is set as appropriate, and is, for example, 400 to 790 mm. The outer diameter of the sheath body 51 is set as appropriate, and is, for example, 1.1 to 11.0 mm. The inner diameter of the sheath body 51 is set as appropriate, and is, for example, 1.05 to 10.95 mm. The clearance between the inner peripheral surface of the sheath body 51 and the outer peripheral surface of the dilator 40 is set as appropriate, and is, for example, 0.01 to 1.00 mm.
　シース本体５１の構成材料は、可撓性がある材質であることが好ましく、例えば、ポリエチレン、ポリプロピレンなどのポリオレフィン、ポリアミド、ポリエチレンテレフタレートなどのポリエステル、ＥＴＦＥ等のフッ素系ポリマー、ＰＥＥＫ（ポリエーテルエーテルケトン）、ポリイミドなどが好適に使用できる。 The constituent material of the sheath body 51 is preferably a flexible material. For example, polyolefin such as polyethylene or polypropylene, polyester such as polyamide or polyethylene terephthalate, fluorine-based polymer such as ETFE, PEEK (polyetheretherketone). ), Polyimide and the like can be suitably used.
　ハブ５４は、シース本体５１の近位部に設けられ、シース本体５１の内腔と連通する。ハブ５４には、ダイレータ４０が貫通する。ポート部５６は、ハブ５４に連結され、ハブ５４の内腔を介してシース本体５１の内腔と連通する。ポート部５６は、端部に三方活栓５７を有している。三方活栓５７にシリンジ等を接続することで、シース本体５１の内腔をプライミングしたり、シース本体５１に造影剤や薬剤等を注入したりすることができる。 The hub 54 is provided at the proximal portion of the sheath body 51 and communicates with the lumen of the sheath body 51. The dilator 40 passes through the hub 54. The port portion 56 is connected to the hub 54 and communicates with the lumen of the sheath body 51 through the lumen of the hub 54. The port portion 56 has a three-way cock 57 at the end. By connecting a syringe or the like to the three-way cock 57, the lumen of the sheath body 51 can be primed, or a contrast agent, a drug, or the like can be injected into the sheath body 51.
　弁体５５は、ハブ５４およびシース本体５１の内腔を封止するための部材である。弁体５５は、柔軟に変形可能であり、ハブ５４の内周面に配置される。弁体５５は、ダイレータ４０の外周面と摺動可能に接触する。また、弁体５５は、ダイレータ４０が挿入された状態で、弾性力によりダイレータ４０を押圧し、ダイレータ４０と外シース５０を固定することができる。なお、弁体５５で固定されても、ダイレータ４０と外シース５０を把持して力を作用させることで、軸方向へ相対的に移動させることは可能である。また、ダイレータ４０をハブ５４から引き抜くことで、弁体５５のダイレータ４０が挿入された孔部は閉じ、ハブ５４の内腔を近位側から封止する。弁体５５は、例えば円盤状の弾性体の中央に切れ目を入れた部材である。弾性体は、例えば天然ゴム、シリコーンゴム、各種エラストマー等である。弁体５５は、ダイレータ４０の抜き差しを許容しつつ、外シース５０を介して血液が漏れることを抑制するとともに、体内へ空気が混入することを抑制する。 The valve body 55 is a member for sealing the lumens of the hub 54 and the sheath body 51. The valve body 55 can be flexibly deformed and is disposed on the inner peripheral surface of the hub 54. The valve body 55 is slidably in contact with the outer peripheral surface of the dilator 40. Further, the valve body 55 can press the dilator 40 with elastic force in a state where the dilator 40 is inserted, and can fix the dilator 40 and the outer sheath 50. Even if the valve body 55 is fixed, it can be relatively moved in the axial direction by gripping the dilator 40 and the outer sheath 50 and applying a force. Further, by pulling out the dilator 40 from the hub 54, the hole portion of the valve body 55 in which the dilator 40 is inserted is closed, and the lumen of the hub 54 is sealed from the proximal side. The valve body 55 is a member having a cut in the center of a disk-like elastic body, for example. Examples of the elastic body include natural rubber, silicone rubber, and various elastomers. The valve body 55 suppresses blood from leaking through the outer sheath 50 while allowing the dilator 40 to be inserted and removed, and suppresses air from entering the body.
　ダイレータ４０および外シース５０は、組み合わされることでシース組立体８０を構成する。ダイレータ４０および外シース５０を組み合わせた状態において、ダイレータ曲げ部４８およびシース曲げ部５２の位置、曲げ方向および曲げ角度は、一致または略一致することが好ましい。これにより、穿刺部６１を望ましい方向へ突出させることができる。 The dilator 40 and the outer sheath 50 are combined to form a sheath assembly 80. In a state in which the dilator 40 and the outer sheath 50 are combined, it is preferable that the positions, bending directions, and bending angles of the dilator bending portion 48 and the sheath bending portion 52 match or substantially match. Thereby, the puncture part 61 can be protruded in a desired direction.
　次に、実施形態に係る医療システム１０を用いて、卵円窩Ｏに孔を開けてアブレーションカテーテル等の複数のデバイスのためのアクセスルートを設ける方法を、図８のフローチャートを参照しつつ説明する。 Next, a method for providing an access route for a plurality of devices such as an ablation catheter by opening a hole in the fossa fossa O using the medical system 10 according to the embodiment will be described with reference to the flowchart of FIG. .
　始めに、大腿静脈に針を穿刺し、この針の中にショートガイドワイヤを挿入する。次に、針を抜去し、ショートガイドワイヤに沿って、カテーテルイントロデューサーを血管内に挿入する。次に、外シース５０の内部にダイレータ４０を挿入したシース組立体８０を準備する（図３を参照）。ダイレータ４０の保持部４６には、付属ガイドワイヤ２０の遠位部が保持されている。次に、ダイレータ４０のルーメン４５にガイドワイヤ９０を挿入する。次に、シース組立体８０を、カテーテルイントロデューサーに挿入し、血管内に挿入する（ステップＳ１０）。続いて、ガイドワイヤ９０を先行させつつ、シース組立体８０の遠位部を右心房Ｒまで徐々に押し進める。次に、ダイレータ４０を、ガイドワイヤ９０に沿って右心房Ｒから大静脈内へ、一旦挿入する。続いて、ダイレータ４０を後退させて右心房Ｒ内へ引き込むと、図５、図６（Ａ）に示すように、ダイレータ４０の遠位側端部が、卵円窩Ｏの近傍へ自然と導かれる。この後、ガイドワイヤ９０をダイレータ４０から抜去する。 First, a needle is punctured into the femoral vein, and a short guide wire is inserted into the needle. Next, the needle is removed and a catheter introducer is inserted into the blood vessel along the short guide wire. Next, a sheath assembly 80 in which the dilator 40 is inserted into the outer sheath 50 is prepared (see FIG. 3). The holding portion 46 of the dilator 40 holds the distal portion of the attached guide wire 20. Next, the guide wire 90 is inserted into the lumen 45 of the dilator 40. Next, the sheath assembly 80 is inserted into the catheter introducer and inserted into the blood vessel (step S10). Subsequently, the distal portion of the sheath assembly 80 is gradually pushed to the right atrium R while the guide wire 90 is advanced. Next, the dilator 40 is temporarily inserted from the right atrium R into the vena cava along the guide wire 90. Subsequently, when the dilator 40 is retracted and drawn into the right atrium R, the distal end of the dilator 40 is naturally guided to the vicinity of the foveal fossa O as shown in FIGS. It is burned. Thereafter, the guide wire 90 is removed from the dilator 40.
　次に、心腔内心エコーカテーテル（ＩＣＥ：Ｉｎｔｒａ　ｃａｒｄｉａｃ　ｅｃｈｏ　ｃａｔｈｅｔｅｒ）により右心房Ｒ内を観察しつつ、ダイレータ４０を遠位側へ押し込む。これにより、図６（Ｂ）に示すように、卵円窩Ｏは、ダイレータ４０によって左心房Ｌ側へ押されて突出した状態となる（ステップＳ１１）。このとき、外シース５０およびダイレータ４０の遠位部が曲がっているため、ダイレータ４０の遠位側の端部が、卵円窩Ｏへ向きやすい。なお、卵円窩Ｏを、左心房Ｌ側へ突出した状態としなくてもよい。 Next, the dilator 40 is pushed distally while observing the inside of the right atrium R with an intracardiac echo catheter (ICE: Intra cardiac echo catheter). Thereby, as shown to FIG. 6 (B), the fossa fossa O will be in the state protruded by the dilator 40 being pushed to the left atrium L side (step S11). At this time, since the outer sheath 50 and the distal portion of the dilator 40 are bent, the distal end portion of the dilator 40 tends to face toward the foveal fossa O. Note that the oval fossa O does not have to protrude to the left atrium L side.
　次に、図６（Ｃ）に示すように、ダイレータ４０の近位側からルーメン４５に穿刺デバイス６０を挿入し、ダイレータ４０の遠位側の端部から突出させる。これにより、穿刺部６１が卵円窩Ｏを穿刺する（ステップＳ１２）。穿刺部６１が卵円窩Ｏを貫通すると、卵円窩Ｏを左心房Ｌ側へ押圧していたダイレータ４０の遠位側端部の一部が、卵円窩Ｏに開けられた孔に入り込む。なお、ダイレータ４０の一部が、卵円窩Ｏの孔に入り込まなくてもよい。 Next, as shown in FIG. 6 (C), the puncture device 60 is inserted into the lumen 45 from the proximal side of the dilator 40 and protruded from the distal end of the dilator 40. Thereby, the puncture part 61 punctures the oval fossa O (step S12). When the puncture portion 61 penetrates the foveal fossa O, a part of the distal end portion of the dilator 40 that has pressed the foveal fossa O to the left atrium L side enters a hole opened in the foveal fossa O. . Note that a part of the dilator 40 may not enter the hole of the oval fossa O.
　次に、穿刺デバイス６０に沿ってダイレータ４０を遠位側へ押し込む。これにより、図６（Ｄ）に示すように、ダイレータ４０のテーパ部４２および外シース５０のシーステーパ部５３が、卵円窩Ｏの孔を押し広げつつ卵円窩Ｏを通過し、左心房Ｌに到達する。テーパ部４２およびシーステーパ部５３が、遠位側へ縮径しているため、卵円窩Ｏの孔を滑らかに広げることができる。また、穿刺部６１により卵円窩Ｏを穿刺した際に、ダイレータ４０のテーパ部４２の一部が、卵円窩Ｏの孔に入り込んでいるため、ダイレータ４０および外シース５０を、卵円窩Ｏの孔に押し込むことが容易である。このとき、テーパ部４２に設けられる保持部４６も、左心房Ｌへ到達する。これにより、保持部４６に保持されている付属ガイドワイヤ２０の遠位部も、左心房Ｌへ到達する（ステップＳ１３）。 Next, the dilator 40 is pushed distally along the puncture device 60. As a result, as shown in FIG. 6D, the tapered portion 42 of the dilator 40 and the sheath tapered portion 53 of the outer sheath 50 pass through the ovary fossa O while expanding the hole of the ovary fossa O, and the left atrium L To reach. Since the taper part 42 and the sheath taper part 53 are reduced in diameter to the distal side, the hole of the oval fossa O can be smoothly expanded. Further, when the oval fossa O is punctured by the puncture portion 61, a part of the tapered portion 42 of the dilator 40 has entered the hole of the oval fossa O, so that the dilator 40 and the outer sheath 50 are connected to the oval fossa. It is easy to push into the O hole. At this time, the holding portion 46 provided in the tapered portion 42 also reaches the left atrium L. Thereby, the distal portion of the attached guidewire 20 held by the holding portion 46 also reaches the left atrium L (step S13).
　次に、付属ガイドワイヤ２０の近位部を移動しないように保持し、ダイレータ４０を遠位側へ押し込む。もしくは、ダイレータ４０の近位部を移動しないように保持し、付属ガイドワイヤ２０の近位部を近位側へ牽引する。これにより、図７（Ａ）に示すように、付属ガイドワイヤ２０の遠位側端部が、保持部４６から離脱する（ステップＳ１４）。また、付属ガイドワイヤ２０を保持部４６から離脱させるために、付属ガイドワイヤ２０を回転させてもよい。付属ガイドワイヤ２０の遠位側端部は、付属ガイドワイヤ２０が保持部４６から離脱した後も、左心房Ｌの内部に維持される。 Next, the proximal portion of the attached guide wire 20 is held so as not to move, and the dilator 40 is pushed to the distal side. Alternatively, the proximal portion of the dilator 40 is held so as not to move, and the proximal portion of the attached guide wire 20 is pulled proximally. Thereby, as shown to FIG. 7 (A), the distal end part of the attached guide wire 20 detaches | leaves from the holding | maintenance part 46 (step S14). Further, the attached guide wire 20 may be rotated in order to detach the attached guide wire 20 from the holding portion 46. The distal end portion of the attached guide wire 20 is maintained inside the left atrium L even after the attached guide wire 20 is detached from the holding portion 46.
　次に、図７（Ｂ）に示すように、外シース５０を残して、ダイレータ４０を、体外へ抜去する（ステップＳ１５）。ダイレータ４０により広げられた卵円窩Ｏの孔は、外シース５０により維持される。付属ガイドワイヤ２０は、外シース５０とともに卵円窩Ｏの孔を貫通している。したがって、外シース５０の外周面に、付属ガイドワイヤ２０が接触している。すなわち、付属ガイドワイヤ２０は、外シース５０の内部に位置しない。外シース５０からダイレータ４０を抜去すると、弁体５５が閉じ、血液の漏えいや、血管内への空気等の混入を抑制できる。 Next, as shown in FIG. 7B, the dilator 40 is removed from the body leaving the outer sheath 50 (step S15). The hole of the oval fossa O expanded by the dilator 40 is maintained by the outer sheath 50. The attached guide wire 20 passes through the hole of the foveal fossa O together with the outer sheath 50. Therefore, the attached guide wire 20 is in contact with the outer peripheral surface of the outer sheath 50. That is, the attached guide wire 20 is not located inside the outer sheath 50. When the dilator 40 is removed from the outer sheath 50, the valve body 55 is closed, and leakage of blood and mixing of air or the like into the blood vessel can be suppressed.
　次に、図７（Ｃ）に示すように、付属ガイドワイヤ２０をガイドとして、他のダイレータ１００および外シース１０１を右心房Ｒまで到達させ、卵円窩Ｏの孔に挿入する（ステップＳ１６）。このとき、付属ガイドワイヤ２０が卵円窩Ｏを既に貫通している。このため、ダイレータ１００および外シース１０１を、付属ガイドワイヤ２０に沿って左心房Ｌへ容易に到達させることができる。付属ガイドワイヤ２０は、外シース５０の内腔ではなく、外側に位置しているため、外シース５０の外側に、ダイレータ１００および外シース１０１を配置できる。ダイレータ１００および外シース１０１の構成は、特に限定されず、公知のものを利用できる。なお、ダイレータ１００および外シース１０１は、ダイレータ４０および外シース５０と同じ構成であってもよい。また、ダイレータ１００を使わずに外シース１０１のみや第２の医療デバイスのみを付属ガイドワイヤ２０に挿入してもよい。 Next, as shown in FIG. 7C, with the attached guide wire 20 as a guide, the other dilator 100 and the outer sheath 101 reach the right atrium R, and are inserted into the hole of the oval fossa O (step S16). . At this time, the attached guide wire 20 has already penetrated the oval fossa O. Therefore, the dilator 100 and the outer sheath 101 can easily reach the left atrium L along the attached guide wire 20. Since the attached guide wire 20 is located outside the inner sheath 50 and not the inner lumen, the dilator 100 and the outer sheath 101 can be disposed outside the outer sheath 50. The configurations of the dilator 100 and the outer sheath 101 are not particularly limited, and known ones can be used. The dilator 100 and the outer sheath 101 may have the same configuration as the dilator 40 and the outer sheath 50. Alternatively, only the outer sheath 101 or only the second medical device may be inserted into the attached guide wire 20 without using the dilator 100.
　また、ダイレータ１００および外シース１０１を卵円窩Ｏの孔に挿入する際に、ダイレータ４０が外シース５０から抜去されておらず、付属ガイドワイヤ２０が、ダイレータ４０の保持部４６に保持されていてもよい。この場合、ダイレータ１００を押し込んで保持部４６に接触させることで、保持部４６から付属ガイドワイヤ２０を容易に離脱させることができる。なお、保持部４６から付属ガイドワイヤ２０を離脱させるために、ダイレータ１００および外シース１０１とは異なるシースを、付属ガイドワイヤ２０に沿って生体管腔内に挿入してもよい。 Further, when the dilator 100 and the outer sheath 101 are inserted into the holes of the oval fossa O, the dilator 40 is not removed from the outer sheath 50, and the attached guide wire 20 is held by the holding portion 46 of the dilator 40. May be. In this case, the attached guide wire 20 can be easily detached from the holding portion 46 by pushing the dilator 100 into contact with the holding portion 46. Note that a sheath different from the dilator 100 and the outer sheath 101 may be inserted into the living body lumen along the attached guide wire 20 in order to detach the attached guide wire 20 from the holding portion 46.
　次に、外シース１０１を残してダイレータ１００を抜去する（ステップＳ１７）。これにより、図７（Ｄ）に示すように、卵円窩Ｏの１つの孔に、外シース５０および外シース１０１が貫通した状態となる。続いて、外シース５０の近位側から、弁体５５を介してガイドワイヤ９０を挿入する。なお、ガイドワイヤ９０および附属ガイドワイヤ２０は、他のガイドワイヤに入れ替えてもよい。 Next, the dilator 100 is removed leaving the outer sheath 101 (step S17). As a result, as shown in FIG. 7D, the outer sheath 50 and the outer sheath 101 pass through one hole of the oval fossa O. Subsequently, the guide wire 90 is inserted from the proximal side of the outer sheath 50 through the valve body 55. The guide wire 90 and the attached guide wire 20 may be replaced with other guide wires.
　この後、ガイドワイヤ９０、付属ガイドワイヤ２１に沿って、アブレーションカテーテル、リングカテーテル等の第２の医療デバイスを挿入する。これにより、卵円窩Ｏを貫通する外シース５０および外シース１０１を利用して、複数の第２の医療デバイスを左心房Ｌへ容易に挿入できる（ステップＳ１８）。左心房Ｌでのアブレーションが完了した後（ステップＳ１９）、各第２の医療デバイスを外シース５０および外シース１０１から体外に抜去する（ステップＳ２０）。さらに、外シース５０および外シース１０１を抜去すると、卵円窩Ｏの孔が収縮する（ステップＳ２１）。これにより、手技が完了する。なお、外シース５０および外シース１０１を介して生体内に挿入する第２の医療デバイスは、アブレーションカテーテルやリングカテーテルに限定されない。外シース５０および外シース１０１を介して第２の医療デバイスを挿入する位置は、左心房Ｌに限定されず、例えば、右心房Ｒ、左心耳、僧帽弁等であってもよい。 Thereafter, a second medical device such as an ablation catheter or a ring catheter is inserted along the guide wire 90 and the attached guide wire 21. Thereby, a some 2nd medical device can be easily inserted in the left atrium L using the outer sheath 50 and the outer sheath 101 which penetrate the oval fossa O (step S18). After the ablation in the left atrium L is completed (step S19), each second medical device is removed from the outer sheath 50 and the outer sheath 101 outside the body (step S20). Further, when the outer sheath 50 and the outer sheath 101 are removed, the hole of the foveal fossa O contracts (step S21). This completes the procedure. Note that the second medical device inserted into the living body via the outer sheath 50 and the outer sheath 101 is not limited to an ablation catheter or a ring catheter. The position where the second medical device is inserted through the outer sheath 50 and the outer sheath 101 is not limited to the left atrium L, and may be, for example, the right atrium R, the left atrial appendage, and the mitral valve.
　以上のように、本実施形態に係る医療システム１０は、生体管腔内の卵円窩Ｏ（生体組織）の孔に複数の線状体を挿入するための医療システム１０であって、軸方向へ貫通するルーメン４５が形成され、ルーメン４５よりも径方向外側で、遠位部に保持部４６が設けられたダイレータ４０（長尺体）と、を有し、ルーメン４５に穿刺デバイス６０を収容可能であり、保持部４６は、付属ガイドワイヤ２０の遠位部を離脱可能に保持する。上記のように構成した医療システム１０は、ダイレータ４０を生体管腔内に挿入し、ダイレータ４０のルーメン４５を介して、穿刺デバイス６０を生体管腔内で突出させ、卵円窩Ｏに孔を形成できる。さらに、穿刺デバイス６０に沿って、ダイレータ４０を卵円窩Ｏの孔に挿入することで、保持部４６に保持される付属ガイドワイヤ２０を卵円窩Ｏの孔に挿入できる。したがって、付属ガイドワイヤ２０を卵円窩Ｏの孔に通すための別のデバイスが不要である。このため、複数の線状体である穿刺デバイス６０および付属ガイドワイヤ２０を、効率よく卵円窩Ｏの孔に挿入できる。これにより、穿刺デバイス６０および付属ガイドワイヤ２０に沿って、外シース５０および外シース１０１を孔に挿入して設置できる。このため、アブレーションカテーテル等の複数のデバイスのための複数のアクセスルートを容易に確保でき、作業効率を高めることができる。また、一度の穿刺で、複数のアクセスルートを確保できるため、安全性が高い。 As described above, the medical system 10 according to the present embodiment is a medical system 10 for inserting a plurality of linear bodies into holes of the oval fossa O (living tissue) in a living body lumen, and is axially And a dilator 40 (elongate body) provided with a holding portion 46 at a distal portion on a radially outer side than the lumen 45, and the puncture device 60 is accommodated in the lumen 45 The holding portion 46 detachably holds the distal portion of the attached guide wire 20. The medical system 10 configured as described above inserts the dilator 40 into the living body lumen, causes the puncture device 60 to protrude in the living body lumen via the lumen 45 of the dilator 40, and forms a hole in the fossa fossa O Can be formed. Further, by inserting the dilator 40 into the hole of the ovary fossa O along the puncture device 60, the attached guide wire 20 held by the holding part 46 can be inserted into the hole of the ovary fossa O. Therefore, another device for passing the attached guide wire 20 through the hole of the foveal fossa O is unnecessary. For this reason, the puncture device 60 and the attached guide wire 20 which are a some linear body can be efficiently inserted in the hole of the oval fossa O. Thereby, the outer sheath 50 and the outer sheath 101 can be inserted into the hole and installed along the puncture device 60 and the attached guide wire 20. For this reason, a plurality of access routes for a plurality of devices such as an ablation catheter can be easily secured, and work efficiency can be improved. Moreover, since a plurality of access routes can be secured by one puncture, safety is high.
　また、保持部４６は、ダイレータ４０の遠位部に形成される孔部である。これにより、付属ガイドワイヤ２０を孔部に嵌合させることで付属ガイドワイヤ２０を離脱可能に保持できる。 Further, the holding part 46 is a hole formed in the distal part of the dilator 40. Thereby, the attached guide wire 20 can be detachably held by fitting the attached guide wire 20 into the hole.
　また、ダイレータ４０は、遠位側の端部に、外径が遠位側へ向かって減少するテーパ部４２（先端部）を有し、保持部４６は、テーパ部４２に設けられる。これにより、付属ガイドワイヤ２０を、ダイレータ４０のできるだけ遠位側に配置できる。このため、付属ガイドワイヤ２０を、卵円窩Ｏの孔へ効率よく挿入できる。また、保持部４６は、外シース５０の内径よりも小さい外径を有するテーパ部４２に設けられることで、外シース５０と干渉し難くなる。このため、ダイレータ４０が、外シース５０の内部を円滑に移動できる。 Further, the dilator 40 has a tapered portion 42 (tip portion) whose outer diameter decreases toward the distal side at the distal end portion, and the holding portion 46 is provided in the tapered portion 42. Thereby, the attached guide wire 20 can be arrange | positioned in the distal side of the dilator 40 as much as possible. For this reason, the attached guide wire 20 can be efficiently inserted into the hole of the oval fossa O. Further, the holding portion 46 is provided in the tapered portion 42 having an outer diameter smaller than the inner diameter of the outer sheath 50, so that it is difficult to interfere with the outer sheath 50. For this reason, the dilator 40 can move smoothly inside the outer sheath 50.
　また、第１の線状体は、卵円窩Ｏに孔を形成することが可能な鋭利またはエネルギーを出力する穿刺部６１を有する穿刺デバイス６０である。これにより、穿刺デバイス６０により卵円窩Ｏに孔を形成し、穿刺デバイス６０に沿って、形成した孔にダイレータ４０を挿入できる。 Further, the first linear body is a puncture device 60 having a puncture portion 61 that outputs sharp or energy capable of forming a hole in the foveal fossa O. Thereby, a hole is formed in the oval fossa O by the puncture device 60, and the dilator 40 can be inserted into the formed hole along the puncture device 60.
　また、医療システム１０は、ダイレータ４０を収容可能な内腔を有する外シース５０を有し、付属ガイドワイヤ２０は、外シース５０の外側に位置する。これにより、ダイレータ４０に沿って外シース５０を孔に配置できるとともに、外シース５０の外側に、付属ガイドワイヤ２０に沿って他の外シース１０１を配置できる。 Also, the medical system 10 has an outer sheath 50 having a lumen that can accommodate the dilator 40, and the attached guide wire 20 is located outside the outer sheath 50. Accordingly, the outer sheath 50 can be disposed in the hole along the dilator 40, and another outer sheath 101 can be disposed along the attached guide wire 20 outside the outer sheath 50.
　また、本実施形態に含まれるダイレータ４０は、生体管腔内の卵円窩Ｏ（生体組織）の孔を広げるためのダイレータ４０であって、当該ダイレータ４０は、軸方向へ貫通するルーメン４５が形成され、ルーメン４５よりも径方向外側で、遠位部に保持部４６が設けられており、保持部４６は、長尺な付属ガイドワイヤ２０（線状体）を離脱可能に保持する。上記のように構成したダイレータ４０は、付属ガイドワイヤ２０を保持部４６に保持した状態で、卵円窩Ｏに形成された孔に挿入できる。このため、保持部が卵円窩Ｏを通った後に、保持部４６から付属ガイドワイヤ２０を離脱させることで、付属ガイドワイヤ２０を、容易に卵円窩Ｏの孔に挿入した状態とすることができる。さらに、ルーメン４５を介して他の線状体である穿刺デバイス６０を生体管腔内で突出させて、卵円窩Ｏに孔を形成できる。このため、複数の線状体である穿刺デバイス６０および付属ガイドワイヤ２０を、効率よく卵円窩Ｏの孔に挿入できる。 The dilator 40 included in the present embodiment is a dilator 40 for expanding the hole of the oval fossa O (living tissue) in the living body lumen, and the dilator 40 has a lumen 45 penetrating in the axial direction. A holding portion 46 is formed at the distal portion and formed radially outside the lumen 45, and the holding portion 46 holds the long attached guide wire 20 (linear body) in a detachable manner. The dilator 40 configured as described above can be inserted into a hole formed in the oval fossa O in a state where the attached guide wire 20 is held by the holding portion 46. For this reason, after the holding part passes through the foveal fossa O, the auxiliary guidewire 20 is easily inserted into the hole of the foveal fossa O by detaching the auxiliary guidewire 20 from the holding part 46. Can do. Furthermore, the puncture device 60 which is another linear body can be protruded in the living body lumen through the lumen 45, and a hole can be formed in the oval fossa O. For this reason, the puncture device 60 and the attached guide wire 20 which are a some linear body can be efficiently inserted in the hole of the oval fossa O.
　また、本発明は、上述の医療システム１０を使用して生体管腔内の卵円窩Ｏ（生体組織）の孔に複数の線状体を挿入するための処置方法（治療方法）をも含む。当該処置方法は、保持部４６に付属ガイドワイヤ２０（第２の線状体）を保持したダイレータ４０（長尺体）を生体管腔内に挿入するステップＳ１０、Ｓ１１と、穿刺デバイス６０をダイレータ４０のルーメン４５に通して卵円窩Ｏの孔に挿入するステップＳ１２と、ダイレータ４０の保持部４６を含む遠位部を生体管腔内の卵円窩Ｏの孔に挿入するステップＳ１３と、付属ガイドワイヤ２０を保持部４６から離脱させるステップＳ１４と、を有する。上記のように構成した処置方法は、ダイレータ４０を生体管腔内に挿入し、ダイレータ４０のルーメン４５を介して、穿刺デバイス６０を生体管腔内で突出させて卵円窩Ｏに孔を形成し、その孔に穿刺デバイス６０を挿入できる。穿刺デバイス６０は、孔を通って左心房Ｌへ到達する。さらに、穿刺デバイス６０に沿って、ダイレータ４０を卵円窩Ｏの孔に挿入することで、保持部４６に保持される付属ガイドワイヤ２０を卵円窩Ｏの孔に挿入できる。したがって、付属ガイドワイヤ２０を卵円窩Ｏの孔に通すための別のデバイスが不要である。このため、複数の線状体である穿刺デバイス６０および付属ガイドワイヤ２０を、効率よく卵円窩Ｏの孔に挿入できる。これにより、穿刺デバイス６０および付属ガイドワイヤ２０に沿って、外シース５０および外シース１０１を孔に挿入して設置できる。このため、アブレーションカテーテル等の複数のデバイスのための複数のアクセスルートを容易に確保でき、作業効率を高めることができる。 The present invention also includes a treatment method (therapeutic method) for inserting a plurality of linear bodies into the holes of the oval fossa O (living tissue) in the living body lumen using the medical system 10 described above. . The treatment method includes steps S10 and S11 in which the dilator 40 (long body) holding the attached guide wire 20 (second linear body) in the holding portion 46 is inserted into the living body lumen, and the puncture device 60 being the dilator. Step S12 for inserting through the lumen 45 of 40 into the hole of the oval fossa O, step S13 of inserting the distal part including the holding part 46 of the dilator 40 into the hole of the oval fossa O in the body lumen, And step S14 for detaching the attached guide wire 20 from the holding portion 46. In the treatment method configured as described above, the dilator 40 is inserted into the living body lumen, and the puncture device 60 is protruded in the living body lumen through the lumen 45 of the dilator 40 to form a hole in the oval fossa O. Then, the puncture device 60 can be inserted into the hole. The puncture device 60 reaches the left atrium L through the hole. Further, by inserting the dilator 40 into the hole of the ovary fossa O along the puncture device 60, the attached guide wire 20 held by the holding part 46 can be inserted into the hole of the ovary fossa O. Therefore, another device for passing the attached guide wire 20 through the hole of the foveal fossa O is unnecessary. For this reason, the puncture device 60 and the attached guide wire 20 which are a some linear body can be efficiently inserted in the hole of the oval fossa O. Thereby, the outer sheath 50 and the outer sheath 101 can be inserted into the hole and installed along the puncture device 60 and the attached guide wire 20. For this reason, a plurality of access routes for a plurality of devices such as an ablation catheter can be easily secured, and work efficiency can be improved.
　なお、本発明は、上述した実施形態のみに限定されるものではなく、本発明の技術的思想内において当業者により種々変更が可能である。例えば、上述した医療システム１０は、卵円窩Ｏ以外の生体内の生体組織の孔に、複数の線状体を挿入するために用いられてもよい。孔を形成する生体組織は、例えば、塞栓された血管等である。生体組織の孔は、穿刺して形成された孔に限定されず、元から生体組織に存在する孔であってもよい。このため、医療システム１０は、穿刺デバイス６０を有さなくてもよい。したがって、ダイレータ４０に収容される第１の長尺体は、穿刺デバイス６０でなくてもよく、例えばガイドワイヤであってもよい。また、本実施形態において、ダイレータ４０および付属ガイドワイヤ２０は、生体組織の孔を貫通するが、完全に貫通しなくてもよい。すなわち、生体組織の孔の形状や行う手技によっては、穿刺デバイス６０および付属ガイドワイヤ２０は、孔を貫通するのではなく、孔の内部に到達してもよい。この場合、孔の内部に、複数のデバイスを導くことができる。 Note that the present invention is not limited to the above-described embodiment, and various modifications can be made by those skilled in the art within the technical idea of the present invention. For example, the above-described medical system 10 may be used to insert a plurality of linear bodies into the holes of living tissue in the living body other than the foveal fossa O. The biological tissue that forms the hole is, for example, an embolized blood vessel. The hole of the living tissue is not limited to the hole formed by puncturing, and may be a hole that originally exists in the living tissue. For this reason, the medical system 10 may not have the puncture device 60. Therefore, the first elongated body accommodated in the dilator 40 may not be the puncture device 60, and may be a guide wire, for example. Moreover, in this embodiment, although the dilator 40 and the attached guide wire 20 penetrate the hole of a biological tissue, it does not need to penetrate completely. That is, depending on the shape of the hole of the biological tissue and the procedure to be performed, the puncture device 60 and the attached guide wire 20 may reach the inside of the hole instead of penetrating the hole. In this case, a plurality of devices can be guided inside the hole.
　また、図９（Ａ）に示す第１の変形例のように、ダイレータ１１０は、２つの保持部４６を備えてもよい。これにより、ダイレータ１１０を生体組織の孔に一度挿入するだけで、２つの付属ガイドワイヤ２０を孔に挿入できる。これにより、複数の付属ガイドワイヤ２０に沿って、複数のデバイスを容易に孔に通すことができる。また、ダイレータに設けられる保持部は、３つ以上であってもよい。なお、前述の実施形態と同様の機能を有する部位には、同一の符号を付し、説明を省略する。 Further, as in the first modification shown in FIG. 9A, the dilator 110 may include two holding portions 46. Thereby, the two attached guide wires 20 can be inserted into the hole only by once inserting the dilator 110 into the hole of the living tissue. Thereby, a plurality of devices can be easily passed through the holes along the plurality of attached guide wires 20. Moreover, the holding part provided in a dilator may be three or more. In addition, the same code | symbol is attached | subjected to the site | part which has a function similar to the above-mentioned embodiment, and description is abbreviate | omitted.
　また、図９（Ｂ）に示す第２の変形例のように、ダイレータ１２０の保持部１２１は、遠位側へ貫通する保持孔１２１Ａを有してもよい。 Further, as in the second modified example shown in FIG. 9B, the holding part 121 of the dilator 120 may have a holding hole 121A penetrating to the distal side.
　また、図９（Ｃ）に示す第３の変形例のように、ダイレータ１３０の保持部１３１は、テーパ部４２よりも近位側に設けられてもよい。この場合、保持部１３１は、外シース５０に干渉しないように、ダイレータ１３０の外周面から突出しないことが好ましい。 Further, as in the third modification shown in FIG. 9C, the holding portion 131 of the dilator 130 may be provided on the proximal side with respect to the tapered portion 42. In this case, it is preferable that the holding portion 131 does not protrude from the outer peripheral surface of the dilator 130 so as not to interfere with the outer sheath 50.
　また、図９（Ｄ）に示す第４の変形例のように、ダイレータ１４０の保持部１４１に形成される孔部の近位部が、縮径部１４２を有してもよい。縮径部１４２は、近位側へ向かって内径が減少する。付属ガイドワイヤ１５０は、この縮径部１４２が嵌合可能な溝状の凹部１５１が周方向に延びて形成される。付属ガイドワイヤ１５０を保持部１４１に挿入すると、縮径部１４２が凹部１５１に入り込む。これにより、保持部１４１は、付属ガイドワイヤ１５０を強固に保持できる。このため、ダイレータ１４０を生体管腔内で搬送する際に、付属ガイドワイヤ１５０が保持部１４１から予期せずに離脱することを抑制できる。付属ガイドワイヤ１５０を保持部１４１から離脱させる際には、付属ガイドワイヤ１５０を、ダイレータ１４０に対して相対的に近位側へ移動させる。これにより、保持部１４１および付属ガイドワイヤ１５０の少なくとも一方が変形し、付属ガイドワイヤ１５０が保持部１４１から離脱できる。 Also, as in the fourth modification shown in FIG. 9D, the proximal portion of the hole formed in the holding portion 141 of the dilator 140 may have a reduced diameter portion 142. The inner diameter of the reduced diameter portion 142 decreases toward the proximal side. The accessory guide wire 150 is formed by extending a groove-shaped recess 151 into which the reduced diameter portion 142 can be fitted in the circumferential direction. When the attached guide wire 150 is inserted into the holding portion 141, the reduced diameter portion 142 enters the recess 151. Thereby, the holding | maintenance part 141 can hold | maintain the attached guide wire 150 firmly. For this reason, when the dilator 140 is transported in the living body lumen, the attached guide wire 150 can be prevented from being unexpectedly detached from the holding portion 141. When the attached guide wire 150 is detached from the holding portion 141, the attached guide wire 150 is moved to the proximal side relative to the dilator 140. Accordingly, at least one of the holding portion 141 and the attached guide wire 150 is deformed, and the attached guide wire 150 can be detached from the holding portion 141.
　また、図１０（Ａ）、（Ｂ）に示す第５の変形例のように、ダイレータ１６０の保持部１６１は、孔部ではなく溝部であってもよい。保持部１６１は、近位側に開く挿入口１６２と、スリット状に延在する側面開口部１６３と、側面開口部１６３を挟む２つの側壁１６４を備えている。保持部１６１は、付属ガイドワイヤ２０を収容可能な内腔が、側面開口部１６３に沿って、挿入口１６２から遠位側へ延在する。保持部１６１は、溝部であっても、付属ガイドワイヤ２０を離脱可能に保持することができる。なお、溝部の構造は、付属ガイドワイヤ２０を挟むように保持できれば、特に限定されない。 Further, as in the fifth modification shown in FIGS. 10A and 10B, the holding portion 161 of the dilator 160 may be a groove portion instead of a hole portion. The holding portion 161 includes an insertion port 162 that opens to the proximal side, a side opening 163 that extends in a slit shape, and two side walls 164 that sandwich the side opening 163. In the holding portion 161, a lumen capable of accommodating the attached guide wire 20 extends from the insertion port 162 to the distal side along the side opening 163. Even if the holding portion 161 is a groove portion, the attached guide wire 20 can be detachably held. The structure of the groove is not particularly limited as long as it can be held so as to sandwich the attached guide wire 20.
　また、図１１（Ａ）、（Ｂ）に示す第６の変形例のように、ダイレータ１７０の保持部１７１は溝部であり、付属ガイドワイヤ１５０の遠位部は、溝状の凹部１５１が周方向に形成されてもよい。凹部１５１の外径は、軸方向に沿って徐々に変化する。このため凹部１５１が生体組織に接触する際の生体への影響が低減し、好ましい。なお、凹部１５１の外径は、軸方向に沿って段差状に変化してもよい。溝部のスリット状の開口部１７２の隙間の幅は、付属ガイドワイヤ１５０の凹部１５１の外径よりも大きく、かつ付属ガイドワイヤ１５０の最大外径（凹部１５１ではない一定の外径を有する部位の外径）よりも小さい。開口部１７２は、遠位側から近位側へ延在し、保持部１７１の近位側の面１７３にも形成される。保持部１７１の近位側の面１７３は、遠位側へ向かってダイレータ４０の径方向外側へ傾斜している。開口部１７２の遠位側には、付属ガイドワイヤ２０の最大外径よりも大きな内径の大径部１７４が設けられている。付属ガイドワイヤ１５０を保持部１７１に保持すると、付属ガイドワイヤ１５０の凹部１５１が、開口部１７２に挟まれる。このとき、スリット状の開口部１７２の隙間の幅は、付属ガイドワイヤ１５０の凹部１５１の外径よりも大きく、かつ付属ガイドワイヤ１５０の最大外径よりも小さい。このため、凹部１５１は、開口部１７２から離脱しない。ダイレータ１７０を生体管腔内で搬送する際には、付属ガイドワイヤ１５０は、近位側へ向かう抵抗力を受ける。しかしながら、開口部１７２は、保持部１７１の近位側の面１７３まで延在しているため、付属ガイドワイヤ１５０が保持部１７１から予期せずに離脱することを抑制できる。付属ガイドワイヤ１５０を保持部１７１から離脱させる際には、付属ガイドワイヤ１５０を、ダイレータ１７０に対して相対的に遠位側へ移動させる。これにより、凹部１５１が開口部１７２に沿ってスライドし、遠位側へ移動する。このため、付属ガイドワイヤ１５０は、遠位側の大径部１７４に到達し、大径部１７４から外部へ放出される。これにより、付属ガイドワイヤ１５０は、保持部１７１から離脱できる。 Further, as in the sixth modification shown in FIGS. 11A and 11B, the holding portion 171 of the dilator 170 is a groove portion, and the distal portion of the attached guide wire 150 has a groove-like recess portion 151 around it. It may be formed in the direction. The outer diameter of the recess 151 gradually changes along the axial direction. For this reason, when the recessed part 151 contacts a biological tissue, the influence on the biological body reduces, and it is preferable. Note that the outer diameter of the recess 151 may change stepwise along the axial direction. The width of the gap of the slit-like opening 172 of the groove is larger than the outer diameter of the concave portion 151 of the attached guide wire 150 and the maximum outer diameter of the attached guide wire 150 (the portion having a constant outer diameter that is not the concave portion 151). Smaller than the outer diameter). The opening 172 extends from the distal side to the proximal side, and is also formed on the proximal surface 173 of the holding portion 171. The proximal surface 173 of the holding portion 171 is inclined outward in the radial direction of the dilator 40 toward the distal side. A large-diameter portion 174 having an inner diameter larger than the maximum outer diameter of the attached guide wire 20 is provided on the distal side of the opening 172. When the attached guide wire 150 is held by the holding portion 171, the concave portion 151 of the attached guide wire 150 is sandwiched between the openings 172. At this time, the width of the gap of the slit-shaped opening 172 is larger than the outer diameter of the concave portion 151 of the attached guide wire 150 and smaller than the maximum outer diameter of the attached guide wire 150. For this reason, the recess 151 does not leave the opening 172. When the dilator 170 is transported in the living body lumen, the attached guide wire 150 receives a resistance force toward the proximal side. However, since the opening 172 extends to the surface 173 on the proximal side of the holding portion 171, the attached guide wire 150 can be prevented from being unexpectedly detached from the holding portion 171. When the attached guide wire 150 is detached from the holding portion 171, the attached guide wire 150 is moved to the distal side relative to the dilator 170. Thereby, the recessed part 151 slides along the opening part 172, and moves to a distal side. For this reason, the attached guide wire 150 reaches the distal-side large-diameter portion 174 and is discharged from the large-diameter portion 174 to the outside. Thereby, the attached guide wire 150 can be detached from the holding portion 171.
　また、図１２（Ａ）に示す第７の変形例のように、ダイレータ１８０の保持部１８１は、接着剤や粘着剤により形成されてもよい。付属ガイドワイヤ２０を、ダイレータ１８０に対して相対的に移動させることで、保持部１８１による連結が解除される。これにより、付属ガイドワイヤ２０は、ダイレータ１８０から離脱できる。 Also, as in the seventh modification shown in FIG. 12A, the holding portion 181 of the dilator 180 may be formed of an adhesive or a pressure-sensitive adhesive. By moving the attached guide wire 20 relative to the dilator 180, the connection by the holding portion 181 is released. Thereby, the attached guide wire 20 can be detached from the dilator 180.
　また、図１２（Ｂ）に示す第８の変形例のように、ダイレータ１９０の保持部１９１は、テーパ面４２Ａから突出せず、テーパ部４２に完全に埋設されてもよい。これにより、卵円窩Ｏに形成した孔にダイレータ１９０を挿入する際に、保持部１９１が妨げとならず、円滑に挿入できる。 Further, as in the eighth modification shown in FIG. 12B, the holding portion 191 of the dilator 190 may not be projected from the tapered surface 42A and may be completely embedded in the tapered portion 42. Thereby, when inserting the dilator 190 in the hole formed in the oval fossa O, the holding | maintenance part 191 does not become obstructive and can insert smoothly.
　さらに、本出願は、２０１６年９月２９日に出願された日本特許出願番号２０１６－１９１０２９号に基づいており、それらの開示内容は、参照され、全体として、組み入れられている。 Furthermore, this application is based on Japanese Patent Application No. 2016-191029 filed on Sep. 29, 2016, and the disclosures thereof are referenced and incorporated as a whole.
　　１０　　医療システム、
　　２０、１５０　　付属ガイドワイヤ（第２の線状体）、
　　４０、１１０、１２０、１３０、１４０、１６０、１７０、１８０、１９０　　ダイレータ、
　　４２　　テーパ部（先端部）、
　　４２Ａ　　テーパ面、
　　４５　　ルーメン、
　　４６、１１１、１２１、１３１、１４１、１６１、１７１、１８１、１９１　　保持部、
　　４６Ａ　　保持孔（孔部）、
　　５０　　外シース、
　　６０　　穿刺デバイス（第１の線状体）、
　　８０　　シース組立体、
　　９０　　ガイドワイヤ（第１の線状体）、
　　Ｏ　　卵円窩（生体組織）、
　　Ｌ　　左心房、
　　Ｒ　　右心房。 10 Medical system,
20, 150 attached guide wire (second linear body),
40, 110, 120, 130, 140, 160, 170, 180, 190 dilator,
42 taper part (tip part),
42A taper surface,
45 lumens,
46, 111, 121, 131, 141, 161, 171, 181, 191 holder,
46A holding hole (hole),
50 outer sheath,
60 Puncture device (first linear body),
80 sheath assembly,
90 guide wire (first linear body),
O foveal fossa (living tissue),
L left atrium,
R Right atrium.

Claims (9)

  1. 　生体管腔内の生体組織の孔に複数の線状体を挿入するための医療システムであって、
    　軸方向へ貫通するルーメンが形成され、前記ルーメンよりも径方向外側で、遠位部に保持部が設けられた長尺体と、を有し、
    　前記ルーメンに第１の線状体を収容可能であり、
    　前記保持部は、第２の線状体の遠位部を離脱可能に保持する医療システム。     A medical system for inserting a plurality of linear bodies into a hole of a biological tissue in a biological lumen,
    A lumen penetrating in the axial direction, having a long body provided with a holding portion at a distal portion, radially outward from the lumen;
    A first linear body can be accommodated in the lumen;
    The holding part is a medical system that holds the distal part of the second linear body in a detachable manner.
  2. 　前記保持部は、前記長尺体の遠位部に形成される孔部または溝部である請求項１に記載の医療システム。 The medical system according to claim 1, wherein the holding part is a hole or a groove formed in a distal part of the elongated body.
  3. 　前記長尺体は、遠位側の端部に、外径が遠位側へ向かって減少する先端部を有し、
    　前記保持部は、前記先端部に設けられる請求項１または２に記載の医療システム。     The elongate body has a tip portion whose outer diameter decreases toward the distal side at a distal end portion,
    The medical system according to claim 1, wherein the holding portion is provided at the tip portion.
  4. 　前記第１の線状体は、生体組織に孔を形成することが可能な鋭利またはエネルギーを出力する穿刺部を有する穿刺デバイスである請求項１～３のいずれか１項に記載の医療システム。 The medical system according to any one of claims 1 to 3, wherein the first linear body is a puncture device having a puncture unit that outputs a sharp or energy capable of forming a hole in a living tissue.
  5. 　前記長尺体を収容可能な内腔を有する外シースをさらに有し、
    　前記第２の線状体は、外シースの外側に位置する請求項１～４のいずれか１項に記載の医療システム。     An outer sheath having a lumen capable of accommodating the elongated body;
    The medical system according to any one of claims 1 to 4, wherein the second linear body is located outside the outer sheath.
  6. 　生体管腔内の生体組織の孔を広げるためのダイレータであって、
    　前記ダイレータは、軸方向へ貫通するルーメンが形成され、前記ルーメンよりも径方向外側で、遠位部に保持部が設けられており、
    　前記保持部は、長尺な線状体を離脱可能に保持するダイレータ。     A dilator for expanding a hole in a living tissue in a living body lumen,
    In the dilator, a lumen penetrating in the axial direction is formed, and a holding portion is provided at a distal portion at a radially outer side than the lumen.
    The holding part is a dilator that holds a long linear body in a detachable manner.
  7. 　前記保持部は、前記ダイレータの遠位部に形成される孔部または溝部である請求項６に記載のダイレータ。 The dilator according to claim 6, wherein the holding part is a hole or a groove formed in a distal part of the dilator.
  8. 　前記ダイレータは、遠位側の端部に、外径が遠位側へ向かって減少する先端部を有し、
    　前記保持部は、前記先端部に設けられる請求項６または７に記載のダイレータ。     The dilator has a tip portion whose outer diameter decreases toward the distal side at a distal end portion;
    The dilator according to claim 6 or 7, wherein the holding portion is provided at the tip portion.
  9. 　請求項１に記載の医療システムを使用して生体管腔内の生体組織の孔に複数の線状体を挿入するための処置方法であって、
    　前記保持部に前記第２の線状体を保持した前記長尺体を生体管腔内に挿入するステップと、
    　前記第１の線状体を前記長尺体のルーメンに通して前記生体組織の孔に挿入するステップと、
    　前記長尺体の前記保持部を含む遠位部を前記生体組織の孔に挿入するステップと、
    　前記第２の線状体を前記保持部から離脱させるステップと、を有する処置方法。     A treatment method for inserting a plurality of linear bodies into a hole in a living tissue in a living body lumen using the medical system according to claim 1,
    Inserting the elongated body holding the second linear body in the holding portion into a living body lumen;
    Inserting the first linear body through the lumen of the elongated body and inserting into the hole of the biological tissue;
    Inserting a distal portion including the holding portion of the elongated body into the hole of the biological tissue;
    Detaching the second linear body from the holding part.
PCT/JP2017/035213 2016-09-29 2017-09-28 Medical system, dilator, and treatment method WO2018062386A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2016191029A JP2019205485A (en) 2016-09-29 2016-09-29 Medical system, dilator, and treatment method
JP2016-191029 2016-09-29

Publications (1)

Publication Number Publication Date
WO2018062386A1 true WO2018062386A1 (en) 2018-04-05

Family

ID=61759836

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/JP2017/035213 WO2018062386A1 (en) 2016-09-29 2017-09-28 Medical system, dilator, and treatment method

Country Status (2)

Country Link
JP (1) JP2019205485A (en)
WO (1) WO2018062386A1 (en)

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH07250839A (en) * 1994-02-22 1995-10-03 Smith & Nephew Dyonics Inc Probe for suture
JPH1142233A (en) * 1996-09-19 1999-02-16 C R Bard Inc Improved device and method for wound suturing
JP2012231969A (en) * 2011-05-02 2012-11-29 Nipro Corp Double-lumen dilator

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH07250839A (en) * 1994-02-22 1995-10-03 Smith & Nephew Dyonics Inc Probe for suture
JPH1142233A (en) * 1996-09-19 1999-02-16 C R Bard Inc Improved device and method for wound suturing
JP2012231969A (en) * 2011-05-02 2012-11-29 Nipro Corp Double-lumen dilator

Also Published As

Publication number Publication date
JP2019205485A (en) 2019-12-05

Similar Documents

Publication Publication Date Title
JP5881081B2 (en) Coaxial transseptal guidewire and needle assembly
EP3769708B1 (en) Medical device
EP3603727B1 (en) Guide wire, medical device
US20070185522A1 (en) Dilator
JP2022028927A (en) Hybrid transseptal dilator
US20190216503A1 (en) Medical device and treatment method
WO2019181634A1 (en) Medical device
JP7197559B2 (en) Guidewires and medical devices
US20230277208A1 (en) Steerable Endoluminal Punch with Introducer and Guidewire
WO2018163899A1 (en) Puncture device, medical device, and treatment method
JP2018051146A (en) Dilator, medical system and treatment method
WO2018047901A1 (en) Medical device and treatment method
WO2018062386A1 (en) Medical system, dilator, and treatment method
WO2018079508A1 (en) Medical device and treatment method
WO2018083685A1 (en) Medical device and treatment method
JP6847617B2 (en) Medical systems and devices
US10285682B2 (en) Medical device and treatment method
JP2018068594A (en) Medical device and treatment method

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: 17856335

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: 17856335

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: JP