WO2018062386A1 - Système médical, dilatateur et procédé de traitement - Google Patents

Système médical, dilatateur et procédé de traitement Download PDF

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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
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WO
WIPO (PCT)
Prior art keywords
dilator
lumen
hole
guide wire
holding
Prior art date
Application number
PCT/JP2017/035213
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English (en)
Japanese (ja)
Inventor
大坪靖一
早川浩一
Original Assignee
テルモ株式会社
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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/fr

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    • 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.

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

Abstract

L'invention concerne un système médical, un dilatateur et un procédé de traitement, selon lesquels une pluralité de corps linéaires peuvent facilement être insérés dans un trou d'un tissu biologique dans une lumière d'un organisme, et l'efficacité de travail peut être augmentée. L'invention porte aussi sur un système médical (10), pour insérer une pluralité de corps linéaires dans un trou d'une fosse ovale (O) dans une lumière d'un organisme, le système médical (10) ayant un dilatateur (40) dans lequel une lumière (45) pénétrant dans la direction axiale de celui-ci est formée et une partie de retenue (46) est fournie à une partie distale de celui-ci davantage à l'extérieur dans la direction radiale que la lumière (45), la lumière (45) étant apte à recevoir un dispositif de perforation (60), et la partie de retenue (46) retenant de manière amovible la partie distale d'un fil-guide attaché (20).
PCT/JP2017/035213 2016-09-29 2017-09-28 Système médical, dilatateur et procédé de traitement WO2018062386A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2016191029A JP2019205485A (ja) 2016-09-29 2016-09-29 医療システムおよびダイレータ並びに処置方法
JP2016-191029 2016-09-29

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WO2018062386A1 true WO2018062386A1 (fr) 2018-04-05

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH07250839A (ja) * 1994-02-22 1995-10-03 Smith & Nephew Dyonics Inc 縫合糸用プローブ
JPH1142233A (ja) * 1996-09-19 1999-02-16 C R Bard Inc 改良された創傷縫合装置及び方法
JP2012231969A (ja) * 2011-05-02 2012-11-29 Nipro Corp ダブルルーメンダイレータ

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH07250839A (ja) * 1994-02-22 1995-10-03 Smith & Nephew Dyonics Inc 縫合糸用プローブ
JPH1142233A (ja) * 1996-09-19 1999-02-16 C R Bard Inc 改良された創傷縫合装置及び方法
JP2012231969A (ja) * 2011-05-02 2012-11-29 Nipro Corp ダブルルーメンダイレータ

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