WO2020196142A1 - Medical device - Google Patents

Medical device Download PDF

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Publication number
WO2020196142A1
WO2020196142A1 PCT/JP2020/011908 JP2020011908W WO2020196142A1 WO 2020196142 A1 WO2020196142 A1 WO 2020196142A1 JP 2020011908 W JP2020011908 W JP 2020011908W WO 2020196142 A1 WO2020196142 A1 WO 2020196142A1
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WO
WIPO (PCT)
Prior art keywords
electrode
balloon
proximal
band
medical device
Prior art date
Application number
PCT/JP2020/011908
Other languages
French (fr)
Japanese (ja)
Inventor
大久保到
周拓
Original Assignee
テルモ株式会社
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by テルモ株式会社 filed Critical テルモ株式会社
Priority to JP2021509248A priority Critical patent/JP7316351B2/en
Publication of WO2020196142A1 publication Critical patent/WO2020196142A1/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor

Definitions

  • the present invention relates to a medical device that is inserted into a living body and ablates a living tissue.
  • IRE Irreversible Electroporation
  • the irreversible electrosurgical method is attracting attention because it is non-thermal and can suppress damage to surrounding blood vessels and nerves.
  • a medical device that treats a cancer that is difficult to remove by surgery by using an irreversible electric perforation method is known.
  • pulmonary vein isolation may be performed to ablate the junction between the pulmonary vein and the left atrium and destroy the myocardial cells. ..
  • high frequencies are generated from the distal part of the ablation catheter to punctate and necrotize the myocardium.
  • the ablation catheter is moved to cauterize the pulmonary vein inflow in a circumferential manner to isolate the pulmonary vein.
  • the medical device described in Patent Document 1 includes an expansion member having a cautery electrode for ablation and a measurement electrode for measuring an electric potential for detecting pulmonary vein isolation.
  • the ablation electrode is arranged at a portion having a large diameter on the proximal side of the expansion member, and the measuring electrode is arranged at a portion having a small diameter on the distal side of the expansion member. Therefore, this medical device can perform ablation by contacting the ablation electrode with the junction between the pulmonary vein and the left atrium while measuring the potential by contacting the measuring electrode inserted into the pulmonary vein with the pulmonary vein. ..
  • the present invention has been made to solve the above-mentioned problems, and an object of the present invention is to provide a medical device capable of satisfactorily contacting an electrode that outputs energy to a living tissue to a target site.
  • a medical device that achieves the above object is arranged on a long shaft portion and a distal side of the shaft portion, extends along the long axis direction of the shaft portion, and can be deformed in the radial direction of the shaft portion.
  • the band has a plurality of bands, and at least one of the bands is arranged on the distal side of the first electrode and the first electrode, which outputs energy to the living tissue, and the flexural rigidity is far. It has a bend that is lower than the adjacent sites on the position side and the proximal side.
  • the bent portion on the distal side of the first electrode that outputs energy is likely to bend. Therefore, the first electrode can be brought into good contact with the target portion while flexibly bending the bent portion in the direction closer to the shaft portion.
  • FIG. 2 It is a top view which shows the medical device which concerns on 1st Embodiment. It is a figure which shows the band part, (A) is a plan view, (B) is a cross-sectional view along the line AA of FIG. 2 (A). It is sectional drawing which shows the distal part of the medical device which concerns on 1st Embodiment. It is sectional drawing which shows the expanded state of the band part of the medical device which concerns on 1st Embodiment. It is sectional drawing which shows the distal part of the medical device which concerns on 2nd Embodiment. It is sectional drawing which shows the expanded state of the band part of the medical device which concerns on 2nd Embodiment.
  • distal side the side to be inserted into the lumen
  • proximal side the hand side to be operated
  • the medical device 10 according to the first embodiment is percutaneously inserted into a living body cavity, contacts a living body tissue at a target site, applies an electric signal, and performs an irreversible electric drilling method.
  • the target of the medical device 10 of the present embodiment is a treatment of electroporating the entrance of a pulmonary vein over the entire circumference in pulmonary vein isolation.
  • the medical device 10 can also be applied to other treatments.
  • the medical device 10 includes a long shaft portion 20, an expansion portion 40 provided at a distal portion of the shaft portion 20, and a hub 60 provided at a proximal portion of the shaft portion 20. have. Further, the medical device 10 has a plurality of band portions 50 provided around the expansion portion 40, and a lead wire 70 for transmitting an electric current to the band portion 50.
  • the band portion 50 has a first electrode 57A that outputs energy to a living tissue and a second electrode 58A that measures an electric potential.
  • the shaft portion 20 has a tubular outer tube 21 and an inner tube 30 arranged inside the second tubular body 23.
  • the outer pipe 21 and the inner pipe 30 are arranged coaxially.
  • the outer pipe 21 and the inner pipe 30 are relatively movable in the axial direction.
  • the outer pipe 21 is fixed to the first pipe body 22, the second pipe body 23 that covers the outer peripheral surface of the first pipe body 22, and the second pipe body 23 that covers the outer peripheral surface of the second pipe body 23. It has 3 tubes 24.
  • the distal ends of the first tube 22 and the second tube 23 are liquidtightly fixed.
  • An expansion lumen 28 is formed outside the first tube body 22 and inside the second tube body 23.
  • An expansion fluid for expanding the expansion portion 40 can be circulated in the expansion lumen 28.
  • the expansion fluid may be a gas or a liquid, and for example, a gas such as helium gas, CO 2 gas, O 2 gas, or laughing gas, or a liquid such as physiological saline, a contrast agent, or a mixture thereof can be used.
  • the second pipe body 23 and the third pipe body 24 are arranged coaxially.
  • the lead wire 70 is arranged so as to be sandwiched between the second pipe body 23 and the third pipe body 24.
  • the first tube body 22 and the second tube body 23 have a step portion 26 extending to the distal side from the distal end surface 25 of the third tube body 24.
  • the step portion 26 has a circular tube shape.
  • An expansion portion 40 and a proximal portion of the band portion 50 are fixed to the outer peripheral surface of the step portion 26.
  • the second tubular body 23 is formed with at least two side holes 27 for communicating the internal expansion lumen 28 to the outside. Each side hole 27 communicates with the inside of the expansion portion 40 described later.
  • the inner tube 30 extends further to the distal side from the tip of the second tube body 23.
  • the distal portion of the expansion portion 40 is fixed to the outer peripheral surface of the inner tube 30 on the distal side of the second tube body 23.
  • a fixing portion 29 for fixing the distal portion of the band portion 50 is fixed to the outer peripheral surface on the distal side of the position where the expansion portion 40 is fixed.
  • a guide wire lumen 31 along the length direction is formed inside the inner pipe 30. A guide wire can be inserted into the guide wire lumen 31.
  • the outer diameter of the shaft portion 20 is not particularly limited, but is preferably minimally invasive and not too large to satisfy compatibility with a general sheath or guiding catheter to be inserted, for example, within 4.0 mm. It is preferably within 2.9 mm.
  • the constituent materials of the first tube body 22, the second tube body 23, the third tube body 24, and the inner tube 30 have a certain degree of flexibility. Further, it is preferable that the constituent materials of the first tube body 22, the second tube body 23, the third tube body 24 and the inner tube 30 have an insulating property.
  • a material include polyolefins such as polyethylene, polypropylene, polybutene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, ionomer, or a mixture of two or more thereof, and a soft polyvinyl chloride resin. Examples thereof include polyamide, polyamide elastomer, polyimide, polyester, polyester elastomer, polyurethane, fluororesin such as polytetrafluoroethylene, silicone rubber, latex rubber and the like.
  • the expansion unit 40 has a first balloon 41 and a second balloon 42 that can be flexibly deformed.
  • the first balloon 41 is a flexibly deformable elastic body that covers the outer peripheral surface of the stepped portion 26 of the second tubular body 23.
  • the distal end and the proximal end of the first balloon 41 are fixed to the step portion 26.
  • At least one of the side holes 27 is arranged inside the first balloon 41. Therefore, the inside of the first balloon 41 communicates with the expansion lumen 28.
  • the second balloon 42 is a flexibly deformable elastic body that covers the outer peripheral surface of the step portion 26 on the distal side of the first balloon 41.
  • the distal end and the proximal end of the second balloon 42 are fixed to the step portion 26.
  • At least one of the side holes 27 is arranged inside the second balloon 42. Therefore, the inside of the second balloon 42 communicates with the expansion lumen 28.
  • the first balloon 41 can be expanded more outward in the radial direction of the shaft portion 20 than the second balloon 42.
  • the shapes of the first balloon 41 and the second balloon 42 are not particularly limited in the cross section passing through the long axis of the shaft portion 20, but are, for example, substantially cylindrical, substantially elliptical, substantially trapezoidal, and the like.
  • the first balloon 41 and the second balloon 42 are preferably thin and flexible. Further, the first balloon 41 and the second balloon 42 are also required to have enough strength to surely spread the band portion 50.
  • the constituent materials of the first balloon 41 and the second balloon 42 those mentioned above for the shaft portion 20 can be used, and other elastomers (for example, various elastomers such as hydrogenated styrene-based thermoplastic elastomer (SEBS)) can be used. Material) can also be used.
  • SEBS hydrogenated styrene-based thermoplastic elastomer
  • the lead wire 70 is linear, has a buried portion 72 embedded inside the outer tube 21, a tip lead wire 71 protruding distally from the distal end surface 25 of the outer tube 21, and an outer tube 21 on the proximal side. It has a proximal lead wire 73 that is led out from.
  • the buried portion 72 is sandwiched between the second pipe body 23 and the third pipe body 24.
  • the number of the conducting wires 70 is preferably equal to or greater than the total number of the number of the first electrode 57A and the number of the second electrodes 58A.
  • the plurality of conductors 70 are formed by a polymorphic spiral structure. Therefore, the plurality of lead wires 70 can carry independent currents without being electrically short-circuited.
  • the diameter of the conducting wire 70 that conducts electricity to the first electrode 57A is preferably larger than the diameter of the conducting wire 70 that conducts electricity to the second electrode 58A. As a result, a large current can be passed through the first electrode 57A, and many second electrodes 58A can be arranged. Therefore, high energy can be output from the first electrode 57A, and the second electrode 58A can be multipolarized.
  • each lead wire 70 is electrically connected to the terminal of the band portion 50.
  • the proximal lead wire 73 is drawn out from the proximal portion of the third tubular body 24 toward the proximal end, and is connected to a power supply unit 12 and a diagnostic device 13 provided outside the shaft portion 20.
  • the power supply unit 12 can supply electricity to the first electrode 57A of the band unit 50.
  • the diagnostic device 13 can measure the potential of the second electrode 58A of the band portion 50.
  • the constituent material of the conducting wire 70 is preferably highly conductive, and is, for example, copper, gold, platinum, silver, aluminum, alloy, carbon fiber, or the like.
  • As the lead wire 70 a known lead wire can be used.
  • each band portion 50 has a substantially constant width and thickness and extends in the long axis direction of the shaft portion 20.
  • the band portion 50 is formed of, for example, a flexible printed circuit board.
  • Each band 50 has flexibility.
  • Each band portion 50 is located on the outer peripheral side of the first balloon 41 and the second balloon 42, and is not fixed to the first balloon 41 and the second balloon 42.
  • the band portion 50 may be partially fixed to the first balloon 41 and / or the second balloon 42.
  • the plurality of band portions 50 are arranged side by side in the circumferential direction Z of the expansion portion 40 on the outer peripheral side of the expansion portion 40.
  • Each band portion 50 extends in the long axis direction of the shaft portion 20.
  • Each band portion 50 has a proximal fixing portion 51 located on the proximal side and a distal fixing portion 52 located on the distal side.
  • the proximal fixing portion 51 is fixed to the outer peripheral surface of the stepped portion 26 of the outer pipe 21.
  • the distal fixing portion 52 is fixed to the outer peripheral surface of the distal portion of the inner tube 30 by the fixing portion 29.
  • each band portion 50 is composed of a substrate layer 53, an adhesive layer 54, a conductive layer 55, and an insulating layer 56.
  • the substrate layer 53 is an insulating layer located inside the shaft portion 20 in the radial direction (hereinafter, referred to as a radial inside).
  • the substrate layer 53 is a base layer to which other layers are attached.
  • the substrate layer 53 is arranged on the entire band 50 from the distal end to the proximal end.
  • the adhesive layer 54 is a layer located on the radial side (hereinafter, referred to as the radial outer side) of the shaft portion 20 with respect to the substrate layer 53.
  • the adhesive layer 54 is a layer that adheres the substrate layer 53 and the conductive layer 55.
  • the conductive layer 55 is a layer having conductivity located on the radial outer side of the adhesive layer 54.
  • the conductive layer 55 includes a first conductive layer 57 having a first electrode 57A and a second conductive layer 58 having a second electrode 58A.
  • the first conductive layer 57 and the second conductive layer 58 are located on the same plane. Although will be described later as a modification, the first conductive layer 57 and the second conductive layer 58 do not have to be located on the same plane.
  • the insulating layer 56 is an insulating layer that partially covers the radial outer side of the conductive layer 55 and the adhesive layer 54. Another adhesive layer may be provided between the insulating layer 56 and the conductive layer 55.
  • the first conductive layer 57 has a first terminal 57B, a first wiring portion 57C, and a first electrode 57A.
  • the first terminal 57B is located in the proximal portion of the band portion 50 and is not covered by the insulating layer 56 and is exposed to the outside in the radial direction.
  • one of the leading wires 71 of the leading wire 70 is electrically connected by solder or the like.
  • the first electrode 57A is located distal to the first terminal 57B of the band portion 50, and is not covered by the insulating layer 56 and is exposed to the outside in the radial direction.
  • the first electrode 57A is located radially outward with respect to a substantially central portion and / or a portion distal to the central portion of the first balloon 41 when the first balloon 41 is expanded (FIG. 4). reference).
  • the first wiring portion 57C connects the first terminal 57B and the first electrode 57A.
  • the first wiring portion 57C is covered with an insulating layer 56.
  • the second conductive layer 58 has a second terminal 58B, a second wiring portion 58C, and a second electrode 58A.
  • the second terminal 58B is located in the proximal portion of the band portion 50 and is not covered by the insulating layer 56 and is exposed to the outside in the radial direction.
  • one of the leading wires 71 of the lead wire 70 is electrically connected by solder or the like.
  • the second electrode 58A is located on the distal side of the band portion 50 with respect to the first electrode 57A, and is not covered by the insulating layer 56 and is exposed to the outside in the radial direction.
  • the second electrode 58A is located radially outside the expanding portion of the second balloon 42 when the second balloon 42 is expanded (see FIG. 4).
  • the second wiring portion 58C connects the second terminal 58B and the second electrode 58A.
  • the second wiring portion 58C is covered with an insulating layer 56.
  • the proximal fixing portion 51 and the tip lead wire 71 of the band portion 50 are collectively covered with one protective tube 75 made of an insulating material. Therefore, the first terminal 57B, the second terminal 58B, and the tip lead wire 71 are not exposed to the outside. Thereby, the electrical safety of the medical device 10 can be improved.
  • the first conductive layer 57 and the second conductive layer 58 are arranged on the substrate layer 53 without contacting each other.
  • the first terminal 57B and the second terminal 58B are arranged in the width direction of the band portion 50.
  • the arrangement and shape of the first terminal 57B and the second terminal 58B are not particularly limited as long as they can be connected to the tip lead wire 71.
  • the first terminal 57B and the second terminal 58B may be arranged side by side in the elongated direction of the band portion 50.
  • the first wiring portion 57C and the second wiring portion 58C extend along different edges of the band portion 50 in the width direction.
  • the first wiring portion 57C does not short-circuit with the second conductive layer 58
  • the second wiring portion 58C does not short-circuit with the first conductive layer 57.
  • the arrangement and shape of the first wiring portion 57C and the second wiring portion 58C are not particularly limited as long as electricity can be transmitted to the first electrode 57A and the second electrode 58A.
  • the first wiring portion 57C may have the same width as the first terminal 57B or the first electrode 57A.
  • the band portion 50 has a bent portion 59 having a partially low flexural rigidity between the first electrode 57A and the second electrode 58A.
  • the bent portion 59 has a constricted portion 59A in which concave notches are formed on both side edges in the width direction.
  • Partially low bending rigidity of the bent portion 59 means that the bending rigidity of the bent portion 59 in the thickness direction of the band portion 50 is higher than that of the portion distal to the bent portion 59 and the portion proximal to the bent portion 59. It means that it is relatively low.
  • the bent portion 59 has a partially low flexural rigidity because the constricted portion 59A is formed.
  • the thickness direction of the band portion 50 is the direction in which the substrate layer 53, the adhesive layer 54, the conductive layer 55, and the insulating layer 56 are laminated.
  • the width direction of the band portion 50 is a direction orthogonal to the elongated direction and the thickness direction of the band portion 50.
  • the band portion 50 has a dimension longer in the width direction than in the thickness direction.
  • the band portion 50 has a structure in which the bent portion 59 can be easily bent so as to be convex inward in the radial direction.
  • the bent portion 59 of the band portion 50 may be previously shaped to be convex to some extent in the radial direction.
  • the form of the bent portion 59 is not particularly limited as long as the bending rigidity of the bent portion 59 is partially low.
  • the area exposed to the outside of the first electrode 57A is larger than the area exposed to the outside of the second electrode 58A. Therefore, energy can be output to the living tissue from the wide area of the first electrode 57A. Therefore, the breadth, depth and homogeneity of the injury range of the first electrode 57A can be improved. Further, since the area of the second electrode 58A is small, the location of the detected potential can be specified with high accuracy.
  • the width of the band portion 50 is not particularly limited, but is, for example, 0.1 to 4.0 mm.
  • the thickness of the band portion 50 is not particularly limited, but is, for example, 0.3 to 1.0 mm.
  • the length of the first electrode 57A along the elongated direction of the band portion 50 is not particularly limited, but is, for example, 1 to 20 mm.
  • the width of the first electrode 57A is not particularly limited, but is, for example, 0.3 to 0.5 mm.
  • the length of the second electrode 58A along the elongated direction of the band portion 50 is not particularly limited, but is, for example, 0.5 to 5 mm, preferably 1 mm.
  • the width of the second electrode 58A is not particularly limited, but is, for example, 0.3 to 0.5 mm.
  • the second electrode 58A and the first electrode 57A are separated to some extent.
  • the distance between the second electrode 58A and the first electrode 57A is not particularly limited, but is, for example, 5 to 20 mm, preferably 10 to 15 mm. Since the second electrode 58A and the first electrode 57A are separated from each other, the output from the first electrode 57A is input to the second electrode 58A after being attenuated by the resistance of the living tissue. Therefore, it is possible to prevent the device for EPS (Electrophysiological Examination) inspection connected to the second electrode 58A from being destroyed by electricity.
  • EPS Electrophysiosiological Examination
  • the constituent materials of the substrate layer 53 and the insulating layer 56 are not particularly limited as long as they have flexibility, but resin materials such as polyimide, polyester, and liquid crystal polymer can be preferably used.
  • the constituent material of the adhesive layer 54 is not particularly limited as long as it can be adhered, but an epoxy resin-based adhesive, an acrylic resin-based adhesive, or the like can be preferably used.
  • the constituent material of the conductive layer 55 is not particularly limited as long as it has conductivity, but for example, copper, carbon silver, or the like can be preferably used.
  • the surfaces of the first electrode 57A and the second electrode 58A may be coated with a material having both conductivity and X-ray contrast. The thickness of the coated layer is, for example, 5-10 ⁇ m. Thereby, the operator can identify the positions of the first electrode 57A and the second electrode 58A under fluoroscopy. Materials having conductivity and X-ray contrast properties are, for example, gold, platinum, tungsten and the like.
  • the plurality of band portions 50 are evenly arranged in the circumferential direction of the shaft portion 20.
  • the electric signal is applied between the adjacent strips 50, but an electrode (or counter electrode) is arranged outside the body, and an electric signal is applied between the extracorporeal electrode (or counter electrode) and the band 50. You may.
  • the hub 60 is connected to the proximal portion of the inner pipe 30.
  • the outer tube 21 located outside the inner tube 30 and movable in the axial direction with respect to the inner tube 30 is slidably connected to the hub 60.
  • the hub 60 has a first port 61 having an opening communicating with the guide wire lumen 31 and a second port 62 having an opening communicating with the expansion lumen 28.
  • the medical device 10 is pushed into the left atrium from the right atrium side along the guide wire inserted into the guide wire lumen 31. As shown in FIG. 4, the medical device 10 is inserted into the distal portion of the band 50 to the entrance of the pulmonary vein 80, which is the target position. That is, the band 50 is introduced from the wide space of the left atrium into the narrow space of the pulmonary vein 80.
  • the second balloon 42 is placed inside the pulmonary vein 80, and the first balloon 41 is placed near the junction 81 between the pulmonary vein 80 and the left atrium.
  • the expansion fluid is supplied into the first balloon 41 and the second balloon 42 through the second port 62, the expansion lumen 28, and the side hole 27.
  • the first balloon 41 and the second balloon 42 expand, and the band portion 50 is pushed by the first balloon 41 and the second balloon 42 and expands radially outward.
  • the outer tube 21 moves to the distal side relative to the inner tube 30, and the proximal portion of the band 50 moves to the distal side.
  • the band portion 50 can be deformed while following the expansion of the expansion portion 40.
  • the distal portion of the band 50 is pushed by the second balloon 42 and expands radially outward. Therefore, at least a part of the second electrode 58A of the band portion 50 is pressed against the inner wall surface of the pulmonary vein 80 by the second balloon 42 in a state of facing outward in the radial direction. Therefore, the second electrode 58A can detect the potential of the pulmonary vein 80 with high accuracy.
  • the proximal portion of the band portion 50 is expanded radially outward by the first balloon 41. Therefore, at least a part of the first electrode 57A of the band portion 50 is arranged outside the portion of the first balloon 41 whose outer diameter decreases toward the distal side. Therefore, the first electrode 57A is pressed against the pulmonary vein 80 and the joint 81 by the first balloon 41 in a state of facing the radial outer side and the distal side. Since the outer diameter of the first balloon 41 is larger than the outer diameter of the second balloon 42, the first electrode 57A can be effectively brought into contact with the joint portion 81 having an inner diameter larger than that of the pulmonary vein 80.
  • the bent portion 59 located between the first electrode 57A and the second electrode 58A is easily bent, it bends inward in the radial direction.
  • the bent portion 59 bends inward in the radial direction a part of the portion between the first electrode 57A and the second electrode 58A of the band portion 50 does not come into contact with or strongly come into contact with the living tissue. Therefore, the band portion 50 is less likely to be affected by the shape of the biological tissue located between the first electrode 57A and the second electrode 58A. Therefore, the first electrode 57A and the second electrode 58A can be deformed to different positions and angles from each other, and can be in good contact with each target portion. Further, since the band portion 50 is formed of a flexible printed circuit board, problems such as disconnection and short circuit are unlikely to occur in the first electrode 57A and / or the second electrode 58A.
  • a pulsed electric signal is applied from the power supply unit 12 to the first electrode 57A of the pair of band portions 50 adjacent to the circumferential direction Z of the shaft portion 20 via the lead wire 70.
  • a current flows between the pair of band portions 50 adjacent to each other in the circumferential direction Z.
  • a pulsed electric signal is applied to the other pair of band portions 50 adjacent to the circumferential direction Z.
  • the application of the electric signal is sequentially performed to all the paired band portions 50 adjacent to the circumferential direction Z.
  • An example of the applied electric signal is given below.
  • the electric field strength applied by the power supply unit 12 is 200 to 1500 V / cm, and the pulse width of the electric signal is 100 ⁇ sec.
  • the application of the electrical signal to all pairs of the band 50 adjacent to the circumferential direction Z is repeated 60 to 360 times in a cycle of once every 1 to 5 seconds according to the refractory period of the ventricular muscle. This causes the cells at the entrance of the pulmonary vein to become necrotic all around.
  • An electric signal may be applied between the plurality of band portions 50 regardless of the adjacency, or an electric signal may be applied from the band portion 50 to the counter electrode plate attached to the body surface.
  • Each second electrode 58A detects the pulmonary vein potential.
  • the second electrode 58A transmits the detected potential to the diagnostic apparatus 13 via the lead wire 70.
  • the diagnostic device 13 diagnoses the state of pulmonary vein divergence by the first electrode 57A from the measured potential. That is, when the pulmonary vein divergence is performed well, the pulmonary vein potential disappears or decreases. Therefore, the diagnostic device 13 can diagnose the state of pulmonary vein divergence by the first electrode 57A at each second position arranged in the circumferential direction of the pulmonary vein from the pulmonary vein potential measured at each second electrode 58A.
  • the diagnostic device 13 may incorporate a three-dimensional potential mapping system.
  • the three-dimensional potential mapping system can identify the position of the measuring electrode 58A from the received signal.
  • the band portion 50 contracts radially inward due to its own restoring force.
  • the outer pipe 21 moves to the proximal side with respect to the inner pipe 30, and the proximal portion of the band portion 50 moves to the proximal side.
  • the band portion 50 can be deformed into a shape close to the original straight line while following the contraction of the expansion portion 40.
  • the medical device 10 is arranged on the long shaft portion 20 and the distal side of the shaft portion 20, extends along the long axis direction of the shaft portion 20, and has a shaft. It has a plurality of band portions 50 that are deformable in the radial direction of the portion 20, and at least one of the band portions 50 is farther than the first electrode 57A and the first electrode 57A that output energy to the living tissue. It has a flexed portion 59, which is located on the position side and has a lower flexural rigidity than the adjacent sites on the distal and proximal sides.
  • the bent portion 59 on the distal side of the first electrode 57A that outputs energy is easily bent. Therefore, the first electrode 57A can be brought into good contact with the target portion while flexibly bending the bent portion 59 in the direction approaching the shaft portion 20.
  • the medical device 10 is arranged between the shaft portion 20 and the band portion 50, and has an expansion portion 40 that can be expanded radially outward of the shaft portion 20.
  • the first electrode 57A and the second electrode 58A arranged on the band portion 50 are pushed by the expanding portion 40 and can be reliably contacted with the target portion.
  • the expansion portion 40 is a member different from the band portion 50, it can be deformed into a shape different from that of the band portion 50. Therefore, the deformation of the band portion 50 is not limited to the deformable range of the expansion portion 40. Therefore, each of the first electrode 57A and the second electrode 58A arranged on the band portion 50 can be pushed by the expansion portion 40 and can be in good contact with each target portion.
  • the band portion 50 is arranged on the distal side of the bent portion 59 and has a second electrode 58A for measuring the potential.
  • the bent portion 59 between the first electrode 57A and the second electrode 58A is easily bent. Therefore, the first electrode 57A and the second electrode 58A can be brought into good contact with each target portion while bending the bent portion 59 in the direction approaching the shaft portion 20. Therefore, in the present medical device 10, both the energy output by the first electrode 57A and the measurement by the second electrode 58A can be satisfactorily performed by one device.
  • the second electrode 58A contacts the wall surface of the pulmonary vein 80, and the first electrode 57A is the junction between the pulmonary vein 80 and the left atrium.
  • Easy to contact 81 Therefore, the potential of the pulmonary vein 80 can be satisfactorily measured by the second electrode 58A, and the joint portion 81 can be satisfactorily treated (for example, treated) by the first electrode 57A.
  • the expansion portion 40 is arranged between the first balloon 41 arranged between the shaft portion 20 and the first electrode 57A and the shaft portion 20 and the second electrode 58A, and is more expandable than the first balloon 41. It has a second balloon 42 having a small outer diameter.
  • the first balloon 41 and the second balloon 42 can be independently expanded so as to have an optimum shape for pressing the first electrode 57A and the second electrode 58A against the target site.
  • the bent portion 59 is likely to be bent so as to approach the shaft portion 20 between the first balloon 41 and the second balloon 42. Therefore, the first electrode 57A and the second electrode 58A can be in good contact with each target portion.
  • the first electrode 57A is arranged radially outside the portion distal to the central portion of the first balloon 41, and the second electrode 58A is the second electrode 58A.
  • the balloon 42 is arranged radially outside the portion including the central portion.
  • the central portion is the center of the shaft portion 20 in the long axis direction.
  • the bent portion 59 has at least one constricted portion 59A, and the width of the band portion 50 in the constricted portion 59A is the width of the band portion 50 in the adjacent portion on the distal side and the proximal side of the constricted portion 59A. Shorter than. As a result, the flexural rigidity of the band portion 50 is partially reduced at the bent portion 59 in which the constricted portion 59A is arranged. Therefore, the band portion 50 can be satisfactorily bent at the bent portion 59. ⁇ Second Embodiment>
  • the medical device 100 according to the second embodiment is different from the first embodiment only in that the expansion portion 110 has only one balloon 111, as shown in FIG.
  • the balloon 111 is a flexibly deformable elastic body that covers the outer peripheral surface of the stepped portion 26 of the outer pipe 21.
  • the distal end and the proximal end of the balloon 111 are fixed to the step portion 26.
  • a side hole 27 is arranged inside the balloon 111. Therefore, the inside of the balloon 111 communicates with the expansion lumen 28.
  • the balloon 111 includes a first site 112 located on the proximal side, a second site 113 located on the distal side, and a recess 114 located between the first site 112 and the second site 113. have. As shown in FIG. 6, the first portion 112 can be expanded more outward in the radial direction of the shaft portion 20 than the second portion 113.
  • the recessed portion 114 projects toward the shaft portion 20 between the first portion 112 and the second portion 113 in a cross section passing through the long axis of the shaft portion 20.
  • the recessed portion 114 is formed between a portion of the first portion 112 that is convex outward in the radial direction and a portion of the second portion 113 that is convex outward in the radial direction in a cross section that passes through the long axis of the shaft portion 20. It is arranged between two inflection points 115.
  • the bent portion 59 tends to bend toward the recessed portion 114 between the first portion 112 and the second portion 113 so as to approach the shaft portion 20. Therefore, the first electrode 57A and the second electrode 58A can be in good contact with each target portion.
  • the first electrode 57A is located radially outward with respect to the substantially central portion and / or the portion distal to the central portion of the first portion 112 when the balloon is expanded.
  • the second electrode 58A is located radially outward of the second portion 113 when the balloon is expanded.
  • the medical device 100 is inserted through the second port 62, the dilated lumen 28, and the side hole 27 with the distal portion of the band 50 inserted to the entrance of the pulmonary vein 80, which is the target position.
  • the expansion fluid is supplied to the balloon 111.
  • the balloon 111 expands, and the band portion 50 is pushed by the balloon 111 and expands radially outward.
  • the distal portion of the band 50 is pushed by the second site 113 and expands radially outward. Therefore, at least a part of the second electrode 58A of the band portion 50 is pressed against the inner wall surface of the pulmonary vein 80 by the second site 113 in a state of facing outward in the radial direction.
  • the second electrode 58A can detect the potential of the pulmonary vein 80 with high accuracy. Further, the proximal portion of the band portion 50 is pushed by the first portion 112 and expands radially outward. At least a portion of the first electrode 57A of the band 50 is located outside the distal portion of the first site 112 whose outer diameter decreases toward the distal side. Therefore, the first electrode 57A is pressed against the joint portion 81 by the first portion 112 in a state of facing the radial outer side and the distal side. Since the first site 112 is larger than the second site 113, the first electrode 57A can be effectively brought into contact with the joint 81 having an inner diameter larger than that of the pulmonary vein 80.
  • the bent portion 59 located between the first electrode 57A and the second electrode 58A bends inward in the radial direction.
  • the concave portion 114 having a convex shape in the radial direction is formed between the first portion 112 and the second portion 113 of the balloon 111, the bent portion 59 bends inward in the radial direction.
  • Cheap When the bent portion 59 bends inward in the radial direction, the portion of the band portion 50 between the first electrode 57A and the second electrode 58A does not come into contact with or strongly come into contact with the living tissue. Therefore, the band portion 50 is less likely to be affected by the shape of the biological tissue located between the first electrode 57A and the second electrode 58A. Therefore, the first electrode 57A and the second electrode 58A can be in close contact with each target portion.
  • the expansion portion 40 includes the first portion 112 arranged between the shaft portion 20 and the first electrode 57A, and the shaft portion 20 and the second electrode 58A. It has one balloon 111 that is disposed between and comprises a second site 113 that is smaller in diameter than the first site 112 and is expandable. As a result, the first electrode 57A can be pressed against the target portion by the first portion 112, and the second electrode 58A can be pressed against the target portion by the second portion 113. Further, since it is only necessary to operate one balloon 111 in order to bring the first electrode 57A and the second electrode 58A into contact with the target portion, the operability is improved.
  • the balloon 111 at the time of expansion is sandwiched between two inflection points 115 between the first portion 112 and the second portion 113 in the cross section passing through the long axis of the shaft portion 20, and is formed by the shaft portion 20. It has a recess 114 that projects toward it.
  • the bent portion 59 tends to bend toward the recessed portion 114 between the first portion 112 and the second portion 113 so as to approach the shaft portion 20. Therefore, the first electrode 57A and the second electrode 58A can be in good contact with each target portion.
  • the expansion portion 130 has only one balloon 131, and the band portion 140 has the bending portion 141 and the proximal bending portion 142. 1 Different from the embodiment.
  • the balloon 131 is a flexibly deformable elastic body that covers the outer peripheral surface of the stepped portion 26 of the outer pipe 21.
  • a side hole 27 is arranged inside the balloon 131. Therefore, the inside of the balloon 131 communicates with the expansion lumen 28.
  • the balloon 131 has a distal transition portion 132, a tubular portion 133, and a proximal transition portion 134. In the expanded state of the balloon 131, the outer diameter of the distal transition portion 132 increases from the fixed position with respect to the step portion 26 at the distal end of the balloon 131 toward the proximal side.
  • the outer diameter of the proximal transition portion 134 increases from the fixed position with respect to the step portion 26 at the proximal end of the balloon 131 toward the distal side.
  • the tubular portion 133 is arranged between the distal transition portion 132 and the proximal transition portion 134.
  • the tubular portion 133 has a cylindrical shape having a substantially constant outer diameter when the balloon 131 is expanded.
  • the first electrode 57A and the second electrode 58A are arranged on the radial outer side of the tubular portion 133.
  • the second electrode 58 is arranged distal to the first electrode 57A.
  • the bent portion 141 is arranged on the distal side of the tubular portion 133. That is, the bent portion 141 is arranged in the vicinity of the distal transition portion 132.
  • the proximal flexion portion 142 is arranged proximal to the tubular portion 133. That is, the proximal flexion portion 142 is arranged in the vicinity of the proximal transition portion 134.
  • Proximal flexion 142 like flexion 141, has lower flexural rigidity than adjacent sites on the distal and proximal sides.
  • the proximal bend 142 may have a configuration similar to that of the bend 141. Therefore, the bent portion 141 and the proximal bent portion 142 are flexible and easily bent.
  • the medical device 120 is inserted into substantially the entire band 140 up to the pulmonary vein 80 having a substantially constant inner diameter.
  • the expansion fluid is supplied to the balloon 131 through the second port 62, the expansion lumen 28, and the side hole 27.
  • the balloon 131 expands, and the band portion 140 is pushed by the balloon 131 and expands radially outward.
  • the first electrode 57A and the second electrode 58A are pressed against the inner wall surface of the pulmonary vein 80 by the cylindrical portion 133.
  • the bent portion 141 is flexible, it bends inward in the radial direction in the vicinity of the distal transition portion 132 that rises substantially vertically from the shaft portion 20.
  • the bent portion 141 can be greatly bent in response to a sudden change in the outer diameter of the distal transition portion 132 of the balloon 131. Further, the proximal bending portion 142 bends inward in the radial direction in the vicinity of the proximal transition portion 134 rising substantially vertically from the shaft portion 20. The proximal bend 142 can be significantly bent in response to a sudden change in outer diameter at the proximal transition 134 of the balloon 131. Therefore, the band portion 140 is likely to be deformed following the shape of the balloon 131 in which the tubular portion 133 is greatly expanded. Therefore, the first electrode 57A and the second electrode 58A arranged between the flexion portion 141 and the proximal flexion portion 142 are in close contact with the inner wall surface of the pulmonary vein 80.
  • the band portion 140 is arranged on the distal side of the first electrode 57A and on the proximal side of the bending portion 141 to measure the potential. It has a second electrode 58A and a proximal flexion portion 142 that is located proximal to the first electrode 57A and has a lower bending rigidity than the distal and proximal adjacent sites, and is in an expanded state.
  • the expansion portion 130 includes a distal transition portion 132 whose outer diameter increases toward the proximal side from a fixed portion with respect to the shaft portion 20 on the distal side of the expansion portion 130, and a shaft portion on the proximal side of the expansion portion 130.
  • a balloon 131 having a proximal transition portion 134 whose outer diameter increases toward the distal side from the fixation site with respect to 20 and a tubular portion 133 located between the distal transition portion 132 and the proximal transition portion 134.
  • the first electrode 57A and the second electrode 58A are arranged radially outside the tubular portion 133, the bent portion 141 is arranged distal to the tubular portion 133, and the proximal bent portion 142 is located. It is arranged proximal to the tubular portion 133.
  • the proximal bending portion 142 bends inward in the radial direction in the vicinity of the proximal transition portion 134 rising from the shaft portion 20. Therefore, the first electrode 57A and the second electrode 58A arranged between the bent portion 141 and the proximal bent portion 142 can be in good contact with each target portion. Further, when the bent portion 141 and the proximal bent portion 142 are bent, the band portion 140 is plastically deformed or damaged in the vicinity of the distal transition portion 132 and the proximal bent portion 142 whose outer diameter suddenly changes. Can be suppressed. Further, since it is only necessary to operate one balloon 111 in order to bring the first electrode 57A and the second electrode 58A into contact with the target portion, the operability is improved.
  • 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.
  • the medical devices 10 and 100 of the above-described embodiment have been shown to be used for treating the pulmonary vein 80, but are for treating other sites such as the renal artery, the ascending vena cava, and the ventricle. May be good.
  • the form of the bent portion 59 formed on the band portion 50 is not particularly limited.
  • the bent portion 59 has at least one thin-walled portion 59B, and the thickness of the band portion 50 in the thin-walled portion 59B is the thickness of the thin-walled portion 59B. It may be thinner than the thickness of the band 50 at the distal and proximal sites. As a result, the flexural rigidity of the band portion 50 is partially reduced at the bent portion 59 in which the thin-walled portion 59B is arranged. Therefore, the band portion 50 can be satisfactorily bent at the bent portion 59.
  • the thin-walled portion 59B may have a groove portion extending in the width direction of the band portion 50 formed on the surface of the band portion 50. As a result, the flexural rigidity of the thin-walled portion 59B can be effectively reduced by the groove portion. Further, since the groove portion extends in the width direction of the band portion 50, the band portion 50 is likely to bend in the thickness direction in the groove portion.
  • the bent portion 59 is formed with both a constricted portion 59A having a short width of the band portion 50 and a thin-walled portion 59B having a thin band portion 50. You may.
  • the flexural rigidity of the band portion 50 is synergistically reduced in the bent portion 59 in which the constricted portion 59A and the thin-walled portion 59B are arranged. Therefore, the band portion 50 can be satisfactorily bent at the bent portion 59.
  • the bending rigidity of the bent portion 59 is bent by the amount of the first conductive layer 57 and the second conductive layer 58 formed by the highly rigid conductor. It may be set lower than each adjacent site on the distal side and the proximal side of the portion 59.
  • the first conductive layer 57 is not arranged at the bent portion 59, but the second conductive layer 58 is arranged. Both the first conductive layer 57 and the second conductive layer 58 may be arranged on the bent portion 59, or the first conductive layer 57 may be arranged without the second conductive layer 58. ..
  • the band portion 50 has a first conductive layer 57 including the first electrode 57A and a second conductive layer 58 including the second electrode 58A, and is orthogonal to the long direction of the band portion 50.
  • the total area of the first conductive layer 57 and the second conductive layer 58 is defined as the conductor area
  • the conductor area of the bent portion 59 is the adjacent portion on the distal side and the proximal side of the bent portion 59. It is smaller than the conductor area.
  • the bent portion 59 can be easily formed on the band portion 50 only by devising the arrangement of the first conductive layer 57 and the second conductive layer 58.
  • the flexural rigidity of the bent portion 59 is set lower than that of the adjacent portions on the distal side and the proximal side of the bent portion 59 due to the flexibility of the constituent material. You may.
  • the bent portion 59 has at least one flexible portion 59C, and the constituent material of the flexible portion 59C is softer than the constituent material of the adjacent portion on the distal side and the proximal side of the flexible portion 59C.
  • the flexural rigidity of the band portion 50 is partially reduced at the bent portion 59 in which the flexible portion 59C is arranged. Therefore, the band portion 50 can be satisfactorily bent at the bent portion 59.
  • a thin-walled portion 59B is formed, but the thin-walled portion 59B may not be formed.
  • the flexible portion 59C is formed on the insulating layer 56, but may be formed on the substrate layer 53, the adhesive layer 54, or the conductive layer 55.
  • the bent portion 59 is an inclined physical property portion in which the bending rigidity gradually decreases from the adjacent portion on the proximal side and / or the distal side of the bent portion 59. It may have 59D.
  • the band portion 50 can be smoothly bent at the bent portion 59, and excessive stress concentration can be suppressed. Therefore, it is possible to prevent the bent portion 59 from being damaged due to bending.
  • one band portion 50 may have a plurality of second electrodes 58A.
  • two second electrodes 58A are aligned in the elongated direction of the band portion 50.
  • Each second electrode 58A is connected to a different lead wire 70 by each second terminal 58B. Therefore, the potential can be measured at two points of one band 50. Therefore, it is possible to detect a potential that cannot be detected by one second electrode 58A.
  • three or more second electrodes 58A may be provided.
  • the plurality of second electrodes 58A may be arranged side by side in the width direction of the band portion 50.
  • the first wiring portion 57C connected to the first electrode 57A and the second wiring portion 57C connected to the second electrode 58A are laminated and arranged in different layers. It may be arranged.
  • the first wiring portion 57C and the first terminal 57B, and the first wiring portion 57C and the first electrode 57A are connected by a conductive member 57D such as gold deposited in the through hole.
  • the second wiring portion 58C and the second terminal 58B, and the second wiring portion 58C and the second electrode 58A are also connected by a conductive member 58D such as gold deposited in the through hole.
  • the medical device does not have to have an extension.
  • the medical device deforms the band portion 50 so as to bend outward and inward in the radial direction by relatively moving the outer pipe 21 and the inner pipe 30 in the long axis direction of the shaft portion 20 without providing the extension portion. be able to.
  • the band portion 50 may be provided with a portion having a partially low flexural rigidity like the bending portion 59 on the proximal side of the first electrode 57A and / or on the distal side of the second electrode 58A.
  • the first electrode 57A and / or the second electrode 58A can be reliably brought into close contact with each target portion.
  • the medical device may have a structure that can change the direction in which the distal portion faces by a hand operation.
  • the medical device may have a magnetic generating means for 3D mapping.
  • the second electrode 58A of the medical device may have a function as the first electrode. In this case, for example, ablation can be performed by passing electricity between the second electrode 58A and the first electrode 57A of the same band portion 50. Further, ablation may be performed by passing electricity between the second electrode 58A and the first electrode 57A of different bands.
  • the strip portion does not have to be a flexible printed circuit board.
  • the medical device 10 may have two expansion lumens, and the first balloon 41 and the second balloon 42 may communicate with different expansion lumens. Thereby, the first balloon 41 and the second balloon 42 can be expanded at each desired different timing.

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Abstract

Provided is a medical device that can successfully bring electrodes for outputting energy to a biological tissue into contact with a target site.　A medical device (10) has: an elongated shaft part (20); and a plurality of band parts (50) which are disposed on the distal side of the shaft part (20), extend in the longitudinal direction of the shaft part (20), and are deformable in the radial direction of the shaft part (20). At least one of the band parts (50) has: a first electrode (57A) for outputting energy to the biological tissue; and a bent part (59) disposed distal to the first electrode (57A) and having lower flexural rigidity than adjacent parts distal and proximal thereto.

Description

医療デバイスMedical device
　本発明は、生体内に挿入され生体組織に対しアブレーションを行う医療デバイスに関する。 The present invention relates to a medical device that is inserted into a living body and ablates a living tissue.
　医療デバイスとして、不可逆電気穿孔法（ＩＲＥ：Ｉｒｒｅｖｅｒｓｉｂｌｅ　Ｅｌｅｃｔｒｏｐｏｒａｔｉｏｎ）による治療を行うものが知られている。不可逆電気穿孔法は、非熱性であり、周囲の血管や神経への損傷を抑えることができることから、注目されている。例えば、外科手術での除去が困難ながんに対して、不可逆電気穿孔法を用いて治療を行う医療装置が知られている。 As a medical device, a device that performs treatment by an irreversible electric drilling method (IRE: Irreversible Electroporation) is known. The irreversible electrosurgical method is attracting attention because it is non-thermal and can suppress damage to surrounding blood vessels and nerves. For example, a medical device that treats a cancer that is difficult to remove by surgery by using an irreversible electric perforation method is known.
　肺静脈壁の心筋スリーブで発生する異常興奮が原因となる心房細動に対して、肺静脈と左心房との接合部をアブレーションし、心筋細胞を破壊する肺静脈隔離術が行われることがある。肺静脈隔離術では、アブレーションカテーテルの遠位部から高周波を発生させて、心筋を点状に焼灼して壊死させる。アブレーションカテーテルは、肺静脈流入部を円周状に焼灼するように移動され、肺静脈を隔離する。 For atrial fibrillation caused by abnormal excitement in the myocardial sleeve of the pulmonary vein wall, pulmonary vein isolation may be performed to ablate the junction between the pulmonary vein and the left atrium and destroy the myocardial cells. .. In pulmonary vein isolation, high frequencies are generated from the distal part of the ablation catheter to punctate and necrotize the myocardium. The ablation catheter is moved to cauterize the pulmonary vein inflow in a circumferential manner to isolate the pulmonary vein.
　例えば特許文献１に記載の医療デバイスは、アブレーションを行う焼灼電極と、肺静脈隔離を検知するために電位を計測する計測電極とを有する拡張部材を備えている。焼灼電極は、拡張部材の近位側の径が大きい部位に配置され、計測電極は、拡張部材の遠位側の径が小さい部位に配置される。したがって、この医療デバイスは、肺静脈に挿入した計測電極を肺静脈に接触させて電位を計測しつつ、肺静脈と左心房との接合部に焼灼電極を接触させて、アブレーションを行うことができる。 For example, the medical device described in Patent Document 1 includes an expansion member having a cautery electrode for ablation and a measurement electrode for measuring an electric potential for detecting pulmonary vein isolation. The ablation electrode is arranged at a portion having a large diameter on the proximal side of the expansion member, and the measuring electrode is arranged at a portion having a small diameter on the distal side of the expansion member. Therefore, this medical device can perform ablation by contacting the ablation electrode with the junction between the pulmonary vein and the left atrium while measuring the potential by contacting the measuring electrode inserted into the pulmonary vein with the pulmonary vein. ..
米国特許第９６５５６７７号明細書U.S. Pat. No. 9,655,677
　特許文献１に記載の医療デバイスの焼灼電極および計測電極は、拡張部材に固定されているため、焼灼電極および計測電極の両方を、望ましい位置に接触させることは困難である。また、焼灼電極および計測電極の配線が、拡張部材に配置されているため、断線や短絡が生じる可能性がある。 Since the ablation electrode and the measurement electrode of the medical device described in Patent Document 1 are fixed to the expansion member, it is difficult to bring both the ablation electrode and the measurement electrode into contact with each other at a desired position. Further, since the wiring of the ablation electrode and the measurement electrode is arranged on the expansion member, disconnection or short circuit may occur.
　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、生体組織にエネルギーを出力する電極を、目的部位へ良好に接触させることができる医療デバイスを提供することを目的とする。 The present invention has been made to solve the above-mentioned problems, and an object of the present invention is to provide a medical device capable of satisfactorily contacting an electrode that outputs energy to a living tissue to a target site.
　上記目的を達成する医療デバイスは、長尺なシャフト部と、前記シャフト部の遠位側に配置され、前記シャフト部の長軸方向に沿って延在し、前記シャフト部の径方向に変形可能である複数の帯部と、を有し、前記帯部の少なくとも１つは、生体組織にエネルギーを出力する第１電極と、前記第１電極よりも遠位側に配置され、曲げ剛性が遠位側および近位側の隣接部位よりも低い屈曲部と、を有する。 A medical device that achieves the above object is arranged on a long shaft portion and a distal side of the shaft portion, extends along the long axis direction of the shaft portion, and can be deformed in the radial direction of the shaft portion. The band has a plurality of bands, and at least one of the bands is arranged on the distal side of the first electrode and the first electrode, which outputs energy to the living tissue, and the flexural rigidity is far. It has a bend that is lower than the adjacent sites on the position side and the proximal side.
　上記のように構成した医療デバイスは、エネルギーを出力する第１電極の遠位側の屈曲部が屈曲しやすい。このため、屈曲部をシャフト部に近づく方向へしなやかに曲げつつ、第１電極を、目的部位へ良好に接触させることができる。 In the medical device configured as described above, the bent portion on the distal side of the first electrode that outputs energy is likely to bend. Therefore, the first electrode can be brought into good contact with the target portion while flexibly bending the bent portion in the direction closer to the shaft portion.
第１実施形態に係る医療デバイスを示す平面図である。It is a top view which shows the medical device which concerns on 1st Embodiment. 帯部を示す図であり、（Ａ）は平面図、（Ｂ）は図２（Ａ）のＡ－Ａ線に沿う断面図である。It is a figure which shows the band part, (A) is a plan view, (B) is a cross-sectional view along the line AA of FIG. 2 (A). 第１実施形態に係る医療デバイスの遠位部を示す断面図である。It is sectional drawing which shows the distal part of the medical device which concerns on 1st Embodiment. 第１実施形態に係る医療デバイスの帯部を拡張させた状態を示す断面図である。It is sectional drawing which shows the expanded state of the band part of the medical device which concerns on 1st Embodiment. 第２実施形態に係る医療デバイスの遠位部を示す断面図である。It is sectional drawing which shows the distal part of the medical device which concerns on 2nd Embodiment. 第２実施形態に係る医療デバイスの帯部を拡張させた状態を示す断面図である。It is sectional drawing which shows the expanded state of the band part of the medical device which concerns on 2nd Embodiment. 第３実施形態に係る医療デバイスの帯部を拡張させた状態を示す断面図である。It is sectional drawing which shows the expanded state of the band part of the medical device which concerns on 3rd Embodiment. 変形例を示す図であり、（Ａ）は第１変形例を示す平面図、（Ｂ）は第２変形例を示す平面図、（Ｃ）は第３変形例を示す平面図、（Ｄ）は第４変形例を示す断面図、（Ｅ）は第５変形例を示す断面図である。It is a figure which shows the modification, (A) is a plan view which shows the 1st modification, (B) is a plan view which shows the 2nd modification, (C) is a plan view which shows the 3rd modification, (D). Is a cross-sectional view showing a fourth modification, and (E) is a cross-sectional view showing a fifth modification. 変形例を示す図であり、（Ａ）は第６変形例を示す平面図、（Ｂ）は第７変形例を示す平面図である。It is a figure which shows the modification, (A) is a plan view which shows the 6th modification, (B) is a plan view which shows the 7th modification. 第８変形例を示す図であり、（Ａ）は平面図、（Ｂ）は図１０（Ａ）のＣ－Ｃ線に沿う断面図である。It is a figure which shows the 8th modification, (A) is a plan view, (B) is a cross-sectional view along line CC of FIG. 10 (A).
　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、図面の寸法は、説明の都合上、誇張されて実際の寸法とは異なる場合がある。また、本明細書及び図面において、実質的に同一の機能を有する構成要素については、同一の符号を付することにより重複説明を省略する。本明細書では、管腔に挿入する側を「遠位側」、操作する手元側を「近位側」と称することとする。
　＜第１実施形態＞ Hereinafter, embodiments of the present invention will be described with reference to the drawings. The dimensions of the drawings may be exaggerated and differ from the actual dimensions for convenience of explanation. Further, in the present specification and the drawings, components having substantially the same function are designated by the same reference numerals, so that duplicate description will be omitted. In the present specification, the side to be inserted into the lumen is referred to as "distal side", and the hand side to be operated is referred to as "proximal side".
<First Embodiment>
　第１実施形態に係る医療デバイス１０は、生体内腔へ経皮的に挿入され、目的部位の生体組織に接触して電気信号を印加し、不可逆電気穿孔法を実施するものである。本実施形態の医療デバイス１０が対象とするのは、肺静脈隔離術において、肺静脈の入口部を全周に渡って電気穿孔する治療である。ただし、医療デバイス１０は、その他の処置にも適用できる。 The medical device 10 according to the first embodiment is percutaneously inserted into a living body cavity, contacts a living body tissue at a target site, applies an electric signal, and performs an irreversible electric drilling method. The target of the medical device 10 of the present embodiment is a treatment of electroporating the entrance of a pulmonary vein over the entire circumference in pulmonary vein isolation. However, the medical device 10 can also be applied to other treatments.
　図１～３に示すように、医療デバイス１０は、長尺なシャフト部２０と、シャフト部２０の遠位部に設けられる拡張部４０と、シャフト部２０の近位部に設けられるハブ６０とを有している。さらに、医療デバイス１０は、拡張部４０の周囲に設けられる複数の帯部５０と、帯部５０へ電流を伝える導線７０とを有している。帯部５０は、生体組織にエネルギーを出力する第１電極５７Ａと、電位を計測する第２電極５８Ａとを有している。 As shown in FIGS. 1 to 3, the medical device 10 includes a long shaft portion 20, an expansion portion 40 provided at a distal portion of the shaft portion 20, and a hub 60 provided at a proximal portion of the shaft portion 20. have. Further, the medical device 10 has a plurality of band portions 50 provided around the expansion portion 40, and a lead wire 70 for transmitting an electric current to the band portion 50. The band portion 50 has a first electrode 57A that outputs energy to a living tissue and a second electrode 58A that measures an electric potential.
　シャフト部２０は、図１、３に示すように、管状の外管２１と、第２管体２３の内側に配置される内管３０とを有している。外管２１および内管３０は、同軸状に配置される。外管２１および内管３０は、相対的に軸方向へ移動可能である。外管２１は、第１管体２２と、第１管体２２の外周面を覆う第２管体２３と、第２管体２３の外周面を覆って第２管体２３に固定される第３管体２４とを有している。 As shown in FIGS. 1 and 3, the shaft portion 20 has a tubular outer tube 21 and an inner tube 30 arranged inside the second tubular body 23. The outer pipe 21 and the inner pipe 30 are arranged coaxially. The outer pipe 21 and the inner pipe 30 are relatively movable in the axial direction. The outer pipe 21 is fixed to the first pipe body 22, the second pipe body 23 that covers the outer peripheral surface of the first pipe body 22, and the second pipe body 23 that covers the outer peripheral surface of the second pipe body 23. It has 3 tubes 24.
　第１管体２２および第２管体２３の遠位端は、液密に固定されている。第１管体２２の外部であって第２管体２３の内部には、拡張ルーメン２８が形成される。拡張ルーメン２８には、拡張部４０を拡張させるための拡張用流体を流通可能である。拡張用流体は気体でも液体でもよく、例えばヘリウムガス、ＣＯ２ガス、Ｏ２ガス、笑気ガス等の気体や、生理食塩水、造影剤、及びその混合剤等の液体を用いることができる。 The distal ends of the first tube 22 and the second tube 23 are liquidtightly fixed. An expansion lumen 28 is formed outside the first tube body 22 and inside the second tube body 23. An expansion fluid for expanding the expansion portion 40 can be circulated in the expansion lumen 28. The expansion fluid may be a gas or a liquid, and for example, a gas such as helium gas, CO 2 gas, O 2 gas, or laughing gas, or a liquid such as physiological saline, a contrast agent, or a mixture thereof can be used.
　第２管体２３および第３管体２４は、同軸状に配置される。第２管体２３と第３管体２４との間には、導線７０が挟まれるように配置される。第１管体２２および第２管体２３は、第３管体２４の遠位端面２５よりも遠位側まで延在する段差部２６を有している。段差部２６は、円管形状を有している。段差部２６の外周面には、拡張部４０と、帯部５０の近位部とが固定されている。第２管体２３は、内部の拡張ルーメン２８を外部へ連通させるための少なくとも２つの側孔２７が形成されている。各々の側孔２７は、後述する拡張部４０の内部に連通する。 The second pipe body 23 and the third pipe body 24 are arranged coaxially. The lead wire 70 is arranged so as to be sandwiched between the second pipe body 23 and the third pipe body 24. The first tube body 22 and the second tube body 23 have a step portion 26 extending to the distal side from the distal end surface 25 of the third tube body 24. The step portion 26 has a circular tube shape. An expansion portion 40 and a proximal portion of the band portion 50 are fixed to the outer peripheral surface of the step portion 26. The second tubular body 23 is formed with at least two side holes 27 for communicating the internal expansion lumen 28 to the outside. Each side hole 27 communicates with the inside of the expansion portion 40 described later.
　内管３０は、第２管体２３の先端よりさらに遠位側まで延在している。第２管体２３よりも遠位側の内管３０の外周面には、拡張部４０の遠位部が固定されている。内管３０は、拡張部４０が固定されている位置よりも遠位側の外周面に、帯部５０の遠位部を固定する固定部２９が固定されている。内管３０の内部には、長さ方向に沿うガイドワイヤルーメン３１が形成される。ガイドワイヤルーメン３１には、ガイドワイヤを挿入可能である。 The inner tube 30 extends further to the distal side from the tip of the second tube body 23. The distal portion of the expansion portion 40 is fixed to the outer peripheral surface of the inner tube 30 on the distal side of the second tube body 23. In the inner tube 30, a fixing portion 29 for fixing the distal portion of the band portion 50 is fixed to the outer peripheral surface on the distal side of the position where the expansion portion 40 is fixed. A guide wire lumen 31 along the length direction is formed inside the inner pipe 30. A guide wire can be inserted into the guide wire lumen 31.
　シャフト部２０の外径は、特に限定されないが、低侵襲であり、かつ挿入する一般的なシースやガイディングカテーテルとの互換性を満たすために大きすぎないことが好ましく、例えば４．０ｍｍ以内、好ましくは２．９ｍｍ以内である。 The outer diameter of the shaft portion 20 is not particularly limited, but is preferably minimally invasive and not too large to satisfy compatibility with a general sheath or guiding catheter to be inserted, for example, within 4.0 mm. It is preferably within 2.9 mm.
　第１管体２２、第２管体２３、第３管体２４および内管３０の構成材料は、ある程度の可撓性を有することが好ましい。また、第１管体２２、第２管体２３、第３管体２４および内管３０の構成材料は、絶縁性を有することが好ましい。そのような材料としては、例えば、ポリエチレン、ポリプロピレン、ポリブテン、エチレン－プロピレン共重合体、エチレン－酢酸ビニル共重合体、アイオノマー、あるいはこれら二種以上の混合物等のポリオレフィンや、軟質ポリ塩化ビニル樹脂、ポリアミド、ポリアミドエラストマー、ポリイミド、ポリエステル、ポリエステルエラストマー、ポリウレタン、ポリテトラフルオロエチレン等のフッ素樹脂、シリコーンゴム、ラテックスゴム等が挙げられる。 It is preferable that the constituent materials of the first tube body 22, the second tube body 23, the third tube body 24, and the inner tube 30 have a certain degree of flexibility. Further, it is preferable that the constituent materials of the first tube body 22, the second tube body 23, the third tube body 24 and the inner tube 30 have an insulating property. Examples of such a material include polyolefins such as polyethylene, polypropylene, polybutene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, ionomer, or a mixture of two or more thereof, and a soft polyvinyl chloride resin. Examples thereof include polyamide, polyamide elastomer, polyimide, polyester, polyester elastomer, polyurethane, fluororesin such as polytetrafluoroethylene, silicone rubber, latex rubber and the like.
　拡張部４０は、柔軟に変形可能な第１バルーン４１および第２バルーン４２を有している。第１バルーン４１は、第２管体２３の段差部２６の外周面を覆う柔軟に変形可能な弾性体である。第１バルーン４１の遠位端および近位端は、段差部２６に固着されている。第１バルーン４１の内部には、側孔２７の少なくとも１つが配置されている。このため、第１バルーン４１の内部は、拡張ルーメン２８と連通している。 The expansion unit 40 has a first balloon 41 and a second balloon 42 that can be flexibly deformed. The first balloon 41 is a flexibly deformable elastic body that covers the outer peripheral surface of the stepped portion 26 of the second tubular body 23. The distal end and the proximal end of the first balloon 41 are fixed to the step portion 26. At least one of the side holes 27 is arranged inside the first balloon 41. Therefore, the inside of the first balloon 41 communicates with the expansion lumen 28.
　第２バルーン４２は、第１バルーン４１よりも遠位側で段差部２６の外周面を覆う柔軟に変形可能な弾性体である。第２バルーン４２の遠位端および近位端は、段差部２６に固着されている。第２バルーン４２の内部には、側孔２７の少なくとも１つが配置されている。このため、第２バルーン４２の内部は、拡張ルーメン２８と連通している。第１バルーン４１は、第２バルーン４２よりも、シャフト部２０の径方向外側へ大きく拡張可能である。シャフト部２０の長軸を通る断面において、第１バルーン４１および第２バルーン４２の形状は、特に限定されないが、例えば、略円筒、略楕円、略台形等である。第１バルーン４１および第２バルーン４２は、薄膜状であり、可撓性を有することが好ましい。また、第１バルーン４１および第２バルーン４２は、帯部５０を確実に押し広げる程度の強度も必要とされる。第１バルーン４１および第２バルーン４２の構成材料は、シャフト部２０について上で挙げたものを用いることができ、また、それ以外（例えば、水添スチレン系熱可塑性エラストマー（ＳＥＢＳ）などの各種エラストマー素材）を用いることもできる。 The second balloon 42 is a flexibly deformable elastic body that covers the outer peripheral surface of the step portion 26 on the distal side of the first balloon 41. The distal end and the proximal end of the second balloon 42 are fixed to the step portion 26. At least one of the side holes 27 is arranged inside the second balloon 42. Therefore, the inside of the second balloon 42 communicates with the expansion lumen 28. The first balloon 41 can be expanded more outward in the radial direction of the shaft portion 20 than the second balloon 42. The shapes of the first balloon 41 and the second balloon 42 are not particularly limited in the cross section passing through the long axis of the shaft portion 20, but are, for example, substantially cylindrical, substantially elliptical, substantially trapezoidal, and the like. The first balloon 41 and the second balloon 42 are preferably thin and flexible. Further, the first balloon 41 and the second balloon 42 are also required to have enough strength to surely spread the band portion 50. As the constituent materials of the first balloon 41 and the second balloon 42, those mentioned above for the shaft portion 20 can be used, and other elastomers (for example, various elastomers such as hydrogenated styrene-based thermoplastic elastomer (SEBS)) can be used. Material) can also be used.
　導線７０は、線状であり、外管２１の内部に埋設される埋設部７２と、外管２１の遠位端面２５から遠位側へ突出する先端導線７１と、近位側で外管２１から外部へ導出される基端導線７３とを有している。埋設部７２は、第２管体２３と第３管体２４の間に挟まれている。導線７０の数は、第１電極５７Ａの数と、第２電極５８Ａの数との合計数以上であることが好ましい。複数の導線７０は、多状巻の螺旋構造で形成される。したがって、複数の導線７０は、電気的に短絡せずに、独立した電流を伝えることができる。第１電極５７Ａへ電気を流す導線７０の径は、第２電極５８Ａへ電気を流す導線７０の径よりも大きいことが好ましい。これにより、第１電極５７Ａへ大電流を流すことができ、かつ多くの第２電極５８Ａを配置できる。したがって、第１電極５７Ａから高いエネルギーを出力でき、かつ第２電極５８Ａを多極化できる。 The lead wire 70 is linear, has a buried portion 72 embedded inside the outer tube 21, a tip lead wire 71 protruding distally from the distal end surface 25 of the outer tube 21, and an outer tube 21 on the proximal side. It has a proximal lead wire 73 that is led out from. The buried portion 72 is sandwiched between the second pipe body 23 and the third pipe body 24. The number of the conducting wires 70 is preferably equal to or greater than the total number of the number of the first electrode 57A and the number of the second electrodes 58A. The plurality of conductors 70 are formed by a polymorphic spiral structure. Therefore, the plurality of lead wires 70 can carry independent currents without being electrically short-circuited. The diameter of the conducting wire 70 that conducts electricity to the first electrode 57A is preferably larger than the diameter of the conducting wire 70 that conducts electricity to the second electrode 58A. As a result, a large current can be passed through the first electrode 57A, and many second electrodes 58A can be arranged. Therefore, high energy can be output from the first electrode 57A, and the second electrode 58A can be multipolarized.
　各々の導線７０の先端導線７１は、帯部５０の端子に電気的に接続される。基端導線７３は、第３管体２４の近位部から基端方向へ引き出され、シャフト部２０の外部に設けられる電源部１２および診断装置１３に接続されている。電源部１２は、帯部５０の第１電極５７Ａに対して電気を供給できる。診断装置１３は、帯部５０の第２電極５８Ａの電位を計測できる。 The tip lead wire 71 of each lead wire 70 is electrically connected to the terminal of the band portion 50. The proximal lead wire 73 is drawn out from the proximal portion of the third tubular body 24 toward the proximal end, and is connected to a power supply unit 12 and a diagnostic device 13 provided outside the shaft portion 20. The power supply unit 12 can supply electricity to the first electrode 57A of the band unit 50. The diagnostic device 13 can measure the potential of the second electrode 58A of the band portion 50.
　導線７０の構成材料は、導電性が高いことが好ましく、例えば銅、金、白金、銀、アルミニウム、合金、または炭素繊維等である。導線７０は、公知の導線を利用できる。 The constituent material of the conducting wire 70 is preferably highly conductive, and is, for example, copper, gold, platinum, silver, aluminum, alloy, carbon fiber, or the like. As the lead wire 70, a known lead wire can be used.
　各々の帯部５０は、図１～３に示すように、略一定の幅および厚さを有して、シャフト部２０の長軸方向に延在している。帯部５０は、例えば、フレキシブルプリント基板によって形成される。各々の帯部５０は、可撓性を有している。各々の帯部５０は、第１バルーン４１および第２バルーン４２の外周側に位置しており、第１バルーン４１および第２バルーン４２とは固定されていない。なお、帯部５０は、第１バルーン４１および／または第２バルーン４２に部分的に固定されてもよい。複数の帯部５０は、拡張部４０の外周側に、拡張部４０の周方向Ｚへ並んで配置されている。各々の帯部５０は、シャフト部２０の長軸方向に延在している。 As shown in FIGS. 1 to 3, each band portion 50 has a substantially constant width and thickness and extends in the long axis direction of the shaft portion 20. The band portion 50 is formed of, for example, a flexible printed circuit board. Each band 50 has flexibility. Each band portion 50 is located on the outer peripheral side of the first balloon 41 and the second balloon 42, and is not fixed to the first balloon 41 and the second balloon 42. The band portion 50 may be partially fixed to the first balloon 41 and / or the second balloon 42. The plurality of band portions 50 are arranged side by side in the circumferential direction Z of the expansion portion 40 on the outer peripheral side of the expansion portion 40. Each band portion 50 extends in the long axis direction of the shaft portion 20.
　各々の帯部５０は、近位側に位置する近位固定部５１と、遠位側に位置する遠位固定部５２とを有している。近位固定部５１は、外管２１の段差部２６の外周面に固定される。遠位固定部５２は、内管３０の遠位部の外周面に、固定部２９によって固定される。近位固定部５１および遠位固定部５２が近接または離間することで、帯部５０の近位固定部５１および遠位固定部５２の間に位置する部位が、シャフト部２０の径方向外側へ向かって撓むように拡張または収縮する。 Each band portion 50 has a proximal fixing portion 51 located on the proximal side and a distal fixing portion 52 located on the distal side. The proximal fixing portion 51 is fixed to the outer peripheral surface of the stepped portion 26 of the outer pipe 21. The distal fixing portion 52 is fixed to the outer peripheral surface of the distal portion of the inner tube 30 by the fixing portion 29. When the proximal fixing portion 51 and the distal fixing portion 52 are brought close to each other or separated from each other, the portion of the band portion 50 located between the proximal fixing portion 51 and the distal fixing portion 52 is moved outward in the radial direction of the shaft portion 20. Expands or contracts to bend toward.
　各々の帯部５０は、図２に示すように、基板層５３と、接着層５４と、導電層５５と、絶縁層５６とにより構成される。基板層５３は、シャフト部２０の径方向の内側（以下、径方向内側と称する。）に位置する絶縁性の層である。基板層５３は、他の層が付着される基礎となる層である。基板層５３は、帯部５０の遠位端から近位端までの全体に配置される。接着層５４は、基板層５３に対して、シャフト部２０の径方向の外側（以下、径方向外側と称する。）に位置する層である。接着層５４は、基板層５３と導電層５５を接着する層である。導電層５５は、接着層５４の径方向外側に位置する導電性を備えた層である。導電層５５は、第１電極５７Ａを有する第１導電層５７と、第２電極５８Ａを有する第２導電層５８とを備えている。第１導電層５７および第２導電層５８は、同一平面上に位置している。なお、後に変形例として説明するが、第１導電層５７および第２導電層５８は、同一平面上に位置しなくてもよい。絶縁層５６は、導電層５５および接着層５４の径方向外側を部分的に覆う絶縁性の層である。絶縁層５６と導電層５５との間に、他の接着層が設けられてもよい。 As shown in FIG. 2, each band portion 50 is composed of a substrate layer 53, an adhesive layer 54, a conductive layer 55, and an insulating layer 56. The substrate layer 53 is an insulating layer located inside the shaft portion 20 in the radial direction (hereinafter, referred to as a radial inside). The substrate layer 53 is a base layer to which other layers are attached. The substrate layer 53 is arranged on the entire band 50 from the distal end to the proximal end. The adhesive layer 54 is a layer located on the radial side (hereinafter, referred to as the radial outer side) of the shaft portion 20 with respect to the substrate layer 53. The adhesive layer 54 is a layer that adheres the substrate layer 53 and the conductive layer 55. The conductive layer 55 is a layer having conductivity located on the radial outer side of the adhesive layer 54. The conductive layer 55 includes a first conductive layer 57 having a first electrode 57A and a second conductive layer 58 having a second electrode 58A. The first conductive layer 57 and the second conductive layer 58 are located on the same plane. Although will be described later as a modification, the first conductive layer 57 and the second conductive layer 58 do not have to be located on the same plane. The insulating layer 56 is an insulating layer that partially covers the radial outer side of the conductive layer 55 and the adhesive layer 54. Another adhesive layer may be provided between the insulating layer 56 and the conductive layer 55.
　第１導電層５７は、第１端子５７Ｂと、第１配線部５７Ｃと、第１電極５７Ａとを有している。第１端子５７Ｂは、帯部５０の近位部に位置し、絶縁層５６に覆われずに径方向外側へ露出している。第１端子５７Ｂは、導線７０の先端導線７１の１つが、はんだ等によって電気的に接続される。第１電極５７Ａは、帯部５０の第１端子５７Ｂよりも遠位側に位置し、絶縁層５６に覆われずに径方向外側へ露出している。第１電極５７Ａは、第１バルーン４１が拡張した際に、第１バルーン４１の略中央部および／または中央部よりも遠位側の部位に対して、径方向外側に位置する（図４を参照）。第１配線部５７Ｃは、第１端子５７Ｂと第１電極５７Ａとを接続する。第１配線部５７Ｃは、絶縁層５６に覆われている。 The first conductive layer 57 has a first terminal 57B, a first wiring portion 57C, and a first electrode 57A. The first terminal 57B is located in the proximal portion of the band portion 50 and is not covered by the insulating layer 56 and is exposed to the outside in the radial direction. In the first terminal 57B, one of the leading wires 71 of the leading wire 70 is electrically connected by solder or the like. The first electrode 57A is located distal to the first terminal 57B of the band portion 50, and is not covered by the insulating layer 56 and is exposed to the outside in the radial direction. The first electrode 57A is located radially outward with respect to a substantially central portion and / or a portion distal to the central portion of the first balloon 41 when the first balloon 41 is expanded (FIG. 4). reference). The first wiring portion 57C connects the first terminal 57B and the first electrode 57A. The first wiring portion 57C is covered with an insulating layer 56.
　第２導電層５８は、第２端子５８Ｂと、第２配線部５８Ｃと、第２電極５８Ａとを有している。第２端子５８Ｂは、帯部５０の近位部に位置し、絶縁層５６に覆われずに径方向外側へ露出している。第２端子５８Ｂは、導線７０の先端導線７１の１つが、はんだ等によって電気的に接続される。第２電極５８Ａは、帯部５０の第１電極５７Ａよりも遠位側に位置し、絶縁層５６に覆われずに径方向外側へ露出している。第２電極５８Ａは、第２バルーン４２が拡張した際に、第２バルーン４２の拡張する部位の径方向外側に位置する（図４を参照）。第２配線部５８Ｃは、第２端子５８Ｂと第２電極５８Ａとを接続する。第２配線部５８Ｃは、絶縁層５６に覆われている。帯部５０の近位固定部５１および先端導線７１は、絶縁材料からなる１つの保護チューブ７５によりまとめて覆われる。したがって、第１端子５７Ｂ、第２端子５８Ｂおよび先端導線７１は、外部へ露出しない。これにより、医療デバイス１０の電気的安全性を向上できる。 The second conductive layer 58 has a second terminal 58B, a second wiring portion 58C, and a second electrode 58A. The second terminal 58B is located in the proximal portion of the band portion 50 and is not covered by the insulating layer 56 and is exposed to the outside in the radial direction. In the second terminal 58B, one of the leading wires 71 of the lead wire 70 is electrically connected by solder or the like. The second electrode 58A is located on the distal side of the band portion 50 with respect to the first electrode 57A, and is not covered by the insulating layer 56 and is exposed to the outside in the radial direction. The second electrode 58A is located radially outside the expanding portion of the second balloon 42 when the second balloon 42 is expanded (see FIG. 4). The second wiring portion 58C connects the second terminal 58B and the second electrode 58A. The second wiring portion 58C is covered with an insulating layer 56. The proximal fixing portion 51 and the tip lead wire 71 of the band portion 50 are collectively covered with one protective tube 75 made of an insulating material. Therefore, the first terminal 57B, the second terminal 58B, and the tip lead wire 71 are not exposed to the outside. Thereby, the electrical safety of the medical device 10 can be improved.
　第１導電層５７および第２導電層５８は、互いに接触せずに、基板層５３上に配置されている。第１端子５７Ｂおよび第２端子５８Ｂは、帯部５０の幅方向に並んでいる。なお、第１端子５７Ｂおよび第２端子５８Ｂの配置および形状は、先端導線７１と接続できれば特に限定されない。例えば、第１端子５７Ｂおよび第２端子５８Ｂは、帯部５０の長尺方向に並んで配置されてもよい。第１配線部５７Ｃおよび第２配線部５８Ｃは、帯部５０の幅方向の異なる縁部に沿って延在する。これにより、第１配線部５７Ｃが、第２導電層５８と短絡しないとともに、第２配線部５８Ｃが、第１導電層５７と短絡しない。なお、第１配線部５７Ｃおよび第２配線部５８Ｃの配置および形状は、電気を第１電極５７Ａおよび第２電極５８Ａに伝えることができれば特に限定されない。例えば、第１配線部５７Ｃは、第１端子５７Ｂまたは第１電極５７Ａと同寸法の幅を有してもよい。 The first conductive layer 57 and the second conductive layer 58 are arranged on the substrate layer 53 without contacting each other. The first terminal 57B and the second terminal 58B are arranged in the width direction of the band portion 50. The arrangement and shape of the first terminal 57B and the second terminal 58B are not particularly limited as long as they can be connected to the tip lead wire 71. For example, the first terminal 57B and the second terminal 58B may be arranged side by side in the elongated direction of the band portion 50. The first wiring portion 57C and the second wiring portion 58C extend along different edges of the band portion 50 in the width direction. As a result, the first wiring portion 57C does not short-circuit with the second conductive layer 58, and the second wiring portion 58C does not short-circuit with the first conductive layer 57. The arrangement and shape of the first wiring portion 57C and the second wiring portion 58C are not particularly limited as long as electricity can be transmitted to the first electrode 57A and the second electrode 58A. For example, the first wiring portion 57C may have the same width as the first terminal 57B or the first electrode 57A.
　帯部５０は、第１電極５７Ａおよび第２電極５８Ａの間に、部分的に曲げ剛性の低い屈曲部５９を有している。屈曲部５９は、幅方向の両側の縁部に凹状の切り込みが形成された括れ部５９Ａを有している。屈曲部５９の曲げ剛性が部分的に低いとは、帯部５０の厚さ方向への屈曲部５９の曲げ剛性が、屈曲部５９よりも遠位側の部位および近位側の部位よりも、相対的に低いことを意味する。屈曲部５９は、括れ部５９Ａが形成されるため、部分的に低い曲げ剛性を有している。帯部５０の厚さ方向は、基板層５３、接着層５４、導電層５５および絶縁層５６が積層される方向である。帯部５０の幅方向は、帯部５０の長尺方向および厚さ方向と直交する方向である。帯部５０は、厚さ方向よりも幅方向へ長い寸法を有する。帯部５０は、屈曲部５９において、径方向内側へ向かって凸状となるように容易に屈曲できる構造を有している。帯部５０の屈曲部５９は、予め、径方向内側へ向かってある程度凸状に形状付けられてもよい。なお、後に変形例として説明するが、屈曲部５９の形態は、屈曲部５９の曲げ剛性が部分的に低ければ、特に限定されない。 The band portion 50 has a bent portion 59 having a partially low flexural rigidity between the first electrode 57A and the second electrode 58A. The bent portion 59 has a constricted portion 59A in which concave notches are formed on both side edges in the width direction. Partially low bending rigidity of the bent portion 59 means that the bending rigidity of the bent portion 59 in the thickness direction of the band portion 50 is higher than that of the portion distal to the bent portion 59 and the portion proximal to the bent portion 59. It means that it is relatively low. The bent portion 59 has a partially low flexural rigidity because the constricted portion 59A is formed. The thickness direction of the band portion 50 is the direction in which the substrate layer 53, the adhesive layer 54, the conductive layer 55, and the insulating layer 56 are laminated. The width direction of the band portion 50 is a direction orthogonal to the elongated direction and the thickness direction of the band portion 50. The band portion 50 has a dimension longer in the width direction than in the thickness direction. The band portion 50 has a structure in which the bent portion 59 can be easily bent so as to be convex inward in the radial direction. The bent portion 59 of the band portion 50 may be previously shaped to be convex to some extent in the radial direction. Although will be described later as a modified example, the form of the bent portion 59 is not particularly limited as long as the bending rigidity of the bent portion 59 is partially low.
　第１電極５７Ａの外部へ露出している面積は、第２電極５８Ａの外部へ露出している面積よりも大きい。このため、第１電極５７Ａの広い面積から、エネルギーを生体組織へ出力できる。このため、第１電極５７Ａによる傷害範囲の広さ、深さおよび均質さを向上できる。また、第２電極５８Ａの面積が小さいことで、検出する電位の場所を高精度に特定できる。 The area exposed to the outside of the first electrode 57A is larger than the area exposed to the outside of the second electrode 58A. Therefore, energy can be output to the living tissue from the wide area of the first electrode 57A. Therefore, the breadth, depth and homogeneity of the injury range of the first electrode 57A can be improved. Further, since the area of the second electrode 58A is small, the location of the detected potential can be specified with high accuracy.
　帯部５０の幅は、特に限定されないが、例えば０．１～４．０ｍｍである。帯部５０の厚さは、特に限定されないが、例えば０．３～１．０ｍｍである。帯部５０の長尺方向に沿う第１電極５７Ａの長さは、特に限定されないが、例えば１～２０ｍｍである。第１電極５７Ａの幅は、特に限定されないが、例えば０．３～０．５ｍｍである。帯部５０の長尺方向に沿う第２電極５８Ａの長さは、特に限定されないが、例えば０．５～５ｍｍ、好ましくは１ｍｍである。第２電極５８Ａの幅は、特に限定されないが、例えば０．３～０．５ｍｍである。 The width of the band portion 50 is not particularly limited, but is, for example, 0.1 to 4.0 mm. The thickness of the band portion 50 is not particularly limited, but is, for example, 0.3 to 1.0 mm. The length of the first electrode 57A along the elongated direction of the band portion 50 is not particularly limited, but is, for example, 1 to 20 mm. The width of the first electrode 57A is not particularly limited, but is, for example, 0.3 to 0.5 mm. The length of the second electrode 58A along the elongated direction of the band portion 50 is not particularly limited, but is, for example, 0.5 to 5 mm, preferably 1 mm. The width of the second electrode 58A is not particularly limited, but is, for example, 0.3 to 0.5 mm.
　第２電極５８Ａおよび第１電極５７Ａは、ある程度離れていることが好ましい。第２電極５８Ａと第１電極５７Ａの間の距離は、特に限定されないが、例えば５～２０ｍｍ、好ましくは１０～１５ｍｍである。第２電極５８Ａおよび第１電極５７Ａが離れているため、第１電極５７Ａからの出力が、生体組織の抵抗によって減衰した後に、第２電極５８Ａに入力される。このため、第２電極５８Ａに接続されるＥＰＳ（Ｅｌｅｃｔｒｏｐｈｙｓｉｏｌｏｇｙ　Ｓｔｕｄｙ：電気生理学的検査）検査のための装置が電気によって破壊されることを抑制できる。 It is preferable that the second electrode 58A and the first electrode 57A are separated to some extent. The distance between the second electrode 58A and the first electrode 57A is not particularly limited, but is, for example, 5 to 20 mm, preferably 10 to 15 mm. Since the second electrode 58A and the first electrode 57A are separated from each other, the output from the first electrode 57A is input to the second electrode 58A after being attenuated by the resistance of the living tissue. Therefore, it is possible to prevent the device for EPS (Electrophysiological Examination) inspection connected to the second electrode 58A from being destroyed by electricity.
　基板層５３および絶縁層５６の構成材料は、可撓性を有すれば特に限定されないが、例えばポリイミド、ポリエステル、液晶ポリマー等の樹脂材料を好適に使用できる。接着層５４の構成材料は、接着可能であれば特に限定されないが、エポキシ樹脂系接着剤、アクリル樹脂系接着剤等を好適に使用できる。導電層５５の構成材料は、導電性を有すれば特に限定されないが、例えば銅、カーボン銀等を好適に使用できる。第１電極５７Ａおよび第２電極５８Ａの表面は、導電性を備えるとともにＸ線造影性を備える材料により被覆されてもよい。被覆される層の厚さは、例えば５～１０μｍである。これにより、術者は、第１電極５７Ａおよび第２電極５８Ａの位置を、Ｘ線透視下で特定である。導電性およびＸ線造影性を備える材料は、例えば金、白金、タングステン等である。 The constituent materials of the substrate layer 53 and the insulating layer 56 are not particularly limited as long as they have flexibility, but resin materials such as polyimide, polyester, and liquid crystal polymer can be preferably used. The constituent material of the adhesive layer 54 is not particularly limited as long as it can be adhered, but an epoxy resin-based adhesive, an acrylic resin-based adhesive, or the like can be preferably used. The constituent material of the conductive layer 55 is not particularly limited as long as it has conductivity, but for example, copper, carbon silver, or the like can be preferably used. The surfaces of the first electrode 57A and the second electrode 58A may be coated with a material having both conductivity and X-ray contrast. The thickness of the coated layer is, for example, 5-10 μm. Thereby, the operator can identify the positions of the first electrode 57A and the second electrode 58A under fluoroscopy. Materials having conductivity and X-ray contrast properties are, for example, gold, platinum, tungsten and the like.
　複数の帯部５０は、図１に示すように、シャフト部２０の周方向に均等に配置される。電気信号は、隣接する帯部５０間に印加されるが、体外に電極（あるいは対極板）を配置し、その体外の電極（あるいは対極板）と帯部５０との間に電気信号を印加してもよい。 As shown in FIG. 1, the plurality of band portions 50 are evenly arranged in the circumferential direction of the shaft portion 20. The electric signal is applied between the adjacent strips 50, but an electrode (or counter electrode) is arranged outside the body, and an electric signal is applied between the extracorporeal electrode (or counter electrode) and the band 50. You may.
　ハブ６０は、図１に示すように、内管３０の近位部が連結されている。内管３０の外側に位置して内管３０に対して軸方向へ移動可能な外管２１は、ハブ６０に対して摺動可能に連結されている。ハブ６０は、ガイドワイヤルーメン３１と連通する開口を有する第１ポート６１と、拡張ルーメン２８と連通する開口を有する第２ポート６２とを有している。 As shown in FIG. 1, the hub 60 is connected to the proximal portion of the inner pipe 30. The outer tube 21 located outside the inner tube 30 and movable in the axial direction with respect to the inner tube 30 is slidably connected to the hub 60. The hub 60 has a first port 61 having an opening communicating with the guide wire lumen 31 and a second port 62 having an opening communicating with the expansion lumen 28.
　次に、第１実施形態に係る医療デバイス１０の作用および効果を説明する。 Next, the actions and effects of the medical device 10 according to the first embodiment will be described.
　医療デバイス１０は、ガイドワイヤルーメン３１に挿入されるガイドワイヤに沿って、右心房側から左心房に押し込まれる。医療デバイス１０は、図４に示すように、帯部５０の遠位部を目的位置である肺静脈８０の入口まで挿入される。すなわち、帯部５０は、左心房の広い空間から、肺静脈８０の狭い空間へ導入される。第２バルーン４２は、肺静脈８０の内部に配置され、第１バルーン４１は、肺静脈８０と左心房の接合部８１の近傍に配置される。次に、第２ポート６２、拡張ルーメン２８および側孔２７を介して、第１バルーン４１および第２バルーン４２内に拡張用流体が供給される。これにより、第１バルーン４１および第２バルーン４２が拡張し、帯部５０が第１バルーン４１および第２バルーン４２によって押されて径方向外側に拡張する。このとき、外管２１が内管３０に対して相対的に遠位側へ移動し、帯部５０の近位部が遠位側へ移動する。これにより、帯部５０は、拡張部４０の拡張に追従しながら変形できる。帯部５０の遠位部は、第２バルーン４２によって押されて径方向外側へ拡張する。このため、帯部５０の第２電極５８Ａの少なくとも一部が、径方向外側を向いた状態で、第２バルーン４２によって肺静脈８０の内壁面に押し付けられる。したがって、第２電極５８Ａは、肺静脈８０の電位を高精度に検出できる。 The medical device 10 is pushed into the left atrium from the right atrium side along the guide wire inserted into the guide wire lumen 31. As shown in FIG. 4, the medical device 10 is inserted into the distal portion of the band 50 to the entrance of the pulmonary vein 80, which is the target position. That is, the band 50 is introduced from the wide space of the left atrium into the narrow space of the pulmonary vein 80. The second balloon 42 is placed inside the pulmonary vein 80, and the first balloon 41 is placed near the junction 81 between the pulmonary vein 80 and the left atrium. Next, the expansion fluid is supplied into the first balloon 41 and the second balloon 42 through the second port 62, the expansion lumen 28, and the side hole 27. As a result, the first balloon 41 and the second balloon 42 expand, and the band portion 50 is pushed by the first balloon 41 and the second balloon 42 and expands radially outward. At this time, the outer tube 21 moves to the distal side relative to the inner tube 30, and the proximal portion of the band 50 moves to the distal side. As a result, the band portion 50 can be deformed while following the expansion of the expansion portion 40. The distal portion of the band 50 is pushed by the second balloon 42 and expands radially outward. Therefore, at least a part of the second electrode 58A of the band portion 50 is pressed against the inner wall surface of the pulmonary vein 80 by the second balloon 42 in a state of facing outward in the radial direction. Therefore, the second electrode 58A can detect the potential of the pulmonary vein 80 with high accuracy.
　また、帯部５０の近位部は、第１バルーン４１によって径方向外側へ拡張する。このため、帯部５０の第１電極５７Ａの少なくとも一部は、第１バルーン４１の、遠位側へ向かって外径が減少する部位の外側に配置される。このため、第１電極５７Ａは、径方向外側および遠位側を向いた状態で、第１バルーン４１によって肺静脈８０と接合部８１に押し付けられる。第１バルーン４１の外径は、第２バルーン４２の外径よりも大きいため、肺静脈８０よりも大きい内径を有する接合部８１へ、第１電極５７Ａを効果的に接触させることができる。そして、第１電極５７Ａと第２電極５８Ａとの間に位置する屈曲部５９は、屈曲しやすいため、径方向内側へ向かって屈曲する。屈曲部５９が径方向内側へ屈曲することで、帯部５０の第１電極５７Ａおよび第２電極５８Ａの間の部位の一部が、生体組織に接触せず、若しくは強く接触しない。このため、帯部５０は、第１電極５７Ａと第２電極５８Ａとの間に位置する生体組織の形状から影響を受け難くなる。したがって、第１電極５７Ａおよび第２電極５８Ａは、互いに異なる位置および角度に変形でき、各々の目的部位に良好に密着できる。さらに、帯部５０は、フレキシブルプリント基板により形成されているため、第１電極５７Ａおよび／または第２電極５８Ａに断線や短絡等の不具合が生じ難い。 Further, the proximal portion of the band portion 50 is expanded radially outward by the first balloon 41. Therefore, at least a part of the first electrode 57A of the band portion 50 is arranged outside the portion of the first balloon 41 whose outer diameter decreases toward the distal side. Therefore, the first electrode 57A is pressed against the pulmonary vein 80 and the joint 81 by the first balloon 41 in a state of facing the radial outer side and the distal side. Since the outer diameter of the first balloon 41 is larger than the outer diameter of the second balloon 42, the first electrode 57A can be effectively brought into contact with the joint portion 81 having an inner diameter larger than that of the pulmonary vein 80. Since the bent portion 59 located between the first electrode 57A and the second electrode 58A is easily bent, it bends inward in the radial direction. When the bent portion 59 bends inward in the radial direction, a part of the portion between the first electrode 57A and the second electrode 58A of the band portion 50 does not come into contact with or strongly come into contact with the living tissue. Therefore, the band portion 50 is less likely to be affected by the shape of the biological tissue located between the first electrode 57A and the second electrode 58A. Therefore, the first electrode 57A and the second electrode 58A can be deformed to different positions and angles from each other, and can be in good contact with each target portion. Further, since the band portion 50 is formed of a flexible printed circuit board, problems such as disconnection and short circuit are unlikely to occur in the first electrode 57A and / or the second electrode 58A.
　電源部１２からは、導線７０を介して、シャフト部２０の周方向Ｚに隣接する一対の帯部５０の第１電極５７Ａへ、パルス状の電気信号が印加される。これにより、周方向Ｚに隣接する一対の帯部５０間に電流が流れる。次に、周方向Ｚに隣接する他の対の帯部５０に対して、パルス状の電気信号が印加される。電気信号の印加は、周方向Ｚに隣接する全ての対となる帯部５０に対して、順次行われる。印加される電気信号の一例を以下に挙げる。電源部１２が印可する電界強度は、２００～１５００Ｖ／ｃｍであり、電気信号のパルス幅は１００μｓｅｃである。周方向Ｚに隣接する帯部５０の全ての対に対する電気信号の印加は、１～５秒に１回のサイクルで、心室筋の不応期に合わせて、６０～３６０回繰り返される。これによって、肺静脈の入口の細胞を全周に渡って壊死させる。なお、隣接に関係なく複数の帯部５０の間で電気信号を印加してもよく、帯部５０から体表に貼り付けられた対極板に対して電気信号を印加してもよい。 A pulsed electric signal is applied from the power supply unit 12 to the first electrode 57A of the pair of band portions 50 adjacent to the circumferential direction Z of the shaft portion 20 via the lead wire 70. As a result, a current flows between the pair of band portions 50 adjacent to each other in the circumferential direction Z. Next, a pulsed electric signal is applied to the other pair of band portions 50 adjacent to the circumferential direction Z. The application of the electric signal is sequentially performed to all the paired band portions 50 adjacent to the circumferential direction Z. An example of the applied electric signal is given below. The electric field strength applied by the power supply unit 12 is 200 to 1500 V / cm, and the pulse width of the electric signal is 100 μsec. The application of the electrical signal to all pairs of the band 50 adjacent to the circumferential direction Z is repeated 60 to 360 times in a cycle of once every 1 to 5 seconds according to the refractory period of the ventricular muscle. This causes the cells at the entrance of the pulmonary vein to become necrotic all around. An electric signal may be applied between the plurality of band portions 50 regardless of the adjacency, or an electric signal may be applied from the band portion 50 to the counter electrode plate attached to the body surface.
　各々の第２電極５８Ａは、肺静脈電位を検出する。第２電極５８Ａは、検出した電位を、導線７０を介して診断装置１３へ送信する。診断装置１３は、計測した電位から、第１電極５７Ａによる肺静脈乖離の状況を診断する。すなわち、肺静脈乖離が良好に行われると、肺静脈電位が消える、または減少する。したがって、診断装置１３は、各々の第２電極５８Ａにおいて計測される肺静脈電位から、肺静脈の周方向に並ぶ各々の第２位置において、第１電極５７Ａによる肺静脈乖離の状況を診断できる。 Each second electrode 58A detects the pulmonary vein potential. The second electrode 58A transmits the detected potential to the diagnostic apparatus 13 via the lead wire 70. The diagnostic device 13 diagnoses the state of pulmonary vein divergence by the first electrode 57A from the measured potential. That is, when the pulmonary vein divergence is performed well, the pulmonary vein potential disappears or decreases. Therefore, the diagnostic device 13 can diagnose the state of pulmonary vein divergence by the first electrode 57A at each second position arranged in the circumferential direction of the pulmonary vein from the pulmonary vein potential measured at each second electrode 58A.
　診断装置１３は、３次元電位マッピングシステムが組み込まれてもよい。３次元電位マッピングシステムは、受信した信号から、計測電極５８Ａの位置を特定できる。 The diagnostic device 13 may incorporate a three-dimensional potential mapping system. The three-dimensional potential mapping system can identify the position of the measuring electrode 58A from the received signal.
　拡張部４０を収縮させると、帯部５０は、自己の復元力によって径方向内側に収縮する。このとき、外管２１が内管３０に対して近位側へ移動し、帯部５０の近位部が近位側へ移動する。これにより、帯部５０は、拡張部４０の収縮に追従しながら元の直線に近い形状に変形できる。 When the expansion portion 40 is contracted, the band portion 50 contracts radially inward due to its own restoring force. At this time, the outer pipe 21 moves to the proximal side with respect to the inner pipe 30, and the proximal portion of the band portion 50 moves to the proximal side. As a result, the band portion 50 can be deformed into a shape close to the original straight line while following the contraction of the expansion portion 40.
　以上のように、第１実施形態に係る医療デバイス１０は、長尺なシャフト部２０と、シャフト部２０の遠位側に配置され、シャフト部２０の長軸方向に沿って延在し、シャフト部２０の径方向に変形可能である複数の帯部５０と、を有し、帯部５０の少なくとも１つは、生体組織にエネルギーを出力する第１電極５７Ａと、第１電極５７Ａよりも遠位側に配置され、曲げ剛性が遠位側および近位側の隣接部位よりも低い屈曲部５９と、を有する。 As described above, the medical device 10 according to the first embodiment is arranged on the long shaft portion 20 and the distal side of the shaft portion 20, extends along the long axis direction of the shaft portion 20, and has a shaft. It has a plurality of band portions 50 that are deformable in the radial direction of the portion 20, and at least one of the band portions 50 is farther than the first electrode 57A and the first electrode 57A that output energy to the living tissue. It has a flexed portion 59, which is located on the position side and has a lower flexural rigidity than the adjacent sites on the distal and proximal sides.
　上記のように構成した医療デバイス１０は、エネルギーを出力する第１電極５７Ａの遠位側の屈曲部５９が屈曲しやすい。このため、屈曲部５９をシャフト部２０に近づく方向へしなやかに曲げつつ、第１電極５７Ａを、目的部位へ良好に接触させることができる。 In the medical device 10 configured as described above, the bent portion 59 on the distal side of the first electrode 57A that outputs energy is easily bent. Therefore, the first electrode 57A can be brought into good contact with the target portion while flexibly bending the bent portion 59 in the direction approaching the shaft portion 20.
　また、医療デバイス１０は、シャフト部２０および帯部５０の間に配置され、シャフト部２０の径方向外側へ拡張可能な拡張部４０を有する。これにより、帯部５０に配置される第１電極５７Ａおよび第２電極５８Ａが、拡張する拡張部４０により押されて、目的部位に確実に接触できる。拡張部４０は、帯部５０とは異なる部材であるため、帯部５０とは異なる形状に変形できる。したがって、帯部５０の変形は、拡張部４０の変形可能な範囲に制限されない。したがって、帯部５０に配置される第１電極５７Ａおよび第２電極５８Ａの各々は、拡張部４０によって押されて、各々の目的部位に良好に接触できる。 Further, the medical device 10 is arranged between the shaft portion 20 and the band portion 50, and has an expansion portion 40 that can be expanded radially outward of the shaft portion 20. As a result, the first electrode 57A and the second electrode 58A arranged on the band portion 50 are pushed by the expanding portion 40 and can be reliably contacted with the target portion. Since the expansion portion 40 is a member different from the band portion 50, it can be deformed into a shape different from that of the band portion 50. Therefore, the deformation of the band portion 50 is not limited to the deformable range of the expansion portion 40. Therefore, each of the first electrode 57A and the second electrode 58A arranged on the band portion 50 can be pushed by the expansion portion 40 and can be in good contact with each target portion.
　また、帯部５０は、屈曲部５９よりも遠位側に配置され、電位を計測する第２電極５８Ａを有する。これにより、医療デバイス１０は、第１電極５７Ａと第２電極５８Ａとの間の屈曲部５９が屈曲しやすい。このため、屈曲部５９をシャフト部２０に近づく方向へ屈曲させつつ、第１電極５７Ａおよび第２電極５８Ａを、各々の目的部位へ良好に接触させることができる。したがって、本医療デバイス１０は、第１電極５７Ａによるエネルギーの出力と、第２電極５８Ａによる計測の両方を１つのデバイスで良好に行うことができる。例えば、医療デバイス１０は、広い左心房から狭い肺静脈８０へ挿入されると、第２電極５８Ａが肺静脈８０の壁面に接触し、第１電極５７Ａが肺静脈８０と左心房との接合部８１に接触しやすい。このため、第２電極５８Ａにより肺静脈８０の電位を良好に計測しつつ、第１電極５７Ａにより接合部８１を良好に処置（例えば、治療）できる。 Further, the band portion 50 is arranged on the distal side of the bent portion 59 and has a second electrode 58A for measuring the potential. As a result, in the medical device 10, the bent portion 59 between the first electrode 57A and the second electrode 58A is easily bent. Therefore, the first electrode 57A and the second electrode 58A can be brought into good contact with each target portion while bending the bent portion 59 in the direction approaching the shaft portion 20. Therefore, in the present medical device 10, both the energy output by the first electrode 57A and the measurement by the second electrode 58A can be satisfactorily performed by one device. For example, when the medical device 10 is inserted from the wide left atrium into the narrow pulmonary vein 80, the second electrode 58A contacts the wall surface of the pulmonary vein 80, and the first electrode 57A is the junction between the pulmonary vein 80 and the left atrium. Easy to contact 81. Therefore, the potential of the pulmonary vein 80 can be satisfactorily measured by the second electrode 58A, and the joint portion 81 can be satisfactorily treated (for example, treated) by the first electrode 57A.
　また、拡張部４０は、シャフト部２０および第１電極５７Ａの間に配置される第１バルーン４１と、シャフト部２０および第２電極５８Ａの間に配置され、第１バルーン４１よりも拡張可能な外径が小さい第２バルーン４２と、を有する。これにより、第１バルーン４１および第２バルーン４２は、第１電極５７Ａおよび第２電極５８Ａを目的部位に押し付けるために最適な形状となるように、独立して拡張可能である。また、屈曲部５９が、第１バルーン４１と第２バルーン４２との間で、シャフト部２０に近づくように屈曲しやすい。このため、第１電極５７Ａおよび第２電極５８Ａは、各々の目的部位に良好に接触できる。 Further, the expansion portion 40 is arranged between the first balloon 41 arranged between the shaft portion 20 and the first electrode 57A and the shaft portion 20 and the second electrode 58A, and is more expandable than the first balloon 41. It has a second balloon 42 having a small outer diameter. As a result, the first balloon 41 and the second balloon 42 can be independently expanded so as to have an optimum shape for pressing the first electrode 57A and the second electrode 58A against the target site. Further, the bent portion 59 is likely to be bent so as to approach the shaft portion 20 between the first balloon 41 and the second balloon 42. Therefore, the first electrode 57A and the second electrode 58A can be in good contact with each target portion.
　また、第１バルーン４１および第２バルーン４２が拡張した状態において、第１電極５７Ａは第１バルーン４１の中央部よりも遠位側の部位の径方向外側に配置され、第２電極５８Ａは第２バルーン４２の中央部を含む部位の径方向外側に配置される。なお、中央部とは、シャフト部２０の長軸方向における中央である。したがって、例えば、医療デバイス１０は、広い左心房から狭い肺静脈８０へ挿入されると、第２電極５８Ａが肺静脈８０の壁面に接触し、第１電極５７Ａが肺静脈８０と左心房との接合部８１に接触しやすい。このため、第２電極５８Ａにより肺静脈８０の電位を良好に計測しつつ、第１電極５７Ａにより接合部８１を良好に処置（例えば、治療）できる。 Further, in the expanded state of the first balloon 41 and the second balloon 42, the first electrode 57A is arranged radially outside the portion distal to the central portion of the first balloon 41, and the second electrode 58A is the second electrode 58A. 2 The balloon 42 is arranged radially outside the portion including the central portion. The central portion is the center of the shaft portion 20 in the long axis direction. Thus, for example, when the medical device 10 is inserted from the wide left atrium into the narrow pulmonary vein 80, the second electrode 58A contacts the wall surface of the pulmonary vein 80 and the first electrode 57A is between the pulmonary vein 80 and the left atrium. Easy to contact the joint 81. Therefore, the potential of the pulmonary vein 80 can be satisfactorily measured by the second electrode 58A, and the joint portion 81 can be satisfactorily treated (for example, treated) by the first electrode 57A.
　また、屈曲部５９は、少なくとも１つの括れ部５９Ａを有し、当該括れ部５９Ａにおける帯部５０の幅は、当該括れ部５９Ａの遠位側および近位側の隣接部位における帯部５０の幅よりも短い。これにより、帯部５０の曲げ剛性が、括れ部５９Ａが配置される屈曲部５９において部分的に低くなる。このため、帯部５０は屈曲部５９において良好に屈曲できる。
　＜第２実施形態＞ Further, the bent portion 59 has at least one constricted portion 59A, and the width of the band portion 50 in the constricted portion 59A is the width of the band portion 50 in the adjacent portion on the distal side and the proximal side of the constricted portion 59A. Shorter than. As a result, the flexural rigidity of the band portion 50 is partially reduced at the bent portion 59 in which the constricted portion 59A is arranged. Therefore, the band portion 50 can be satisfactorily bent at the bent portion 59.
<Second Embodiment>
　第２実施形態に係る医療デバイス１００は、図５に示すように、拡張部１１０が１つのバルーン１１１のみを有する点でのみ、第１実施形態と異なる。 The medical device 100 according to the second embodiment is different from the first embodiment only in that the expansion portion 110 has only one balloon 111, as shown in FIG.
　バルーン１１１は、外管２１の段差部２６の外周面を覆う柔軟に変形可能な弾性体である。バルーン１１１の遠位端および近位端は、段差部２６に固着されている。バルーン１１１の内部には、側孔２７が配置されている。このため、バルーン１１１の内部は、拡張ルーメン２８と連通している。バルーン１１１は、近位側に位置する第１の部位１１２と、遠位側に位置する第２の部位１１３と、第１の部位１１２および第２の部位１１３の間に位置する窪み部１１４とを有している。第１の部位１１２は、図６に示すように、第２の部位１１３よりも、シャフト部２０の径方向外側へ大きく拡張可能である。窪み部１１４は、バルーン１１１の拡張時に、シャフト部２０の長軸を通る断面において、第１の部位１１２と第２の部位１１３との間で、シャフト部２０に向かって突出している。窪み部１１４は、シャフト部２０の長軸を通る断面において、第１の部位１１２の径方向外側へ凸状の部位と、第２の部位１１３の径方向外側へ凸状の部位との間で、２つの変曲点１１５に挟まれて配置される。これにより、屈曲部５９が、第１の部位１１２と第２の部位１１３との間の窪み部１１４に向かって、シャフト部２０に近づくように屈曲しやすい。このため、第１電極５７Ａおよび第２電極５８Ａは、各々の目的部位に良好に接触できる。 The balloon 111 is a flexibly deformable elastic body that covers the outer peripheral surface of the stepped portion 26 of the outer pipe 21. The distal end and the proximal end of the balloon 111 are fixed to the step portion 26. A side hole 27 is arranged inside the balloon 111. Therefore, the inside of the balloon 111 communicates with the expansion lumen 28. The balloon 111 includes a first site 112 located on the proximal side, a second site 113 located on the distal side, and a recess 114 located between the first site 112 and the second site 113. have. As shown in FIG. 6, the first portion 112 can be expanded more outward in the radial direction of the shaft portion 20 than the second portion 113. When the balloon 111 is expanded, the recessed portion 114 projects toward the shaft portion 20 between the first portion 112 and the second portion 113 in a cross section passing through the long axis of the shaft portion 20. The recessed portion 114 is formed between a portion of the first portion 112 that is convex outward in the radial direction and a portion of the second portion 113 that is convex outward in the radial direction in a cross section that passes through the long axis of the shaft portion 20. It is arranged between two inflection points 115. As a result, the bent portion 59 tends to bend toward the recessed portion 114 between the first portion 112 and the second portion 113 so as to approach the shaft portion 20. Therefore, the first electrode 57A and the second electrode 58A can be in good contact with each target portion.
　第１電極５７Ａは、バルーンが拡張した際に、第１の部位１１２の略中央部および／または中央部よりも遠位側の部位に対して、径方向外側に位置する。第２電極５８Ａは、バルーンが拡張した際に、第２の部位１１３の径方向外側に位置する。 The first electrode 57A is located radially outward with respect to the substantially central portion and / or the portion distal to the central portion of the first portion 112 when the balloon is expanded. The second electrode 58A is located radially outward of the second portion 113 when the balloon is expanded.
　次に、第２実施形態に係る医療デバイス１００の作用および効果を説明する。 Next, the actions and effects of the medical device 100 according to the second embodiment will be described.
　医療デバイス１００は、図６に示すように、帯部５０の遠位部を目的位置である肺静脈８０の入口まで挿入された状態で、第２ポート６２、拡張ルーメン２８および側孔２７を介して、バルーン１１１に拡張用流体が供給される。これにより、バルーン１１１が拡張し、帯部５０がバルーン１１１によって押されて径方向外側に拡張する。帯部５０の遠位部は、第２の部位１１３によって押されて径方向外側へ拡張する。このため、帯部５０の第２電極５８Ａの少なくとも一部は、径方向外側を向いた状態で、第２の部位１１３によって肺静脈８０の内壁面に押し付けられる。このため、第２電極５８Ａは、肺静脈８０の電位を高精度に検出できる。また、帯部５０の近位部は、第１の部位１１２によって押されて径方向外側へ拡張する。帯部５０の第１電極５７Ａの少なくとも一部は、第１の部位１１２の、遠位側へ向かって外径が減少する遠位部の外側に配置される。このため、第１電極５７Ａは、径方向外側および遠位側を向いた状態で、第１の部位１１２によって接合部８１に押し付けられる。第１の部位１１２は、第２の部位１１３よりも大きいため、肺静脈８０よりも内径が大きい接合部８１へ、第１電極５７Ａを効果的に接触させることができる。そして、第１電極５７Ａと第２電極５８Ａの間に位置する屈曲部５９は、径方向内側へ向かって屈曲する。このとき、バルーン１１１の第１の部位１１２と第２の部位１１３の間に、径方向内側へ凸状の窪み部１１４が形成されるため、屈曲部５９は、径方向内側へ向かって屈曲しやすい。屈曲部５９が径方向内側へ屈曲することで、帯部５０の第１電極５７Ａおよび第２電極５８Ａの間の部位が、生体組織に接触せず、若しくは強く接触しない。このため、帯部５０は、第１電極５７Ａと第２電極５８Ａの間に位置する生体組織の形状から影響を受け難くなる。したがって、第１電極５７Ａおよび第２電極５８Ａは、各々の目的部位に良好に密着できる。 As shown in FIG. 6, the medical device 100 is inserted through the second port 62, the dilated lumen 28, and the side hole 27 with the distal portion of the band 50 inserted to the entrance of the pulmonary vein 80, which is the target position. Then, the expansion fluid is supplied to the balloon 111. As a result, the balloon 111 expands, and the band portion 50 is pushed by the balloon 111 and expands radially outward. The distal portion of the band 50 is pushed by the second site 113 and expands radially outward. Therefore, at least a part of the second electrode 58A of the band portion 50 is pressed against the inner wall surface of the pulmonary vein 80 by the second site 113 in a state of facing outward in the radial direction. Therefore, the second electrode 58A can detect the potential of the pulmonary vein 80 with high accuracy. Further, the proximal portion of the band portion 50 is pushed by the first portion 112 and expands radially outward. At least a portion of the first electrode 57A of the band 50 is located outside the distal portion of the first site 112 whose outer diameter decreases toward the distal side. Therefore, the first electrode 57A is pressed against the joint portion 81 by the first portion 112 in a state of facing the radial outer side and the distal side. Since the first site 112 is larger than the second site 113, the first electrode 57A can be effectively brought into contact with the joint 81 having an inner diameter larger than that of the pulmonary vein 80. Then, the bent portion 59 located between the first electrode 57A and the second electrode 58A bends inward in the radial direction. At this time, since the concave portion 114 having a convex shape in the radial direction is formed between the first portion 112 and the second portion 113 of the balloon 111, the bent portion 59 bends inward in the radial direction. Cheap. When the bent portion 59 bends inward in the radial direction, the portion of the band portion 50 between the first electrode 57A and the second electrode 58A does not come into contact with or strongly come into contact with the living tissue. Therefore, the band portion 50 is less likely to be affected by the shape of the biological tissue located between the first electrode 57A and the second electrode 58A. Therefore, the first electrode 57A and the second electrode 58A can be in close contact with each target portion.
　以上のように、第２実施形態に係る医療デバイス１００において、拡張部４０は、シャフト部２０および第１電極５７Ａの間に配置される第１の部位１１２と、シャフト部２０および第２電極５８Ａの間に配置され、第１の部位１１２よりも拡張可能な径が小さい第２の部位１１３と、を備える１つのバルーン１１１を有する。これにより、第１電極５７Ａを第１の部位１１２によって目的部位へ押し付けるとともに、第２電極５８Ａを第２の部位１１３によって目的部位へ押し付けることができる。また、第１電極５７Ａおよび第２電極５８Ａを目的部位に接触させるために、１つのバルーン１１１を操作するのみでよいため、操作性が向上する。 As described above, in the medical device 100 according to the second embodiment, the expansion portion 40 includes the first portion 112 arranged between the shaft portion 20 and the first electrode 57A, and the shaft portion 20 and the second electrode 58A. It has one balloon 111 that is disposed between and comprises a second site 113 that is smaller in diameter than the first site 112 and is expandable. As a result, the first electrode 57A can be pressed against the target portion by the first portion 112, and the second electrode 58A can be pressed against the target portion by the second portion 113. Further, since it is only necessary to operate one balloon 111 in order to bring the first electrode 57A and the second electrode 58A into contact with the target portion, the operability is improved.
　また、拡張時のバルーン１１１は、シャフト部２０の長軸を通る断面において、第１の部位１１２と第２の部位１１３との間に、２つの変曲点１１５に挟まれてシャフト部２０に向かって突出する窪み部１１４を有する。これにより、屈曲部５９が、第１の部位１１２と第２の部位１１３との間の窪み部１１４に向かって、シャフト部２０に近づくように屈曲しやすい。このため、第１電極５７Ａおよび第２電極５８Ａは、各々の目的部位に良好に接触できる。
　＜第３実施形態＞ Further, the balloon 111 at the time of expansion is sandwiched between two inflection points 115 between the first portion 112 and the second portion 113 in the cross section passing through the long axis of the shaft portion 20, and is formed by the shaft portion 20. It has a recess 114 that projects toward it. As a result, the bent portion 59 tends to bend toward the recessed portion 114 between the first portion 112 and the second portion 113 so as to approach the shaft portion 20. Therefore, the first electrode 57A and the second electrode 58A can be in good contact with each target portion.
<Third Embodiment>
　第３実施形態に係る医療デバイス１２０は、図７に示すように、拡張部１３０が１つのバルーン１３１のみを有し、帯部１４０が屈曲部１４１および近位屈曲部１４２を有する点で、第１実施形態と異なる。 In the medical device 120 according to the third embodiment, as shown in FIG. 7, the expansion portion 130 has only one balloon 131, and the band portion 140 has the bending portion 141 and the proximal bending portion 142. 1 Different from the embodiment.
　バルーン１３１は、外管２１の段差部２６の外周面を覆う柔軟に変形可能な弾性体である。バルーン１３１の内部には、側孔２７が配置されている。このため、バルーン１３１の内部は、拡張ルーメン２８と連通している。バルーン１３１は、遠位移行部１３２と、筒状部１３３と、近位移行部１３４とを有している。バルーン１３１が拡張した状態において、遠位移行部１３２は、バルーン１３１の遠位端の段差部２６に対する固定位置から近位側へ向かって、外径が大きくなっている。バルーン１３１が拡張した状態において、近位移行部１３４は、バルーン１３１の近位端の段差部２６に対する固定位置から遠位側へ向かって、外径が大きくなっている。筒状部１３３は、遠位移行部１３２と近位移行部１３４との間に配置される。筒状部１３３は、バルーン１３１が拡張した状態において、略一定の外径を有する円筒形状である。 The balloon 131 is a flexibly deformable elastic body that covers the outer peripheral surface of the stepped portion 26 of the outer pipe 21. A side hole 27 is arranged inside the balloon 131. Therefore, the inside of the balloon 131 communicates with the expansion lumen 28. The balloon 131 has a distal transition portion 132, a tubular portion 133, and a proximal transition portion 134. In the expanded state of the balloon 131, the outer diameter of the distal transition portion 132 increases from the fixed position with respect to the step portion 26 at the distal end of the balloon 131 toward the proximal side. In the expanded state of the balloon 131, the outer diameter of the proximal transition portion 134 increases from the fixed position with respect to the step portion 26 at the proximal end of the balloon 131 toward the distal side. The tubular portion 133 is arranged between the distal transition portion 132 and the proximal transition portion 134. The tubular portion 133 has a cylindrical shape having a substantially constant outer diameter when the balloon 131 is expanded.
　第１電極５７Ａおよび第２電極５８Ａは、筒状部１３３の径方向外側に配置される。第２電極５８は、第１電極５７Ａよりも遠位側に配置される。 The first electrode 57A and the second electrode 58A are arranged on the radial outer side of the tubular portion 133. The second electrode 58 is arranged distal to the first electrode 57A.
　屈曲部１４１は、筒状部１３３よりも遠位側に配置される。すなわち、屈曲部１４１は、遠位移行部１３２の近傍に配置される。近位屈曲部１４２は、筒状部１３３よりも近位側に配置される。すなわち、近位屈曲部１４２は、近位移行部１３４の近傍に配置される。近位屈曲部１４２は、屈曲部１４１と同様に、遠位側および近位側の隣接部位よりも低い曲げ剛性を有する。近位屈曲部１４２は、屈曲部１４１と同様の構成であり得る。したがって、屈曲部１４１および近位屈曲部１４２は、柔軟であり、屈曲しやすい。 The bent portion 141 is arranged on the distal side of the tubular portion 133. That is, the bent portion 141 is arranged in the vicinity of the distal transition portion 132. The proximal flexion portion 142 is arranged proximal to the tubular portion 133. That is, the proximal flexion portion 142 is arranged in the vicinity of the proximal transition portion 134. Proximal flexion 142, like flexion 141, has lower flexural rigidity than adjacent sites on the distal and proximal sides. The proximal bend 142 may have a configuration similar to that of the bend 141. Therefore, the bent portion 141 and the proximal bent portion 142 are flexible and easily bent.
　次に、第３実施形態に係る医療デバイス１２０の作用および効果を説明する。 Next, the action and effect of the medical device 120 according to the third embodiment will be described.
　医療デバイス１２０は、帯部１４０の略全体を、内径が略一定となる肺静脈８０まで挿入される。この状態で、第２ポート６２、拡張ルーメン２８および側孔２７を介して、バルーン１３１に拡張用流体が供給される。これにより、バルーン１３１が拡張し、帯部１４０がバルーン１３１によって押されて径方向外側に拡張する。第１電極５７Ａおよび第２電極５８Ａは、円筒部１３３によって、肺静脈８０の内壁面に押し付けられる。このとき、屈曲部１４１は、柔軟であるため、シャフト部２０から略垂直に立ち上がる遠位移行部１３２の近傍で、径方向内側へ向かって屈曲する。屈曲部１４１は、バルーン１３１の遠位移行部１３２における急激な外径の変化に対応して、大きく屈曲できる。また、近位屈曲部１４２は、シャフト部２０から略垂直に立ち上がる近位移行部１３４の近傍で、径方向内側へ向かって屈曲する。近位屈曲部１４２は、バルーン１３１の近位移行部１３４における急激な外径の変化に対応して、大きく屈曲できる。このため、帯部１４０は、筒状部１３３が大きく拡張したバルーン１３１の形状に追従して変形しやすい。したがって、屈曲部１４１および近位屈曲部１４２の間に配置される第１電極５７Ａおよび第２電極５８Ａは、肺静脈８０の内壁面に密着する。 The medical device 120 is inserted into substantially the entire band 140 up to the pulmonary vein 80 having a substantially constant inner diameter. In this state, the expansion fluid is supplied to the balloon 131 through the second port 62, the expansion lumen 28, and the side hole 27. As a result, the balloon 131 expands, and the band portion 140 is pushed by the balloon 131 and expands radially outward. The first electrode 57A and the second electrode 58A are pressed against the inner wall surface of the pulmonary vein 80 by the cylindrical portion 133. At this time, since the bent portion 141 is flexible, it bends inward in the radial direction in the vicinity of the distal transition portion 132 that rises substantially vertically from the shaft portion 20. The bent portion 141 can be greatly bent in response to a sudden change in the outer diameter of the distal transition portion 132 of the balloon 131. Further, the proximal bending portion 142 bends inward in the radial direction in the vicinity of the proximal transition portion 134 rising substantially vertically from the shaft portion 20. The proximal bend 142 can be significantly bent in response to a sudden change in outer diameter at the proximal transition 134 of the balloon 131. Therefore, the band portion 140 is likely to be deformed following the shape of the balloon 131 in which the tubular portion 133 is greatly expanded. Therefore, the first electrode 57A and the second electrode 58A arranged between the flexion portion 141 and the proximal flexion portion 142 are in close contact with the inner wall surface of the pulmonary vein 80.
　以上のように、第３実施形態に係る医療デバイス１２０において、帯部１４０は、第１電極５７Ａよりも遠位側に配置され、屈曲部１４１よりも近位側に配置されて電位を計測する第２電極５８Ａと、第１電極５７Ａよりも近位側に配置され、曲げ剛性が遠位側および近位側の隣接部位よりも低い近位屈曲部１４２と、を有し、拡張した状態の拡張部１３０は、当該拡張部１３０の遠位側のシャフト部２０に対する固定部位から近位側へ向かって外径が大きくなる遠位移行部１３２と、当該拡張部１３０の近位側のシャフト部２０に対する固定部位から遠位側へ向かって外径が大きくなる近位移行部１３４と、遠位移行部１３２および近位移行部１３４の間に位置する筒状部１３３と、を有するバルーン１３１であり、第１電極５７Ａおよび第２電極５８Ａは、筒状部１３３の径方向外側に配置され、屈曲部１４１は、筒状部１３３よりも遠位側に配置され、近位屈曲部１４２は、筒状部１３３よりも近位側に配置される。これにより、バルーン１３１が拡張すると、屈曲部１４１は、シャフト部２０から立ち上がる遠位移行部１３２の近傍で、径方向内側へ向かって屈曲する。さらに、近位屈曲部１４２は、シャフト部２０から立ち上がる近位移行部１３４の近傍で、径方向内側へ向かって屈曲する。このため、屈曲部１４１および近位屈曲部１４２の間に配置される第１電極５７Ａおよび第２電極５８Ａは、各々の目的部位に良好に接触できる。また、屈曲部１４１および近位屈曲部１４２が屈曲することで、外径が急激に変化する遠位移行部１３２および近位屈曲部１４２の近傍で、帯部１４０に塑性変形や破損が生じることを抑制できる。また、第１電極５７Ａおよび第２電極５８Ａを目的部位に接触させるために、１つのバルーン１１１を操作するのみでよいため、操作性が向上する。 As described above, in the medical device 120 according to the third embodiment, the band portion 140 is arranged on the distal side of the first electrode 57A and on the proximal side of the bending portion 141 to measure the potential. It has a second electrode 58A and a proximal flexion portion 142 that is located proximal to the first electrode 57A and has a lower bending rigidity than the distal and proximal adjacent sites, and is in an expanded state. The expansion portion 130 includes a distal transition portion 132 whose outer diameter increases toward the proximal side from a fixed portion with respect to the shaft portion 20 on the distal side of the expansion portion 130, and a shaft portion on the proximal side of the expansion portion 130. A balloon 131 having a proximal transition portion 134 whose outer diameter increases toward the distal side from the fixation site with respect to 20 and a tubular portion 133 located between the distal transition portion 132 and the proximal transition portion 134. The first electrode 57A and the second electrode 58A are arranged radially outside the tubular portion 133, the bent portion 141 is arranged distal to the tubular portion 133, and the proximal bent portion 142 is located. It is arranged proximal to the tubular portion 133. As a result, when the balloon 131 expands, the bent portion 141 bends inward in the radial direction in the vicinity of the distal transition portion 132 rising from the shaft portion 20. Further, the proximal bending portion 142 bends inward in the radial direction in the vicinity of the proximal transition portion 134 rising from the shaft portion 20. Therefore, the first electrode 57A and the second electrode 58A arranged between the bent portion 141 and the proximal bent portion 142 can be in good contact with each target portion. Further, when the bent portion 141 and the proximal bent portion 142 are bent, the band portion 140 is plastically deformed or damaged in the vicinity of the distal transition portion 132 and the proximal bent portion 142 whose outer diameter suddenly changes. Can be suppressed. Further, since it is only necessary to operate one balloon 111 in order to bring the first electrode 57A and the second electrode 58A into contact with the target portion, the operability is 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、上述の実施形態の医療デバイス１０、１００は、肺静脈８０の処置に用いるものを示したが、それ以外の部位、例えば、腎動脈、上行大静脈、心室などを処置するものであってもよい。 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 medical devices 10 and 100 of the above-described embodiment have been shown to be used for treating the pulmonary vein 80, but are for treating other sites such as the renal artery, the ascending vena cava, and the ventricle. May be good.
　また、帯部５０に形成される屈曲部５９の形態は、特に限定されない。例えば、図８（Ａ）に示す第１変形例のように、屈曲部５９は、少なくとも１つの薄肉部５９Ｂを有し、当該薄肉部５９Ｂにおける帯部５０の厚さは、当該薄肉部５９Ｂの遠位側および近位側の隣接部位における帯部５０の厚さよりも薄くてもよい。これにより、帯部５０の曲げ剛性が、薄肉部５９Ｂが配置される屈曲部５９において部分的に低くなる。このため、帯部５０は屈曲部５９において良好に屈曲できる。薄肉部５９Ｂは、帯部５０の表面に帯部５０の幅方向へ延在する溝部が形成されてもよい。これにより、薄肉部５９Ｂの曲げ剛性を、溝部によって効果的に減少させることができる。また、溝部が帯部５０の幅方向へ延在するため、帯部５０が、溝部において厚さ方向へ屈曲しやすい。 Further, the form of the bent portion 59 formed on the band portion 50 is not particularly limited. For example, as in the first modification shown in FIG. 8A, the bent portion 59 has at least one thin-walled portion 59B, and the thickness of the band portion 50 in the thin-walled portion 59B is the thickness of the thin-walled portion 59B. It may be thinner than the thickness of the band 50 at the distal and proximal sites. As a result, the flexural rigidity of the band portion 50 is partially reduced at the bent portion 59 in which the thin-walled portion 59B is arranged. Therefore, the band portion 50 can be satisfactorily bent at the bent portion 59. The thin-walled portion 59B may have a groove portion extending in the width direction of the band portion 50 formed on the surface of the band portion 50. As a result, the flexural rigidity of the thin-walled portion 59B can be effectively reduced by the groove portion. Further, since the groove portion extends in the width direction of the band portion 50, the band portion 50 is likely to bend in the thickness direction in the groove portion.
　また、図８（Ｂ）に示す第２変形例のように、屈曲部５９は、帯部５０の幅が短い括れ部５９Ａと、帯部５０の厚さが薄い薄肉部５９Ｂの両方が形成されてもよい。これにより、帯部５０の曲げ剛性が、括れ部５９Ａおよび薄肉部５９Ｂが配置される屈曲部５９において相乗的に低くなる。このため、帯部５０は屈曲部５９において良好に屈曲できる。 Further, as in the second modification shown in FIG. 8B, the bent portion 59 is formed with both a constricted portion 59A having a short width of the band portion 50 and a thin-walled portion 59B having a thin band portion 50. You may. As a result, the flexural rigidity of the band portion 50 is synergistically reduced in the bent portion 59 in which the constricted portion 59A and the thin-walled portion 59B are arranged. Therefore, the band portion 50 can be satisfactorily bent at the bent portion 59.
　また、図８（Ｃ）に示す第３変形例のように、剛性の高い導電体により形成される第１導電層５７および第２導電層５８の量によって、屈曲部５９の曲げ剛性を、屈曲部５９の遠位側および近位側の各々の隣接部位よりも低く設定してもよい。本変形例では、屈曲部５９に第１導電層５７は配置されず、第２導電層５８が配置されている。なお、屈曲部５９に、第１導電層５７および第２導電層５８の両方が配置されてもよく、または、第２導電層５８が配置されずに第１導電層５７が配置されてもよい。以上のように、帯部５０は、第１電極５７Ａを含む第１導電層５７と、第２電極５８Ａを含む第２導電層５８と、を有し、帯部５０の長尺方向と直交する断面において第１導電層５７および第２導電層５８の合計の面積を導電体面積と定義し、屈曲部５９の導電体面積は、当該屈曲部５９の遠位側および近位側の隣接部位の導電体面積よりも小さい。これにより、第１導電層５７および第２導電層５８の配置の工夫のみによって、帯部５０に屈曲部５９を容易に形成できる。 Further, as in the third modification shown in FIG. 8C, the bending rigidity of the bent portion 59 is bent by the amount of the first conductive layer 57 and the second conductive layer 58 formed by the highly rigid conductor. It may be set lower than each adjacent site on the distal side and the proximal side of the portion 59. In this modification, the first conductive layer 57 is not arranged at the bent portion 59, but the second conductive layer 58 is arranged. Both the first conductive layer 57 and the second conductive layer 58 may be arranged on the bent portion 59, or the first conductive layer 57 may be arranged without the second conductive layer 58. .. As described above, the band portion 50 has a first conductive layer 57 including the first electrode 57A and a second conductive layer 58 including the second electrode 58A, and is orthogonal to the long direction of the band portion 50. In the cross section, the total area of the first conductive layer 57 and the second conductive layer 58 is defined as the conductor area, and the conductor area of the bent portion 59 is the adjacent portion on the distal side and the proximal side of the bent portion 59. It is smaller than the conductor area. As a result, the bent portion 59 can be easily formed on the band portion 50 only by devising the arrangement of the first conductive layer 57 and the second conductive layer 58.
　また、図８（Ｄ）に示す第４変形例のように、構成材料の柔軟性によって、屈曲部５９の曲げ剛性を、屈曲部５９の遠位側および近位側の隣接部位よりも低く設定してもよい。屈曲部５９は、少なくとも１つの柔軟部５９Ｃを有し、当該柔軟部５９Ｃの構成材料は、柔軟部５９Ｃの遠位側および近位側の隣接部位の構成材料よりも柔らかい。これにより、帯部５０の曲げ剛性が、柔軟部５９Ｃが配置される屈曲部５９において部分的に低くなる。このため、帯部５０は屈曲部５９において良好に屈曲できる。図８（Ｄ）に示す柔軟部５９Ｃは、薄肉部５９Ｂが形成されるが、薄肉部５９Ｂは形成されなくてもよい。柔軟部５９Ｃに薄肉部５９Ｂを形成することで、帯部５０の曲げ剛性を、相乗的に低くすることができる。柔軟部５９Ｃは、絶縁層５６に形成されるが、基板層５３、接着層５４、または導電層５５に形成されてもよい。 Further, as in the fourth modification shown in FIG. 8D, the flexural rigidity of the bent portion 59 is set lower than that of the adjacent portions on the distal side and the proximal side of the bent portion 59 due to the flexibility of the constituent material. You may. The bent portion 59 has at least one flexible portion 59C, and the constituent material of the flexible portion 59C is softer than the constituent material of the adjacent portion on the distal side and the proximal side of the flexible portion 59C. As a result, the flexural rigidity of the band portion 50 is partially reduced at the bent portion 59 in which the flexible portion 59C is arranged. Therefore, the band portion 50 can be satisfactorily bent at the bent portion 59. In the flexible portion 59C shown in FIG. 8D, a thin-walled portion 59B is formed, but the thin-walled portion 59B may not be formed. By forming the thin portion 59B on the flexible portion 59C, the bending rigidity of the band portion 50 can be synergistically reduced. The flexible portion 59C is formed on the insulating layer 56, but may be formed on the substrate layer 53, the adhesive layer 54, or the conductive layer 55.
　また、図８（Ｅ）に示す第５変形例のように、屈曲部５９は、当該屈曲部５９の近位側および／または遠位側の隣接部位から曲げ剛性が徐々に減少する傾斜物性部５９Ｄを有してもよい。これにより、帯部５０は、屈曲部５９において滑らかに屈曲でき、応力が集中しすぎることを抑制できる。このため、屈曲部５９が屈曲することによって破損することを抑制できる。 Further, as in the fifth modification shown in FIG. 8 (E), the bent portion 59 is an inclined physical property portion in which the bending rigidity gradually decreases from the adjacent portion on the proximal side and / or the distal side of the bent portion 59. It may have 59D. As a result, the band portion 50 can be smoothly bent at the bent portion 59, and excessive stress concentration can be suppressed. Therefore, it is possible to prevent the bent portion 59 from being damaged due to bending.
　また、図９（Ａ）に示す第６変形例のように、１つの帯部５０が、複数の第２電極５８Ａを有してもよい。例えば、２つの第２電極５８Ａが、帯部５０の長尺方向に並んでいる。各々の第２電極５８Ａは、各々の第２端子５８Ｂによって異なる導線７０に接続される。このため、１つの帯部５０の２カ所で、電位を計測できる。したがって、１つの第２電極５８Ａでは検出できない電位を、検出することが可能となる。なお、第２電極５８Ａは、３つ以上設けられてもよい。また、図９（Ｂ）に示す第７変形例のように、複数の第２電極５８Ａは、帯部５０の幅方向へ並んで配置されてもよい。 Further, as in the sixth modification shown in FIG. 9A, one band portion 50 may have a plurality of second electrodes 58A. For example, two second electrodes 58A are aligned in the elongated direction of the band portion 50. Each second electrode 58A is connected to a different lead wire 70 by each second terminal 58B. Therefore, the potential can be measured at two points of one band 50. Therefore, it is possible to detect a potential that cannot be detected by one second electrode 58A. In addition, three or more second electrodes 58A may be provided. Further, as in the seventh modification shown in FIG. 9B, the plurality of second electrodes 58A may be arranged side by side in the width direction of the band portion 50.
　また、図１０に示す第８変形例のように、第１電極５７Ａに接続される第１配線部５７Ｃと、第２電極５８Ａに接続される第２配線部５７Ｃは、積層されて異なる階層に配置されてもよい。第１配線部５７Ｃと第１端子５７Ｂとの間、および第１配線部５７Ｃと第１電極５７Ａとの間は、スルーホールに蒸着された金等の導電部材５７Ｄにより接続される。また、第２配線部５８Ｃと第２端子５８Ｂとの間、および第２配線部５８Ｃと第２電極５８Ａとの間も、スルーホールに蒸着された金等の導電部材５８Ｄにより接続される。これにより、第１配線部５７Ｃおよび第２配線部５８Ｃを、同一の面に形成する必要がなくなるため、第１電極５７Ａの幅を広げることができる。 Further, as in the eighth modification shown in FIG. 10, the first wiring portion 57C connected to the first electrode 57A and the second wiring portion 57C connected to the second electrode 58A are laminated and arranged in different layers. It may be arranged. The first wiring portion 57C and the first terminal 57B, and the first wiring portion 57C and the first electrode 57A are connected by a conductive member 57D such as gold deposited in the through hole. Further, the second wiring portion 58C and the second terminal 58B, and the second wiring portion 58C and the second electrode 58A are also connected by a conductive member 58D such as gold deposited in the through hole. As a result, it is not necessary to form the first wiring portion 57C and the second wiring portion 58C on the same surface, so that the width of the first electrode 57A can be widened.
　また、医療デバイスは、拡張部を有さなくてもよい。医療デバイスは、拡張部を備えなくても、外管２１および内管３０をシャフト部２０の長軸方向へ相対的に移動させることで、帯部５０を径方向外側および内側へ撓むように変形させることができる。 Also, the medical device does not have to have an extension. The medical device deforms the band portion 50 so as to bend outward and inward in the radial direction by relatively moving the outer pipe 21 and the inner pipe 30 in the long axis direction of the shaft portion 20 without providing the extension portion. be able to.
　また、帯部５０は、屈曲部５９と同様に曲げ剛性が部分的に低い部位を、第１電極５７Ａよりも近位側および／または第２電極５８Ａよりも遠位側に備えてもよい。これにより、第１電極５７Ａおよび／または第２電極５８Ａを、各々の目的部位へ確実に密着させることができる。 Further, the band portion 50 may be provided with a portion having a partially low flexural rigidity like the bending portion 59 on the proximal side of the first electrode 57A and / or on the distal side of the second electrode 58A. As a result, the first electrode 57A and / or the second electrode 58A can be reliably brought into close contact with each target portion.
　また、医療デバイスは、手元での操作で遠位部の向く方向を変更できる構造を備えてもよい。また、医療デバイスは、３Ｄマッピング用の磁気発生手段を有してもよい。また、医療デバイスの第２電極５８Ａは、第１電極としての機能を備えてもよい。この場合、例えば、同じ帯部５０の第２電極５８Ａおよび第１電極５７Ａの間で電気を流すことで、アブレーションを行うことが可能である。また、異なる帯部の第２電極５８Ａおよび第１電極５７Ａの間で電気を流すことで、アブレーションを行ってもよい。また、帯部は、フレキシブルプリント基板でなくてもよい。 Further, the medical device may have a structure that can change the direction in which the distal portion faces by a hand operation. In addition, the medical device may have a magnetic generating means for 3D mapping. Further, the second electrode 58A of the medical device may have a function as the first electrode. In this case, for example, ablation can be performed by passing electricity between the second electrode 58A and the first electrode 57A of the same band portion 50. Further, ablation may be performed by passing electricity between the second electrode 58A and the first electrode 57A of different bands. Further, the strip portion does not have to be a flexible printed circuit board.
　また、第１実施形態に係る医療デバイス１０が、２つの拡張ルーメンを有し、第１バルーン４１および第２バルーン４２が、異なる拡張ルーメンに連通してもよい。これにより、第１バルーン４１および第２バルーン４２は、各々の望ましい異なるタイミングで拡張可能である。 Further, the medical device 10 according to the first embodiment may have two expansion lumens, and the first balloon 41 and the second balloon 42 may communicate with different expansion lumens. Thereby, the first balloon 41 and the second balloon 42 can be expanded at each desired different timing.
　なお、本出願は、２０１９年３月２６日に出願された日本特許出願２０１９－５８９３０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。 Note that this application is based on Japanese Patent Application No. 2019-58930 filed on March 26, 2019, and the disclosure contents thereof are referred to and incorporated as a whole.
　　１０、１００、１２０　　医療デバイス
　　２０　　シャフト部
　　２１　　外管
　　３０　　内管
　　４０、１１０、１３０　　拡張部
　　４１　　第１バルーン
　　４２　　第２バルーン
　　５０、１４０　　帯部
　　５３　　基板層
　　５４　　接着層
　　５５　　導電層
　　５６　　絶縁層
　　５７　　第１導電層
　　５７Ａ　　第１電極
　　５７Ｂ　　第１端子
　　５７Ｃ　　第１配線部
　　５８　　第２導電層
　　５８Ａ　　第２電極
　　５８Ｂ　　第２端子
　　５８Ｃ　　第２配線部
　　５９、１４１　　屈曲部
　　５９Ａ　　括れ部
　　５９Ｂ　　薄肉部
　　５９Ｃ　　柔軟部
　　８０　　肺静脈
　　８１　　接合部
　　１１１、１３１　　バルーン
　　１１２　　第１の部位
　　１１３　　第２の部位
　　１１４　　窪み部
　　１３２　　遠位移行部
　　１３３　　筒状部
　　１３４　　近位移行部
　　１４２　　近位屈曲部 10, 100, 120 Medical device 20 Shaft part 21 Outer pipe 30 Inner pipe 40, 110, 130 Expansion part 41 First balloon 42 Second balloon 50, 140 Band part 53 Substrate layer 54 Adhesive layer 55 Conductive layer 56 Insulation layer 57th 1 Conductive layer 57A 1st electrode 57B 1st terminal 57C 1st wiring part 58 2nd conductive layer 58A 2nd electrode 58B 2nd terminal 58C 2nd wiring part 59, 141 Bending part 59A Constricted part 59B Thin-walled part 59C Flexible part 80 Lung Venous 81 Joints 111, 131 Balloon 112 First part 113 Second part 114 Depression 132 Distal transition 133 Cylindrical 134 Proximal transition 142 Proximal flexion

Claims (13)

  1. 　長尺なシャフト部と、
    　前記シャフト部の遠位側に配置され、前記シャフト部の長軸方向に沿って延在し、前記シャフト部の径方向に変形可能である複数の帯部と、を有し、
    　前記帯部の少なくとも１つは、
    　生体組織にエネルギーを出力する第１電極と、
    　前記第１電極よりも遠位側に配置され、曲げ剛性が遠位側および近位側の隣接部位よりも低い屈曲部と、を有する医療デバイス。     With a long shaft
    It has a plurality of strips that are arranged on the distal side of the shaft portion, extend along the long axis direction of the shaft portion, and are deformable in the radial direction of the shaft portion.
    At least one of the bands
    The first electrode that outputs energy to living tissue and
    A medical device having a flexural rigidity located distal to the first electrode and having a flexural rigidity lower than that of adjacent sites on the distal and proximal sides.
  2. 　前記シャフト部および帯部の間に配置され、前記シャフト部の径方向外側へ拡張可能な拡張部を有する請求項１に記載の医療デバイス。 The medical device according to claim 1, which is arranged between the shaft portion and the band portion and has an expansion portion that can be expanded radially outward of the shaft portion.
  3. 　前記帯部は、前記屈曲部よりも遠位側に配置され、電位を計測する第２電極を有する請求項２に記載の医療デバイス。 The medical device according to claim 2, wherein the band portion is arranged on the distal side of the bent portion and has a second electrode for measuring an electric potential.
  4. 　前記拡張部は、前記シャフト部および第１電極の間に配置される第１バルーンと、前記シャフト部および第２電極の間に配置され、前記第１バルーンよりも拡張可能な外径が小さい第２バルーンと、を有する請求項３に記載の医療デバイス。 The expansion portion has a first balloon arranged between the shaft portion and the first electrode, and a second balloon arranged between the shaft portion and the second electrode and having a smaller outer diameter that can be expanded than the first balloon. 2. The medical device according to claim 3, which comprises two balloons.
  5. 　前記第１バルーンおよび第２バルーンが拡張した状態において、前記第１電極は前記第１バルーンの中央部よりも遠位側の部位の径方向外側に配置され、前記第２電極は前記第２バルーンの中央部を含む部位の径方向外側に配置される請求項４に記載の医療デバイス。 In the expanded state of the first balloon and the second balloon, the first electrode is arranged radially outside the portion distal to the central portion of the first balloon, and the second electrode is the second balloon. The medical device according to claim 4, wherein the medical device is arranged radially outside the portion including the central portion of the balloon.
  6. 　前記拡張部は、前記シャフト部および第１電極の間に配置される第１の部位と、前記シャフト部および第２電極の間に配置され、前記第１の部位よりも拡張可能な径が小さい第２の部位と、を備える１つのバルーンを有する請求項３に記載の医療デバイス。 The expansion portion is arranged between the shaft portion and the second electrode and a first portion arranged between the shaft portion and the first electrode, and has a smaller expandable diameter than the first portion. The medical device of claim 3, comprising one balloon comprising a second site.
  7. 　拡張時の前記バルーンは、前記シャフト部の長軸を通る断面において、前記第１の部位と第２の部位との間に、２つの変曲点に挟まれて前記シャフト部に向かって突出する窪み部を有する請求項６に記載の医療デバイス。 The balloon at the time of expansion is sandwiched between two inflection points between the first portion and the second portion in a cross section passing through the long axis of the shaft portion and projects toward the shaft portion. The medical device according to claim 6, which has a recess.
  8. 　前記帯部は、前記第１電極よりも遠位側に配置され、前記屈曲部よりも近位側に配置されて電位を計測する第２電極と、
    　前記第１電極よりも近位側に配置され、曲げ剛性が遠位側および近位側の隣接部位よりも低い近位屈曲部と、を有し、
    　拡張した状態の前記拡張部は、当該拡張部の遠位側の前記シャフト部に対する固定部位から近位側へ向かって外径が大きくなる遠位移行部と、当該拡張部の近位側の前記シャフト部に対する固定部位から遠位側へ向かって外径が大きくなる近位移行部と、前記遠位移行部および近位移行部の間に位置する筒状部と、を有するバルーンであり、
    　前記第１電極および第２電極は、前記筒状部の径方向外側に配置され、
    　前記屈曲部は、前記筒状部よりも遠位側に配置され、
    　前記近位屈曲部は、前記筒状部よりも近位側に配置される請求項２に記載の医療デバイス。     The band portion is arranged on the distal side of the first electrode and is arranged on the proximal side of the bent portion to measure the potential.
    It has a proximal flexion that is located proximal to the first electrode and has a lower flexural rigidity than the distal and proximal flanks.
    The expanded portion is a distal transition portion whose outer diameter increases toward the proximal side from a fixed portion on the distal side of the expanded portion with respect to the shaft portion, and the proximal side of the expanded portion. A balloon having a proximal transition portion whose outer diameter increases toward the distal side from a fixed portion with respect to the shaft portion, and a tubular portion located between the distal transition portion and the proximal transition portion.
    The first electrode and the second electrode are arranged on the radial outer side of the tubular portion.
    The bent portion is arranged on the distal side of the tubular portion.
    The medical device according to claim 2, wherein the proximal bend is located proximal to the tubular portion.
  9. 　前記屈曲部は、少なくとも１つの括れ部を有し、当該括れ部における前記帯部の幅は、当該括れ部の遠位側および近位側の隣接部位における前記帯部の幅よりも短い請求項１～８のいずれか１項に記載の医療デバイス。 The bent portion has at least one constricted portion, and the width of the band portion in the constricted portion is shorter than the width of the band portion in the adjacent portion on the distal side and the proximal side of the constricted portion. The medical device according to any one of 1 to 8.
  10. 　前記屈曲部は、少なくとも１つの薄肉部を有し、当該薄肉部における前記帯部の厚さは、当該薄肉部の遠位側および近位側の隣接部位における前記帯部の厚さよりも薄い請求項１～９のいずれか１項に記載の医療デバイス。 The bent portion has at least one thin-walled portion, and the thickness of the band portion in the thin-walled portion is thinner than the thickness of the band portion in the adjacent portion on the distal side and the proximal side of the thin-walled portion. The medical device according to any one of Items 1 to 9.
  11. 　前記薄肉部は、前記帯部の表面に前記帯部の幅方向へ延在する溝部が形成される請求項１０に記載の医療デバイス。 The medical device according to claim 10, wherein the thin-walled portion has a groove portion extending in the width direction of the band portion formed on the surface of the band portion.
  12. 　前記屈曲部は、少なくとも１つの柔軟部を有し、当該柔軟部の構成材料は、当該柔軟部の遠位側および近位側の隣接部位の構成材料よりも柔らかい請求項１～１１のいずれか１項に記載の医療デバイス。 The bent portion has at least one flexible portion, and the constituent material of the flexible portion is any one of claims 1 to 11 which is softer than the constituent material of the adjacent portion on the distal side and the proximal side of the flexible portion. The medical device according to item 1.
  13. 　前記帯部は、電位を計測する第２電極を有し、
    　前記帯部は、前記第１電極を含む第１導電層と、前記第２電極を含む第２導電層と、を有し、
    　前記帯部の長尺方向と直交する断面において前記第１導電層および第２導電層の合計の面積を導電体面積と定義し、
    　前記屈曲部の導電体面積は、当該屈曲部の遠位側および近位側の隣接部位の導電体面積よりも小さい請求項１～１２のいずれか１項に記載の医療デバイス。     The band portion has a second electrode for measuring an electric potential, and has a second electrode.
    The band portion has a first conductive layer including the first electrode and a second conductive layer including the second electrode.
    The total area of the first conductive layer and the second conductive layer in the cross section orthogonal to the long direction of the band portion is defined as the conductor area.
    The medical device according to any one of claims 1 to 12, wherein the conductor area of the bent portion is smaller than the conductor area of adjacent portions on the distal side and the proximal side of the bent portion.
PCT/JP2020/011908 2019-03-26 2020-03-18 Medical device WO2020196142A1 (en)

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Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2016127920A (en) * 2014-12-31 2016-07-14 バイオセンス・ウエブスター・(イスラエル)・リミテッドBiosense Webster (Israel), Ltd. Basket catheter with improved spine flexibility
US20180168511A1 (en) * 2016-12-19 2018-06-21 Boston Scientific Scimed Inc. Distally-facing electrode array with longitudinally mounted splines

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2016127920A (en) * 2014-12-31 2016-07-14 バイオセンス・ウエブスター・(イスラエル)・リミテッドBiosense Webster (Israel), Ltd. Basket catheter with improved spine flexibility
US20180168511A1 (en) * 2016-12-19 2018-06-21 Boston Scientific Scimed Inc. Distally-facing electrode array with longitudinally mounted splines

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