WO2020188823A1 - Cathéter - Google Patents

Cathéter Download PDF

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Publication number
WO2020188823A1
WO2020188823A1 PCT/JP2019/011913 JP2019011913W WO2020188823A1 WO 2020188823 A1 WO2020188823 A1 WO 2020188823A1 JP 2019011913 W JP2019011913 W JP 2019011913W WO 2020188823 A1 WO2020188823 A1 WO 2020188823A1
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WO
WIPO (PCT)
Prior art keywords
tip
end side
shaft member
shaft portion
wire
Prior art date
Application number
PCT/JP2019/011913
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English (en)
Japanese (ja)
Inventor
佐々木　卓也
洋輝 神山
Original Assignee
日本ライフライン株式会社
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 日本ライフライン株式会社 filed Critical 日本ライフライン株式会社
Priority to PCT/JP2019/011913 priority Critical patent/WO2020188823A1/fr
Priority to JP2020547254A priority patent/JPWO2020188823A1/ja
Publication of WO2020188823A1 publication Critical patent/WO2020188823A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/38—Applying electric currents by contact electrodes alternating or intermittent currents for producing shock effects
    • A61N1/39—Heart defibrillators

Definitions

  • the present invention relates to a catheter comprising a shaft member reinforced with a wire or a wire bundle.
  • an electrode catheter in which the base end portion of a catheter shaft is formed by a resin tube (blade tube) reinforced by a metal braid such as stainless steel is known (see, for example, Patent Document 1 below).
  • a resin tube blade tube
  • a metal braid such as stainless steel
  • the tip of the catheter shaft is configured with such a blade tube, the flexibility of the tip is impaired.
  • the present inventors consist of a blade tube reinforced by braiding over the entire length, and at least the braid that reinforces the tip portion is made of resin.
  • a catheter shaft which is a blade tube manufactured by (see Patent Document 2 below).
  • an electrode catheter having a catheter shaft composed of a blade tube reinforced by a resin braid over its entire length (claim 2 of Patent Document 2), a tip portion reinforced by a resin braid, and a metal.
  • an electrode catheter (claim 3 of Patent Document 2) provided with a catheter shaft having a proximal end portion reinforced by a braided material.
  • a catheter equipped with a catheter shaft reinforced with a resin braid over its entire length cannot sufficiently improve torque transmission because the braid for reinforcing the proximal end portion is also made of resin.
  • a catheter having a catheter shaft having a tip portion reinforced by a resin braid and a proximal end portion reinforced by a metal braid has a resin blade tube constituting the distal end portion and a proximal end portion. Since it is manufactured by fusing the metal blade tubes that compose it, the resin braid that reinforces the tip part and the metal braid that reinforces the base end part are not continuous, so torque transmission is possible. It cannot be improved sufficiently.
  • a catheter having such a configuration is prone to kink at the boundary between the distal end portion and the proximal end portion where the constituent materials of the braid are switched.
  • An object of the present invention is to provide a catheter having a good balance between excellent torque transmission and good flexibility at the tip of a shaft. Another object of the present invention is to provide a catheter having excellent kink resistance. Yet another object of the present invention is to provide a catheter in which the lumen formed on the shaft is not stepped or the liquid tightness of the lumen is not impaired.
  • the catheter of the present invention includes an insulating shaft member including a tip end side shaft portion and a proximal end side shaft portion, and a handle connected to the proximal end.
  • the base end side shaft portion is composed of a base end side portion of a metal wire or a metal wire bundle and a blade tube reinforced by a braid in which a resin wire or a resin wire bundle is woven.
  • the tip-side shaft portion is characterized by comprising a coil tube in which the tip-side portion of the metal wire or the metal wire bundle is reinforced by a coil wound spirally.
  • the base end portion (base end side shaft portion) of the shaft member is reinforced by a braid in which a metal wire (bundle) and a resin wire (bundle) are woven.
  • the tip part (tip side shaft part) of the shaft member is composed of a coil tube reinforced by a coil wound with a metal wire (bundle), and a reinforcing material (braid or coil) containing metal over the entire length of the shaft member. ), And the metal wire (bundle) forming the braid at the base end side shaft part and the metal wire (bundle) forming the coil at the tip end side shaft part are continuous, which is excellent. It can exhibit torque transmission.
  • the metal wire (bundle) forming the braid at the base end side shaft portion and the metal wire (bundle) forming the coil at the tip end side shaft portion are continuous, the base end side shaft portion and Kinking does not occur at the boundary with the shaft portion on the tip side, and the kink resistance is excellent.
  • tip portion (tip side shaft portion) of the shaft member is reinforced by a coil made of a metal wire (bundle), it is better than the case where it is reinforced by a braid made of a metal wire (bundle). It has flexibility.
  • the shaft member constituting the catheter of the present invention has a reinforcing layer formed by the braid or the coil, an inner portion located inside the reinforcing layer, and an outer portion located outside the reinforcing layer. And then It is preferable that the inner portion is integrally formed from the tip end to the base end of the shaft member.
  • the catheter having such a configuration, it is possible to sufficiently secure the integrity as a shaft member.
  • At least one lumen is formed in the inner portion constituting the catheter of the above (2) by partitioning with a resin tube. It is preferable that the resin tube is integrally formed from the tip end to the base end of the shaft member.
  • a step may be generated in the lumen formed on the shaft member at this boundary. The liquidtightness of the lumen is not impaired.
  • the catheter of the present invention has a first DC electrode group composed of a plurality of ring-shaped electrodes mounted on the tip end side shaft portion of the shaft member, and the tip end side separated from the first DC electrode group toward the proximal end side.
  • a second DC electrode group consisting of a plurality of ring-shaped electrodes mounted on the side shaft portion, a first lead wire group consisting of lead wires connected to each of the electrodes constituting the first DC electrode group, and the second DC electrode.
  • the defibrillation catheter includes a second lead wire group consisting of lead wires connected to each of the electrodes constituting the group.
  • the catheter of the present invention is an electrode catheter including at least one ring-shaped electrode attached to the tip end side shaft portion of the shaft member and a lead wire connected to the ring-shaped electrode. Is preferable.
  • a guide wire lumen is formed in an inner portion located inside the reinforcing layer formed by the braid or the coil. It is effective to adopt the configuration of the present invention when the catheter shaft has a guide wire lumen and the proportion of the resin constituting the shaft is low, as in the case of a catheter having such a configuration.
  • the catheter of the present invention is excellent in torque transmission and kink resistance, and is also excellent in flexibility at the tip side shaft portion of the shaft member.
  • FIG. 1 It is a top view which shows the defibrillation catheter which concerns on 1st Embodiment of this invention. It is a top view which shows the tip part of the defibrillation catheter shown in FIG. It is a cross-sectional view (IIIA-IIIA cross-sectional view of FIG. 2) of the tip side shaft portion of the defibrillation catheter shown in FIG. It is a cross-sectional view (IIIB-IIIB cross-sectional view) of the shaft portion on the proximal end side of the defibrillation catheter shown in FIG. It is explanatory drawing which shows typically the form of the braid and the coil which reinforce the shaft member of the defibrillation catheter shown in FIG.
  • FIG. 5 is a cross-sectional view (VIA-VIA cross-sectional view) of a shaft portion on the distal end side of the defibrillation catheter shown in FIG.
  • FIG. 5 is a cross section (VIB-VIB cross-sectional view) of a shaft portion on the proximal end side of the defibrillation catheter shown in FIG.
  • FIG. 5 is a top view which shows the defibrillation catheter which concerns on 3rd Embodiment of this invention.
  • FIG. 7 is a cross-sectional view (VIIIA-VIIIA cross-sectional view) of the distal shaft portion of the defibrillation catheter shown in FIG. 7. It is a cross section (VIIIB-VIIIB sectional view) of the shaft portion on the proximal end side of the defibrillation catheter shown in FIG. 7. It is explanatory drawing which shows typically the form of the braid and the coil which reinforce the shaft member of the defibrillation catheter shown in FIG. 7. It is a top view which shows the electrode catheter which concerns on 4th Embodiment of this invention.
  • FIG. 10 is a cross-sectional view (XA-XA cross-sectional view) of a shaft portion on the distal end side of the electrode catheter shown in FIG.
  • FIG. 10 is a cross-sectional view (XB-XB cross-sectional view) of a shaft portion on the proximal end side of the electrode catheter shown in FIG.
  • the defibrillation catheter 100 of this embodiment shown in FIGS. 1 to 3 has a shaft member 10 having a multi-lumen structure including an distal end side shaft portion 11 and a proximal end side shaft portion 12, and a shaft member 10 thereof.
  • the first DC electrode group 31G consisting of the handle 20 connected to the base end and eight ring-shaped electrodes 31 mounted on the tip end side shaft portion 11 of the shaft member 10 and the first DC electrode group 31G separated from the base end side.
  • the second DC electrode group 32G composed of eight ring-shaped electrodes 32 mounted on the tip side shaft portion 11 and the tip side shaft portion 11 between the first DC electrode group 31G and the second DC electrode group 32G were mounted.
  • a wire 43 and an operation wire 51 capable of pulling the base end thereof in order to bend the tip end side shaft portion 11 of the shaft member 10 are provided, and between the first DC electrode group 31G and the second DC electrode group 32G.
  • a catheter that defibrillates in the heart cavity by applying voltages of different polarities to the shaft member 10, and the base end side shaft portion 12 of the shaft member 10 is a base end side portion of the metal wire bundle 181 and a resin. It is composed of a composite blade tube reinforced by a braid 183 in which a wire bundle 182 is woven, and the tip side shaft portion 11 is a coil reinforced by a coil 184 in which the tip side portion of the metal wire bundle 181 is spirally wound.
  • the central lumen 10L which is composed of a tube and serves as a guide wire lumen, and the first sub-lumen 11L and the second sub-lumen 12L arranged so as to face each other across the central lumen 10L so as to face each other across the central lumen 10L.
  • the first lead wire group 41G extends to the first sublumen 11L
  • the second lead wire group 42G has a second sublumen. It extends to 12L
  • the lead wire 43 extends to the third sublumen 13L
  • the operating wire 51 extends to the fourth sublumen 14L.
  • the defibrillation catheter 100 of the present embodiment includes a shaft member 10, a handle 20, a first DC electrode group 31G, a second DC electrode group 32G, a ring-shaped electrode 33 for potential measurement, a tip tip 35, and a first. It includes a 1-lead wire group 41G, a second lead wire group 42G, a lead wire 43, and an operation wire 51.
  • the shaft member 10 constituting the defibrillation catheter 100 is an insulating tube member having a multi-lumen structure including a distal end side shaft portion 11 and a proximal end side shaft portion 12.
  • the outer diameter of the shaft member 10 is, for example, 1.2 to 3.3 mm, and a suitable example is 2 .. It is 0 mm.
  • the tip portion of the shaft member 10 is shown linearly in FIGS. 1 and 2, the tip portion usually has a specific curved shape.
  • the curved shape of such a tip portion include, but are not limited to, the shapes disclosed in Japanese Patent Application Laid-Open No. 2012-50673 and Japanese Patent Application Laid-Open No. 2012-192124.
  • the curved shape of such a tip portion is a shape when no force is received from the outside. For example, when the shaft member 10 is passed through a linear lumen, the shaft member 10 is deformed linearly and the shaft member. When 10 is passed through a curved lumen, it curves according to the shape of the lumen. Further, the shape of the tip portion can be changed by operating the handle 20 described later.
  • the tip end side shaft portion 11 of the shaft member 10 includes a reinforcing layer 191 in which a coil 184 is embedded in a resin, and an inner portion 16 made of a resin located inside the reinforcing layer 191. It is a coil tube having an outer portion 17 made of resin located outside the reinforcing layer 191.
  • the base end side shaft portion 12 of the shaft member 10 includes a reinforcing layer 192 in which the braid 183 is embedded in resin and an inner portion 16 made of resin located inside the reinforcing layer 192.
  • a blade tube having an outer portion 17 made of resin located outside the reinforcing layer 192.
  • the shaft member 10 (inner portion 16) has a central lumen 10L as a guide wire lumen and four sub-lumens (first sub-lumen 11L, second sub-lumen 12L, third sub-lumen 13L) around the central lumen 10L. , 4th sublumen 14L), respectively, formed by being partitioned by a resin tube 15.
  • the diameter of the central lumen 10L is, for example, 0.4 to 1.0 mm, and a suitable example is 0.75 mm.
  • the ratio of the diameter of the central lumen 10L to the outer diameter of the shaft member 10 is preferably 0.2 or more, and a suitable example is 0.375 (0.75 / 2.0).
  • the first sublumen 11L and the second sublumen 12L are arranged so as to face each other with the central lumen 10L in between. Further, the third sublumen 13L and the fourth sublumen 14L are arranged so as to face each other with the central lumen 10L interposed therebetween.
  • the cross sections of the first sublumen 11L, the second sublumen 12L, and the third sublumen 13L are each capsule-shaped (oval), whereby the outer diameter of the shaft member 10 is not unnecessarily expanded. , The area of the lumen lumen can be secured widely, and the assembly work can be simplified.
  • Examples of the resin constituting the inner portion 16 and the outer portion 17 include a thermoplastic polyamide-based elastomer, and a polyether block amide (PEBAX) is particularly preferable.
  • PEBAX polyether block amide
  • the hardness of the resin constituting the inner portion 16 is preferably 25D to 40D.
  • the hardness of the resin constituting the outer portion 17 is preferably 35D to 72D.
  • the resin tube 15 that partitions the rumen is made of a fluororesin having high insulating properties such as a perfluoroalkyl vinyl ether copolymer (PFA) and polytetrafluoroethylene (PTFE).
  • a fluororesin having high insulating properties such as a perfluoroalkyl vinyl ether copolymer (PFA) and polytetrafluoroethylene (PTFE).
  • a coil 184 is embedded as a reinforcing material in the reinforcing layer 191 of the tip end side shaft portion 11. Further, as shown in FIG. 3B, a braid 183 is embedded as a reinforcing material in the reinforcing layer 192 of the base end side shaft portion 12.
  • the braid 183 embedded in the reinforcing layer of the base end side shaft portion 12 is formed by knitting the base end side portion of the metal wire bundle 181 and the resin wire bundle 182. Further, the coil 184 embedded in the reinforcing layer of the tip end side shaft portion 11 is formed by spirally winding the tip end side portion continuous with the base end side portion of the metal wire bundle 181.
  • the metal wire bundle 181 constituting the coil 184 is continuous (the base end side portion of the metal wire bundle 181 constitutes the braid 183, and the tip end side portion thereof constitutes the coil 184. ) Therefore, it is possible to exhibit excellent torque transmission property even though the ratio of the resin is low by having the central lumen 10L.
  • the metal wire bundle 181 forming the braid 183 on the base end side shaft portion 12 and the metal wire bundle 181 forming the coil 184 on the tip end side shaft portion 11 are continuous, so that the base end side shaft portion 12 Kink does not occur at the boundary between the shaft portion 11 and the tip end side shaft portion 11, and the kink resistance is also excellent.
  • the tip end side shaft portion 11 of the shaft member 10 is reinforced by the "coil 184" by the metal wire bundle 181
  • the shaft member is reinforced by the "braid” by the metal wire bundle 181. It has excellent flexibility at the tip of 10.
  • the lead wire of the electrode is attached to the tube wall of the tip side shaft portion 11 as compared with the case where the tip side shaft portion 11 is reinforced by the "braid".
  • the work of forming a side hole for passing the lead wire 41, 42 and 43) and passing the lead wire can be easily performed.
  • the constituent materials of the metal wire bundle 181 constituting the coil 184 and the braid 183 are not particularly limited, and all known metal materials constituting the coil tube and the blade tube can be used, for example, stainless steel. It can be exemplified.
  • the constituent material of the resin wire bundle 182 constituting the braid 183 can be selected from resins that can exert a reinforcing effect by being embedded.
  • resins that can exert a reinforcing effect by being embedded.
  • PEEK resin, polyimide resin, polyamide resin, polyester resin and the like can be selected. Among these, PEEK resin is particularly preferable.
  • the wire diameter of the metal wire forming the metal wire bundle 181 and the resin wire forming the resin wire bundle 182 is usually 30 to 100 ⁇ m, and a suitable example is 60 ⁇ m.
  • the braid 183 that reinforces the base end side shaft portion 12 has 16 striking numbers and 2 holding numbers, and each of the eight metal elements is composed of two metal elements.
  • the wire bundle 181 and the eight resin wire bundles 182, each of which is composed of two resin wires, are alternately arranged at equal angular intervals in the circumferential direction.
  • the number of braids to reinforce the shaft on the base end side and the number of holdings can be changed as appropriate.
  • the number of strokes is preferably 8 to 32, and the number of braids is preferably 1 to 4.
  • the handle 20 constituting the defibrillation catheter 100 of the present embodiment includes a handle body 21, a knob 22, and a strain relief 24.
  • the knob 22 By rotating the knob 22, the shape of the tip portion of the shaft member 10 can be changed.
  • a first DC electrode group 31G and a second DC electrode group 32G are mounted on the outer periphery of the tip end side shaft portion 11 which is the tip end portion of the shaft member 10.
  • the "electrode group” refers to a plurality of electrodes that form the same pole (have the same polarity) or have the same purpose and are mounted at narrow intervals (for example, 5 mm or less). An aggregate.
  • the first DC electrode group is formed by mounting a plurality of electrodes constituting the same pole (-pole or + pole) at a narrow interval at the tip portion of the tube member.
  • the number of electrodes constituting the first DC electrode group varies depending on the width of the electrodes and the arrangement interval, but is, for example, 4 to 13, preferably 8 to 10.
  • the first DC electrode group 31G is composed of eight ring-shaped electrodes 31.
  • the electrodes 31 constituting the first DC electrode group 31G are via a lead wire (lead wire 41 constituting the first lead wire group 41G shown in FIGS. 3A and 3B) and a connector built in the base end portion of the handle 20. It is connected to the terminal of the same pole in the DC power supply.
  • the width of the electrode 31 (length W1 in the axial direction) is preferably 2 to 5 mm, and a suitable example is 4 mm. If the width of the electrode 31 is too narrow, the amount of heat generated when a voltage is applied becomes excessive, which may damage the surrounding tissue. On the other hand, if the width of the electrode 31 is too wide, the flexibility and flexibility of the portion of the shaft member 10 to which the first DC electrode group 31G is mounted may be impaired.
  • the mounting interval of the electrodes 31 is preferably 1 to 5 mm, and a suitable example is 2 mm.
  • the first DC electrode group 31G is located in the coronary sinus.
  • the second DC electrode group a plurality of electrodes forming poles (+ poles or-poles) opposite to those of the first DC electrode group are formed at the tip portion of the tube member separated from the mounting position of the first DC electrode group toward the proximal end side. It is installed at narrow intervals.
  • the number of electrodes constituting the second DC electrode group varies depending on the width of the electrodes and the arrangement interval, but is, for example, 4 to 13, preferably 8 to 10.
  • the second DC electrode group 32G is composed of eight ring-shaped electrodes 32.
  • the electrode 32 constituting the second DC electrode group 32G is a DC power supply device via a lead wire (lead wire 42 constituting the second lead wire group 42G shown in FIG. 3B) and a connector built in the base end portion of the handle 20. It is connected to the terminal of the same pole in (the terminal of the pole opposite to the one to which the first DC electrode group 31G is connected).
  • voltages having different polarities are applied to the first DC electrode group 31G (electrode 31) and the second DC electrode group 32G (electrode 32), and the first DC electrode group 31G and the second DC electrode group 32G are separated from each other.
  • the electrodes have different polarities (when one electrode group has a negative electrode, the other electrode group has a positive electrode).
  • the width of the electrode 32 (length W2 in the axial direction) is preferably 2 to 5 mm, and a suitable example is 4 mm. If the width of the electrode 32 is too narrow, the amount of heat generated when a voltage is applied becomes excessive, which may damage the surrounding tissue. On the other hand, if the width of the electrode 32 is too wide, the flexibility and flexibility of the portion of the shaft member 10 to which the second DC electrode group 32G is mounted may be impaired.
  • the mounting interval of the electrodes 32 is preferably 1 to 5 mm, and a suitable example is 2 mm.
  • the second DC electrode group 32G is located in the right atrium.
  • the electrodes constituting the first DC electrode group 31G and the second DC electrode group can also be used for measuring the potential.
  • Electrodes 33 used for potential measurement are mounted on the outer periphery of the tip end side shaft portion 11 (between the first DC electrode group 31G and the second DC electrode group 32G).
  • the electrode 33 is connected to the electrocardiograph via a lead wire (lead wire 43 shown in FIGS. 3A and 3B) and a connector incorporated in the base end portion of the handle 20.
  • the width of the electrode 33 (length W3 in the axial direction) is preferably 0.5 to 2.0 mm, and a suitable example is 1.2 mm. If the width of the electrode 33 is too wide, the measurement accuracy of the electrocardiographic potential may be lowered, or it may be difficult to identify the site where the abnormal potential is generated.
  • a tip 35 is attached to the tip of the intracardiac defibrillation catheter 100.
  • the tip 35 is formed with a through hole communicating with the central lumen 10L of the shaft member 10.
  • a lead wire is not connected to the tip 35, and the tip 35 is not used as an electrode in this embodiment. However, it can also be used as an electrode by connecting a lead wire.
  • the constituent material of the tip 35 is not particularly limited, such as a metal material such as platinum and stainless steel, and various resin materials.
  • the separation distance between the first DC electrode group 31G (base end side electrode 31) and the second DC electrode group 32G (tip side electrode 32) is preferably 40 to 100 mm, more preferably 50 to 90 mm.
  • the electrodes 31 that make up the first DC electrode group 31G, the electrodes 32 that make up the second DC electrode group 32G, and the electrodes 33 for potential measurement are platinum or platinum-based in order to improve the contrast with X-rays. It is preferably made of an alloy.
  • the first lead wire group 41G shown in FIGS. 3A and 3B is an aggregate of eight lead wires 41 connected to each of the eight electrodes 31 constituting the first DC electrode group 31G. With the first lead wire group 41G (lead wire 41), each of the eight electrodes 31 constituting the first DC electrode group 31G can be electrically connected to the DC power supply device.
  • the eight electrodes 31 constituting the first DC electrode group 31G are connected to different lead wires 41, respectively.
  • Each of the lead wires 41 is welded to the inner peripheral surface of the electrode 31 at the tip portion thereof, and enters the first sublumen 11L from the side hole formed in the pipe wall of the tip side shaft portion 11.
  • the eight lead wires 41 that have entered the first sublumen 11L extend to the first sublumen 11L as the first lead wire group 41G.
  • the second lead wire group 42G shown in FIG. 3B is an aggregate of eight lead wires 42 connected to each of the eight electrodes 32 constituting the second DC electrode group 32G. With the second lead wire group 42G (lead wire 42), each of the eight electrodes 32 constituting the second DC electrode group 32G can be electrically connected to the DC power supply device.
  • the eight electrodes 32 constituting the second DC electrode group 32G are connected to different lead wires 42, respectively.
  • Each of the lead wires 42 is welded to the inner peripheral surface of the electrode 32 at the tip portion thereof, and enters the second sublumen 12L from the side hole formed in the pipe wall of the tip side shaft portion 11.
  • the eight lead wires 42 that have entered the second sublumen 12L extend to the second sublumen 12L as the second lead wire group 42G.
  • the first lead wire group 41G (8 lead wires 41) extends to the first sublumen 11L
  • the second lead wire group 42G (8 lead wires 42) extends to the second sublumen 12L.
  • the four lead wires 43 shown in FIGS. 3A and 3B are connected to each of the electrodes 33 for potential measurement.
  • Each of the electrodes 33 can be connected to the electrocardiograph by the lead wire 43.
  • the four electrodes 33 used for the potential measurement are connected to different lead wires 43, respectively.
  • Each of the lead wires 43 is welded to the inner peripheral surface of the electrode 33 at the tip portion thereof, and enters the third sublumen 13L from the side hole formed in the tube wall of the tip side shaft portion 11 to enter the third sublumen 13L. It extends to the sublumen 13L.
  • the lead wire 41, the lead wire 42, and the lead wire 43 are all made of a resin-coated wire in which the outer peripheral surface of the metal lead wire is coated with a resin such as polyimide.
  • the film thickness of the coating resin is about 2 to 30 ⁇ m.
  • 51 is an operating wire.
  • the operation wire 51 extends to the fourth sublumen 14L and extends eccentrically with respect to the central axis of the shaft member 10.
  • the tip portion of the operation wire 51 is fixed to the tip tip 35 by, for example, solder.
  • the base end portion of the operation wire 51 is connected to the knob 22 of the handle 20.
  • the operation wire 51 is pulled by operating the knob 22. As a result, the shape of the tip portion of the shaft member 10 can be changed.
  • the operating wire 51 is made of stainless steel or a Ni—Ti superelastic alloy, but it does not necessarily have to be made of metal.
  • the operation wire 51 may be made of, for example, a high-strength non-conductive wire.
  • the mechanism for deflecting the tip of the shaft member is not limited to this, and may be provided with, for example, a leaf spring.
  • the first lead wire group 41G (lead wire 41), the second lead wire group 42G (lead wire 42), and the lead wire 43 are insulated even inside the handle 20. It is preferably isolated.
  • the defibrillation catheter 100 of the present embodiment applies electrical energy directly to the fibrillating heart by applying a DC voltage between the first DC electrode group 31G and the second DC electrode group 32G.
  • a catheter for defibrillation treatment is applied.
  • the defibrillation catheter 100 of the present embodiment is arranged in the heart chamber so that the first DC electrode group 31G is located in the coronary sinus and the second DC electrode group 32G is located in the right atrium. As a result, the heart is sandwiched between the first DC electrode group 31G and the second DC electrode group 32G.
  • a guide wire is first inserted into the right atrium from the inferior vena cava and then into the coronary sinus ostium on the posterior inferior wall of the right atrium.
  • the defibrillation catheter 100 is inserted into the right atrium from the inferior vena cava, further inserted into the coronary sinus ostium on the posterior inferior wall of the right atrium, and inserted into the coronary sinus.
  • the procedure of inserting the defibrillation catheter 100 from the inferior vena cava into the right atrium and inserting it into the coronary sinus ostium is more invasive than the approach from the superior vena cava. It is preferable because it has low properties.
  • the defibrillation catheter 100 of the present embodiment is suitably used when performing cardiac catheterization in which atrial fibrillation is likely to occur.
  • the intracardiac defibrillation catheter 100 is pre-inserted into the patient's heart chamber before cardiac catheterization.
  • the electrocardiogram measured by the constituent electrodes of the 1st DC electrode group 31G and / or the 2nd DC electrode group 32G or the electrode 33 for measuring the potential is monitored, and if atrial fibrillation occurs, it is monitored.
  • the cardiac catheterization is interrupted, and defibrillation treatment is performed with the defibrillation catheter 100.
  • a DC voltage is applied between the first DC electrode group 31G and the second DC electrode group 32G via the first lead wire group 41G and the second lead wire group 42G to cause fibrillation.
  • the electric energy supplied to the heart by the defibrillation catheter 100 is preferably 10 to 30 J.
  • the defibrillation catheter 100 of the present embodiment can be manufactured as follows. First, a tubular inner portion forming material to be a common inner portion 16 of the shaft member 10 (tip side shaft portion 11 and proximal end side shaft portion 12) is formed by extrusion molding. The obtained inner portion forming material is formed by partitioning the central lumen 10L and the sub-lumens 11L to 14L by the resin tube 15 over the entire length thereof.
  • the metal wire bundle 181 and the resin wire bundle 182 are woven on the outer peripheral surface of the inner portion forming material to form a braid over the entire length of the inner portion forming material.
  • the resin wire bundle 182 is removed by irradiating the braid formed on the outer peripheral surface of the tip portion (the portion serving as the inner portion 16 of the tip side shaft portion 11) of the inner portion forming material with laser irradiation. ..
  • laser irradiation a wavelength that is easily absorbed only by the constituent material of the resin wire bundle 182 (does not damage the constituent resin of the inner portion forming material or the metal wire bundle 181) is selected.
  • a coil (coil 184) in which the metal wire bundle 181 is spirally wound along the outer peripheral surface of the inner portion forming material from which the resin wire bundle 182 has been removed is formed.
  • a braid (braid 183) remains at the base end portion of the inner portion forming material that has not been irradiated with the laser.
  • the metal wire bundle 181 forming the coil 184 on the outer peripheral surface of the tip portion of the inner portion forming material and the metal wire bundle 181 forming the braid 183 on the outer peripheral surface of the base end portion of the inner portion forming material are formed. , It is formed continuously without being cut at the boundary between the tip end portion and the base end portion.
  • a tubular outer portion serving as an outer portion 17 of the shaft member 10 (tip side shaft portion 11 and proximal end side shaft portion 12).
  • the tip of the layer structure as shown in FIG. 3A is formed.
  • a shaft member 10 including a side shaft portion 11 and a base end side shaft portion 12 having a layered structure as shown in FIG. 3B is formed.
  • the resin constituting the reinforcing layer 191 shown in FIG. 3A is filled with a part of the outer portion forming material melted during the heat treatment of the tubular laminate by flowing into the gap of the coil 184.
  • the resin constituting the reinforcing layer 192 shown in FIG. 3B is filled with a part of the outer portion forming material melted during the heat treatment of the tubular laminate by flowing into the gaps of the braid 183.
  • the inner portion 16 constituting the shaft member 10 obtained by the above steps is integrally formed of an extrusion-molded inner portion forming material, and the inner portion 16 has a tip-side shaft portion. There is no seam at the boundary between 11 and the base end side shaft portion. Further, since the resin tube 15 that separately forms the central lumen 10L and the sub-lumens 11L to 14L is formed over the entire length of the inner portion forming material, the tip side shaft portion 11 and the proximal end side shaft portion are formed. There are no seams at the boundaries.
  • the catheter 100 of the present embodiment provided with the shaft member 10 obtained by such a step, the lumen formed on the shaft member 10 at the boundary between the distal end side shaft portion 11 and the proximal end side shaft portion 12 ( The central lumen 10L and the sub-lumens 11L to 14L) are not stepped, and the liquidtightness of the lumen is not impaired.
  • the metal forming the braid 183 is reinforced by a reinforcing material (braid 183 or coil 184) including the metal wire bundle 181 over the entire length of the shaft member 10. Since the wire bundle 181 and the metal wire bundle 181 constituting the coil 184 are continuous, excellent torque transmission is exhibited even though the ratio of the resin is low due to the central lumen 10L. be able to. Further, since the metal wire bundle 181 constituting the braid 183 and the metal wire bundle 181 forming the coil 184 are continuous, the kink resistance is also excellent. Further, since the shaft portion 11 on the tip end side of the shaft member 10 is reinforced by the coil 184 by the metal wire bundle 181, the flexibility at the tip portion of the shaft member 10 is also excellent.
  • the definement catheter 200 of this embodiment shown in FIGS. 5, 6A and 6B is connected to a shaft member 60 having a multi-lumen structure including a distal end side shaft portion 61 and a proximal end side shaft portion 62 and the proximal end thereof.
  • the first DC electrode group 31G composed of the control handle 25 and the eight ring-shaped electrodes 31 mounted on the tip end side shaft portion 61 of the shaft member 60, and the tip end side away from the first DC electrode group 31G.
  • For potential measurement mounted on the tip side shaft portion 61 between the second DC electrode group 32G composed of eight ring-shaped electrodes 32 mounted on the side shaft portion 61 and the first DC electrode group 31G and the second DC electrode group 32G.
  • the first lead wire group consisting of the four ring-shaped electrodes 33, the tip tip 35 attached to the tip of the shaft member 10, and the lead wire 41 connected to each of the electrodes 31 constituting the first DC electrode group 31G.
  • a second lead wire group 42G composed of a 41G and a lead wire 42 connected to each of the electrodes 32 constituting the second DC electrode group 32G, and a lead wire 43 connected to each of the ring-shaped electrodes 33 for potential measurement.
  • a first operation wire 511 capable of pulling the base end of the shaft member 60 in order to bend the tip end side shaft portion 61 in the first direction (the direction indicated by the arrow A in FIG. 5), and the tip end side shaft portion 61.
  • the first DC electrode group 31G and the second DC electrode group 32G are provided with a second operation wire 512 capable of pulling the base end thereof in order to bend in the second direction (the direction indicated by the arrow B in FIG. 5).
  • a catheter that defibrillates in the heart cavity by applying voltages of different electrodes to and from the shaft member 60, and the base end side shaft portion 62 of the shaft member 60 is a base end side portion of the metal wire bundle 181.
  • the composite blade tube reinforced by the braid 183 in which the resin wire bundle 182 is woven, and the tip side shaft portion 61 is reinforced by the coil 184 in which the tip side portion of the metal wire bundle 181 is spirally wound. It consists of a coil tube.
  • FIGS. 1 to 3 the same components as the defibrillation catheter 100 of the first embodiment are shown in FIGS. 1 to 3 (FIGS. 3A and 3B). It has the same code.
  • the defibrillation catheter 200 of the present embodiment includes a shaft member 60, a control handle 25, a first DC electrode group 31G, a second DC electrode group 32G, a ring-shaped electrode 33 for potential measurement, a tip tip 35, and the like. It includes a first lead wire group 41G, a second lead wire group 42G, a lead wire 43, a first operation wire 511, and a second operation wire 512.
  • the shaft member 60 constituting the defibrillation catheter 200 is an insulating tube member having a multi-lumen structure including a distal end side shaft portion 61 and a proximal end side shaft portion 62. Although the tip portion of the shaft member 60 is shown linearly in FIG. 5, the tip portion usually has a specific curved shape.
  • the tip-side shaft portion 61 of the shaft member 60 includes a reinforcing layer 691 in which a coil 184 is embedded in resin, and an inner portion 66 made of resin located inside the reinforcing layer 691. It is a coil tube having an outer portion 67 made of resin located outside the reinforcing layer 691.
  • the base end side shaft portion 62 of the shaft member 60 includes a reinforcing layer 692 in which the braid 183 is embedded in resin and an inner portion 66 made of resin located inside the reinforcing layer 692.
  • a blade tube having an outer portion 67 made of resin located outside the reinforcing layer 692.
  • the shaft member 60 (inner portion 66) is formed by forming a central lumen 60L as a guide wire lumen and six sub-lumens 61L to 66L around the central lumen 60L, each of which is partitioned by a resin tube 65. Has been done.
  • the first sublumen 61L and the second sublumen 62L are arranged so as to face each other with the central lumen 60L in between. Further, the third sublumen 63L and the fourth sublumen 64L are arranged so as to face each other with the central lumen 60L interposed therebetween. Further, the fifth sublumen 65L and the sixth sublumen 66L are arranged so as to face each other with the central lumen 60L in between.
  • the cross sections of the first sublumen 61L, the second sublumen 62L, the third sublumen 63L, and the fourth sublumen 64L are capsule-shaped (oval), respectively.
  • the cross sections of the 5th sublumen 65L and the 6th sublumen 66L are circular, respectively.
  • the first lead wire group 41G shown in FIGS. 6A and 6B is an assembly of eight lead wires 41 connected to each of the eight electrodes 31 constituting the first DC electrode group 31G.
  • Each of the lead wires 41 enters the first sublumen 61L through a side hole formed in the pipe wall of the tip end side shaft portion 61.
  • the eight lead wires 41 that have entered the first sublumen 61L extend to the first sublumen 61L as the first lead wire group 41G.
  • the second lead wire group 42G shown in FIG. 6B is an aggregate of eight lead wires 42 connected to each of the eight electrodes 32 constituting the second DC electrode group 32G.
  • Each of the lead wires 42 enters the second sublumen 62L through a side hole formed in the pipe wall of the tip end side shaft portion 61.
  • the eight lead wires 42 that have entered the second sublumen 62L extend to the second sublumen 62L as the second lead wire group 42G.
  • the first lead wire group 41G (8 lead wires 41) extends to the first sublumen 61L
  • the second lead wire group 42G (8 lead wires 42) extends to the second sublumen 62L.
  • the first sublumen 61L extending to the first lead wire group 41G and the second sublumen 62L extending the second lead wire group 42G sandwich the central lumen 60L. By being arranged so as to face each other, a sufficient separation distance between the first lead wire group 41G and the second lead wire group 42G can be secured.
  • the lead wire 43 shown in FIGS. 6A and 6B is connected to each of the electrodes 33 for measuring the potential.
  • Each of the lead wires 43 enters the third sublumen 63L through a side hole formed in the pipe wall of the tip end side shaft portion 61 and extends to the third sublumen 63L.
  • the defibrillation catheter 200 of the present embodiment has a first operation wire 511 for bending the tip end side shaft portion 61 of the shaft member 60 in the first direction (direction indicated by the arrow A) and the tip end side shaft portion 61. It is provided with a second operation wire 512 for bending in a second direction (direction indicated by an arrow B).
  • the first operation wire 511 is movably inserted in the fifth sublumen 65L of the shaft member 60 in the pipe axis direction.
  • the tip portion of the first operation wire 511 is connected and fixed to the tip tip 35 by, for example, solder filled in the internal space of the tip tip 35. Further, the base end of the first operation wire 511 is connected to the knob 27 of the control handle 25 and can be pulled.
  • the second operation wire 512 is movably inserted in the sixth sublumen 66L of the shaft member 60 in the pipe axis direction.
  • the tip portion of the second operation wire 512 is connected and fixed to the tip tip 35 by, for example, solder filled in the internal space of the tip tip 35.
  • the base end of the second operation wire 512 is connected to the knob 27 of the control handle 25 so that the tension operation can be performed.
  • the first operation wire 511 is pulled and moves to the base end side of the fifth sublumen 65L, and the tip end side shaft portion 61 is first. It can be bent in a direction (direction indicated by arrow A).
  • the second operation wire 512 is pulled and moves to the base end side of the sixth sublumen 66L, and the tip end side shaft portion 61 is moved. It can be bent in the second direction (the direction indicated by the arrow B).
  • the metal wire bundle 181 is reinforced by a reinforcing material (braid 183 or coil 184) including the metal wire bundle 181 over the entire length of the shaft member 60, and further constitutes the braid 183.
  • the metal wire bundle 181 constituting the coil 184 are continuous, so that excellent torque transmission can be exhibited even though the ratio of the resin is low by having the central lumen 60L. ..
  • the metal wire bundle 181 constituting the braid 183 and the metal wire bundle 181 forming the coil 184 are continuous, the kink resistance is also excellent.
  • the tip-side shaft portion 61 of the shaft member 60 is reinforced by the coil 184 by the metal wire bundle 181, the flexibility at the tip portion of the shaft member 10 is also excellent.
  • the defibrillation catheter 300 of this embodiment shown in FIGS. 7, 8A and 8B is connected to a shaft member 70 having a multi-lumen structure including a distal end side shaft portion 71 and a proximal end side shaft portion 72 and the proximal end thereof.
  • the first DC electrode group 31G composed of the handle 20 and the eight ring-shaped electrodes 31 mounted on the tip end side shaft portion 71 of the shaft member 70, and the tip end side separated from the first DC electrode group 31G toward the proximal end side.
  • the second DC electrode group 32G composed of eight ring-shaped electrodes 32 mounted on the shaft portion 71, and the tip side shaft portion 71 of the shaft member 70 between the first DC electrode group 31G and the second DC electrode group 32G were mounted.
  • a first consisting of four ring-shaped electrodes 33 for measuring potential, a tip tip 35 attached to the tip of a shaft member 70, and a lead wire 41 connected to each of the electrodes 31 constituting the first DC electrode group 31G.
  • a lead wire group 42G composed of a lead wire group 41G, a lead wire 42 connected to each of the electrodes 32 constituting the second DC electrode group 32G, and a lead connected to each of the ring-shaped electrode 33 for potential measurement.
  • a wire 43 and an operating wire 51 capable of pulling the base end thereof in order to bend the tip end side shaft portion 71 of the shaft member 70 are provided, and the first DC electrode group 31G and the second DC electrode group 32G are provided.
  • a catheter that defibrillates in the heart chamber by applying voltages of different polarities between the two, and the base end side shaft portion 72 of the shaft member 70 is a base end side portion of the metal wire 186.
  • FIGS. 7 and 8B the same components as the defibrillation catheter 100 of the first embodiment are shown in FIGS. 1 to 3 (FIGS. 3A and 3B). It has the same code.
  • the defibrillation catheter 300 of the present embodiment includes a shaft member 70, a handle 20, a first DC electrode group 31G, a second DC electrode group 32G, a ring-shaped electrode 33 for potential measurement, a tip tip 35, and a first. It includes a 1-lead wire group 41G, a second lead wire group 42G, a lead wire 43, and an operation wire 51.
  • the shaft member 70 constituting the defibrillation catheter 300 is an insulating tube member having a multi-lumen structure including a distal end side shaft portion 71 and a proximal end side shaft portion 72. Although the tip portion of the shaft member 70 is shown linearly in FIG. 7, the tip portion usually has a specific curved shape.
  • the tip-side shaft portion 71 of the shaft member 70 includes a reinforcing layer 791 in which a coil 189 is embedded in resin, and an inner portion 76 made of resin located inside the reinforcing layer 791. It is a coil tube having an outer portion 77 made of resin located outside the reinforcing layer 791.
  • the base end side shaft portion 72 of the shaft member 70 includes a reinforcing layer 792 in which the braid 188 is embedded in resin, and an inner portion 76 made of resin located inside the reinforcing layer 792.
  • a blade tube having an outer portion 77 made of resin located outside the reinforcing layer 792.
  • the braid 188 embedded in the reinforcing layer of the base end side shaft portion 72 is formed by knitting the base end side portion of the metal wire 186 and the resin wire 187. Further, the coil 189 embedded in the reinforcing layer of the tip side shaft portion 71 is formed by spirally winding the tip end side portion of the metal wire 186.
  • the metal wire 186 constituting the coil 189 is continuous (the base end side portion of the metal wire 186 forms the braid 188, and the tip end side portion thereof constitutes the coil 189. ) Therefore, it is possible to exhibit excellent torque transmission property even though the ratio of the resin is low by having the central lumen 10L.
  • the metal wire 186 forming the braid 188 at the base end side shaft portion 72 and the metal wire 186 forming the coil 189 at the tip end side shaft portion 71 are continuous, the base end side shaft portion 72 No kinking occurs at the boundary between the tip side shaft portion 71 and the tip end side shaft portion 71, and the kink resistance is also excellent.
  • the tip end side shaft portion 71 of the shaft member 70 is formed by a metal wire 186 “coil 1 Since it is reinforced by "89", it is superior in flexibility at the tip portion of the shaft member 70 as compared with the case where it is reinforced by "braiding” by the metal wire 186.
  • the lead wire of the electrode is attached to the tube wall of the tip side shaft portion 71 as compared with the case where the tip side shaft portion 71 is reinforced by the "braid".
  • the work of forming a side hole for passing the lead wire 41, 42 and 43) and passing the lead wire can be easily performed.
  • Examples of the constituent material of the metal wire 186 include the same metal material as the constituent material of the metal wire bundle 181 in the first embodiment.
  • Examples of the constituent material of the resin wire 187 include the same resin material as the constituent material of the resin wire bundle 182 in the first embodiment.
  • the braid 188 that reinforces the base end side shaft portion 72 has 16 striking numbers and 1 holding number, and has 8 metal wire 186 and 8 resin wire 187. Are alternately arranged at equal intervals in the circumferential direction.
  • the shaft member 70 (inner portion 76) is formed by forming a central lumen 70L as a guide wire lumen and eight sub-lumens 71L to 78L around the central lumen 70L, each of which is partitioned by a resin tube. ing.
  • the cross sections of the eight sublumens 71L to 78L are circular with a diameter smaller than that of the central lumen 70L, respectively.
  • the first sublumen 71L and the fifth sublumen 75L are arranged so as to face each other with the central lumen 70L interposed therebetween.
  • the first sub-lumen 71L has three lead wires 41 constituting the first lead wire group 41G extending, and the fifth sub-lumen 75L has three lead wires constituting the second lead wire group 42G. 42 is postponed.
  • the second sublumen 72L and the sixth sublumen 76L are arranged so as to face each other with the central lumen 70L in between.
  • the second sub-lumen 72L has three lead wires 41 constituting the first lead wire group 41G extending
  • the sixth sub-lumen 76L has three lead wires constituting the second lead wire group 42G. 42 is postponed.
  • the third sublumen 73L and the seventh sublumen 77L are arranged so as to face each other with the central lumen 70L in between.
  • the third sublumen 73L has two lead wires 41 constituting the first lead wire group 41G extending, and the seventh sublumen 77L has two lead wires constituting the second lead wire group 42G. 42 is postponed.
  • the fourth sublumen 74L and the eighth sublumen 78L are arranged so as to face each other with the central lumen 70L in between.
  • Four lead wires 43 connected to each of the ring-shaped electrodes for potential measurement extend to the fourth sublumen 74L, and an operation wire 51 extends to the eighth sublumen 78L.
  • the defibrillation catheter 300 of this embodiment over the entire length of the shaft member 70. It is reinforced by a reinforcing material (braid 188 or coil 189) including the metal wire 186, and the metal wire 186 constituting the braid 188 and the metal wire 186 constituting the coil 189 are continuous, so that the center By having the lumen 60L, excellent torque transmission can be exhibited even though the ratio of the resin is low.
  • a reinforcing material (braid 188 or coil 189) including the metal wire 186, and the metal wire 186 constituting the braid 188 and the metal wire 186 constituting the coil 189 are continuous, so that the center By having the lumen 60L, excellent torque transmission can be exhibited even though the ratio of the resin is low.
  • the metal wire 186 constituting the braid 188 and the metal wire 186 forming the coil 189 are continuous, the kink resistance is also excellent. Further, since the shaft portion 71 on the tip end side of the shaft member 70 is reinforced by the coil 189 made of the metal wire 186, the flexibility at the tip portion of the shaft member 10 is also excellent.
  • the electrode catheter 400 of this embodiment shown in FIGS. 10, 11A and 11B is a shaft member 80 having a multi-lumen structure in which a distal shaft portion 81 and a proximal shaft portion 82 are formed and lumens 81L to 84L are formed.
  • the tip electrode 36 connected to the tip end side of the shaft member 80, the ring-shaped electrodes 37 to 39 mounted on the outer peripheral surface of the tip end side shaft portion 81 of the shaft member 80, and the lead connected to the tip electrode 36.
  • the lead wires 47 to 49 connected to each of the ring-shaped electrodes 37 to 39, and the tip end side shaft portion 81 of the shaft member 80 in the first direction (the direction indicated by the arrow A in FIG. 10).
  • the base end is bent.
  • a second operation wire 512 that can be pulled and operated and a control handle 25 mounted on the base end side of the shaft member 80 are provided, and a lumen 82L is provided on the pipe wall of the shaft portion 81 on the tip end side of the shaft member 80 from the outer peripheral surface.
  • the side holes leading to are formed corresponding to the mounting positions of the ring-shaped electrodes 37 to 39, the lead wires 46 to 49 are made by coating the metal core wire with resin, and the lead wire 46 of the tip electrode 36 extends to the lumen 81L.
  • the lead wires 47 to 49 of the ring-shaped electrodes 37 to 39 are connected to the ring-shaped electrodes 37 to 39 by joining their respective tips to the inner peripheral surfaces of the ring-shaped electrodes 37 to 39, and It enters the lumen 82L from the side hole and extends to the lumen 82L, and the tip of the first operation wire 511 is fixed to the tip electrode 36 and extends to the lumen 83L for the second operation.
  • the tip of the wire 512 is fixed to the tip electrode 36 and extends to the lumen 84L, and the base end side shaft portion 82 of the shaft member 80 is formed by the base end side portion of the metal wire bundle 181 and the resin. It is composed of a composite blade tube reinforced by a braid 183 in which a wire bundle 182 is woven, and the tip side shaft portion 81 is a coil reinforced by a coil 184 in which the tip side portion of the metal wire bundle 181 is spirally wound. Consists of tubes.
  • 27 is a knob for swinging the shaft member 80 (catheter tip deflection operation).
  • the electrode catheter 400 includes a shaft member 80, a tip electrode 36 fixed to the tip thereof, ring-shaped electrodes 37 to 39 attached to a flexible portion at the tip of the shaft member 80, and a shaft member. It is provided with a control handle 25 mounted on the base end side of the 80.
  • the tip portion of the shaft member 80 is composed of the tip end side shaft portion 81, and the proximal end portion thereof is composed of the proximal end side shaft portion 82.
  • the tip end side shaft portion 81 can be bent (bent) by pulling the operation wire (first operation wire 511 or second operation wire 512).
  • the outer diameter of the shaft member 80 is usually 0.6 to 3 mm, preferably 1.3 to 2.4 mm.
  • the length of the shaft member 80 is usually 400 to 1500 mm, preferably 700 to 1200 mm.
  • the length of the tip-side shaft portion 81 is, for example, 30 to 300 mm, preferably 50 to 250 mm.
  • a control handle 25 is mounted on the base end side of the shaft member 80.
  • a connector having a plurality of terminals is provided in the control handle 25, and the terminals of the connector are the base ends of the lead wires 46 and 47 to 49 connected to each of the tip electrode 36 and the ring-shaped electrodes 37 to 39. The parts are connected. Further, the control handle 25 is equipped with a knob 27 for bending the tip end side shaft portion 81 of the shaft member 80.
  • the tip end side shaft portion 81 of the shaft member 80 includes a reinforcing layer 891 in which a coil 184 is embedded in resin, and an inner portion 86 made of resin located inside the reinforcing layer 891. It is a coil tube having an outer portion 87 made of resin located outside the reinforcing layer 891.
  • the base end side shaft portion 82 of the shaft member 80 includes a reinforcing layer 892 in which the braid 183 is embedded in the resin and an inner portion 86 made of the resin located inside the reinforcing layer 892.
  • a blade tube having an outer portion 87 made of resin located outside the reinforcing layer 892.
  • Examples of the resin constituting the inner portion 86 include thermoplastic polyamide-based elastomers, and in particular, polyether block amide (PEBAX) is preferable.
  • the hardness of the resin constituting the inner portion 86 is, for example, 25D to 40D.
  • a first operation wire 511 and a second operation wire 512 are inserted into the lumens 83L and the lumen 84L having relatively small diameters arranged so as to face each other with the central axis of the shaft member 80 interposed therebetween, respectively.
  • the lumen 81L and the lumen 82L are relatively large-diameter lumens arranged so as to face each other with the central axis of the shaft member 80 interposed therebetween.
  • a lead wire 46 connected to the tip electrode 36 is inserted through the lumen 81L, and a lead wire 47 to 49 connected to each of the ring-shaped electrodes 37 to 39 is inserted through the lumen 82L.
  • the lead wire 46 is connected to the tip electrode 36 because its tip is connected and fixed to the tip electrode 36 by solder filled in the internal space of the tip electrode 36.
  • the lead wires 47 to 49 are connected to the ring-shaped electrodes 37 to 39 by joining their respective tips to the inner peripheral surfaces of the ring-shaped electrodes 37 to 39, and the tip-side shaft portion of the shaft member 80. It enters the lumen 82L through a side hole formed in the pipe wall of 81 and is inserted into the lumen 82L.
  • the outer portion 87 is made of a resin material that covers the inner portion 86.
  • the resin material constituting the outer portion 87 include thermoplastic polyamide-based elastomers, and in particular, polyether block amide (PEBAX) is preferable.
  • the outer portion 87 may be composed of tubes having the same physical properties along the axial direction, but it is preferable that the hardness changes (decreases) in an inclined manner or in a step-down manner toward the tip end direction.
  • a coil 184 is embedded as a reinforcing material in the reinforcing layer 891 of the tip end side shaft portion 81.
  • a braid 183 is embedded as a reinforcing material in the reinforcing layer 892 of the base end side shaft portion 82.
  • the braid 183 embedded in the reinforcing layer 892 of the base end side shaft portion 82 is formed by knitting the base end side portion of the metal wire bundle 181 and the resin wire bundle 182. Further, the coil 184 embedded in the reinforcing layer 891 of the tip end side shaft portion 81 is formed by spirally winding the tip end side portion of the metal wire bundle 181.
  • the metal wire bundle 181 constituting the coil 184 is continuous (the base end side portion of the metal wire bundle 181 constitutes the braid 183, and the tip end side portion thereof constitutes the coil 184. ), Therefore, excellent torque transmission can be exhibited.
  • the metal wire bundle 181 forming the braid 183 in the base end side shaft portion 82 and the metal wire bundle 181 forming the coil 184 in the tip end side shaft portion 81 are continuous, so that the base end side shaft portion 82 Kinking does not occur at the boundary between the shaft portion 81 and the tip end side shaft portion 81, and the kink resistance is also excellent.
  • the tip end side shaft portion 81 of the shaft member 80 is reinforced by the "coil 184" by the metal wire bundle 181
  • the shaft member is reinforced by the "braid” by the metal wire bundle 181. It has excellent flexibility at the tip of 80.
  • the electrode catheter 400 of the present embodiment includes a first operation wire 511 for bending the tip end side shaft portion 81 of the shaft member 80 in the first direction (direction indicated by the arrow A), and the tip end side shaft portion of the shaft member 80.
  • a second operation wire 512 for bending the 81 in the second direction (direction indicated by the arrow B) is provided.
  • the first operation wire 511 is inserted inside the shaft member 80 (lumen 83L) so as to be movable in the pipe axis direction.
  • the tip of the first operation wire 511 is connected and fixed to the tip electrode 36 by solder filled in the internal space of the tip electrode 36. Further, the base end of the first operation wire 511 can be pulled and operated by being connected to the knob 27 of the control handle 25.
  • the second operation wire 512 is inserted inside the shaft member 80 (lumen 84L) so as to be movable in the pipe axis direction.
  • the tip of the second operation wire 512 is connected and fixed to the tip electrode 36 by solder, similarly to the first operation wire 511. Further, the base end of the second operation wire 512 can be pulled and operated by being connected to the knob 27 of the control handle 25.
  • the first operation wire 511 is pulled and moves to the proximal end side of the lumen 83L, and the distal end side shaft portion 81 is moved. It can be bent in the first direction (the direction indicated by the arrow A).
  • the second operation wire 512 is pulled and moves to the base end side of the lumen 84L, and the tip end side shaft portion 81 is moved in the second direction ( It can be bent in the direction indicated by the arrow B).

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Abstract

La présente invention concerne un cathéter qui présente à la fois une excellente propriété de transmission de couple et une souplesse satisfaisante dans la portion d'extrémité distale d'une tige en un bon équilibre.　Un cathéter (100) selon la présente invention est pourvu : d'un élément tige (10) isolant comprenant une partie de tige côté extrémité distale (11) et une partie de tige côté extrémité proximale (12) ; et une poignée (20) reliée à l'extrémité proximale de l'élément tige (10), la partie de tige côté extrémité proximale (12) comprend un tube tressé renforcé d'une tresse (183) dans lequel une section côté extrémité proximale d'un faisceau de fils d'élément métallique (181) et un faisceau de fils d'élément de résine (182) sont tressés, et la partie de tige côté extrémité distale (11) comprend un tube de bobine renforcé par une bobine (184) dans lequel une section côté extrémité distale du faisceau de fils d'élément métallique (181) est enroulée en spirale.
PCT/JP2019/011913 2019-03-20 2019-03-20 Cathéter WO2020188823A1 (fr)

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PCT/JP2019/011913 WO2020188823A1 (fr) 2019-03-20 2019-03-20 Cathéter
JP2020547254A JPWO2020188823A1 (ja) 2019-03-20 2019-03-20 カテーテル

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PCT/JP2019/011913 WO2020188823A1 (fr) 2019-03-20 2019-03-20 Cathéter

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US20120101480A1 (en) * 2010-10-21 2012-04-26 Boston Scientific Scimed, Inc. Catheter shaft
US9877781B2 (en) * 2010-11-19 2018-01-30 St. Jude Medical, Atrial Fibrillation Division, Inc. Electrode catheter device with indifferent electrode for direct current tissue therapies
US20150100043A1 (en) * 2013-10-09 2015-04-09 Biosense Webster (Israel) Ltd. Catheter with cross-braided proximal section and helical-coiled distal end

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JP2007301360A (ja) * 2006-05-09 2007-11-22 Olympus Medical Systems Corp 処置具挿脱用補助装置
JP2017153633A (ja) * 2016-02-29 2017-09-07 日本ライフライン株式会社 心腔内除細動カテーテル

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