WO2021191988A1 - 心腔内除細動カテーテルシステム - Google Patents

心腔内除細動カテーテルシステム Download PDF

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Publication number
WO2021191988A1
WO2021191988A1 PCT/JP2020/012792 JP2020012792W WO2021191988A1 WO 2021191988 A1 WO2021191988 A1 WO 2021191988A1 JP 2020012792 W JP2020012792 W JP 2020012792W WO 2021191988 A1 WO2021191988 A1 WO 2021191988A1
Authority
WO
WIPO (PCT)
Prior art keywords
power supply
defibrillation
catheter
electrode group
lead wire
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/JP2020/012792
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English (en)
French (fr)
Japanese (ja)
Inventor
卓也 平尾
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Japan Lifeline Co Ltd
Original Assignee
Japan Lifeline Co Ltd
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 Japan Lifeline Co Ltd filed Critical Japan Lifeline Co Ltd
Priority to PCT/JP2020/012792 priority Critical patent/WO2021191988A1/ja
Priority to JP2022509797A priority patent/JPWO2021191988A1/ja
Priority to TW110103669A priority patent/TW202204004A/zh
Publication of WO2021191988A1 publication Critical patent/WO2021191988A1/ja
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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    • 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 arithmetic processing unit performs a preliminary charge of the DC power supply unit and sets it in order to store a predetermined voltage in the DC power supply unit prior to the setting input of the electric energy applied when defibrillation is performed.
  • a voltage determined based on the input electric energy hereinafter referred to as "target voltage"
  • target voltage a voltage determined based on the input electric energy
  • the predetermined voltage is preferably the maximum voltage that can be stored in the DC power supply unit.
  • the discharge time is defined as the charging time by discharging a part of the voltage stored (fully charged) in the DC power supply unit by pre-charging to set the target voltage. Since it is remarkably short in comparison, the time from the setting input of electric energy to the accumulation of the target voltage in the DC power supply unit can be remarkably shortened.
  • the defibrillation catheter system having such a configuration, even if the voltage accumulated in the DC power supply unit decreases with time, the corresponding voltage is charged again, so that the voltage is accumulated in the DC power supply unit.
  • the existing voltage can be substantially maintained at a predetermined voltage.
  • Each of the electrodes constituting the second DC electrode group is provided with a second lead wire group composed of a plurality of lead wires having a tip connected to each of the electrodes;
  • the power supply device includes the DC power supply unit and With the arithmetic processing unit A catheter connection connector connected to the proximal end side of the first lead wire group and the second lead wire group of the defibrillation catheter, An electrocardiograph connector connected to the input terminal of the electrocardiograph, It is provided with the electrocardiograph connector connected to the catheter connector and the branch connection connected to the arithmetic processing unit; When the electrocardiographic potential is measured by the electrodes constituting the first DC electrode group and / or the second DC electrode group of the defibrillation catheter, the electrocardiographic potential information from the defibrillation catheter is transmitted to the catheter connection connector and the branch connection portion.
  • the first DC of the defibrillation catheter is transmitted from the DC power supply unit via the output circuit of the arithmetic processing unit, the branch connection unit, and the catheter connection connector. It is preferable that voltages having different polarities are applied to the electrode group and the second DC electrode group.
  • the defibrillation catheter that constitutes such an intracardiac defibrillation catheter system is inserted into the heart cavity so that the first DC electrode group is located in the coronary vein and the second DC electrode group is located in the right atrium. Then, the power supply device applies voltages having different polarities to the first DC electrode group and the second DC electrode group via the first lead wire group and the second lead wire group (first DC electrode group and second DC electrode group). By applying a DC voltage between the groups), electrical energy is directly applied to the defibrillating heart, which results in defibrillation treatment.
  • the pre-charging starts when the main power switch is turned on, so that the pre-charging is surely completed when the electric energy is set (predetermined in the DC power supply unit). Can accumulate voltage).
  • the ON / OFF switch interposed between the catheter connection connector and the electrocardiograph connection connector is set to "ON”, and the ON / OFF switch is set between the catheter connection connector and the arithmetic processing unit.
  • the intervening ON / OFF switch is set to "OFF”
  • the electrocardiograph information from the defibrillation catheter is input to the electrocardiograph via the catheter connection connector, the branch connection part and the electrocardiograph connection connector. Can be done.
  • the ON / OFF switch interposed between the catheter connection connector and the electrocardiograph connection connector is set to "OFF"
  • the ON / OFF switch interposed between the catheter connection connector and the arithmetic processing unit is set to "ON”.
  • the branch connection portion is composed of a changeover switch having one circuit and two contacts, and the catheter connection connector is connected to the common contact. It may be a switching unit in which the electrocardiograph connector is connected to one contact and the arithmetic processing unit is connected to the second contact.
  • the electrocardiographic information from the defibrillation catheter is connected to the catheter connection connector, the branch connection part (switching part) and the electrocardiograph connection. It can be input to the electrocardiograph via the connector.
  • the first DC electrode group and the first DC electrode group of the defibrillation catheter are connected from the DC power supply unit via the output circuit of the arithmetic processing unit, the branch connection unit (switching unit), and the catheter connection connector. Voltages having different polarities can be applied to the 2DC electrode group.
  • the defibrillation catheter is attached to the tube member apart from the first DC electrode group or the second DC electrode group.
  • a group of potential measurement electrodes consisting of multiple electrodes is composed of a plurality of lead wires whose tips are connected to each of the electrodes constituting the potential measurement electrode group, and the base end side thereof includes a lead wire group for potential measurement connected to the catheter connection connector of the power supply device.
  • the power supply device is formed with a path that directly connects the catheter connection connector and the electrocardiograph connection connector.
  • the electrocardiographic information measured by the electrodes constituting the potential measurement electrode group is transmitted from the catheter connection connector of the power supply device to the electrocardiogram connection connector via the electrocardiograph connection connector without passing through the branch connection portion. It is preferable to input to the total.
  • the potential measurement electrode group The electrocardiograph can acquire the electrocardiographic potential measured by the electrocardiograph, and defibrillation treatment can be performed while monitoring the electrocardiographic potential with the electrocardiograph.
  • the arithmetic processing unit of the power supply device has the first DC electrode group and the second DC of the defibrillation catheter based on an external input.
  • the impedance between the electrodes is measured, and a discharge or additional charge is controlled in order to store the target voltage determined based on the measured impedance and the set input electric energy in the DC power supply unit. Is preferable.
  • the electrocardiograph is connected to an electrocardiographic measuring means other than the defibrillation catheter.
  • the electrocardiographic potential is measured even in the case of defibrillation treatment in which the electrocardiograph cannot acquire the electrocardiographic potential from the first DC electrode group and the second DC electrode group of the defibrillation catheter.
  • the electrocardiograph can acquire the electrocardiographic potential measured by the means, and defibrillation treatment can be performed while monitoring the electrocardiographic potential with the electrocardiograph.
  • FIG. 5 is an explanatory plan view showing a defibrillation catheter constituting the catheter system shown in FIG. 1.
  • FIG. 5 is an explanatory plan view (a diagram for explaining dimensions and hardness) showing a defibrillation catheter constituting the catheter system shown in FIG. 1.
  • It is a cross-sectional view which shows the AA cross section of FIG. 2 is a cross-sectional view showing a BB cross section, a CC cross section, and a DD cross section of FIG.
  • FIG. 1 it is a block diagram which shows the flow of the electrocardiographic information in the electrocardiographic potential measurement mode after turning on the main power switch.
  • the catheter system shown in FIG. 1 it is a block diagram which shows the flow of the information concerning the measured value of the impedance between the electrode group in the defibrillation mode after the input of a mode changeover switch, and the electrocardiographic information.
  • the catheter system shown in FIG. 1 it is a block diagram which shows the flow of the electrocardiographic information in the electrocardiographic measurement mode after a lapse of a certain time after inputting a mode changeover switch.
  • the catheter system shown in FIG. 1 it is a block diagram which shows the state at the time of applying a DC voltage in the defibrillation mode after the input of an application execution switch.
  • the intracardiac defibrillation catheter system of the present embodiment includes a defibrillation catheter 100, a power supply device 700, an electrocardiograph 800, and an electrocardiographic measuring means 900.
  • the multi-lumen tube 10 (insulating tube member having a multi-lumen structure) constituting the defibrillation catheter 100 has four lumens (first lumen 11, second lumen 12). , 3rd lumen 13, 4th lumen 14) are formed.
  • 15 is a fluororesin layer for partitioning the lumen
  • 16 is an inner (core) portion made of a low-hardness nylon elastomer
  • 17 is an outer (shell) portion made of a high-hardness nylon elastomer.
  • 18 in FIG. 4 is a stainless wire forming a braided blade.
  • the fluororesin layer 15 that partitions the rumen is made of a highly insulating material such as a perfluoroalkyl vinyl ether copolymer (PFA) or polytetrafluoroethylene (PTFE).
  • PFA perfluoroalkyl vinyl ether copolymer
  • PTFE polytetrafluoroethylene
  • the braided blade composed of the stainless wire 18 is formed only in the region shown by L5 in FIG. 3, and is provided between the inner portion 16 and the outer portion 17 as shown in FIG.
  • the outer diameter of the multi-lumen tube 10 is, for example, 1.2 to 3.3 mm.
  • the handle 20 constituting the defibrillation catheter 100 in the present embodiment includes a handle body 21, a knob 22, and a strain relief 24. By rotating the knob 22, the tip of the multi-lumen tube 10 can be deflected (swinged).
  • the first DC electrode group 31G, the second DC electrode group 32G, and the proximal end side potential measurement electrode group 33G are mounted on the outer periphery of the multi-lumen tube 10 (the tip region where no braid is formed inside).
  • the "electrode group” is a set of 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). Refers to the body.
  • the width (length in the axial direction) of the electrode 32 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 multi-lumen tube 10 where the second DC electrode group 32G is provided may be impaired.
  • the width (length in the axial direction) of the electrode 33 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.
  • the separation distance d3 between the second DC electrode group 32G (electrode 32 on the proximal end side) and the potential measurement electrode group 33G on the proximal end side (electrode 33 on the distal end side) is preferably 5 to 50 mm, and a suitable example is shown. For example, it is 30 mm.
  • the electrodes 31, 32, 33 constituting the first DC electrode group 31G, the second DC electrode group 32G, and the proximal end potential measurement electrode group 33G are platinum or platinum-based in order to improve the contrastability with respect to X-rays. It is preferably made of the alloy of.
  • the second lead wire group 42G shown in FIGS. 4 and 5 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 power supply device 700.
  • the first lead group 41G extends to the first lumen 11 and the second lead group 42G extends to the second lumen 12, so that both are in the multi-lumen tube 10. It is completely isolated. Therefore, when the voltage required for defibrillation is applied, a short circuit between the first lead wire group 41G (first DC electrode group 31G) and the second lead wire group 42G (second DC electrode group 32G) is performed. Can be reliably prevented.
  • the four electrodes 33 constituting the base end side potential measurement electrode group 33G 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 lumen 13 through a side hole formed in the tube wall of the multi-lumen tube 10.
  • the four lead wires 43 that have entered the third lumen 13 extend to the third lumen 13 as the third lead wire group 43G.
  • 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 conductor wire is coated with a resin such as polyimide.
  • the film thickness of the coating resin is about 2 to 30 ⁇ m.
  • 65 is a pull wire.
  • the pull wire 65 extends to the fourth lumen 14 and extends eccentrically with respect to the central axis of the multi-lumen tube 10.
  • a cylindrical connector 50 having a plurality of pin terminals (51, 52, 53) projecting in the tip direction arranged on the tip surface 50A is provided at the base end portion of the handle 20. It is built-in. Further, as shown in FIGS. 6 to 8, each of the three lead wire groups (first lead wire group 41G, second lead wire group 42G, third lead wire group 43G) is inserted inside the handle 20.
  • the three insulating tubes (first insulating tube 26, second insulating tube 27, third insulating tube 28) are extended.
  • the first lead wire group 41G extending from the base end opening of the first insulating tube 26 is separated into eight lead wires 41 constituting the lead wire group 41G, and each of these lead wires 41 is a tip surface 50A of the connector 50. It is connected and fixed by solder to each of the pin terminals arranged in.
  • a region in which a pin terminal (pin terminal 51) to which the lead wire 41 constituting the first lead wire group 41G is connected and fixed is arranged is referred to as a “first terminal group region”.
  • the tip of the second insulating tube 27 (about 10 mm from the tip) is inserted into the second lumen 12 of the multi-lumen tube 10, whereby the second lead wire group 42G extends to the second insulating tube 27. It is connected to the second lumen 12 to be used.
  • the second insulating tube 27 connected to the second lumen 12 of the connector 50 (tip surface 50A on which the pin terminal is arranged) passes through the inner hole of the second protective tube 62 extending inside the handle 20. It extends to the vicinity and forms an insertion passage that guides the base end portion of the second lead wire group 42G to the vicinity of the connector 50.
  • the tip of the third insulating tube 28 (about 10 mm from the tip) is inserted into the third lumen 13 of the multi-lumen tube 10, whereby the third lead wire group 43G extends to the third insulating tube 28. It is connected to the third lumen 13.
  • the third insulating tube 28 connected to the third lumen 13 of the connector 50 (tip surface 50A on which the pin terminal is arranged) passes through the inner hole of the second protective tube 62 extending inside the handle 20. It extends to the vicinity and forms an insertion passage that guides the base end portion of the third lead wire group 43G to the vicinity of the connector 50.
  • a nylon elastomer such as "Pebox” (registered trademark of ARKEMA) is exemplified. be able to.
  • the first The first lead wire group 41G extends in the insulating tube 26, the second lead wire group 42G extends in the second insulating tube 27, and the third lead wire group 43G extends in the third insulating tube 28.
  • the first lead wire group 41G, the second lead wire group 42G, and the third lead wire 43G can be completely isolated from each other even inside the handle 20.
  • a short circuit (particularly) between the first lead wire group 41G, the second lead wire group 42G, and the third lead wire group 43G inside the handle 20 is applied.
  • Short circuit between the lead wires extending near the opening of the lumen) can be reliably prevented.
  • the lead wire 41 (the base end portion of the lead wire 41 extending from the base end opening of the first insulating tube 26) and the second lead wire group forming the first lead wire group 41G.
  • the lead wire 42 (the base end portion of the lead wire 42 extending from the base end opening of the second insulating tube 27) constituting the 42G can be reliably and orderly separated. If the partition plate 55 is not provided, the lead wire 41 and the lead 42 cannot be separated (separated) in an orderly manner, and there is a risk that they will be mixed.
  • the lead wire 41 constituting the first lead wire group 41G and the lead wire 42 constituting the second lead wire group 42G to which voltages having different polarities are applied are separated from each other by the partition plate 55 and come into contact with each other. Therefore, when the defibrillation catheter 100 is used, even if the voltage required for intracardiac defibrillation is applied, the lead wire 41 (first insulating tube) constituting the first lead wire group 41G is applied.
  • the lead wire 42 extending from the base end opening of 26 and the lead wire 42 forming the second lead wire group 42G (lead wire 42 extending from the base end opening of the second insulating tube 27). No short circuit occurs with the base end portion).
  • the distal edge of the partition plate 55 is located closer to the distal end than either the proximal end of the first insulating tube 26 or the proximal end of the second insulating tube 27.
  • the lead wire extending from the base end opening of the first insulating tube 26 (lead wire 41 constituting the first lead wire group 41G) and the lead extending from the base end opening of the second insulating tube 27
  • a partition plate 55 is always present between the wire (lead wire 42 constituting the second lead wire group 42G), and a short circuit due to contact between the lead wire 41 and the lead wire 42 is surely prevented. Can be done.
  • the height of the resin molded body (distance from the base end surface to the tip end surface) is preferably higher than the height of the partition plate 55, and when the height of the partition plate 55 is 8 mm, it is set to, for example, 9 mm.
  • the power supply device 700 constituting the catheter system of the present embodiment includes a DC power supply unit 71, a catheter connection connector 72, an electrocardiograph connection connector 73, and an external switch (input means) 74. , The arithmetic processing unit 75, the branch connection unit 76, and the electrocardiogram input connector 77 are provided.
  • the catheter connection connector 72 is connected to the connector 50 of the defibrillation catheter 100, and is electrically connected to the proximal end side of the first lead wire group (41G), the second lead wire group (42G), and the third lead wire group (43G). Connected to.
  • the mode of the power supply device 700 After the application of the voltage from the DC power supply unit 71 is stopped, the mode of the power supply device 700 returns to the "electrocardiographic potential measurement mode", and the first DC electrode group 31G and the second DC electrode group 32G of the defibrillation catheter 100 The electrocardiographic information from the constituent electrodes is input to the electrocardiograph 800 (Step 18).

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  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Radiology & Medical Imaging (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Electrotherapy Devices (AREA)
PCT/JP2020/012792 2020-03-23 2020-03-23 心腔内除細動カテーテルシステム Ceased WO2021191988A1 (ja)

Priority Applications (3)

Application Number Priority Date Filing Date Title
PCT/JP2020/012792 WO2021191988A1 (ja) 2020-03-23 2020-03-23 心腔内除細動カテーテルシステム
JP2022509797A JPWO2021191988A1 (https=) 2020-03-23 2020-03-23
TW110103669A TW202204004A (zh) 2020-03-23 2021-02-01 心腔內除顫導管系統

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Application Number Priority Date Filing Date Title
PCT/JP2020/012792 WO2021191988A1 (ja) 2020-03-23 2020-03-23 心腔内除細動カテーテルシステム

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2024106285A1 (ja) * 2022-11-15 2024-05-23 株式会社カネカ 心腔内除細動カテーテルシステムの制御方法

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS6323675A (ja) * 1986-05-14 1988-01-30 ベントリテツクス 除細動装置とその使用方法と電気パルス発生装置と心臓刺激装置
JPH06315540A (ja) * 1990-05-18 1994-11-15 Hewlett Packard Co <Hp> 細動除去方法及び装置
JP2014200314A (ja) * 2013-04-01 2014-10-27 オリンパス株式会社 除細動装置
JP2018068981A (ja) * 2016-11-04 2018-05-10 日本ライフライン株式会社 心腔内除細動カテーテルシステム
WO2019155941A1 (ja) * 2018-02-07 2019-08-15 株式会社カネカ 除細動カテーテルシステム、除細動用電源装置および除細動用電源装置の制御方法

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS6323675A (ja) * 1986-05-14 1988-01-30 ベントリテツクス 除細動装置とその使用方法と電気パルス発生装置と心臓刺激装置
JPH06315540A (ja) * 1990-05-18 1994-11-15 Hewlett Packard Co <Hp> 細動除去方法及び装置
JP2014200314A (ja) * 2013-04-01 2014-10-27 オリンパス株式会社 除細動装置
JP2018068981A (ja) * 2016-11-04 2018-05-10 日本ライフライン株式会社 心腔内除細動カテーテルシステム
WO2019155941A1 (ja) * 2018-02-07 2019-08-15 株式会社カネカ 除細動カテーテルシステム、除細動用電源装置および除細動用電源装置の制御方法

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2024106285A1 (ja) * 2022-11-15 2024-05-23 株式会社カネカ 心腔内除細動カテーテルシステムの制御方法

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TW202204004A (zh) 2022-02-01

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