WO2010067719A1 - Intracardiac defibrillation catheter - Google Patents
Intracardiac defibrillation catheter Download PDFInfo
- Publication number
- WO2010067719A1 WO2010067719A1 PCT/JP2009/070002 JP2009070002W WO2010067719A1 WO 2010067719 A1 WO2010067719 A1 WO 2010067719A1 JP 2009070002 W JP2009070002 W JP 2009070002W WO 2010067719 A1 WO2010067719 A1 WO 2010067719A1
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- lead wire
- group
- lumen
- insulating tube
- electrode group
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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
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/0404—Electrodes for external use
- A61N1/0408—Use-related aspects
- A61N1/046—Specially adapted for shock therapy, e.g. defibrillation
-
- 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
- A61N1/395—Heart defibrillators for treating atrial fibrillation
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
- A61B5/25—Bioelectric electrodes therefor
- A61B5/279—Bioelectric electrodes therefor specially adapted for particular uses
- A61B5/28—Bioelectric electrodes therefor specially adapted for particular uses for electrocardiography [ECG]
- A61B5/283—Invasive
- A61B5/287—Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
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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
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
- A61N1/056—Transvascular endocardial electrode systems
- A61N1/0563—Transvascular endocardial electrode systems specially adapted for defibrillation or cardioversion
-
- 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
- A61N1/3968—Constructional arrangements, e.g. casings
Definitions
- the present invention relates to an intracardiac defibrillation catheter that is inserted into a heart chamber to remove atrial fibrillation.
- An external defibrillator is known as a defibrillator for removing atrial fibrillation (see, for example, Patent Document 1).
- AED an external defibrillator
- electrical energy is given to the patient's body by attaching an electrode pad to the patient's body surface and applying a DC voltage.
- the electrical energy flowing from the electrode pad into the patient's body is usually 150 to 200 J, and a part (usually about several percent to 20%) of the fluid flows to the heart and is used for the defibrillation treatment.
- Atrial fibrillation is likely to occur during cardiac catheterization, and even in this case, it is necessary to perform cardioversion.
- AED that supplies electric energy from outside the body, it is difficult to supply effective electric energy (for example, 10 to 30 J) to the heart that is causing fibrillation.
- the present invention has been made based on the circumstances as described above, and an object of the present invention is to ensure the necessary and sufficient electric energy for defibrillation for the heart that has undergone atrial fibrillation during cardiac catheterization. It is an object of the present invention to provide an intracardiac defibrillation catheter that can be supplied to a patient. Another object of the present invention is to provide an intracardiac defibrillation catheter capable of performing defibrillation treatment without causing burns on the patient's body surface.
- the intracardiac defibrillation catheter of the present invention is a catheter for defibrillation inserted into the heart chamber, An insulating tube member having a multi-lumen structure; A handle connected to the proximal end of the tube member; A first electrode group (first DC electrode group) composed of a plurality of ring-shaped electrodes attached to the distal end region of the tube member; A second electrode group (second DC electrode group) composed of a plurality of ring-shaped electrodes mounted on the tube member apart from the first DC electrode group on the proximal end side; A substantially cylindrical connector that is built in the proximal end portion of the handle and has a plurality of pin terminals that protrude in the distal direction disposed on the distal end surface; A first insulating tube having a distal end connected to the first lumen of the tube member, extending inside the handle, and having a proximal end opened in the vicinity of the connector; A second insulating tube having a distal end connected to the second lumen of
- the intracardiac defibrillation catheter having such a configuration is inserted into the heart chamber such that the first DC electrode group is located in the coronary vein and the second DC electrode group is located in the right atrium, and the first lead wire is inserted. Voltages having different polarities are applied to the first DC electrode group and the second DC electrode group via the group and the second lead wire group (a DC voltage is applied between the first DC electrode group and the second DC electrode group). Thus, electrical energy is directly applied to the heart that is causing fibrillation, whereby defibrillation treatment is performed.
- the first DC electrode group and the second DC electrode group of the defibrillation catheter disposed in the heart chamber electrical energy is directly applied to the fibrillated heart.
- the electrical stimulation (electric shock) necessary and sufficient for treatment can be reliably applied only to the heart. And since electrical energy can be given directly to the heart, it does not cause burns on the patient's body surface.
- a first lead wire group consisting of lead wires connected to each of the electrodes constituting the first DC electrode group, and a second lead wire group consisting of lead wires connected to each of the electrodes constituting the second DC electrode group. are respectively extended in different lumens (first lumen and second lumen) of the tube member, so that they are completely insulated and isolated in the tube member. For this reason, when a voltage necessary for defibrillation in the heart chamber is applied, a short circuit is reliably prevented from occurring between the first lead wire group and the second lead wire group in the tube member. be able to.
- first lead wire group and the second lead wire group are respectively extended to different insulating tubes (first insulating tube and second insulating tube) extending inside the handle. Both are completely insulated and isolated even inside the handle. For this reason, When a voltage necessary for intracardiac defibrillation is applied, it is possible to reliably prevent a short circuit from occurring between the first lead wire group and the second lead wire group inside the handle.
- the lead wire constituting the first lead wire group (the base end portion of the lead wire extending from the base end opening of the first insulating tube) by the partition plate separating the first terminal group region and the second terminal group region )
- the lead wires constituting the second lead wire group (the base end portion of the lead wire extending from the base end opening of the second insulating tube) can be reliably and orderly separated.
- the partition plate separating the first terminal group region and the second terminal group region separates and contacts the lead wires constituting the first lead wire group and the lead wires constituting the second lead wire group. Therefore, when a voltage necessary for defibrillation in the heart chamber is applied, the lead wires constituting the first lead wire group (the base end of the lead wire extending from the base end opening of the first insulating tube) Part) and the lead wire constituting the second lead wire group (the base end portion of the lead wire extending from the base end opening of the second insulating tube) is surely prevented from being short-circuited. Can do.
- the partition plate separating the first terminal group region and the second terminal group region incorporates the lead wire constituting the first lead wire group and the lead wire constituting the second lead wire group in the handle. Since it can be connected to a terminal group concentrated on the distal end surface of one connector, there is no need to connect multiple connectors (cords) to the base end side of the handle, the configuration is simplified, and defibrillation The operability as a moving catheter is improved.
- the distal end edge of the partition plate is positioned on the distal end side with respect to the proximal end of the first insulating tube and the proximal end of the second insulating tube. Preferably it is.
- the lead wire (lead wire constituting the first lead wire group) extending from the proximal end opening of the first insulating tube, and the second insulating tube Since there is always a partition plate between the lead wires extending from the base end opening (lead wires constituting the second lead wire group), it is ensured that both are in contact and short-circuited. Can be prevented.
- a proximal-side potential measurement electrode group comprising a plurality of ring-shaped electrodes mounted on the tube member and spaced from the second DC electrode group on the proximal end side; , A third insulating tube having a distal end connected to the third lumen of the tube member, extending into the handle, and having a proximal end opened in the vicinity of the connector; A plurality of lead wires connected to each of the electrodes constituting the proximal end side potential measurement electrode group, extending into the third lumen of the tube member and the third insulating tube, A third lead wire group extending from the proximal end opening of the tube and divided into the plurality of lead wires, and each of the divided lead wires is connected and fixed to each of the pin terminals of the connector; It is preferable to become.
- the cardiac potential (particularly, the cardiac potential of the superior vena cava where an abnormal potential is likely to occur) can be measured by the proximal potential measuring electrode group. Defibrillation treatment can be performed while monitoring the potential.
- the third lead wire group extends to a third lumen different from any of the lumens (first lumen and second lumen) from which the first lead wire group or the second lead wire group extends.
- the third lead wire group in the tube member is completely insulated and isolated from both the first lead wire group and the second lead wire group. For this reason, when a voltage necessary for defibrillation in the heart chamber is applied, a short circuit occurs between the third lead wire group and the first lead wire group or the second lead wire group in the tube member. This can be surely prevented.
- the third lead wire group extends in the third insulating tube having the tip connected to the third lumen, so that the third lead wire group inside the handle becomes the first lead wire group.
- the second lead wire group are completely insulated and isolated from each other. For this reason, when a voltage necessary for defibrillation in the heart chamber is applied, a short circuit is caused between the third lead wire group and the first lead wire group or the second lead wire group even inside the handle. It is possible to reliably prevent the occurrence.
- a pull wire for tip deflection operation extends to the fourth lumen of the tube member.
- the pull wire for the tip deflection operation is formed by using the lumen (the first lead wire group, the second lead wire group, or the third lead wire group extending). Since the first lumen, the second lumen, and the third lumen) extend to a different lumen (fourth lumen), the lead wires constituting the lead wire group are formed by the pull wires that move in the axial direction during the tip deflection operation. There is no damage (eg, scratches).
- the intracardiac defibrillation catheter of the present invention is preferably inserted into the heart chamber in order to remove atrial fibrillation that occurs during cardiac catheterization.
- the intracardiac defibrillation catheter of the present invention is a catheter for defibrillation inserted into the heart chamber, An insulating tube member having a multi-lumen structure; A handle connected to the proximal end of the tube member; A first electrode group (first DC electrode group) composed of a plurality of ring-shaped electrodes attached to the distal end region of the tube member; A second electrode group (second DC electrode group) composed of a plurality of ring-shaped electrodes mounted on the tube member apart from the first DC electrode group on the proximal end side; A substantially cylindrical connector that is built in the proximal end portion of the handle and has a plurality of pin terminals that protrude in the distal direction disposed on the distal end surface; A first insulating tube having a distal end connected to the first lumen of the tube member, extending inside the handle, and having a proximal end opened in the vicinity of the connector; A second insulating tube having a distal end connected to the second lumen
- the intracardiac defibrillation catheter having such a configuration is inserted into the heart chamber such that the first DC electrode group is located in the coronary vein and the second DC electrode group is located in the right atrium, and the first lead wire is inserted. Voltages having different polarities are applied to the first DC electrode group and the second DC electrode group via the group and the second lead wire group (a DC voltage is applied between the first DC electrode group and the second DC electrode group). Thus, electrical energy is directly applied to the heart that is causing fibrillation, whereby defibrillation treatment is performed.
- the first DC electrode group and the second DC electrode group of the defibrillation catheter disposed in the heart chamber electrical energy is directly applied to the fibrillated heart.
- the electrical stimulation (electric shock) necessary and sufficient for treatment can be reliably applied only to the heart. And since electrical energy can be given directly to the heart, it does not cause burns on the patient's body surface.
- a first lead wire group consisting of lead wires connected to each of the electrodes constituting the first DC electrode group, and a second lead wire group consisting of lead wires connected to each of the electrodes constituting the second DC electrode group. are respectively extended in different lumens (first lumen and second lumen) of the tube member, so that they are completely insulated and isolated in the tube member. For this reason, when a voltage necessary for defibrillation in the heart chamber is applied, a short circuit is reliably prevented from occurring between the first lead wire group and the second lead wire group in the tube member. be able to.
- first lead wire group and the second lead wire group are respectively extended to different insulating tubes (first insulating tube and second insulating tube) extending inside the handle. Both are completely insulated and isolated even inside the handle. Therefore, it is possible to reliably prevent a short circuit from occurring between the first lead wire group and the second lead wire group inside the handle when a voltage necessary for intracardiac defibrillation is applied. Can do.
- the plurality of lead wires constituting the first lead wire group and the plurality of lead wires constituting the second lead wire group are the base ends of the insulating tube (first insulating tube or second insulating tube).
- the part (base end part) that extends from the opening and is divided and connected and fixed to each pin terminal of the connector is solidified with resin, so that the shape of each lead wire does not change Because it is held, when the intracardiac defibrillation catheter of the present invention is manufactured (for example, when a wired connector is mounted inside the handle), the lead wire extending from the proximal end opening of the insulating tube Can be prevented from being kinked or coming into contact with the edge of the pin terminal.
- the plurality of lead wires constituting the first lead wire group and the plurality of lead wires constituting the second lead wire group can be kept separated from each other by the resin (insulation by the resin).
- a lead wire constituting the first lead wire group (a base end portion of the lead wire extending from the base end opening of the first insulating tube); It is possible to reliably prevent a short circuit from occurring between the lead wires constituting the second lead wire group (the base end portion of the lead wire extending from the base end opening of the second insulating tube).
- the lead wires constituting the first lead wire group and the lead wires constituting the second lead wire group are connected to terminals intensively arranged on the distal end surface of one connector built in the handle. Therefore, it is not necessary to connect a plurality of connectors (cords) to the proximal end side of the handle, the configuration is simplified, and the operability as a defibrillation catheter is improved.
- the proximal end portion of the first insulating tube and the proximal end portion of the second insulating tube are embedded in the resin.
- the intracardiac defibrillation catheter having such a configuration, it extends from the proximal end opening of the insulating tube (the first insulating tube or the second insulating tube) until it is connected and fixed to the pin terminal.
- the entire area of each lead wire can be completely covered with resin, and the shape of the lead wire (base end portion) can be completely held and fixed.
- a proximal-side potential measurement electrode group including a plurality of ring-shaped electrodes attached to the tube member and spaced from the second DC electrode group to the proximal end side; , A third insulating tube having a distal end connected to the third lumen of the tube member, extending into the handle, and having a proximal end opened in the vicinity of the connector; A plurality of lead wires connected to each of the electrodes constituting the proximal end side potential measurement electrode group, extending into the third lumen of the tube member and the third insulating tube, A third lead wire group extending from the proximal end opening of the tube and divided into the plurality of lead wires, and each of the divided lead wires is connected and fixed to each of the pin terminals of the connector; It is preferable to become.
- a plurality of lead wires (base end portions) constituting the third lead wire group which extend from the base end opening of the third insulating tube and are divided and connected and fixed to each of the pin terminals of the connector. It is preferable that these shapes are retained by being solidified with the resin.
- the cardiac potential (particularly, the cardiac potential of the superior vena cava where an abnormal potential is likely to occur) can be measured by the proximal potential measuring electrode group. Defibrillation treatment can be performed while monitoring the potential.
- the third lead wire group extends to a third lumen different from any of the lumens (first lumen and second lumen) from which the first lead wire group or the second lead wire group extends.
- the third lead wire group in the tube member is completely insulated and isolated from both the first lead wire group and the second lead wire group. For this reason, when a voltage necessary for defibrillation in the heart chamber is applied, a short circuit occurs between the third lead wire group and the first lead wire group or the second lead wire group in the tube member. This can be surely prevented.
- the third lead wire group extends in the third insulating tube having the tip connected to the third lumen, so that the third lead wire group inside the handle becomes the first lead wire group.
- the second lead wire group are completely insulated and isolated from each other. For this reason, when a voltage necessary for defibrillation in the heart chamber is applied, a short circuit is caused between the third lead wire group and the first lead wire group or the second lead wire group even inside the handle. It is possible to reliably prevent the occurrence.
- a pull wire for tip deflection operation extends to the fourth lumen of the tube member.
- the pull wire for the tip deflection operation is formed by using the lumen (the first lead wire group, the second lead wire group, or the third lead wire group extending). Since the first lumen, the second lumen, and the third lumen) extend to a different lumen (fourth lumen), the lead wires constituting the lead wire group are formed by a pull wire that moves in the axial direction during the tip deflection operation. There is no damage (eg, scratches).
- the intracardiac defibrillation catheter of the present invention is preferably inserted into the heart chamber to remove atrial fibrillation that occurs during cardiac catheterization.
- the electrical energy necessary and sufficient for defibrillation can be reliably supplied to the heart that has undergone atrial fibrillation or the like during cardiac catheterization. In addition, it does not cause burns on the patient's body surface and is less invasive. In addition, it is ensured that a short circuit will occur between the first lead wire group and the second lead wire group inside the tube member and the handle when a voltage necessary for intracardiac defibrillation is applied. Can be prevented.
- the lead wires constituting the first lead wire group (of the first insulating tube) Between the lead wire portion extending from the base end opening) and the lead wire constituting the second lead wire group (the base end portion of the lead wire extending from the base end opening of the second insulating tube).
- the lead wires constituting the first lead wire group Between the lead wire portion extending from the base end opening) and the lead wire constituting the second lead wire group (the base end portion of the lead wire extending from the base end opening of the second insulating tube).
- the lead wire extending from the proximal end opening of the insulating tube is kinked or contacted with the edge of the pin terminal at the time of manufacture. Can be prevented.
- FIG. 1 is a plan view for explaining one embodiment of an intracardiac defibrillation catheter of the present invention (a diagram for explaining dimensions and hardness).
- FIG. 2 is a transverse sectional view showing a section AA in FIG. 1.
- FIG. 2 is a transverse sectional view showing a BB section, a CC section, and a DD section in FIG.
- FIG. 2 is a perspective view showing an internal structure of a handle of an embodiment of the intracardiac defibrillation catheter shown in FIG. 1.
- FIG. 1 is a plan view for explaining one embodiment of an intracardiac defibrillation catheter of the present invention (a diagram for explaining dimensions and hardness).
- FIG. 2 is a transverse sectional view showing a section AA in FIG. 1.
- FIG. 2 is a transverse sectional view showing a BB section, a CC section, and a DD section in FIG.
- FIG. 2 is a perspective view showing an internal structure of a handle of
- FIG. 6 is a partially enlarged view of the inside (front end side) of the handle shown in FIG. 5.
- FIG. 6 is a partially enlarged view of the inside (base end side) of the handle shown in FIG. 5.
- It which looked at the connection state to the pin terminal of the lead wire shown in FIG. 10 from the front end side.
- FIGS. 2C to 2C are cross-sectional views showing a BB cross section, a CC cross section, and a DD cross section of FIG.
- the intracardiac defibrillation catheter 100 of this embodiment includes a multi-lumen tube 10, a handle 20, a first DC electrode group 31G, a second DC electrode group 32G, a proximal-side potential measurement electrode group 33G, A lead wire group 41G, a second lead wire group 42G, and a third lead wire group 43G are provided.
- the multi-lumen tube 10 (insulating tube member having a multi-lumen structure) constituting the intracardiac defibrillation catheter 100 of this embodiment has four lumens (first A lumen 11, a second lumen 12, a third lumen 13, and a fourth lumen 14) are formed.
- 15 is a fluororesin layer that divides 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.
- 3 and 18 in FIG. 3 is a stainless steel wire forming a braided blade.
- the fluororesin layer 15 partitioning the lumen is made of a highly insulating material such as perfluoroalkyl vinyl ether copolymer (PFA) or polytetrafluoroethylene (PTFE).
- PFA perfluoroalkyl vinyl ether copolymer
- PTFE polytetrafluoroethylene
- the nylon elastomer that forms the outer portion 17 of the multi-lumen tube 10 has a hardness that varies depending on the axial direction. Thereby, the multi-lumen tube 10 is comprised so that hardness may become high in steps toward the base end side from the front end side.
- the hardness of the region indicated by L1 (length 52 mm) (hardness by a D-type hardness meter) is 40, and the hardness of the region indicated by L2 (length 108 mm) is 55, L3 (long).
- the hardness of the region shown by 25.7 mm) is 63, the hardness of the region shown by L4 (length 10 mm) is 68, and the hardness of the region shown by L5 (length 500 mm) is 72.
- the braided blade composed of the stainless steel wire 18 is formed only in the region indicated by L5 in FIG. 2, 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 method for manufacturing the multi-lumen tube 10 is not particularly limited.
- the handle 20 constituting the intracardiac defibrillation catheter 100 of this embodiment includes a handle main 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-side potential measurement electrode group 33G are attached to the outer periphery of the multi-lumen tube 10 (a distal end region where no braid is formed).
- the “electrode group” is a set of a plurality of electrodes that constitute the same pole (having the same polarity) or are mounted at a narrow interval (for example, 5 mm or less) with the same purpose. Refers to the body.
- the first DC electrode group is formed by mounting a plurality of electrodes constituting the same pole (-pole or + pole) at a narrow interval in the tip region of the multi-lumen tube.
- the number of electrodes constituting the first DC electrode group varies depending on the width and arrangement interval of the electrodes, but is 4 to 13, for example, and preferably 8 to 10.
- the first DC electrode group 31 ⁇ / b> G includes eight ring-shaped electrodes 31 attached to the tip region of the multi-lumen tube 10.
- the electrodes 31 constituting the first DC electrode group 31G are connected to terminals of the same pole in the DC power supply device via lead wires (lead wires 41 constituting the first lead wire group 41G) and connectors described later. .
- the width (length in the axial direction) of the electrode 31 is preferably 2 to 5 mm, and is 4 mm as a suitable example. If the width of the electrode 31 is too narrow, the amount of heat generated when a voltage is applied may be excessive, which may damage surrounding tissues. On the other hand, if the width of the electrode 31 is too wide, the flexibility and flexibility of the portion of the multi-lumen tube 10 where the first DC electrode group 31G is provided may be impaired.
- the mounting interval of the electrodes 31 is preferably 1 to 5 mm, and 2 mm is a preferable example.
- the first DC electrode group 31G is located, for example, in the coronary vein.
- the second DC electrode group is spaced from the mounting position of the first DC electrode group of the multi-lumen tube toward the base end side, and a plurality of electrodes constituting a pole (+ pole or ⁇ pole) opposite to the first DC electrode group are narrow Installed at intervals.
- the number of electrodes constituting the second DC electrode group varies depending on the width and arrangement interval of the electrodes, but is 4 to 13, for example, and preferably 8 to 10.
- the second DC electrode group 32G is composed of eight ring-shaped electrodes 32 that are mounted on the multi-lumen tube 10 while being spaced apart from the mounting position of the first DC electrode group 31G toward the proximal end side.
- the electrode 32 constituting the second DC electrode group 32G is connected to a terminal (first DC electrode group) of the same polarity in the DC power supply device via a lead wire (lead wire 42 constituting the second lead wire group 42G) and a connector described later.
- the electrode groups have different polarities (when one electrode group is a negative electrode, the other electrode group is a positive electrode).
- the width (length in the axial direction) of the electrode 32 is preferably 2 to 5 mm, and is 4 mm as a suitable example. If the width of the electrode 32 is too narrow, the amount of heat generated at the time of voltage application 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 mounting interval of the electrodes 32 is preferably 1 to 5 mm, and 2 mm is a preferable example.
- the second DC electrode group 32G is located, for example, in the right atrium.
- the proximal-side potential measurement electrode group 33G is separated from the attachment position of the second DC electrode group 32G toward the proximal end side, and the four ring electrodes 3 attached to the multi-lumen tube 10. It is composed of three.
- the electrodes 33 constituting the proximal-side potential measuring electrode group 33G are connected to the electrocardiograph via lead wires (lead wires 43 constituting the third lead wire group 43G) and connectors described later.
- the width (length in the axial direction) of the electrode 33 is preferably 0.5 to 2.0 mm, and 1.2 mm is a preferable example. If the width of the electrode 33 is too wide, the measurement accuracy of the cardiac potential is lowered, or it is difficult to specify the site where the abnormal potential is generated.
- the mounting interval of the electrodes 33 (the distance between adjacent electrodes) is preferably 1.0 to 10.0 mm, and 5 mm is a preferable example.
- the proximal-side potential measurement electrode group 33G is located, for example, in the superior vena cava where an abnormal potential is likely to occur.
- a distal tip 35 is attached to the distal end of the intracardiac defibrillation catheter 100.
- a lead wire is not connected to the tip chip 35 and 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 metal materials such as platinum and stainless steel, various resin materials, and the like.
- the separation distance d2 between the first DC electrode group 31G (base end side electrode 31) and the second DC electrode group 32G (tip end side electrode 32) is preferably 40 to 100 mm, and 66 mm is a preferable example. is there.
- the distance d3 between the second DC electrode group 32G (base end side electrode 32) and the base end side potential measurement electrode group 33G (tip end side electrode 33) is preferably 5 to 50 mm, and a suitable example is shown. 30 mm.
- platinum or a platinum-based material is used in order to improve the contrast with respect to X-rays. It is preferable to consist of these alloys.
- the first lead wire group 41G shown in FIGS. 3 and 4 is an aggregate of eight lead wires 41 connected to each of the eight electrodes (31) constituting the first DC electrode group (31G). .
- 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, and enters the first lumen 11 from a side hole formed in the tube wall of the multi-lumen tube 10.
- the eight lead wires 41 that have entered the first lumen 11 extend to the first lumen 11 as a first lead wire group 41G.
- the second lead wire group 42G shown in FIGS. 3 and 4 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 eight electrodes 32 constituting the second DC electrode group 32G can be electrically connected to the DC power supply device by the second lead wire group 42G (lead wire 42).
- 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 the second lumen 12 (the first lead wire group 41G extends from the side hole formed in the tube wall of the multi-lumen tube 10. A different lumen from the existing first lumen 11 is entered.
- the eight lead wires 42 that have entered the second lumen 12 extend to the second lumen 12 as a second lead wire group 42G.
- the first lead wire group 41G extends to the first lumen 11 and the second lead wire group 42G extends to the second lumen 12. Fully insulated and isolated. Therefore, when a voltage necessary 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). Can be reliably prevented.
- the third lead wire group 43G shown in FIG. 3 is an assembly of four lead wires 43 connected to each of the electrodes (33) constituting the proximal-side potential measurement electrode group (33G). With the third lead wire group 43G (lead wire 43), each of the electrodes 33 constituting the proximal end side potential measurement electrode group 33G can be connected to an electrocardiograph.
- 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 from 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 a third lead wire group 43G.
- the third lead wire group 43G extending to the third lumen 13 is completely insulated and isolated from both the first lead wire group 41G and the second lead wire group 42G. Therefore, when a voltage necessary for defibrillation is applied, the third lead wire group 43G (base end side potential measurement electrode group 33G) and the first lead wire group 41G (first DC electrode group 31G) or the first A short circuit between the two lead wire group 42G (second DC electrode group 32G) can be reliably prevented.
- 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 conducting wire is covered with a resin such as polyimide.
- the coating resin has a thickness of about 2 to 30 ⁇ m.
- reference numeral 71 denotes a pull wire.
- the pull wire 71 extends to the fourth lumen 14 and extends eccentrically with respect to the central axis of the multi-lumen tube 10.
- the tip portion of the pull wire 71 is fixed to the tip tip 35 with solder. Further, a large diameter portion for retaining (a retaining portion) may be formed at the tip of the pull wire 71. Thereby, the tip tip 35 and the pull wire 71 are firmly coupled, and the tip tip 35 can be reliably prevented from falling off.
- the proximal end portion of the pull wire 71 is connected to the knob 22 of the handle 20, and the pull wire 71 is pulled by operating the knob 22, whereby the distal end portion of the multi-lumen tube 10 is deflected.
- the pull wire 71 is made of stainless steel or a Ni—Ti superelastic alloy, but is not necessarily made of metal.
- the pull wire 71 may be constituted by a high-strength non-conductive wire, for example. Note that the mechanism for deflecting the distal end portion of the multi-lumen tube is not limited to this, and may be a plate spring, for example.
- the first lead wire group 41G, the second lead wire group 42G, and the third lead wire group 43G are insulated and isolated even inside the handle 20. .
- FIG. 5 is a perspective view showing the internal structure of the handle of the intracardiac defibrillation catheter 100 of the present embodiment
- FIG. 6 is a partially enlarged view of the inside of the handle (distal side)
- FIG. FIG. 5 is a perspective view showing the internal structure of the handle of the intracardiac defibrillation catheter 100 of the present embodiment
- FIG. 6 is a partially enlarged view of the inside of the handle (distal side)
- the base end portion of the multi-lumen tube 10 is inserted into the distal end opening of the handle 20, whereby the multi-lumen tube 10 and the handle 20 are connected.
- a cylindrical connector 50 formed by arranging a plurality of pin terminals (51, 52, 53) protruding in the distal direction on the distal end surface 50 ⁇ / b> A is provided at the proximal end of the handle 20.
- each of the three lead wire groups (first lead wire group 41G, second lead wire group 42G, and third lead wire group 43G) is provided inside the handle 20.
- Three insulating tubes (a first insulating tube 26, a second insulating tube 27, and a third insulating tube 28) to be inserted extend.
- the distal end portion (about 10 mm from the distal end) of the first insulating tube 26 is inserted into the first lumen 11 of the multi-lumen tube 10, whereby the first insulating tube 26 is
- the first lead wire group 41G is connected to the first lumen 11 extending.
- the first insulating tube 26 connected to the first lumen 11 passes through the inner hole of the first protective tube 61 extending inside the handle 20 and is connected to the connector 50 (tip surface 50A on which the pin terminal is disposed). It extends to the vicinity and forms an insertion path that guides the proximal end portion of the first lead wire group 41G to the vicinity of the connector 50.
- the first lead wire group 41G extending from the multi-lumen tube 10 extends inside the handle 20 (inner hole of the first insulating tube 26) without being kinked. Can do.
- the first lead wire group 41G extending from the base end opening of the first insulating tube 26 is divided into eight lead wires 41 constituting the first lead wire group 41G, and each of the lead wires 41 is a front end surface 50A of the connector 50.
- each of the lead wires 41 is a front end surface 50A of the connector 50.
- a region where the pin terminals (pin terminals 51) to which the lead wires 41 constituting the first lead wire group 41G are connected and fixed is arranged is referred to as a “first terminal group region”.
- the eight electrodes 31 constituting the first DC electrode group 31G are connected via the eight lead wires 41 constituting the first lead wire group 41G and the connector 50 (pin terminals 51 in the first terminal group region). And can be connected to a terminal of one of the poles in the DC power supply device.
- the distal end portion (about 10 mm from the distal end) of the second insulating tube 27 is inserted into the second lumen 12 of the multi-lumen tube 10, whereby the second lead wire group 42G extends in the second insulating tube 27.
- the second insulating tube 27 connected to the second lumen 12 passes through the inner hole of the second protective tube 62 extending to the inside of the handle 20 and is connected to the connector 50 (tip surface 50A on which the pin terminal is disposed). It extends to the vicinity and forms an insertion path that guides the proximal end portion of the second lead wire group 42G to the vicinity of the connector 50.
- the second lead wire group 42G extending from the multi-lumen tube 10 extends inside the handle 20 (inner hole of the second insulating tube 27) without being kinked. Can do.
- the second lead wire group 42G extending from the proximal end opening of the second insulating tube 27 is divided into eight lead wires 42 constituting the second lead wire group 42G, and each of these lead wires 42 is a front end surface 50A of the connector 50.
- a region where the pin terminals (pin terminals 52) to which the lead wires 42 constituting the second lead wire group 42G are connected and fixed is disposed is referred to as a “second terminal group region”.
- the eight electrodes 32 constituting the second DC electrode group 32G are connected via the eight lead wires 42 constituting the second lead wire group 42G and the connector 50 (pin terminals 52 in the second terminal group region).
- the terminal of the other pole in the direct current power supply device can be connected.
- the distal end portion (about 10 mm from the distal end) of the third insulating tube 28 is inserted into the third lumen 13 of the multi-lumen tube 10, whereby the third lead wire group 43G extends in the third insulating tube 28.
- the third insulating tube 28 connected to the third lumen 13 passes through the inner hole of the second protective tube 62 extending inside the handle 20 and is connected to the connector 50 (tip surface 50A on which the pin terminal is disposed). It extends to the vicinity and forms an insertion path for guiding the proximal end portion of the third lead wire group 43G to the vicinity of the connector 50.
- the third lead wire group 43G extending from the multi-lumen tube 10 extends inside the handle 20 (inner hole of the third insulating tube 28) without kinking. Can do.
- the third lead wire group 43G extending from the proximal end opening of the third insulating tube 28 is divided into four lead wires 43 constituting the third lead wire group 43, and each of the lead wires 43 is connected to the distal end surface 50A of the connector 50.
- an area where the pin terminals (pin terminals 53) to which the lead wires 43 constituting the third lead wire group 43G are connected and fixed is arranged is referred to as a “third terminal group area”.
- the four electrodes 33 constituting the proximal-side potential measurement electrode group 33G are transferred to the electrocardiograph via the four lead wires 43 and the connector 50 (pin terminal 53) constituting the third lead wire group 43G.
- examples of the constituent material of the insulating tubes include polyimide resin, polyamide resin, and polyamideimide resin. .
- a polyimide resin is particularly preferable because of its high hardness, easy insertion of the lead wire group, and capable of thin molding.
- the thickness of the insulating tube is preferably 20 to 40 ⁇ m, and is 30 ⁇ m as a suitable example.
- nylon elastomer such as “Pebax” (registered trademark of ARKEMA) is exemplified. be able to.
- the first lead wire group 41G extends in the first insulating tube 26, and in the second insulating tube 27. Since the second lead wire group 42G extends and the third lead wire group 43G extends in the third insulating tube 28, the first lead wire group 41G, The two-lead wire group 42G and the third lead wire 43G can be completely insulated and isolated. As a result, when a voltage necessary for defibrillation is applied, a short circuit between the first lead wire group 41G, the second lead wire group 42G, and the third lead wire 43G inside the handle 20 (particularly, Short circuit between the lead wire groups extending near the opening of the lumen can be reliably prevented.
- the first insulating tube 26 is protected by the first protective tube 61, and the second insulating tube 27 and the third insulating tube 28 are protected by the second protective tube 52.
- the insulating tube is protected by the first protective tube 61, and the second insulating tube 27 and the third insulating tube 28 are protected by the second protective tube 52.
- the distal end surface 50A of the connector 50 on which a plurality of pin terminals are arranged is divided into a first terminal group region, a second terminal group region, and a third terminal group region.
- a partition plate 55 for separating the lead wire 41 and the lead wire 42 and the lead wire 43 from each other is provided.
- the partition plate 55 that partitions the first terminal group region, the second terminal group region, and the third terminal group region is formed by molding an insulating resin into a bowl shape having flat surfaces on both sides.
- the insulating resin constituting the partition plate 55 is not particularly limited, and a general-purpose resin such as polyethylene can be used.
- the thickness of the partition plate 55 is, for example, 0.1 to 0.5 mm, and 0.2 mm is a preferable example.
- the height of the partition plate 55 (distance from the base end edge to the front end edge) is higher than the separation distance between the front end surface 50A of the connector 50 and the insulating tubes (the first insulating tube 26 and the second insulating tube 27).
- the separation distance is 7 mm
- the height of the partition plate 55 is, for example, 8 mm.
- the distal end edge cannot be positioned on the distal end side with respect to the proximal end of the insulating tube.
- 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) constituting the first lead wire group 41G, and the second lead wire group
- 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 isolated.
- the lead wires 41 constituting the first lead wire group 41G and the lead wires 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 are in contact with each other. Therefore, when the intracardiac defibrillation catheter 100 is used, even if a voltage necessary for the intracardiac defibrillation is applied, the lead wires 41 (the first leads 41G constituting the first lead wire group 41G) The lead end portion of the lead wire 41 extending from the base end opening of the insulating tube 26 and the lead wire 42 constituting the second lead wire group 42G (the lead extending from the base end opening of the second insulating tube 27). A short circuit does not occur with the base end portion of the line 42.
- the lead wire 41 constituting the first lead wire group 41G is connected to the second terminal.
- the lead 41 When connected to a pin terminal in the group region, the lead 41 straddles the partition wall 55, so that a connection error can be easily found.
- the lead wire 43 (pin terminal 53) constituting the third lead wire group 43G is separated from the lead wire 41 (pin terminal 51) by the partition plate 55 together with the lead wire 42 (pin terminal 52).
- the present invention is not limited to this, and may be separated from the lead wire 42 (pin terminal 52) by the partition plate 55 together with the lead wire 41 (pin terminal 51).
- the distal end edge of the partition wall plate 55 is positioned on the distal end side with respect to both the proximal end of the first insulating tube 26 and the proximal end of the second insulating tube 27. ing.
- the lead wire (lead wire 41 constituting the first lead wire group 41G) extending from the base end opening of the first insulating tube 26 and the lead extending from the base end opening of the second insulating tube 27 are provided.
- the partition plate 55 is always present, and the short circuit due to the contact between the lead wires 41 and the lead wires 42 is surely prevented. Can do.
- eight lead wires 41 extending from the base end opening of the first insulating tube 26 and connected and fixed to the pin terminal 51 of the connector 50, and from the base end opening of the second insulating tube 27
- Eight lead wires 42 extending and fixedly connected to the pin terminal 52 of the connector 50, and four leads extending from the proximal end opening of the third insulating tube 28 and fixedly connected to the pin terminal 53 of the connector 50
- the shape of the wire 43 is held and fixed by fixing the periphery of the wire 43 with the resin 80.
- the resin 80 that retains the shape of the lead wire is formed into a cylindrical shape having the same diameter as the connector 50, and the pin terminal, the lead wire, the base end portion of the insulating tube, and the partition plate 55 are formed inside the resin molded body. Is embedded. According to the configuration in which the proximal end portion of the insulating tube is embedded in the resin molded body, the lead wire (base) from the base end opening of the insulating tube until it is connected and fixed to the pin terminal. The entire area of the end portion can be completely covered with the resin 80, and the shape of the lead wire (base end portion) can be completely held and fixed. Further, the height of the resin molded body (distance from the base end surface to the front end surface) is preferably higher than the height of the partition plate 55, and is 9 mm, for example, when the height of the partition plate 55 is 8 mm.
- the resin 80 constituting the resin molded body is not particularly limited, but it is preferable to use a thermosetting resin or a photocurable resin.
- a thermosetting resin or a photocurable resin Specifically, urethane-based, epoxy-based, and urethane-epoxy-based curable resins can be exemplified.
- the shape of the lead wire is held and fixed by the resin 80, when the intracardiac defibrillation catheter 100 is manufactured (when the connector 50 is mounted inside the handle 20), It is possible to prevent the lead wire extending from the base end opening of the insulating tube from being kinked or coming into contact with the edge of the pin terminal (for example, cracking occurs in the coating resin of the lead wire).
- each lead wire extending from the base end opening of the insulating tube and fixed in contact with each pin terminal is embedded in the resin molded body is as follows. In this way, it can be manufactured.
- Lead wire soldering process As shown in FIG. 8, the eight lead wires 41 constituting the first lead wire group 41G and the eight lead wires constituting the second lead wire group 42G are provided on each of the pin terminals arranged on the distal end surface 50A of the connector 50.
- the lead wires 42 and the four lead wires 43 constituting the third lead wire group 43G are connected and fixed with solder.
- the tip ends of these lead wires (lead wire 41, lead wire 42, lead wire 43) are respectively electrode groups (first DC electrode group 31G, second DC electrode group 32G, proximal potential measuring electrode group 33G). Are already connected to the electrodes (electrode 31, electrode 32, electrode 33).
- a lead wire group (first lead wire group 41G, second lead wire group 42G, third lead wire group 43G) by these lead wires (lead wire 41, lead wire 42, lead wire 43) extends.
- the insulating tubes (the first insulating tube 26, the second insulating tube 27, and the third insulating tube 28) each have a distal end portion of the lumen of the multi-lumen tube 10 (the first lumen 11, the second lumen 12, By being inserted deeply into the third lumen 13), it is retracted to the tip side (upper side in the figure).
- each of the first insulating tube 26, the second insulating tube 27, and the third insulating tube 28 is moved to the base end side (lowered in the same figure).
- the distance between the distal end surface 50A of the connector 50 and the base end of each insulating tube is shorter than the height of the partition plate 55, for example, 7 mm.
- the distal ends of the insulating tubes are the lumens of the multi-lumen tube 10 (the first lumen 11, the second lumen 12, The third lumen 13) is inserted about 10 mm (the state shown in FIG. 6).
- FIG. 11 is a view of the connection state of the lead wire shown in FIG. 10 to the pin terminal as viewed from the tip side. As shown in FIG. The terminal 52) and the lead wire 43 (pin terminal 53) are separated by the partition plate 55.
- first lead wire 41, second lead wire 42, third lead wire 43 connected and fixed to pin terminals (pin terminal 51, pin terminal 52, pin terminal 53).
- the constituent material of the mold 90 is not particularly limited, but a fluorine-based resin such as PTFE, PFA, FEP, ETFE, and PVDF is preferable because of good releasability.
- a sheet in which both ends of a sheet made of such a fluororesin are bonded with an adhesive tape to form a cylinder can be used.
- the height of the mold 90 is, for example, 10 mm.
- Curable resin injection process Next, as shown in FIG. 13, a curable resin 80A is injected into the mold 90 using a Dispenser or the like.
- the liquid level of the injected curable resin 80A (the distance of the liquid surface from the tip surface 50A of the connector 50) is set to 9 mm, for example.
- lead wires (lead wire 41, lead wire 42, lead wire) extending from the base end opening of the insulating tube and connected and fixed to the pin terminals (pin terminal 51, pin terminal 52, pin terminal 53) of connector 50 are provided. 43) and the partition plate 55 are embedded in the curable resin 80A.
- the curable resin injected into the mold 90 is photocured or thermally cured, and then FIG.
- the lead wire (first lead wire 41, first lead wire 41, which is made of a cured resin 80, is a cylindrical molded body having the same diameter as the connector 50, and is fixed to the pin terminal by removing the mold 90.
- a resin molded body (9 mm high molded body having the structure shown in FIG. 7) in which the second lead wire 42, the third lead wire 43) and the partition plate 55 are embedded can be obtained.
- the periphery of the lead wire is solidified with resin means that the lead wire (base end portion) from extending from the base end opening of the insulating tube to being fixed to the pin terminal is fixed. This is to form a resin molded body that fills the entire region, and is clearly distinguished from simple potting.
- a direct current voltage is applied between the first DC electrode group 31G and the second DC electrode group 32G, so that electrical energy is directly applied to the heart causing fibrillation.
- This is a catheter for performing defibrillation treatment by applying a function and is different from a conventionally known electrode catheter used for arrhythmia diagnosis (cardiac potential measurement) and ablation treatment.
- the intracardiac defibrillation catheter 100 of this embodiment is suitably used when performing cardiac catheterization that is likely to cause atrial fibrillation.
- the cardiac catheterization is performed after the intracardiac defibrillation catheter 100 is inserted into the heart chamber of the patient in advance.
- the intracardiac defibrillation catheter 100 is inserted into the heart chamber such that the first DC electrode group 31G is located in the coronary vein 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.
- the electrocardiogram measured by the proximal potential measurement electrode group 33G is monitored (monitored), and when atrial fibrillation occurs, the cardiac catheterization is interrupted and the intracardiac defibrillation catheter is interrupted.
- Defibrillation treatment with 100 is performed. Specifically, 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. Give electrical energy directly to the heart.
- the electrical energy supplied to the heart by the intracardiac defibrillation catheter 100 is preferably 10 to 30 J. If the electrical energy is too low, sufficient defibrillation therapy cannot be performed. On the other hand, when the electrical energy is excessive, there is a risk that the surrounding tissue where the first DC electrode group 31G and the second DC electrode group 32G are located is damaged.
- the horizontal axis represents time and the vertical axis represents potential.
- the time (t 1 ) is, for example, 1.5 to 10.0 seconds
- the measured peak voltage (V 1 ) is, for example, 300 to 500V.
- intracardiac defibrillation catheter 100 of the present embodiment although it is low compared to the AED, high electric energy is supplied (a high voltage is applied), so that it has not been a problem with conventional electrode catheters. It is necessary to reliably prevent the occurrence of a short circuit and ensure safety.
- the first lead wire group 41G connected to the first DC electrode group 31G is connected to the first lumen 11 formed in the multi-lumen tube 10 and the first inside the handle 20.
- the multi-lumen tube 10 is formed with a second lead wire group 42G that extends into the insulating tube 26 and is connected to the pin terminal 51 in the first terminal group region of the connector 50 and connected to the second DC electrode group 32G.
- the second lumen 12 and the handle 20 are extended into the second insulating tube 27 and connected to the pin terminal 52 in the second terminal group region of the connector 50, and connected to the proximal potential measuring electrode group 33G.
- the third group of lead wires 43G is connected to the third lumen 13 and the handle 20 formed in the multi-lumen tube 10. Third by extending into the insulating tube 28 in connected to the pin terminal 53 in the third terminal group region of the connector 50.
- the first lead wire group 41G, the second lead wire group 42G, and the third lead wire 43G can be completely insulated and isolated within the multi-lumen tube 10 and the handle 20. Accordingly, when a voltage necessary for defibrillation is applied, the first lead wire group 41G (first DC electrode group 31G), the second lead wire group 42G (second DC electrode group 32G), and the third lead wire It is possible to reliably prevent a short circuit between the group 43G (base end side potential measurement electrode group 33G).
- the lead wires 41 constituting the first lead wire group 41G and the lead wires 42 constituting the second lead wire group 42G are separated from each other by the partition plate that partitions the first terminal group region and the second terminal group region. Therefore, when the intracardiac defibrillation catheter 100 is used, even if a voltage necessary for the intracardiac defibrillation is applied, the lead 41 constituting the first lead group 41G is used. (The base end portion of the lead wire 41 extending from the base end opening of the first insulating tube 26) and the lead wire 42 (the base end opening of the second insulating tube 27) constituting the second lead wire group 42G. A short circuit does not occur between the lead wire 42 and the base end portion of the lead wire 42.
- the eight lead wires 41 extending from the proximal end opening of the first insulating tube 26 and divided and connected and fixed to each of the pin terminals 51 of the connector 50 and the proximal end opening of the second insulating tube 27 are separated.
- the four lead wires 43 connected and fixed to the respective 53 are held in their respective shapes by being solidified with resin, so that when the intracardiac defibrillation catheter 100 is manufactured ( When the connector 50 is attached to the inside of the handle 20, the insulating tube (the first insulating tube 26, the second insulating tube 27, the third insulating tube 28) extends from the proximal end opening. Out lead wires can be prevented that the (lead wire 41, lead wires 42, lead wires 43) is damaged or contact or kink, the edge of the pin terminal.
- the intracardiac defibrillation catheter of this invention is not limited to these, A various change is possible.
- the connector in an intracardiac defibrillation catheter provided with a partition plate as described above for partitioning a first terminal group region and a second terminal group region, the connector extends from the proximal end opening of the insulating tube. Even if the periphery of the lead wire connected and fixed to the pin terminal is not solidified with resin, it is included in the present invention.
- the first terminal group region and Even the one that does not include a partition plate that partitions the second terminal group region is included in the present invention.
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Abstract
Description
AEDによる除細動治療では、患者の体表に電極パッドを装着して直流電圧を印加することにより、患者の体内に電気エネルギーを与える。ここに、電極パッドから患者の体内に流れる電気エネルギーは、通常150~200Jとされ、そのうちの一部(通常、数%~20%程度)が心臓に流れて除細動治療に供される。 An external defibrillator (AED) is known as a defibrillator for removing atrial fibrillation (see, for example, Patent Document 1).
In defibrillation treatment by AED, electrical energy is given to the patient's body by attaching an electrode pad to the patient's body surface and applying a DC voltage. Here, the electrical energy flowing from the electrode pad into the patient's body is usually 150 to 200 J, and a part (usually about several percent to 20%) of the fluid flows to the heart and is used for the defibrillation treatment.
しかしながら、電気エネルギーを体外から供給するAEDによっては、細動を起こしている心臓に対して効果的な電気エネルギー(例えば10~30J)を供給することは困難である。 Thus, atrial fibrillation is likely to occur during cardiac catheterization, and even in this case, it is necessary to perform cardioversion.
However, depending on the AED that supplies electric energy from outside the body, it is difficult to supply effective electric energy (for example, 10 to 30 J) to the heart that is causing fibrillation.
一方、体外から供給される電気エネルギーが高い割合で心臓に流れた場合には、心臓の組織が損傷を受ける虞も考えられる。
また、AEDによる除細動治療では、電極パッドを装着した体表に火傷が生じやすい。そして、上記のように、心臓に流れる電気エネルギーの割合が少ない場合には、電気エネルギーの供給を繰り返して行うことによって火傷の程度が重くなり、カテーテル術を受けている患者にとって相当の負担となる。 That is, sufficient defibrillation treatment cannot be performed when the proportion of electrical energy supplied from outside the body is small (for example, about several percent).
On the other hand, when the electrical energy supplied from outside the body flows to the heart at a high rate, the heart tissue may be damaged.
Further, in the defibrillation treatment by AED, burns are likely to occur on the body surface to which the electrode pad is attached. And as mentioned above, when the ratio of the electrical energy flowing to the heart is small, repeated supply of electrical energy increases the degree of burns, which is a considerable burden for patients undergoing catheterization. .
本発明の他の目的は、患者の体表に火傷を生じさせることなく、除細動治療を行うことのできる心腔内除細動カテーテルを提供することにある。 The present invention has been made based on the circumstances as described above, and an object of the present invention is to ensure the necessary and sufficient electric energy for defibrillation for the heart that has undergone atrial fibrillation during cardiac catheterization. It is an object of the present invention to provide an intracardiac defibrillation catheter that can be supplied to a patient.
Another object of the present invention is to provide an intracardiac defibrillation catheter capable of performing defibrillation treatment without causing burns on the patient's body surface.
マルチルーメン構造を有する絶縁性のチューブ部材と、
前記チューブ部材の基端に接続されたハンドルと、
前記チューブ部材の先端領域に装着された複数のリング状電極からなる第1電極群(第1DC電極群)と、
前記第1DC電極群から基端側に離間して前記チューブ部材に装着された複数のリング
状電極からなる第2電極群(第2DC電極群)と、
前記ハンドルの基端部に内蔵され、先端方向に突出する複数のピン端子を先端面に配置してなる略円筒状のコネクタと、
前記チューブ部材の第1ルーメンに先端部が連結され、前記ハンドルの内部に延在し、前記コネクタの近傍で基端が開口する第1絶縁性チューブと、
前記チューブ部材の第2ルーメンに先端部が連結され、前記ハンドルの内部に延在し、前記コネクタの近傍で基端が開口する第2絶縁性チューブと、
前記第1DC電極群を構成する電極の各々に接続された複数のリード線からなり、前記チューブ部材の第1ルーメンおよび前記第1絶縁性チューブ内に延在し、当該第1絶縁性チューブの基端開口から延び出して、前記複数のリード線に分割され、分割されたリード線の各々が前記コネクタの有するピン端子の各々に接続固定される第1リード線群と、
前記第2DC電極群を構成する電極の各々に接続された複数のリード線からなり、前記チューブ部材の第2ルーメンおよび前記第2絶縁性チューブ内に延在し、当該第2絶縁性チューブの基端開口から延び出して、前記複数のリード線に分割され、分割されたリード線の各々が前記コネクタの有するピン端子の各々に接続固定される第2リード線群と、
複数のピン端子が配置された前記コネクタの先端面を、前記第1リード線群を構成するリード線が接続固定されたピン端子が配置されている第1端子群領域と、前記第2リード線群を構成するリード線が接続固定されたピン端子が配置されている第2端子群領域とに仕切り、前記第1リード線群を構成するリード線(第1絶縁性チューブの基端開口から延び出したリード線の基端部分)と、前記第2リード線群を構成するリード線(第2絶縁性チューブの基端開口から延び出したリード線の基端部分)とを隔離する隔壁板と、を備えてなり、
除細動を行うときには、前記第1DC電極群と、前記第2DC電極群とに、互いに異なる極性の電圧が印加されることを特徴とする。 (1) The intracardiac defibrillation catheter of the present invention is a catheter for defibrillation inserted into the heart chamber,
An insulating tube member having a multi-lumen structure;
A handle connected to the proximal end of the tube member;
A first electrode group (first DC electrode group) composed of a plurality of ring-shaped electrodes attached to the distal end region of the tube member;
A second electrode group (second DC electrode group) composed of a plurality of ring-shaped electrodes mounted on the tube member apart from the first DC electrode group on the proximal end side;
A substantially cylindrical connector that is built in the proximal end portion of the handle and has a plurality of pin terminals that protrude in the distal direction disposed on the distal end surface;
A first insulating tube having a distal end connected to the first lumen of the tube member, extending inside the handle, and having a proximal end opened in the vicinity of the connector;
A second insulating tube having a distal end connected to the second lumen of the tube member, extending into the handle, and having a proximal end opened in the vicinity of the connector;
A plurality of lead wires connected to each of the electrodes constituting the first DC electrode group, extending into the first lumen of the tube member and the first insulating tube, and a base of the first insulating tube A first lead wire group extending from the end opening and divided into the plurality of lead wires, and each of the divided lead wires is connected and fixed to each of the pin terminals of the connector;
A plurality of lead wires connected to each of the electrodes constituting the second DC electrode group, extending into the second lumen of the tube member and the second insulating tube, and a base of the second insulating tube A second lead wire group extending from the end opening and divided into the plurality of lead wires, and each of the divided lead wires is connected and fixed to each of the pin terminals of the connector;
A first terminal group region in which pin terminals to which lead wires constituting the first lead wire group are connected and fixed are arranged on the front end surface of the connector in which a plurality of pin terminals are arranged, and the second lead wire The lead wires constituting the group are divided into second terminal group regions where pin terminals to which the lead wires are connected and fixed are arranged, and lead wires constituting the first lead wire group (extending from the proximal end opening of the first insulating tube) A partition plate that separates a lead end portion of the lead wire extended from the lead wire constituting the second lead wire group (a base end portion of the lead wire extending from the base end opening of the second insulating tube); With
When defibrillation is performed, voltages having different polarities are applied to the first DC electrode group and the second DC electrode group.
そして、心臓に直接的に電気エネルギーを与えることができるので、患者の体表に火傷を生じさせることもない。 As described above, according to the first DC electrode group and the second DC electrode group of the defibrillation catheter disposed in the heart chamber, electrical energy is directly applied to the fibrillated heart. The electrical stimulation (electric shock) necessary and sufficient for treatment can be reliably applied only to the heart.
And since electrical energy can be given directly to the heart, it does not cause burns on the patient's body surface.
心腔内除細動に必要な電圧を印加したときに、ハンドル内部において、第1リード線群と、第2リード線群との間で短絡が発生することを確実に防止することができる。 Further, the first lead wire group and the second lead wire group are respectively extended to different insulating tubes (first insulating tube and second insulating tube) extending inside the handle. Both are completely insulated and isolated even inside the handle. For this reason,
When a voltage necessary for intracardiac defibrillation is applied, it is possible to reliably prevent a short circuit from occurring between the first lead wire group and the second lead wire group inside the handle.
前記チューブ部材の第3ルーメンに先端部が連結され、前記ハンドルの内部に延在し、前記コネクタの近傍で基端が開口する第3絶縁性チューブと、
前記基端側電位測定電極群を構成する電極の各々に接続された複数のリード線からなり、前記チューブ部材の第3ルーメンおよび前記第3絶縁性チューブ内に延在し、当該第3絶縁性チューブの基端開口から延び出して、前記複数のリード線に分割され、分割されたリード線の各々が前記コネクタの有するピン端子の各々に接続固定される第3リード線群と、を備えてなることが好ましい。 (3) In the intracardiac defibrillation catheter of the present invention, a proximal-side potential measurement electrode group comprising a plurality of ring-shaped electrodes mounted on the tube member and spaced from the second DC electrode group on the proximal end side; ,
A third insulating tube having a distal end connected to the third lumen of the tube member, extending into the handle, and having a proximal end opened in the vicinity of the connector;
A plurality of lead wires connected to each of the electrodes constituting the proximal end side potential measurement electrode group, extending into the third lumen of the tube member and the third insulating tube, A third lead wire group extending from the proximal end opening of the tube and divided into the plurality of lead wires, and each of the divided lead wires is connected and fixed to each of the pin terminals of the connector; It is preferable to become.
加されたときに、チューブ部材内において、第3リード線群と、第1リード線群または第2リード線群との間で短絡が発生することを確実に防止することができる。 The third lead wire group extends to a third lumen different from any of the lumens (first lumen and second lumen) from which the first lead wire group or the second lead wire group extends. Thus, the third lead wire group in the tube member is completely insulated and isolated from both the first lead wire group and the second lead wire group. For this reason, when a voltage necessary for defibrillation in the heart chamber is applied, a short circuit occurs between the third lead wire group and the first lead wire group or the second lead wire group in the tube member. This can be surely prevented.
マルチルーメン構造を有する絶縁性のチューブ部材と、
前記チューブ部材の基端に接続されたハンドルと、
前記チューブ部材の先端領域に装着された複数のリング状電極からなる第1電極群(第1DC電極群)と、
前記第1DC電極群から基端側に離間して前記チューブ部材に装着された複数のリング状電極からなる第2電極群(第2DC電極群)と、
前記ハンドルの基端部に内蔵され、先端方向に突出する複数のピン端子を先端面に配置してなる略円筒状のコネクタと、
前記チューブ部材の第1ルーメンに先端部が連結され、前記ハンドルの内部に延在し、前記コネクタの近傍で基端が開口する第1絶縁性チューブと、
前記チューブ部材の第2ルーメンに先端部が連結され、前記ハンドルの内部に延在し、前記コネクタの近傍で基端が開口する第2絶縁性チューブと、
前記第1DC電極群を構成する電極の各々に接続された複数のリード線からなり、前記チューブ部材の第1ルーメンおよび前記第1絶縁性チューブ内に延在し、当該第1絶縁性チューブの基端開口から延び出して、前記複数のリード線に分割され、分割されたリード線の各々が前記コネクタの有するピン端子の各々に接続固定される第1リード線群と、
前記第2DC電極群を構成する電極の各々に接続された複数のリード線からなり、前記チューブ部材の第2ルーメンおよび前記第2絶縁性チューブ内に延在し、当該第2絶縁性チューブの基端開口から延び出して、前記複数のリード線に分割され、分割されたリード線の各々が前記コネクタの有するピン端子の各々に接続固定される第2リード線群とを備えてなり、
前記第1絶縁性チューブの基端開口から延び出して分割され、前記コネクタのピン端子の各々に接続固定された、前記第1リード線群を構成する複数のリード線(基端部分)、および、前記第2絶縁性チューブの基端開口から延び出して分割され、前記コネクタのピン端子の各々に接続固定された、前記第2リード線群を構成する複数のリード線(基端部分)は、これらの周囲が樹脂で固められることにより、それぞれの形状が保持されており
、
除細動を行うときには、前記第1DC電極群と、前記第2DC電極群とに、互いに異なる極性の電圧が印加されることを特徴とする。 (6) The intracardiac defibrillation catheter of the present invention is a catheter for defibrillation inserted into the heart chamber,
An insulating tube member having a multi-lumen structure;
A handle connected to the proximal end of the tube member;
A first electrode group (first DC electrode group) composed of a plurality of ring-shaped electrodes attached to the distal end region of the tube member;
A second electrode group (second DC electrode group) composed of a plurality of ring-shaped electrodes mounted on the tube member apart from the first DC electrode group on the proximal end side;
A substantially cylindrical connector that is built in the proximal end portion of the handle and has a plurality of pin terminals that protrude in the distal direction disposed on the distal end surface;
A first insulating tube having a distal end connected to the first lumen of the tube member, extending inside the handle, and having a proximal end opened in the vicinity of the connector;
A second insulating tube having a distal end connected to the second lumen of the tube member, extending into the handle, and having a proximal end opened in the vicinity of the connector;
A plurality of lead wires connected to each of the electrodes constituting the first DC electrode group, extending into the first lumen of the tube member and the first insulating tube, and a base of the first insulating tube A first lead wire group extending from the end opening and divided into the plurality of lead wires, and each of the divided lead wires is connected and fixed to each of the pin terminals of the connector;
A plurality of lead wires connected to each of the electrodes constituting the second DC electrode group, extending into the second lumen of the tube member and the second insulating tube, and a base of the second insulating tube A second lead wire group that extends from the end opening and is divided into the plurality of lead wires, and each of the divided lead wires is connected and fixed to each of the pin terminals of the connector;
A plurality of lead wires (base end portions) constituting the first lead wire group, which are divided by extending from a base end opening of the first insulating tube and connected and fixed to each of the pin terminals of the connector; and A plurality of lead wires (base end portions) constituting the second lead wire group, which are divided by extending from the base end opening of the second insulating tube and connected and fixed to the pin terminals of the connector, Each of these shapes is retained by being solidified with resin.
When defibrillation is performed, voltages having different polarities are applied to the first DC electrode group and the second DC electrode group.
そして、心臓に直接的に電気エネルギーを与えることができるので、患者の体表に火傷を生じさせることもない。 As described above, according to the first DC electrode group and the second DC electrode group of the defibrillation catheter disposed in the heart chamber, electrical energy is directly applied to the fibrillated heart. The electrical stimulation (electric shock) necessary and sufficient for treatment can be reliably applied only to the heart.
And since electrical energy can be given directly to the heart, it does not cause burns on the patient's body surface.
ているので、ハンドルの基端側に複数のコネクタ(コード)を接続させる必要はなく、構成が簡単になり、除細動カテーテルとしての操作性が向上する。 Further, the lead wires constituting the first lead wire group and the lead wires constituting the second lead wire group are connected to terminals intensively arranged on the distal end surface of one connector built in the handle. Therefore, it is not necessary to connect a plurality of connectors (cords) to the proximal end side of the handle, the configuration is simplified, and the operability as a defibrillation catheter is improved.
前記チューブ部材の第3ルーメンに先端部が連結され、前記ハンドルの内部に延在し、前記コネクタの近傍で基端が開口する第3絶縁性チューブと、
前記基端側電位測定電極群を構成する電極の各々に接続された複数のリード線からなり、前記チューブ部材の第3ルーメンおよび前記第3絶縁性チューブ内に延在し、当該第3絶縁性チューブの基端開口から延び出して、前記複数のリード線に分割され、分割されたリード線の各々が前記コネクタの有するピン端子の各々に接続固定される第3リード線群と、を備えてなることが好ましい。
また、前記第3絶縁性チューブの基端開口から延び出して分割され、前記コネクタのピン端子の各々に接続固定された、前記第3リード線群を構成する複数のリード線(基端部分)は、これらの周囲が、前記樹脂で固められることにより、それぞれの形状が保持されていることが好ましい。 (8) In the intracardiac defibrillation catheter of the present invention, a proximal-side potential measurement electrode group including a plurality of ring-shaped electrodes attached to the tube member and spaced from the second DC electrode group to the proximal end side; ,
A third insulating tube having a distal end connected to the third lumen of the tube member, extending into the handle, and having a proximal end opened in the vicinity of the connector;
A plurality of lead wires connected to each of the electrodes constituting the proximal end side potential measurement electrode group, extending into the third lumen of the tube member and the third insulating tube, A third lead wire group extending from the proximal end opening of the tube and divided into the plurality of lead wires, and each of the divided lead wires is connected and fixed to each of the pin terminals of the connector; It is preferable to become.
Also, a plurality of lead wires (base end portions) constituting the third lead wire group, which extend from the base end opening of the third insulating tube and are divided and connected and fixed to each of the pin terminals of the connector. It is preferable that these shapes are retained by being solidified with the resin.
しているので、先端偏向操作時において軸方向に移動するプルワイヤにより、リード線群を構成するリード線が損傷(例えば擦過傷)を受けるようなことはない。 According to the intracardiac defibrillation catheter having such a configuration, the pull wire for the tip deflection operation is formed by using the lumen (the first lead wire group, the second lead wire group, or the third lead wire group extending). Since the first lumen, the second lumen, and the third lumen) extend to a different lumen (fourth lumen), the lead wires constituting the lead wire group are formed by a pull wire that moves in the axial direction during the tip deflection operation. There is no damage (eg, scratches).
また、心腔内除細動に必要な電圧が印加されたときに、チューブ部材およびハンドルの内部において、第1リード線群と、第2リード線群との間で短絡が発生することを確実に防止することができる。 According to the intracardiac defibrillation catheter of the present invention, the electrical energy necessary and sufficient for defibrillation can be reliably supplied to the heart that has undergone atrial fibrillation or the like during cardiac catheterization. In addition, it does not cause burns on the patient's body surface and is less invasive.
In addition, it is ensured that a short circuit will occur between the first lead wire group and the second lead wire group inside the tube member and the handle when a voltage necessary for intracardiac defibrillation is applied. Can be prevented.
、図3は、図1のA-A断面を示す横断面図、図4(a)~(c)は、図1のB-B断面、C-C断面、D-D断面を示す横断面図である。 1 and 2 are explanatory plan views showing an embodiment of the intracardiac defibrillation catheter of the present invention, FIG. 3 is a cross-sectional view showing the AA cross section of FIG. 1, and FIG. 4 (a). FIGS. 2C to 2C are cross-sectional views showing a BB cross section, a CC cross section, and a DD cross section of FIG.
好適な一例を示せば、図2において、L1(長さ52mm)で示す領域の硬度(D型硬度計による硬度)は40、L2(長さ108mm)で示す領域の硬度は55、L3(長さ25.7mm)で示す領域の硬度は63、L4(長さ10mm)で示す領域の硬度は68、L5(長さ500mm)で示す領域の硬度は72である。 The nylon elastomer that forms the
As a preferred example, in FIG. 2, the hardness of the region indicated by L1 (
マルチルーメンチューブ10の外径は、例えば1.2~3.3mmとされる。
マルチルーメンチューブ10を製造する方法としては特に限定されるものではない。 The braided blade composed of the
The outer diameter of the
The method for manufacturing the
摘まみ22を回転操作することにより、マルチルーメンチューブ10の先端部を偏向(首振り)させることができる。 The
By rotating the
れ、好ましくは8~10個とされる。 The first DC electrode group is formed by mounting a plurality of electrodes constituting the same pole (-pole or + pole) at a narrow interval in the tip region of the multi-lumen tube. Here, the number of electrodes constituting the first DC electrode group varies depending on the width and arrangement interval of the electrodes, but is 4 to 13, for example, and preferably 8 to 10.
第1DC電極群31Gを構成する電極31は、リード線(第1リード線群41Gを構成するリード線41)および後述するコネクタを介して、直流電源装置における同一の極の端子に接続されている。 In the present embodiment, the first
The
電極31の幅が狭過ぎると、電圧印加時の発熱量が過大となって、周辺組織に損傷を与える虞がある。一方、電極31の幅が広過ぎると、マルチルーメンチューブ10における第1DC電極群31Gが設けられている部分の可撓性・柔軟性が損なわれることがある。
Here, the width (length in the axial direction) of the
If the width of the
心腔内除細動カテーテル100の使用時(心腔内に配置されるとき)において、第1DC電極群31Gは、例えば冠状静脈内に位置する。 The mounting interval of the electrodes 31 (distance between adjacent electrodes) is preferably 1 to 5 mm, and 2 mm is a preferable example.
When the
第2DC電極群32Gを構成する電極32は、リード線(第2リード線群42Gを構成するリード線42)および後述するコネクタを介して、直流電源装置における同一の極の端子(第1DC電極群31Gが接続されているものとは逆の極の端子)に接続される。
これにより、第1DC電極群31G(電極31)と、第2DC電極群32G(電極32)とに、互いに異なる極性の電圧が印加され、第1DC電極群31Gと、第2DC電極群32Gとは、互いに極性の異なる電極群(一方の電極群が-極のときに、他方の電極群は+極)となる。 In the present embodiment, the second
The
Thereby, voltages having different polarities are applied to the first
電極32の幅が狭過ぎると、電圧印加時の発熱量が過大となって、周辺組織に損傷を与える虞がある。一方、電極32の幅が広過ぎると、マルチルーメンチューブ10における第2DC電極群32Gが設けられている部分の可撓性・柔軟性が損なわれることがある。
Here, the width (length in the axial direction) of the
If the width of the
心腔内除細動カテーテル100の使用時(心腔内に配置されるとき)において、第2DC電極群32Gは、例えば右心房に位置する。 The mounting interval of the electrodes 32 (distance between adjacent electrodes) is preferably 1 to 5 mm, and 2 mm is a preferable example.
When the
3から構成されている。
基端側電位測定電極群33Gを構成する電極33は、リード線(第3リード線群43Gを構成するリード線43)および後述するコネクタを介して心電図計に接続される。 In the present embodiment, the proximal-side potential
It is composed of three.
The
電極33の幅が広過ぎると、心電位の測定精度が低下したり、異常電位の発生部位の特定が困難となったりする。 Here, the width (length in the axial direction) of the
If the width of the
心腔内除細動カテーテル100の使用時(心腔内に配置されるとき)において、基端側電位測定電極群33Gは、例えば、異常電位が発生しやすい上大静脈に位置する。 The mounting interval of the electrodes 33 (the distance between adjacent electrodes) is preferably 1.0 to 10.0 mm, and 5 mm is a preferable example.
When the
この先端チップ35には、リード線は接続されておらず、本実施形態では電極として使用していない。但し、リード線を接続させることにより、電極として使用することも可能である。先端チップ35の構成材料は、白金、ステンレスなどの金属材料、各種の樹脂材料など、特に限定されるものではない。 A
A lead wire is not connected to the
第1リード線群41G(リード線41)により、第1DC電極群31Gを構成する8個の電極31の各々を直流電源装置に電気的に接続することができる。 The first
With the first
第2リード線群42G(リード線42)により、第2DC電極群32Gを構成する8個の電極32の各々を直流電源装置に電気的に接続することができる。 The second
Each of the eight
るとともに、マルチルーメンチューブ10の管壁に形成された側孔から第2ルーメン12(第1リード線群41Gが延在する第1ルーメン11とは異なるルーメン)に進入する。第2ルーメン12に進入した8本のリード線42は、第2リード線群42Gとして、第2ルーメン12に延在する。 The eight
第3リード線群43G(リード線43)により、基端側電位測定電極群33Gを構成する電極33の各々を、心電図計に接続することができる。 The third
With the third
プルワイヤ71は、第4ルーメン14に延在し、マルチルーメンチューブ10の中心軸に対して偏心して延びている。 3 and 4,
The
プルワイヤ71は、ステンレスやNi-Ti系超弾性合金製で構成してあるが、必ずしも金属で構成する必要はない。プルワイヤ71は、たとえば高強度の非導電性ワイヤなどで構成してもよい。
なお、マルチルーメンチューブの先端部を偏向させる機構は、これに限定されるものではなく、例えば、板バネを備えてなるものであってもよい。 On the other hand, the proximal end portion of the
The
Note that the mechanism for deflecting the distal end portion of the multi-lumen tube is not limited to this, and may be a plate spring, for example.
また、図5乃至図7に示すように、ハンドル20の内部には、3本のリード線群(第1リード線群41G、第2リード線群42G、第3リード線群43G)の各々が挿通される3本の絶縁性チューブ(第1絶縁性チューブ26、第2絶縁性チューブ27、第3絶縁性チューブ28)が延在している。 As shown in FIGS. 5 and 7, a
5 to 7, each of the three lead wire groups (first
第1ルーメン11に連結された第1絶縁性チューブ26は、ハンドル20の内部に延在する第1の保護チューブ61の内孔を通ってコネクタ50(ピン端子が配置された先端面50A)の近傍まで延びており、第1リード線群41Gの基端部をコネクタ50の近傍に案内する挿通路を形成している。これにより、マルチルーメンチューブ10(第1ルーメン11)から延び出した第1リード線群41Gは、キンクすることなく、ハンドル20の内部(第1絶縁性チューブ26の内孔)を延在することができる。
第1絶縁性チューブ26の基端開口から延び出した第1リード線群41Gは、これを構成する8本のリード線41にばらされ、これらリード線41の各々は、コネクタ50の先端面50Aに配置されたピン端子の各々にハンダにより接続固定されている。ここに、第1リード線群41Gを構成するリード線41が接続固定されたピン端子(ピン端子51)が配置されている領域を「第1端子群領域」とする。
これにより、第1DC電極群31Gを構成する8個の電極31は、第1リード線群41Gを構成する8本のリード線41およびコネクタ50(第1端子群領域におけるピン端子51)を介して、直流電源装置における一方の極の端子に接続することができる。 As shown in FIGS. 5 and 6, the distal end portion (about 10 mm from the distal end) of the first insulating
The first insulating
The first
Thus, the eight
第2ルーメン12に連結された第2絶縁性チューブ27は、ハンドル20の内部に延在する第2の保護チューブ62の内孔を通ってコネクタ50(ピン端子が配置された先端面50A)の近傍まで延びており、第2リード線群42Gの基端部をコネクタ50の近傍に
案内する挿通路を形成している。これにより、マルチルーメンチューブ10(第2ルーメン12)から延び出した第2リード線群42Gは、キンクすることなく、ハンドル20の内部(第2絶縁性チューブ27の内孔)を延在することができる。
第2絶縁性チューブ27の基端開口から延び出した第2リード線群42Gは、これを構成する8本のリード線42にばらされ、これらリード線42の各々は、コネクタ50の先端面50Aに配置されたピン端子の各々にハンダにより接続固定されている。ここに、第2リード線群42Gを構成するリード線42が接続固定されたピン端子(ピン端子52)が配置されている領域を「第2端子群領域」とする。
これにより、第2DC電極群32Gを構成する8個の電極32は、第2リード線群42Gを構成する8本のリード線42およびコネクタ50(第2端子群領域におけるピン端子52)を介して、直流電源装置における他方の極の端子に接続することができる。 The distal end portion (about 10 mm from the distal end) of the second insulating
The second insulating
The second
Thereby, the eight
第3ルーメン13に連結された第3絶縁性チューブ28は、ハンドル20の内部に延在する第2の保護チューブ62の内孔を通ってコネクタ50(ピン端子が配置された先端面50A)の近傍まで延びており、第3リード線群43Gの基端部をコネクタ50の近傍に案内する挿通路を形成している。これにより、マルチルーメンチューブ10(第3ルーメン13)から延び出した第3リード線群43Gは、キンクすることなく、ハンドル20の内部(第3絶縁性チューブ28の内孔)を延在することができる。
第3絶縁性チューブ28の基端開口から延び出した第3リード線群43Gは、これを構成する4本のリード線43にばらされ、これらリード線43の各々は、コネクタ50の先端面50Aに配置されたピン端子の各々にハンダにより接続固定されている。ここに、第3リード線群43Gを構成するリード線43が接続固定されたピン端子(ピン端子53)が配置されている領域を「第3端子群領域」とする。
これにより、基端側電位測定電極群33Gを構成する4個の電極33は、第3リード線群43Gを構成する4本のリード線43およびコネクタ50(ピン端子53)を介して、心電図計に接続することができる。 The distal end portion (about 10 mm from the distal end) of the third insulating
The third insulating
The third
As a result, the four
絶縁性チューブの肉厚としては、20~40μmであることが好ましく、好適な一例を示せば30μmである。 Here, examples of the constituent material of the insulating tubes (the first insulating
The thickness of the insulating tube is preferably 20 to 40 μm, and is 30 μm as a suitable example.
隔壁板55の高さ(基端縁から先端縁までの距離)は、コネクタ50の先端面50Aと絶縁性チューブ(第1絶縁性チューブ26および第2絶縁性チューブ27)との離間距離より高いことが必要であり、この離間距離が7mmの場合、隔壁板55の高さは、例えば8mmとされる。高さが7mm未満の隔壁板では、その先端縁を、絶縁性チューブの基端よりも先端側に位置させることができない。 The thickness of the
The height of the partition plate 55 (distance from the base end edge to the front end edge) is higher than the separation distance between the
している。
これにより、第1絶縁性チューブ26の基端開口から延び出したリード線(第1リード線群41Gを構成するリード線41)と、第2絶縁性チューブ27の基端開口から延び出たリード線(第2リード線群42Gを構成するリード線42)との間には、常に隔壁板55が存在することになり、リード線41とリード線42との接触による短絡を確実に防止することができる。 In the
Thereby, the lead wire (
そして、絶縁性チューブの基端部が樹脂成形体の内部に埋め込まれている構成によれば、絶縁性チューブの基端開口より延び出してからピン端子に接続固定されるまでのリード線(基端部分)の全域を樹脂80によって完全に覆うことができ、リード線(基端部分)の形状を完全に保持固定することができる。
また、樹脂成形体の高さ(基端面から先端面までの距離)は、隔壁板55の高さよりも高いことが好ましく、隔壁板55の高さが8mmの場合に、例えば9mmとされる。 The
According to the configuration in which the proximal end portion of the insulating tube is embedded in the resin molded body, the lead wire (base) from the base end opening of the insulating tube until it is connected and fixed to the pin terminal. The entire area of the end portion can be completely covered with the
Further, the height of the resin molded body (distance from the base end surface to the front end surface) is preferably higher than the height of the
図8に示すように、コネクタ50の先端面50Aに配置されたピン端子の各々に、第1リード線群41Gを構成する8本のリード線41、第2リード線群42Gを構成する8本のリード線42、第3リード線群43Gを構成する4本のリード線43の各々をハンダにより接続固定する。
ここに、これらのリード線(リード線41、リード線42、リード線43)の先端は、それぞれ、電極群(第1DC電極群31G、第2DC電極群32G、基端側電位測定電極群33G)を構成する電極(電極31、電極32、電極33)に既に接続されている。
また、これらのリード線(リード線41、リード線42、リード線43)によるリード線群(第1リード線群41G、第2リード線群42G、第3リード線群43G)が延在している絶縁性チューブ(第1絶縁性チューブ26、第2絶縁性チューブ27、第3絶縁性チューブ28)は、それぞれの先端部をマルチルーメンチューブ10のルーメン(第1ル
ーメン11、第2ルーメン12、第3ルーメン13)に深く挿入させることにより、先端側(同図において上側)に退避させている。 (1) Lead wire soldering process:
As shown in FIG. 8, the eight
Here, the tip ends of these lead wires (
Further, a lead wire group (first
次に、図9に示すように、リード線41が接続固定されたピン端子51が配置されている第1端子群領域と、リード線42が接続固定されたピン端子52が配置されている第2端子群領域およびリード線43が接続固定されたピン端子53が配置されている第3端子群領域とを仕切り、リード線41と、リード線42およびリード線43とを隔離するように、コネクタ50の先端面50Aに隔壁板55を載置する。
ここに、リード線43(ピン端子53)は、リード線42(ピン端子52)とともに、隔壁板55によってリード線41(ピン端子51)から隔離されている。
隔壁板55の高さは、例えば8mmとされる。 (2) Partition plate placement process:
Next, as shown in FIG. 9, the first terminal group region in which the
Here, the lead wire 43 (pin terminal 53) is separated from the lead wire 41 (pin terminal 51) by the
The height of the
次に、図10に示すように、第1絶縁性チューブ26、第2絶縁性チューブ27、第3絶縁性チューブ28の各々を基端側に移動する(同図において下降させる)。
絶縁性チューブの移動後において、コネクタ50の先端面50Aと、各絶縁性チューブの基端との離間距離は、隔壁板55の高さより短く、例えば7mmとされる。
なお、絶縁性チューブをこれよりも更に移動させること(離間距離を7mm未満とすること)は、これに伴ってリード線に過大な張力がかかるので実質的に不可能である。
このとき、絶縁性チューブ(第1絶縁性チューブ26、第2絶縁性チューブ27、第3絶縁性チューブ28)の先端部は、マルチルーメンチューブ10のルーメン(第1ルーメン11、第2ルーメン12、第3ルーメン13)に、10mm程度挿入した状態(図6に示した状態)となっている。 (3) Insulating tube moving process:
Next, as shown in FIG. 10, each of the first insulating
After the movement of the insulating tube, the distance between the
In addition, it is substantially impossible to move the insulating tube further (make the separation distance less than 7 mm) because an excessive tension is applied to the lead wire.
At this time, the distal ends of the insulating tubes (the first insulating
次に、図12に示すように、ピン端子(ピン端子51、ピン端子52、ピン端子53)に接続固定されたリード線(第1リード線41、第2リード線42、第3リード線43)および隔壁板55を取り囲むように型枠90を装着する。
型枠90の構成材料としては特に制限されるものではないが、離型性が良好であることから、PTFE、PFA、FEP、ETFE、PVDFなどのフッ素系樹脂が好ましい。型枠90は、これらのフッ素系樹脂からなるシートの両端部を粘着テープで貼り合わせて筒状にしたものを用いることができる。型枠90の高さは、例えば10mmとされる。 (4) Forming process:
Next, as shown in FIG. 12, lead wires (
The constituent material of the
次に、図13に示すように、Dispenserなどを用いて型枠90内に硬化性樹脂80Aを注入する。
ここに、注入された硬化性樹脂80Aの液面レベル(コネクタ50の先端面50Aからの液面の距離)を例えば9mmとする。
これにより、絶縁性チューブの基端開口から延び出してコネクタ50のピン端子(ピン端子51、ピン端子52、ピン端子53)に接続固定されたリード線(リード線41、リード線42、リード線43)の全域および隔壁板55が、硬化性樹脂80Aに埋め込まれた状態となる。 (5) Curable resin injection process:
Next, as shown in FIG. 13, a
Here, the liquid level of the injected
As a result, lead wires (
次に、型枠90内に注入された硬化性樹脂を光硬化または熱硬化させ、その後、図14
に示すように、型枠90を取り外すことにより、硬化樹脂80からなり、コネクタ50と同径の円筒状で成形体であって、ピン端子に接続固定されたリード線(第1リード線41、第2リード線42、第3リード線43)および隔壁板55を埋め込んでなる樹脂成形体(図7に示した構造を有する高さ9mmの成形体)を得ることができる。
このように、本実施形態において、リード線の周囲が樹脂で固められるとは、絶縁性チューブの基端開口より延び出してからピン端子に接続固定されるまでのリード線(基端部分)の全域を埋め込む樹脂成形体を形成することであり、単なるポッティングとは明確に区別される。 (6) Resin curing and mold removal step:
Next, the curable resin injected into the
As shown, the lead wire (
Thus, in this embodiment, the periphery of the lead wire is solidified with resin means that the lead wire (base end portion) from extending from the base end opening of the insulating tube to being fixed to the pin terminal is fixed. This is to form a resin molded body that fills the entire region, and is clearly distinguished from simple potting.
心腔内除細動カテーテル100は、第1DC電極群31Gが冠状静脈内に位置し、第2DC電極群32Gが右心房内に位置するようにして心腔内に挿入される。これにより、第1DC電極群31Gと第2DC電極群32Gとによって心臓が挟み込まれるような状態となる。 The
The
電気エネルギーが過少である場合には、十分な除細動治療を行うことができない。一方、電気エネルギーが過剰である場合には、第1DC電極群31Gおよび第2DC電極群32Gが位置する周辺の組織が損傷を受ける虞がある。 Here, the electrical energy supplied to the heart by the
If the electrical energy is too low, sufficient defibrillation therapy cannot be performed. On the other hand, when the electrical energy is excessive, there is a risk that the surrounding tissue where the first
先ず、第1DC電極群31Gが-極、第2DC電極群32Gが+極となるよう、両者の間で直流電圧が印加されることにより、電気エネルギーが供給されて測定電位が立ち上がる(V1 は、このときのピーク電圧である。)。一定時間(t1 )経過後、第1DC電極群31Gが+極、第2DC電極群32Gが-極となるよう、±を反転した直流電圧が両者の間で印加されることにより、電気エネルギーが供給されて測定電位が立ち上がる(V2 は、このときのピーク電圧である。)。 FIG. 15 is a diagram illustrating a potential waveform measured when predetermined electrical energy (for example, set output = 10 J) is applied by the
First, by applying a DC voltage between the first
、高い電気エネルギーを供給する(高い電圧が印加される)ため、従来の電極カテーテルでは問題とされなかった、短絡(ショート)の発生を確実に防止して、安全性を確保する必要がある。 In the
従って、除細動に必要な電圧を印加されたときに、第1リード線群41G(第1DC電極群31G)と、第2リード線群42G(第2DC電極群32G)と、第3リード線群43G(基端側電位測定電極群33G)と間の短絡を確実に防止することができる。 As a result, the first
Accordingly, when a voltage necessary for defibrillation is applied, the first
例えば、第1端子群領域と第2端子群領域とを仕切る上記のような隔壁板を備えている心腔内除細動カテーテルにあっては、絶縁性チューブの基端開口から延び出してコネクタのピン端子に接続固定されたリード線の周囲を樹脂で固めていないものであっても本発明に包含される。
また、絶縁性チューブの基端開口から延び出してコネクタのピン端子に接続固定されたリード線の周囲を樹脂で固めている心腔内除細動カテーテルにあっては、第1端子群領域
と第2端子群領域とを仕切る隔壁板を備えていないものであっても本発明に包含される。 As mentioned above, although one Embodiment of this invention was described, the intracardiac defibrillation catheter of this invention is not limited to these, A various change is possible.
For example, in an intracardiac defibrillation catheter provided with a partition plate as described above for partitioning a first terminal group region and a second terminal group region, the connector extends from the proximal end opening of the insulating tube. Even if the periphery of the lead wire connected and fixed to the pin terminal is not solidified with resin, it is included in the present invention.
In the intracardiac defibrillation catheter that extends from the proximal end opening of the insulating tube and is fixed around the lead wire connected and fixed to the pin terminal of the connector with a resin, the first terminal group region and Even the one that does not include a partition plate that partitions the second terminal group region is included in the present invention.
10 マルチルーメンチューブ
11 第1ルーメン
12 第2ルーメン
13 第3ルーメン
14 第4ルーメン
15 フッ素樹脂層
16 インナー(コア)部
17 アウター(シェル)部
18 ステンレス素線
20 ハンドル
21 ハンドル本体
22 摘まみ
24 ストレインリリーフ
26 第1絶縁性チューブ
27 第2絶縁性チューブ
28 第3絶縁性チューブ
31G 第1DC電極群
31 リング状電極
32G 第2DC電極群
32 リング状電極
33G 基端側電位測定電極群
33 リング状電極
35 先端チップ
41G 第1リード線群
41 リード線
42G 第2リード線群
42 リード線
43G 第3リード線群
43 リード線
51 ピン端子
52 ピン端子
53 ピン端子
55 隔壁板
61 第1の保護チューブ
62 第2の保護チューブ
71 プルワイヤ
80 樹脂(硬化樹脂)
80A 硬化性樹脂
90 型枠 DESCRIPTION OF
80A curable resin
90 formwork
Claims (10)
- 心腔内に挿入されて除細動を行うためのカテーテルであって、
マルチルーメン構造を有する絶縁性のチューブ部材と、
前記チューブ部材の基端に接続されたハンドルと、
前記チューブ部材の先端領域に装着された複数のリング状電極からなる第1電極群と、
前記第1電極群から基端側に離間して前記チューブ部材に装着された複数のリング状電極からなる第2電極群と、
前記ハンドルの基端部に内蔵され、先端方向に突出する複数のピン端子を先端面に配置してなるコネクタと、
前記チューブ部材の第1ルーメンに先端部が連結され、前記ハンドルの内部に延在し、前記コネクタの近傍で基端が開口する第1絶縁性チューブと、
前記チューブ部材の第2ルーメンに先端部が連結され、前記ハンドルの内部に延在し、前記コネクタの近傍で基端が開口する第2絶縁性チューブと、
前記第1電極群を構成する電極の各々に接続された複数のリード線からなり、前記チューブ部材の第1ルーメンおよび前記第1絶縁性チューブ内に延在し、当該第1絶縁性チューブの基端開口から延び出して、前記複数のリード線に分割され、分割されたリード線の各々が前記コネクタの有するピン端子の各々に接続固定される第1リード線群と、
前記第2電極群を構成する電極の各々に接続された複数のリード線からなり、前記チューブ部材の第2ルーメンおよび前記第2絶縁性チューブ内に延在し、当該第2絶縁性チューブの基端開口から延び出して、前記複数のリード線に分割され、分割されたリード線の各々が前記コネクタの有するピン端子の各々に接続固定される第2リード線群と、
複数のピン端子が配置された前記コネクタの先端面を、前記第1リード線群を構成するリード線が接続固定されたピン端子が配置されている第1端子群領域と、前記第2リード線群を構成するリード線が接続固定されたピン端子が配置されている第2端子群領域とに仕切り、前記第1リード線群を構成するリード線と、前記第2リード線群を構成するリード線とを隔離する隔壁板と、を備えてなり、
除細動を行うときには、前記第1電極群と、前記第2電極群とに、互いに異なる極性の電圧が印加されることを特徴とする心腔内除細動カテーテル。 A catheter inserted into the heart chamber for defibrillation,
An insulating tube member having a multi-lumen structure;
A handle connected to the proximal end of the tube member;
A first electrode group consisting of a plurality of ring-shaped electrodes attached to the tip region of the tube member;
A second electrode group consisting of a plurality of ring-shaped electrodes mounted on the tube member apart from the first electrode group on the proximal side;
A connector built in a proximal end portion of the handle and having a plurality of pin terminals protruding in the distal direction arranged on the distal end surface;
A first insulating tube having a distal end connected to the first lumen of the tube member, extending inside the handle, and having a proximal end opened in the vicinity of the connector;
A second insulating tube having a distal end connected to the second lumen of the tube member, extending into the handle, and having a proximal end opened in the vicinity of the connector;
A plurality of lead wires connected to each of the electrodes constituting the first electrode group, extending into the first lumen of the tube member and the first insulating tube, and a base of the first insulating tube A first lead wire group extending from the end opening and divided into the plurality of lead wires, and each of the divided lead wires is connected and fixed to each of the pin terminals of the connector;
A plurality of lead wires connected to each of the electrodes constituting the second electrode group, extending into the second lumen of the tube member and the second insulating tube, and a base of the second insulating tube; A second lead wire group extending from the end opening and divided into the plurality of lead wires, and each of the divided lead wires is connected and fixed to each of the pin terminals of the connector;
A first terminal group region in which pin terminals to which lead wires constituting the first lead wire group are connected and fixed are arranged on the front end surface of the connector in which a plurality of pin terminals are arranged, and the second lead wire A lead terminal constituting the first lead wire group and a lead constituting the second lead wire group are partitioned into a second terminal group region where pin terminals to which the lead wires constituting the group are connected and fixed are arranged. A partition plate that separates the wire,
When performing defibrillation, an intracardiac defibrillation catheter in which voltages having different polarities are applied to the first electrode group and the second electrode group. - 前記隔壁板の先端縁は、前記第1絶縁性チューブの基端および前記第2絶縁性チューブの基端よりも先端側に位置していることを特徴とする請求項1に記載の心腔内除細動カテーテル。 2. The intracardiac cavity according to claim 1, wherein a distal end edge of the partition plate is located on a distal end side with respect to a proximal end of the first insulating tube and a proximal end of the second insulating tube. Defibrillation catheter.
- 前記第2電極群から基端側に離間して前記チューブ部材に装着された複数のリング状電極からなる基端側電位測定電極群と、
前記チューブ部材の第3ルーメンに先端部が連結され、前記ハンドルの内部に延在し、前記コネクタの近傍で基端が開口する第3絶縁性チューブと、
前記基端側電位測定電極群を構成する電極の各々に接続された複数のリード線からなり、前記チューブ部材の第3ルーメンおよび前記第3絶縁性チューブ内に延在し、当該第3絶縁性チューブの基端開口から延び出して、前記複数のリード線に分割され、分割されたリード線の各々が前記コネクタの有するピン端子の各々に接続固定される第3リード線群と、を備えてなることを特徴とする請求項1または請求項2に記載の心腔内除細動カテーテル。 A proximal-side potential measurement electrode group comprising a plurality of ring-shaped electrodes mounted on the tube member apart from the second electrode group on the proximal side;
A third insulating tube having a distal end connected to the third lumen of the tube member, extending into the handle, and having a proximal end opened in the vicinity of the connector;
A plurality of lead wires connected to each of the electrodes constituting the proximal end side potential measurement electrode group, extending into the third lumen of the tube member and the third insulating tube, A third lead wire group extending from the proximal end opening of the tube and divided into the plurality of lead wires, and each of the divided lead wires is connected and fixed to each of the pin terminals of the connector; The intracardiac defibrillation catheter according to claim 1 or 2, characterized by comprising: - 先端偏向操作用のプルワイヤが、前記チューブ部材の第4ルーメンに延在していることを特徴とする請求項3に記載の心腔内除細動カテーテル。 The intracardiac defibrillation catheter according to claim 3, wherein a pull wire for tip deflection operation extends to a fourth lumen of the tube member.
- 心臓カテーテル術中に起こる心房細動を除去するために心腔内に挿入されることを特徴とする請求項1乃至請求項4の何れかに記載の心腔内除細動カテーテル。 The intracardiac defibrillation catheter according to any one of claims 1 to 4, wherein the catheter is inserted into the heart chamber in order to remove atrial fibrillation that occurs during cardiac catheterization.
- 心腔内に挿入されて除細動を行うためのカテーテルであって、
マルチルーメン構造を有する絶縁性のチューブ部材と、
前記チューブ部材の基端に接続されたハンドルと、
前記チューブ部材の先端領域に装着された複数のリング状電極からなる第1電極群と、
前記第1電極群から基端側に離間して前記チューブ部材に装着された複数のリング状電極からなる第2電極群と、
前記ハンドルの基端部に内蔵され、先端方向に突出する複数のピン端子を先端面に配置してなるコネクタと、
前記チューブ部材の第1ルーメンに先端部が連結され、前記ハンドルの内部に延在し、前記コネクタの近傍で基端が開口する第1絶縁性チューブと、
前記チューブ部材の第2ルーメンに先端部が連結され、前記ハンドルの内部に延在し、前記コネクタの近傍で基端が開口する第2絶縁性チューブと、
前記第1電極群を構成する電極の各々に接続された複数のリード線からなり、前記チューブ部材の第1ルーメンおよび前記第1絶縁性チューブ内に延在し、当該第1絶縁性チューブの基端開口から延び出して、前記複数のリード線に分割され、分割されたリード線の各々が前記コネクタの有するピン端子の各々に接続固定される第1リード線群と、
前記第2電極群を構成する電極の各々に接続された複数のリード線からなり、前記チューブ部材の第2ルーメンおよび前記第2絶縁性チューブ内に延在し、当該第2絶縁性チューブの基端開口から延び出して、前記複数のリード線に分割され、分割されたリード線の各々が前記コネクタの有するピン端子の各々に接続固定される第2リード線群とを備えてなり、
前記第1絶縁性チューブの基端開口から延び出して分割され、前記コネクタのピン端子の各々に接続固定された、前記第1リード線群を構成する複数のリード線、および、前記第2絶縁性チューブの基端開口から延び出して分割され、前記コネクタのピン端子の各々に接続固定された、前記第2リード線群を構成する複数のリード線は、これらの周囲が樹脂で固められることにより、それぞれの形状が保持されており、
除細動を行うときには、前記第1電極群と、前記第2電極群とに、互いに異なる極性の電圧が印加されることを特徴とする心腔内除細動カテーテル。 A catheter inserted into the heart chamber for defibrillation,
An insulating tube member having a multi-lumen structure;
A handle connected to the proximal end of the tube member;
A first electrode group consisting of a plurality of ring-shaped electrodes attached to the tip region of the tube member;
A second electrode group consisting of a plurality of ring-shaped electrodes mounted on the tube member apart from the first electrode group on the proximal side;
A connector built in a proximal end portion of the handle and having a plurality of pin terminals protruding in the distal direction arranged on the distal end surface;
A first insulating tube having a distal end connected to the first lumen of the tube member, extending inside the handle, and having a proximal end opened in the vicinity of the connector;
A second insulating tube having a distal end connected to the second lumen of the tube member, extending into the handle, and having a proximal end opened in the vicinity of the connector;
A plurality of lead wires connected to each of the electrodes constituting the first electrode group, extending into the first lumen of the tube member and the first insulating tube, and a base of the first insulating tube A first lead wire group extending from the end opening and divided into the plurality of lead wires, and each of the divided lead wires is connected and fixed to each of the pin terminals of the connector;
A plurality of lead wires connected to each of the electrodes constituting the second electrode group, extending into the second lumen of the tube member and the second insulating tube, and a base of the second insulating tube; A second lead wire group that extends from the end opening and is divided into the plurality of lead wires, and each of the divided lead wires is connected and fixed to each of the pin terminals of the connector;
A plurality of lead wires constituting the first lead wire group, which are divided by extending from a proximal end opening of the first insulating tube, and are connected and fixed to each of the pin terminals of the connector; and the second insulation The plurality of lead wires constituting the second lead wire group, which are divided by extending from the proximal end opening of the conductive tube and connected and fixed to each of the pin terminals of the connector, have their periphery hardened with resin. Each shape is retained by
When performing defibrillation, an intracardiac defibrillation catheter in which voltages having different polarities are applied to the first electrode group and the second electrode group. - 前記第1絶縁性チューブの基端部および前記第2絶縁性チューブの基端部が、前記樹脂中に埋め込まれていることを特徴とする請求項6に記載の心腔内除細動カテーテル。 The intracardiac defibrillation catheter according to claim 6, wherein a proximal end portion of the first insulating tube and a proximal end portion of the second insulating tube are embedded in the resin.
- 前記第2電極群から基端側に離間して前記チューブ部材に装着された複数のリング状電極からなる基端側電位測定電極群と、
前記チューブ部材の第3ルーメンに先端部が連結され、前記ハンドルの内部に延在し、前記コネクタの近傍で基端が開口する第3絶縁性チューブと、
前記基端側電位測定電極群を構成する電極の各々に接続された複数のリード線からなり、前記チューブ部材の第3ルーメンおよび前記第3絶縁性チューブ内に延在し、当該第3絶縁性チューブの基端開口から延び出して、前記複数のリード線に分割され、分割されたリード線の各々が前記コネクタの有するピン端子の各々に接続固定される第3リード線群と、を備えてなることを特徴とする請求項6または請求項7に記載の心腔内除細動カテーテル。 A proximal-side potential measurement electrode group comprising a plurality of ring-shaped electrodes mounted on the tube member apart from the second electrode group on the proximal side;
A third insulating tube having a distal end connected to the third lumen of the tube member, extending into the handle, and having a proximal end opened in the vicinity of the connector;
A plurality of lead wires connected to each of the electrodes constituting the proximal end side potential measurement electrode group, extending into the third lumen of the tube member and the third insulating tube, A third lead wire group extending from the proximal end opening of the tube and divided into the plurality of lead wires, and each of the divided lead wires is connected and fixed to each of the pin terminals of the connector; The intracardiac defibrillation catheter according to claim 6 or 7, characterized by comprising: - 先端偏向操作用のプルワイヤが、前記チューブ部材の第4ルーメンに延在していることを特徴とする請求項8に記載の心腔内除細動カテーテル。 The intracardiac defibrillation catheter according to claim 8, wherein a pull wire for tip deflection operation extends to a fourth lumen of the tube member.
- 心臓カテーテル術中に起こる心房細動を除去するために心腔内に挿入されることを特徴とする請求項6乃至請求項9の何れかに記載の心腔内除細動カテーテル。 The intracardiac defibrillation catheter according to any one of claims 6 to 9, wherein the catheter is inserted into the heart chamber in order to remove atrial fibrillation that occurs during cardiac catheterization.
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CN200980146922.0A CN102223912B (en) | 2008-12-12 | 2009-11-27 | Intracardiac defibrillation catheter |
KR1020117014755A KR101261746B1 (en) | 2008-12-12 | 2009-11-27 | Intracardiac defibrillation catheter |
HK11113174.8A HK1158562A1 (en) | 2008-12-12 | 2011-12-06 | Intracardiac defibrillation catheter |
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JP2008316715A JP4346109B1 (en) | 2008-12-12 | 2008-12-12 | Defibrillation catheter |
JP2008-316716 | 2008-12-12 | ||
JP2008316716A JP4346110B1 (en) | 2008-12-12 | 2008-12-12 | Defibrillation catheter |
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EP3939652A4 (en) * | 2019-03-15 | 2022-09-28 | Japan Lifeline Co., Ltd. | Intercardiac defibrillation catheter |
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JP2014023721A (en) * | 2012-07-26 | 2014-02-06 | Japan Lifeline Co Ltd | Electrode catheter |
CN106362292A (en) * | 2015-08-21 | 2017-02-01 | 贾玉和 | Dual-purpose catheter used for intracardial mapping and defibrillation |
JP6570123B2 (en) * | 2016-02-29 | 2019-09-04 | 日本ライフライン株式会社 | Intracardiac defibrillation catheter |
JP6544776B2 (en) * | 2017-03-07 | 2019-07-17 | 日本ライフライン株式会社 | Electrode catheter |
JP6560288B2 (en) * | 2017-03-31 | 2019-08-14 | 日本ライフライン株式会社 | Defibrillation catheter system |
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MY135619A (en) * | 2002-11-12 | 2008-05-30 | Nitto Denko Corp | Epoxy resin composition for semiconductor encapsulation, and semiconductor device using the same |
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US3942536A (en) * | 1971-03-15 | 1976-03-09 | Mieczyslaw Mirowski | Cardioverting device having single intravascular catheter electrode system and method for its use |
US3942536B1 (en) * | 1971-03-15 | 1987-03-24 | ||
US4603705A (en) * | 1984-05-04 | 1986-08-05 | Mieczyslaw Mirowski | Intravascular multiple electrode unitary catheter |
JPH05115567A (en) * | 1991-08-14 | 1993-05-14 | Cardiac Pacemakers Inc | Remover for thin movement in blood vessel |
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EP3939652A4 (en) * | 2019-03-15 | 2022-09-28 | Japan Lifeline Co., Ltd. | Intercardiac defibrillation catheter |
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CN102223912B (en) | 2014-02-12 |
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