WO2010067719A1

WO2010067719A1 - Intracardiac defibrillation catheter

Info

Publication number: WO2010067719A1
Application number: PCT/JP2009/070002
Authority: WO
Inventors: 謙二森
Original assignee: 日本ライフライン株式会社
Priority date: 2008-12-12
Filing date: 2009-11-27
Publication date: 2010-06-17
Also published as: KR20110091787A; CN102223912B; KR101261746B1; HK1158562A1; CN102223912A

Abstract

An intracardiac defibrillation catheter is equipped with a tube member (10) having a multilumen structure, a handle (20), a first DC electrode group (31G), a second DC electrode group (32G), a connector (50), insulating tubes (26, 27), a first lead wire group (41G) connecting the constituent electrodes (31) of the first DC electrode group (31G) to the pin terminals of the connector (50), a second lead wire group (42G) connecting the constituent electrodes(32) of the second DC electrode group (32G) to the pin terminals of the connector (50), and a separating sheet (55) separating the end surface (50A) of the connector (50) into a first terminal group region and a second terminal group region. Electric energy required and sufficient for defibrillation can be reliably supplied, thereby performing defibrillation without burning the skin of the patient.

Description

Intracardiac defibrillation catheter

The present invention relates to an intracardiac defibrillation catheter that is inserted into a heart chamber to remove atrial fibrillation.

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.

See JP 2001-112874 A

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.

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. .

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.

(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.

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.

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.

Also, 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.

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.

Furthermore, 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 ) And 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.

Furthermore, 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.

Furthermore, 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.

(2) In the intracardiac defibrillation catheter of the present invention, 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.

According to the intracardiac defibrillation catheter having such a configuration, 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.

(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.

According to the intracardiac defibrillation catheter having such a configuration, 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. 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.

Further, 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. And 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.

(4) In the intracardiac defibrillation catheter of (3) above, it is preferable that a pull wire for tip deflection operation extends to the fourth lumen of the tube member.

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 the pull wires that move in the axial direction during the tip deflection operation. There is no damage (eg, scratches).

(5) 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.

(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.

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. 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.

Further, 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.

Further, since 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). When a voltage necessary for defibrillation in the heart chamber is applied, 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).

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.

(7) In the intracardiac defibrillation catheter of the present invention, it is preferable that the proximal end portion of the first insulating tube and the proximal end portion of the second insulating tube are embedded in the resin.

According to 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.

(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.

(9) In the intracardiac defibrillation catheter according to (8), it is preferable that a pull wire for tip deflection operation extends to the fourth lumen of the tube member.

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).

(10) The intracardiac defibrillation catheter of the present invention is preferably inserted into the heart chamber to remove atrial fibrillation that occurs during cardiac catheterization.

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.

According to the intracardiac defibrillation catheter of (1) above, when a voltage necessary for the intracardiac defibrillation is applied, 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). Thus, it is possible to reliably prevent a short circuit from occurring.

According to the intracardiac defibrillation catheter of (6) above, 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.

It is an explanatory top view showing one embodiment of an intracardiac defibrillation catheter of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS 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. 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 is explanatory drawing which shows the preparation procedures (the soldering process of a lead wire) of the structure shown in FIG. It is explanatory drawing which shows the preparation procedures (mounting process of a partition plate) of the structure shown in FIG. It is explanatory drawing which shows the preparation procedures (movement process of an insulating tube) of the structure shown in FIG. It is the figure which looked at the connection state to the pin terminal of the lead wire shown in FIG. 10 from the front end side. It is explanatory drawing which shows the preparation procedures (formwork mounting process) of the structure shown in FIG. It is explanatory drawing which shows the preparation procedures (injection process of curable resin) of the structure shown in FIG. It is explanatory drawing which shows the preparation procedures (the removal process of a formwork) of the structure shown in FIG. It is an electric potential waveform diagram measured when predetermined | prescribed electric energy is provided with the intracardiac defibrillation catheter of this invention.

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.

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.

As shown in FIGS. 3 and 4, 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.

3 and 4, 15 is a fluororesin layer that divides the lumen, 16 is an inner (core) portion made of a low hardness nylon elastomer, and 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).

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.
As a preferred example, in FIG. 2, 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). Here, 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. 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.

In the present embodiment, 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. .

Here, 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 (distance between adjacent electrodes) is preferably 1 to 5 mm, and 2 mm is a preferable example.
When the intracardiac defibrillation catheter 100 is used (when placed in the heart chamber), 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. Here, 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.

In the present embodiment, 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 terminal of the opposite polarity to that to which 31G is connected).
Thereby, voltages having different polarities are applied to the first DC electrode group 31G (electrode 31) and the second DC electrode group 32G (electrode 32), and the first DC electrode group 31G and the second DC electrode group 32G are: The electrode groups have different polarities (when one electrode group is a negative electrode, the other electrode group is a positive electrode).

Here, 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 (distance between adjacent electrodes) is preferably 1 to 5 mm, and 2 mm is a preferable example.
When the intracardiac defibrillation catheter 100 is used (when placed in the heart chamber), the second DC electrode group 32G is located, for example, in the right atrium.

In the present embodiment, 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.

Here, 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.
When the intracardiac defibrillation catheter 100 is used (when placed in the heart chamber), 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.

As the

electrodes

31, 32, 33 constituting the first DC electrode group 31G, the second DC electrode group 32G, and the proximal-side potential measurement electrode group 33G, 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). .
With the first lead wire group 41G (lead wire 41), each of the eight electrodes 31 constituting the first DC electrode group 31G can be electrically connected to the DC power supply device.

The eight electrodes 31 constituting the first DC electrode group 31G are connected to different lead wires 41, respectively. Each of the lead wires 41 is welded to the inner peripheral surface of the electrode 31 at the tip portion, 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.

As described above, 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.

As described above, 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. Here, the coating resin has a thickness of about 2 to 30 μm.

3 and 4, 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.

On the other hand, 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.

In the fourth lumen 14 of the multi-lumen tube 10, only the pull wire 71 extends, and the lead wire (group) does not extend. Thereby, it is possible to prevent the lead wire from being damaged (for example, scratched) by the pull wire 71 moving in the axial direction during the deflection operation of the distal end portion of the multi-lumen tube 10.

In the intracardiac defibrillation catheter 100 of the present embodiment, 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), and FIG. FIG.

As shown in FIG. 5, 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.

As shown in FIGS. 5 and 7, 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. Built in.
5 to 7, 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.

As shown in FIGS. 5 and 6, 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. Thereby, the first lead wire group 41G extending from the multi-lumen tube 10 (first lumen 11) 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. Are fixedly connected to each of the pin terminals arranged by soldering. Here, 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”.
Thus, 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. Connected to the second lumen 12.
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. Accordingly, the second lead wire group 42G extending from the multi-lumen tube 10 (second lumen 12) 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. Are fixedly connected to each of the pin terminals arranged by soldering. Here, 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”.
Thereby, 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. Connected to the third lumen 13.
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. As a result, the third lead wire group 43G extending from the multi-lumen tube 10 (third lumen 13) 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. Are fixedly connected to each of the pin terminals arranged by soldering. Here, 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”.
As a result, 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. Can be connected to.

Here, examples of the constituent material of the insulating tubes (the first insulating tube 26, the second insulating tube 27, and the third insulating tube 28) include polyimide resin, polyamide resin, and polyamideimide resin. . Of these, 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 μm, and is 30 μm as a suitable example.

Moreover, as a constituent material of the protective tube (the first protective tube 61 and the second protective tube 62) into which the insulating tube is inserted, nylon elastomer such as “Pebax” (registered trademark of ARKEMA) is exemplified. be able to.

According to the intracardiac defibrillation catheter 100 of the present embodiment having the above-described configuration, 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.

Further, in the handle 20, 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. Thereby, for example, it is possible to prevent the insulating tube from being damaged by contact and rubbing of the constituent members (movable parts) of the knob 22 during the deflection operation of the distal end portion of the multi-lumen tube 10.

In the intracardiac defibrillation catheter 100 of the present embodiment, 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). When the separation distance is 7 mm, the height of the partition plate 55 is, for example, 8 mm. In the partition plate having a height of less than 7 mm, the distal end edge cannot be positioned on the distal end side with respect to the proximal end of the insulating tube.

According to such a configuration, 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.

Further, when an error occurs when the lead wire is connected and fixed to the pin terminal during the manufacture of the intracardiac defibrillation catheter, for example, the lead wire 41 constituting the first lead wire group 41G is connected to the second terminal. 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). However, 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).

In the intracardiac defibrillation catheter 100 of the present embodiment, 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.
Thereby, 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. Between the wires (the lead wires 42 constituting the second lead wire group 42G), 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.

As shown in FIG. 7, 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.

Here, 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. Specifically, urethane-based, epoxy-based, and urethane-epoxy-based curable resins can be exemplified.

According to the above configuration, since 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). .

The structure as shown in FIG. 7, that is, a structure in which 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.

(1) 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.
Here, 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).
Further, 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).

(2) Partition plate placement process:
Next, as shown in FIG. 9, the first terminal group region in which the pin terminal 51 to which the lead wire 41 is connected and fixed and the pin terminal 52 to which the lead wire 42 is connected and fixed are arranged. The connector is separated from the second terminal group region and the third terminal group region where the pin terminal 53 to which the lead wire 43 is connected and fixed is disposed, and the lead wire 41, the lead wire 42, and the lead wire 43 are isolated. The partition plate 55 is placed on the front end surface 50 </ b> A of the 50.
Here, the lead wire 43 (pin terminal 53) 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 height of the partition plate 55 is, for example, 8 mm.

(3) Insulating tube moving process:
Next, as shown in FIG. 10, 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).
After the movement of the insulating tube, 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.
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 tube 26, the second insulating tube 27, and the third insulating tube 28) 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.

(4) Forming process:
Next, as shown in FIG. 12, lead wires (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). ) And the mold plate 90 so as to surround the partition plate 55.
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. As the formwork 90, 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.

(5) 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.
Here, 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.
As a result, 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.

(6) Resin curing and mold removal step:
Next, the curable resin injected into the mold 90 is photocured or thermally cured, and then FIG.
As shown, 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.
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.

In the intracardiac defibrillation catheter 100 of this embodiment, 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. Particularly preferably, 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.

During cardiac catheterization, 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.

Here, 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.

FIG. 15 is a diagram illustrating a potential waveform measured when predetermined electrical energy (for example, set output = 10 J) is applied by the intracardiac defibrillation catheter 100 of the present embodiment. In the figure, the horizontal axis represents time and the vertical axis represents potential.
First, by applying a DC voltage between the first DC electrode group 31G and the second DC electrode group 32G so that the first DC electrode group 31G is the negative electrode and the second positive electrode group 32G, the electric potential is supplied and the measurement potential rises (V ₁ is This is the peak voltage at this time.) After a lapse of a certain time (t ₁ ), a DC voltage obtained by inverting ± is applied between the two so that the first DC electrode group 31G becomes a positive electrode and the second DC electrode group 32G becomes a negative electrode. When supplied, the measurement potential rises (V ₂ is the peak voltage at this time).

Here, the time (t ₁ ) is, for example, 1.5 to 10.0 seconds, and the measured peak voltage (V ₁ ) is, for example, 300 to 500V.

In the 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.

Therefore, in the intracardiac defibrillation catheter 100, 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.

As a result, 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).

Further, 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.

Further, 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 eight lead wires 42 that are extended and divided and connected and fixed to each of the pin terminals 52 of the connector 50, and the pin terminals of the connector 50 that are extended and divided from the proximal end opening of the third insulating tube 28. 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.

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.

DESCRIPTION OF SYMBOLS 100 Intracardiac defibrillation catheter 10 Multi-lumen tube 11 1st lumen 12 2nd lumen 13 3rd lumen 14 4th lumen 15 Fluororesin layer 16 Inner (core) part 17 Outer (shell) part 18 Stainless steel strand 20 Handle 21 handle body 22 knob 24 strain relief 26 first insulating tube 27 second insulating tube 28 third insulating tube 31G first DC electrode group 31 ring electrode 32G second DC electrode group 32 ring electrode 33G proximal side potential Measurement electrode group 33 Ring-shaped electrode 35 Tip tip 41G First lead wire group 41 Lead wire 42G Second lead wire group 42 Lead wire 43G Third lead wire group 43 Lead wire 51 Pin terminal 52 Pin terminal 53 Pin terminal 55 Bulkhead plate 61 First Protective tube 62 Second protective tube 71 Pull wire 80 Resin (cured resin)
80A curable resin
90 formwork

Claims

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.
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.
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:
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.
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.
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.
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.
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:
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.
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.