JP6876091B2 - Intracardiac defibrillation catheter - Google Patents

Description

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

If atrial fibrillation occurs during cardiac catheterization, cardioversion should be performed. Applicants have an insulating tube member having a multi-lumen structure, a handle connected to the base end of the tube member, and the tube member as a catheter for performing such defibrillation in the heart cavity. A first DC electrode group composed of a plurality of ring-shaped electrodes mounted on the tip region of the above, and a second DC electrode composed of a plurality of ring-shaped electrodes mounted on the tube member separated from the first DC electrode group toward the proximal end side. A second group consisting of a group, 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 composed of lead wires connected to each of the electrodes constituting the second DC electrode group. A lead wire group is provided, and the first lead wire group and the second lead wire group extend to different lumens of the tube member, and when defibrillation is performed, the first DC electrode group is provided. And, a intracardiac defibrillation catheter in which voltages having different polarities are applied to the second DC electrode group is proposed (see Patent Document 1).

By inserting an intracardiac defibrillation catheter having such a configuration into the right atrium from the superior vena cava, and further inserting it into the opening of the coronary sinus (coronary sinus ostium) on the posterior inferior wall of the right atrium. , The 1st DC electrode group is located in the coronary sinus and the 2nd DC electrode group is located in the right atrium, and then voltages of different polarities are applied to the 1st DC electrode group and the 2nd DC electrode group. To do. As a result, the heart causing atrial fibrillation can be provided with sufficient electrical energy necessary for defibrillation.

FIG. 6 is a cross-sectional view of the tip region of the tube member constituting the defibrillation catheter described in Patent Document 1, and the tube member 110 has four lumens (first lumen 111, second lumen 112, The third lumen 113 and the fourth lumen 114) are formed.
In FIG. 6 , 115 is a resin tube made of a fluororesin for partitioning a lumen, 116 is an inner part made of a low-hardness nylon elastomer, 117 is an outer part made of a high-hardness nylon elastomer, and 118 is a braided part. It is a stainless wire rod that forms.

As shown in FIG. 6 , in the first lumen 111, a first lead wire group 141G composed of lead wires 141 connected to each of the electrodes constituting the first DC electrode group extends, and the second lumen 112 A second lead wire group 142G composed of lead wires 142 connected to each of the electrodes constituting the second DC electrode group extends to the third lumen 113, and is connected to each of the electrodes for potential measurement in the third lumen 113. A third lead wire group 143G composed of the lead wires 143 and a fourth lead wire group 144G composed of the lead wires 144 extend, and an operation wire 171 extends to the fourth lumen 114.

In this way, the first lead wire group 141G and the second lead wire group 142G extend to different lumens (first lumen 111, second lumen 112) of the tube member, respectively, so that the heart is formed. When the voltage required for intracavitary defibrillation is applied, a short circuit occurs between the first lead wire group 141G (first DC electrode group) and the second lead wire group 142G (second DC electrode group). Can be prevented.

Japanese Unexamined Patent Publication No. 2010-63708

The procedure of inserting an intracardiac defibrillation catheter from the inferior vena cava into the right atrium and inserting it into the coronary sinus opening (approach from the inferior vena cava) is to insert it from the superior vena cava into the right atrium and coronary vein. It is less invasive than the conventional procedure of inserting into the sinus (approach from the superior vena cava).

However, in the approach from the inferior vena cava, it is difficult to insert the intracardiac defibrillation catheter into the coronary sinus ostium, and even after inserting it into the coronary venous sinus, torque is applied to untwist the tube member. It is complicated because it requires operations such as.

To deal with such a problem, it is conceivable to insert an intracardiac defibrillation catheter along a guide wire previously inserted into the coronary sinus ostium when approaching from the inferior vena cava.

In order to insert the intracardiac defibrillation catheter into the target site along the guide wire, a lumen (guide wire lumen) through which the guide wire can be inserted is formed in the tube member of the intracardiac defibrillation catheter. There is a need.

However, the tube member having the guide wire lumen in addition to the lead wire and the lumen for extending the operation wire has a high space occupancy (the resin occupies a low ratio), and the first lead wire group is extended. Since the thickness of the resin that separates the rumen to be operated and the lumen to extend the second lead wire group is also reduced, the first lead wire group (first DC electrode group) is applied when the voltage required for defibrillation is applied. And the second lead wire group (second DC electrode group) may cause a short circuit.

Further, the defibrillation catheter provided with the tube member having a high space occupancy (low resin occupancy) due to having the guide wire lumen is inferior in torque transmission.

The present invention has been made based on the above circumstances.
The first object of the present invention is that it can be inserted into a target site in the heart cavity along a guide wire, and a first lead wire group (first electrode group) and a second lead wire group (second electrode group). It is an object of the present invention to provide an intracardiac defibrillation catheter capable of reliably preventing a short circuit between and.

A second object of the present invention is intracardiac defibrillation capable of exhibiting excellent torque transmission even though the proportion of the resin constituting the tube member is low due to the presence of the guide wire lumen. An articulated catheter will be provided.

(1) The intracardiac defibrillation catheter of the present invention includes an insulating tube member, a handle connected to the base end of the tube member, and a plurality of ring-shaped electrodes attached to the tip region of the tube member. A first DC electrode group composed of, a second DC electrode group composed of a plurality of ring-shaped electrodes mounted on the tip region of the tube member separated from the first DC electrode group toward the proximal end side, and the first DC electrode group. A first lead wire group consisting of lead wires connected to each of the constituent electrodes and a second lead wire group consisting of lead wires connected to each of the electrodes constituting the second DC electrode group are provided. A catheter that defibrillates in the heart cavity by applying voltages of different polarities between the first DC electrode group and the second DC electrode group.
The tube member is a multi-lumen structure having a central lumen through which a guide wire can be inserted, which is partitioned by a fluororesin tube, and at least a pair of sub-lumens arranged so as to face each other with the central lumen in between. Yes,
The lead wires constituting the first lead wire group extend to one of the pair of sublumens, and the lead wires constituting the second lead wire group extend to the other of the pair of sublumens. Ori,
The ratio of the diameter of the central lumen to the outer diameter of the tube member is 0.2 or more .

According to the intracardiac defibrillation catheter having such a configuration, the lead wires constituting the first lead wire group and the lead wires constituting the second lead wire group face each other with the central lumen in between. By extending to one and the other of the pair of sublumens arranged in the above, the lead wires constituting the first lead wire group and the lead wires forming the second lead wire group are sufficiently separated from each other. In this state, it can be completely insulated and isolated in the tube member.

(2) In the intracardiac defibrillation catheter of the present invention, the first lead wire group extends to one of the pair of sublumens, and the second lead wire group extends to the other of the pair of sublumens. It is preferable to be present.

According to the intracardiac defibrillation catheter having such a configuration, the first lead wire group (all the lead wires constituting the lead wire group) and the second lead wire group (all the lead wires constituting the lead wire group) are formed. , The first lead wire group and the second lead wire group are sufficiently separated from each other by extending to one and the other of the pair of sublumes arranged so as to face each other with the central lumen in between. In this state, it can be completely insulated and isolated in the tube member.

(3) In the intracardiac defibrillation catheter of the present invention, the tube member is reinforced by a braid over its entire length, and at least the braid that reinforces the tip region of the tube member is made of resin. Is preferable.

According to the intracardiac defibrillation catheter having such a configuration, since the tube member is reinforced by the braid over the entire length, excellent torque is obtained despite the low proportion of resin due to the central lumen. Can exert transmissibility.
Further, since the braid that reinforces the tip region of the tube member is made of resin, it is possible to easily form a side hole for passing the lead wire of the electrode in the tube wall of the tip region of the tube member. The resin wire material exposed on the inner peripheral surface of the side hole does not damage the lead wire inserted into the side hole.

(4) In the intracardiac defibrillation catheter of the above (3), it is preferable that the tube member is reinforced by a resin braid over its entire length.

According to the intracardiac defibrillation catheter having such a configuration, since the tube member is reinforced by the braid over the entire length, excellent torque is obtained despite the low proportion of resin due to the central lumen. Can exert transmissibility.
Further, since the braid is made of resin, a side hole for passing the lead wire of the electrode can be easily formed in the tube wall in the tip region of the tube member, and the side hole is exposed on the inner peripheral surface of the side hole. The resin wire does not damage the lead wire inserted into the side hole.
Further, since the braid is made of resin, a short circuit does not occur through this braid.
Further, the tube member (blade tube) reinforced by the resin braid over the entire length can be manufactured by one extrusion molding, for example, the tip portion reinforced by the resin braid and the metal braid. It is easier to manufacture as compared with a blade tube formed by joining a base end portion reinforced by. In addition, kink, which is likely to occur in the tube portion where the constituent materials of the braid are switched, does not occur.

According to the intracardiac defibrillation catheter of the present invention, it can be inserted into a target site in the heart chamber along a guide wire, even if it is inserted into the coronary sinus ostium by an approach from the inferior vena cava. It can be done easily.
Further, according to the intracardiac defibrillation catheter of the present invention, a short circuit between the first lead wire group (first DC electrode group) and the second lead wire group (second DC electrode group) can be reliably prevented. Can be done.

Further, according to the intracardiac defibrillation catheter of the present invention in which the tube member is reinforced by a resin braid over the entire length, the proportion of the resin constituting the tube member is reduced by having the central lumen. Nevertheless, excellent torque transmission can be exhibited.

It is a top view which shows the defibrillation catheter which concerns on 1st Embodiment of this invention. It is explanatory drawing which shows the tip region of the defibrillation catheter shown in FIG. It is a cross-sectional view (AA cross-sectional view) of the tip region of the defibrillation catheter shown in FIG. It is a cross-sectional view (BB cross-sectional view) of the tip region of the defibrillation catheter shown in FIG. It is a top view which shows the defibrillation catheter which concerns on 2nd Embodiment of this invention. It is a cross-sectional view (CC cross-sectional view) of the tip region of the defibrillation catheter shown in FIG. It is a cross-sectional view which shows the tip region of the conventional defibrillation catheter.

<First Embodiment>
The defibrillation catheter 100 of this embodiment shown in FIGS. 1 to 3 (FIGS. 3A and 3B) has a multi-lumen tube 10, a handle 20 connected to the base end thereof, and a tip region of the multi-lumen tube 10. The first DC electrode group 31G composed of eight mounted ring-shaped electrodes 31 and the eight ring-shaped electrodes 32 mounted in the tip region of the multi-lumen tube 10 separated from the first DC electrode group 31G toward the proximal end side. A second DC electrode group 32G, four ring-shaped electrodes 33 for potential measurement mounted in the tip region of the multi-lumen tube 10 between the first DC electrode group 31G and the second DC electrode group 32G, and a multi-lumen tube. A first lead wire group 41G composed of a tip tip 35 mounted on the tip of 10 and a lead wire 41 connected to each of the electrodes 31 constituting the first DC electrode group 31G, and an electrode constituting the second DC electrode group 32G. A second lead wire group 42G composed of lead wires 42 connected to each of the 32s and a lead wire 43 connected to each of the ring-shaped electrodes 33 for potential measurement are provided, and the first DC electrode group 31G and the first DC electrode group 31G are provided. A catheter that defibrillates in the heart cavity by applying voltages of different polarities to the 2DC electrode group 32G, and the multi-lumen tube 10 is reinforced by a resin braid 18 over its entire length. At the same time, the central lumen 10L, which is the guide wire lumen, and the first sub-lumen 11L and the second sub-lumen 12L arranged so as to face each other across the central lumen 10L so as to face each other with the central lumen 10L in between. The first lead wire group 41G extends to the first sublumen 11L, and the second lead wire group 42G has a second sublumen. It extends to 12L, and the lead wire 43 extends to the third sublumen 13L.

The defibrillation catheter 100 of the present embodiment includes a multi-lumen tube 10, a handle 20, a first DC electrode group 31G, a second DC electrode group 32G, a ring-shaped electrode 33 for potential measurement, a tip tip 35, and the like. The first lead wire group 41G, the second lead wire group 42G, and the lead wire 43 are provided.

The multi-lumen tube 10 constituting the defibrillation catheter 100 is an insulating tube member having a multi-lumen structure.
The outer diameter of the multi-lumen tube 10 is, for example, 1.2 to 3.3 mm, and a suitable example is 2.0 mm.

Although the tip region of the multi-lumen tube 10 is shown linearly in FIGS. 1 and 2, the tip region usually has a specific curved shape.
Examples of the curved shape of such a tip region include, but are not limited to, the shapes disclosed in Japanese Patent Application Laid-Open No. 2012-50673 and Japanese Patent Application Laid-Open No. 2012-192124.
The curved shape of such a tip region is a shape when no force is received from the outside. For example, when the multi-lumen tube 10 is passed through a linear lumen, the multi-lumen tube 10 is deformed linearly and is multi-layered. When the lumen tube 10 is passed through a curved lumen, it bends according to the shape of the lumen. Further, the shape of the tip region can be changed by operating the handle 20 described later.

As shown in FIGS. 3A and 3B, the multi-lumen tube 10 constituting the defibrillation catheter 100 of this embodiment includes an inner portion 16 made of resin and an outer portion 17 made of resin covering the inner portion 16. , A blade tube including a resin braid 18 embedded inside an outer portion 17 over the entire length of the multi-lumen tube 10.

The multi-lumen tube 10 (inner portion 16) has a central lumen 10L as a guide wire lumen and four sub-lumens (first sub-lumen 11L, second sub-lumen 12L, third sub-lumen) around the central lumen 10L. The 13L and the fourth sublumen 14L) are formed by being partitioned by the resin tube 15, respectively.

The diameter of the central lumen 10L is, for example, 0.4 to 1.0 mm, and a suitable example is 0.75 mm.
The ratio of the diameter of the central lumen 10L to the outer diameter of the multi-lumen tube 10 is preferably 0.2 or more, and a suitable example is 0.375 (0.75 / 2.0).

The first sublumen 11L and the second sublumen 12L are arranged so as to face each other with the central lumen 10L in between.
Further, the third sublumen 13L and the fourth sublumen 14L are arranged so as to face each other with the central lumen 10L interposed therebetween.

The cross sections of the first sublumen 11L, the second sublumen 12L, and the third sublumen 13L are each capsule-shaped (oval), whereby the outer diameter of the multi-lumen tube 10 is expanded more than necessary. Therefore, a large area of the lumen lumen can be secured, and the assembly work can be simplified.

Examples of the resin constituting the inner portion 16 and the outer portion 17 include thermoplastic polyamide-based elastomers, and especially, polyether block amide (PEBAX) is preferable.

The hardness of the resin constituting the inner portion 16 is preferably 25D to 40D.
The hardness of the resin constituting the outer portion 17 is preferably 35D to 72D. The resin constituting the outer portion 17 usually has a hardness different depending on the axial direction.

The resin tube 15 for partitioning the rumen is made of a fluororesin having high insulating properties such as a perfluoroalkyl vinyl ether copolymer (PFA) and polytetrafluoroethylene (PTFE).

As shown in FIGS. 3A and 3B, a resin braid 18 as a reinforcing material is embedded in the outer portion 17 over the entire length of the multi-lumen tube 10.
In the cross-sectional view shown in FIGS. 3A and 3B, the braid 18 is composed of 16 sets (32 pieces) of resin wires arranged at equal angular intervals in the circumferential direction.

In this way, since the multi-lumen tube 10 is reinforced with the braid 18 (becomes a blade tube) over the entire length, it is excellent even though the ratio of the resin is low due to having the central lumen 10L. It is possible to demonstrate the torque transmission.

Further, since the braid 18 is made of resin, a short circuit does not occur through the braid 18. Further, since the braid 18 is made of resin, side holes for passing the lead wires (lead wires 41, 42 and 43) of the electrodes can be easily formed in the tube wall in the tip region of the multi-lumen tube 10. Further, the lead wire inserted into the side hole is not damaged by the resin wire material exposed on the inner peripheral surface of the side hole.

When a metal braid is embedded instead of the resin braid 18, it becomes difficult to form a side hole for passing the lead wire of the electrode in the tube wall in the tip region of the multi-lumen tube 10, and the side hole can be formed. Even if this is the case, since the metal wire constituting the braid is exposed on the inner peripheral surface of the side hole, the lead wire of the electrode comes into contact with the metal wire during the manufacture and use of the defibrillation catheter, and the lead wire It is conceivable that the resin coating layer constituting the lead wire is damaged and the insulating property of the lead wire is impaired. Therefore, it is not possible to embed a metal braid over the entire length including the tip region of the multi-lumen tube 10.

The constituent material of the braid 18 (resin wire) is selected from resins that can exert a reinforcing effect by being embedded.
The hardness of the constituent material of the braid 18 is preferably 72D or more. If this hardness is too small, a sufficient reinforcing effect and, by extension, good torque transmission may not be exhibited.
The flexural modulus (ISO178 or JIS K7171) of the constituent material of the braid 18 is usually 500 to 19,000 MPa, preferably 2,000 to 7,000 MPa, and more preferably 3,500 to 4,200. A suitable example is 4,200 MPa.

Examples of suitable reinforcing resins constituting the braid 18 (resin wire) include PEEK resin, polyimide resin, polyamide resin, polyester resin, and the like, of which PEEK resin is particularly preferable.

The wire diameter of the resin wire rod constituting the braid 18 is usually 30 to 100 μm, and a suitable example is 60 μm.
The number of strokes of the braid 18 is usually 8 to 32, and 16 is a suitable example.
The number of braids 18 is usually 1 to 4, and a suitable example is 2.

As shown in FIG. 1, the handle 20 constituting the defibrillation catheter 100 of the present embodiment includes a handle body 21, a knob 22, and a strain relief 24.
By rotating the knob 22, the shape of the tip region of the multi-lumen tube 10 can be changed.

A first DC electrode group 31G and a second DC electrode group 32G are mounted on the outer periphery of the tip region of the multi-lumen tube 10.
In the present invention, the "electrode group" refers to a plurality of electrodes that form the same pole (have the same polarity) or have the same purpose and are mounted at narrow intervals (for example, 5 mm or less). An aggregate.

The first DC electrode group is formed by mounting a plurality of electrodes constituting the same pole (-pole or + pole) at narrow intervals in the tip region of the tube member. Here, the number of electrodes constituting the first DC electrode group varies depending on the width of the electrodes and the arrangement interval, but is, for example, 4 to 13, preferably 8 to 10.

In the present embodiment, the first DC electrode group 31G is composed of eight ring-shaped electrodes 31. The electrodes 31 constituting the first DC electrode group 31G are via lead wires (lead wires 41 constituting the first lead wire group 41G shown in FIGS. 3A and 3B) and a connector built in the base end of the handle 20. It is connected to the terminal of the same pole in the DC power supply.

Here, the width of the electrode 31 (length W1 in the axial direction) is preferably 2 to 5 mm, and a suitable example is 4 mm.
If the width of the electrode 31 is too narrow, the amount of heat generated when a voltage is applied becomes excessive, which may damage the surrounding tissue. On the other hand, if the width of the electrode 31 is too wide, the flexibility and flexibility of the portion of the multi-lumen tube 10 to which the first DC electrode group 31G is mounted may be impaired.

The mounting interval of the electrodes 31 (separation distance between adjacent electrodes) is preferably 1 to 5 mm, and a suitable example is 2 mm.
When the intracardiac defibrillation catheter 100 is used (when placed in the heart chamber), the first DC electrode group 31G is located in the coronary sinus.

In the second DC electrode group, in the tip region of the tube member separated from the mounting position of the first DC electrode group to the proximal end side, a plurality of electrodes forming poles (+ poles or-poles) opposite to those of the first DC electrode group are formed. It is installed at narrow intervals. Here, the number of electrodes constituting the second DC electrode group varies depending on the width of the electrodes and the arrangement interval, but is, for example, 4 to 13, preferably 8 to 10.

In the present embodiment, the second DC electrode group 32G is composed of eight ring-shaped electrodes 32. The electrode 32 constituting the second DC electrode group 32G is a DC power supply device via a lead wire (lead wire 42 constituting the second lead wire group 42G shown in FIG. 3B) and a connector built in the base end portion of the handle 20. It is connected to the terminal of the same pole in (the terminal of the pole opposite to the one to which the first DC electrode group 31G is connected).
As a result, voltages having different polarities are applied to the first DC electrode group 31G (electrode 31) and the second DC electrode group 32G (electrode 32), and the first DC electrode group 31G and the second DC electrode group 32G are separated from each other. The electrodes have different polarities (when one electrode group has a negative electrode, the other electrode group has a positive electrode).

Here, the width of the electrode 32 (length W2 in the axial direction) is preferably 2 to 5 mm, and a suitable example is 4 mm.
If the width of the electrode 32 is too narrow, the amount of heat generated when a voltage is applied becomes excessive, which may damage the surrounding tissue. On the other hand, if the width of the electrode 32 is too wide, the flexibility and flexibility of the portion of the multi-lumen tube 10 to which the second DC electrode group 32G is mounted may be impaired.

The mounting interval of the electrodes 32 (separation distance between adjacent electrodes) is preferably 1 to 5 mm, and a suitable example is 2 mm.
When using the intracardiac defibrillation catheter 100 (when placed in the heart chamber), the second DC electrode group 32G is located in the right atrium.

The electrodes constituting the first DC electrode group 31G and the second DC electrode group can also be used for measuring the potential.

Four ring-shaped electrodes 33 used for potential measurement are mounted on the outer periphery of the multi-lumen tube 10 (between the first DC electrode group 31G and the second DC electrode group 32G).
The electrode 33 is connected to the electrocardiograph via a lead wire (lead wire 43 shown in FIGS. 3A and 3B) and a connector incorporated in the base end portion of the handle 20.

Here, the width of the electrode 33 (length W3 in the axial direction) is preferably 0.5 to 2.0 mm, and a suitable example is 1.2 mm.
If the width of the electrode 33 is too wide, the measurement accuracy of the electrocardiographic potential may be lowered, or it may be difficult to identify the site where the abnormal potential is generated.

A tip 35 is attached to the tip of the intracardiac defibrillation catheter 100.
No lead wire is connected to the tip 35, and the tip 35 is not used as an electrode in this embodiment. However, it can also be used as an electrode by connecting a lead wire. The constituent material of the tip 35 is not particularly limited, such as a metal material such as platinum and stainless steel, and various resin materials.

The separation distance between the first DC electrode group 31G (electrode 31 on the proximal end side) and the second DC electrode group 32G (electrode 32 on the distal end side) is preferably 40 to 100 mm, more preferably 50 to 90 mm.

The electrodes 31 that make up the first DC electrode group 31G, the electrodes 32 that make up the second DC electrode group 32G, and the electrodes 33 for potential measurement are platinum or platinum-based in order to improve the contrast with X-rays. It is preferably made of an alloy.

The first lead wire group 41G shown in FIGS. 3A and 3B is an aggregate of eight lead wires 41 connected to each of the eight electrodes 31 constituting the first DC electrode group 31G.
With the first lead wire group 41G (lead wire 41), each of the eight electrodes 31 constituting the first DC electrode group 31G can be electrically connected to the DC power supply device.

The eight electrodes 31 constituting the first DC electrode group 31G are connected to different lead wires 41, respectively. Each of the lead wires 41 is welded to the inner peripheral surface of the electrode 31 at the tip portion thereof, and enters the first sublumen 11L through a side hole formed in the tube wall of the multi-lumen tube 10. The eight lead wires 41 that have entered the first sublumen 11L extend to the first sublumen 11L as the first lead wire group 41G.

The second lead wire group 42G shown in FIG. 3B is an aggregate of eight lead wires 42 connected to each of the eight electrodes 32 constituting the second DC electrode group 32G.
With the second lead wire group 42G (lead wire 42), each of the eight electrodes 32 constituting the second DC electrode group 32G can be electrically connected to the DC power supply device.

The eight electrodes 32 constituting the second DC electrode group 32G are connected to different lead wires 42, respectively. Each of the lead wires 42 is welded to the inner peripheral surface of the electrode 32 at the tip portion thereof, and enters the second sublumen 12L from the side hole formed in the tube wall of the multi-lumen tube 10. The eight lead wires 42 that have entered the second sublumen 12L extend to the second sublumen 12L as the second lead wire group 42G.

As described above, the first lead wire group 41G (8 lead wires 41) extends to the first sublumen 11L, and the second lead wire group 42G (8 lead wires 42) extends to the second sublumen 12L. The first sublumen 11L extending to the first lead wire group 41G and the second sublumen 12L extending the second lead wire group 42G sandwich the central lumen 10L. By being arranged so as to face each other, a sufficient separation distance between the first lead wire group 41G and the second lead wire group 42G can be secured.

The four lead wires 43 shown in FIGS. 3A and 3B are connected to each of the electrodes 33 for measuring the potential. Each of the electrodes 33 can be connected to the electrocardiograph by the lead wire 43.

The four electrodes 33 used for the potential measurement are connected to different lead wires 43, respectively. Each of the lead wires 43 is welded to the inner peripheral surface of the electrode 33 at the tip portion thereof, and enters the third sub-lumen 13L from the side hole formed in the tube wall of the multi-lumen tube 10, and the third sub It extends to the lumen 13L.

The lead wire 41, the lead wire 42, and the lead wire 43 are all made of a resin-coated wire in which the outer peripheral surface of the metal conductor wire is coated with a resin such as polyimide. Here, the film thickness of the coating resin is about 2 to 30 μm.

In FIGS. 3A and 3B, 51 is an operating wire.
The operation wire 51 extends to the fourth sublumen 14L and extends eccentrically with respect to the central axis of the multi-lumen tube 10.

The tip portion of the operation wire 51 is fixed to the tip tip 35 by, for example, solder.
On the other hand, the base end portion of the operation wire 51 is connected to the knob 22 of the handle 20, and the operation wire 51 is pulled by operating the knob 22. Thereby, the shape of the tip region of the multi-lumen tube 10 can be changed.

The operating wire 51 is made of stainless steel or a Ni—Ti superelastic alloy, but it does not necessarily have to be made of metal. The operation wire 51 may be made of, for example, a high-strength non-conductive wire.
The mechanism for deflecting the tip of the multi-lumen tube is not limited to this, and may be provided with, for example, a leaf spring.

In the fourth sublumen 14L of the multi-lumen tube 10, only the operation wire 51 extends, and the lead wire (group) does not extend. As a result, it is possible to prevent the lead wire from being damaged (for example, scratched) by the operating wire 51 that moves in the axial direction during the deflection operation of the tip portion of the multi-lumen tube 10.

In the defibrillation catheter 100 of the present embodiment, the first lead wire group 41G (lead wire 41), the second lead wire group 42G (lead wire 42), and the lead wire 43 are insulated even inside the handle 20. It is preferably isolated.

The defibrillation catheter 100 of the present embodiment directly applies electrical energy to the fibrillating heart by applying a DC voltage between the first DC electrode group 31G and the second DC electrode group 32G. A catheter for defibrillation treatment.

The defibrillation catheter 100 of the present embodiment is arranged in the heart chamber so that the first DC electrode group 31G is located in the coronary sinus and the second DC electrode group 32G is located in the right atrium. As a result, the heart is sandwiched between the first DC electrode group 31G and the second DC electrode group 32G.

To place in such a state, a guide wire is first inserted into the right atrium from the inferior vena cava and then into the coronary sinus ostium on the posterior inferior wall of the right atrium.
Next, along this guide wire, the defibrillation catheter 100 is inserted into the right atrium from the inferior vena cava, further inserted into the coronary sinus ostium on the posterior inferior wall of the right atrium, and inserted into the coronary sinus. (Advance).
Here, the procedure of inserting the defibrillation catheter 100 into the right atrium from the inferior vena cava and inserting it into the coronary sinus ostium (approach from the inferior vena cava) is more invasive than the approach from the superior vena cava. It is preferable because it has low properties.

The defibrillation catheter 100 of the present embodiment is preferably used when performing cardiac catheterization in which atrial fibrillation is likely to occur. Particularly preferably, the intracardiac defibrillation catheter 100 is pre-inserted into the patient's heart chamber before cardiac catheterization.

During cardiac catheterization, the electrocardiogram measured by the constituent electrodes of the 1st DC electrode group 31G and / or the 2nd DC electrode group 32G or the electrode 33 for potential measurement is monitored, and if atrial fibrillation occurs, it is monitored. , Cardiac catheterization is interrupted and defibrillation treatment is performed with the defibrillation catheter 100. 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. Gives electrical energy directly to the living heart.

Here, the electric energy supplied to the heart by the defibrillation catheter 100 is preferably 10 to 30 J.
If the electrical energy is too low, sufficient defibrillation treatment cannot be performed. On the other hand, when the electric energy is excessive, the surrounding tissues in which the first DC electrode group 31G and the second DC electrode group 32G are located may be damaged.

According to the intracardiac defibrillation catheter 100 of the present embodiment, the catheter can be inserted into the target site in the heart chamber along the guide wire, and is inserted into the coronary sinus ostium by the approach from the inferior vena cava. Can be easily implemented.

Further, according to the intracardiac defibrillation catheter 100, the first sublumen 11L in which the first lead wire group 41G extends and the second sublumen in which the second lead wire group 42G extends are extended. Since the 12Ls are arranged so as to face each other with the central lumen 10L in between, the first lead wire group 41G and the second lead wire group 42G are sufficiently separated from each other, and the multi-lumens are multi-lumen. It can be completely insulated and isolated in the tube 10. As a result, when the voltage required for cardioversion is applied, between the first lead wire group 41G (first DC electrode group 31G) and the second lead wire group 42G (second DC electrode group 32G). It is possible to surely prevent a short circuit from occurring.

Further, since the multi-lumen tube 10 constituting the intracardiac defibrillation catheter 100 is reinforced by the resin braid 18 over the entire length, excellent torque transmission can be exhibited. Further, since the braid 18 is made of resin, a short circuit does not occur through the braid 18.

<Second Embodiment>
FIG. 4 is a plan view showing the defibrillation catheter 200 of the present embodiment, and FIG. 5 is a cross-sectional view (CC sectional view of FIG. 4) of the tip region of the defibrillation catheter 200.

The defibrillation catheter 200 of the present embodiment is attached to a multi-lumen tube 60 having a flexible tip, a control handle 80 connected to the base end of the multi-lumen tube 60, and a flexible tip of the multi-lumen tube 60. The first DC electrode group 31G composed of the eight ring-shaped electrodes 31 and the eight ring-shaped electrodes attached to the tip flexible portion of the multi-lumen tube 60 separated from the first DC electrode group 31G toward the proximal end side. A second DC electrode group 32G composed of electrodes 32, and four ring-shaped electrodes 33 for potential measurement attached to the tip flexible portion of the multi-lumen tube 60 between the first DC electrode group 31G and the second DC electrode group 32G. The first lead wire group 41G and the second DC electrode group 32G, which consist of a tip tip 35 attached to the tip of the multi-lumen tube 60 and lead wires 41 connected to each of the electrodes 31 constituting the first DC electrode group 31G. A second lead wire group 42G composed of lead wires 42 connected to each of the electrodes 32 constituting the above, a lead wire 43 connected to each of the ring-shaped electrodes 33 for potential measurement, and the tip of the multi-lumen tube 60 can be used. In order to bend the flexible portion in the first direction (the direction indicated by the arrow A in FIG. 4), the first operation wire 511 capable of pulling the base end thereof and the flexible portion at the tip of the multi-lumen tube 60 are placed in the second direction. In order to bend in the direction indicated by the arrow B in FIG. 4, a second operation wire 512 capable of pulling the base end thereof is provided, and is provided between the first DC electrode group 31G and the second DC electrode group 32G. It is a catheter that defibrillates in the heart cavity by applying voltages of different electrodes to each other.

As shown in FIG. 5, the multi-lumen tube 60 constituting the defibrillation catheter 200 of this embodiment includes an inner portion 68 made of resin, an outer portion 69 made of resin covering the inner portion 68, and a multi-lumen. It is a blade tube including a resin braid 18 embedded inside an outer portion 69 over the entire length of the tube 60.

In the multi-lumen tube 60 (inner portion 68), a central lumen 60L as a guide wire lumen and six sub-lumens 61L to 66L around the central lumen 60L are respectively partitioned by a resin tube 67. It is formed.

The first sublumen 61L and the second sublumen 62L are arranged so as to face each other with the central lumen 60L in between.
Further, the third sublumen 63L and the fourth sublumen 64L are arranged so as to face each other with the central lumen 60L interposed therebetween.
Further, the fifth sublumen 65L and the sixth sublumen 66L are arranged so as to face each other with the central lumen 60L interposed therebetween.

The cross sections of the first sublumen 61L, the second sublumen 62L, the third sublumen 63L, and the fourth sublumen 64L are capsule-shaped (oval), respectively.
The cross sections of the fifth sublumen 65L and the sixth sublumen 66L are circular, respectively.

Further, the multi-lumen tube 60 is reinforced by a resin braid 18 over its entire length, similarly to the multi-lumen tube 10 constituting the defibrillation catheter 100 according to the first embodiment.

The first lead wire group 41G shown in FIG. 5 is an aggregate of eight lead wires 41 connected to each of the eight electrodes 31 constituting the first DC electrode group 31G.
With the first lead wire group 41G (lead wire 41), each of the eight electrodes 31 constituting the first DC electrode group 31G can be electrically connected to the DC power supply device.

The eight electrodes 31 constituting the first DC electrode group 31G are connected to different lead wires 41, respectively. Each of the lead wires 41 is welded to the inner peripheral surface of the electrode 31 at the tip portion thereof, and enters the first sublumen 61L through a side hole formed in the tube wall of the multi-lumen tube 60. The eight lead wires 41 that have entered the first sublumen 61L extend to the first sublumen 61L as the first lead wire group 41G.

The second lead wire group 42G shown in FIG. 5 is an aggregate of eight lead wires 42 connected to each of the eight electrodes 32 constituting the second DC electrode group 32G.
With the second lead wire group 42G (lead wire 42), each of the eight electrodes 32 constituting the second DC electrode group 32G can be electrically connected to the DC power supply device.

The eight electrodes 32 constituting the second DC electrode group 32G are connected to different lead wires 42, respectively. Each of the lead wires 42 is welded to the inner peripheral surface of the electrode 32 at the tip portion thereof, and enters the second sublumen 62L from the side hole formed in the tube wall of the multi-lumen tube 60. The eight lead wires 42 that have entered the second sublumen 62L extend to the second sublumen 62L as the second lead wire group 42G.

As described above, the first lead wire group 41G (8 lead wires 41) extends to the first sublumen 61L, and the second lead wire group 42G (8 lead wires 42) extends to the second sublumen 62L. The first sublumen 61L extending to the first lead wire group 41G and the second sublumen 62L extending the second lead wire group 42G sandwich the central lumen 60L. By being arranged so as to face each other, a sufficient separation distance between the first lead wire group 41G and the second lead wire group 42G can be secured.

The four lead wires 43 shown in FIG. 5 are connected to each of the electrodes 33 for measuring the potential. Each of the electrodes 33 can be connected to the electrocardiograph by the lead wire 43.

The four electrodes 33 used for the potential measurement are connected to different lead wires 43, respectively. Each of the lead wires 43 is welded to the inner peripheral surface of the electrode 33 at the tip portion thereof, and enters the third sublumen 63L from the side hole formed in the tube wall of the multi-lumen tube 60 to enter the third sublumen 63L. It extends to the lumen 63L.

The defibrillation catheter 200 of the present embodiment has a first operation wire 511 for bending the tip flexible portion of the multi-lumen tube 60 in the first direction (direction indicated by the arrow A), and the tip flexible portion. It is provided with a second operation wire 512 for bending in a second direction (direction indicated by an arrow B).
Here, the "tip flexible portion" refers to a tip region of a multi-lumen tube that can be bent by pulling an operation wire (first operation wire 511, second operation wire 512).

The first operation wire 511 is movably inserted in the fifth sublumen 65L of the multi-lumen tube 60 in the pipe axial direction. The tip portion of the first operation wire 511 is connected and fixed to the tip tip 35 by, for example, solder filled in the internal space of the tip tip 35. Further, the base end of the first operation wire 511 is connected to the knob 85 of the control handle 80 so that the pull operation can be performed.

On the other hand, the second operation wire 512 is movably inserted in the sixth sublumen 66L of the multi-lumen tube 60 in the tube axial direction. The tip portion of the second operation wire 512 is connected and fixed to the tip tip 35 by, for example, solder filled in the internal space of the tip tip 35. Further, the base end of the second operation wire 512 is connected to the knob 85 of the control handle 80 so that the tension operation can be performed.

When the knob 85 of the control handle 80 is rotated in the A1 direction shown in FIG. 4, the first operation wire 511 is pulled and moves to the base end side of the fifth sublumen 65L, and the tip flexible portion is moved in the first direction. It can be bent in the direction indicated by the arrow A.
On the other hand, when the knob 85 of the control handle 80 is rotated in the B1 direction shown in FIG. 4, the second operation wire 512 is pulled and moves to the base end side of the sixth sublumen 66L, and the tip flexible portion is moved to the base end side. It can be bent in two directions (the direction indicated by the arrow B).

As shown in FIG. 5, a lead wire is not inserted through the fourth sublumen 64L of the multi-lumen tube 60, which is an empty lumen.

According to the defibrillation catheter 200 of this embodiment, the first sublumen 61L in which the first lead wire group 41G extends and the second sublumen 62L in which the second lead wire group 42G extends. However, since the central lumen 60L is arranged so as to face each other, the first lead wire group 41G and the second lead wire group 42G are sufficiently separated from each other in the multi-lumen tube 60. It can be completely isolated. As a result, when the voltage required for cardioversion is applied, between the first lead wire group 41G (first DC electrode group 31G) and the second lead wire group 42G (second DC electrode group 32G). It is possible to surely prevent a short circuit from occurring.

Although the embodiments of the present invention have been described above, the present invention is not limited to these, and various modifications can be made.
For example, the braid that reinforces the tip region of the multi-lumen tube to which the electrodes are mounted is made of resin (the same braid as the braid 18), and the braid that reinforces the base end region of the multi-lumen tube to which the electrodes are not mounted is stainless steel or the like. It may be made of metal.

100 defibrillation catheter 10 multi-lumen tube 10L central lumen 11L-14L sublumen 15 resin tube 16 inner part 17 outer part 18 braid 20 handle 21 handle body 22 knob 24 strain relief 31G 1st DC electrode group 32G 2nd DC electrode group 31 , 32, 33 Electrode 35 Tip tip 41G 1st lead wire group 42G 2nd lead wire group 41, 42, 43 Lead wire 51 Operation wire 200 Definement catheter 60 Multi-lumen tube 60L Central lumen 61L-66L Sublumen 68 Inner Part 68 Outer part 67 Resin tube 80 Control handle 85 Knob

Claims (4)

A first electrode group consisting of an insulating tube member, a handle connected to the base end of the tube member, and a plurality of ring-shaped electrodes mounted on the tip region of the tube member, and a base from the first electrode group. A first group consisting of a second electrode group consisting of a plurality of ring-shaped electrodes mounted on the tip region of the tube member separated from the end side and a lead wire connected to each of the electrodes constituting the first electrode group. A lead wire group and a second lead wire group composed of lead wires connected to each of the electrodes constituting the second electrode group are provided, and between the first electrode group and the second electrode group. A catheter that defibrillates in the heart cavity by applying voltages of different polarities.
The tube member is a multi-lumen structure having a central lumen through which a guide wire can be inserted, which is partitioned by a fluororesin tube, and at least a pair of sub-lumens arranged so as to face each other with the central lumen in between. Yes,
The lead wires constituting the first lead wire group extend to one of the pair of sublumens, and the lead wires constituting the second lead wire group extend to the other of the pair of sublumens. Ori,
An intracardiac defibrillation catheter characterized in that the ratio of the diameter of the central lumen to the outer diameter of the tube member is 0.2 or more. The first aspect of claim 1, wherein the first lead wire group extends to one of the pair of sublumens, and the second lead wire group extends to the other of the pair of sublumens. Intraluminal defibrillation catheter. The intracardiac cavity according to claim 1 or 2, wherein the tube member is reinforced by a braid over its entire length, and at least the braid that reinforces the tip region of the tube member is made of resin. Defibrillation catheter. The intracardiac defibrillation catheter according to claim 3, wherein the tube member is reinforced by a resin braid over its entire length.

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