JP2019122862A - Intracardiac defibrillation catheter - Google Patents

Abstract

To provide a defibrillation catheter that can be inserted into a target site in a heart chamber along guide wire, and can reliably prevent short-circuiting between a first lead wire group and a second lead wire group.SOLUTION: A defibrillation catheter includes a multi-lumen tube 10, a first DC electrode group 31G, a second DC electrode group 32G, a first lead wire group 41G comprising lead wire 41 connected to each of a constituent electrode 31 of the first DC electrode group 31G, and a second lead wire group 42G comprising lead wire 42 connected to each of a constituent electrode 32 of the second DC electrode group 32G. The defibrillation catheter applies voltage between the first DC electrode group 31G and the second DC electrode group 32G. The multi-lumen tube 10 has a central lumen 10 L capable of inserting guide wire, and sub-lumens 11 L and 12 L oppositely disposed across this. The first lead wire group 41G is extended to the sub-lumen 11 L, and the second lead wire group 42G is extended to the sub-lumen 12 L.SELECTED DRAWING: Figure 3B

Description

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

  If atrial fibrillation occurs during cardiac catheterization, it is necessary to perform electrical defibrillation. The applicant has used an insulating tube member having a multi-lumen structure, a handle connected to the proximal end of the tube member, and the tube member as a catheter for performing such defibrillation in the heart chamber. A first DC electrode group comprising a plurality of ring electrodes mounted in the distal end region of the second DC electrode, and a second DC electrode comprising a plurality of ring electrodes spaced apart from the first DC electrode group toward the proximal end and mounted on the tube member A second lead wire group comprising a first lead wire group comprising a lead wire connected to each of the electrodes constituting the first DC electrode group, and a second lead wire comprising the lead wire connected to each of the electrodes constituting the second DC electrode group; And a lead wire group, wherein the first lead wire group and the second lead wire group extend to different lumens of the tube member, and when performing defibrillation, the first DC And polar permanent, the said first 2DC electrode group has proposed the intracardiac defibrillation catheter different polarity voltage is applied to each other (see Patent Document 1).

  By inserting the intracardiac defibrillation catheter of such a configuration into the right atrium from the superior vena cava and further inserting it into the opening (coronary sinus ostium) in the posterior lower wall of the right atrium. After the first DC electrode group is positioned in the coronary sinus and the second DC electrode group is positioned in the right atrium, voltages of different polarities are applied to the first DC electrode group and the second DC electrode group Do. As a result, it is possible to provide the heart causing atrial fibrillation with sufficient electric energy necessary for defibrillation.

FIG. 6 is a transverse cross-sectional view of the distal end region of a tube member constituting the defibrillation catheter described in Patent Document 1. Four tube lumens (a first lumen 111, a second lumen 112, A third lumen 113 and a fourth lumen 114) are formed.
In FIG. 6 , 115 is a resin tube made of fluorocarbon resin that divides the lumen, 116 is an inner part made of low-hardness nylon elastomer, 117 is an outer part made of high-hardness nylon elastomer, and 118 is a braid Is a stainless steel wire that forms

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

  As described above, the first lead wire group 141G and the second lead wire group 142G respectively extend to different lumens of the tube member (the first lumen 111 and the second lumen 112). When a voltage necessary for intraluminal 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) It can be prevented.

JP, 2010-63708, A

  The intracardiac defibrillation catheter is inserted from the inferior vena cava into the right atrium and inserted into the coronary sinus opening (approach from the inferior vena cava), and it is inserted from the superior vena cava into the right atrium. It is less invasive than the conventional procedure (approach from the superior vena cava) for insertion into the stoma.

  However, in the approach from the inferior vena cava, the operation of inserting the intracardiac defibrillation catheter into the coronary sinus opening is difficult, and after inserting it into the coronary sinus opening, the torque is applied to untwist the tube member. And other operations are necessary and complicated.

  To address such problems, it is conceivable to insert an intracardiac defibrillation catheter along a guide wire previously inserted into the coronary sinus orifice when performing an approach 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, in the tube member having a guide wire lumen in addition to the lumen for extending the lead wire and the operation wire, the proportion of space becomes high (the proportion of resin becomes low) and the first lead wire group is extended Since the thickness of the resin separating the lumen for extending the second lead wire and the lumen for extending the second lead wire is also reduced, the first lead wire group (first DC electrode group) is applied when a voltage necessary for defibrillation is applied. And the second lead group (second DC electrode group) may cause a short circuit.

  Moreover, the defibrillation catheter provided with the tube member in which the ratio occupied by the space is high (the ratio occupied by the resin is low) by having the guide wire lumen is inferior in torque transmission.

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

  According to a second object of the present invention, there is an intracardiac defibrillation capable of exhibiting excellent torque transferability despite the fact that the proportion of the resin constituting the tube member is lowered by having the guide wire lumen. It will provide a dynamic catheter.

(1) The intracardiac defibrillation catheter according to the present invention comprises an insulating tube member, a handle connected to the proximal end of the tube member, and a plurality of ring electrodes attached to the distal end region of the tube member. A second DC electrode group comprising a first DC electrode group consisting of a plurality of ring electrodes spaced apart from the first DC electrode group to the proximal end side and attached to the distal end region of the tube member; It comprises: a first lead wire group consisting of a lead wire connected to each of the constituting electrodes; and a second lead wire group consisting of a lead wire connected to each of the electrodes constituting the second DC electrode group, A catheter for performing defibrillation in a heart cavity by applying voltages of different polarities to each other 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 and at least one pair of sub-lumens disposed to face each other across the central lumen.
The lead wire constituting the first lead wire group extends to one of the pair of sub-lumens, and the lead wire constituting the second lead wire group extends to the other of the pair of sub-lumens It is characterized by

  According to the intracardiac defibrillation catheter having such a configuration, the lead wire forming the first lead wire group and the lead wire forming the second lead wire group are opposed to each other across the central lumen. By extending to one and the other of the pair of sub-lumens disposed in the first group, the lead wires constituting the first lead wire group and the lead wires constituting the second lead wire group are sufficiently separated from each other. In this state, complete insulation isolation can be achieved in the tube member.

(2) In the intracardiac defibrillation catheter according to the present invention, the first lead group extends to one of the pair of sub-lumens, and the second lead group extends to the other of the pair of sub-lumens. It is preferable to exist.

  According to the intracardiac defibrillation catheter having such a configuration, the first lead group (all the leads constituting the same) and the second lead group (all the leads constituting the same) The first lead wire group and the second lead wire group are sufficiently separated by extending to one side and the other side of the pair of sub-lumens disposed to face each other across the central lumen, respectively. In this state, insulation can be completely isolated in the tube member.

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

According to such an intracardiac defibrillation catheter, since the tube member is reinforced by the braid over the entire length, excellent torque can be obtained despite the fact that the resin content is reduced by having the central lumen. Transmission can be demonstrated.
Further, since the braid reinforcing the distal end 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 through the tube wall of the distal end region of the tube member, The resin wire exposed on the inner peripheral surface of the side hole does not damage the lead wire inserted in the side hole.

(4) In the intracardiac defibrillation catheter according to (3) , preferably, the tube member is reinforced by a resin braid over the entire length thereof.

According to such an intracardiac defibrillation catheter, since the tube member is reinforced by the braid over the entire length, excellent torque can be obtained despite the fact that the resin content is reduced by having the central lumen. Transmission can be demonstrated.
Further, since the braid is made of resin, it is possible to easily form a side hole for passing the lead wire of the electrode through the tube wall in the tip region of the tube member, and to expose the inner peripheral surface of the side hole The resin wire does not damage the lead wire inserted into the side hole.
In addition, since the braid is made of resin, short circuiting does not occur through this braid.
Further, the tube member (blade tube) reinforced by resin braid over the entire length can be manufactured by one extrusion molding, for example, the tip portion reinforced by resin braid and metal braid It is easy to manufacture as compared with a blade tube formed by joining with the proximal end portion reinforced by the. In addition, there is no kink that is likely to occur in the tube portion where the material of braiding changes.

According to the intracardiac defibrillation catheter of the present invention, the catheter can be inserted along the guide wire into the target site in the heart cavity, and even if it is an operation inserted into the coronary sinus by the 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.

  Further, according to the intracardiac defibrillation catheter of the present invention in which the tube member is reinforced with 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 showing a defibrillation catheter concerning a 1st embodiment of the present invention. It is explanatory drawing which shows the front-end | tip area | region of the defibrillation catheter shown in FIG. It is a cross-sectional view (AA sectional drawing) of the front-end | tip area | region of the defibrillation catheter shown in FIG. It is a cross-sectional view (BB sectional drawing) of the front-end | tip area | 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 sectional drawing) of the front-end | tip area | region of the defibrillation catheter shown in FIG. FIG. 7 is a cross-sectional view showing the tip region of a conventional defibrillation catheter.

First Embodiment
The defibrillation catheter 100 of this embodiment shown in FIGS. 1 to 3 (FIGS. 3A and 3B) comprises a multilumen tube 10, a handle 20 connected to its proximal end, and a distal end region of the multilumen tube 10. A first DC electrode group 31G comprising eight ring electrodes 31 mounted, and eight ring electrodes 32 mounted at the distal end region of the multi-lumen tube 10 at a proximal end side from the first DC electrode group 31G. , A ring-shaped electrode 33 for potential measurement mounted on a 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 10 includes a tip 35 attached to the tip of 10 and a lead wire 41 connected to each of the electrodes 31 constituting the first DC electrode group 31G. A second lead wire group 42G consisting of a lead wire 42 connected to each of the first lead wire group 41G and the electrodes 32 constituting the second DC electrode group 32G, and a ring electrode 33 for potential measurement A catheter comprising a lead wire 43 and performing defibrillation in a heart cavity by applying voltages of different polarities to each other between a first DC electrode group 31G and a second DC electrode group 32G. The lumen tube 10 is reinforced by a resin braid 18 over its entire length, and a central lumen 10L serving as a guide wire lumen and a first sub-lumen 11L and a first sublumen 11L disposed opposite to each other with the central lumen 10L interposed therebetween. A third sub-lumen 13L and a third sub-lumen 13L arranged to face each other across the central lumen 10L and the second sub-lumen 12L. The first lead group 41G extends to the first sublumen 11L, and the second lead group 42G extends to the second sublumen 12L. Extends to the third sub-lumen 13L.

  The defibrillation catheter 100 according to the present embodiment includes a multilumen 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, and a distal end tip 35. A first lead wire group 41G, a second lead wire group 42G, and a 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 is 2.0 mm as a preferable example.

1 and 2, although the tip region of the multi-lumen tube 10 is shown linearly, the tip region usually has a specific curve shape.
Although the shape disclosed by Unexamined-Japanese-Patent No. 2012-50673, 2012-192124 etc. can be illustrated as such curve shape of a front end area | region, It is not limited to these.
In addition, the curve shape of such a tip region is a shape when receiving no force from the outside, for example, when the multi-lumen tube 10 is passed through a linear lumen, it is deformed into a linear shape, When the lumen tube 10 is passed through a curved lumen, it curves according to the shape of the lumen. Further, the shape of the distal end region can be changed by the operation of the handle 20 described later.

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

  A multi-lumen tube 10 (inner portion 16) has a central lumen 10L as a guide wire lumen and four sub-lumens around the central lumen 10L (a first sub-lumen 11L, a second sub-lumen 12L, a third sub-lumen Each of 13 L and the fourth sub-lumen 14 L) is formed by being divided by the resin tube 15.

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

The first sub-lumen 11L and the second sub-lumen 12L are disposed to face each other across the central lumen 10L.
The third sub-lumen 13L and the fourth sub-lumen 14L are disposed to face each other across the central lumen 10L.

  The cross sections of the first sub-lumen 11L, the second sub-lumen 12L and the third sub-lumen 13L are each capsule-shaped (elliptical), thereby enlarging the outer diameter of the multi-lumen tube 10 more than necessary As a result, the area of the lumen can be secured widely, and the assembling operation can be simplified.

  As a resin which comprises the inner part 16 and the outer part 17, a thermoplastic polyamide-type elastomer can be mentioned, Especially, polyether block amide (PEBAX) is preferable.

It is preferable that the hardness of resin which comprises the inner part 16 is 25D-40D.
It is preferable that the hardness of resin which comprises the outer part 17 is 35D-72D. In addition, as resin which comprises the outer part 17, the thing of the hardness which changes with axial directions is used normally.

  The resin tube 15 that partitions and forms the lumen is made of a highly insulating fluorocarbon resin such as perfluoroalkylvinylether copolymer (PFA) or polytetrafluoroethylene (PTFE).

As shown in FIGS. 3A and 3B, a braid 18 made of a resin, which is a reinforcing material, is embedded inside 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 formed by arranging 16 sets (32) of resin wire rods at equal angular intervals in the circumferential direction.

  As described above, the multi-lumen tube 10 is reinforced with the braid 18 over the entire length (which is a blade tube), so that the central lumen 10L is excellent in spite of the fact that the proportion of resin is low. Torque transferability can be exhibited.

  Also, since the braid 18 is made of resin, no short circuit will occur through the braid 18. Further, since the braid 18 is made of resin, it is possible to easily form a side hole for passing the lead wires (lead wires 41, 42 and 43) of the electrodes through the tube wall in the tip region of the multi-lumen tube 10, Further, the resin wire exposed on the inner circumferential surface of the side hole does not damage the lead wire inserted in the side hole.

  When a metal braid is embedded in place 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 a side hole can be formed. Even when the defibrillation catheter is manufactured and used, the lead wire of the electrode comes in contact with the metal wire to expose the metal wire forming the braid on the inner peripheral surface of the side hole. It is possible that the resin coating layer which comprises these is damaged and the insulation of the said lead wire is impaired. Therefore, it is not possible to embed the metal braid over the entire length including the distal end region of the multi-lumen tube 10.

The constituent material of the braid 18 (resin wire) is selected from resins which can exhibit a reinforcing effect by being embedded.
The hardness of the constituent material of the braid 18 is preferably 72 D or more. If the hardness is too low, sufficient reinforcing effect and eventually good torque transmission may not be exhibited.
The flexural modulus (ISO 178 or JIS K 7171) of the 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. And a preferred example is 4,200 MPa.

  PEEK resin, a polyimide resin, a polyamide resin, a polyester resin etc. can be mentioned as a suitable reinforcement resin which comprises braid 18 (resin wire material), Among these, PEEK resin is especially preferable.

The wire diameter of the resin wire forming the braid 18 is usually 30 to 100 μm, and 60 μm as a preferable example.
The number of strikes of the braid 18 is usually 8 to 32, and 16 is a preferred example.
The number of braids 18 is usually 1 to 4 and 2 is a preferred example.

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 distal end 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 distal end region of the multi-lumen tube 10.
In the present invention, “electrode group” refers to a plurality of electrodes which constitute the same pole (having the same polarity) or which have the same purpose and which are attached at narrow intervals (for example, 5 mm or less) An aggregate is said.

  In the first DC electrode group, a plurality of electrodes constituting the same pole (− pole or + pole) are attached 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 31 G is configured of eight ring-shaped electrodes 31. The electrodes 31 constituting the first DC electrode group 31G are connected via lead wires (lead wires 41 constituting the first lead wire group 41G shown in FIG. 3A and FIG. 3B) and a connector incorporated in the proximal end of the handle 20. It is connected to the terminal of the same pole in the DC power supply device.

Here, the width (axial length W1) of the electrode 31 is preferably 2 to 5 mm, and is 4 mm as a preferable example.
If the width of the electrode 31 is too narrow, the amount of heat generation at the time of voltage application becomes 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 to which the first DC electrode group 31G is attached may be impaired.

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

  In the second DC electrode group, in the distal end region of the tube member spaced apart from the mounting position of the first DC electrode group on the proximal side, a plurality of electrodes constituting poles (+ pole or − pole) opposite to the first DC electrode group It is worn 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 32 G is configured of eight ring 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 incorporated in the base end of the handle 20 Are connected to terminals of the same pole at the same terminal (a terminal of the opposite pole to that to which the first DC electrode group 31G is connected).
As a result, voltages of 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 It becomes an electrode group (When one electrode group is-pole, the other electrode group is + pole) from which polarity mutually differs.

Here, the width (axial length W2) of the electrode 32 is preferably 2 to 5 mm, and is 4 mm as a preferable example.
If the width of the electrode 32 is too narrow, the amount of heat generation at the time of voltage application becomes excessive, which may damage 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 attached may be impaired.

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

  In addition, the electrode which comprises 31 G of 1st DC electrode groups and 2nd DC electrode group can also be used in order to measure an electric potential.

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

Here, the width (axial length W3) of the electrode 33 is preferably 0.5 to 2.0 mm, and is 1.2 mm as a preferable example.
If the width of the electrode 33 is too wide, the measurement accuracy of the cardiac potential may be reduced, or it may be difficult to identify the generation site of the abnormal potential.

At the tip of the intracardiac defibrillation catheter 100, a tip 35 is attached.
A lead wire is not connected to the distal end tip 35, and the distal end 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 distal end tip 35 is not particularly limited, such as metal materials such as platinum and stainless steel, various resin materials, and the like.

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

  As the electrode 31 constituting the first DC electrode group 31G, the electrode 32 constituting the second DC electrode group 32G, and the electrode 33 for potential measurement, platinum or platinum-based to improve the contrast property with respect to X-rays It is preferably made of an alloy.

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

  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 its tip end portion, and enters the first sub-lumen 11 L from the side hole formed in the tube wall of the multi-lumen tube 10. The eight lead wires 41 entering the first sub-lumen 11L extend to the first sub-lumen 11L as a first lead wire group 41G.

The second lead wire group 42G shown in FIG. 3B is an assembly 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 its tip end portion, and enters the second sub-lumen 12 L from the side hole formed in the tube wall of the multi-lumen tube 10. The eight lead wires 42 entering the second sub-lumen 12L extend to the second sub-lumen 12L as a second lead wire group 42G.

  As described above, the first lead wire group 41G (eight lead wires 41) extends to the first sub-lumen 11L, and the second lead wire group 42G (eight lead wires 42) is the second sub-lumen 12L , And the second sub-lumen 12L, in which the second lead group 42G extends, sandwiching the central lumen 10L. By arranging so as to face each other, a sufficient distance between the first lead wire group 41G and the second lead wire group 42G can be secured.

  Four leads 43 shown in FIGS. 3A and 3B are connected to each of the electrodes 33 for potential measurement. Leads 43 allow each of the electrodes 33 to be connected to the electrocardiograph.

  The four electrodes 33 used for 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 its tip portion, and enters the third sub-lumen 13L from the side hole formed in the tube wall of the multi-lumen tube 10, 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 lead is covered with a resin such as polyimide. Here, the film thickness of the coating resin is about 2 to 30 μm.

In FIG. 3A and FIG. 3B, 51 is a wire for operation.
The operation wire 51 extends to the fourth sub-lumen 14 L 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 35 by, for example, a solder.
On the other hand, the proximal 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 distal end region of the multi-lumen tube 10 can be changed.

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

  Only the operation wire 51 extends in the fourth sub-lumen 14L of the multi-lumen tube 10, and the lead wire (s) does not. As a result, when the distal end portion of the multi-lumen tube 10 is deflected, the lead wire can be prevented from being damaged (for example, scratched) by the operation wire 51 moved in the axial direction.

  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 also insulated inside the handle 20. It is preferable that it is isolated.

  The defibrillation catheter 100 according to the present embodiment applies the direct current voltage between the first DC electrode group 31G and the second DC electrode group 32G to directly give electrical energy to the heart causing fibrillation to thereby apply electrical energy. It is a catheter for performing defibrillation treatment.

  The defibrillation catheter 100 of this embodiment is placed in the heart cavity such 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.

In order to be placed in such a state, first, a guide wire is inserted from the inferior vena cava into the right atrium, and further inserted into the coronary sinus opening in the posterior lower wall of the right atrium.
Next, the defibrillation catheter 100 is inserted from the inferior vena cava into the right atrium along the guide wire, and further inserted into the coronary sinus opening in the posterior lower wall of the right atrium and inserted into the coronary sinus. (Go forward).
Here, the procedure (the approach from the inferior vena cava) in which the defibrillation catheter 100 is inserted from the inferior vena cava into the right atrium and inserted into the coronary sinus opening is more invasive than the approach from the superior vena cava It is preferable because of its low nature.

  The defibrillation catheter 100 of the present embodiment is suitably used when performing cardiac catheterization in which atrial fibrillation is apt to occur. Particularly preferably, the intracardiac defibrillation catheter 100 is preinserted into the patient's cardiac cavity prior to cardiac catheterization.

  During cardiac catheterization, an electrocardiogram measured by the constituent electrodes of the first DC electrode group 31G and / or the second DC electrode group 32G or the electrode 33 for measuring the potential is monitored (monitoring), and atrial fibrillation occurs. Interrupt cardiac catheterization and perform defibrillation therapy 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. It directly supplies electrical energy to the heart.

Here, the electrical 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 therapy can not be performed. On the other hand, when the electrical energy is excessive, there is a possibility that the tissue in the vicinity where 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 along the guide wire into the target site in the cardiac cavity, and is inserted into the coronary sinus opening by the approach from the inferior vena cava. But it can be easily implemented.

  Further, according to the intracardiac defibrillation catheter 100, the first sub-lumen 11L in which the first lead wire group 41G extends and the second sub-lumen in which the second lead wire group 42G extends. The multi-lumens in which the first lead wire group 41G and the second lead wire group 42G are sufficiently separated by being disposed to face each other with the central lumen 10L interposed therebetween. It can be completely isolated within the tube 10. Thereby, when a voltage necessary for intracardiac defibrillation is applied, a voltage between the first lead wire group 41G (the first DC electrode group 31G) and the second lead wire group 42G (the second DC electrode group 32G) Can reliably prevent the occurrence of a short circuit.

  Further, the multi-lumen tube 10 constituting the intracardiac defibrillation catheter 100 is reinforced by the resin braid 18 over the entire length, so that excellent torque transmission can be exhibited. Also, since the braid 18 is made of resin, no short circuit will 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 transverse cross-sectional view (sectional view taken along the line C-C of FIG. 4) of the distal end region of the defibrillation catheter 200 .

  The defibrillation catheter 200 of the present embodiment is attached to the multi-lumen tube 60 having a distal flexible portion, the control handle 80 connected to the proximal end of the multi-lumen tube 60, and the distal flexible portion of the multi-lumen tube 60 A first DC electrode group 31G comprising eight ring electrodes 31 and an eight ring shape attached to the distal flexible portion of the multi-lumen tube 60 at a distance from the first DC electrode group 31G to the proximal end side A second DC electrode group 32G composed of the electrodes 32, and four ring-shaped electrodes 33 for potential measurement mounted on the flexible end portion of the multi-lumen tube 60 between the first DC electrode group 31G and the second DC electrode group 32G Connected to the tip 31 of the multi-lumen tube 60 and the electrode 31 constituting the first DC electrode group 31 G. A second lead wire group 42G consisting of a lead wire 42 connected to each of a first lead wire group 41G consisting of a lead wire 41 and an electrode 32 constituting a second DC electrode group 32G, and a ring-shaped electrode 33 for potential measurement A first operation for pulling the proximal end of the lead wire 43 connected to each of the first and second ends of the multi-lumen tube 60 so as to bend the distal end flexible portion in the first direction (the direction shown by arrow A in FIG. Wire 511, and a second operation wire 512 capable of pulling the proximal end of the multi-lumen tube 60 in order to bend the distal end flexible portion in a second direction (the direction indicated by arrow B in FIG. 4). It is a catheter that performs defibrillation in the heart cavity by applying voltages of different polarities to each other between the first DC electrode group 31G and the second DC electrode group 32G.

  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 comprising a resin-made braid 18 embedded inside the outer portion 69 over the entire length of the tube 60.

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

The first sub-lumen 61L and the second sub-lumen 62L are disposed to face each other across the central lumen 60L.
The third sub-lumen 63L and the fourth sub-lumen 64L are disposed to face each other across the central lumen 60L.
The fifth sub-lumen 65L and the sixth sub-lumen 66L are disposed to face each other with the central lumen 60L interposed therebetween.

The cross sections of the first sub-lumen 61L, the second sub-lumen 62L, the third sub-lumen 63L, and the fourth sub-lumen 64L are each capsule shaped (small).
Also, the cross sections of the fifth sub-lumen 65L and the sixth sub-lumen 66L are each circular.

  Further, the multi-lumen tube 60 is reinforced by a resin braid 18 over the entire length, as with 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 assembly of eight lead wires 41 connected to each of the eight electrodes 31 constituting the first DC electrode group 31G.
Each of the eight electrodes 31 constituting the first DC electrode group 31G can be electrically connected to the DC power supply device by the first lead wire group 41G (lead wire 41).

  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 its tip end portion, and enters the first sub-lumen 61 L from a side hole formed in the tube wall of the multi-lumen tube 60. The eight lead wires 41 entering the first sub-lumen 61L extend to the first sub-lumen 61L as a first lead wire group 41G.

The second lead wire group 42G shown in FIG. 5 is an assembly 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 circumferential surface of the electrode 32 at its tip portion, and enters the second sub-lumen 62 L from the side hole formed in the tube wall of the multi-lumen tube 60. The eight lead wires 42 entering the second sub-lumen 62L extend to the second sub-lumen 62L as a second lead wire group 42G.

  As described above, the first lead wire group 41G (eight lead wires 41) extends to the first sub-lumen 61L, and the second lead wire group 42G (eight lead wires 42) is the second sub-lumen 62L , And the second sub-lumen 62L, in which the second lead group 42G extends, sandwiching the central lumen 60L. By arranging so as to face each other, a sufficient distance between the first lead wire group 41G and the second lead wire group 42G can be secured.

  Four lead wires 43 shown in FIG. 5 are connected to each of the electrodes 33 for potential measurement. Leads 43 allow each of the electrodes 33 to be connected to the electrocardiograph.

  The four electrodes 33 used for 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 its tip portion, and enters the third sub-lumen 63L from the side hole formed in the tube wall of the multi-lumen tube 60, It extends to the lumen 63L.

The defibrillation catheter 200 of this embodiment includes a first operation wire 511 for bending the distal flexible portion of the multi-lumen tube 60 in a first direction (the direction indicated by the arrow A), and the distal flexible portion. And a second operation wire 512 for bending in a second direction (direction indicated by arrow B).
Here, the “tip flexible portion” refers to a tip region of a multi-lumen tube that can be bent by pulling the manipulation wires (the first manipulation wire 511 and the second manipulation wire 512).

  The first operation wire 511 is inserted in the fifth sub-lumen 65 </ b> L of the multi-lumen tube 60 so as to be movable in the axial direction of the tube. The distal end portion of the first operation wire 511 is connected and fixed to the distal end tip 35 by, for example, a solder filled in the internal space of the distal end tip 35. Further, the proximal end of the first operation wire 511 is connected to the knob 85 of the control handle 80 so that it can be pulled.

  On the other hand, the second operation wire 512 is inserted in the sixth sub-lumen 66L of the multi-lumen tube 60 so as to be movable in the axial direction of the tube. The distal end portion of the second operation wire 512 is connected and fixed to the distal end tip 35 by, for example, a solder filled in the internal space of the distal end tip 35. Further, the proximal end of the second operation wire 512 is connected to the knob 85 of the control handle 80 so that it can be pulled.

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

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

  According to the defibrillation catheter 200 of this embodiment, the first sub-lumen 61L in which the first lead wire group 41G extends and the second sub-lumen 62L in which the second lead wire group 42G extends. Are disposed to face each other with the central lumen 60L in between, in a state where the first lead wire group 41G and the second lead wire group 42G are sufficiently separated, in the multi-lumen tube 60 It can be completely isolated and isolated. Thereby, when a voltage necessary for intracardiac defibrillation is applied, a voltage between the first lead wire group 41G (the first DC electrode group 31G) and the second lead wire group 42G (the second DC electrode group 32G) Can reliably prevent the occurrence of a short circuit.

As mentioned above, although embodiment of this invention was described, this invention is not limited to these, A various change is possible.
For example, the braid that reinforces the distal end region of the multilumen tube to which the electrode is attached is made of resin (a braid similar to the braid 18), and the braid that reinforces the proximal end region of the multilumen tube not having the electrode attached is stainless steel or the like It may be made of metal.

100 defibrillation catheter 10 multi-lumen tube 10 L central lumen 11 L-14 L sub-lumen 15 resin tube 16 inner part 17 outer part 18 braided 20 handle 21 handle main body 22 pinch 24 strain relief 31 G 1st DC electrode group 32 G 2nd DC electrode group 31 , 32, 33 electrode 35 tip 41G first lead wire group 42G second lead wire group 41, 42, 43 lead wire 51 operation wire 200 defibrillation catheter 60 multilumen tube 60L central lumen 61L to 66L sublumen 68 inner Part 68 Outer part 67 Resin tube 80 Control handle 85 Picking

Claims (4)

An insulating tube member, a handle connected to the proximal end of the tube member, a first electrode group including a plurality of ring-shaped electrodes mounted in a distal end region of the tube member, and a base from the first electrode group A second electrode group comprising a plurality of ring-like electrodes mounted on the end region of the tube member spaced apart to the end side, and a first wire comprising a lead wire connected to each of the electrodes constituting the first electrode group A lead wire group and a second lead wire group consisting of a lead wire connected to each of the electrodes constituting the second electrode group, and between the first electrode group and the second electrode group A catheter for performing defibrillation in a heart chamber 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 and at least one pair of sub-lumens disposed to face each other across the central lumen.
The lead wire constituting the first lead wire group extends to one of the pair of sub-lumens, and the lead wire constituting the second lead wire group extends to the other of the pair of sub-lumens An intracardiac defibrillation catheter characterized in that   2. The apparatus according to claim 1, wherein the first lead group extends to one of the pair of sub-lumens, and the second lead group extends to the other of the pair of sub-lumens. Intracardiac 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 the braid reinforcing at least a distal end 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 the entire length thereof.

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