JP4937391B2 - 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.

An external defibrillator (AED) is known as a defibrillator for removing atrial fibrillation (see, for example, Patent Document 1).
In defibrillation treatment by AED, electrical energy is given to the patient's body by attaching an electrode pad to the patient's body surface and applying a DC voltage. Here, the electrical energy flowing from the electrode pad into the patient's body is usually 150 to 200 J, and a part (usually, about several percent to 20%) of the fluid flows to the heart and is used for defibrillation treatment.

Thus, atrial fibrillation is likely to occur during cardiac catheterization, and even in this case, it is necessary to perform cardioversion.
However, depending on the AED that supplies electric energy from outside the body, it is difficult to supply effective electric energy (for example, 10 to 30 J) to the heart that is causing fibrillation.

That is, sufficient defibrillation treatment cannot be performed when the proportion of electrical energy supplied from outside the body is small (for example, about several percent).
On the other hand, when the electrical energy supplied from outside the body flows to the heart at a high rate, the heart tissue may be damaged.
Further, in the defibrillation treatment by AED, burns are likely to occur on the body surface to which the electrode pad is attached. And as mentioned above, when the ratio of the electrical energy flowing through the heart is small, repeated supply of electrical energy increases the degree of burns, which places a heavy burden on the patient undergoing catheterization.

  In order to solve such a problem, the applicant of the present invention is a catheter for defibrillation inserted into a heart chamber, and an insulating tube member having a multi-lumen structure, and a proximal end of the tube member A first DC electrode group composed of a plurality of ring-shaped electrodes attached to a distal end region of the tube member, and attached to the tube member spaced from the first DC electrode group to the proximal end side A second DC electrode group comprising a plurality of ring-shaped electrodes; a first lead wire group comprising lead wires connected to each of the electrodes constituting the first DC electrode group; and each electrode constituting the second DC electrode group A second lead wire group consisting of lead wires connected to each other; the first lead wire group and the second lead wire group extending to different lumens of the tube member, Do fibrillation Kiniwa, said first 1DC electrode group, the said first 2DC electrode group has proposed the intracardiac defibrillation catheter different polarity voltage is applied to each other (see Patent Document 2). Although the tube member constituting the intracardiac defibrillation catheter can be bent at the distal end portion by operating the handle, the shape thereof is a straight line and no curve is formed.

  According to the intracardiac defibrillation catheter having such a configuration, the electrical energy necessary and sufficient for defibrillation can be reliably supplied to the heart that has undergone atrial fibrillation during cardiac catheterization. In addition, the patient's body surface is not burned and is less invasive. Further, it is possible to reliably prevent a short circuit from occurring between the first lead wire group and the second lead wire group when a voltage necessary for intracardiac defibrillation is applied.

JP 2001-112874 A JP 2010-63708 A

The defibrillation treatment by the intracardiac defibrillation catheter described in Patent Document 2 is performed as follows.
As shown in FIG. 7, an intracardiac defibrillation catheter 150 is inserted into the right atrium 82 from the superior vena cava 81, and further, the opening of the coronary sinus 83 in the posterior lower wall of the right atrium 82 (coronary veins). The first DC electrode group 131G is positioned in the coronary sinus 83 and the second DC electrode group 132G is positioned in the right atrium 82, and then the first DC electrode group 131G and the first DC electrode group 131G are inserted into the sinus ostium 84). Voltages having different polarities are applied to the 2DC electrode group 132G. Thereby, electric energy can be directly given to the heart causing fibrillation.

  However, the intracardiac defibrillation catheter described in Patent Document 2 has the following problems.

(1) The coronary sinus in which the first DC electrode group is to be located is a relatively thin blood vessel, and the opening diameter of the coronary sinus ostium in the inner wall of the right atrium is small. For this reason, it is extremely difficult to perform the operation of guiding the distal end portion of the defibrillation catheter inserted into the right atrium into the coronary sinus ostium (the operation of finding the position of the coronary sinus ostium).
Further, when a defibrillation catheter made of a straight tube is inserted into the heart chamber, the pushing force may be concentrated on the distal end to damage the inner wall of the blood vessel.

(2) The electrodes constituting the first DC electrode group and the second DC electrode group are also used for measuring the cardiac potential. In the measurement of the cardiac potential, an electrode positioned in the right atrium (a constituent electrode of the second DC electrode group) is brought into contact with the inner wall of the right atrium, in particular, the front inner wall of the right atrium where the flow of electricity is large (pushing). It is desirable to hit.
In order to efficiently perform defibrillation, it is preferable to arrange a defibrillation catheter so that the heart is sandwiched between the first DC electrode group and the second DC electrode group, and the first DC electrode group is positioned. Since the coronary sinus is on the posterior surface of the left side of the heart, it is desirable to bring the second DC electrode group into contact with the anterior inner wall of the right atrium.

However, since the internal space increases when the superior vena cava reaches the right atrium (the diameter of the tube that defines this space increases), as shown in FIG. The defibrillation catheter 150 inserted into the coronary sinus ostium 84 in the wall passes through the lumen (internal space) of the right atrium 82, and the defibrillation catheter 150 (second DC electrode group 132G) is passed through the right atrium 82. It is difficult to make it abut against the inner wall.
In particular, since the anterior inner wall of the right atrium 82 is offset (displaced) forward from the imaginary line connecting the superior vena cava 81 and the inferior vena cava 85, a defibrillation catheter 150 (second DC) is formed on the anterior inner wall of the right atrium. Electrode group) cannot be brought into contact, and if the defibrillation catheter 150 (second DC electrode group 132G) is forced to come into contact with the inner wall of the right atrium, defibrillation will occur. The catheter 150 is kinked.

  (3) The coronary sinus in which the first DC electrode group is to be located is a thin and curved blood vessel, and its position and shape vary depending on age, sex, etc., and therefore the defibrillation catheter 150 to which the first DC electrode group is attached. It is difficult to push the distal portion of this into the coronary sinus.

The present invention has been made based on the above situation.
The first object of the present invention is that the operability is good, and the distal end portion can be easily guided to the target site when inserted into the heart chamber, without damaging the inner wall of the blood vessel and the like. Even when inserted into a relatively wide lumen (internal space), the electrode group (second DC electrode group) can be brought into contact with or close to the inner wall defining the lumen, and is thin and curved An object of the present invention is to provide a defibrillation catheter that can easily push forward a distal end portion to which an electrode group (first DC electrode group) is attached even in a blood vessel.

  The second object of the present invention is that the operability is good and the distal end portion can be easily guided to the coronary sinus ostium in the inner wall of the right atrium at the time of insertion into the heart chamber, so that the inner wall of the blood vessel is damaged. In the case of insertion from the superior vena cava into the coronary sinus ostium in the posterior inferior wall of the right atrium, the electrode group (second DC electrode group) can be brought into contact with or close to the anterior inner wall of the right atrium. An object of the present invention is to provide a defibrillation catheter that can easily push the distal end portion of a catheter equipped with the first DC electrode group) in the coronary sinus.

(1) An intracardiac defibrillation catheter of the present invention includes an insulating tube member, a handle connected to the proximal end of the tube member, and a plurality of ring electrodes attached to a distal end region of the tube member A first electrode group (first DC electrode group) comprising: a second electrode group (first electrode group comprising a plurality of ring-shaped electrodes mounted on the distal end region of the tube member spaced from the first DC electrode group toward the proximal end side 2DC electrode group), and a catheter that performs defibrillation in the heart chamber by applying voltages of different polarities to the first DC electrode group and the second DC electrode group,
A first curved portion formed by bending a distal end portion to which the first DC electrode group is mounted in a distal end region of the tube member;
On the base end side of the second DC electrode group, an S-shaped (sigmoid curve-shaped) second curved portion on a plane different from the plane including the first curved portion is formed,
The bending shape (degree of bending) of the first curved portion is changed by the operation of the handle.

(2) The tube member includes the first curved portion to which the first DC electrode group is attached, the first straight portion to which the second DC electrode group is attached, and the S-shaped (sigmoid curved shape) second portion. It is preferable that the curved portion and the second straight portion reaching the base end are connected.

Since the first curved portion (curved tip portion) is formed in the tip region of the tube member, the tip of the catheter is rotated around the axis when the catheter is inserted, so that the tip of the catheter is moved to the target site (for example, coronary vein). Can be directed to the cave).
Further, since the distal end portion is curved by the first curved portion, the operability at the time of insertion can be improved and the inner wall of the blood vessel can be prevented from being damaged.

  Furthermore, if the bending direction of the first curved portion is determined according to the shape of the second curved portion, the catheter is advanced along the bending direction (the target direction to which the distal end of the catheter is directed), after insertion. The first curved portion (first DC electrode group) is positioned at the target site, and the first straight portion (second DC electrode group) is in contact with or close to the inner wall (for example, the front inner wall of the right atrium) at the target site. Can be made.

Further, by changing the bending shape of the first curved portion to which the first DC electrode group is attached (further bending and changing the degree of bending) by operating the handle, the distal end portion of the catheter is moved to the target site (for example, coronal shape). Can be easily guided to the sinus ostium).
Further, when the first curved portion is advanced in a thin and curved blood vessel, the degree of curvature of the first curved portion is changed so as to conform to the curved blood vessel shape. In this case, the first curved portion can be easily pushed forward.

  The S-shaped (sigmoid curve-shaped) second curved portion that is on a plane different from the plane including the first curved portion is formed on the base end side of the second DC electrode group, thereby passing through the blood vessel. Even when inserting into a wide lumen (internal space), the first straight portion (second DC electrode group) on the distal end side of the second curved portion is separated from the inner wall (for example, the right atrium of the right atrium). It is possible to contact or approach the front inner wall.

(3) In the intracardiac defibrillation catheter of the present invention, the first DC electrode group is positioned in the coronary sinus and the second DC electrode is positioned in the right atrium so as to be positioned in the right atrium. Is preferred.

As a result, the defibrillation catheter is disposed so as to sandwich the heart between the first DC electrode group attached to the first curved portion and the second DC electrode group attached to the first straight portion.
Since the first curved portion is formed in the distal end region of the tube member, the distal end of the catheter inserted from the superior vena cava into the right atrium is coronally formed by rotating the handle around the axis when inserting the catheter. Can be directed to the sinus ostium.

  If the bending direction of the first curved portion is determined according to the shape of the second curved portion, the catheter is advanced along the bending direction (the direction in which the distal end of the catheter is directed), and the first curved portion is By inserting the coronary sinus into the coronary sinus, the first curved portion (first DC electrode group) is positioned in the coronary sinus after the insertion, and the first straight portion (second DC electrode group) is placed on the front inner wall of the right atrium. It can abut or be in close proximity.

  In addition, by changing the curved shape of the first curved portion by operating the handle (further bending and changing the degree of bending), the distal end portion of the catheter inserted from the superior vena cava into the right atrium is used as the coronary sinus ostium. Can be easily guided (finding the location of the coronary sinus ostium). Further, by changing the degree of curvature of the first curved portion along the shape of the coronary sinus by the operation of the handle, the first curved portion is changed in the coronary sinus having a different position or shape depending on age or sex. It can be pushed easily.

  By forming an S-shaped (sigmoid curve-shaped) second curved portion on a plane different from the plane including the first curved portion on the base end side from the second DC electrode group, the superior vena cava When inserting into the coronary sinus ostium on the posterior lower wall of the right atrium, the first straight line portion (second DC electrode group) on the distal end side of the second curved portion is brought into contact with or close to the front inner wall of the right atrium. it can.

(4) In this intracardiac defibrillation catheter, it is preferable that the plane including the first curved portion and the plane including the second curved portion are orthogonal to each other.

  Since the coronary sinus extends horizontally along the boundary between the left atrium and the left ventricle on the left posterior surface of the heart, when the first curved portion (first DC electrode group) is inserted into the coronary sinus, The first straight line portion (second DC electrode group) and the second curved portion on the proximal end side of the first curved portion can be positioned vertically along the inner wall of the right atrium, whereby the front side of the right atrium It becomes possible to contact or approach the inner wall.

(5) In this intracardiac defibrillation catheter, when the first straight portion is viewed from a position on the near side of the second straight portion, the first curved portion is curved leftward. preferable.

  With such a shape, when the first curved portion (first DC electrode group) is inserted into the coronary sinus, the first straight portion to which the second DC electrode group is attached extends from the superior vena cava. Since the two straight portions can be offset forward, the first curved portion (first DC electrode group) is positioned in the coronary sinus and the first straight portion (second DC electrode group) after insertion of the catheter. ) Can be brought into contact or close to the anterior inner wall of the right atrium.

(6) In the intracardiac defibrillation catheter of the present invention, it is preferably disposed in the heart chamber in order to remove atrial fibrillation that occurs during cardiac catheterization.

Since the intracardiac defibrillation catheter of the present invention has the first curved portion formed by bending the distal end portion, the operability is good, and the target site (for example, at the time of insertion into the heart chamber) The tip of the catheter can be easily guided to the coronary sinus ostium, and the inner wall of the blood vessel is not damaged.
In addition, since the S-shaped (sigmoid curve-shaped) second curved portion is provided on the proximal end side of the first straight portion (second DC electrode group), the defibrillation catheter can be relatively moved via the blood vessel. Even when inserting into a large lumen (internal space), the first straight portion (second DC electrode group) is in contact with or close to the inner wall (for example, the front inner wall of the right atrium) that defines the lumen. Can be made.
Furthermore, by changing the curved shape of the first bending portion by the handle operation, the distal end portion to which the first DC electrode group is mounted can be easily pushed even in a thin and curved blood vessel (for example, a coronary sinus). it can.

The intracardiac defibrillation catheter of the present invention, which is disposed in the heart chamber so that the first DC electrode group is located in the coronary sinus and the second DC electrode group is located in the right atrium, has the first bending portion. By having it, the operability is good, and when inserting into the heart chamber, the distal end portion of the catheter can be easily guided to the coronary sinus ostium opening in the posterior lower wall of the right atrium, the inner wall of the blood vessel etc. Will not hurt.
In addition, by having the S-shaped (sigmoid curve) second curve portion, when this defibrillation catheter is inserted from the superior vena cava into the coronary sinus ostium in the posterior lower wall of the right atrium, The first straight portion (second DC electrode group) can be brought into contact with or close to the front inner wall of the right atrium.
Furthermore, by changing the bending shape of the first bending portion by the handle operation, the distal end portion to which the first DC electrode group is attached can be easily pushed in the coronary sinus.

It is explanatory drawing which shows one Embodiment of the defibrillation catheter of this invention, (1) is a front view, (2) is a top view [AA arrow line view of (1)]. It is explanatory drawing which shows the front-end | tip area | region of the defibrillation catheter shown in FIG. 1, (1) is a front view, (2) is a top view [BB arrow view of (1)]. It is a cross-sectional view which shows CC cross section of FIG. 1 (1). FIG. 3 is a plan view showing a state where the curved shape of the first curved portion is changed by a handle operation in the defibrillation catheter shown in FIG. 1. It is explanatory drawing which shows the state which inserted the defibrillation catheter shown in FIG. 1 in the heart chamber. It is an electric potential waveform diagram measured when predetermined | prescribed electric energy is provided with the defibrillation catheter shown in FIG. It is explanatory drawing which shows the state which inserted the conventional defibrillation catheter in the heart chamber.

Hereinafter, an embodiment of the present invention will be described.
The defibrillation catheter 100 of the present embodiment is a first DC comprising a multi-lumen tube 10, a handle 20 connected to the proximal end thereof, and eight ring-shaped electrodes 31 attached to the distal end region of the multi-lumen tube 10. An electrode group 31G, a second DC electrode group 32G composed of eight ring-shaped electrodes 32 mounted on the distal end region of the multi-lumen tube 10 and spaced from the first DC electrode group 31G to the proximal end side, and the first DC electrode group 31G And the second DC electrode group 32G, four ring-shaped electrodes 33 for potential measurement, and a tip 35 attached to the tip of the multi-lumen tube 10, and the first DC electrode group 31G A catheter that performs defibrillation in the heart chamber by applying voltages of different polarities to the second DC electrode group 32G; The tube 10 includes a first curved portion 101 having a curved tip portion to which the first DC electrode group 31G is mounted, a first straight portion 102 to which the second DC electrode group 32G is mounted, and a first curved portion 101. The S-shaped (sigmoid curve-shaped) second curved line portion 103 on the plane orthogonal to the plane is connected to the second straight line portion 104 reaching the base end; the first straight line portion 102 is the second straight line portion 104. When viewed from a position closer to the front, the first curved portion 101 is curved to the left side, and the curved shape (degree of bending) of the first curved portion 101 is changed by the operation of the handle 20. The defibrillation catheter 100 is disposed in the heart chamber 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.

  The multi-lumen tube 10 (insulating tube member having a multi-lumen structure) constituting the defibrillation catheter 100 of the present embodiment includes a first curved portion 101, a first straight portion 102, a second curved portion 103, and the like. The second linear portion 104 is connected to form a three-dimensional shape. In FIG. 1, a part of the multi-lumen tube 10 (second linear portion 104) in the length direction is omitted and is illustrated in a short form. The first curved portion 101, the first straight portion 102, and the second curved portion 103 belong to the tip region of the multi-lumen tube 10.

The first curved portion 101 of the multi-lumen tube 10 is formed by bending the tip portion to which the first DC electrode group 31G is attached.
The first curve portion 101 is equipped with two potential measurement electrodes together with the first DC electrode group 31G.

  As a bending direction of the first curved portion 101 (a direction in which the distal end of the defibrillation catheter 100 is directed), the first straight portion 102 is viewed from a position in front of the second straight portion 104, that is, FIG. It is “left side” (left curve) in plan view as shown in (2) and FIG. 2 (2).

The first curved portion 101 is formed by forming the end portion of the multi-lumen tube 10 in a curved line shape such as an arc.
When the 1st curve part 101 is circular arc shape, the curvature radius (R) shall be 15-40 mm, for example, and a center angle ((theta)) will be 70-120 degrees, for example.
The first curved portion 101 may be formed by connecting a plurality of arcs having different curvatures. In this case, the first curved portion 101 may include a relaxation curve or a short straight line connecting adjacent arcs. The length of the 1st curve part 101 shall be 70-90 mm normally, and if it shows a suitable example, it will be 75 mm.
The curved shape (the degree of bending) of the first curved portion 101 can be changed (further bent) by operating the handle 20.

  A second DC electrode group 32G and two potential measurement electrodes 33 are attached to the first straight line portion 102 on the proximal end side of the first curved portion 101. The length of the 1st straight part 102 shall be 60-90 mm normally, and will be 80 mm if a suitable example is shown.

The second curved line portion 103 on the proximal end side of the first straight line portion 102 is an S-shaped (sigmoid curved line) portion on a plane orthogonal to the plane including the first curved line portion 101.
The second curved portion 103 is formed in an S shape (sigmoid curved shape) by two curved portions (angles) that are curved in opposite directions. A short straight line portion may be included between the two curved portions.
The second curved portion 103 forms a step (G) between the first straight portion 102 on the distal end side thereof and the second straight portion 104 on the proximal end side of the second curved portion 103.
The length of the 2nd curve part 103 shall be 30-60 mm normally, and if it shows a suitable example, it is 50 mm. The magnitude | size of the level | step difference (G) formed by the 2nd curve part 103 shall be 15-25 mm normally, and will be 20 mm if a suitable example is shown.
Note that the shape of the second curved portion 103 does not substantially change even when the handle 20 is operated.

  The second straight line portion 104 on the proximal end side of the second curved line portion 103 is a straight line portion that reaches the proximal end of the multi-lumen tube 10. The length of the 2nd straight part 104 shall be 400-600 mm normally, and if it shows a suitable example, it will be 500 mm.

  The shape of the multi-lumen tube 10 shown in FIGS. 1 and 2 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, Normally, the first curved portion 101 and the second curved portion 103 are linearly deformed, and when the multi-lumen tube 10 is passed through a curved lumen, the first straight portion 102 and the second straight portion 104 are usually Curves according to the shape of the lumen.

As shown in FIG. 3, the multi-lumen tube 10 is formed with four lumens (first lumen 11, second lumen 12, third lumen 13, and fourth lumen 14).
In FIG. 3, 15 is a fluororesin layer that defines a lumen, 16 is an inner (core) portion made of a low-hardness nylon elastomer, 17 is an outer (shell) portion made of a high-hardness nylon elastomer, Is a stainless steel wire forming a braided blade.

  The fluororesin layer 15 partitioning the lumen is made of a highly insulating material such as perfluoroalkyl vinyl ether copolymer (PFA) or polytetrafluoroethylene (PTFE).

  The nylon elastomer that forms the outer portion 17 of the multi-lumen tube 10 has a hardness that varies depending on the axial direction. Thereby, the multi-lumen tube 10 is comprised so that hardness may become high in steps toward the base end side from the front end side.

  The braided blade composed of the stainless steel wire 18 is provided between the inner portion 16 and the outer portion 17 in a portion excluding the tip region. The outer diameter of the multi-lumen tube 10 is, for example, 1.2 to 3.3 mm.

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 bending shape (the degree of bending) of the first curved portion 101 of the multi-lumen tube 10 can be changed.

A first DC electrode group 31G and a second DC electrode group 32G are attached to the outer periphery (the first curved portion 101 and the first straight portion 102) of the multi-lumen tube 10.
In the present invention, the “electrode group” refers to a plurality of electrodes constituting the same pole (having the same polarity) or having the same purpose and mounted at a narrow interval (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 a narrow interval in the first curved portion 101 of the multi-lumen tube. Here, the number of electrodes constituting the first DC electrode group varies depending on the width and arrangement interval of the electrodes, but is 4 to 13, for example, and preferably 8 to 10.

In the present embodiment, the first DC electrode group 31 </ b> G includes eight ring-shaped electrodes 31 attached to the first curved portion 101 of the multi-lumen tube 10.
The electrode 31 constituting the first DC electrode group 31G is connected to a DC power supply via a lead wire (lead wire 41 constituting the first lead wire group 41G shown in FIG. 3) and a connector built in the proximal end portion of the handle 20. It is connected to the terminal of the same pole in the device.

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

The mounting interval of the electrodes 31 (the distance between adjacent electrodes) is preferably 1 to 5 mm, and 2 mm if a suitable example is shown.
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.

  The second DC electrode group is spaced from the mounting position of the first DC electrode group of the multi-lumen tube toward the base end side, and a plurality of electrodes constituting the opposite pole (+ pole or −pole) to the first DC electrode group are narrow. Installed at intervals. Here, the number of electrodes constituting the second DC electrode group varies depending on the width and arrangement interval of the electrodes, but is 4 to 13, for example, and preferably 8 to 10.

In the present embodiment, the second DC electrode group 32G includes eight ring-shaped electrodes 32 that are mounted on the first straight portion 102 of the multi-lumen tube 10 so as to be spaced apart from the mounting position of the first DC electrode group 31G toward the proximal end side. It is configured.
The electrode 32 constituting the second DC electrode group 32G is connected to a DC power source via a lead wire (lead wire 42 constituting the second lead wire group 42G shown in FIG. 3) and a connector built in the proximal end portion of the handle 20. It is connected to a terminal of the same pole in the device (a terminal of a pole opposite to that to which the first DC electrode group 31G is connected).
Thereby, voltages having different polarities are applied to the first DC electrode group 31G (electrode 31) and the second DC electrode group 32G (electrode 32), and the first DC electrode group 31G and the second DC electrode group 32G are: The electrode groups have different polarities (when one electrode group is a negative electrode, the other electrode group is a positive electrode).

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

The mounting interval of the electrodes 32 (the distance between adjacent electrodes) is preferably 1 to 5 mm, and 2 mm if a suitable example is shown.
When the intracardiac defibrillation catheter 100 is used (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.

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 electrodes 33 used for potential measurement are mounted.
As shown in FIGS. 1 and 2, two electrodes 33 for potential measurement are mounted on each of the first curved portion 101 and the first straight portion 102 of the multi-lumen tube 10.
The electrode 33 is connected to the electrocardiograph via a lead wire (lead wire 43 shown in FIG. 3) and a connector built in the proximal 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 1.2 mm if a suitable example is shown.
If the width of the electrode 33 is too wide, the measurement accuracy of the cardiac potential is lowered, or it is difficult to specify the site where the abnormal potential is generated.

A distal tip 35 is attached to the distal end of the intracardiac defibrillation catheter 100.
A lead wire is not connected to the tip chip 35 and is not used as an electrode in this embodiment. However, it can also be used as an electrode by connecting a lead wire. The constituent material of the tip 35 is not particularly limited, such as metal materials such as platinum and stainless steel, various resin materials, and the like.

  The distance between the first DC electrode group 31G (base end side electrode 31) and the second DC electrode group 32G (tip end side electrode 32) is preferably 40 to 100 mm, and 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, in order to improve the contrast property for X-rays, It is preferably made of an alloy.

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

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

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

  The eight electrodes 32 constituting the second DC electrode group 32G are connected to different lead wires 42, respectively. Each of the lead wires 42 is welded to the inner peripheral surface of the electrode 32 at the tip portion thereof, and the second lumen 12 (the first lead wire group 41G extends from the side hole formed in the tube wall of the multi-lumen tube 10. A different lumen from the existing first lumen 11 is entered. The eight lead wires 42 that have entered the second lumen 12 extend to the second lumen 12 as a second lead wire group 42G.

  As described above, the first lead wire group 41G extends to the first lumen 11 and the second lead wire group 42G extends to the second lumen 12. Fully insulated and isolated. Therefore, when a voltage necessary for defibrillation is applied, a short circuit between the first lead wire group 41G (first DC electrode group 31G) and the second lead wire group 42G (second DC electrode group 32G). Can be reliably prevented.

  The four lead wires 43 shown in FIG. 3 are connected to each of the electrodes 33 for potential measurement. Each of the electrodes 33 can be connected to an electrocardiograph by a 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 lumen 13 from the side hole formed in the tube wall of the multi-lumen tube 10, and enters the third lumen 13. Extend.

  As described above, the lead wire 43 extending to the third lumen 13 is completely insulated and isolated from both the first lead wire group 41G and the second lead wire group 42G. For this reason, when a voltage necessary for defibrillation is applied, the lead wire 43 (potential measurement electrode 33) and the first lead wire group 41G (first DC electrode group 31G) or the second lead wire group 42G. A short circuit with (second DC electrode group 32G) can be reliably prevented.

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

In FIG. 3, 51 is a pull wire.
The pull wire 51 extends to the fourth lumen 14 and extends eccentrically with respect to the central axis of the multi-lumen tube 10.

The tip end portion of the pull wire 51 is fixed to the tip tip 35 with solder.
On the other hand, the proximal end portion of the pull wire 51 is connected to the knob 22 of the handle 20, and the pull wire 51 is pulled by operating the knob 22. Thereby, the curve shape (degree of curve) of the 1st curve part 101 of the multi-lumen tube 10 can be changed. Specifically, when the knob 22 of the handle 20 is rotated counterclockwise from the state shown in FIG. 1 (2), the first curved portion 101 curved to the left side (lower side in the figure) As shown in FIG. 4, it further curves to the left (the curvature of the first curved portion 101 increases).

The pull wire 51 is made of stainless steel or a Ni—Ti superelastic alloy, but is not necessarily made of metal. The pull wire 51 may be composed of, for example, a high-strength non-conductive wire.
Note that the mechanism for deflecting the distal end portion of the multi-lumen tube is not limited to this, and may be a plate spring, for example.

  In the fourth lumen 14 of the multi-lumen tube 10, only the pull wire 51 extends, and the lead wire (group) does not extend. Thereby, it is possible to prevent the lead wire from being damaged (for example, scratched) by the pull wire 51 moving in the axial direction during the deflection operation of the distal end 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 preferable that it is isolated.

  The defibrillation catheter 100 of the present embodiment directly applies electrical energy to the heart that is causing fibrillation by applying a DC voltage between the first DC electrode group 31G and the second DC electrode group 32G. It is a catheter for performing defibrillation treatment.

  The defibrillation catheter 100 of this embodiment is disposed in the heart chamber 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 arrange in such a state, the defibrillation catheter 100 of the present embodiment is first inserted into the right atrium from the superior vena cava and further inserted into the coronary sinus ostium in the posterior lower wall of the right atrium. Advance in the coronary sinus.

Since the multi-lumen tube 10 constituting the defibrillation catheter 100 of the present embodiment has the first curved portion 101 whose tip portion is curved, the handle 20 is pivoted when inserted into the heart chamber. By rotating around, the tip of the defibrillation catheter 100 inserted into the right atrium from the superior vena cava can be directed to the coronary sinus ostium.
Further, by changing (further bending) the curved shape of the first curved portion 101 by operating the handle 20, the distal end portion of the defibrillation catheter 100 inserted into the right atrium from the superior vena cava is used as the coronary sinus ostium. Can be easily guided (finding the location of the coronary sinus ostium in the right atrium).
Further, by changing the degree of curvature of the first curved portion 101 along the shape of the coronary sinus by the operation of the handle 20, in the coronary sinus having a different position and shape depending on age, sex, etc. The curved portion 101 can be easily pushed forward.

  The multi-lumen tube 10 has an S-shaped (sigmoid curve-shaped) second curved portion 103 on a plane orthogonal to the plane including the first curved portion 101, and the multi-lumen tube 10 is made to have the first straight portion 102. 5 when viewed from a position on the front side of the second straight line portion 104 (in a plan view as shown in FIG. 1B), the first curved portion 101 is bent to the left side, and therefore FIG. As shown in FIG. 5, when the first curved portion 101 (first DC electrode group 31G) of the multi-lumen tube 10 is positioned in the coronary sinus 83 extending in the left direction of the heart, the second straight portion 104 is in the superior vena cava. 81, and the second curved portion 103 is located on the inner wall from the superior vena cava 81 to the front side of the right atrium 82, whereby the first straight portion 102 (second DC electrode group 32G) is located in the right atrium 82. Abutting against the front inner wall It can be close to each other. As a result, it is possible to measure the potential on the front inner wall of the right atrium 82 where the flow of electricity is large, using the constituent electrodes 32 of the second DC electrode group 32G.

  The defibrillation catheter 100 of the present embodiment is suitably used when performing cardiac catheterization in which atrial fibrillation is likely to occur. Particularly preferably, the cardiac catheterization is performed after the intracardiac defibrillation catheter 100 is inserted into the heart chamber of the patient in advance.

  During cardiac catheterization, the 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 potential measurement is monitored (monitoring), and when atrial fibrillation occurs The cardiac catheterization is interrupted, and the defibrillation treatment using the defibrillation catheter 100 is performed. Specifically, a DC voltage is applied between the first DC electrode group 31G and the second DC electrode group 32G via the first lead wire group 41G and the second lead wire group 42G to cause fibrillation. Give electrical energy directly to the heart.

Here, the electrical energy supplied to the heart by the intracardiac defibrillation catheter 100 is preferably 10 to 30 J.
If the electrical energy is too low, sufficient defibrillation therapy cannot be performed. On the other hand, when the electrical energy is excessive, there is a risk that the surrounding tissue where the first DC electrode group 31G and the second DC electrode group 32G are located is damaged.

FIG. 6 is a diagram showing a potential waveform measured when predetermined electrical energy (for example, set output = 10 J) is applied by the intracardiac defibrillation catheter 100 of the present embodiment. In the figure, the horizontal axis represents time and the vertical axis represents potential.
First, a DC voltage is applied between the first DC electrode group 31G and the second DC electrode group 32G so that the first and second DC electrode groups 31G and 32G have a positive pole, whereby electric energy is supplied and the measurement potential rises (V ₁ is This is the peak voltage at this time.) After a certain time (t ₁ ) elapses, a DC voltage obtained by inverting ± is applied between the two so that the first DC electrode group 31G becomes a positive electrode and the second DC electrode group 32G becomes a negative electrode. When supplied, the measurement potential rises (V ₂ is the peak voltage at this time).
Here, the time (t ₁ ) is, for example, 1.5 to 10.0 seconds, and the measured peak voltage (V ₁ ) is, for example, 300 to 500V.

As mentioned above, although one Embodiment of this invention was described, the intracardiac defibrillation catheter of this invention is not limited to these, A various change is possible.
For example, the mounting position of the electrode 33 for potential measurement is not between the first DC electrode group 21G and the second DC electrode group 32G but on the distal end side with respect to the first DC electrode group 31G or the proximal end side with respect to the second DC electrode group 32G. It can also be installed.

100 Intracardiac defibrillation catheter 10 Multi-lumen tube 101 First curved portion 102 First straight portion 103 Second curved portion 104 Second straight portion 11 First lumen 12 Second lumen 13 Third lumen 14 Fourth Lumen 15 Fluorine resin layer 16 Inner (core) portion 17 Outer (shell) portion 18 Stainless steel wire 20 Handle 21 Handle body 22 Knob 24 Strain relief 31G First DC electrode group 31 Ring electrode 32G Second DC electrode group 32 Ring shape Electrode 33 Ring-shaped electrode 35 Tip tip 41G First lead wire group 41 Lead wire 42G Second lead wire group 42 Lead wire 43 Lead wire 51 Pull wire

Claims (6)

An insulating tube member, a handle connected to the proximal end of the tube member, a first electrode group comprising a plurality of ring-shaped electrodes attached to a distal end region of the tube member, and a base from the first electrode group And a second electrode group composed of a plurality of ring-shaped electrodes mounted on the distal end region of the tube member and spaced apart on the end side, the first electrode group and the second electrode group having different polarities A catheter that performs defibrillation in the heart chamber by applying a voltage,
A first curved portion formed by bending a distal end portion to which the first electrode group is mounted in a distal end region of the tube member;
An S-shaped second curved portion that is on a plane different from the plane including the first curved portion is formed on the base end side of the second electrode group,
An intracardiac defibrillation catheter, wherein the curved shape of the first curved portion is changed by the operation of the handle.   The tube member includes the first curved portion to which the first electrode group is attached, the first straight portion to which the second electrode group is attached, the second curved portion, and a second straight line that reaches the proximal end. The intracardiac defibrillation catheter according to claim 1, wherein the catheter is connected to a portion.   The intracardiac defibrillation according to claim 2, wherein the first electrode group is located in the coronary sinus and the second electrode group is disposed in the heart chamber so as to be located in the right atrium. Arterial catheter.   The intracardiac defibrillation catheter according to claim 3, wherein a plane including the first curved portion and a plane including the second curved portion are orthogonal to each other.   5. The intracardiac chamber removal according to claim 4, wherein the first curved portion is curved leftward when the first straight portion is viewed from a position closer to the front than the second straight portion. Fibrillation catheter.   6. An intracardiac defibrillation catheter according to claim 5, wherein the catheter is placed in the heart chamber to remove atrial fibrillation that occurs during cardiac catheterization.

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